(Please refer to the full SmPC before prescribing)
Indication: Symptomatic treatment of severe sialorrhoea in adolescents and children over three years of age, with chronic neurological disorders. Not recommended for children younger than three years of age. Should be prescribed by physicians experienced in the treatment of neurological disorders. Dosage & Administration: Oral tablets; can be divided into equal doses. Weight-based dosing schedule – initiation: 0.02mg/kg three times daily; modification: titrated in increments of 0.02mg/kg per week depending on therapeutic response and tolerability; maximum: 0.1mg/kg three times daily, not to exceed 1.5–3mg per dose. Other formulations are available for doses which cannot be achieved with tablet format, or for patients unable to swallow tablets. Following dose titration, monitor efficacy/tolerability at least every 3 months. Contraindications: Hypersensitivity to glycopyrronium bromide or any of the excipients. Glaucoma. Urinary retention. Severe renal impairment (estimated glomerular filtration rate [eGFR] <30ml/min/1.73m2, including those with end stage renal disease requiring dialysis). History of intestinal obstruction, ulcerative colitis, paralytic ileus, pyloric stenosis or myasthenia gravis. Pregnancy or breast-feeding. Concomitant treatment with potassium chloride (solid oral dose) or anticholinergics. Precautions and Warnings: Indicated for paediatric use only. Limited data are available on the use of glycopyrronium in adults with pathological drooling; should not be used in patients over 65 years of age. Co-administration with food markedly reduces systemic exposure; administer ≥1 hour prior or ≥2 hours following meals, or at consistent times with respect to food intake; avoid high fat food. If co-administration with food is required, dosing should be consistently performed during food intake. 30% dose reduction required for patients with mild to moderate renal impairment (eGFR <90 – ≥30ml/min/1.73m2). Hepatic impairment is not thought to result in clinically relevant increases in systemic exposure, however, clinical studies have not been conducted in this setting. Anticholinergic effects may be dose dependent and difficult to assess in a disabled child; advise carer to stop treatment and seek advice in the event of: constipation, urinary retention, pneumonia, allergic reaction, pyrexia, very hot weather, changes in behaviour – following evaluation, prescriber to decide if dose reduction or discontinuation are appropriate (discontinue if pneumonia is present). Published safety data for long-term use (>24 weeks) are not available; recommended for short-term intermittent use, total treatment duration should be kept as short as possible. Benefit-risk should be carefully considered, and patients closely monitored, in cases of continuous or repeated intermittent use. Should not be administered to children with mild to moderate sialorrhoea. Use with caution in patients with gastro-oesophageal reflux disease, pre-existing constipation, diarrhoea, compromised blood brain barrier (intraventicular shunt, brain tumour, encephalitis), acute myocardial infarction, hypertension, coronary artery disease, cardiac arrhythmias and conditions characterised by tachycardia (including thyrotoxicosis, cardiac insufficiency, cardiac surgery); advise carer to measure pulse rate if the child seems unwell, and to report occurrences of very fast or very slow heart rate. Patients should receive adequate daily dental hygiene and regular dental health checks. Behavioural changes should be monitored. Not suitable for patients with rare hereditary problems of galactose intolerance, the total lactase deficiency, glucose-galactose malabsorption or fructose intolerance. No short or long-term effects on neurodevelopment or growth have been reported, however, no studies have been conducted to specifically address these issues, or effects on the reproductive system. Interactions: No interaction studies have been performed. Cautious consideration (and dose adjustment, where appropriate) required prior to concomitant use of: antispasmodics, topiramate, sedating antihistamines, neuroleptics/antipsychotics, skeletal muscle relaxants, tricyclic antidepressants and monoamine oxidase inhibitors, opioids, corticosteroids. Medicinal products with anticholinergic properties may cause cumulative parasympatholytic effects, including: dry mouth, urinary retention, constipation and confusion, and an increased risk of anticholinergic intoxication syndrome. Fertility, Pregnancy and Lactation: No data are available on the effects of glycopyrronium bromide tablets on male or female fertility; murine (rat) data indicate decreased rates of conception and survival at weaning. Insufficient data available in the public domain to adequately assess effects on the reproductive system in young adults. Contraindicated during pregnancy (no data available in this setting) and breast-feeding (safety in breast-feeding has not been established); women of child-bearing potential should consider effective contraception, where appropriate. Effects on ability to drive and use machinery: Moderate influence – glycopyrronium may cause blurred vision, dizziness and other effects that may impair a patient’s ability to perform skilled tasks (such as driving, riding a bicycle or using machinery); these undesirable effects are increased with increasing dose. Adverse Events: Adverse reactions are more common with higher doses and prolonged use. The most common (incidence ≥15%) anticholinergic adverse reactions reported during placebo-controlled studies were gastrointestinal events: dry mouth, constipation, diarrhoea and vomiting; other anticholinergic-related events occurring in ≥15% of patients included: urinary retention, flushing, and nasal congestion. Very common (≥1/10): irritability, flushing, nasal congestion, reduced bronchial secretions, dry mouth, constipation, diarrhoea, vomiting, urinary retention. Common (≥1/100 to <1/10): upper respiratory tract infection, pneumonia, urinary tract infection, agitation, drowsiness, epistaxis, rash, pyrexia. Overdose: Overdose can result in anticholinergic syndrome; clinical manifestations are caused by CNS effects and/or peripheral nervous system effects. Patients/caregivers should be counselled to ensure accurate dosing to prevent anticholinergic reactions due to overdose or dosing errors. Please refer to relevant SmPC for full information on adverse events (including those of uncommon, rare, very rare or unknown frequency), overdose, and guidance on the management of selected adverse reactions and overdose. Legal Category: POM. Price: 30 tablets: 1mg £79.00; 2mg £123.00. Marketing Authorisation Number: 1mg PL20117/0094; 2mg PL20117/0095. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK. Date reviewed: November 2024. Version number 10103111712 v 2.0
MAT-UK-XLP-0038-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: Schizophrenia; moderate to severe manic and major depressive episodes in bipolar disorder; prevention of recurrence of manic or depressed episodes in bipolar patients who have previously responded to quetiapine treatment; add-on treatment of major depressive episodes in patients with major depressive disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. Available strengths: 50, 150, 200, 300, 400mg (x60 tablets) and 600mg (x30 tablets). Dosage: Schizophrenia, moderate to severe manic episodes in bipolar disorder: Administer at least one hour before meal. 300mg day 1, 600mg day 2; recommended daily dose 600mg; max dose 800mg daily. Adjust dose within the effective dose range of 400mg to 800mg per day, depending on clinical response and tolerability. No dosage adjustment necessary for maintenance therapy in schizophrenia. Major depressive episodes in bipolar disorder: Administer at bedtime. 50mg day 1; 100mg day 2; 200mg day 3, 300mg day 4. Recommended daily dose 300mg; Doses over 300mg at experienced physician’s discretion. Preventing recurrence in bipolar disorder: Continue on the same dose between 300-800mg at bedtime. Use the lowest effective dose for maintenance therapy. For add-on treatment of major depressive episodes in MDD: Administer prior to bedtime. 50mg (day 1 & 2), 150mg (day 3 & 4), dose may be increased to 300mg/day on individual patient evaluation. Maintain at lowest effective dose. Elderly: use with caution, especially during initial dosing period. Start on 50mg/day and increase in 50mg/day increments to an effective dose. In elderly patients with major depressive episodes in MDD, 50mg/day day 1-3, 100mg/day day 4, 150mg/day day 8. Use the lowest effective dose. Based on individual patient, if dose increase to 300mg/day is required, this should not be before day 22. Efficacy and safety not evaluated in bipolar patients over 65 with depressive episodes. Paediatric Population: Biquelle XL is not recommended in children and adolescents below 18 years. Hepatic impairment: use with caution in patients with known hepatic impairment, especially during initial dosing period. Start on 50mg/day and increase in increments of 50mg/day to an effective dose. Renal impairment: No dose adjustment necessary. Administration: Once daily without food. Swallow tablets whole – do not split, chew, or crush. Patients on quetiapine immediate-release tablets may be switched to quetiapine prolonged-release tablets at equivalent total daily dosage taken once daily. Individual dose adjustments may be necessary. Contraindications: Patients with hypersensitivity to active substance or excipients; concomitant use of cytochrome P450 CYP 3A4 inhibitors (e.g., HIV protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin, nefazodone). Special warnings and precautions for use:. Long-term efficacy and safety in MDD patients has been evaluated as monotherapy but not as add-on therapy. Not recommended for use in children and adolescents <18 years old due to lack of data. Closely supervise and monitor patients, especially those at high risk, for worsening suicidal behaviour/thoughts and unusual changes in behaviour, particularly in early treatment and after dose changes. Consider potential risk of suicide-related events after abrupt cessation of quetiapine treatment. Assess metabolic parameters at initiation of and regularly throughout treatment – monitor and manage any weight gain and any lipid changes; observe for signs and symptoms of hyperglycaemia; diabetic patients and those at risk for diabetes mellitus should be monitored regularly for worsening glucose control; consider dose reduction/ discontinuation if symptoms of tardive dyskinesia appear– symptoms can worsen or even arise after treatment discontinuation; discontinue if neuroleptic malignant syndrome develops and treat appropriately; if akathisia develops (most likely in first weeks of treatment), increasing dose may be detrimental; if somnolence occurs, onset usually within first 3 days of treatment (may need to consider treatment discontinuation); orthostatic hypotension has been reported, usually during titration – can increase risk of falls, especially in elderly; caution in those with cardiovascular disease, risk factors for VTE, cerebrovascular disease, other conditions predisposing to hypotension, elderly patients with Parkinson’s disease/parkinsonism, patients receiving concomitant CNS depressants and those at risk for sleep apnoea (e.g. overweight/male), history of seizures, risk factors for neutropenia, concomitant use of medications with anti-cholinergic (muscarinic) effects, diagnosis or history of urinary retention, prostatic hypertrophy, intestinal obstruction related conditions, increased intraocular pressure/narrow angle glaucoma, family history of QT prolongation, risk factors for stroke, risk of aspiration pneumonia, history of alcohol or drug abuse. Caution when used with medicines known to cause electrolyte imbalance or increase QT interval, or with neuroleptics, especially in elderly, those with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia, hypomagnesaemia, or in combination with other centrally acting medicines or alcohol. In patients with suspected cardiomyopathy or myocarditis discontinuation of quetiapine should be considered. Concomitant administration with other serotonergic agents e.g. MAO inhibitors, SSRIs, SNRIs or tricyclic antidepressants may result in serotonin syndrome which can be potentially life-threatening. If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome suspected, consider dose reduction or discontinuation. Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalised Exanthematous Pustulosis (AGEP), Erythema Multiforme (EM) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which can be life threatening or fatal have been reported very rarely with quetiapine treatment. SCARs commonly present with one or more of the following symptoms: extensive cutaneous rash which may be pruritic or associated with pustules, exfoliative dermatitis, fever, lymphadenopathy, and possible eosinophilia or neutrophilia. Most of these reactions occurred within 4 weeks after initiation of quetiapine therapy, some DRESS reactions occurred within 6 weeks after initiation of quetiapine therapyIf signs and symptoms suggestive of these severe skin reactions appear, withdraw quetiapine immediately and consider alternative treatment. Constipation and intestinal obstruction have been reported, including fatalities in those at higher risk for obstruction including those taking multiple medicines that decrease intestinal motility and may not report constipation symptoms. Patients with intestinal obstruction/ileus should be managed with close monitoring and urgent care. Pancreatitis has been reported. Severe neutropenia has been reported, mostly within months of initiation. Discontinue if neutrophil count <1.0x109/L – monitor neutrophil count and for signs of infection. Consider neutropenia if infection or fever, especially if no predisposing factor. Advise to immediately report signs/symptoms of agranulocytosis/infection, promptly check white blood cell and absolute neutrophil count. Contains lactose; do not use if rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption. Interactions: Use with caution in combination with centrally acting medicines or alcohol. Use with caution in combination with serotonergic medicines e.g. MAO inhibitors, SSRIs, SNRIs, tricyclic antidepressants due to increased risk of serotonin syndrome. Concomitant use with CYP3A4 inhibitors contraindicated. Do not consume grapefruit juice. Use caution if patients are taking medicines with anti-cholinergic (muscarinic) effects. False positive results reported in enzyme immunoassays for methadone and tricyclic antidepressants. Recommend confirmation of questionable immunoassay screening results by an appropriate chromatographic technique. Hepatic enzyme inducers e.g. carbamazepine, phenytoin lead to increased clearance of quetiapine. If receiving a hepatic enzyme inducer, only initiate quetiapine if benefits outweigh risks of removing enzyme inducer. Any change in inducer must be gradual and if required, should be replaced with a non-inducer (e.g. sodium valproate). Data in combination with divalproex or lithium in manic episodes limited. A higher incidence of extrapyramidal events were observed with lithium and quetiapine vs placebo and quetiapine in a randomised 6 week study. Caution if used concomitantly with medicines known to cause electrolyte imbalances or increase the QT interval. Not approved for dementia-related psychosis. Advise gradual withdrawal over 1-2 weeks to avoid acute withdrawal symptoms. Pregnancy: Only use in pregnancy if benefits justify potential risks. If exposed to antipsychotics in third trimester, monitor newborns carefully for adverse events. Breastfeeding: Decide whether to discontinue breast-feeding or discontinue quetiapine taking into account benefit of breastfeeding for the child and benefit of therapy for the woman. Ability to drive and use machines: Advise patients not to drive or operate machinery until individual susceptibility to effects on mental alertness is known. Side effects: For full list of side effects consult SmPC. ‘Very Common’, ‘Common’ and ‘Serious’ side effects included in this prescribing information. Very common (≥1/10): decreased haemoglobin, elevations in serum triglycerides, elevations in total cholesterol (predominantly LDL), decreases in HDL cholesterol, weight gain, dizziness, somnolence, headache, extrapyramidal symptoms, dry mouth and withdrawal (discontinuation) symptoms. Common (≥1/100 to <1/10): leucopenia, decreased neutrophil count, eosinophils increased, hyperprolactinaemia, decreases in total T4, decreases in free T4, decreases in total T3, increases in TSH, increased appetite, increased blood glucose to hyperglycaemic levels, abnormal dreams and nightmares, suicidal ideation and suicidal behaviour, dysarthria, tachycardia, palpitations, blurred vision, orthostatic hypotension, dyspnoea, constipation, dyspepsia, vomiting, elevations in serum alanine aminotransferase, elevations in gamma-GT levels, mild asthenia, peripheral oedema, irritability, pyrexia. Serious uncommon: Neutropenia, thrombocytopenia, anaemia, decreased platelet count, hypersensitivity, hypothyroidism, hyponatraemia, diabetes mellitus, exacerbation of pre-existing diabetes mellitus, seizure, tardive dyskinesia, QT prolongation, bradycardia, dysphagia, raised serum aspartate aminotransferase, urinary retention; Serious rare: agranulocytosis, metabolic syndrome, venous thromboembolism, pancreatitis, intestinal obstruction/ileus, jaundice, hepatitis, priapism, neuroleptic malignant syndrome, raised blood creatine phosphokinase; Serious very rare: anaphylactic reaction, inappropriate ADH secretion, angioedema, Stevens Johnson Syndrome, rhabdomyolysis; Serious frequency unknown: cardiomyopathy, myocarditis, stroke, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), cutaneous vasculitis, Acute Generalised Exanthematous Pustulosis (AGEP), neonatal drug withdrawal syndrome. MA number: PL 35533/0051-55. Cost: £29.45 for 50mg, £49.45 for 150mg, £49.45 for 200mg, £74.45 for 300mg, £98.95 for 400mg (x60 pack), £70.73 for 600mg (x30 pack). MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Legal category: POM. Date last reviewed: November 2025. Version Number: MAT-UK-XLP-0003-1 | November 2025
MAT-UK-XLP-0039-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: Regular treatment of asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting β2 agonist. Available strengths: 25µg/50µg; 25µg/125µg & 25µg/250µg salmeterol/fluticasone per metered dose pressurised inhalation, suspension. Dosage and method of use: Inhalation use. Adults and adolescents 12 years and older: two inhalations twice daily. Children 4 years and older: two inhalations 25 µg/50 µg twice daily. Titrate to lowest dose at which effective control of symptoms is maintained and if long-term control maintained at lowest dose, consider testing inhaled corticosteroid alone or combination once daily. Combisal 25 µg /50 µg not appropriate for adults and children with severe asthma. Maximum licensed dose of fluticasone propionate in children is 100 µg twice daily. No data in children under 4 years. AeroChamber Plus® spacer device can be used. This may increase drug delivery to lungs with increase in risk of systemic adverse effects. Advise patients to rinse mouth out with water and spit out, and/or brush teeth after each dose of medicine to minimize risk of oropharyngeal candidiasis and hoarseness. Patients should be made aware that Combisal must be used daily for optimum benefit, even when asymptomatic. Contraindications: Hypersensitivity to active substance or excipients. Special warnings and precautions for use: Do not use to treat acute asthma for which fast- and short-acting bronchodilator required or initiate Combisal during an exacerbation, or if asthma is significantly worsening or acutely deteriorating. Serious asthma related adverse events and exacerbations may occur during treatment, ask patient to continue treatment but to seek medical advice if symptoms remain uncontrolled or worsen. Increased use of reliever medication, or decreased response to reliever medication, indicate deterioration of asthma control and should be reviewed by a physician. Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment. Once asthma symptoms are controlled, consider gradual dose reduction with regular review of the patient. The lowest effective dose of combisal should be used. Treatment should not be stopped abruptly. Use with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway; severe cardiovascular disorders or heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or predisposed to low levels of serum potassium. Discontinue if paradoxical bronchospasm occurs. Systemic effects may occur with ICS, including Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects. It is important the patient is reviewed regularly, and the dose of ICS is reduced to the lowest dose at which effective asthma control is maintained. Prolonged use of high doses of ICS may result in adrenal suppression and acute adrenal crisis. Consider additional systemic corticosteroid cover during periods of stress or elective surgery. Monitor patients transferring from oral steroids for impaired adrenal reserve. Avoid concomitant use with Ritonavir unless potential benefit outweighs the risk. Combisal is not indicated for use in the treatment of patients with COPD. Visual disturbance reported with steroid use – if blurred vision or other visual disturbances, consider referral to ophthalmologist for evaluation of possible causes e.g. cataract, glaucoma, central serous chorioretinopathy. If prolonged treatment in children, monitor height and ensure dose of inhaled steroid is lowest at which effective asthma control is maintained. Interactions: The following combinations should be avoided: Ritonavir, ketoconazole, itraconazole, cobicistat containing products or other potent CYP3A4 inhibitors, moderate CYP3A inhibitors e.g. erythromycin (if benefit outweighs risk, monitor for systemic steroid side effects); non- selective and selective β blockers; xanthine derivatives, steroids and diuretics in acute severe asthma. Other β adrenergic containing drugs can have an additive effect. Pregnancy & Lactation: Administer only if expected benefit to mother is greater than any possible risk to fetus. Discontinue breastfeeding or discontinue combisal therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Effects on ability to drive and use machines: No or negligible influence. Side effects: For full list of side effects consult SmPC. ‘Very Common’ and ‘Common’ side effects included in prescribing information. Very common (≥1/10) side effects: headache, nasopharyngitis. Common (≥1/100 to <1/10) side effects: candidiasis of mouth and throat, pneumonia, bronchitis, hypokalaemia, throat irritation, hoarseness/dysphonia, sinusitis, contusions, muscle cramps, traumatic fractures, arthralgia, myalgia. MA number: PL 36532/0001-0003. Cost: £13.50 for 25/50µg, £10.48 for 25/125µg, £13.99 for 25/250µg. MAH: Genetic S.p.A., Via G. Della Monica 26, 84083 Castel San Giorgio (SA), Italy. Distributed in the UK by: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG. Legal category: POM. Date reviewed: February 2025 Version number: 1010422348 v 8.0
