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Produced by COMPOSITION 100 g of cream contain: Active substance : piroxicam 1 g Excipients: polyethylene glycol 1000 monocetyl ether, polypropylene glycol, cetostearyl alcohol, phenylethyl alco- hol, non - allergenic fragrance, fatty acid polyglycol esters, purified water q.s. PHARMACEUTICAL FORM AND CONTENT 50 g tube 1% cream PHARMACOTHERAPEUTIC GROUP Non - steroidal anti - inflammatory agent for topical use. MARKETING AUTHORISATION HOLDER: BIOHEALTH PHARMACEUTICALS S.r.l. Via Bolognese, 250 – 51020 Pistoia MANUFACTURED AND CONTROLLED BY SPECIAL PRODUCT’S LINE S.r.l. Via Campobello, 15 - Pomezia (Rome) THERAPEUTIC INDICATIONS Painful and phlogistic conditions in joints, muscles, tendons and ligaments either of rheumatic origin or re- sulting from injuries in the said areas. CONTRAINDICATIONS Ascertained individual hypersensitivity towards the product. PRECAUTIONS FOR USE The percentage of active substance absorbed through the skin generally does not reach such concentrations in the circulation as to make the warnings effective and to expose the user to the risk of side - effects related to the drug’s systemic administration. Use in pregnancy and lactation As a precautionary measure its use is contraindicated during pregnancy and lactation unless the physician deems it absolutely necessary. INTERACTIONS According to bioavailability studies, it is highly unlikely that piroxicam cream will displace other drugs that are bound to plasma proteins. However, physicians must follow up patients treated with piroxicam cream and drugs with highly specific protein bonds to make any dosage adjustments required. IPSOFLOG 1% CREAM - PIROXICAM
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