Galantamine

Indication: mild to moderately severe dementia of the Alzheimer type; the diagnosis should be confirmed according to current clinical guidelines by an experienced physician, therapy should occur under the supervision of a physician, and treatment should only be initiated if a caregiver is available to regularly monitor medicinal product intake. Tolerance and dosing should be reassessed regularly, preferably within three months of starting; maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment. In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered. Discontinuation should be considered when there is no longer evidence of therapeutic effect or if treatment is not tolerated; there is no rebound effect after abrupt discontinuation (e.g. in preparation for surgery). SWITCHING from galantamine tablets or oral solution to prolonged-release capsules: administer the same total daily dose — the last dose of tablets or oral solution should be taken in the evening and the prolonged-release capsule started once daily the following morning. HEPATIC IMPAIRMENT: in moderate impairment (Child-Pugh 7-9), begin with an 8 mg prolonged-release capsule once every other day, preferably in the morning, for one week, then 8 mg once daily for four weeks; daily doses should not exceed 16 mg. No dosage adjustment is required in mild hepatic impairment. Severe hepatic impairment (Child-Pugh >9) is contraindicated. CONCOMITANT TREATMENT: dose reductions can be considered in patients treated with potent CYP2D6 or CYP3A4 inhibitors. PAEDIATRIC: there is no relevant use of galantamine in the paediatric population. Ensure adequate fluid intake during treatment; monitor weight during therapy.