MAT-UK-XLP-0040-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: Hypertension; stable angina pectoris. Dosage & Administration: Adjust dose based on individual response. Hypertension: initial and maintenance dose: 5mg once daily. Dose adjustments to 2.5mg or 10mg permitted per response, and additional antihypertensives may be added if necessary. Angina pectoris: initial dose: 5mg once daily. Dose increase to 10mg once daily permitted if required. Elderly: consider lowest available dose for initiation. Paediatric: limited data available – please see ‘Precautions, Warnings and Interactions’. Renal impairment: no dose adjustment required. Hepatic impairment: patients may respond to lower doses due to elevated felodipine plasma concentrations. Swallow whole with water in the morning, do not divide, crush, or chew. Administer without food or following a light meal low in fat/carbohydrate. Contraindications: Pregnancy; hypersensitivity to felodipine or any of the excipients; decompensated heart failure; acute myocardial infarction; unstable angina pectoris; haemodynamically significant cardiac valvular obstruction; dynamic cardiac outflow obstruction. Precautions, Warnings, and Interactions: May cause significant hypotension with subsequent tachycardia, which may lead to myocardial ischaemia in susceptible patients. Higher therapeutic concentrations and response in patients with clearly reduced liver function. Metabolised by CYP3A4 – avoid concomitant administration of CYP3A4 inducers (carbamazepine, phenytoin, phenobarbital, rifampicin, barbiturates, efavirenz, nevirapine, hypericum perforatum [St. John’s wort]), or inhibitors (itraconazole, erythromycin, cimetidine, ketoconazole, anti-HIV/protease inhibitors [ritonavir], and certain flavonoids present in grapefruit juice) as these extensively decrease or increase felodipine plasma levels, respectively; consider felodipine dose adjustment and discontinuation of CYP3A4 inducer/inhibitor in the event of reduced efficacy/clinically significant adverse events due to depressed/elevated felodipine exposure, respectively. Do not take in combination with grapefruit juice. May increase tacrolimus concentration – follow tacrolimus serum concentration and adjust dose as required when administered with felodipine. Not suitable for patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains castor oil – may cause stomach upset/diarrhoea. Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis – can be avoided/reversed with careful oral hygiene. Paediatrics: Long-term effects of felodipine on growth, puberty and general development have not been studied; long-term efficacy of paediatric antihypertensive therapy to reduce adult cardiovascular morbidity/mortality has not been established. Hypertensive emergencies: efficacy and safety has not been studied in this setting. Pregnancy and Lactation: Contraindicated in pregnancy – foetal developmental effects observed in non-clinical reproductive toxicity studies. Not recommended during breast feeding – detected in breast milk, insufficient data available on effect on infants. No data available on fertility impact. Effects on ability to drive and use machinery: Minor or moderate influence on ability to drive and use machinery; caution recommended especially at the start of treatment. Ability to react may be impaired in patients with headache, nausea, dizziness, or fatigue. Adverse Events: Most events are dose-dependent, transient (diminish with time), and appear at the start of treatment or after a dose increases. Very common (≥1/10): peripheral oedema. Common (≥1/100, <1/10): headache, flush. Felodipine can also cause palpitations, dizziness, and fatigue. Dose-dependent ankle swelling can occur due to precapillary vasodilatation (unrelated to generalised fluid retention). Overdose: May cause excessive peripheral vasodilation with marked hypotension and sometimes bradycardia. Please refer to SmPC for full information on adverse events (including those of uncommon, rare, or very rare frequency) and management of overdose. Legal Category: POM. Price: 28 tablets: 2.5mg £4.25; 5mg £1.98; 10mg £1.98. Marketing Authorisation Number: 2.5mg PL 20117/0397; 5mg PL 20117/0398; 10mg PL 20117/0399. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK. Date reviewed: November 2024 Version number: 101013111713 v 2.0
MAT-UK-XLP-0041-1 | June 2026
Contraindicated in female children and women of childbearing potential unless conditions of Pregnancy Prevention Programme (Prevent) are met. Only use Valproate in such individuals if other treatments are ineffective or not tolerated. Contraindicated in pregnancy unless no suitable alternative treatment. If patient becomes pregnant or is planning a pregnancy, immediately refer to specialist. Risk minimisation materials that form Prevent can be accessed here: https://www.gov.uk/guidance/valproate-use-by-women-and-girls
(Please refer to the full SmPC before prescribing)
Indications: Under 55: For all female and all male patients initiating valproate: Treatment of generalised, partial or other epilepsy only when there is no other effective or tolerated treatment. For all female patients aged over 55 years and male patients established on treatment with valproate or aged over 55 years: Treatment of generalised, partial or other epilepsy. Available strengths: 200, 300 and 500mg prolonged-release tablets x 14, 30, 48, 72, 90 or 100 tablets. Dosage: Adults: start 600mg daily, increase by 200mg at three-day intervals until controlled (usually 1000-2000mg/day). If control not achieved, can increase to 2500mg per day. Children over 20kg: Initial dose 400mg/day with spaced increases until controlled (usually 20-30mg/kg bodyweight per day). If control not achieved, can increase to 35mg/kg bodyweight per day. In children requiring >40mg/kg/day, monitor clinical chemistry and haematology. Children under 20kg: Use alternative formulation of sodium valproate. Elderly: Determine dose by seizure control. Renal impairment: May need to decrease dose in patients with renal insufficiency or to increase the dose in patients on haemodialysis. Valproate is dialysable. Adjust dose according to clinical monitoring. Hepatic impairment: Do not use salicylates concomitantly as they use same metabolic pathway. Liver dysfunction including fatal hepatic failure has occurred in patients whose treatment included valproic acid. Female children and women of childbearing potential aged under 55 years: Do not initiate new patients on valproate or prescribe unless two specialists independently consider and document there are no other effective/tolerated treatments. Must be supervised by a specialist. For existing patients, where possible, switch to another treatment unless two specialists independently consider and document there are no other effective/tolerated treatments. In patients continuing valproate, carefully reconsider benefits/risks regularly, at least annually. Must be prescribed and dispensed as per Valproate Pregnancy Prevention Programme. Preferably prescribe as monotherapy at lowest effective dose – divide daily dose into at least two single doses. Male children and men aged under 55 years: Do not initiate new patients on valproate unless two specialists independently consider and document there is no other effective/tolerated treatment, or the risk of infertility/potential risk of testicular toxicity are not applicable. Specialists should discuss and complete the risk acknowledgment form with the patient/carer at initiation to make them aware of the risk of infertility and data showing testicular toxicity in animals exposed to valproate. Combined therapy: Taper other anti-convulsants slowly then gradually initiate Dyzantil – target dose being reached after about 2 weeks. Might need to raise dose by 5-10mg/kg/day when used in combination with liver enzyme inducing anti-convulsants. Once known enzyme inducers withdrawn, a reduced Dyzantil dose may maintain seizure control. If barbiturates used concomitantly, reduce dose, especially if sedation observed (particularly in children). Administration: Oral administration, swallow whole; don’t crush/chew. Contraindications: Pregnancy unless two specialists independently consider and document there is no effective/tolerated alternative. Women of childbearing potential aged under 55 years, unless two specialists independently consider and document there is no other effective/tolerated treatment and conditions of pregnancy prevention programme fulfilled. These conditions apply to women who are not currently sexually active, unless there are compelling reasons to indicate there is no risk of pregnancy. Active liver disease. Personal/family history of severe hepatic dysfunction, especially drug related. Patients with urea cycle disorders. Hypersensitivity to sodium valproate, valproic acid or excipients. Porphyria. Patients with mitochondrial disorders due to mutations in the nuclear gene encoding mitochondrial enzyme polymerase γ (POLG) and in children under two suspected of having POLG-related disorder. Patients with uncorrected systemic primary carnitine deficiency. Special warnings and precautions for use: Blood cell count, bleeding time and coagulation tests recommended prior to initiation. Discontinue gradually under specialist supervision, monitor for sudden recurrence of symptoms. Generic switching of valproate preparations not normally recommended. Liver dysfunction: Severe liver damage including hepatic failure, sometimes fatal, reported very rarely – risk factors: under 3 years old, severe seizure disorders, organic brain disease and/or congenital metabolic disorders including mitochondrial disorders such as carnitine deficiency, urea cycle disorders, POLG mutations or degenerative disease associated with mental retardation. Avoid concomitant salicylates in those under 3 years due to liver toxicity risk; do not use salicylates in those under 16 years. Monotherapy advised in children under 3 years, weigh benefit against risk of liver damage or pancreatitis before initiation. Advise patients to monitor for clinical signs of liver damage, report immediately to a physician and withdraw drug. Measure liver function before therapy and periodically during first 6 months, especially in patients at risk and those with history of liver disease. On changes to concomitant medicinal products known to impact the liver, liver monitoring should be restarted. Terminate therapy (and concomitant salicylates) if abnormally low prothrombin rate with other abnormalities (decreased fibrinogen/coagulation factors; increased bilirubin/transaminases). Patients with known/suspected mitochondrial disease: May trigger/worsen clinical signs of mitochondrial disease caused by mutations of mitochondrial DNA as well as nuclear encoded POLG gene. May lead to acute liver failure and liver-related death. Consider POLG mutation testing if family history or suggestive symptoms. Pancreatitis: May be severe and fatal. Promptly evaluate (including serum amylase) patients with nausea, vomiting or acute abdominal pain. Risk factors: Young children, severe seizures, and neurological impairment with combination anti-convulsant therapy. Hepatic failure with pancreatitis increases risk of fatal outcome. In case of pancreatitis, discontinue valproate. Female children, females of childbearing potential under 55 and pregnant women: Inform patient that valproate has high teratogenic potential – children exposed in utero have a high risk of congenital malformations (11%) and neurodevelopment disorders (up to 30-40%) which may lead to permanent disability. Ensure the patient understands and acknowledges the risk of lower weight at birth for the gestational age for children exposed to valproate in utero. Females of childbearing potential must meet conditions of pregnancy prevention programme Make every effort to switch female children to alternative treatment before adulthood. Annually reassess those who have experienced menarche and consider alternative treatment options. Pregnancy must be excluded before valproate therapy initiated. Must use effective contraception without interruption during valproate therapy. Concomitant use with