Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Ibuprofen
PCO Manufacturing Ltd.
M01AE01
Ibuprofen
100 mg/5ml
Oral suspension
Product not subject to medical prescription
ibuprofen
Authorised
2014-08-15
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER NUROFEN ® FOR CHILDREN ORANGE 100 MG/5 ML ORAL SUSPENSION ibuprofen 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. FURTHER 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. lbuprofen 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 temperature (fever). 2. BEFORE GIVING NUROFEN FOR CHILDREN TO YOUR CHILD This medicine is suitable for the majority of people, but certain people should not use it. Talk Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 08 March 2021 CRN00C00D Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen for Children Orange 100 mg/5 ml oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen 100 mg/5 ml (equivalent to 2.0% w/v) Excipients with known effect Maltitol syrup Sodium Wheat starch For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension _Product imported from Greece_ 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 (contains wheat starch) Glycerin Purified Water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 08 March 2021 CRN00C00D Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. 6.5 NATURE AND CONTENTS OF CONTAINER Amber-coloured bottle with a child-resistant closure fitted with a liner. The bottle contains 150 ml of product. The bottle has an insert included in the bottleneck to facilitate the use of the syringe. The product is supplied with the following dosing device: O A 5 ml oral dosing syringe, comprised of an orange piston and a clear barrel. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING Shake the bottle before use. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/337/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 th August 2014 10 DATE OF REVISION OF THE TEXT March 2021 Διαβάστε το πλήρες έγγραφο