Ibuprofen

Adults and children 12 years and over The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The recommended dose is one tablet to be taken every 4 to 6 hours as necessary (maximum 3 tablets in 24 hours). Do not exceed the recommended dose. Pregnancy See Section 4.3 CONTRAINDICATIONS and Section 4.6 FERTILITY, PREGNANCY AND LACTATION. Children under 12 years BRUFEN PAIN should not be administered to children aged less than 12 years. This product should not be used for more than 3 days at a time except on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. Excessive use can be harmful and increase the risk of heart attack, stroke or liver

Ibuprofen is contraindicated for use in patients with: • known hypersensitivity or idiosyncratic reaction to ibuprofen (or any of the inactive ingredients) • known hypersensitivity to aspirin and other NSAIDs • asthma that is aspirin or NSAID sensitive • active gastrointestinal bleeding or peptic ulceration • renal impairment • heart failure • severe liver impairment • undergoing treatment of perioperative pain in a setting of coronary artery bypass surgery (CABG) Use of BRUFEN PLUS is contraindicated during the third trimester of pregnancy (see Section 4.6 FERTILITY, PREGNANCY AND LACTATION). BRUFEN PLUS should not be taken with other products containing ibuprofen, aspirin, or with other anti- inflammatory medicines or other medicines being taken regularly unless under medical

BRUFEN PLUS should be used with caution in patients with: • Previous history of gastrointestinal haemorrhage or ulcers • Asthma who have not previously taken NSAIDs • Hepatic, or cardiac impairment BRUFEN PLUS should be used with caution in: • Pregnancy (See Section 4.6 FERTILITY, PREGNANCY AND LACTATION) • Elderly patients (See Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, USE IN ELDERLY) BRUFEN PLUS should be taken with caution with other products containing aspirin or salicylates. As with other NSAIDs, excessive use of BRUFEN PLUS may increase the risk of heart attack, stroke or liver damage in both patients with predisposing cardiovascular risk factors and in normal patients. Refer to Section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS, for additional information. Identified precautions Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. BRUFEN PAIN should not be used …

Ibuprofen (like other NSAIDs) should be avoided in combination with: • Aspirin: Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, no clinically relevant effect is considered to be likely for occasional ibuprofen use. • Other NSAIDs including aspirin and cyclooxygenase-2-selective inhibitors: Avoid the use of two or more NSAIDS as this may increase the risk of adverse effects. The following interactions with ibuprofen have been noted: • ACE inhibitors, diuretics and other antihypertensives: Ibuprofen can reduce the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and beta-blockers with possible loss of blood pressure control and hyperkalaemia. Ibuprofen may reduce the antihypertensive and natriuretic effect of diuretics. Diuretics can increase the risk of nephrotoxicity of NSAIDs. The combined use of the three …

Adverse effects with non-prescription (OTC) or short-term use ibuprofen are rare and may include: • Gastrointestinal-dyspepsia, heartburn, nausea, loss of appetite, stomach pain, diarrhoea. • Central nervous system (CNS) –dizziness, fatigue, headache, nervousness. • Hypersensitivity reactions – skin rashes and itching. Rarely exfoliative dermatitis and epidermal necrolysis have been reported with ibuprofen. • Rare cases of photosensitivity. • Cardiovascular fluid retention and in some cases oedema. These effects are rare at non-prescription doses. The frequencies of adverse effects are defined by MedDRA frequency convention and system organ classification as follows: Very common: ≥1/10 Common: ≥1/100, <1/10 Uncommon: ≥1/1,000, <1/100 Rare: ≥1/10,000, <1/1,000 Very Rare: <1/10,000, including isolated reports. Not known: Cannot be estimated from the available data Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of: a) non-specific …

In adults the dose response effect is less clear cut than in children where ingestion of more than 400 mg/kg may cause symptoms. The half-life in overdose is 1.5-3 hours. Symptoms: Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as vertigo, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning, hyperkalaemia and metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may occur. Exacerbation of asthma is possible in asthmatics. Management: Management should be symptomatic …

Effects on fertility The use of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ibuprofen should be considered. Use in pregnancy Category C: Ibuprofen inhibits prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation and may delay labour and birth. Use of ibuprofen is thus contraindicated during the third trimester of pregnancy, including the last few days before expected birth. Data from epidemiological studies suggest an increased risk of miscarriage after the use of a prostaglandin synthesis inhibitor in early pregnancy. Further, there is insufficient experience about the safety of use of ibuprofen in humans during pregnancy. BRUFEN PAIN tablets should therefore not be used during the …