Ibuprofen 200mg film-coated tablets (POM)

… erapy - active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - cerebrovascular or other active bleeding - unclarified blood-f …

… episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - cerebrovascular or other active bleeding - unclarified blood-formation disturbances Ibuprofen is contraindicated in children below 20 kg body weight or younger than 6 years of age (see section 4.2 …

Ibuprofen is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acetylsalicylic acid or other NSAIDs - history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomitin …

… trointestinal bleeding or perforation, related to previous NSAIDs therapy - active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - cerebrovascular or othe …

Ibuprofen is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acetylsalicylic acid or other NSAIDs - history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomitin …

Ibuprofen is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acetylsalicylic acid or other NSAIDs - history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomitin …

… egnancy (see section 4.6) - significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - cerebrovascular or other active bleeding - unclarified blood-formation disturbances Ibuprofen is contraindicated in children below 20 kg body weight or younger than 6 years of age (see section 4.2).

… peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - cerebrovascular or other active bleeding - unclarified blood-formation disturbances Ibuprofen is contraindica …

… trointestinal bleeding or perforation, related to previous NSAIDs therapy - active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - cerebrovascular or othe …

Ibuprofen is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acetylsalicylic acid or other NSAIDs - history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - severe renal failure or severe hepatic failure (see section 4.4). - severe heart failure (NYHA Class IV) - last trimester of pregnancy (see section 4.6) - significant dehydration (caused by vomitin …

Ibuprofen is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acet …

… be observed carefully. In case of long-term treatment with ibuprofen a periodical monitoring of hepatic and renal function as well as the blood count is necessary, especially in high risk patients. Consumption of alcohol should be avoided since it may intensify side effects of NSAIDs, especially if affecting the gastrointestinal tract or the central nervous system. Patients on ibuprofen should report to their doctor signs or symptoms of gastro-intestinal ulceration or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or oedema. Paediatri …

… should undergo regular medical supervision to monitor for adverse events. Ibuprofen should only be administered under strict consideration of the benefit-risk ratio in the following conditions:  - Systemic Lupus Erythematosus (SLE) or mixed connective tissue diseases.  - Congenital disturbance of porphyrin metabolism (e.g. acute intermittent porphyria)  - The first and second trimester of pregnancy  - Lactation Special care has to be taken in the following cases:  - Gastrointestinal diseases including chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease)  - Cardiac insufficiency and …

… hematosus (SLE) or mixed connective tissue diseases.  - Congenital disturbance of porphyrin metabolism (e.g. acute intermittent porphyria)  - The first and second trimester of pregnancy  - Lactation Special care has to be taken in the following cases:  - Gastrointestinal diseases including chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease)  - Cardiac insufficiency and hypertension  - Reduced renal function  - Hepatic dysfunction  - Disturbed haematopoiesis  - Blood coagulation defects  - Allergies, hay fever, chronic swelling of nasal mucosa, adenoids, chronic obstructive airway disease or bronchial asthma  - Immediately after major surgical interventions Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without wa …

The use of Ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the increased risk of ulceration or bleeding (see section 4.5). 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). Patients tre …

… I bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low-dose acetylsalicylic …

… ction, heart failure, hepatic dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID treatment is generally 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. Hepatic: Hepatic dysfunction (see sections 4.2, 4.3 and 4.8). SLE and mixed connective tissue disease In patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases …

… 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). Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues 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. Masking of symptoms of underlying infections Ibuprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infec …

… ction, heart failure, hepatic dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID treatment is generally 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. Hepatic: Hepatic dysfunction (see sections 4.2, 4.3 and 4.8). SLE and mixed connective tissue disease In patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases …

… mptoms, skin rash, weight gain or oedema. Paediatric population There is a risk of renal impairment in dehydrated children and adolescents. Ibuprofen 200mg film-coated Tablets contain sodium: This medicine contains less than 1mmol sodium (23mg) per 200mg film-coated tablets, that is to say essentially 'sodium-free'.

… should undergo regular medical supervision to monitor for adverse events. Ibuprofen should only be administered under strict consideration of the benefit-risk ratio in the following conditions:  - Systemic Lupus Erythematosus (SLE) or mixed connective tissue diseases.  - Congenital disturbance of porphyrin metabolism (e.g. acute intermittent porphyria)  - The first and second trimester of pregnancy  - Lactation Special care has to be taken in the following cases:  - Gastrointestinal diseases including chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease)  - Cardiac insufficiency and …

… ction 4.5). 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, anticoagulants such as warfarin or heparin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (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 gastrointestinal disease (ul …

… ly 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. Other precautions Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after taking/administering ibuprofen therapy must be stopped. Medically required measures, in line with the symptoms, must be initiated by specialist personnel. Bronchospasm, urticaria or angioedema may be precipitated in patients suffering from or with a previous history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic d …

… me 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 doses (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 daily) 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 …

… e myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low-dose ibuprofen (e.g. ≤ 1200 mg daily) 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 …

… breast milk, but with therapeutic doses during short term treatment the risk for influence on infant seems unlikely. If, however, longer treatment is prescribed, early weaning should be considered. Fertility The use of ibuprofen may impair fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withd …

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