Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
lacosamide
UCB Pharma S.A.
N03AX18
lacosamide
Antiepileptics,
Epilepsies, Partial
Lacosamide UCB 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.,
Revision: 6
Authorised
2019-08-26
121 B. PACKAGE LEAFLET 122 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LACOSAMIDE UCB 50 MG FILM-COATED TABLETS LACOSAMIDE UCB 100 MG FILM-COATED TABLETS LACOSAMIDE UCB 150 MG FILM-COATED TABLETS LACOSAMIDE UCB 200 MG FILM-COATED TABLETS 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 Lacosamide UCB is and what it is used for 2. What you need to know before you take Lacosamide UCB 3. How to take Lacosamide UCB 4. Possible side effects 5. How to store Lacosamide UCB 6. Contents of the pack and other information 1. WHAT LACOSAMIDE UCB IS AND WHAT IT IS USED FOR WHAT LACOSAMIDE UCB IS Lacosamide UCB 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 LACOSAMIDE UCB IS USED FOR • Lacosamide UCB 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 year and older to treat primary generalised tonic-clonic seizures (major fits, including loss of con Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 50 mg film-coated tablets Lacosamide UCB 100 mg film-coated tablets Lacosamide UCB 150 mg film-coated tablets Lacosamide UCB 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lacosamide UCB 50 mg film-coated tablets Each film-coated tablet contains 50 mg lacosamide. Lacosamide UCB 100 mg film-coated tablets Each film-coated tablet contains 100 mg lacosamide. Lacosamide UCB 150 mg film-coated tablets Each film-coated tablet contains 150 mg lacosamide. Lacosamide UCB 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 Lacosamide UCB 50 mg film-coated tablets Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed with ‘SP’ on one side and ‘50’ on the other side. Lacosamide UCB 100 mg film-coated tablets Dark yellow, oval film-coated tablets with approximate dimensions of 13.2 mm x 6.1 mm, and debossed with ‘SP’ on one side and ‘100’ on the other side. Lacosamide UCB 150 mg film-coated tablets Salmon, oval film-coated tablets with approximate dimensions of 15.1 mm x 7.0 mm, and debossed with ‘SP’ on one side and ‘150’ on the other side. Lacosamide UCB 200 mg film-coated tablets Blue, oval film-coated tablets with approximate dimensions of 16.6 mm x 7.8 mm, and debossed with ‘SP’ on one side and ‘200’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lacosamide UCB 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. Lacosamide UCB is indicated as adjunctive therapy 3 • 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 Lesen Sie das vollständige Dokument