Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Paracetamol; Codeine phosphate hemihydrate; Caffeine
Clonmel Healthcare Ltd
N02BE; N02BE51
Paracetamol; Codeine phosphate hemihydrate; Caffeine
500/8/30 milligram(s)
Effervescent tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
2002-10-11
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER MAXILIEF EFFERVESCENT TABLETS Paracetamol 500mg Codeine Phosphate Hemihydrate 8mg Caffeine 30mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What Maxilief Effervescent Tablets are and what they are used for 2. What you need to know before you take Maxilief Effervescent Tablets 3. How to take Maxilief Effervescent Tablets 4. Possible side effects 5. How to store Maxilief Effervescent Tablets 6. Contents of the pack and other information. 1. WHAT MAXILIEF EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR Maxilief Effervescent Tablets contain paracetamol 500 mg, codeine phosphate hemihydrate 8 mg and caffeine 30 mg. Paracetamol is an analgesic (a painkiller) and an antipyretic (reduces fever). This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. Codeine phosphate hemihydrate also has some weak cough suppressant action. Caffeine is a stimulant which acts to enhance the analgesic effects of paracetamol. Maxilief Effervescent Tablets are used for the relief of headache, including migraine, musculoskeletal pain, toothache, backache, common cold, influenza and menstrual pain. Codeine can be used in children over 12 years of age for the short-term relief of acute moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alo Läs hela dokumentet
Health Products Regulatory Authority 19 May 2022 CRN00CWMM Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Maxilief Effervescent Tablets Paracetamol 500mg Codeine Phosphate Hemihydrate 8mg Caffeine 30mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500mg, Codeine Phosphate 8mg and Caffeine 30mg. Excipients with known effect: Sorbitol (E420) 50mg and Sodium 388mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent Tablets Flat, white, bevelled-edge tablets, scored on one side and plain on reverse. The scoreline is only to facilitate breaking and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of symptoms of headache, including migraine, musculoskeletal pain, toothache, backache, common cold, influenza and menstrual pain. 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 For oral administration only. Adults (including the elderly) Two tablets dissolved in a glass of water three to four times in a 24 hour period as required. The dose should not be repeated more frequently than every 6 hours. A maximum of 8 tablets in 24 hours should not be exceeded. Paediatric population: Maxilief is contraindicated in children below the age of 12 years for the symptomatic treatment of cold (see section 4.3). _Children aged 16 to 18 years:_ One to two tablets dissolved in a glass of water every 6 hours when necessary up to a maximum of 8 tablets in 24 hours. _Children aged 12 to 15 years:_ One tablet dissolved in a glass of water every 6 hours when necessary up to a maximum of four tablets in 24 hours. _Children aged less than 12 years:_ Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codei Läs hela dokumentet