REMINYL PROLONGED RELEASE CAPSULE 8 MG [SIN13019P]

Product Info

REMINYL PROLONGED RELEASE CAPSULE 8 MG

[SIN13019P]

Indications
REMINYL® is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type.

Dosage and Administration
Dosage – Adults
Ensure adequate fluid intake during treatment.

Starting dose
The recommended starting dose of REMINYL® prolonged-release capsules is 8 mg once daily for 4 weeks.

The dose of REMINYL® should be gradually increased to the maintenance dose to minimize side effects.

Maintenance dose
The initial maintenance dose is 16 mg/day (16 mg once a day with capsules) and patients should be maintained on 16 mg/day for at least 4 weeks. An increase to the maximum recommended maintenance dose of 24 mg/day (24 mg once a day with capsules) should be considered after appropriate assessment including evaluation of clinical benefit and tolerability.

Treatment withdrawal
There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).

Re-initiation of therapy
If the treatment is interrupted for longer than several days, treatment should be re-initiated with the lowest daily dose and gradually increased to the maximum tolerated dose to achieve the desired clinical effect. The incidence and severity of adverse events are generally related to the higher doses of REMINYL®.

Special populations
Pediatrics
Use of REMINYL® in children is not recommended. No data on the use of REMINYL® in pediatric patients are available.

Renal impairment
Galantamine plasma concentrations may be increased in patients with moderate (creatinine clearance = 52–104 mL/min) to severe (creatinine clearance = 9–51 mL/min) renal impairment.

For patients with a creatinine clearance >9 mL/min, no dosage adjustment is required (see Pharmacokinetic Properties – Special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The use of REMINYL® is not recommended in patients with creatinine clearance less than 9 mL/min because no data are available.

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), for prolonged-release capsules, based on pharmacokinetic modeling, dosing should begin with 8 mg every other day for at least one week, preferably taken in the morning. Thereafter, patients should proceed with 8 mg once daily for prolonged-release capsules for at least four weeks. In these patients, total daily doses should not exceed 16 mg.

No dosage adjustment is required for patients with mild hepatic impairment. In patients with severe hepatic impairment (Child-Pugh score >9), the use of REMINYL® is not recommended.

Concomitant treatment
In patients treated with potent CYP2D6 or CYP3A4 inhibitors (e.g. ketoconazole), dose reductions can be considered (see Interactions – Other drugs affecting the metabolism of galantamine – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Administration
REMINYL® is administered orally.

REMINYL® prolonged-release capsules should be administered once daily in the morning, preferably with food.

Contraindications
REMINYL® should not be administered to patients with a known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulations.