Country: Malta
Language: English
Source: Malta Medicines Authority
Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece
N03AX18
LACOSAMIDE 10 mg/ml
SYRUP
LACOSAMIDE 10 mg/ml
POM
ANTIEPILEPTICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-06-16
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ANLAMYL 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 Anlamyl is and what it is used for 2. What you need to know before you take Anlamyl 3. How to take Anlamyl 4. Possible side effects 5. How to store Anlamyl 6. Contents of the pack and other information 1. WHAT ANLAMYL IS AND WHAT IT IS USED FOR WHAT ANLAMYL IS Anlamyl 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 ANLAMYL IS USED FOR Anlamyl 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANLAMYL DO NOT TAKE ANLAMYL • if you are allergic to lacosamide, or Read the complete document
OGYÉI/34127/2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Anlamyl 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 Anlamyl syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg sodium and 0.032 mg aspartame (E951). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup. A slightly viscous clear, colourless to yellow-brown liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anlamyl 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. Anlamyl 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 2 2 STARTING DOSE TITRATION (INCREMENTAL STEPS) Read the complete document