Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ESLICARBAZEPINEACETAAT 600 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N03AF04
ESLICARBAZEPINEACETAAT 600 mg/stuk
Tablet
CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201)
Oraal gebruik
Eslicarbazepine
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ESLICARBAZEPINE ACETAAT EXELTIS 200 MG, TABLETTEN ESLICARBAZEPINE ACETAAT EXELTIS 400 MG, TABLETTEN ESLICARBAZEPINE ACETAAT EXELTIS 600 MG, TABLETTEN ESLICARBAZEPINE ACETAAT EXELTIS 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 Leggi il documento completo3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains the active substance eslicarbazepine acetate. belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits. 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). 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
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Eslicarbazepine Acetaat Exeltis 200 mg tabletten Eslicarbazepine Acetaat Exeltis 400 mg tabletten Eslicarbazepine Acetaat Exeltis 600 mg tabletten Eslicarbazepine Acetaat Exeltis 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 600 mg of eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate. [200 mg] Excipient(s) with known effect: sodium 1.05 mg. [400 mg] Excipient(s) with known effect: sodium 2.19 mg. [600 mg] Excipient(s) with known effect: sodium 3.26 mg. [800 mg] Excipient(s) with known effect: sodium 4.34 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Eslicarbazepine Acetaat Exeltis 200 mg tabletten 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. Eslicarbazepine Acetaat Exeltis 400 mg tabletten 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. Eslicarbazepine Acetaat Exeltis 600 mg tabletten White to off-white tablets, oblong and biconvex, with a break score on both sides with a length of about 17.0 mm and a thickness of about 5.7 mm. The tablet can be divided into equal doses. Eslicarbazepine Acetaat Exeltis 800 mg tabletten 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 Eslicarbazepine Acetaat Exeltis is indicated as: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; • adj Leggi il documento completo