Nchi: Uholanzi
Lugha: Kiholanzi
Chanzo: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LACOSAMIDE 50 mg/stuk
Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)
N03AX18
LACOSAMIDE 50 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E 1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Lacosamide
2018-04-18
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Zilibra 50 mg filmomhulde tabletten Zilibra 100 mg filmomhulde tabletten Zilibra 150 mg filmomhulde tabletten Zilibra 200 mg filmomhulde tabletten Lacosamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 Zilibra is and what it is used for 2. What you need to know before you take Zilibra 3. How to take Zilibra 4. Possible side effects 5. How to store Zilibra 6. Contents of the pack and other information 1. WHAT ZILIBRA IS AND WHAT IT IS USED FOR WHAT ZILIBRA IS Zilibra contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy. - You have been given this medicine to lower the number of fits (seizures) you have. WHAT ZILIBRA IS USED FOR Zilibra is used: - on its own and in association with other antiepileptic medicines in adults, adolescents and children aged 2 years and older to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain; - in association with other antiepileptic medicines in adults, adolescents and children aged 4 years and older to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause). 2 Soma hati kamili
1 1. NAME OF THE MEDICINAL PRODUCT Zilibra 50 mg filmomhulde tabletten Zilibra 100 mg filmomhulde tabletten Zilibra 150 mg filmomhulde tabletten Zilibra 200 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zilibra 50 mg filmomhulde tabletten Each film-coated tablet contains 50 mg lacosamide. Zilibra 100 mg filmomhulde tabletten Each film-coated tablet contains 100 mg lacosamide. Zilibra 150 mg filmomhulde tabletten Each film-coated tablet contains 150 mg lacosamide. Zilibra 200 mg filmomhulde tabletten Each film-coated tablet contains 200 mg lacosamide. 3. PHARMACEUTICAL FORM Film-coated tablet Zilibra 50 mg filmomhulde tabletten Pinkish, oval film-coated tablets with approximate dimensions of 10 mm x 5 mm and debossed with ‘LAC’ on one side and ‘50’ on the other side. Zilibra 100 mg filmomhulde tabletten Dark yellow, oval film-coated tablets with approximate dimensions of 13 mm x 6 mm and debossed with‘LAC’ on one side and ‘100’ on the other side. Zilibra 150 mg filmomhulde tabletten Salmon, oval film-coated tablets with approximate dimensions of15 mm x 7 mm and debossed with ‘LAC’ on one side and ‘150’ on the other side. Zilibra 200 mg filmomhulde tabletten Blue, oval film-coated tablets with approximate dimensions of 16.5 mm x 7.5 mm and debossed with ‘LAC’ on one side and ‘200’ on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Zilibra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Zilibra is indicated as adjunctive therapy - in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. - in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The physician shoul Soma hati kamili