ORUVAIL Gel Ref.[7741] Active ingredients: Ketoprofen

• Hands should be washed thoroughly after each application of the Gel.
• Treatment should be discontinued immediately upon development of any skin reaction, including cutaneous reactions after co-application of octocrylene-containing products.
• It is recommended to protect areas by wearing clothing during all the application of the Gel and two weeks following its discontinuation to avoid the risk of photosensitisation.
• The gel must not come into contact with mucous membrane or the eyes
• The recommended length of treatment should not be exceeded (see section 4.2) due to the risk of developing contact dermatitis and photosensitivity reactions which increases over time.
• Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population
• The safety and efficacy of ketoprofen gel in children have not been established
• Although systemic effects are minimal, the gel should be used with caution in patients with reduced heart, liver or renal function: isolated cases of systemic adverse reactions consisting of renal affections have been reported.
• Should a skin rash occur after gel application, treatment must be stopped.
• Do not apply Oruvail Gel beneath occlusive dressing.
• Areas of skin treated with Oruvail Gel should not be exposed to direct sunlight, or solarium ultraviolet light, either during treatment or for two weeks following treatment discontinuation, in order to avoid phototoxicity reactions and photoallergy.
• Keep the gel away from naked flames. Do not incinerate.

Interactions are unlikely as serum concentrations following topical administration are low.

Serious interactions have been recorded after the use of high dose methotrexate with non-steroidal anti-inflammatory agents, including ketoprofen, when administered by the systemic route.

Pregnancy

No embryopathic effects have been demonstrated in animals and there is epidemiological evidence of the safety of ketoprofen in human pregnancy. Nevertheless, it is recommended that ketoprofen should be avoided during the first and second trimester of pregnancy.

During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy, prolonged bleeding time in both mother and child may occur. Non-steroidal anti-inflammatory drugs may also delay labour. Therefore, ketoprofen is contraindicated during the last trimester of pregnancy.

Lactation

Trace amounts of ketoprofen are excreted in breast milk; therefore Oruvail Gel should not be used during breast feeding.

None known.

The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).

Immune System disorders

Not known: anaphylactic shock, angioedema, hypersensitivity reactions

Skin and subcutaneous tissue disorders

Uncommon: Local skin reactions such as erythema, eczema, pruritis and burning sensations.

Rare: Dermatological: photosensitisation and urticaria. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalised have occurred rarely.

Renal and urinary disorders

Very rare: Cases of aggravation of previous renal insufficiency

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

The gel should not be diluted.