Posology : מינונים

4.2    Posology and method of administration

Posology
The recommended dose is 50 mg of opicapone.
Ongentys 50 mg should be taken once-daily at bedtime at least one hour before or after levodopa combinations.

Dose adjustments of antiparkinsonian therapy
Ongentys 50 mg is to be administered as an adjunct to levodopa treatment and enhances the effects of levodopa. Hence, it is often necessary to adjust levodopa dose by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating the treatment with opicapone according to the clinical condition of the patient (see section 4.4).

Missed dose
If one dose is missed, the next dose should be taken as scheduled. The patient should not take an extra dose to make up for the missed dose.

Special populations

Elderly
No dose adjustment is needed for elderly patients (see section 5.2).
Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.
Renal impairment
No dose adjustment is necessary in patients with renal impairment, as opicapone is not excreted by the kidney (see section 5.2).

Hepatic impairment
No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A).
There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B). Caution must be exercised in these patients and dose adjustment may be necessary (see section 5.2).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, opicapone is not recommended in these patients (see section 5.2).

Paediatric population
There is no relevant use of Ongentys 50 mg in the paediatric population with Parkinson’s disease and motor fluctuations.

Method of administration

Oral use.
The capsules should be swallowed whole with water.