Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Ibuprofen
Brillpharma (Ireland) Limited
M01AE; M01AE01
Ibuprofen
400 milligram(s)
Film-coated tablet
Propionic acid derivatives; ibuprofen
Not marketed
2019-01-25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBUPROFEN BRIL 400 MG FILM-COATED TABLETS Ibuprofen The PL includes alternative texts for different legal status in different countries as follows: -Boxed texts are only applicable for OTC versions. - [Grey shaded text in brackets ] are only applicable for prescription versions. [For medicines available only on prescription:] 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. It includes any possible side effects not listed in this leaflet. See section 4.] [For medicines available without a prescription:] < 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 with a fever and 5 days with pain. WHAT IS IN THIS LEAFLET: 1. What Ibuprofen Bril is and what is it used for 2. What you need to know before you take Ibuprofen Bril 3. How to take Ibuprofen Bril 4. Possible side effects 5. How to store Ibuprofen Bril 6. Contents of the pack and other information 1. WHAT IBUPROFEN BRIL IS AND WHAT IS IT USED FOR Ibuprofen Bril belongs to a group of medicines called NSAID (non-steroidal anti- inflammatory drugs) which work by reducing pain, inflammation and Przeczytaj cały dokument
Health Products Regulatory Authority 10 September 2021 CRN00C1FC Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen Bril 400 mg film-coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg ibuprofen Excipient with known effect: lactose monohydrate 16 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Ibuprofen Bril 400mg film-coated tablets white, about 16.7 mm X 7.8 mm capsule shaped, film-coated tablets, with break line on both sides. The tablets can be divided in equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Symptomatic treatment of_ -For short term symptomatic treatment of mild to moderate pain such as headache (including migraine), dysmenorrhoea (period pain), dental pain, and fever and pain in the common cold. -Symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), and in painful swelling and inflammation after soft tissue injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Undesirable effects may be minimised by using lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4) The tablet should be swallowed with a glass of water during or after meal The ibuprofen dose depends on the patient's age and body weight. _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 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. If in adults this product is required for more than 3 days in the case of fever or migraine headache, or for more than 4 days for pain relief, or if symptoms worsen the patient is advised to consult a doctor. If in children and adolescents, this medicinal product is r Przeczytaj cały dokument