Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
amifampridine
SERB SA
N07XX05
amifampridine
Other nervous system drugs
Lambert-Eaton Myasthenic Syndrome
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Revision: 21
Authorised
2009-12-23
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER FIRDAPSE 10 MG TABLETS amifampridine This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 FIRDAPSE is and what it is used for 2. What you need to know before you take FIRDAPSE 3. How to take FIRDAPSE 4. Possible side effects 5. How to store FIRDAPSE 6. Contents of the pack and other information 1. WHAT FIRDAPSE IS AND WHAT IS IT USED FOR FIRDAPSE is used to treat symptoms of a disease of the nerves and the muscles called Lambert-Eaton myasthenic syndrome or LEMS in adults. This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness. It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS). In patients suffering from this disease, a chemical substance called acetylcholine, which communicates nerve impulses to muscles is not released normally and the muscle doesn't receive some or all of the nerve's signals. FIRDAPSE works by increasing the release of acetylcholine and helps the muscle to receive the nerve signals. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FIRDAPSE DO NOT TAKE FIRDAPSE If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, round tablet, flat-faced on one side and scored on the other side. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. Posology FIRDAPSE should be given in divided doses, three or four times a day. The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day. No single dose should exceed 20 mg. Tablets are to be taken with food. Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state. If treatment is discontinued, patients may experience some of the symptoms of LEMS. _Renal or hepatic impairment _ FIRDAPSE should be used with caution in patients with renal or hepatic impairment. A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function. For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended. Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days. If any adverse reaction Lees het volledige document