Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
IBUPROFEN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
M01AE01
IBUPROFEN 400 mg
COATED TABLET
IBUPROFEN 400 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2009-06-24
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBUPROFEN ACTAVIS 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. - 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 signs of illness 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 Ibuprofen Actavis is and what it is used for 2. What you need to know before you take Ibuprofen Actavis 3. How to take Ibuprofen Actavis 4. Possible side effects 5. How to store Ibuprofen Actavis 6. Contents of the pack and other information 1. WHAT IBUPROFEN ACTAVIS IS AND WHAT IT IS USED FOR Ibuprofen Actavis belongs to a group of medicines called NSAID (non-steroidal anti-inflammatory drugs) which work by reducing pain, inflammation and fever. Ibuprofen Actavis is used to provide relief from mild to moderate pain such as headache, including migraine headache, dental pain, period pain and fever. If you are over 12 years of age your doctor may also prescribe this or higher doses for the treatment of rheumatoid arthritis, osteoarthritis, or other inflammatory or painful joint conditions, as well as for inflammatory and painful conditions of soft tissues such as muscles. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN ACTAVIS DO NOT TAKE IBUPROFEN ACTAVIS: - 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 ul Soma hati kamili
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen Actavis 400 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg ibuprofen. For the 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 doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate pain, such as headache including migraine headache, dental pain. Primary dysmenorrhoea. Fever. Rheumatic conditions such as arthritic diseases (e.g. rheumatoid arthritis including juvenile rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), non-articular rheumatic conditions, other muscular and joint disorders, and soft tissue injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). If a child or adolescent requires this medicinal product for more than 3 days, or if symptoms worsen, a doctor should be consulted. The ibuprofen dose depends on the patient’s age and body weight. The maximum single daily dose for adults should not exceed 800 mg of ibuprofen. The tablet should be swallowed with a glass of water during or after a meal. Page 2 of 14 _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. _Children 6-12 years (>20 kg):_ Children 6-9 years (20-29 kg): 200 mg 1-3 times a day with intervals of 4 to 6 hours as required. The maximum daily dose should not exceed 600 mg. Children 10-12 years (30-40 kg): 200 mg 1-4 times a day with intervals of 4 to Soma hati kamili