Active Ingredient: Galantamine
Symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
For this indication, competent medicine agencies globally authorize below treatments:
Oral, 8 milligrams galantamine, once daily to breakfast, over the duration of 4 weeks. Afterwards, oral, between 16 milligrams galantamine and 24 milligrams galantamine, once daily to breakfast. The maximum allowed total dose is 24 milligrams galantamine daily.
The recommended starting dose is 8 mg/day for 4 weeks.
The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within 3 months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
The initial maintenance dose is 16 mg/day and patients should be maintained on 16 mg/day for at least 4 weeks.
An increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability.
In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered.
It should be administered orally, once daily in the morning, preferably with food. Adequate fluid intake during treatment should be ensured.
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