País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
PARACETAMOL, CODEINE PHOSPHATE, BUCLIZINE HYDROCHLORIDE
McNeil Healthcare (Ireland) Ltd
N02BE51
PARACETAMOL, CODEINE PHOSPHATE, BUCLIZINE HYDROCHLORIDE
500/8/6.25 Milligram
Film Coated Tablet
Product not subject to medical prescription
Analgesics and antipyretics
Authorised
1998-04-01
! ! Paracetamol 500 mg, Codeine phosphate 8 mg, Buclizine hydrochloride 6.25 mg Paracetamol 500 mg, Codeine phosphate 8 mg, X turn over ! ! ! ! ! ! i i i 17-0244 364902F _HEALTHCARE (IRELAND) LTD._ i 12 tablet pack containing 8 MIGRALEVE ® PINK and 4 MIGRALEVE ® YELLOW tablets packs of 12 tablets MIGRALEVE ® PINK MIGRALEVE ® PACKS ON SALE IN YOUR PHARMACY FREQUENCY UNKNOWN: ■ Agitation, addiction or withdrawal symptoms (e.g., tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly). ■ Breathing difficulty. People who use medicines containing paracetamol every day for a long time could get certain side-effects, including liver and kidney damage. People taking paracetamol in the usual way for shorter periods have not had these problems, but liver function tests may be affected. REPORTING OF SIDE-EFFECTS: If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +35316764971; Fax: +35316762517 Website: www.hpra.ie; Email: medsafety@hpra.ie. By reporting effects you can help provide more information on the safety of the medicine. 5 HOW TO STORE MIGRALEVE ® Do not store above 30˚C. Keep the product out of the sight and reach of children. Do not use after the expiry date printed on the carton and blister. 6 FURTHER INFORMATION WHAT’S IN THIS MEDICINE? THE ACTIVE INGREDIENTS IN EACH MIGRALEVE ® PINK TABLET ARE: Paracetamol 500 mg, Codeine phosphate 8 mg and Buclizine hydrochloride 6.25 mg. OTHER INGREDIENTS ARE: magnesium stearate, colloidal anhydrous silica, stearic acid, pregelatinised maize starch, gelatin, hypromellose, macrogol, E127 (erythrosine), aluminium oxide and E171 (titanium dioxide). THE ACTIVE INGREDIENTS IN EACH MIGRALEVE ® YELLOW TABLET ARE: Paracetamol 500 mg and Codeine phosphate 8 mg. OTHER INGREDIENTS ARE Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Migraleve Pink Film-coated Tablets Paracetamol 500mg Codeine Phosphate 8mg Buclizine Hydrochloride 6.25mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Migraleve Pink tablet contains: Paracetamol 500 mg (as Paracetamol DC 96%), Codeine phosphate 8 mg, Buclizine hydrochloride 6.25 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. (Tablet) Pink 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. Adults, children 16 years and over, and the elderly: 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, two Migraleve Yellow tablets every 4 hours. Maximum dose: 8 tablets (two Migraleve Pink and six Migraleve Yellow) in 24 hours. Paediatric population: 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 treatment is required, one Migraleve Yellow tablet every 4 hours. Maximum dose: 4 tablets (one Migraleve Pink and three Migraleve Yellow) in 24 hours. Children aged below 12 years: Do not give to children under 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see Section 4.3 and Section 4.4). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ Leia o documento completo