Ibuprofen 200 mg Film-coated tablet - PL 13606/0319

… tory of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4) Last trimester of pregnancy

… n the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4) Last trimester of …

… tory of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4) Last trimester of pregnancy

Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or hist …

… ria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4) Last trimester of pregnancy

… tion or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4) Last trimester of pregnancy

… tory of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4) Last trimester of pregnancy

Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NS …

… bleeding and perforation which may be fatal. Respiratory Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. Other NSAIDs The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5). SLE and mixed connective tissue disease Systemic lupus erythematosus as well as mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8) Renal Renal impairment …

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Respiratory Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. Other NSAIDs The use of ibuprofen with concomitant NSAIDs …

… ngitis (see section 4.8) Renal Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose. Hepatic Hepatic dysfunction (see sections 4.3 and 4.8). Cardiovascular and cerebrovascular effects Caution (discussion with doctor or pharmacist) is required prior to starting treatment in pa …

… . If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately, and an alternative treatment considered (as appropriate). Information related to excipients This medicinal product contains lactose monohydrate and should not be given to patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Information on sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. The label will include: Read the enclosed lea …

… . If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately, and an alternative treatment considered (as appropriate). Information related to excipients This medicinal product contains lactose monohydrate and should not be given to patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Information on sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. The label will include: Read the enclosed lea …

… e has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction. Impaired female fertility There is some evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treat …

… disease. Other NSAIDs The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5). SLE and mixed connective tissue disease Systemic lupus erythematosus as well as mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8) Renal Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis a …

… . If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately, and an alternative treatment considered (as appropriate). Information related to excipients This medicinal product contains lactose monohydrate and should not be given to patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Information on sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. The label will include: Read the enclosed lea …

… ngitis (see section 4.8) Renal Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose. Hepatic Hepatic dysfunction (see sections 4.3 and 4.8). Cardiovascular and cerebrovascular effects Caution (discussion with doctor or pharmacist) is required prior to starting treatment in pa …

… onohydrate and should not be given to patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Information on sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. The label will include: Read the enclosed leaflet before taking this product Do not take if you: • have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding • are all …

… s as well as mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8) Renal Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses …

… e available. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Masking of symptoms of underlying infections Ibuprofen 200 mg film-coated tablets can ma …

… required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Clinical studies suggest that the use of ibuprofen, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.≤ 1200mg/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 trea …

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Respiratory Bronchospasm may be precipitated in pa …

… mple myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.≤ 1200mg/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 long-term 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. Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction ass …

… oses, - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.3 and 5.3). Breast-feeding: In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely. See section 4.4 regarding female fertility.

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