Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
IBUPROFEN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
M01AE01
IBUPROFEN 200 mg
FILM-COATED TABLET
IBUPROFEN 200 mg
OTC
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2009-04-14
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IRFEN 200 MG FILM-COATED TABLETS Ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 has told you. - 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 days in children and adolescents - after 7 days in adults WHAT IS IN THIS LEAFLET : 1. What Irfen is and what it is used for 2. What you need to know before you take Irfen 3. How to take Irfen 4. Possible side effects 5. How to store Irfen 6. Contents of the pack and other information 1. WHAT IRFEN IS AND WHAT IT IS USED FOR Irfen belongs to a group of medicines called NSAID (non-steroidal anti-inflammatory drugs) which work by reducing pain, inflammation and fever. Irfen 200 mg is used to provide relief from mild to moderate pain such as headache, including migraine headache, dental pain, period pain and fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRFEN DO NOT TAKE IRFEN: - 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 inflammation (NSAIDs) - if you are suffering from an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more of these episodes in the past - if you suf Izlasiet visu dokumentu
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irfen 200 mg film-coated tablet Irfen 400 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg ibuprofen. Each film-coated tablet contains 400 mg ibuprofen. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). This product is for short-term use only, not longer than 7 days in adults. If symptoms persist or worsen a doctor should be consulted. <200 mg:> If a child or adolescent requires this medicinal product for more than 3 days, or if symptoms worsen, a doctor should be consulted. <400 mg:> If an 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 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. 200 mg only: _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 6 hours as required. The m Izlasiet visu dokumentu