Regulatory Information
A. MENARINI SINGAPORE PTE. LTD.
A. MENARINI SINGAPORE PTE. LTD.
Therapeutic
Pharmacy Only
Formulation Information
GEL
**DOSAGE AND ADMINISTRATION** Apply a thin layer of gel on the area of affected skin, once or twice a day, gently massaging to help absorption. Opening of the soft tube: unscrew the cap and perforate the diaphragm of aluminium with the point of the inverted cap.  Pre-filling of the dispensing tube: push the dispenser cap several times or push the base of the tube until the gel appears; it is advisable to use it in a horizontal position.  Consult your physician in case of allergic or other kind of skin reactions. Seek your physician's advice if the condition occurs repeatedly or if you have noted any kind of recent change in its characteristics. Caution: do not exceed recommended doses without consulting your physician. Use only for brief periods of treatment **Paediatric population** The safety and efficacy of ketoprofen gel in children have not been established.
TOPICAL
Medical Information
**INDICATIONS** 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, torticollis, lumbago). Phlebitis, periphlebitis, lymphoangitis, superficial lymphoadenitis. Erythemas and cutaneous phlogistic processes.
**CONTRAINDICATIONS** - History of hypersensitivity to the active substance or to any of the excipients included in section “Composition” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ - History of any photosensitivity reactions. - Known hypersensitivity reactions, such as asthma symptoms, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid or other NSAIDs. - History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, UV blockers or parfumes. - Sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation (see section “Special warning and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Application on pathological skin changes such as eczema or acne; in Infectious skin or open wounds. - Third trimester of pregnancy (see section "Use in Pregnancy and Breastfeeding" – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
M02AA10
ketoprofen
Manufacturer Information
A. MENARINI SINGAPORE PTE. LTD.
A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L.