POWERGEL

Posology Powergel should be applied topically to the affected area two or three times daily. Maximum duration of use should not exceed 10 days. Paediatric population Not recommended in children under 12 years of age. The safety and efficacy of ketoprofen gel in children have not been established.

Method of administration For cutaneous use. Powergel should be applied with gentle massage only.

Tube or dispenser:

Apply 5 to 10cm of gel (100-200mg ketoprofen) with each application; for the pump dispenser push the pump 3-6 times.

4). There have been reports of localised skin reactions due to photosensitivity, including erythema, pruritus and burning sensations, which might spread beyond the area of application. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.

Other systemic effects of anti-inflammatory drugs: hypersensitivity, gastrointestinal and renal disorders (these depend on the transdermic spreading of the active ingredient, hence on the amount of gel applied, on the surface involved, on the degree of intactness of the skin, on the duration of the treatment and on the use of occlusive bandages).

Since marketing, the following adverse reactions have been reported. They have been listed according to classes of organ and system and classified according to their frequency as follows: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); not known (the frequency cannot be established based on the available data).

System Organ Class Uncommon Rare Very rare Not known Infections and infestations Secondary impetigo Blood and lymphatic system disorders Eosinophilia Immune system disorders Anaphylactic reactions, including anaphylactic shock, angioedema, hypersensitivity reactions Eye disorders Eyelid oedema Vascular disorders Vasculitis Gastrointestinal disorders Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema Skin and subcutaneous tissue disorders Localised skin reactions such as erythema , eczema, pruritus and burning sensation Dermatitis (allergic, bullous, contact, exfoliative, vesicular), urticaria, blister, photosensitivity reaction, photosensitivity allergic reaction, skin exfoliation, skin oedema Renal and urinary disorders New cases or worsening of existing cases of renal insufficience.

General Pyrexia disorders and administration site conditions Injury, poisoning and procedural complications Wound complication Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti-inflammatory drugs.

• The gel should be used with caution in patients with reduced heart, liver or renal function: isolated cases of systemic adverse reactions affecting renal function have been reported. • The topical use of large amounts of product may give rise to systemic effects such as hypersensitivity and asthma.

• The treatment should be interrupted if rash appears. • The recommended length of treatment should not be exceeded due to the risk of developing contact dermatitis and photosensitivity reactions increases over time. • Hands should be washed thoroughly after each application of the product.

• 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 avoid exposure of treated skin to direct sunlight including solarium (sunbeds), and to protect treated areas by wearing clothing during treatment with the product and for two weeks following its discontinuation to avoid the risk of photosensitisation.

• Do not use with occlusive dressings. • The gel must not come into contact with mucous membranes and with the eyes. • 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 use of topical products, especially if it is prolonged, may give rise to phenomena of sensitisation or local irritation. • The excipients citral, citronellols, coumarin, farnesol, geraniol, d-limonene and linalool may cause allergic reactions.

• Ethanol may cause a burning sensation on damaged skin.

1. • History of any photosensitivity reaction. • Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria to fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs. • History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or perfumes.

4). • Ketoprofen gel should not be applied to open or infected wounds or lesions of the skin, such as occurs, for example, with eczema or acne, or near the eyes. 6).