Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
opicapone
Bial - Portela Cª, S.A.
N04
opicapone
Anti-Parkinson drugs
Parkinson Disease
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.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.
Revision: 8
Authorised
2016-06-24
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ONGENTYS 25 MG HARD CAPSULES opicapone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ongentys is and what it is used for 2. What you need to know before you take Ongentys 3. How to take Ongentys 4. Possible side effects 5. How to store Ongentys 6. Contents of the pack and other information 1. WHAT ONGENTYS IS AND WHAT IT IS USED FOR Ongentys contains the active substance opicapone. It is used to treat Parkinson’s disease and associated movement problems. _ _ Parkinson's disease is a progressive disease of the nervous system that causes shaking and affects your movement. Ongentys is for use in adults who are already taking medicines containing levodopa and DOPA decarboxylase inhibitors. It increases the effects of levodopa and helps to relieve the symptoms of Parkinson’s disease and movement problems. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONGENTYS DO NOT TAKE ONGENTYS: - if you are allergic to opicapone or any of the other ingredients of this medicine (listed in section 6); - if you have a tumour of the adrenal gland (known as phaeochromocytoma), or of the nervous system (known as paraganglioma), or any other tumour which increase the risk of severe high blood pressure; - if you have ever suffered from neuroleptic malignant syndrome which is a rare reaction to antipsychotic medicines; - if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury; - if you are taking certai Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ongentys 25 mg hard capsules Ongentys 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ongentys 25 mg hard capsules Each hard capsule contains 25 mg of opicapone. Excipient(s) with known effect Each hard capsule contains 171.9 mg of lactose (as monohydrate). Ongentys 50 mg hard capsules Each hard capsule contains 50 mg of opicapone. Excipient(s) with known effect Each hard capsule contains 148.2 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule) Ongentys 25 mg hard capsules Light blue capsules, size 1, approximately 19 mm, imprinted “OPC 25” on the cap and “Bial” on the body. Ongentys 50 mg hard capsules Dark blue capsules, size 1, approximately 19 mm, imprinted “OPC 50” on the cap and “Bial” on the body. 4. CLINICAL PARTICULARS 4.1 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. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 50 mg of opicapone. Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations. _Dose adjustments of antiparkinsonian therapy _ Ongentys 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 need Прочитайте повний документ