País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
IBUPROFEN
McNeil Healthcare (Ireland) Ltd
M01AE01
IBUPROFEN
100 MG/5ml
Oral Suspension
Product not subject to medical prescription
Propionic acid derivatives
Authorised
2006-05-26
PIL‐ tracked V4 24.07.2017 Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER PROVIN 100MG/5ML 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, pharmacist or nurse has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If your child gets 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 your child does not feel better or feels worse after 3 days or for infants aged 3 -5 months, after 24 hours. WHAT IS IN THIS LEAFLET 1. What Provin Oral Suspension is and what it is used for. 2. What you need to know before you use Provin Oral Suspension 3. How to use Provin Oral Suspension 4. Possible side effects 5. How to store Provin Oral Suspension 6. Contents of the pack and other information 1 WHAT PROVIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory painkillers (NSAIDs). This medicine is used for the relief of pain from teething and toothache, earache, backache, minor muscular pains, aches and sprains. It can also be used to bring down high temperature (also called fever) and relieve the symptoms of colds and flu. This product is intended for use in children aged 3 months to 12 years. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE PROVIN ORAL SUSPENSION X DO NOT GIVE YOUR CHILD THIS MEDICINE: If s/he is allergic to ibuprofen or any of the ingredients of this medicine (listed in section 6). If s/he has had a BAD ALLERGIC REACTION (e.g. asthma, runny nose, swelling of face, tongue and throat, rash) after taking Ibuprofen, or any other ingredient (see section 6), ASPIRIN or NON-STEROIDAL ANTI- INFLAMMATORY (NSAIDS) PAINKILLERS . If s/he weighs less than 5 kg. If Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Provin 100 mg / 5 ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen 100 mg/5ml. Excipients with known effect : Sodium methylhydroxybenzoate (E219) - 9mg per 5ml Sodium propylhydroxybenzoate (E217) - 1mg per 5ml Maltitol - 1ml per 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 Ibuprofen 100 mg/5 ml Oral Suspension is used as an analgesic for relief of mild to moderate muscular pain, symptomatic relief of headache, earache, dental pain and backache. It can also be used in minor injuries such as sprains and strains. Ibuprofen 100 mg/5 ml Oral Suspension is effective in the relief of feverishness and 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). _Children:_ Not recommended for children weighing less than 5 kg. For pain and fever - 20mg/kg/day in divided doses Infants 3-6 months weighing more than 5kg: One 2.5ml dose may be taken 3 times in 24 hours Infants 6-12 months: 2.5ml three times a day. Children 1-2 years: 2.5ml three to four times a day Children 3-7 years: 5ml three to four times a day Children 8-12 years: 10ml three to four times a day. A minimum of 4 hours can be left between each dose. Do not use more than 4 times a day. Do not give to children under 3 months of age. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Leia o documento completo