Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Ibuprofen
Rowa Pharmaceuticals Limited
M01AE; M01AE01
Ibuprofen
400 milligram(s)
Film-coated tablet
Oral use
Pack size: 12 and 24 film-coated tablets
Product not subject to medical prescription
Temmler Werke Gmbh
Propionic acid derivatives
Propionic acid derivatives; ibuprofen
For the management of muscular pain, backache, dental pain and dysmenorrhoea
Marketed
2015-03-13
PACKAGE LEAFLET: INFORMATION FOR THE USER BRUPRO 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 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. WHAT IS IN THIS LEAFLET 1. What Brupro Max is and what it is used for 2. What you need to know before you take Brupro Max 3. How to take Brupro Max 4. Possible side effects 5. How to store Brupro Max 6. Contents of the pack and other information. 1. WHAT BRUPRO MAX IS AND WHAT IT IS USED FOR Brupro Max 400 mg Film-coated tablets contain the active substance ibuprofen. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) that relieve pain and lower fever. This medicine is used to manage muscle pain, backache, dental pain and period pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUPRO MAX DO NOT TAKE BRUPRO MAX: - if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) - if you have a history of shortness of breath, asthma attacks or skin reactions (swelling or hives) after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) - if you have an active or history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (two or more distinct episodes of proven ulceration or bleeding) - if you have a history of gastro-intestinal bleeding or perforation, related to previous NSAIDs therapy - if you have severe heart failure, liver failure or kidney failure - if you have a condition which increases your tendency to bleeding - if you Lestu allt skjalið
Health Products Regulatory Authority 15 March 2023 CRN00D8ZT Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brupro Max 400mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of ibuprofen. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film–coated tablet. White, oblong, biconvex film-coated tablets with a score notch on both sides (length approx. 16.1mm, width approx. 7.1mm) The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of muscular pain, backache, dental pain and dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The lowest effective dose should be used for the shortest duration necessary to control symptoms (_see section 4.4_). Adults and children over the age of 12 years only: The usual dose is 400mg and subsequently if necessary 400mg every 4-6 hours with a maximum of 1200mg in a 24 hour period. Children under the age of 12 years: Not recommended. Elderly: No specific dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case, dosage should be assessed individually. 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. Take ibuprofen tablets with a glass of water. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation. For oral administration. To be taken preferably with or after food. 4.3 CONTRAINDICATIONS Ibuprofen is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ibuprofe Lestu allt skjalið