Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
eslicarbazepine acetate
BIAL - Portela & Ca, S.A.
N03AF04
eslicarbazepine acetate
Antiepileptics,
Epilepsy
Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.
Revision: 31
Authorised
2009-04-21
120 B. PACKAGE LEAFLET 121 PACKAGE LEAFLET: INFORMATION FOR THE USER ZEBINIX 200 MG TABLETS Eslicarbazepine acetate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 Zebinix is and what it is used for 2. What you need to know before you take Zebinix 3. How to take Zebinix 4. Possible side effects 5. How to store Zebinix 6. Contents of the pack and other information 1. WHAT ZEBINIX IS AND WHAT IT IS USED FOR Zebinix contains the active substance eslicarbazepine acetate. Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits. Zebinix is used: • on its own (monotherapy) in adult patients with newly diagnosed epilepsy • with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age who are experiencing seizures that affect one part of the brain (partial seizure). These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation) Zebinix has been given to you by your doctor to reduce your number of seizures. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEBINIX DO NOT TAKE ZEBINIX : • if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients of this medicine (listed in section 6); • if you suffer from a certain type of heart rhythm disorder (second or third degree atriovent Baca dokumen lengkapnya
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zebinix 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of eslicarbazepine acetate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 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. 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). _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/min: no dose adjustment required. - CL CR 30-60 ml/min: initial dose of 200 mg (or 5 mg/kg in children above 6 years) once daily or 400 mg (or 10 mg/kg in children above 6 years) every other day for 2 weeks followed by a once daily dose of 400 mg (or 10 mg Baca dokumen lengkapnya