Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bial Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal Tel:+351 22 986 61 00 Fax: +351 22 986 61 90 e-mail: info@bial.com
Ongentys is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
The recommended dose of opicapone is 50 mg. Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations.
Opicapone enhances the effects of levodopa. Hence, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating the treatment with opicapone (see section 4.4).
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.
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.
No dose adjustment is necessary in patients with renal impairment, as opicapone is not excreted by the kidney (see section 5.2).
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, Ongentys is not recommended in these patients (see section 5.2).
There is no relevant use of Ongentys in the paediatric population with Parkinson’s disease and motor fluctuations.
Oral use.
The capsules should be swallowed whole with water.
There is no known specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of opicapone by gastric lavage and/or inactivation by administering activated charcoal should be considered.
HDPE bottles: 3 years.
Blisters: 5 years.
This medicinal product does not require any special temperature storage conditions.
Blisters: Store in the original blister in order to protect from moisture.
HDPE bottles: Keep the bottle tightly closed in order to protect from moisture.
Ongentys 25 mg hard capsules:
White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10 or 30 capsules.
OPA/Al/PVC//Al blisters containing 10 or 30 capsules.
Ongentys 50 mg hard capsules:
White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10, 30 or 90 capsules.
OPA/Al/PVC//Al blisters containing 10, 30 or 90 capsules
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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