Ibuprofen , Film Coated Tablet
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NEW ZEALAND DATA SHEET IBUPROFEN 1. Product Name IBUPROFEN 200 mg film coated tablet. 2. Qualitative and Quantitative Composition Each film coated tablet contains 200 mg of ibuprofen. For the full list of excipients, see section 6.1. 3. Pharmaceutical Form IBUPROFEN 200 mg tablets are white, circular, biconvex, film coated tablet, with "IBU 200" embossed on one side and plain on the other side. Do not halve tablets. 4. Clinical Particulars 4.1 Therapeutic indications • Rheumatoid arthritis • Osteoarthritis • Juvenile rheumatoid arthritis • Primary dysmenorrhoea • Pyrexia Ibuprofen is also indicated for the relief of acute and/or chronic pain states in which there is an inflammatory component. 4.2 Dose and method of administration Dose After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest duration should be used. Adults The recommended initial dosage of Ibuprofen is 1200 -1800 mg per day in divided doses. Some patients can be maintained on 600 -1200 mg per day. In severe of acute conditions it can be advantageous to increase the dosage until the acute phase is brought under control, providing that the total daily dose does not exceed 2400 mg in divided doses. Primary dysmenorrhoea The initial dose is 400 - 800 mg at the first sign of pain or menstrual bleeding, then 400 mg 4-6 hourly with a maximum total daily dose of 1,600 mg. Page 1 of 16 Maintenance dose In all indications, the dose should be adjusted for each patient and the smallest dose that results in acceptable control of the symptoms employed. In general, patients with rheumatoid arthritis and osteoarthritis tend to require higher doses than patients with other conditions. Special populations Paediatric The daily dosage of Ibuprofen is 20 mg per kg of body weight in divided doses. In juvenile rheumatoid arthritis, up to 40 mg per kg of bodyweight in divided doses may be given. In children weighing less than 30 kg the total dose should not exceed 500 mg in a 24-hour period. Do not give IBUPROFEN film coated tablets to children under 7 years. Elderly In elderly patients receiving 600 - 1,200 mg daily ibuprofen appeared to be well tolerated. However, since elderly patients may have a degree of impaired liver or renal function the adult dosage should be used with caution. Impaired liver function Ibuprofen should be used with caution in patients with impaired liver function (see section 4.4). Impaired renal function Ibuprofen should be used with caution in patients with impaired renal function (see section 4.4). Method of administration In order to achieve a faster onset of action, the dose may be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofen with food. Take Ibuprofen tablets with plenty of fluid. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on, to avoid oral discomfort and throat irritation. 4.3 Contraindications • Known hypersensitivity to ibuprofen or any of the excipients listed in section 6.1. • Hypersensitivity (e.g. asthma, rhinitis or urticaria) to aspirin or other non-steroidal anti- inflammatory drugs. • History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. • Active or history of ulcerative colitis, Crohn’s disease, recurrent peptic ulceration or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding). • Severe heart failure (NYHA IV). • Severe liver failure. • Severe renal failure (glomerular filtration below 30 mL/min). • Conditions involving an increased tendency or active bleeding. • During the third trimester of pregnancy. 4.4 Special warnings and precautions for use Prolonged use of any painkillers may induce headaches, which must not be treated with increased doses of the painkillers, including ibuprofen. Through concomitant consumption of alcohol, NSAID-related undesirable effects, particularly those that concern the gastrointestinal tract or the central nervous system, may be increased on use of NSAIDs. Page 2 of 16 Cardiovascular and thrombotic events Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day), may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use. Hypertension NSAIDs may lead to the onset of new hypertension or worsening of pre-existing hypertension and patients taking anti-hypertensives with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter. Heart failure Fluid retention and oedema have been reported in association with ibuprofen, therefore, the medicine should be used with caution in patients with a history of heart failure or hypertension. Gastrointestinal events Ibuprofen should be used with extreme caution, and at the lowest effective dose, in patients with a history of gastro-intestinal haemorrhage or ulcer since their condition may be exacerbated. All NSAIDs can cause gastrointestinal discomfort and serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation, which may increase with dose or duration of use but can occur at any time without warning. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, as well as patients requiring concomitant low dose aspirin, or for other drugs likely to increase gastrointestinal risk (see section 4.5). The concomitant administration of ibuprofen and other NSAIDs, including cyclooxygenase-2 (COX- 2) selective inhibitors, should be avoided due to the increased risk of ulceration or bleeding (see section 4.5). Caution is advised in patients with risk factors for gastrointestinal events who may be at greater risk of developing serious gastrointestinal events, e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism. Caution should be exercised in patients receiving concomitant medication which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin re-uptake inhibitors or antiplatelet drugs such as aspirin (see section 4.5). The concurrent use of aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events. Page 3 of 16 When gastrointestinal bleeding or ulcerations occur in patients receiving NSAIDs, the drug should be withdrawn immediately. Doctors should warn patients about the signs and symptoms of serious gastrointestinal toxicity Severe skin reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy. In the majority of cases, the onset of the reaction occurs within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. In exceptional cases, varicella can be at the origin of serious cutaneous and soft tissue infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of ibuprofen in case of varicella. Infections and infestations Exacerbation of skin infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of ibuprofen the patient is therefore recommended to go to a doctor without delay. Respiratory disorder Caution is required if ibuprofen is administered to patients suffering from, or with a previous history of bronchial asthma, chronic rhinitis or allergic diseases since ibuprofen has been reported to cause bronchospasm, urticaria or angioedema in such patients. Allergic reactions Severe acute hypersensitivity