Ibuprofen 200 mg Tablet PL43461/0004 (GSL)

… 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 (see section 4.6).

… 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 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 (see section 4.6).

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 histo …

… 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 (see section 4.6).

… ion 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 (see section 4.6).

… 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 (see section 4.6).

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 …

… eatment considered (as appropriate). Respiratory: Bronchospasm may be precipitated in patients suffering from or with a previous 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 those with mixed connective tissue disease –increased risk of aseptic meningitis (see section 4.8). Renal: Ren …

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 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. Severe cutaneous adverse reactions (SCARs): Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necr …

… gitis (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 …

… ated disorders: Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactase malabsorption should not take this medicine. Advice for patients on a controlled sodium diet: This medicine contains less than 1 mmol sodium (23mg) per two tablets, that is to say essentially 'sodium-free'. The leaflet will include: Th …

… , monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. Excipients: Advice for patients with sugar-related disorders: Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactase malabsorption should not take this medicine. Advice for patients on …

… 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 limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of …

… sease. 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 those with 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 …

… , monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. Excipients: Advice for patients with sugar-related disorders: Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactase malabsorption should not take this medicine. Advice for patients on …

… gitis (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 …

… with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactase malabsorption should not take this medicine. Advice for patients on a controlled sodium diet: This medicine contains less than 1 mmol sodium (23mg) per two tablets, that is to say essentially 'sodium-free'. The leaflet will include: This medicine contains less than 1 mmol sodium (23mg) per two tablets, that is to say essentially 'sodium-free'. If you have been told by your doctor that you have an …

… 5). SLE and mixed connective tissue disease: Systemic lupus erythematosus as well as those with 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 antiplatelet 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 can mask symptoms of infection, …

… 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 use of ibuprofen, particularly at a high dose (2400 mg/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. ≤ 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 trea …

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 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. Severe cutaneous adverse reactions (SCARs): Severe …

… ple myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 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 long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, s …

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

Tablet core: Lactose, starch, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, hypromellose. Tablet coating: Sucrose, talc, titanium dioxide (E171), sodium benzoate (E211), starch, carnauba wax.

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