Company: Marketed by Rowex.
Legal category: Pharmacy only. Sport permitted.
Active ingredient: Brupro: Ibuprofen 200mg. Brupro Max: Ibuprofen 400mg.
Description: White, round or oblong, biconvex film coated tablets, respectively. Brupro Max: Scored on both sides.
Presentation: Brupro: 200mg-12, €1.86; 200mg-24, €3.09. Brupro Max: 400mg-12, €3.05; 400mg-24, €5.38.
Indications: Brupro: Short-term management of mild to moderate pain, fever and symptoms of colds and influenza. Brupro Max: Management of muscular pain, backache, dental pain and dysmenorrhoea.
Pharmacology: Ibuprofen is a phenylpropionic acid derivative with analgesic, anti-inflammatory and antipyretic activity. Its therapeutic effects as a nonsteroidal anti-inflammatory drug (NSAID) are thought to result from its inhibitory effect on the enzyme cyclo-oxygenase, which results in a marked reduction in prostaglandin synthesis.
Dosage: Adults: Swallow whole with a glass of water, with or after food. Initially, 400mg and subsequently if necessary 200–400mg every four hours (maximum 1200mg in 24 hours). Use lowest dose for shortest duration possible. Elderly: Initiate with lowest dose available. Renal/hepatic impairment: Assess dose individually. Children: 12 years and older: As per adults. Under 12 years: Not recommended.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. History of gastrointestinal bleeding or perforation related to previous NSAID therapy, active (or history) recurrent peptic ulcer/haemorrhage (≥2 distinct episodes of proven ulceration or bleeding), severe heart/ hepatic/ renal failure, conditions increasing bleeding tendency. Asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Pregnancy, lactation.
Special precautions: Caution: Renal, hepatic or cardiac impairment (assess renal function prior to initiation and regularly thereafter, use lowest possible dose), elderly (discontinue if no benefit or intolerance occurs), history of heart failure/ hypertension, (history of) bronchial asthma, initiation in considerably dehydrated patients, intercranial haemorrhage and bleeding diathesis, history of GI disease. GI bleeding, ulceration or perforation reported (can be fatal, discontinue if occurs); risk higher with increasing dose, history of ulcer (especially if complicated with haemorrhage or perforation); consider combination with protective agents. History of GI toxicity (report any unusual abdominal symptoms, especially in initial stages of treatment). Long-term use at high doses associated with small, increased risk of arterial thrombotic events. Serious skin reactions (some fatal) reported very rarely (discontinue at first signs of hypersensitivity). History of hypertension/mild to moderate congestive heart failure (monitor for fluid retention and oedema). Uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, initiating longer-term treatment of patients with risk factors for cardiovascular events (assess risk/benefit). Supervise prolonged use. May mask signs of infection. Aseptic meningitis observed rarely. May impair female fertility. Driving/using machines.
Drug interactions: Only use warfarin or heparin under direct medical supervision. Avoid: Other NSAIDs including cyclooxygenase-2 selective inhibitors. Caution: Antihypertensives, beta-blockers, diuretics, ACE inhibitors, oral corticosteroids, anticoagulants, selective serotonin re-uptake inhibitors, antiplatelets. Cardiac glycosides, lithium, methotrexate, ciclosporin, aminoglycosides, cholestyramine, quinolones, sulfonylureas, probenecid, oral hypoglycaemic agents, mifepristone, tacrolimus, zidovudine, potent CYP2C9 inhibitors, ginkgo biloba.
Adverse drug reactions: Gastrointestinal disorders.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417.
E-mail: rowex@rowa-pharma.ie