oestrogen-containing products may result in decreased valproate efficacy – monitor clinical response upon initiation/discontinuation. Review valproate treatment annually. Ensure Patient Guide and Card provided. If planning pregnancy, reassess and consider alternative treatment options. Make every effort to switch to alternative treatment prior to conception and before stopping contraception. If switching not possible, counsel woman on risks of valproate for unborn child. If pregnancy occurs, she must immediately contact her GP to be referred to a specialist to re-evaluate treatment. Discuss and complete an annual risk acknowledgement form with the patient/carer at treatment initiation and during each annual review by the specialist. Male children and men: All male patients and/or carers should be made aware of the potential risk to children born to men treated with valproate in the 3 months before conception, of the risk of infertility in men and of the data available showing testicular toxicity in animals exposed to valproate and the uncertain clinical relevance. A retrospective observational study suggests an increased risk of neuro-developmental disorders (NDDs) in children born to men treated with valproate in the 3 months prior to conception compared to those born to men treated with lamotrigine or levetiracetam. As a precautionary measure, GPs and specialists should inform male patients about this potential risk and recommend the need for male patients and their female partner to use effective contraception, while using valproate and for at least 3 months after treatment discontinuation. Male patients should not donate sperm during treatment or for at least 3 months after treatment discontinuation. Male patients treated with valproate should be regularly reviewed by their GP or specialist. For male patients planning to conceive a child, the specialist should consider and discuss other suitable treatment options with the male patients. Individual circumstances should be evaluated in each case. Educational materials are available for healthcare professionals and male patients. A patient guide should be provided to male patients using valproate. Males under 55 – at the initiation of treatment, the specialist should discuss and complete risk acknowledgement form to ensure all male children and men under 55 are aware of the potential risk to offspring and of the risk of infertility in males and testicular toxicity in animals. Aggravated convulsions: May see reversible worsening of convulsion frequency and severity (including status epilepticus), or onset of new types of convulsions with valproate – consult physician immediately if aggravated convulsions. Suicidal ideation and behaviour: Monitor for signs and behaviour – consider appropriate treatment. Severe Cutaneous Adverse Reactions (SCARS) and Angiodema: SCARS such as Steven-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme and angioedema have been reported in association with valproate treatment, monitor closely and inform patients about the signs and symptoms of serious skin manifestations. If signs and symptoms of SCARS or angioedema are observed, prompt assessment is needed and discontinue treatment if confirmed. Nervous System Disorders: Sedation occasionally occurs, usually when in combination with other anti-convulsants. Possible increase in alertness, occasionally aggression, hyperactivity, behavioural deterioration. Rarely lethargy occasionally progressing to stupor with hallucinations/convulsions. Encephalopathy and coma rarely reported – often with too high starting dose/too rapid dose escalation or concomitant use of other anti-convulsants. Usually reversible on treatment withdrawal/dose reduction. Carbapenem agents: Concomitant use not recommended. Tests: Blood tests recommended before initiation/before surgery/in case of spontaneous bruising/bleeding. Renal insufficiency: may be necessary to decrease dosage. Adjust according to clinical monitoring. Patients with systemic lupus erythematosus: Use on a benefit/risk basis. Urea cycle disorders and risk of hyperammonaemia: If urea cycle enzymatic deficiency suspected, perform metabolic investigations prior to treatment due to risk of hyperammonaemia which may occur without change in liver function tests and is usually transient. If vomiting, ataxia, clouding of consciousness occur, discontinue Dyzantil. Patients at risk of hypocarnitinaemia: valproate may trigger or worsen hypocarnitinaemia which can result in hyperammonaemia (that may lead to hyperammonaemic encephalopathy). Other symptoms such as liver toxicity, hypoketotic hypoglycaemia, myopathy including cardiomyopathy, rhabdomyolysis and Fanconi syndrome have been observed, mainly in patients with risk factors for or pre-existing hypocarnitinaemia. Risk factors: metabolic disorders including mitochondrial disorders related to carnitine, impaired carnitine nutritional uptake, patients younger than 10 years, concomitant use of pivalate-conjugated medicines or of other antiepileptics. Advise patients to immediately report signs such as ataxia, impaired consciousness and vomiting. Consider carnitine supplementation when hypocarnitinaemia symptoms observed. Valproate should only be used in patients with systemic primary carnitine deficiency and corrected hypocarnitinaemia if benefits outweigh risks and there is no therapeutic alternative. Implement carnitine monitoring in these patients. Warn patients with carnitine palmitoyltransferase (CPT) type II deficiency of greater risk of rhabdomyolysis, consider carnitine supplementation. Weight gain: factor for polycystic ovary syndrome, monitor weight increases. Warn patients that valproate commonly causes weight gain. Diabetic patients: Valproate eliminated mainly through kidneys partly as ketone bodies which may give false positive in urine testing of possible diabetics. Alcohol: Intake not recommended during therapy. Effects of valproate on other drugs: Valproate may potentiate effect of: antipsychotics e.g. olanzapine, MAO inhibitors, antidepressants, benzodiazepines, carbamazepine: monitor clinically and adjust doses as necessary – valproate may potentiate effect of other psychotropics. Valproate may decrease plasma concentrations of: olanzapine, total phenytoin. Valproate may increase plasma concentrations of: phenobarbital (reduce dose if sedation), primidone (monitor for adverse effects e.g. sedation and adjust dose as necessary), phenytoin free form (monitor for possible overdose symptoms), lamotrigine (monitor for lamotrigine toxicity and reduce lamotrigine dose as necessary), felbamate, rufinamide (caution in children), propofol (consider reducing propofol dose), zidovudine (monitor for toxicity), nimodipine (decrease nimodipine if hypotension) Effects of other drugs on valproate: Drugs leading to a decrease in valproate plasma concentrations: liver enzyme inducing antiepileptics (adjust dose according to clinical response and blood levels), mefloquine/chloroquine (may lower seizure threshold – adjust valproate dose), carbapenem antibiotics (avoid use – if cannot avoid, monitor valproic acid blood levels), rifampicin (adjust valproate dose), protease inhibitors e.g. lopinavir, ritonavir; cholestyramine, oestrogen-containing products, including contraceptives (monitor valproate serum levels), metamizole and methotrexate (monitor clinical response and valproate serum levels). Drugs leading to an increase in valproate plasma concentrations: felbamate (monitor valproate dose), highly protein bound agents e.g. aspirin, cimetidine, erythromycin. Valproic acid metabolite levels may increase with concomitant phenytoin or phenobarbital – monitor for hyperammonaemia. Anticoagulant effects of warfarin/other coumarin anticoagulants may be increased-monitor prothrombin time. Caution using concomitantly with newer antiepileptics whose pharmacodynamics not well known. Concomitant administration with topiramate or acetazolamide associated with encephalopathy and/or hyperammonaemia – monitor, especially if at-risk e.g. pre-existing encephalopathy. Concomitant use of salicylates should be avoided in children under 3 due to risk of liver toxicity. Concomitant use with pivalate-conjugated medicines increases risk of carnitine depletion and should be avoided, monitor for hypocarnitinaemia. Co-administration with quetiapine may increase risk of neutropenia/leucopenia. Concomitant use with multiple anticonvulsant therapy increases risk of liver damage, especially in young children. Concomitant use with cannabidiol increases the incidence of elevated liver transaminases. Monitor liver enzymes when valproate used with other anti-convulsants with potential hepatotoxicity including cannabidiol and consider dose reduction/discontinuation if significant liver parameter anomalies. Clozapine: Concomitant treatment of valproate and clozapine may increase the risk of neutropenia and clozapine-induced myocarditis. If concomitant use is necessary, careful monitoring for both events is required. Fertility, pregnancy and lactation: Contraindicated in pregnancy unless two specialists independently consider and document that there is no alternative (risk/benefit decision). Contraindicated in women of child-bearing potential under 55 unless two specialists independently consider and document that there is no alternative and that conditions of Pregnancy Prevention Programme fulfilled. Valproate monotherapy and polytherapy including other anti-epileptics – increased risk of major congenital malformations, developmental disorders, hearing impairment/deafness. If valproate-exposed pregnancy, refer by GP to a specialist for evaluation and counselling. If valproate taken during pregnancy, haemorrhagic syndrome, hypoglycaemia, hypothyroidism, withdrawal syndrome has been reported in neonates. In utero exposure to valproate can lead to a lower weight at birth for the gestational age. In preclinical studies a dose-related foetal weight decrease was demonstrated in animals exposed to valproate in utero compared to unexposed animals. Epidemiological studies have reported a decrease in mean birth weight, and higher risk of being born with a low birthweight (<2500 grams) or small gestational age (defined as birth weight below the 10th percentile corrected for their gestational age, stratified by gender) for children exposed to valproate in utero in comparison to unexposed or lamotrigine-exposed children. Available data in humans do not allow for a conclusion on a potential dose-related effect. Valproate excreted in breast milk, may cause haematological disorders in infants. Decide whether to discontinue breast-feeding or discontinue valproate. Amenorrhea, polycystic ovaries and increased testosterone reported in women taking valproate. May impair fertility in men. Fertility dysfunction is in some cases reversible at least 3 months after discontinuation. Dose reduction may improve fertility function. Males and potential risk of neuro-developmental disorders in children of fathers treated with valproate in the 3 months prior to conception. A retrospective observational study in 3 Nordic countries suggests an increased risk of neuro-developmental disorders (NDDs) in children (from 0 to 11 years old) born to men treated with valproate as monotherapy in the 3 months prior to conception compared to those born to men treated with lamotrigine or levetiracetam as monotherapy, with a pooled adjusted hazard ratio (HR) of 1.50 (95% CI: 1.09-2.07). The adjusted cumulative risk of NDDs ranged between 4.0% to 5.6% in the valproate group versus between 2.3% to 3.2% in the composite lamotrigine/levetiracetam group. The study was not large enough to investigate associations with specific NDD subtypes and study limitations included potential confounding by indication and differences in follow-up time between exposure groups. Overall, an