… 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).
• Use in children under 12 years of age.
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
• Patients with allergy to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or with a …
… s as well as 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 …
Identical in both labels. Surrounding text shown from Strides Pharma UK Ltd.
… 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 …
… 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 If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).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 …
… 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 …
… 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 …