Ibuprofen 200mg Coated Tablets PL 29831/0116

Concepts (40)

• +Angioedema (deep swelling)Contraindicated

  Ibuprofen is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Ibuprofen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Ibuprofen should not be used in patients with active, or …

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• +Bleeding riskContraindicated

  … ts. Ibuprofen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Ibuprofen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding. Ibuprofen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic f …

  Source SmPC ↗
• +Heart conditionsContraindicated

  … astrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding. Ibuprofen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic failure and renal failure (see section 4.4). Use during pregnancy Ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.6).

  Source SmPC ↗
• +Stomach and gutContraindicated

  … ts. Ibuprofen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Ibuprofen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding. Ibuprofen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic f …

  Source SmPC ↗
• +Liver conditionsContraindicated

  … astrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding. Ibuprofen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic failure and renal failure (see section 4.4). Use during pregnancy Ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.6).

  Source SmPC ↗
• +Allergy to the medicineContraindicated

  Ibuprofen is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Ibuprofen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Ibu …

  Source SmPC ↗
• +BlockageContraindicated

  … ts. Ibuprofen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Ibuprofen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding. Ibuprofen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic f …

  Source SmPC ↗
• +PregnancyContraindicated

  … with conditions involving an increased tendency to bleeding. Ibuprofen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic failure and renal failure (see section 4.4). Use during pregnancy Ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.6).

  Source SmPC ↗
• +Kidney conditionsContraindicated

  … astrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding. Ibuprofen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic failure and renal failure (see section 4.4). Use during pregnancy Ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.6).

  Source SmPC ↗
• +Breathing conditionsContraindicated

  Ibuprofen is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Ibuprofen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Ibuprofen should not be used in patients with active, or …

  Source SmPC ↗
• +Taken with other medicinesWarning

  … effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). As with other NSAIDs, ibuprofen may mask the signs of infection. The use of ibuprofen product with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors should be avoided due to the increased risk of ulceration or bleeding (See section 4.5 Interactions). Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (See section 4.2 Posology and administrati …

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• +DehydrationWarning

  … nts with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. Renal effects Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other renal pathologic changes. Renal toxicity has also been seen in patients in whom renal …

  Source SmPC ↗
• +Older peopleWarning

  … se of ibuprofen product with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors should be avoided due to the increased risk of ulceration or bleeding (See section 4.5 Interactions). Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (See section 4.2 Posology and administration). Paed …

  Source SmPC ↗
• +Salt and mineral balanceWarning

  … al function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state. 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. SLE and mixed connective tissue disease In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see below a …

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• +Intolerance to an ingredientWarning

  … • are a smoker. If symptoms persist consult your doctor. Do not exceed the stated dose. Keep out of the sight and reach of children. Ibuprofen 200mg Coated Tablets contain sucrose and sodium Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium-free'.

  Source SmPC ↗
• +FertilityWarning

  … is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease Impaired female 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, …

  Source SmPC ↗
• +InfectionWarning

  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). As with other NSAIDs, ibuprofen may mask the signs of infection. The use of ibuprofen product with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors should be avoided due to the increased risk of ulceration or bleeding (See section 4.5 Interact …

  Source SmPC ↗
• +LactoseWarning

  … • are a smoker. If symptoms persist consult your doctor. Do not exceed the stated dose. Keep out of the sight and reach of children. Ibuprofen 200mg Coated Tablets contain sucrose and sodium Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium-free'.

  Source SmPC ↗
• +Acid build-up in the bloodWarning

  … al function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state. 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. SLE and mixed connective tissue disease In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see below a …

  Source SmPC ↗
• +Sodium and potassium contentWarning

  … blets contain sucrose and sodium Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium-free'.

  Source SmPC ↗
• +ChildrenWarning

  … rly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (See section 4.2 Posology and administration). Paediatric population There is a risk of renal impairment in dehydrated children and adolescents. Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, h …

  Source SmPC ↗
• +Serotonin effectsWarning

  … a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal 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. NSAIDs should be given with care to patients with a history of ulcerative colitis or Croh …

  Source SmPC ↗
• +Blood clotsWarning

  … 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. Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events such as 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 tre …

  Source SmPC ↗
• +UnclassifiedWarning

  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). As with other NSAIDs, ibuprofen may mask the signs of infection. The use of ibuprofen product with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors should be avoided due to the …

  Source SmPC ↗
• +Blood vessel conditionsWarning

  … as 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, …

  Source SmPC ↗
• +BreastfeedingPregnancy

  … the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed. Therefore, ibuprofen is contraindicated during the last trimester of pregnancy (see Section 4.3) Lactation In the limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding. See section 4.4 Special warnings a …

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• +Alcohol—Not in scanned sections

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• +Benzyl alcohol—Not in scanned sections

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• +Obstructed blood flow from the heart—Not in scanned sections

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• +Hormone disorders—Not in scanned sections

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• +Enzyme deficiency—Not in scanned sections

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• +Heart rhythm block—Not in scanned sections

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• +Eye conditions—Not in scanned sections

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• +Sugar alcohols—Not in scanned sections

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• +Porphyria—Not in scanned sections

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• +Propylene glycol—Not in scanned sections

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• +Heart rhythm (QT interval)—Not in scanned sections

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• +Shock—Not in scanned sections

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• +Thyroid—Not in scanned sections

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• +Gap needed after another medicine—Not in scanned sections

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