Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Eletriptan hydrobromide
Dowelhurst Ltd
N02CC06
Eletriptan hydrobromide
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401
PACKAGE LEAFLET: INFORMATION FOR THE USER. RELPAX® 40MG FILM-COATED TABLETS (eletriptan hydrobromide) 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. The name of your medicine is Relpax 40mg film-coated tablets but will be referred to as Relpax throughout the remainder of the leaflet. Relpax is also available in 20mg strength. WHAT IS IN THIS LEAFLET 1. WHAT RELPAX IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RELPAX 3. HOW TO TAKE RELPAX 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE RELPAX 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT RELPAX IS AND WHAT IT IS USED FOR 1. WHAT RELPAX IS AND WHAT IT IS USED FOR Relpax contains the active substance eletriptan. Relpax 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. Relpax can 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 RELPAX YOU TAKE DO NOT TAKE RELPAX: • 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 he Lue koko asiakirja
1. NAME OF THE MEDICINAL PRODUCT RELPAX 40 mg film coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION RELPAX 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. RELPAX 40 mg film-coated tablets Round, convex orange tablets debossed with ‘REP 40’ on one side and ‘Pfizer’ on the other. 4.1 THERAPEUTIC INDICATIONS RELPAX is indicated in adults for the acute treatment of the headache phase of migraine attacks, with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology RELPAX 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. RELPAX, if taken during the aura phase, has not been demonstrated to prevent migraine headache and therefore RELPAX should only be taken during the headache phase of migraine._ _ RELPAX 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 RELPAX 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 dose. _If no response is obtained:_ If a patient does not achieve a headache response to the first dose of RELPAX within 2 hours, a second dose should not be taken for the same attack as clinical trials have not adequately established efficacy with the second dose. Clinical trials show that patients who do not respond to the treatment of an attack are still likely to respond to the treatment of a subsequent attack_. _ Patients who do not obtain satisfactory efficacy after an appropriate trial of 40 mg, (e.g. good tolerability and fa Lue koko asiakirja