Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Ibuprofen
Reckitt Benckiser Ireland Ltd
M01AE; M01AE01
Ibuprofen
60 milligram(s)
Suppository
Product not subject to medical prescription
Propionic acid derivatives; ibuprofen
Marketed
2008-09-12
PACKAGE LEAFLET: INFORMATION FOR THE USER Nurofen for Children 60mg Suppositories Age 3 months to 2 years Ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet: you might need to read it again Ask your pharmacist if you need more information or advice If your child gets 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 your child does not feel better or if your child feels worse after 3 days. WHAT IS IN THIS LEAFLET: 1. What Nurofen for Children is and what it is used for 2. What you need to know before giving Nurofen for Children to your child 3. How to use Nurofen for Children 4. Possible side-effects 5. How to store Nurofen for Children 6. Contents of the pack and other information 1. WHAT NUROFEN FOR CHILDREN 60MG SUPPOSITORIES AGE 3 MONTHS TO 2 YEARS IS AND WHAT IT IS USED FOR? The active ingredient (which makes this medicine work) is ibuprofen which is a non-steroidal anti- inflammatory (NSAID) painkiller. Ibuprofen is used as an analgesic (painkiller) for the relief of teething and toothache pain, earache, headache, muscular minor aches and sprains, sore throats and cold and flu symptoms. Nurofen for Children Suppositories Age 3 months to 2 years also reduces a high temperature (fever). 2. WHAT YOU NEED TO KNOW BEFORE GIVING NUROFEN FOR CHILDREN SUPPOSITORIES AGE 3 MONTHS TO 2 YEARS TO YOUR CHILD This medicine is suitable for the majority of children but certain children should not use it. Talk to your pharmacist or doctor if you are at all unsure DO NOT GIVE THIS MEDICINE TO YOUR CHILD IF: They suffer from hypersensitivity to any of the ingredients in this medicine (see section 6) They have ever had a reaction (e.g. asthma, runny nose, rash, swelling of the face, tongue, lips or throat or stomach bl Læs hele dokumentet
Health Products Regulatory Authority 13 January 2023 CRN00D5XN Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen for Children 60 mg Suppositories Age 3 months to 2 years 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains: Ibuprofen 60 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suppository White or yellowy-white cylindrical suppositories 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of fever and relief of mild to moderate pain, such as teething pain, toothache, headache, sprains and strains and to ease the pain of sore throats and earache. Relief of pain and fever associated with colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For short term use only. Do not use in children under 3 months of age without medical advice. The maximum total daily dose of Nurofen for Children 60 mg Suppositories Age 3 months to 2 years is 20-30 mg/Kg of body weight, administered in three to four single doses. This can be achieved as follows: AGE (WEIGHT) SINGLE DOSE DAILY DOSE 3-9 months (6.0–8.0 Kg) 1 suppository 3 times a day, leaving 6-8 hours between doses 9 months -2 years (8.0–12.0 Kg) 1 suppository 4 times a day, leaving 6 hours between doses Do not use this product in children weighing less than 6kg. For children aged 3-5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. If in children aged from 6 months this medicinal product is required for 3 days, or if symptoms worsen a doctor should be consulted. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). METHOD OF ADMINISTRATION For rectal use only. 4.3 CONTRAINDICATIONS Patients with severe hepatic failure, severe renal failure or severe heart failure (see section 4.4). History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct Læs hele dokumentet