increased risk of NDDs in children of fathers treated with valproate in the 3 months prior to conception is possible however the causal role of valproate is not confirmed. In addition, the study did not evaluate the risk of NDDs to children born to men stopping valproate for more than 3 months prior to conception (i.e., allowing a new spermatogenesis without valproate exposure). As a precautionary measure, GPs and specialists should inform male patients about this potential risk and recommend the need for male patients and their female partner to use effective contraception, while using valproate and for at least 3 months after treatment discontinuation. Male patients should not donate sperm during treatment or for at least 3 months after treatment discontinuation. Male patients treated with valproate should be regularly reviewed by their GP or specialist. For male patients planning to conceive a child, the specialist should consider and discuss other suitable treatment options with the male patients. Individual circumstances should be evaluated in each case. Effects on ability to drive/use machines: May cause transient drowsiness especially in cases of polytherapy or association with benzodiazepines. Undesirable effects: For full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects included in this prescribing information. Very common (≥1/10) Tremor, nausea. Common (≥1/100 to <1/10) Anaemia, thrombocytopenia, hyponatraemia, weight increase, confusional state, hallucinations, aggression, agitation, disturbance in attention, extrapyramidal disorder, stupor, somnolence, convulsion, memory impairment, headache, nystagmus, deafness, haemorrhage, vomiting, gingival disorder, stomatitis, gastralgia, diarrhoea, liver injury, increased liver enzymes, hypersensitivity, transient and/or dose related alopecia, nail and nail bed disorders, urinary incontinence, dysmenorrhea. Uncommon (≥1/1,000 to <1/100) serious side effects: Pancytopenia, leucopenia, SIADH, coma, encephalopathy, reversible parkinsonism, ataxia, paraesthesia, aggravated convulsions, vasculitis, pleural effusion (eosinophilic), pancreatitis (sometimes fatal), angioedema, osteoporosis, fractures, renal failure, peripheral oedema. Rare serious (≥1/10,000 to <1/1,000) side effects: Myelodysplastic syndrome, bone marrow failure, hypothyroidism, hyperammonaemia, psychomotor hyperactivity, learning disorder, reversible dementia associated with reversible cerebral atrophy, cognitive disorder, diplopia, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome, systemic lupus erythematosus, rhabdomyolysis, tubulointerstitial nephritis, reversible Fanconi syndrome, male infertility, polycystic ovaries, coagulation factors decreased, abnormal coagulation tests. Very rare (<1/10,000) serious side effects: Hepatic failure, sometimes fatal. Serious, frequency not known (cannot be estimated from the available data): hypocarnitinaemia, acquired Pelger-Huet anomaly, hyperpigmentation MA Number: PL35533/0152-0154 Cost: £2.45 for 200mg; £3.67 for 300mg & £6.11 500mg (x30 tablets). Preclinical safety data: In mice, rats, and rabbits, in utero exposure to valproate induced a dose-related decrease in foetal weight, intra-uterine growth restriction and reduction in crown rump length compared to unexposed animals. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG. Legal category: POM. Date reviewed: July 2025 Version number: 1010506966 v 9.0
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MAT-UK-XLP-0042-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: Symptomatic treatment of mild to moderately severe dementia of the Alzheimer type in adults. Available Strengths: 8, 16 and 24mg x 28 capsules. Dosage and method of use: Diagnosis of probable Alzheimer type dementia should be confirmed before starting treatment according to current clinical guidelines. Therapy should occur under supervision of a physician, and with an available carer who will regularly monitor treatment intake. Administer once daily in morning preferably with food, and swallow whole with liquid. Do not crush or chew capsules. Ensure adequate fluid intake during treatment. Recommended starting dose: 8mg/day for 4 weeks. Initial maintenance dosing: 16mg/day for at least 4 weeks. Consider increase of maintenance dose to 24mg/day on individual basis after appropriate assessment. Consider dose reduction to 16mg/day if not showing increased response or not tolerating 24mg/day. Reassess tolerance and dosing regularly within first 3 months of treatment and thereafter. Consider discontinuing when evidence of therapeutic effect no longer present, or treatment not tolerated. No rebound effect after abrupt discontinuation. If switching from galantamine immediate-release to Gatalin XL, administer same total daily dose. If switching to once-daily regimen, take last dose of immediate-release tablets/oral solution in evening and start Gatalin XL once daily following morning. Consider dose reductions if treated with potent CYP2D6 or CYP3A4 inhibitors. If moderately impaired hepatic function (Child-Pugh score 7-9), start with 8mg once every other day, preferably taken in morning, for 1 week, thereafter proceed with usual starting dose. Daily dose should not exceed 16mg in these patients. Contraindications: Hypersensitivity to galantamine or any excipients; patients with both significant renal and hepatic dysfunction; creatinine clearance less than 9ml/min; severe hepatic impairment (Child-Pugh score greater than 9). Special warnings and precautions for use: Serious skin conditions e.g. Stevens-Johnson syndrome have been reported; inform patients about signs of serious skin reactions; discontinue at first appearance of skin rash. Monitor patient’s weight during therapy. May have vagotonic effect on heart rate including bradycardia and atrioventricular node block – caution in ‘sick sinus syndrome’, supraventricular cardiac conduction disturbances, uncorrected electrolyte disturbance, medicines reducing heart rate e.g. digoxin, beta-blockers. Caution in patients with cardiovascular diseases e.g. immediate post-myocardial infarction, new-onset atrial fibrillation, second degree heart block or greater, unstable angina pectoris, congestive heart failure, and cerebrovascular diseases. Caution should be observed in patients with prolongation of the QTc interval, in patients treated with drugs affecting the QTc interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances. Also caution in those at increased risk of developing peptic ulcers, history of severe asthma, obstructive pulmonary disease or active pulmonary infections. Not recommended if gastrointestinal obstruction or recovering from gastrointestinal surgery, in patients with urinary outflow obstruction or recovering from bladder surgery. Seizures have been reported. Interactions: Do not give concomitantly with other cholinomimetics e.g. ambenonium, donepezil, neostigmine, pyridostigmine, rivastigmine, systemic pilocarpine. Potential to antagonise effect of anticholinergics. If anticholinergics abruptly stopped, potential risk that galantamine effect exacerbated. Interaction possible with medicines that reduce heart rate e.g. digoxin, beta-blockers, calcium channel blockers, amiodarone. Caution with medicines that have potential to cause torsades de pointes – consider an ECG. May exaggerate succinylcholine-type muscle relaxation during anaesthesia, especially if pseudocholinesterase deficient. Consider galantamine dose reduction if treated with potent CYP2D6 or CYP3A4 inhibitors. Not recommended in children. Pregnancy and breastfeeding: Do not use while breast-feeding. Caution in pregnant women. Ability to drive/use machines: Minor/moderate influence on ability to drive and use machines – possible dizziness and somnolence. Side effects: For full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects included in the prescribing information. Very common (≥1/10): vomiting, nausea. Common (≥1/100 to <1/10): decreased appetite, hallucination, depression, syncope, dizziness, tremor, headache, somnolence, lethargy, bradycardia, hypertension, abdominal pain, abdominal pain upper, diarrhoea, dyspepsia, abdominal discomfort, muscle spasms, fatigue, asthenia, malaise, weight decreased, fall, laceration. Uncommon Serious (≥1/1000 to <1/100): hypersensitivity, seizures, extrapyramidal disorder, supraventricular extrasystoles, atrioventricular block first degree, sinus bradycardia, palpitations, hepatic enzyme increased. Rare Serious (≥1/10000 to <1/1000): hepatitis, Stevens-Johnson Syndrome, acute generalized exanthematous pustulosis, erythema multiforme, atrioventricular block complete. MA number: PL 35533/0015-0017. Cost: £25.94 for 8mg; £32.45 for 16mg; £39.90 for 24mg (x28). MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG. Legal category: POM. Date last reviewed: March 2025. Version number: 10100671179 v 4.0
MAT-UK-XLP-0043-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. Available strengths: 2mg and 4mg x 28 prolonged-release capsules. Dosage and method of use: 4mg once daily except in patients with impaired liver or severely impaired kidney function (GFR ≤ 30ml/min) for whom recommended dose is 2mg once daily. In case of troublesome adverse reactions dose may be reduced from 4mg to 2mg once daily. Effect of treatment should be re-evaluated after 2-3 months. Take capsules with or without food and swallow whole. Not recommended for children. Contraindications: Hypersensitivity to the active substance or any excipient, urinary retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon. Special warnings and precautions for use: Use with caution in patients with significant bladder outlet obstruction at risk of urinary retention, gastrointestinal obstructive disorders, renal impairment, hepatic disease, autonomic neuropathy, hiatus hernia, at risk of decreased gastrointestinal motility, risk factors for QT prolongation including: congenital or documented acquired QT prolongation, electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia, bradycardia, relevant pre-existing cardiac diseases, concomitant administration of drugs known to prolong QT-interval including Class IA and Class III anti-arrhythmics. Avoid concomitant treatment with potent CYP3A4 inhibitors. Consider organic reasons for urge and frequency before treatment. Capsules contain lactose and sodium. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Concomitant treatment with other drugs possessing antimuscarinic properties may result in more pronounced therapeutic effect and side effects. Conversely, therapeutic effect of tolterodine may be reduced by concomitant administration of muscarinic cholinergic receptor agonist. Effect of prokinetics like metoclopramide and cisapride may be decreased by tolterodine. Effects on ability to drive and use machines: May cause accommodation disturbances and influence reaction time, ability to drive/ use machines may be negatively affected. Pregnancy/lactation: Not recommended during pregnancy; avoid during breastfeeding. Side effects: For the full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects included. Very common (≥1/10): dry mouth; Common (≥1/100 to <1/10): sinusitis, dizziness, somnolence, headache, dry eyes, abnormal vision (including abnormal accommodation), dyspepsia, constipation, abdominal pain, flatulence, diarrhoea, dysuria, fatigue, peripheral oedema. Serious Uncommon (≥1/1000 to <1/100): hypersensitivity, cardiac failure, arrhythmia, urinary retention. Serious (unknown frequency): anaphylactoid reactions, tachycardia, angioedema. Cases of aggravation of symptoms of dementia have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for treatment of dementia. MA number: PL 35533/0148-0149 Cost £12.89 for 4mg x 28, £11.60 for 2mg x 28. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire GU32 3QG. Legal category: POM. Date last reviewed: March 2025. Version number: 1010083024 v 8.0
