País: Israel
Língua: inglês
Origem: Ministry of Health
FAMPRIDINE
MEDISON PHARMA LTD
N07XX07
TABLETS PROLONGED RELEASE
FAMPRIDINE 10 MG
PER OS
Required
BIOGEN IDEC LTD, UK
FAMPRIDINE
FAMPRIDINE
FAMPYRA is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7)
2017-03-31
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only FAMPYRA 10 MG PROLONGED-RELEASE TABLETS ACTIVE INGREDIENT: EACH TABLET CONTAINS: fampridine 10 mg INACTIVE INGREDIENTS AND ALLERGENS: See section 6 (Additional information). READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. • If you have any further questions, consult your doctor or pharmacist. • This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? FAMPYRA is intended to improve walking in adult patients with multiple sclerosis suffering from walking problems (EDSS 4-7). THERAPEUTIC GROUP: pyridine isomer, potassium channel blocker. In multiple sclerosis, inflammatory process destroys the protective myelin sheath around the neurons (nerve cells) leading to muscle weakness, muscle stiffness and difficulty walking. FAMPYRA belongs to a group of medicines blocking potassium channels; these medicines prevent potassium from leaving the neurons which have been damaged by multiple sclerosis, thus enabling signal passage in the neurons and allowing improvement of walking. 2. BEFORE USING THIS MEDICINE: DO NOT USE THIS MEDICINE IF: • you are SENSITIVE (allergic) to fampridine or any of the other ingredients of this medicine (see section 6) • you currently suffer or have ever suffered from SEIZURES • you suffer from MODERATE TO SEVERE KIDNEY PROBLEMS • you are taking a medicine containing the active ingredient cimetidine • you are taking any OTHER MEDICINE CONTAINING FAMPRIDINE. This may increase your risk of serious side effects. SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE USING FAMPYRA, TELL YOUR DOCTOR OR PHARMACIST IF: • you feel your heartbeats (palpitations). • you are prone to infections. • you need a walkin Leia o documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 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 Fampyra 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). Fampyra 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). 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, Fampyra should be discontinued • Fampyra 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 Fampyra (see above). The re-evaluation should include withdrawal of Fampyra and performing an assessment of walking ability. Fampyra should be discontinued if patients 2 no longer receive walking benefit. Missed Dose The usual dosing regimen should always b Leia o documento completo