Држава: Малта
Језик: Енглески
Извор: Medicines Authority
ELETRIPTAN HYDROBROMIDE
Pfizer Hellas S.A.
N02CC06
ELETRIPTAN HYDROBROMIDE
FILM-COATED TABLET
ELETRIPTAN HYDROBROMIDE 20 milligram(s)
POM
ANALGESICS
Authorised
2013-10-28
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER ELETRIPTAN 20 AND 40MG FILM-COATED TABLETS ELETRIPTAN 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 Eletriptan is and what it is used for 2. What you need to know before you take Eletriptan 3. How to take Eletriptan 4. Possible side effects 5. How to store Eletriptan 6. Contents of the pack and other information 1. WHAT ELETRIPTAN IS AND WHAT IT IS USED FOR Eletriptan contains the active substance eletriptan. Eletriptan is one of a group of medicines called serotonin receptor agonists. Serotonin is a natural substance found in the brain that helps to narrow the blood vessels. Eletriptancan be used to treat migraine headache with or without aura in adults. Before the start of a migraine headache, you may experience a phase called an aura, which can involve vision disorders, numbness and speech disorders. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELETRIPTAN DO NOT TAKE ELETRIPTAN: • If you are allergic (hypersensitive) to eletriptan, or any of the other ingredients of this medicine (listed in section 6). • If you have severe liver or kidney disease. • If you have moderate to severe high blood pressure or untreated mild high blood pressure. • If you have ever had heart problems, [e.g. heart attack, angina, heart failure or significant abnormal heart rhythm (arrhythmia), temporary, sudden narrowing of one of the coronary arteries]. • If you have poor circulation (peripheral vascular disease). • If you have ever had a stroke Прочитајте комплетан документ
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Eletriptan 20 mg film-coated tablets Eletriptan 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Eletriptan 20 mg film-coated tablets Each film-coated tablet contains 20 mg eletriptan (as hydrobromide). Excipients with known effect: Each film-coated tablet contains 23 mg lactose and 0.036 mg Sunset yellow Eletriptan 40 mg film-coated tablets Each film-coated tablet contains 40 mg eletriptan (as hydrobromide). Excipients with known effect: Each film-coated tablet contains 46 mg lactose and 0.072 mg Sunset yellow For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Eletriptan 20 mg film-coated tablets Round, convex, orange, of dimension 6.25 mm, debossed with ‘REP 20’ on one side and ‘Pfizer’ on the other. Eletriptan 40 mg film-coated tablets Round, convex, orange, of dimension 8 mm, debossed with ‘REP 40’ on one side and ‘Pfizer’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eletriptan is indicated in adults for acute treatment of the headache phase of migraine attacks, with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Eletriptan tablets should be taken as early as possible after the onset of migraine headache but they are also effective if taken at a later stage during a migraine attack. Page 2 of 12 Eletriptan, if taken during the aura phase, has not been demonstrated to prevent migraine headache and therefore Eletriptan should only be taken during the headache phase of migraine. _ _ Eletriptan tablets should not be used prophylactically _. _ _ _ _Adults (18-65 years of age): _ The recommended initial dose is 40 mg. _If headache returns within 24 hours_ : If the migraine headache recurs within 24 hours of an initial response, a second dose of the same strength of Eletriptan has been shown to be effective in treating the recurrence. If a second dose is required, it should not be taken within 2 hours of the initial d Прочитајте комплетан документ