Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Ibuprofen
Imbat Limited
M01AE; M01AE01
Ibuprofen
100 mg/5ml
Oral suspension
Product not subject to medical prescription
Propionic acid derivatives; ibuprofen
Authorised
2013-10-11
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER NUROFEN ® FOR CHILDREN ORANGE 100MG/5ML ORAL SUSPENSION (ibuprofen) Your medicine is available using the above name but will be referred to as Nurofen for Children throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. IT CONTAINS IMPORTANT INFORMATION. KEEP THIS LEAFLET: YOU MIGHT NEED IT AGAIN. If you have any further questions after you have read it, ask your doctor or pharmacist. This medicine is designed to help bring down a high temperature and relieves pain from headaches, earache, sore throats, minor aches and sprains, cold and flu symptoms, teething and toothache. This medicine is suitable for most babies over 3 months of age, children and adults. FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. Section 3 shows the different amounts that children need. SPEAK TO YOUR DOCTOR IF YOUR CHILD: suffers from any of the conditions listed in Section 2 of the leaflet. is taking other medicines. See Section 2. is not getting better, or you feel at all concerned. See Section 3. develops a rash, breathing problems or diarrhoea and gets very tired. See Section 3. DO NOT USE THIS MEDICINE AND SPEAK TO YOUR DOCTOR IF YOU ARE PREGNANT, THINK YOU MAY BE PREGNANT OR TRYING TO GET PREGNANT OR ARE BREAST-FEEDING. See Section 2. IN THIS LEAFLET: 1. WHAT NUROFEN FOR CHILDREN IS AND WHAT IT IS USED FOR 2. 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 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 also reduces a high tempera Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen for Children Orange 100mg/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of suspension contains 100 mg Ibuprofen (equivalent to 2% w/v). Also contains maltitol syrup and sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. _Product imported from Spain:_ An off-white orange flavoured syrupy suspension. 4 CLINICAL PARTICULARS As per PA0979/032/001 5 PHARMACOLOGICAL PROPERTIES As per PA0979/032/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Maltitol syrup Citric acid Sodium citrate Sodium chloride Sodium saccharin Domiphen bromide Polysorbate 80 Xanthan gum Orange flavour Glycerol (E422) Purified water 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _8_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _3_ _6_ _7_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Amber-coloured 150 ml bottle with a 5 ml oral dosing syringe in an cardboard outer carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICIN Baca dokumen lengkapnya