4.2 Posology and method of administration
Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4).
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.
There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).
Switching to Reminyl XL prolonged-release capsules from Reminyl tablets or Reminyl oral solution
It is recommended that the same total daily dose of galantamine is administered to patients. Patients switching to the once-daily regimen should take their last dose of Reminyl tablets or oral solution in the evening and start Reminyl XL prolonged-release capsules once daily the following morning.
Galantamine plasma concentration may be increased in patients with moderate to severe renal impairment (see section 5.2)
For patients with a creatinine clearance ≥ 9ml/min, no dosage adjustment is required.
In patients with severe renal impairment (creatinine clearance less than 9 ml/min), the use of galantamine is contraindicated (see section 4.3).
Galantamine plasma consentreation may be increased in patients with moderate to severe hepatic impairment (see section 5.2).
In patients with moderately impaired hepatic function (Child‑Pugh score 7‑9), based on pharmacokinetic modelling, it is recommended that dosing should begin with 8 mg prolonged-release capsule once every other day, preferably taken in the morning, for 1 week. Thereafter, patients should proceed with 8 mg once daily for 4 weeks. In these patients, daily doses should not exceed 16 mg.
In patients with severe hepatic impairment (Child-Pugh score greater than 9), the use of galantamine is contraindicated (see section 4.3).
No dosage adjustment is required for patients with mild hepatic impairment.
In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered (see section 4.5).
There is no relevant use of galantamine in the paediatric population.
Method of administration
Reminyl prolonged-release capsules s should be administered orally, once daily in the morning; preferably with food. The capsules should be swallowed whole together with some liquid. The capsules must not be chewed or crushed.
Ensure adequate fluid intake during treatment (see section 4.8)
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Because no data are available on the use of galantamine in patients with severe hepatic (Child-Pugh score greater than 9) and severe renal (creatinine clearance less than 9 ml/min) impairment, galantamine is contraindicated in these populations. Galantamine is contraindicated in patients who have both significant renal and hepatic dysfunction.