Galantamine (as galantamine hydrobromide) 4mg/5ml

Oral solution

Treatment of mild to moderate dementia of the Alzheimer’s type

Posology
Adults/Elderly
- Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines
- Starting dose
The recommended starting dose is 8 mg/day (4 mg twice a day) for 4 weeks.
- Maintenance dose
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 (8 mg twice a 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 (12 mg twice a 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.
- Treatment withdrawal
There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).
Renal impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe renal impairment
For patients with a creatinine clearance ≥9 ml/min, no dosage adjustment is required.
The use of galantamine is contraindicated in patients with creatinine clearance less than 9 ml/min
Hepatic impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment 
In patients with moderately impaired hepatic function (Child-Pugh score 7-9), based on pharmacokinetic modelling, it is recommended that dosing should begin with 4 mg once daily, preferably taken in the morning, for at least 1 week. Thereafter, patients should proceed with      4 mg twice daily for at least 4 weeks. In these patients, daily doses should not exceed 8 mg twice daily.
In patients with severe hepatic impairment (Child-Pugh score greater than 9), the use of galantamine is contraindicated 
No dosage adjustment is required for patients with mild hepatic impairment.
Concomitant treatment
In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered (see section 4.5).
Paediatric population
There is no relevant use of galantamine in the paediatric population.

Method of administration
Memoback oral solution should be administered orally, twice a day, preferably with morning and evening meals. Ensure adequate fluid intake during treatment