… 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 …
… um effective dose for the shortest possible duration to control symptoms (see GI and cardiovascular risks below).
The elderly are at increased risk of the serious consequences of adverse reactions.
Caution should be exercised when initiating treatment with ibuprofen in children with considerable dehydration. There is a risk of renal impairment in dehydrated children.
Bronchospasms may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inh …
… 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 If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).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 …
… 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 …