Fastum Gel

Fastum Gel

ketoprofen

Manufacturer:

A. Menarini

Distributor:

Zuellig
Full Prescribing Info
Contents
Ketoprofen.
Action
Well-known is the marked antiphlogistic and pain-antagonizing activity of ketoprofen, the most effective compound in this sense amongst the synthesized nonsteroid drugs. This is the active substance of ketoprofen gel which therefore enables the topical percutaneous treatment of the painful, phlogistic or traumatic affections of the joints, the tendons, the ligaments and the muscles. It also contributes in contingent association with the proper treatments by usual route to the prompt recovery of the superficial inflammatory processes involving skin, veins, lymphatic vessels, lymph glands. A suitable excipient ensures the transcutaneous penetration of ketoprofen without provoking any systemic-like side effects; tolerability is excellent in the application site even for the most sensitive skin.
Indications/Uses
Painful, phlogistic or traumatic affections of the joints, tendons, ligaments and muscles (arthritis, periarthritis, arthrosynovitis, tendinitis, tenosynovitis, bursitis, contusions, sprains, luxations, lesions of the knee's meniscus, tortocollis, lumbago). Phlebitis, erythemas and cutaneous phlogistic processes.
Dosage/Direction for Use
Apply the gel (3-5 cm, depending on the extent of the involved area) on the skin once or twice daily, gently rubbing in to help absorption.
Contraindications
Hypersensitivity reactions to ketoprofen.
Special Precautions
The use, especially if prolonged, of topical products may cause phenomena of sensitisation or local irritation. In order to avoid any reaction of hypersensitivity or photosensitivity, avoid exposure to direct sunlight, including solarium (sunbeds), during treatment and the 2 weeks thereafter.
It is advisable not to apply Fastum Gel on open wounds or in any other case in which there has been a loss of skin integrity. Fastum gel does not cause habituation.
Use in pregnancy & lactation: In pregnant and breastfeeding women, it should be administered only in cases of real necessity and under medical supervision.
Use In Pregnancy & Lactation
In pregnant and breastfeeding women, it should be administered only in cases of real necessity and under medical supervision.
Side Effects
There have been reports of localized skin reactions which may subsequently spread beyond the application area and in isolated cases, may be severe and generalized: Erythema burns, pruritus, allergic skin reactions, dermatitis, contact eczema, photosensitivity reactions, urticaria, boil eruptions.
The frequency and entity of such effects are sensibly reduced by avoiding exposure to the sunlight (including solarium), during treatment and the 2 weeks thereafter. There have been reports of isolated cases of systemic adverse reactions eg, renal disorders. The undesired effects are generally transitory. However, should they occur, it is advised to consult a physician or pharmacist. It is important to inform the physician or pharmacist of the onset of any undesired effects not mentioned previously.
Drug Interactions
No interactions of Fastum Gel with other drugs have been reported. It is however, opportune to monitor patients under treatment with cumarinic substances.
Storage
Store at temperatures not exceeding 25°C.
ATC Classification
M02AA10 - ketoprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Presentation/Packing
Topical gel 25 mg/g x 30 g, 50 g.
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