देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Ibuprofen
Bluefish Pharmaceuticals AB
M01AE01
Ibuprofen
Film-coated tablet
ibuprofen
Marketed
2022-09-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MYBUFEN 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. Always take 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 you get any side effects, talk to your doctor, pharmacist or nurse. 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 adolescents. • - after 3 days in the treatment of fever and after 4 days in the treatment of pain in adults. WHAT IS IN THIS LEAFLET: 1. What Mybufen Max is and what it is used for 2. What you need to know before you take Mybufen Max 3. How to take Mybufen Max _ _ 4. Possible side effects 5. How to store Mybufen Max 6. Contents of the pack and other information 1. WHAT MYBUFEN MAX IS AND WHAT IT IS USED FOR Ibuprofen belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAID). This medicinal product is used for the short-term symptomatic treatment of mild to moderate pain such as headaches, toothache, muscular pain, period pain and/or fever in adolescents from 40 kg bodyweight (12 years of age and above) and adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYBUFEN MAX DO NOT TAKE MYBUFEN MAX: - If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). -If you have previously reacted with bronchospasm, asthma attacks, swelling of the nasal mucosa, angioedema or skin reactions following previous intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). -If you suffer from unclarified blood-formation disturbances. -If you suffer from severe liver or severe kidney impairment. -If you have previously had a gastrointestinal bl पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 20 March 2024 CRN00F30S Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mybufen Max 400 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg ibuprofen. Excipients with known effect: Each film-coated tablet contains 28.5 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 400 mg: White, oblong, biconvex film-coated tablets scored on both sides (length: 17 mm, width: 8 mm). The score line is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mybufen Max 400 mg film-coated tablets is indicated for: - Short-term symptomatic treatment of mild to moderate pain (e.g. headache, toothache, muscular pain, dysmenorrhea) and/or fever of duration less than to 3 days. Mybufen Max is indicated in adults and adolescents from 40 kg body weight (12 years of age and above). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The ibuprofen dose depends on patient's age or body weight. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Mybufen Max 400 mg film-coated tablets: Adults and adolescents from 12 years of age (≥ 40 kg body weight): Initial dose 400 mg ibuprofen. If necessary, additional doses of 400 mg ibuprofen can be taken every 4-6 hours as necessary.. A total dose of 1200 mg ibuprofen should not be exceeded in any 24-hour period. Special populations Elderly: NSAIDs (Nonsteroidal anti-inflammatories) should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. (See section 4.4, special warnings and special precautions for use). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Renal insufficiency: No dose adjustment is requir पूरा दस्तावेज़ पढ़ें