Država: Nizozemska
Jezik: nizozemski
Izvor: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ESLICARBAZEPINEACETAAT
Stada Arzneimittel AG
N03AF04
ESLICARBAZEPINEACETAAT
Tablet
CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201)
Oraal gebruik
Eslicarbazepine
2019-08-28
PACKAGE LEAFLET: INFORMATION FOR THE USER Feoxan 200 mg tabletten Feoxan 400 mg tabletten Feoxan 800 mg tabletten 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. Whatis and what it is used for 2. What you need to know before you take Pročitajte cijeli dokument3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT FEOXAN 200MG, 400 MG, 800 MG IS AND WHAT IT IS USED FOR Feoxan 200mg, 400 mg, 800 mg contains the active substance eslicarbazepine acetate. Feoxan 200mg, 400 mg, 800 mg belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits. Feoxan 200mg, 400 mg, 800 mg 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). Feoxan 200mg, 400 mg, 800 mg has been given to you by your doctor to reduce your number of seizures. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE : if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epile
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Feoxan 200 mg tabletten Feoxan 400 mg tabletten Feoxan 800 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of eslicarbazepine acetate. Each tablet contains 400 mg of eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate. Excipient with known effect [200 mg] : Each tablet contains 1,09 mg sodium [400 mg] : Each tablet contains 2,17 mg sodium [800 mg] : Each tablet contains 4,35 mg sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet.200 mg tablets White to off-white tablets, oblong and biconvex, with a break score on both sides with a length of about 11.8 mm and a thickness of about 3.9 mm. The tablet can be divided into equal doses. Pročitajte cijeli dokument400 mg tablets White to off-white tablets, oblong and biconvex, with a break score on both sides with a length of about 15.0 mm and a thickness of about 4.9 mm. The tablet can be divided into equal doses. 800 mg tablets White to off-white tablets, oblong and biconvex, with a break score on both sides with a length of about 18.9 mm and a thickness of about 6.1 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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_ 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