Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Lacosamide
KRKA, d.d., Novo mesto
N03AX18
Lacosamide
50 milligram(s)
Film-coated tablet
lacosamide
Marketed
2020-09-25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LACOSAMIDE KRKA 50 MG FILM-COATED TABLETS LACOSAMIDE KRKA 100 MG FILM-COATED TABLETS LACOSAMIDE KRKA 150 MG FILM-COATED TABLETS LACOSAMIDE KRKA 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 Krka is and what it is used for 2. What you need to know before you take Lacosamide Krka 3. How to take Lacosamide Krka 4. Possible side effects 5. How to store Lacosamide Krka 6. Contents of the pack and other information 1. WHAT LACOSAMIDE KRKA IS AND WHAT IT IS USED FOR WHAT LACOSAMIDE KRKA IS Lacosamide Krka 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 KRKA IS USED FOR - It is used: o 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. o 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 g Lestu allt skjalið
Health Products Regulatory Authority 02 January 2024 CRN00DWTP Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lacosamide Krka 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg lacosamide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pale off-pink, oval, biconvex, film-coated tablets engraved with 50 on one side, tablet dimension: approx. 11 x 5 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lacosamide Krka 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 Krka 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The physician should prescribe the most appropriate formulation and strength according to weight and dose. The recommended posology for adults, adolescents and children from 2 years of age is summarised in the following table. Lacosamide must be taken twice a day, approximately 12 hours apart. 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/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. Patients should not take a double dose. ADOLESCENTS AND CHILDREN WEIGHING 50 KG OR MORE, AND ADULTS STARTING DOSE TITRATION (INCREMENTAL STEPS) MAXIMUM RECOMMENDED DOSE MONOTHERAPY: 50 mg twice a day (100 mg/day) or 100 mg twice a day (200 m Lestu allt skjalið