THERAPEUTIC INDICATIONS

Benign trauma, especially sports injuries, sprains, tendonitis, musculotendinous. Swelling and post-traumatic pain

POSOLOGY AND METHOD OF ADMINISTRATION

2 applications daily on the painful or inflamed region. Ensure gel penetration via gentle and prolonged massage
Maximum duration of use should not exceed 7 days
Use in children, Not recommended as safety in children has not been established

CONTRA-INDICATIONS

This medicinal product is contraindicated in the following situations:

History of any photosensitivity reaction
Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic, or other NSAID,
History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or perfumes,
History of allergy to any of the excipients,
Damaged skin, irrespective of the type of lesion: weeping dermatoses, eczema, infected skin lesions, burns or wounds, Sun exposure, even in case of hazy sun, including UV light from solarium, should be avoided during the treatment and 2 weeks after its discontinuation.

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Should a skind rash occur after gel application, stop treatment
Although plasma level after administration of ketoprofen gel are much lower than those reached after oral administration. Caution should still be exercised in patiens with a history of or active gastrointestinal bleeding, peptic ulcer, inflammatory disease of the gastrointestinal tract or severe renal impairment. As in the case with other NSAIDs ketoprofen does not cure the underlying disease. Although systemic effects are minimal, the gel should be used with caution in patients with severe renal impairment.
Use in pregnancy: no embryopathic effects have been demonstrated in animals and there is epidemiological evidence of the safety of ketoprofen should be avoided during pregnancy. NSAIDs may also delay labour.
The Profenid gel should not be using during lactation
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 photosensitization
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-applications of octocrylene containing products
The gel must not be applied to mucous membranes or to the eyes
Ketoprofen gel should not be applied under occlusive dressings
By extrapolation from other routes of administration : when prescribing this drug, the physician should take into account the cases of secondary anovulatory infertility due to non-rupture of the graafian follicle, reversible on treatment discontinuation, that have been reported in patients receiving long-term treatment with certain prostaglandin synthesis inhibitors.

INTERACTIONS

Interactions are unlikely as serum concentrations following topical administration are low. No interaction of ketoprofen gel with other drugs have been reported. It is however advisable to monitor patients under treatment with coumarinic substances

PREGNANCY AND LACTATION

Use in pregnancy : No embryopathic effects have been demonstrated in animals and there is epidemiological evidence of the safety ketoprofen should be avoided during pregnancy. NSAIDs may also delay labor

The profenid gel should not be used during lactation.

UNDESIRABLE EFFECTS

Immune system disorders:

Not known: anaphylactic shock, angioderma, hyersensivity reactions.

Gastrointestinal disorders:

Although plasma levels after administration of ketoprofen gel are much lower than those reached after oral administration, systemic gastrointestinal side effects (such as nausea, abdominal pain, vomiting and flatulence) are possible under rare circumstances depending on the amount of gel applied and the application of the gel to a large area of skin. Uncommon: nausea; not known: abdominal pain, vomiting, flatulence

Skin and Subcutaneous tissue disorders:

Uncommon: erythema, pruritus, eczema
Rare: photosensitivity reactions, dermatitis bullous, urticarial, localized skin reactions have been reported which may spread outside the application site.
Not known: burning sensations

Renal and Urinary disorders

Very rare: worsening renal insuffieciency

OVERDOSAGE

The risk of over dosage is minimal with topical application. If accidentally ingested the gel may cause systemic adverse effects depending on the amount ingested. If overdosage occurs, treat symptomatically

PHARMACOLOGICAL PROPERTIES

Ketoprofen is a non-steroidal anti-inflammatory drug of the propionic acid group derived from arylcarboxylic acid. It has anti-inflammatory and analgesic action.

Presentation

Box of 1 aluminium tube @ 30 g

Reg No.: DKL0821204628A1

Manufactured by

Sanofi Winthrop Industrie, Amilly, France

Imported and Package by

PT Aventis Pharma, Jakarta - Indonesia

Date of revision: 25 July 2018

Based on approval 7 March 2018 (CCDSv4-LRC091112)

This information is intended for Health Care Professional only. See local product information for full details information

PROFENID GEL