MAT-UK-XLP-0044-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: Initial treatment in adults of Parkinson’s disease as monotherapy to delay the introduction of levodopa or in combination with levodopa, over the course of the disease, when levodopa effect wears off or becomes inconsistent and fluctuations in therapeutic effect occur. Available strengths: Repinex XL (ropinirole) 2, 4, and 8mg x 28 tablets. Dosage and method of use: Tablets to be taken once daily, at similar time each day, with or without food, and swallowed whole. Individual dose titration against efficacy and tolerability recommended. Starting dose is 2mg once daily for first week, then increased to 4mg once daily from the second week of treatment. If symptomatic control not achieved, daily dose may be increased by 2mg at weekly or longer intervals up to 8mg once daily; if symptomatic control still not achieved, daily dose may be increased by 2-4mg at 2 weekly or longer intervals. Maximum daily dose is 24mg. Patients should be maintained on the lowest dose that achieves symptomatic control. When given as adjunct to levodopa, it may be possible to gradually reduce levodopa dose, depending on clinical response. In advanced Parkinson’s Disease patients taking Repinex XL tablets in combination with levodopa, dyskinesias can occur during initial titration of Repinex XL tablets. In clinical trials, a reduction in levodopa dose was shown to potentially ameliorate dyskinesia. In patients with mild to moderate renal impairment (creatine clearance between 30-50 ml/min), no dose adjustment is necessary. In end stage renal disease where on haemodialysis, recommended initial dose 2mg once daily. Escalate dose according to tolerability and efficacy. Recommended maximum dose 18mg/day. Consider slower titration in patients aged 75 years or older. Not recommended for use in children below 18 years of age. Contraindications: Hypersensitivity to active substance or excipients; severe renal impairment (creatinine clearance <30 ml/min) without regular haemodialysis; hepatic impairment. Special warnings and precautions for use: Inform patients that ropinirole is associated with somnolence and episodes of sudden sleep onset during daily activities, particularly in Parkinson’s disease. Advise caution while driving or operating machines. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines, consider dose reduction or termination. Due to risk of hypotension, blood pressure monitoring recommended, especially at start of treatment, in patients with severe cardiovascular disease (especially coronary insufficiency). Patinets with major psychiatric or psychotic disorders, or a history of these disorders, should , only be treated with dopamine agonists if potential benefits outweigh risks. Regularly monitor for development of impulse control disorders, including pathological gambling, increased libido, hypersexuality, compulsive spending/buying, binge or compulsive eating; if symptoms develop, consider dose reduction/tapered discontinuation. If rapid gastrointestinal transit occurs, risk of incomplete release of active substance and residue being passed in the stool. Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy – therefore tapering treatment is recommended. Dopamine agonist withdrawal syndrome may occur when tapering or discontinuing dopamine agonists including ropinirole – possible higher risk with impulse control disorders and those on a high daily dose and/or high cumulative doses. Symptoms include apathy, anxiety, depression, fatigue, sweating and pain and do not respond to levodopa – inform patients about withdrawal symptoms before tapering off and discontinuing ropinirole and closely monitor. If severe and/or persistent symptoms, consider temporary re-administration of ropinirole at lowest effective dose. Mania: Patients should be regularly monitored for the development of mania. Patients and carers should be made aware that symptoms of mania can occur with or without the symptoms of impulse control disorders in patients treated with Repinex XL tablets. Dose reduction/tapered discontinuation should be considered if such symptoms develop.Inform patients that hallucinations can occur. Repinex XL 2mg contains lactose – not to be used in patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Repinex XL 4mg contains sunset yellow (E110) which may cause allergic reactions. Interactions: Concomitant treatment with neuroleptics and other centrally active dopamine antagonists e.g. sulpiride or metoclopramide, should be avoided. Increased plasma concentrations of ropinirole have been observed in patients treated with high doses of oestrogens. In patients already receiving hormone replacement therapy (HRT), ropinirole treatment may be initiated in the normal manner. However, it may be necessary to adjust the ropinirole dose, in accordance with clinical response, if HRT is stopped or introduced during treatment with ropinirole. Ropinirole principally metabolised by CYP1A2 – in patients on ropinirole, dose may need to be adjusted when medicines known to inhibit CYP1A2, e.g., ciprofloxacin, enoxacin, or fluvoxamine, are introduced or withdrawn. Smoking induces CYP1A2 metabolism – if patients stop or start smoking during treatment with Repinex XL, dose adjustment may be required. In patients receiving the combination of vitamin K antagonists and ropinirole, cases of unbalanced INR have been reported. Increased clinical and biological surveillance (INR) is warranted Pregnancy and lactation: Repinex XL not recommended during pregnancy unless potential benefit to patient outweighs the potential risk to the foetus. Ropinirole should not be used during lactation. Ability to drive: May have major effect on ability to drive/use machines. Refrain from driving/using machines if presenting with hallucinations, somnolence or sudden sleep episodes. Side effects: When Repinex XL is used as a monotherapy, side effects include: Very Common (≥1/10): somnolence, syncope, nausea; Common (≥1/100 to <1/10): dizziness (including vertigo), sudden onset of sleep, hallucinations, constipation, vomiting, heartburn, abdominal pain, peripheral oedema, leg oedema; Uncommon (≥1/1,000 to <1/100): excessive daytime somnolence, hiccups, psychotic reactions (other than hallucinations) including delirium, delusion, paranoia, postural hypotension, hypotension; Not known (cannot be estimated from the available data): Impulse control disorders e.g. pathological gambling, increased libido, hypersexuality, compulsive shopping, binge eating, compulsive eating, mania, aggression, hypersensitivity reactions (including urticaria, angioedema, rash, pruritus), hepatic reactions, mainly increased liver enzymes, dopamine dysregulation syndrome, dopamine agonist withdrawal syndrome (including apathy, anxiety, depression, fatigue, sweating and pain), spontaneous penile erection. When Repinex XL is used as an adjunct therapy, side effects include: Very Common (>1/10): dyskinesia, somnolence, nausea; Common (≥1/100 to <1/10): dizziness (including vertigo), somnolence, sudden onset of sleep, confusion, postural hypotension, hypotension, nausea, ; Not known (cannot be estimated from the available data): Dopamine agonist withdrawal syndrome (including apathy, anxiety, depression, fatigue, sweating and pain). MA number: PL 35533/0023-0025. Cost: £6.20 for 2mg x 28 pack, £12.50 for 4mg x 28 pack, £21.00 for 8mg x 28 pack. MAH: Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom. Legal Category: POM. Date last reviewed: June 2025. Version number: 1010112063 v 13.0
MAT-UK-XLP-0045-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: For treatment of non-malignant pain of moderate intensity when opioid necessary for obtaining adequate analgesia, in adults. Not suitable for the treatment of acute pain. Available Strengths: Transdermal patches 5µg/hr, 10µg/hr, 15 µg/hr and 20µg/hr over a 7-day period, 4 patches per pack. Dosage and method of use: Prior to starting treatment with opioids, a strategy should be put in place with patients for ending treatment in order to minimise the risk of addiction and drug withdrawal syndrome. Administer every 7th day. Use lowest dose (5µg/hr) as initial dose with consideration given to opioid history and medical status of patient. During initiation of treatment, short-acting supplemental analgesics may be required. During titration process, dose may be adjusted every 3-days (72 hours). Thereafter, 7-day dosing interval should be maintained. Subsequent dose increases may be titrated based on need for supplemental pain relief and patient’s analgesic response to patch. To increase dose, replace with larger patch or combination of patches applied in different places to achieve desired dose. Recommended that no more than 2 patches be applied at same time, to maximum total dose of 40µg/hr. Do not apply new patch to same skin site within 3-4 weeks. Monitor regularly to assess optimum dose and duration of treatment. Possibility of hyperalgesia, tolerance, and progression of underlying disease should be considered if inadequate pain control. Consider Sevodyne dose reduction, discontinuation or treatment review.. If long-term pain treatment necessary, careful and regular monitoring required. Buprenorphine concentrations decrease gradually after patch removal. Subsequent opioid should not be administered within 24 hours after patch removal. Sevodyne can be used as an alternative to other opioids. No dose adjustment necessary in renal impairment or the elderly. Monitor patients with hepatic insufficiency; if severe hepatic impairment, consider alternate therapy. Apply to non-irritated, intact skin of upper outer arm, upper chest, upper back or side of chest. Patch must not be divided or cut in, to pieces. Sevodyne should not be used longer than necessary. Contraindications: In patients: with known hypersensitivity to buprenorphine or excipients; who are opioid dependent and for narcotic withdrawal treatment; have conditions in which respiratory centre and function are severely impaired or may become so; receiving MAO inhibitors or have taken them within the last two weeks; suffering from myasthenia gravis or delirium tremens. Special warnings and precautions for use: Caution in patients with respiratory depression, CNS depressants co-administration, serotonergic agents, psychological dependence, abuse profile and history of substance abuse, acute alcohol intoxication, sleep apnoea, head injury, shock, reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure, severe hepatic impairment, constipation Significant respiratory depression associated with buprenorphine, particularly by intravenous route. Overdose deaths have occurred when addicts intravenously abused buprenorphine, usually with concomitant benzodiazepines. Caution when prescribing Sevodyne to patients with or suspected drug or alcohol abuse or serious mental illness. In those physically dependent on full µ-opioid agonists, buprenorphine may precipitate an abstinence syndrome. