Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Paracetamol; Codeine phosphate
Johnson & Johnson (Ireland) Limited
N02BE; N02BE51
Paracetamol; Codeine phosphate
500 mg/8 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Not marketed
1978-04-01
MIGRALEVE ® FILM COATED TABLETS MIGRALVE PINK MIGRALEVE YELLOW PARACETAMOL 500 MG, CODEINE PHOSPHATE 8 MG, PARACETAMOL 500 MG, BUCLIZINE HYDROCHLORIDE 6.25 MG CODEINE PHOSPHATE 8 MG READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However you still need to take MIGRALEVE® carefully to get the best results from it. ■ Keep this leaflet. You may need to read it again. ■ Ask your pharmacist if you need more information or advice. ■ You must contact a doctor if your symptoms worsen or do not improve after 3 days. ■ If any of the side-effects get serious or if you notice any side-effects not listed in this leaflet, please talk to your doctor or pharmacist. IN THIS LEAFLET 4. Possible side-effects 1. What MIGRALEVE® is and what it is used for 5. How to store MIGRALEVE® 2. Before you take MIGRALEVE® 6. Further information 3. How to take MIGRALEVE® 7. Facts about Migraine 1 WHAT MIGRALEVE® IS AND WHAT IT IS USED FOR MIGRALEVE® is a medicine which is used for the treatment of migraine attacks, including the symptoms of migraine headache, nausea and vomiting. There are two types of MIGRALEVE® tablet available: ■ MIGRALEVE® PINK tablets ■ MIGRALEVE® YELLOW tablets They are available separately or together in one pack. MIGRALEVE® PINK tablets contain paracetamol and codeine which eases pain and buclizine which helps relieve nausea and vomiting. The Pink tablets therefore treat all the symptoms of migraine. If taken at the first sign of a migraine, MIGRALEVE® Pink tablets can prevent an attack from developing. MIGRALEVE® YELLOW tablets contain paracetamol and codeine for the treatment of pain and relief of continuing migraine symptoms. They should always be taken after the first dose of MIGRALEVE® Pink tablets. MIGRALEVE® can be used in children over 12 years of age for the short term relief of moderate pain not relieved by other pain killers such as paracetamol or ibuprofen alone. MIGRALEVE® contains codeine. Cod Lire le document complet
Health Products Regulatory Authority 23 June 2022 CRN00CY7Z Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Migraleve Yellow Film-coated Tablets Paracetamol 500mg Codeine phosphate 8mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Migraleve Yellow tablet contains: Paracetamol 500 mg (as Paracetamol DC 96%). Codeine phosphate 8 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. (Tablet) Yellow film-coated capsule-shaped tablets engraved ‘MGE’ on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of migraine attacks which can include the symptoms of migraine headache, nausea and vomiting. Route of administration: oral. Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Do not take for more than 3 days continuously without medical review. If prescribed do not take for longer than directed. Codeine-containing products should be used at the lowest effective dose for the shortest period of time. Adults and the elderly: One to two Migraleve Pink tablets to be swallowed immediately it is known that a migraine attack has started or is imminent. If further treatment is required, one to two Migraleve Yellow tablets every 4-6 hours. Maximum dose: 8 tablets (two Migraleve Pink and six Migraleve Yellow) in 24 hours. Paediatric population: Children aged 16 – 18 years: One to two Migraleve Pink tablets to be swallowed immediately it is known that a migraine attack has started or is imminent. If further treatment is required, one to two Migraleve Yellow tablets every 6 hours. Maximum dose: 8 tablets (two Migraleve Pink and six Migraleve Yellow) in 24 hours. Children 12 – 15 years: One Migraleve Pink tablet to be swallowed immediately it is known that a migraine attack has started or is imminent. If further treatmen Lire le document complet