Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
IBUPROFEN
Dr. Max Pharma Limited First Floor Roxbourghe House, 273-287 Regent Street, London W1B 2HA, United Kingdom
M01AE01
IBUPROFEN 400 mg
FILM-COATED TABLET
IBUPROFEN 400 mg
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2013-12-06
1/8 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN DR.MAX 400 MG FILM-COATED TABLETS Ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Ibuprofen Dr.Max 400 mg carefully to get the best results from it. - 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 3-5 days. IN THIS LEAFLET: 1. What Ibuprofen Dr.Max 400 mg is and what it is used for 2. What you need to know before you take Ibuprofen Dr.Max 400 mg 3. How to take Ibuprofen Dr.Max 400 mg 4. Possible side effects 5. How to store Ibuprofen Dr.Max 400 mg 6. Contents of the pack and other information 1. WHAT IBUPROFEN DR.MAX 400 MG IS AND WHAT IT IS USED FOR Ibuprofen Dr.Max 400 mg belongs to a group of medicines called NSAID (non-steroidal anti- inflammatory drugs) which work by reducing pain, inflammation and fever. Ibuprofen Dr.Max 400 mg is used to provide relief from mild to moderate pain such as headache, including migraine headache, dental pain, pain in soft tissue injuries such as bruises and sprains, period pain and fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN DR.MAX 400 MG DO NOT TAKE IBUPROFEN DR.MAX 400 MG - if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). - if you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid or other drugs for pain and inflammation (NSAIDs). - if you have suffered from an ulcer or bleeding in the stomach or small intestine (duodenum) related to previous use of drugs for pain and Aqra d-dokument sħiħ
1/12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen Dr.Max 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg ibuprofen. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 400 mg tablet: White, oval, biconvex film-coated tablets with a score on one face. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate pain, such as headache including migraine headache, dental pain, pain in soft tissue injuries such as bruises and sprains. Primary dysmenorrhoea. Fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). This product is for short-term use only, not longer than 7 days. If symptoms persist or worsen a doctor should be consulted. If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. _MILD TO MODERATE PAIN AND FEVER _ _Adults and adolescents older than 12 years (≥40 kg): _ 200-400 mg given as a single dose or 3-4 times a day with an interval of 4 to 6 hours. The dosage in migraine headache should be: 400 mg given as a single dose, if necessary 400 mg with intervals of 4 to 6 hours. The maximum daily dose should not exceed 1200 mg. 2/12 _PRIMARY DYSMENORRHOEA _ _Adults and adolescents over 12 years of age: _ 200-400 mg 1-3 times a day, with an interval of 4-6 hours, as needed. The maximum daily dose should not exceed 1200 mg. _ELDERLY _ The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored. _IMPAIRED RENAL FUNCTION _ In patients with mild or moderate reduction of renal function, the dose should be kept as low as possible for Aqra d-dokument sħiħ