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. In patients who present with CSA, consider decreasing the total opioid dosage. Increased absorption of buprenorphine may occur if patches exposed to external heat sources. Fever in febrile patients may result in increased absorption and thereby increased risk of opioid reactions. Concomitant use of buprenorphine and other serotonergic agents may result in the potentially fatal serotonin syndrome – symptoms include mental-status changes, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms. Carefully monitor patients on concomitant serotonergic agents, especially during treatment initiation and dose increases. If serotonin syndrome suspected, consider dose reduction or discontinuation of therapy depending on symptom severity. For all patients, prolonged use may lead to drug dependence (addiction), even at therapeutic doses. Repeated use of Sevodyne can lead to opioid use disorder (OUD), a higher and longer duration of opiod treatment can increase the risk. The risk of OUD is increased in patients with a personal or family history of substance and alcohol use disorders, in current tobacco users or in patients with a personal history of other mental health disorders. During treatment inform the patient of the risks and signs of OUD. Consider additional support and monitoring if at risk of opioid misuse. Monitor patients for signs of drug-seeking behaviour, including review of concomitant opioids and psychoactive drugs. Explain risks of developing tolerance. Overuse, misuse or abuse may result in overdose and/or death. Closely monitor for signs of misuse, abuse or addiction. Regularly review clinical need for analgesia. Drug withdrawal syndrome may occur upon abrupt cessation. If withdrawal occurs, is generally mild, begins after 2 days, may last up to 2 weeks. Gradually taper the dose to minimise symptoms of withdrawal when therapy is no longer required. Tapering of a high dose may take weeks to months. Opioid withdrawal can manifest as: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other possible symptoms include irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate. Consider hyperalgesia if the patient on long-term opioid therapy presents with increased pain – may resolve with opioid dose reduction. Application site reaction usually mild or moderate skin inflammation (irritant contact dermatitis) – may include erythema, oedema, pruritus, rash, vesicles, burning sensation. Monitor application sites for reaction. Diagnostic procedure should be performed if allergic contact dermatitis suspected to determine if sensitisation has occurred and its cause. In patients taking CYP3A4 inhibitors, titrate dose carefully as reduced dosage might be sufficient. Not recommended for analgesia in immediate post-operative period or in situations characterised by narrow therapeutic index or rapidly varying analgesic requirement. Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). Opioids may cause an increase in serum prolactin and decreases in plasma cortisol and testosterone with possible clinical symptoms. Use cautiously with other central nervous system depressants, benzodiazepines and serotonergic medicinal products due to increased risk of serotonin syndrome. The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effects. Only concomitantly prescribe sedative medicines if no other treatment options possible. The dose and duration of concomitant use should be limited. The concomitant use of Sevodyne with gabapentinoids may result in respiratory depression, hypotension, profound sedation, coma or death. Concomitant administration with anticholinergics or medications with anticholinergic activity may result in increased anticholinergic adverse effects. Inform patients of signs and symptoms of respiratory depression and sedation and monitor closely. Pregnancy and Breastfeeding: Not recommended during breastfeeding. Do not use during pregnancy or in women of childbearing potential not using effective contraception unless benefit justifies potential risk to foetus. If prolonged opioid use required in pregnancy, advise of risk of neonatal opioid withdrawal syndrome – ensure treatment available. Use during labour may depress neonate respiration – ensure antidote for child available. Driving: Patients should be warned about effect on driving and, if experiencing dizziness, drowsiness or blurred vision, they should not drive or use machines for at least 24 hours after patch removed Side effects: For the full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects are included in prescribing information. Very common (≥1/10) side effects: headache, dizziness, somnolence, constipation, nausea, vomiting, pruritus, erythema, application site reaction. Common (≥1/100 to <1/10) side effects: anorexia, confusion, depression, insomnia, nervousness, anxiety, tremor, dyspnoea, abdominal pain, diarrhoea, dyspepsia, dry mouth, rash, sweating, exanthema, muscular weakness, arthralgia, tiredness, asthenic conditions, peripheral oedema. Uncommon Serious (≥1/1000 to <1/100) side effects: hypersensitivity, tachycardia, circulatory collapse, drug withdrawal syndrome. Rare/very rare Serious (<1/10000 to <1/1000) side effects: anaphylactic reaction, psychotic disorder, angina pectoris, respiratory depression, respiratory failure, drug dependence. Unknown frequency Serious side effects: anaphylactoid reaction, seizures, neonatal drug withdrawal syndrome. MA number: PL 35533/0059-0061 (5µg/hr,10µg/hr, 20µg/hr). PL 35533/0135 (15 µg/hr). Cost: £5.53 for 5µg/hr patch x4 pack; £9.93 for 10µg/hr patch x4 pack; £15.48 for 15 µg/hr patch x4 pack and £18.09 for 20µg/hr patch x4 pack. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire GU32 3QG. Legal category: POM. Date last reviewed: February 2025. Version number: 1010311145 v 16.0
MAT-UK-XLP-0046-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: Treatment of type 2 diabetes mellitus in adults when dietary management and exercise do not result in adequate glycaemic control, as a monotherapy or in combination with other antidiabetic agents or insulin. Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with impaired glucose tolerance and/or impaired fasting glucose and/or increased HbA1C who are at risk and progressing towards type 2 diabetes mellitus despite lifestyle modifications for 3–6 months. Posology and method of Administration: Adults with normal renal function (GFR ≥90mL/min): Starting dose of one 500mg SR tablet once daily with evening meal. Adjust dose based on blood glucose measurements every 10 to 15 days in increments of 500mg, to a maximum dose of 2000mg once daily, until glycaemic control achieved. A slow increase of dose may improve gastro-intestinal tolerability. Reduction in the risk or delay onset of type 2 diabetes: Regularly monitor (every 3-6 months) glycaemic status and risk factors to evaluate treatment. Re-evaluate therapy if patient implements diet and/or exercise improvements. Monotherapy in type 2 diabetes and combination with other oral antidiabetic agents: If glycaemic control is not achieved, consider Sukkarto SR 1000mg twice daily with food; then consider standard metformin tablets to a maximum of 3000mg daily. If transferring from another oral antidiabetic agent, discontinue and initiate Sukkarto SR at the dose indicated above. For patients already treated with metformin, the dose of Sukkarto SR should be equivalent to the daily dose of metformin in tablets (prolonged or immediate release). In patients treated with metformin dose above 2000mg daily, switching to metformin prolonged release tablets is not recommended. Combination with insulin: Usual starting dose of Sukkarto SR is one 500mg tablet once daily or the equivalent daily dose of metformin in tablets (prolonged or immediate release) up to a maximum of 1500mg or 2000mg for patients on 750mg or 1000mg tablets, respectively, with the evening meal; adjust insulin dose according to blood glucose measurements. Elderly: Adjust metformin dosage based on renal function; regular assessment of renal function is necessary. Paediatric population: Sukkarto SR should not be used in children. Contraindications: Hypersensitivity to metformin or any excipients; acute metabolic acidosis (including lactic acidosis or diabetic ketoacidosis); diabetic pre-coma; severe renal failure (glomerular filtration rate [GFR] < 30mL/min); acute conditions with potential to alter renal function (including dehydration, severe infection or shock); acute or chronic disease which may cause tissue hypoxia (decompensated, acute or unstable heart failure, respiratory failure, recent myocardial infarction or shock); hepatic insufficiency; acute alcohol intoxication; alcoholism. Precautions and warnings: Lactic acidosis: metformin should be discontinued and contact with a healthcare professional recommended if dehydrated. Patients/caregivers should be informed of risk of lactic acidosis and if suspected metformin should be discontinued and immediate medical attention sought. Medicinal products that can acutely impair renal function (e.g. antihypertensives, NSAIDs, diuretics) should be initiated with caution. Renal function: GFR should be assessed before initiation and regularly thereafter. Discontinue temporarily in the presence of conditions that alter renal function. Cardiac function: monitor cardiac and renal function regularly in patients with stable chronic heart failure. Elderly patients: metformin initiation not recommended. Discontinue Sukkarto SR prior to using iodinated contrast agents, do not reinstitute until 48 hours afterwards and renal function has been re-evaluated as stable. Discontinue at the time of surgery with general, spinal or epidural anaesthesia and do not reinstate until 48 hours afterwards when renal function has been re-evaluated as stable. Patients should continue their diet with regular carbohydrate intake during the day. Usual laboratory tests for diabetes monitoring should be performed regularly. Metformin may reduce vitamin B12 serum levels, in case of suspicion of deficiency or in patients with risk factors for B12 deficiency, monitor serum levels. Caution advised when used in combination with insulin or other oral antidiabetics (e.g., sulphonylureas or meglitinides) due to possible hypoglycaemia. Interactions: Concomitant use not recommended with alcohol or iodinated contrast agents. Closely monitor renal function when using NSAIDs, including selective cyclooxygenase II inhibitors, ACE-inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. More frequent blood glucose monitoring required, and dose adjustments may be necessary when using medicinal products with intrinsic hyperglycaemic activity (e.g. glucocorticoids (systemic and local) and sympathomimetics). Caution is advised and dose adjustment may be required during co-administration of organic cation transporters Pregnancy & Lactation: Maintain blood glucose levels as close to normal throughout pregnancy. If clinically needed, the use of metformin can be considered during pregnancy and in the periconceptional phase as an addition or an alternative to insulin. Metformin is excreted into breast milk. A decision should be made whether to discontinue nursing, taking into account the benefit of breast-feeding and the potential risk to adverse effects on the child. Effects on ability to drive and use machines: Metformin alone does not affect the ability to drive or operate machinery. However, there is a risk of hypoglycaemia when used in combination with other anti-diabetic agents. Undesirable effects: Please refer to the SmPC for full list of adverse events. Very common (≥1/10): gastrointestinal disorders (e.g. nausea, vomiting, diarrhoea, abdominal pain, loss of appetite). Common (≥1/100 to <1/10): taste disturbances, vitamin B12 decrease/insufficiency. Very rare (<1/10,000): lactic acidosis, isolated reports of liver function test abnormalities, hepatitis, skin reactions such as erythema, pruritus, urticaria. Overdose: Hypoglycaemia has not been seen with metformin doses of up to 85g although lactic acidosis has occurred in such circumstances. High overdose or concomitant risks may lead to lactic acidosis which is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis. Legal category: POM. Marketing Authorisation Numbers: Sukkarto SR 500mg: PL 20117/0110; 750mg: PL 20117/0277; 1000mg: PL 20117/0111. Price: 56 tablets Sukkarto SR 500mg: £3.46; 750mg: £2.87; 1000mg: £5.24. 28 tablets Sukkarto SR 500mg: £1.73, 1000mg: £2.77. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK. Date Reviewed: March 2025 Version number: 10103111834 v 3.0.
