Source: Health Products Regulatory Authority (IE) Revision Year: 2010 Publisher: Helsinn Birex Pharm. Limited, Damastown, Mulhuddart, Dublin 15, Ireland
Known hypersensitivity to nimesulide or to any other excipients in the gel.
Use in patients in whom aspirin, or other medicinal products inhibiting prostaglandin synthesis, induced allergic reactions such as rhinitis, urticaria or bronchospasm. Use on broken or denuded skin or in the presence of local infection. Simultaneous use with other topical creams. Use in children under 12 years.
Nimesulide 3% w/w gel should not be applied to skin wounds or open injuries.
Nimesulide 3% w/w gel should not be allowed to come into contact with the eyes or mucous membranes; in case of accidental contact, wash immediately with water.
The product should never be taken by mouth. Hands should be washed after applying the product.
Nimesulide 3% w/w gel should not be used with occlusive dressings.
Nimesulide 3% w/w gel is not recommended for use in children under 12 years (see section 4.3).
Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration.
Patients with gastro-intestinal bleeding, active or suspected peptic ulcer, severe renal or hepatic dysfunction, severe coagulation disorders or severe/non controlled heart failure should be treated with caution.
Since Nimesulide 3% w/w gel has not been studied in hypersensitive subjects, particular caution should be used when treating patients with known hypersensitivity to other NSAIDs. The possibility of developing hypersensitivity in the course of therapy cannot be excluded.
Since with other topical NSAIDs burning sensation and exceptionally photodermatitis can occur, care should be taken during treatment with Nimesulide 3% w/w gel.
To reduce the risk of photosensitivity, patients should be warned against exposure to direct and solarium sunlight.
If symptoms persist or the condition is aggravated medical advice should be sought.
This product contains parahydroxybenzoates. These substances may cause allergic reactions (possibly delayed).
No interactions of Nimesulide 3% w/w gel with other medicinal products are known or to be expected via the topical route.
There are no data relevant to the topical use of Nimesulide 3% w/w gel in pregnant women or during breastfeeding. Therefore, Nimesulide 3% w/w gel should not be used during pregnancy or lactation unless clearly necessary.
No studies on the effect of Nimesulide 3% w/w gel on the ability to drive and use machines have been performed.
The following side effects listing is based on reports from clinical studies, in a limited number of patients, where mild local reactions have been reported. The reporting rates are classified as: very common (>1/10); common (>1/100, <1/10), uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000), including isolated cases.
Common: Itching Erythema
Not applicable.
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