Nazione: Svezia
Lingua: svedese
Fonte: Läkemedelsverket (Medical Products Agency)
lakosamid
Medical Valley Invest AB
N03AX18
lacosamide
10 mg/ml
Sirap
metylparahydroxibensoat Hjälpämne; glycerol 85% Hjälpämne; sorbitol Hjälpämne; lakosamid 10 mg Aktiv substans
Receptbelagt
Förpacknings: Flaska, 200 ml (med doskopp och doseringsspruta)
Godkänd
2020-04-02
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT [LACOSAMIDE MEDICAL VALLEY] 10 MG/ML SYRUP 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 [invented name] is and what it is used for 2. What you need to know before you take [invented name] 3. How to take [invented name] 4. Possible side effects 5. How to store [invented name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR WHAT [INVENTED NAME] IS [invented name] 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 [INVENTED NAME] IS USED FOR - [invented name] 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 generalised epilepsy (the type of epilepsy that is thought to have a genetic cause). 2. WHAT YOU NEED TO KNOW BEFORE YOU Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Lacosamide Medical Valley] 10 mg/ml syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of syrup contains 10 mg lacosamide. 1 bottle of 200 ml contains 2,000 mg lacosamide. Excipients with known effect: Each ml of syrup contains 187 mg sorbitol (E 420), 2.27 mg methyl parahydroxybenzoate (E 218), and 1.35 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup A slightly viscous clear, colourless to yellow-brown liquid with the smell and taste of strawberries. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [invented name] 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. [invented name] 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 Leggi il documento completo