Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Ibuprofen
Pinewood Laboratories Ltd
M01AE01
Ibuprofen
200 mg/5ml
Oral suspension
ibuprofen
Not marketed
2020-12-18
PACKAGE LEAFLET: INFORMATION FOR THE USER FENOPINE FOR CHILDREN SIX PLUS STRAWBERRY 200 MG/5 ML ORAL SUSPENSION ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 Fenopine for Children is and what it is used for 2. What you need to know before you give/take Fenopine for Children 3. How to give/take Fenopine for Children 4. Possible side effects 5. How to store Fenopine for Children 6. Contents of the pack and other information 1. WHAT FENOPINE FOR CHILDREN IS AND WHAT IT IS USED FOR Fenopine for Children contains ibuprofen. Ibuprofen belongs to a group of medicines called Non- Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, and high body temperature. This product has been specifically formulated for children as it is given by mouth to: • reduce fever • relieve symptoms of mild to moderate pain For use in children from 20 kg body weight (6 years) to 40 kg body weight (12 years). 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE/TAKE FENOPINE FOR CHILDREN DO NOT GIVE/TAKE FENOPINE FOR CHILDREN IF YOU OR YOUR CHILD: • has an allergy or hypersensitivity to Ibuprofen or any of the other ingredients in this medicine (see _Section 6_ _and Section 2: Important information about ingredients_ ) • has had an allergic reaction or wheezing e.g. an asthma attack, runny nose, skin reaction or swelling after taking aspirin or other non-steroidal anti-inflammatory painkillers • has ever had a stomach ulcer Läs hela dokumentet
Health Products Regulatory Authority 20 December 2023 CRN00DXXS Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fenopine for Children Six Plus Strawberry 200mg/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of suspension contains 200 mg of ibuprofen. Excipients with known effect Liquid Maltitol 4.25 g/5 ml Sodium Benzoate (E 211) 10 mg/5 ml Propylene Glycol (E1520) 5.2 mg/5 ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension White/cream suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fenopine for Children is indicated in children aged 6 to 12 years. For the short-term symptomatic treatment of mild to moderate pain. For the short-term symptomatic treatment of fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For pain and fever: The daily dosage for children is 20-30mg/kg bodyweight in divided doses. Using the dosing device provided this can be achieved as follows: CHILD'S AGE (WEIGHT) QUANTITY AND METHOD OF ADMINISTRATION FREQUENCY (IN 24 HOUR PERIOD) 6-9 years (20-29 kg) 1 x 200 mg/5 ml (One 5 ml dose) 3 times 10-12 years (30-40 kg) 1 x 300 mg/7.5 ml (5 ml + 2.5 ml) 3 times Doses should be given approximately every 6 to 8 hours. For patients with sensitive stomachs it is recommended that Fenopine for Children is taken during a meal. _Not intended for children under 6 years of age or under 20kg._ Method of administration For oral use. For short-term use only If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Health Products Regulatory Authority 20 December 2023 CRN00DXXS Page 2 of 10 Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Special patient groups Renal insufficiency: (see section 5.2) No dose reduction is required in patients with mild to moderate impairment to renal function (patients with severe renal insufficiency, see section 4. Läs hela dokumentet