Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
SUMATRIPTAN SUCCINATE
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
N02CC01
SUMATRIPTAN SUCCINATE
50 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Selective serotonin (5HT1) agonists
Authorised
2012-01-27
IMIGRAN TM MIGRAINE RELIEF 50MG FILM-COATED TABLETS SUMATRIPTAN Package leaflet: Information for the user 1 WHAT THESE TABLETS DO 2 CHECK BEFORE YOU TAKE… 3 HOW TO TAKE THE TABLETS 4 POSSIBLE SIDE EFFECTS 5 STORING YOUR MEDICINE 6 MORE ABOUT THE MEDICINE 7 MORE ABOUT MIGRAINE READ THIS LEAFLET CAREFULLY BEFORE TAKING THESE TABLETS. REMEMBER THIS MEDICINE IS FOR YOU. Never give the tablets to someone else, because it may harm them, even if their symptoms seem to be the same as yours. KEEP THIS LEAFLET – you may need to read it again. It contains important information. If you have any further questions or there is anything you do not understand, ask your doctor or pharmacist. Throughout this leaflet, Imigran Migraine Relief 50mg film-coated tablets are referred to as Imigran Migraine Relief. If you have any further questions or there is anything you do not understand, ask your doctor or pharmacist. Throughout this leaflet, Imigran Migraine Relief 50mg film-coated tablets are referred to as Imigran Migraine Relief. 1 What these tablets do IMIGRAN MIGRAINE RELIEF IS USED TO TREAT MIGRAINE. These tablets contain sumatriptan, which belongs to a group of medicines called triptans _(5-HT¹ receptor agonists)_. Migraine symptoms may be caused by the temporary swelling of blood vessels in the head due to a temporary imbalance in the body’s natural chemicals. The tablets are believed to work on this imbalance and reduce the swelling of these blood vessels. The tablets help to take away the headache and other symptoms of a migraine attack such as feeling sick (nausea) and sensitivity to light and sound. Imigran Migraine Relief is also used for menstrual migraines. They start to relieve migraine headache about 30 minutes after you take them. 2 Check before you take… Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imigran Migraine Relief 50mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing 50mg of sumatriptan base as the succinate salt. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink film-coated, triangular shaped, biconvex, tablet debossed “GS 1YM” on one face and ‘50’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imigran tablets are indicated for the acute treatment of migraine attacks with or without aura, including the acute treatment of menstrually associated migraine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Imigran Migraine Relief is indicated for the acute intermittent treatment of migraine. Imigran Migraine Relief should not be used prophylactically. Imigran Migraine Relief is recommended as monotherapy for the acute treatment of a migraine and should not be given concomitantly with other acute migraine therapies. If a patient fails to respond to a single dose of Imigran Migraine Relief there are no reasons, either on theoretical grounds or from limited clinical experience, to withhold products containing aspirin or non-steroidal anti-inflammatory drugs for further treatment of the attack. It is advisable that Imigran Migraine Relief be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered. ADULTS ONLY: The recommended adult dose of oral Imigran Migraine Relief is a single 50mg tablet. Some patients may require 100mg. If a patient does not respond to the first dose of Imigran Migraine Relief, a second dose should not be taken for the same attack. Imigran Migraine Relief may be taken for subsequent attacks. If th Přečtěte si celý dokument