Country: Sweden
Language: Swedish
Source: Läkemedelsverket (Medical Products Agency)
ketoprofen
Euromedica Norge ASA
M02AA10
ketoprofen
2,5 %
Gel
etanol, vattenfri Hjälpämne; ketoprofen 25 mg Aktiv substans
Receptbelagt
Ketoprofen
Avregistrerad
2004-04-28
SUMMARY OF PRODUCT CHARACTERISTICS 2 1 NAME OF THE MEDICINAL PRODUCT Orudis 2.5% gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g gel contains 25 mg ketoprofen. Excipient(s) with known effect: Ethanol 313 mg in each 1 g of Orudis gel (see section 4.4) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel for cutaneous use. A colourless transparent gel with a scent of lavender. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of mild to moderate local pain associated with muscle and/or joints injuries, e.g., sport injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The gel should be applied on to 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. _Paediatric population_ The safety and efficacy of ketoprofen gel in children have not been established. Method of administration For cutaneous use. The gel should be massaged onto the skin for a few minutes. 4.3 CONTRAINDICATIONS The gel is contraindicated in the following cases: • history of any photosensitivity reaction • known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAID • history of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or perfumes 3 • sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation • history of hypersensitivity to one of the excipients • on pathological skin changes such as eczema or acne; or in infectious skin or open wounds • third trimester of pregnancy (see section 4.6) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The gel should be used with caution in patients with reduced heart, liver or renal function: isolated Read the complete document