MAT-UK-XLP-0047-1 | June 2026
(Please refer to the full SmPC before prescribing)
Indications: All strengths: Major depressive episodes (MDEs), prevention of recurrence of MDEs. 37.5, 75, 150 and 225mg: generalised anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder, with or without agoraphobia. Available strengths: 37.5, 75, 150, 225 and 300mg x 28 capsules. Dosage: MDEs: recommended starting dose 75mg once daily, if not responding, increase up to maximum 375 mg/day. GAD and SAD: recommended starting dose 75mg once daily. Panic disorder: 37.5mg/day for 7 days, then increased to 75mg/day. GAD, SAD and panic disorder patients not responding to 75mg/day increase up to maximum 225mg/day. For all indications maintain lowest effective dose; dose increases can be made at 2 weeks intervals or more; due to risk of dose-related adverse effects, only make dose increments after clinical evaluation; patients should usually be treated for several months or longer with regular reassessment. Caution in elderly. Not recommended in those under 18 years. Caution if GFR 30-70ml/min. In mild or moderate hepatic impairment, severe renal impairment (GFR < 30 ml/min) or haemodialysis reduce dose by 50%. Caution in severe hepatic impairment - reduce dose by more than 50%. Abrupt discontinuation should be avoided. Gradually reduce over several weeks/months to reduce risk of withdrawal reactions and monitor closely. Suicide/suicidal thoughts and aggression have been observed during venlafaxine dosing changes including discontinuation. Most commonly reported withdrawal symptoms: dizziness, sensory disturbances, agitation, nausea, vomiting, tremor, vertigo, headache, flu syndrome, visual impairment, hypertension. Administration: Take with food, at approximately same time each day. Swallow whole with fluid – do not divide, crush, chew, or dissolve. Patients on venlafaxine immediate-release tablets may be switched to venlafaxine prolonged-release capsules at nearest equivalent daily dosage. Contraindications: Hypersensitivity to active substance or excipients. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) due to risk of serotonin syndrome. Do not initiate for at least 14 days after discontinuation of an irreversible/reversible MAOI. Discontinue for at least 7 days before starting an irreversible/reversible MAOI. Special warnings/precautions for use: Advise patients not to use alcohol, considering its CNS-effects, potential to clinically worsen psychiatric conditions and potential for adverse interactions with venlafaxine. Ethanol can affect the prolonged-release coating, causing dose dumping and potential toxicity. Write prescriptions for the smallest quantity consistent with good patient management to reduce risk of overdose. Monitor patients for risk of suicide-related events until improvement occurs. Monitor for clinical worsening, suicidal behaviour or changes in behaviour. Observe carefully (risk of potentially life-threatening serotonin syndrome) if given concomitantly with other serotonergic agents e.g. SSRIs, SNRIs, triptans, amphetamines, lithium, sibutramine, St John’s Wort, fentanyl and analogues, tramadol, buprenorphine, dextromethorphan, tapentadol, pethidine, methadone, pentazocine; agents that impair serotonin metabolism e.g. MAO-inhibitors, serotonin precursors e.g. tryptophan; or with antipsychotics and other dopamine antagonists, particularly during treatment initiation and dose increases. Reduce dose or discontinue if serotonin syndrome suspected. Monitor patients with raised intraocular pressure or at risk for acute narrow-angle glaucoma. Screen for high blood pressure and control pre-existing hypertension before starting treatment. Review blood pressure periodically, after starting treatment and dose increases. Caution in patients whose underlying conditions might be compromised by increases in blood pressure or heart rate, patients with recent history of myocardial infarction, unstable heart disease or at high risk of serious cardiac arrhythmia or QTc prolongation (consider risk-benefit balance). Caution if history or family history of bipolar disorder or aggression; if predisposition to bleeding, including use of anticoagulants or platelet inhibitors; if on diuretics or volume-depleted (risk of hyponatraemia/SIADH); use with caution if history of convulsions and discontinue in patients who develop seizures. Measure serum cholesterol during long-term treatment. Co-administration with weight loss agents not recommended. In patients who develop akathisia, increasing dose may be detrimental. Advise patients about importance of dental hygiene. In diabetic patients, insulin and/or oral antidiabetic dosage may need adjustment. SSRIs and SNRIs may cause symptoms of sexual dysfunction which may continue after discontinuation. SSRIs/SNRIs may increase the risk of postpartum haemorrhage. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking venlafaxine. Interactions: Must not be used with irreversible, non-selective MAOIs; concomitant treatment with reversible, selective MAOIs and linezolid not recommended. Serotonin syndrome – if concomitant treatment with SSRI, SNRI or serotonin receptor agonist (triptan) clinically warranted, carefully observe, particularly when starting treatment and dose increases. Caution when used in combination with other CNS-active substances, CYP3A4 inhibitors, lithium, imipramine, haloperidol, metoprolol. 150mg contains Allura red (E129) and Sunset Yellow FCF (E110) and 225mg contains Carmoisine (E122), which may cause allergic reactions. Avoid co-administration with medicines prolonging QTc interval (risk of QTc prolongation/ventricular arrhythmias). Pregnancy/breastfeeding: Only use in pregnancy if benefits outweigh risk. Discontinuation symptoms may be seen in newborns if used before birth. Potential increased risk of persistent pulmonary hypertension in newborn. Potential increased risk of postpartum haemorrhage if SSRI/SNRI exposure within month prior to birth. Risk to suckling child cannot be excluded – make decision to continue/discontinue breast-feeding or continue/discontinue Vencarm XL. Effect on driving: Caution patients on their ability to drive or operate hazardous machinery. Side effects: For full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects included in this prescribing information. Very common (≥1/10) side effects: insomnia, headache, dizziness, sedation, nausea, dry mouth, constipation and hyperhidrosis (including night sweats). Common (≥1/100 to <1/10) side effects: decreased appetite, confusional state, depersonalisation, abnormal dreams, nervousness, libido decreased, agitation, anorgasmia, akathisia, tremor, paraesthesia, dysgeusia, visual impairment, accommodation disorder, including vision blurred, mydriasis, tinnitus, tachycardia, palpitations, hypertension, hot flush, dyspnoea, yawning, diarrhoea, vomiting, rash, pruritus, hypertonia, urinary hesitation, urinary retention, pollakiuria, menorrhagia, metrorrhagia, erectile dysfunction, ejaculation disorder, fatigue, asthenia, chills, weight decreased, weight increased, blood cholesterol increased. Uncommon (≥1/1,000 to <1/100) serious side effects: gastrointestinal haemorrhage, LFT abnormal, angioedema. Rare serious (≥1/10,000 to <1/1,000) side effects: agranulocytosis, aplastic anaemia, pancytopenia, neutropenia, anaphylactic reaction, SIADH, hyponatraemia, neuroleptic malignant syndrome (NMS), serotonin syndrome, convulsion, angle-closure glaucoma, Torsades de Pointes, ventricular tachycardia, ventricular fibrillation, ECG QT prolonged, interstitial lung disease, pancreatitis, hepatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, rhabdomyolysis. Very rare (<1/10,000) serious side effects: thrombocytopaenia, tardive dyskinesia, mucosal haemorrhage, prolonged bleeding time. Not known (frequency cannot be estimated) serious side effects: suicidal ideation and behaviours, Stress cardiomyopathy (Takotsubo cardiomyopathy), postpartum haemorrhage. Overdose: severe poisoning symptoms may occur in adults after intake of approximately 3 grams of venlafaxine. Overdose with venlafaxine is reported predominantly in combination with alcohol and/or other medicinal products including cases with fatal outcome. The most commonly reported events include tachycardia, changes in level of consciousness, mydriasis, convulsion and vomiting. Other reported events include electrocardiographic changes, ventricular tachycardia, bradycardia, hypotension, vertigo and death. Severe poisoning may require complex emergency treatment and monitoring. In the event of suspected overdose, contact the National Poisons Information Service (NPIS). MA number: 37.5-225mg: PL 35533/0074-0077, 300mg: PL 35533/0296. Cost: £3.30 for 37.5mg; £2.59 for 75mg; £3.89 for 150mg and £9.90 for 225mg and £26.40 for 300mg (x28). MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG. Legal category: POM. Version number: MAT-UK-XLP-0018-2 | March 2026
MAT-UK-XLP-0048-1 | June 2026
MAT-UK-XLP-0037-1 | June 2026
