Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LACOSAMIDE
Helm AG Nordkanalstrasse 28 20097 HAMBURG (DUITSLAND)
N03AX18
LACOSAMIDE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Lacosamide
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROLOSE (E 463); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MAGNESIUMSTEARAAT (E 470b); POLYETHYLEENGLYCOL (E 1521); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-11-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Lacoala 50 mg filmomhulde tabletten Lacoala 100 mg filmomhulde tabletten Lacoala 150 mg filmomhulde tabletten Lacoala 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 Lacoala is and what it is used for 2. What you need to know before you take Lacoala 3. How to take Lacoala 4. Possible side effects 5. How to store Lacoala 6. Contents of the pack and other information 1. WHAT LACOALA IS AND WHAT IT IS USED FOR WHAT LACOALAIS Lacoala 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 Lacoala is used for • Lacoala is used in adults, adolescents and children aged 4 years and older. • It is used to treat a certain type of epilepsy called “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. • Lacoala may be used on its own or with other antiepileptic medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACOALA DO NOT TAKE LACOALA - if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in Section 6). If you are not sure whether you are allergic, please discuss with your doctor - if you have a certain type of heart beat problem called s Lees het volledige document
1. NAME OF THE MEDICINAL PRODUCT Lacoala 50 mg filmomhulde tabletten Lacoala 100 mg filmomhulde tabletten Lacoala 150 mg filmomhulde tabletten Lacoala 200 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lacoala 50 mg film-coated tablets Each film-coated tablet contains 50 mg lacosamide. Lacoala 100 mg film-coated tablets Each film-coated tablet contains 100 mg lacosamide. Lacoala 150 mg film-coated tablets Each film-coated tablet contains 150 mg lacosamide. Lacoala 200 mg film-coated tablets Each film-coated tablet contains 200 mg lacosamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Lacoala 50 mg film-coated tablets Pinkish, oval film-coated tablets with a size of appr. 10 mm x 5 mm, marked with ‘LAC’ on one side and ‘50’ on the other side. Lacoala 100 mg film-coated tablets Dark yellow, oval film-coated tablets with a size of appr. 13 mm x 6 mm, marked with ‘LAC’ on one side and ‘100’ on the other side. Lacoala 150 mg film-coated tablets Salmon, oval film-coated tablets with a size of appr. 15 mm x 7 mm, marked with ‘LAC’ on one side and ‘150’ on the other side. Lacoala 200 mg film-coated tablets Blue, oval film-coated tablets with a size of appr. 16.5 mm x 7.5 mm, marked with ‘LAC’ on one side and ‘200’ on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Lacoala is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lacosamide must be taken twice a day (usually once in the morning and once in the evening). Lacosamide may be taken with or without food. If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose within 6 hours of the next one, he/s Lees het volledige document