Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
OPICAPONE
TRUEMED LTD, ISRAEL
N04BX04
HARD CAPSULE
OPICAPONE 50 MG
PER OS
Required
BIAL - PORTELA & Cª, S.A, PORTUGAL
OPICAPONE
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.
2022-07-18
Page 2 of 6 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only ONGENTYS 50 MG HARD CAPSULES ACTIVE INGREDIENT: EACH HARD CAPSULE OF ONGENTYS 50 MG CONTAINS OPICAPONE 50 MG. For Inactive ingredients and allergens in this medicine see section 2 ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Ongentys 50 mg is used as adjunctive therapy in adults with Parkinson’s disease who are taking medicines containing levodopa/DOPA decarboxylase inhibitors and who are not sufficiently controlled. THERAPEUTIC GROUP: Anti-Parkinson drugs, other dopaminergic agents. Treatment with Ongentys 50 mg increases the effectiveness of levodopa and helps relieve the symptoms of Parkinson’s disease and movement problems. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient opicapone or to any of the other ingredients this medicine contains (see section 6 'Additional information'); • you have a tumour of the adrenal gland (known as phaeochromocytoma), or of the nervous system (known as paraganglioma), or any other tumour which increases the risk of severe high blood pressure; • you have ever suffered from neuroleptic malignant syndrome which is a rare reaction to antipsychotic medicines; • you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury; • you are taking certain antidepressants called monoamine-oxidase inhibitors (MAOI) (e.g. phenelzine, tranylcypromine Perskaitykite visą dokumentą
1 1. NAME OF THE MEDICINAL PRODUCT Ongentys® 50 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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 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 50 mg 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. 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. 2 _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 ex Perskaitykite visą dokumentą