Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Ibuprofen
Pinewood Laboratories Ltd
M01AE; M01AE01
Ibuprofen
100 mg/5ml
Oral suspension
Product not subject to medical prescription
Propionic acid derivatives; ibuprofen
Marketed
2010-09-03
PACKAGE LEAFLET: INFORMATION FOR THE USER FENOPINE 100 MG/5 ML ORAL SUSPENSION IBUPROFEN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. 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/your child does not feel better or if you/your child feel worse after 1 day (infants 3-6 months weighing more than 5 kg) or 3 days (children aged over 6 months). WHAT IS IN THIS LEAFLET 1. What Ibuprofen Oral Suspension is and what it is used for 2. What you need to know before you give Ibuprofen Oral Suspension 3. How to give Ibuprofen Oral Suspension 4. Possible side effects 5. How to store Ibuprofen Oral Suspension 6. Contents of the pack and other information 1. WHAT IBUPROFEN ORAL SUSPENSION IS AND WHAT IT IS USED FOR Ibuprofen Oral Suspension contains Ibuprofen as the active ingredient. This belongs to a group of medicines called NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). Ibuprofen Oral Suspension is used for the treatment of fever and of mild to moderate pain in children aged from 3 months (weighing over 5 kg) to 12 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE IBUPROFEN ORAL SUSPENSION DO NOT GIVE THIS MEDICINE IF YOUR CHILD : • is allergic (hypersensitive) to ibuprofen or any of the other ingredients in this medicine ( _see_ _Section 6_ ) • has had an asthma attack, runny nose, skin reactions (e.g. reddening, hives) after taking aspirin or other non-steroidal anti-inflammatory painkillers • has (or has had two or more episodes of) a stomach ulcer, perforation or bleeding • has severe kidney, heart or liver problems • is sufferin Citiți documentul complet
Health Products Regulatory Authority 17 July 2023 CRN00DM10 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fenopine 100mg/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of suspension contains100 mg of Ibuprofen. Excipients with known effect Liquid Maltitol (E965) 1ml/5ml Sodium Methyl Parahydroxybenzoate (E219) 9.0mg/5ml Sodium Propyl Parahydroxybenzoate (E217) 1.0mg/5ml Propylene Glycol (E1520) 5.2 mg/5ml For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral suspension White uniform suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fenopine 100 mg/5 ml Paediatric Oral Suspension is indicated for the symptomatic treatment of fever and of mild to moderate pain in children from 3 months weighing more than 5 kg to 12 years only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology If in children aged from 6 months this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. For infants aged 3-5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persists. Doses should be given approximately every 6 to 8 hours. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Paediatric population: This product is not recommended for use in children below 3 months (5 kg), as there is insufficient experience of treatment in children of that age with ibuprofen. The daily dosage is 20-30 mg/kg bodyweight in divided doses. Using the dosing device provided this can be achieved as follows: Infants 3 – 6 months weighing more than 5 kg: One 2.5 ml (50 mg) dose Ibuprofen may be taken 3 times in 24 hours. Infants 6 – 12 months (weighing 8 – 10 kg): One 2.5 ml (50 mg) dose Ibuprofen may be taken 3 times in 24 hours. Infants and children 1 – 3 years (weighing 10 – 15 kg): One 5.0 ml (100 mg) dose Ibuprofen may be taken 3 times in 24 hours. Children 4 – 6 y Citiți documentul complet