Calprofen Ibuprofen Suspension

… ory 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).

… n section 6.1. 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 o …

… ory 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 to any of the excipients listed in section 6.1. 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 (see section 4.6).

… on 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).

… ory 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 to any of the excipients listed in section 6.1. 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 …

… e risk of ulceration or bleeding, such as oral corticosteroids, or anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). Caution should be taken when using ibuprofen with excessive alcohol or heavy alcohol drinkers. Alcohol may increase the risk of gastrointestinal bleeding. When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Immune system: Ibuprofen may cause severe allergic reactions including very rare cases …

… t contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Maltitol may have a laxative effect. The calorific value of maltitol is 2.3 kcal/g. Sodium methylhydroxybenzoate (E219) and sodium propylhydroxybenzoate (E217) may cause allergic reactions which could possibly be delayed. This medicine contains 4.67mg propylene glycol (E1520) in each 5 ml dose, which is equivalent to 0.93 mg/ml. This medicine contains 0.0005 mg of alcohol (ethanol) in each 5ml. The amount in 5ml of …

… doctor if symptoms persist or worsen. 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 and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8). Renal: Renal impairment as …

… tions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate). Dehydration: There is a risk of renal impairment in dehydrated children. This product contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Maltitol m …

Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to relieve symptoms (see 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. Masking of symptoms of underlying infections: This medicine can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the …

… matosus and 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) 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. Hepatobiliary disorders: Hepatic dysfunction (see sections 4.3 and 4.8) Cardiovascular and cerebrovascular effects: Caution (discussion with doctor or pharmacist) is required prior to starti …

… hese reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate). Dehydration: There is a risk of renal impairment in dehydrated children. This product contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Maltitol may have a laxative effect. The calorific value of maltitol is 2.3 kcal/g. Sodium methylhydroxybenzoate (E219) and sodium propylhydroxybenzoate (E217) may cause allergic reactions which could possibly be delayed. This medicine contains 4.67mg propylene glycol (E1520) in e …

… 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 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 …

… symptoms (see 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. Masking of symptoms of underlying infections: This medicine can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial c …

… matosus and 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) 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. Hepatobiliary disorders: Hepatic dysfunction (see sections 4.3 and 4.8) Cardiovascular and cerebrovascular effects: Caution (discussion with doctor or pharmacist) is required prior to starti …

… within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate). Dehydration: There is a risk of renal impairment in dehydrated children. This product contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Maltitol may have a laxative effect. The calorific value of maltitol is …

… hese reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate). Dehydration: There is a risk of renal impairment in dehydrated children. This product contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Maltitol may have a laxative effect. The calorific value of maltitol is 2.3 kcal/g. Sodium methylhydroxybenzoate (E219) and sodium propylhydroxybenzoate (E217) may cause allergic reactions which could possibly be delayed. This medicine contains 4.67mg propylene glycol (E1520) in e …

… tive effect. The calorific value of maltitol is 2.3 kcal/g. Sodium methylhydroxybenzoate (E219) and sodium propylhydroxybenzoate (E217) may cause allergic reactions which could possibly be delayed. This medicine contains 4.67mg propylene glycol (E1520) in each 5 ml dose, which is equivalent to 0.93 mg/ml. This medicine contains 0.0005 mg of alcohol (ethanol) in each 5ml. The amount in 5ml of this medicine is equivalent to less than 1ml beer or wine. The small amount of alcohol in this medicine will n …

… available. Patients with a history of GI toxicity, particularly when 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, or anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). Caution should be taken when using ibuprofen with excessive alcohol or heavy alcohol drinkers. Alcohol may increase the risk of gastrointestinal bleeding. When GI bleeding or ulceration occurs in p …

… ol drinkers. Alcohol may increase the risk of gastrointestinal bleeding. When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Immune system: Ibuprofen may cause severe allergic reactions including very rare cases of anaphylaxis (see section 4.8). Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash or blisters. If any of these symptoms occur, patients should stop use and seek medical help right away. Severe cutaneous adverse reactions (SCARs): Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson Syndrome (SJS) and Toxic Epidermal …

… equired 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 treat …

Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to relieve symptoms (see 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. Masking of symptoms of underlying infections: Th …

… 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 …

…  - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, this medicine is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breastfeeding In limited studies, ibuprofen appears in breast milk in very low concentrations and is unlikely to affect the breastfed infant adversely. Fertility See section 4.4 regarding female fertility.

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