ONGENTYS Hard capsule Ref.[9758] Active ingredients: Opicapone

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Bial Portela & Cยช, S.A., ร€ 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

Therapeutic indications

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.

Posology and method of administration

Posology

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.

Dose adjustments of antiparkinsonian therapy

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).

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 โ‰ฅ85 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, Ongentys is not recommended in these patients (see section 5.2).

Paediatric population

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

Method of administration

Oral use.

The capsules should be swallowed whole with water.

Overdose

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.

Shelf life

HDPE bottles: 3 years.

Blisters: 5 years.

Special precautions for storage

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.

Nature and contents of container

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.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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