البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ESLICARBAZEPINE ACETATE
TRUEMED LTD, ISRAEL
N03AF04
TABLETS
ESLICARBAZEPINE ACETATE 200 MG
PER OS
Required
BIAL - PORTELA & Cª, S.A, PORTUGAL
ESLICARBAZEPINE
Zebinix is indicated as:• monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;• adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.
2022-10-23
Page 1 of 7 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only ZEBINIX 200 MG ZEBINIX 800 MG TABLETS ACTIVE INGREDIENT: EACH ZEBINIX 200 MG TABLET CONTAINS 200 MG ESLICARBAZEPINE ACETATE. EACH ZEBINIX 800 MG TABLET CONTAINS 800 MG ESLICARBAZEPINE ACETATE. For inactive ingredients and allergens in the medicine, see 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 to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Zebinix is used: as a single medicine (monotherapy) for treatment of partial seizures with or without secondary generalisation in adult patients with newly diagnosed epilepsy. with other antiepileptic medicines (adjunctive therapy), for treatment of adult, adolescent and pediatric patients above 6 years of age experiencing partial seizures with or without secondary generalisation. THERAPEUTIC GROUP: antiepileptic medicines, carboxamide derivatives. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to the active ingredient eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients in this medicine (see section 6 'Additional information'). You suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block). SPECIAL WARNINGS ABOUT USING THIS MEDICINE CONTACT YOUR DOCTOR IMMEDIATELY: If you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of اقرأ الوثيقة كاملة
1 1. NAME OF THE MEDICINAL PRODUCT Zebinix® 200 mg Zebinix® 800 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zebinix 200mg Each tablet contains 200 mg of eslicarbazepine acetate. Zebinix 800mg Each tablet contains 800 mg of eslicarbazepine acetate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Zebinix 200mg White oblong tablets, engraved ’ESL 200’ on one side and scored on the other side, with a length of 11 mm. The tablet can be divided into equal doses. _ _ Zebinix 800mg White oblong tablets, engraved ‘ESL 800’on one side and scored on the other side, with a length of 19 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zebinix is indicated as: monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy. The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after one or two weeks. Based on individual response, the dose may be increased to 1,200 mg once daily. Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see section 5.1). _ _ _ _ _ _ _ _ _ _ 2 _SPECIAL POPULATIONS _ _Elderly (over 65 years of age) _ No dose adjustment is needed in the elderly population provided that the renal function is not disturbed. Due to very limited data on the 1,600 mg monotherapy regimen in the elderly, this dose is not recommended for this population. _Renal impairment _ Caution should be exercised in the treatment of patients, adult and children above 6 years of age, with renal impairment and the dose should be adjusted according to creatinine clearance (CL CR ) as follows: - CL CR >60 ml/mi اقرأ الوثيقة كاملة