Posology : מינונים

4.2.    Posology and method of administration

Posology
Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed whole.

Initial dose
1.5 mg twice a day.

Dose titration
The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.

If adverse effects (e.g. nausea, vomiting, abdominal pain or loss of appetite) or weight decrease are observed during treatment, these may respond to omitting one or more doses. If adverse effects persist, the daily dose should be reduced to the previous well-tolerated dose.

Maintenance dose
1.5 mg to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well-tolerated dose.

The recommended maximum daily dose is 6 mg twice a day.

Re-initiation of therapy
The incidence and severity of adverse events are generally increased with higher doses.
If treatment is interrupted for longer than three days, treatment should be re-initiated at 1.5 mg twice daily and titrated as described above.

Special populations

Paediatric population
Children and adolescents (age below 18 years): The use of Rivastigmine in children has not been studied and is therefore not recommended.

Renal and hepatic impairment
No dose adjustment is necessary for patients with renal or hepatic impairment.

However, due to increased exposure in moderate renal and mild to moderate hepatic impairment, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose dependent adverse reactions. Patients with severe hepatic impairment have not been studied, however, Rivastigmine Dexcel may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).