البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
Fampridine
Biogen Netherlands B.V.
N07XX07
fampridine
Other nervous system drugs
Multiple Sclerosis
Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale 4-7).
Revision: 16
Authorised
2011-07-20
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE USER FAMPYRA 10 MG PROLONGED-RELEASE TABLETS fampridine 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 Fampyra is and what it is used for 2. What you need to know before you take Fampyra 3. How to take Fampyra 4. Possible side effects 5. How to store Fampyra 6. Contents of the pack and other information 1. WHAT FAMPYRA IS AND WHAT IT IS USED FOR Fampyra contains the active substance fampridine which belongs to a group of medicines called potassium channel blockers. They work by stopping potassium leaving the nerve cells which have been damaged by MS. This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better. Fampyra is a medicine used to improve walking in adults (18 years and over) with Multiple Sclerosis (MS) related walking disability. In multiple sclerosis, inflammation destroys the protective sheath around the nerves leading to muscle weakness, muscle stiffness and difficulty walking. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMPYRA DO NOT TAKE FAMPYRA − if you are ALLERGIC to fampridine or any of the other ingredients of this medicine (listed in section 6) − if you have a seizure or have ever had a SEIZURE (also referred to as a fit or convulsion) − if your doctor or nurse has told you that you have moderate or severe KIDNEY PROBLEMS − if you are taking a medicine called cimetidine − if you are TAKING ANY OTHER MEDICINE CONTAINING FAMPRIDINE . This m اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fampyra 10 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 10 mg of fampridine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. An off-white, film coated, oval biconvex 13 x 8 mm tablet with flat edge debossed with A10 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with fampridine is restricted to prescription and supervision by physicians experienced in the management of MS. Posology The recommended dose is one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening). Fampridine should not be administered more frequently or at higher doses than recommended (see section 4.4). The tablets should be taken without food (see section 5.2). _Missed dose _ The usual dosing regimen should always be followed. A double dose should not be taken if a dose is missed. Starting and evaluating Fampyra treatment • Initial prescription should be limited to two to four weeks of therapy as clinical benefits should generally be identified within two to four weeks after starting Fampyra • An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW) or Twelve Item Multiple Sclerosis Walking Scale (MSWS-12), is recommended to evaluate improvement within two to four weeks. If no improvement is observed, the treatment should be discontinued • This medicinal product should be discontinued if benefit is not reported by patients. _ _ Re-evaluating Fampyra treatment If decline in walking ability is observed, physicians should consider an interruption to treatment in order to reassess the benefits of fampridine (see above). The re-evaluation should include withdrawal 3 of this medicinal produc اقرأ الوثيقة كاملة