Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
eslicarbazepine acetate
BIAL - Portela Ca, S.A.
N03AF04
eslicarbazepine acetate
Antiepileptics,
Epilepsy
Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
Revision: 5
Withdrawn
2009-04-21
52 B. PACKAGE LEAFLET Medicinal product no longer authorised 53 PACKAGE LEAFLET: INFORMATION FOR THE USER EXALIEF 400 MG TABLETS Eslicarbazepine acetate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Exalief is and what it is used for 2. Before you take Exalief 3. How to take Exalief 4. Possible side effects 5. How to store Exalief 6. Further information 1. WHAT EXALIEF IS AND WHAT IT IS USED FOR Exalief belongs to a group of medicines called anti-epileptics used to treat epilepsy, a condition where someone has repeated seizures or fits. Exalief is used in adult patients who are already taking other anti-epileptic medicines and are still 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). Exalief has been given to you by your doctor to reduce your number of seizures. 2. BEFORE YOU TAKE EXALIEF DO NOT TAKE EXALIEF IF : • you are allergic (hypersensitive) to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients • you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block) TAKE SPECIAL CARE WITH EXALIEF Contact your doctor immediately if: • you have rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. These could be signs of an allergic reaction. • you suffer from confusion, worsening of seizures or decreased conscious Izlasiet visu dokumentu
1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Exalief 400 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of eslicarbazepine acetate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White circular biconvex tablets, engraved ‘ESL 400’on one side and scored on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Exalief must be 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 1200 mg once daily (see section 5.1). _Elderly (over 65 years of age) _ Caution should be exercised in the treatment of elderly patients as there is limited safety information on the use of Exalief in these patients. _Paediatric population _ The safety and efficacy of Exalief in children below 18 years has not yet been established. No data are available. _Patients with renal impairment _ Caution should be exercised in the treatment of patients 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 400 mg every other day for 2 weeks followed by a once daily dose of 400 mg. However, based on individual response, the dose may be increased. - CL CR <30 ml/min: use is not recommended in patients with severe renal impairment due to insufficient data _ _ _Patients with hepatic impairment _ No dose adjustment is needed in patients with mild to moderate hepatic impairment. The pharmacokinetics of eslicarbazep Izlasiet visu dokumentu