Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Ibuprofen; Codeine phosphate hemihydrate
The Boots Company Plc
N02AJ; N02AJ08
Ibuprofen; Codeine phosphate hemihydrate
200 mg/12.8 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Opioids in combination with non-opioid analgesics; codeine and ibuprofen
Marketed
2010-12-17
INFORMATION FOR THE USER [BOOTS LOGO] Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets Ibuprofen, Codeine Phosphate Hemihydrate 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 has 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 within 3 days - This medicine can only be used for the short term treatment of acute moderate pain such as headaches, rheumatic and muscular pain, backache, migraine, period pain, dental pain and neuralgia that is not relieved by aspirin, ibuprofen or paracetamol alone - This medicine should only be taken when necessary - YOU SHOULD ONLY TAKE THIS PRODUCT FOR A MAXIMUM OF 3 DAYS at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice - THIS MEDICINE CONTAINS CODEINE WHICH CAN CAUSE ADDICTION if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it - IF YOU TAKE THIS MEDICINE FOR HEADACHES FOR MORE THAN 3 DAYS it can make them worse 1. What Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets are and what they are used for 2. What you need to know before you take Ibuprofen and Codeine 200 mg/12.8 mg film- coated tablets 3. How to take Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets 4. Possible side effects 5. How to store Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets 6. Contents of the pack and other information 1. WHAT IBUPROFEN AND CODEINE 200 MG/12.8 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR This medicine contains codeine. Codeine belongs to a group of medicine Izlasiet visu dokumentu
Health Products Regulatory Authority 11 May 2020 CRN009JN7 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Ibuprofen and Codeine 200mg / 12.8 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient mg/tablet Ibuprofen 200 mg Codeine Phosphate Hemihydrate 12.8 mg Excipients with known effect mg/tablet Sodium Starch Glycolate (Type A) 45 mg (11 mg Sodium) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film Coated Tablet (Tablet) White capsule-shaped tablet embossed with ‘I +’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is indicated in patients older than 12 years of age. For the short term treatment of acute moderate pain which is not considered to be relieved by other analgesics (e.g. paracetamol, ibuprofen or aspirin) alone, such as: rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). RECOMMENDED DOSAGE: _ADULTS OVER 18 YEARS:_ One or two tablets every four to six hours. Do not take more than 6 tablets in 24 hours. Leave at least four hours between doses. _CHILDREN AGED 12 YEARS TO 18 YEARS:_ The recommended dose for children 12 years and older is one or two tablets every 6 hours when necessary up to a maximum of 6 tablets in 24 hours. _CHILDREN UNDER 12 YEARS:_ This medicine 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 codeine to morphine (see sections 4.3 and 4.4). _ELDERLY:_ No special dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case dosage should be assessed individually. Do not take for more than 3 days continuously without medical review. The patien Izlasiet visu dokumentu