TILOKET

Posology Adults To be applied two to four times daily to the skin in the painful or inflamed region for up to 7 days. Apply gently but massage well to ensure gel penetration. 5grams correspond to approximately 14cm of gel) Elderly There are no specific dosage recommendations for the elderly Paediatric population Children under 15 years: Not recommended, as safety in children has not been established.

Method of administration Local route.

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).

The below mentioned adverse reactions have been collected in the post-marketing experience. System Organ Class 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).

Infections and infestations Secondary impetigo Blood and lymphatic system disorders Eosinophilia Immune System disorder Anaphylactic reaction, angioedema, hypersensitivity Eye disorders Eyelid oedema Vascular disorders Vasculitis Gastrointestinal disorders Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema Skin and subcutaneous tissue disorders Rash (erythematous, generalised, maculo-papular, papular, pruritic, pustular, vesicular), eczema, pruritus, burning sensations application site burn.

Dermatitis (allergic, bullous, contact, exfoliative, vesicular), urticaria, blister, photosensitivity reaction, allergic reaction, skin exfoliation, skin oedema. Renal and urinary disorders Acute renal failure, insufficiency aggravated General disorder and administration site condition Pyrexia Injury, poisoning and procedural complications Wound complication Elderly patients are particularly susceptible to the adverse effects of non- steroidal anti-inflammatory drugs Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

For topical use only. • 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.

• The topical use of large amounts of product may give rise to systemic effects such as hypersensitivity and asthma. • 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 treated areas by wearing clothing during all the application of the gel and two weeks following its discontinuation to avoid the risk of photosensitisation. • Do not apply Tiloket Gel beneath occlusive dressings.

• The gel must not come in contact with mucous membrane or the eyes. • Keep the gel away from naked flames. Do not incinerate. • Should a skin rash occur after gel application, treatment must be stopped. 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.

• Areas of skin treated with Tiloket 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.

• The use of topical products, especially if it is prolonged, may give rise to phenomena of sensitisation or local irritation. • Keep out of the sight and reach of children.

1 • Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria to fenofibrate, tiaprofenic acid, acetylsalicylic acid or to other Non-Steroidal Anti-Inflammatory drugs (NSAID). 4). • Exudative dermatoses, on pathological skin changes such as eczema or acne; or in infected skin lesions, open wounds, broken skin and sores.

• Tiloket gel should not be applied to mucous membranes, anal or genital areas, eyes or used with occlusive dressings. • Third trimester of pregnancy.