Profenid 2.5% Topical Gel 30 gm

Nonsteroidal Anti-inflammatory Drug (NSAID) used in the symptomatic treatment of mild to moderate local pain associated with muscle and/or joints injuries.

-Adults: the gel should be applied on the painful or inflamed area two to three times daily. The amount of gel should be adjusted so that it covers the painful area. The total daily dose shall not exceed 15 grams per day. (7.5 grams correspond to approximately 14 cm gel). The length of treatment should not exceed one week. The gel should be massaged onto the skin for a few minutes. -The safety and efficacy of ketoprofen gel in children has not been established.

Hypersensitivity reactions, erythema, pruritus, eczema, photosensitivity reactions, dermatitis bullous, urticaria, localized skin reactions have been reported which may spread outside the application site, burning sensations and very rarely, can cause worsening of renal insufficiency.

-The gel must not come into contact with mucous membranes of the eyes. Treatment should be discontinued immediately upon development of any skin reaction. -Protect the treated region with clothing when outdoor, even in the absence of direct sun. This should be done during treatment with the product & for two weeks following its discontinuation to avoid the risk of photosensitization. -Careful and prolonged handwashing should be carried out after each use of the gel. -The gel must not be used with occlusive dressings. -Should not be given to patients suffering from hypersensitivity to ketoprofen. -Contraindicated in patients who experience bronchospasm, asthma, rhinitis, or urticaria with nonsteroidal anti-inflammatory drug (NSAID) or aspirin therapy. -NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including MI and stroke. -NSAIDs may cause potentially fatal serious skin adverse events including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Store at room temperature.

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

-Ketoprofen crosses the placenta, maternal use of NSAIDs should be avoided beginning at 20 weeks' gestation. If NSAID use is necessary between 20 and 30 weeks' gestation, limit use to the lowest effective dose and shortest duration possible. Based on available information, NSAIDs can be continued during the first 2 trimesters of pregnancy in patients with rheumatic and musculoskeletal diseases; use in the third trimester is not recommended. -Ketoprofen is present in breast milk. NSAIDs are considered compatible for the treatment of rheumatic and musculoskeletal diseases in lactating patients, maternal use of NSAIDs should be avoided if the breastfeeding infant has platelet dysfunction, thrombocytopenia, or a ductal-dependent cardiac lesion. -Ask you physician before taking any medication during pregnancy or lactation.

SANOFI