Gatalin XL (Galantamine) Prolonged-release Capsules Prescribing Information
(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. 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. 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. Not recommended in children. 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: April 2023. Version number: 10100671179 v 3.0
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For further information please call: 01730 231148,
email: [email protected] or visit www.aspirepharma.co.uk
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148
For more information about Gatalin XL, please see the abbreviated prescribing information.
Revision reference – Gatalin XL_28_01.02.2024
