Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Ibuprofen ph. eur.
Pinewood Laboratories Ltd
M01AE01
Ibuprofen ph. eur.
200/5 milligram(s)/millilitre
Oral suspension
Product subject to prescription which may be renewed (B)
ibuprofen
Not marketed
2019-02-01
PACKAGE LEAFLET: INFORMATION FOR THE USER FENOPINE 200 MG/5 ML ORAL SUSPENSION Ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING/GIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - 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. WHAT IS IN THIS LEAFLET 1. What Fenopine 200 mg/5 ml Oral Suspension is and what it is used for 2. What you need to know before you give/take Fenopine 200 mg/5 ml Oral Suspension 3. How to give/take Fenopine 200 mg/5 ml Oral Suspension 4. Possible side effects 5. How to store Fenopine 200 mg/5 ml Oral Suspension 6. Contents of the pack and other information _ _ 1. WHAT FENOPINE 200MG/5ML ORAL SUSPENSION IS AND WHAT IT IS USED FOR Fenopine 200 mg/5 ml Oral Suspension contains Ibuprofen as the active ingredient. This belongs to a group of medicines called NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). Fenopine 200 mg/5 ml Oral Suspension is given to children under 12 as a painkiller for relief of mild to moderate muscular pain, headache, teething pain and toothache. It also reduces the temperature in fever (e.g. colds, influenza and post-immunisation fever). For adults and children over 12 it can also be used for backache, migraines, neuralgia and relief from non-serious arthritic conditions. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE/TAKE FENOPINE 200 MG/5 ML ORAL SUSPENSION DO NOT GIVE/TAKE FENOPINE 200 MG/5 ML ORAL SUSPENSION 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 no Прочитајте комплетан документ
Health Products Regulatory Authority 17 July 2023 CRN00DM4T Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fenopine 200 mg/5 ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of suspension contains 200 mg of Ibuprofen. Excipients with known effect Liquid Maltitol 4.25g/5ml Sodium Benzoate (E 211) 10 mg/5ml Propylene Glycol (E1520) 5.2 mg/5ml 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 Children under 12 years Ibuprofen 200 mg/5 ml Oral Suspension is indicated for rheumatic or muscular pain, headache, dental pain, feverishness (including post-immunisation pyrexia), symptoms of cold and influenza. Over 12 years Ibuprofen 200 mg/5 ml Oral Suspension is indicated for R heumatic or muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Leave at least four hours between doses and do not take more than the recommended amount in any 24 hour period. Not to be given to children under 3 months of age, except on the advice of a doctor This product should only be given to infants who weigh more than 5kg. If in children aged from 6 months and in adolescents 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 persist. The daily dosage for children is 20- 30mg/kg bodyweight in divided doses. Using the dosing device provided this can be achieved as follows: 3 to 6 months (weighing more than 5 kg): 1.25ml (50mg), up to 3 times in 24 hour Прочитајте комплетан документ