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Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk • NSAIDs is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse

perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

CompositionActive ingredient:Each 100 gm gel contains, Ketoprofen ………..2.500 gmInactive ingredient:Carbomer 940, Trolamine, Lavender Oil & Alcohol.

Pharmaceutical formGel.

Pharmacological actionPharmacodynamics: Profenid gel contains ketoprofen, a phenyl propionic acid derivative of a non-steroid nature with analgesic and

prostaglandin synthesis and thrombocyte aggregation.Pharmacokinetics: Plasma and tissue levels of ketoprofen have been measured in 24 patients undergoing knee surgery. After repeated percutaneous administration of *TM* gel, the plasma levels were about 60 fold less (9 - 39 ng/g) than those obtained after a single oral dose of ketoprofen (490 - 3300 ng/g). Tissue levels in the actual area were within the same concentration range, for the gel as for the oral treatment, though the gel had a considerably higher interindividual variability. Bioavailability of ketoprofen after topical administration has been estimated to be approximately 5% of the level obtained after an orally administered dose based on urinary excretion data. The protein binding in plasma is approximately 99%. Ketoprofen is excreted through the kidneys mainly as glucuronide conjugate.

IndicationsFor the symptomatic treatment of mild to moderate local pain associated with muscle and/or joints injuries, e.g. sport injuries.

Dosage and administrationGeneral

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.Special Populations

not been established.

ContraindicationsBecause of cross-reactions, Ketoprofen gel shall not be used by patients with known hypersensitivity reactions, such as symptoms of

tiaprofenic acid , or acetylsalicylic acid or other non-steroidal

History of hypersensitivity to any of the excipients .

History of photosensitivity reaction.

UV blocker or parfumes. Do not use Ketoprofen gel if you cannot avoid sun exposure, even hazy sun, including UV light from solarium during treatment and for 2 weeks after its discontinuation.Ketoprofen gel must not be used on pathological skin changes such as eczema or acne; or in infected skin or open wounds.Ketoprofen is also contra-indicated during the third trimester of pregnancy.

Immune System disorders:Unknown: Hypersensitivity reactionsSkin and Subcutaneous tissue disorders:Less frequent (1/100 - 1/1000): Erythema, pruritus, eczema.Rare (<1/1000): Photosensitivity reactions, dermatitis bullous, urticaria. Localized skin reactions have been reported which may spread outside the application site. Unknown: Burning sensationsRenal and Urinary disorders:Very rare:

Drug InteractionsInteractions are unlikely as serum concentrations following topical administration are low.

Pregnancy In the absence of clinical experience with the topical form and by reference with the systemic forms:

As the safety of ketoprofen in pregnant women has not been

trimester of pregnancy should be avoided.During the third trimester:During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy, prolonged bleeding time in both mother and child, may occur.

LactationNo data is available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.

Warnings & PrecautionsThe gel should be used with caution in patients with reduced heart, liver or renal function. The gel must not be used with occlusive dressings. The gel must not come into contact with mucous membranes of the eyes. Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene containing products. 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 discontinu-ation to avoid the risk of photosensitization. Careful and prolonged hand washing should be carried out after each use of the gel.

dose for the shortest possible duration necessary to control symptoms.

StorageStore below 30º C.

Keep all medicines out of reach of children

PackageProfenid ® 2.5%: Carton box containing 1 Al tube of 30 gm gel

S3

Produced by SANOFI Egypt s.a.e.Under license of Laboratoire Aventis / France

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°

,

Brand name: Profenid Gel

Version number: S3

Bar code: 912 Country: EgyptDate: 17.03.2013Designer: G. HabibDimensions: 300 x 175 mmColor:

E042913

E042913 - Pamph Profenid Gel S@n

This document has been digitally signed by the following people within the VISTAlink system,

following the sanofi-aventis group guidelines.

Plant: CAIRO- EGYPT

Packaging material code: E042913

Packaging material name: Pamph Profenid Gel S@n

Second packaging material code: 41154

VISTAlink folder number: 1057186

VISTAlink PDF version: 2

Reason Signed by Date

Market marketing validation Mohamed Fawzy (Egyptmarketing department team) 23/05/2013 19:10:59

Market medical affairs validation Samy Abdelsalam (Egyptmedical affairs team) 24/06/2013 14:24:32

Market regulatory validation Nermeen Nassar (Egyptregulatory affairs team) 15/07/2013 10:44:43

Plant final technical validation Gamal Habib (Cairo packagingteam) 15/07/2013 10:51:50

Plant quality validation Madlen Samir (Cairo qualityassurance team) 16/07/2013 12:57:03

Plant ready to print Gamal Habib (Cairo packagingteam) 29/08/2013 11:14:00

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