Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
Nutra Essential OTC, S.L. C/La Granja 1-28108 Alcobendas Madrid , Spain
M01AE01
IBUPROFEN 40 mg/ml
ORAL SUSPENSION
IBUPROFEN 40 mg/ml
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-04-07
PATIENT INFORMATION LEAFLET IBUPROFEN NUTRA ESSENTIAL 40 MG / ML ORAL SUSPENSION Ibuprofen READ ALL OF THIS PATIENT INFORMATION LEAFLET CAREFULLY BEFORE STARTING TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse have told you - Keep this leaflet. You may need to read it again. - Ask our 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 or your child do not feel better or if you or your child feel worse after 24 hours (infants aged 3-5 months, weighing more than 5kg) or after 3 days (children aged from 6 months, adolescents and adults). WHAT IS IN THIS LEAFLET: 1. What Ibuprofen Nutra Essential is and what it is used for 2. What you need to know before you take Ibuprofen Nutra Essential 3. How to take Ibuprofen Nutra Essential 4. Possible side effects 5. How to store Ibuprofen Nutra Essential 6. Contents of the pack and other information 1. WHAT IBUPROFEN NUTRA ESSENTIAL IS AND WHAT IT IS USED FOR Ibuprofen belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAID). This medicinal product is indicated for the treatment of fever and mild to moderate pain in adults and children aged over 3 months. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN NUTRA ESSENTIAL DO NOT TAKE IBUPROFEN NUTRA ESSENTIAL: - If you are allergic to ibuprofen or any other components of this medicine (included in section 6). - If you have had a stomach or duodenal haemorrhage or have suffered from a perforation in the digestive system whilst taking a non-steroidal anti-inflammatory drugs. - If you suffer from or have suffered from, a stomach or duodenal ulcer or haemorrhage on more than one occasion. - If you have had allergic reactions such as asthma, rhinitis or hives when taking aspirin or other non-steroid Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen Nutra Essential 40 mg / ml oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral suspension contains 40 mg of ibuprofen. Excipient(s) with known effect: Each millilitre of oral suspension contains 500 mg of liquid maltitol and 5.79 mg of sodium. For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM White or off-white, viscous, oral suspension with strawberry flavour. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic treatment of fever Treatment of mild or moderate pain. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). _Paediatric population _ _ _ The dose of ibuprofen to administer depends on the age and weight of the child. For children aged between 3 months and 12 years, the recommended daily dose is 20 to 30 mg/kg of weight, in three or four doses (see the table below). The interval between doses shall depend on the evolution of the symptoms, but it shall never be less than 4 hours. The following dosage guideline in recommended. AGE BODY WEIGHT POSOLOGY Children aged from 3 to 6 months Approx. from 5 to 7.6 kg 1.25 ml 3 times daily (corresponds to 150 mg of ibuprofen/day) Children aged from 6 to 12 months Approx. from 7.7 to 9 kg 1.25 ml of 3 to 4 times daily (corresponds to 150-200 mg of ibuprofen/day) Children aged from 1 to 3 years Approx. from 10 to 15 kg 2.5 ml 3 times daily (corresponds to 300 mg of ibuprofen/day) Children aged from 4 to 6 years Approx. from 16 to 20 kg 3.75 ml 3 times daily (corresponds to 450 mg of ibuprofen/day) Children aged from 7 to 9 years Approx. from 21 to 29 kg 5 ml 3 times daily (equivalent to 600 mg of ibuprofen/day) Children aged from 10 to 12 years Approx. from 30 to 40 kg 7.5 ml 3 times daily (equivalent to 900 mg of ibuprofen/day) Use of this medicinal product is not recommended in children aged under 3 months or under 5 kg. Fo Prečítajte si celý dokument