KETOPROFEN

For cutaneous use. Penetration of the gel by gentle and prolonged massage on the painful or inflamed surface for up to seven days. Two to four daily applications of approximately 2 to 4 g gel, representing approximately 5 to 10 cm. The usual maximum dose is 15 g per day.

4).

Children (under 15 years):

Not recommended, as safety in children has not been established.

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).

Infections and infestations:

Not known: Secondary impetigo Blood and lymphatic system disorders Not known: Eosinophilia Immune system disorders Not known: anaphylactic shock, angioedema, hypersensitivity reactions Eye disorders Not known: Eyelid oedema Vascular disorders Not known: Vasculitis Gastrointestinal disorders Not known: Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema Skin and subcutaneous tissue disorders Uncommon: Local skin reactions such as rash, erythema, eczema, pruritus and burning sensation, application site burn.

Rare:

Photosensitisation, urticaria, bullous/contact/exfoliative/vesicular dermatitis, phlyctenular eczema, blister, photosensitivity reaction, allergic reaction, skin exfoliation, skin oedema.

Not known:

Stevens-Johnson syndrome.

Renal and urinary disorders Very rare:

Cases of aggravation of previous renal insufficiency, acute renal failure General disorders and administration site conditions Not known: Pyrexia Injury, poisoning and procedural complications Not known: Wound complication 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

). 6). • Patholgical skin changes such as dermatosis, eczema or acne, infected skin lesions, or open wounds. • Not to be applied neither to mucous membranes, anal or genital areas, nor on the eyes. • Not to be used with occlusive dressings.

• Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene-containing products. 4 Special warnings and precautions for use For topical use only.

Hands should be washed thoroughly before use and immediately after each application of product (unless they are the area being treated). It is recommended to protect treated areas by wearing clothing during all the application of the product and two weeks following its discontinuation to avoid the risk of photosensitisation.

Topical application of large amounts may result in systemic effects including hypersensitivity and asthma (renal disease has also been reported). 2) due to the risk of developing contact dermatitis and photosensitivity reactions which increases over time.

Serious skin reactions, such as Stevens-Johnson Syndrome (SJS), have been reported in association with the use of NSAIDs, including ketoprofen gel. Patients should be informed about the signs and symptoms of serious skin manifestations.

Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Masking of symptoms of underlying infections Ketoprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection.

This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When ketoprofen is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.

• Known allergy to Ketoprofen, to substances of similar activity to aspirin. 1. • History of any photosensitivity reactions. • Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs (including when taken by mouth).

• History of skin allergy to ketoprofen, tiaprofenic acid, fenobrate or UV blocker or perfumes. • Sun exposure, even in the case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation (see Section