Generic name: Carbamide (Urea) Composition: Each 100 gm contains: Carbamide (Urea) 10gm Pharmaceutical form: White smooth homogenous cream free from lumps and foreign matter. CLINICAL PARTICULARS Therapeutic indications For the treatment of ichthyosis and hyperkeratotic skin conditions associated with atopic eczema, xeroderma, asteatosis and other chronic dry skin conditions. Posology and method of administration Carbamide Cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry, and apply sparingly twice daily. Occlusive dressings may be used but are usually unnecessary because of the self-occlusive nature of the cream. Contraindications Known hypersensitivity to the product. Special warnings and precautions for use Avoid application to moist or broken skin. Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce build-up but not totally remove it. Interaction with other medicinal products and other forms of interaction Carbamide Cream may increase the penetration through the skin barrier of other topically applied medicaments. Fertility, pregnancy and lactation Animal reproduction studies have not been conducted with Carbamide (urea) Cream. Carbamide (urea) Cream should only be used if the anticipated benefits outweigh the risks. Effects on ability to drive and use machines Carbamide Cream does not interfere with the ability to drive or use machines. Undesirable effects May produce local irritations (including erythema, burning or pruritus) and oedema when applied to sensitive, moist or fissured skin. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via sending e-mail to pv@memphis.com.eg or via Pv.followup@edaegypt.gov.eg Overdose Topical applications of excessive amounts of Carbamide Cream might cause skin irritation but no other effects would be expected. Ingestion of a large amount of Carbamide Cream would be expected to result in gastrointestinal irritation (nausea and vomiting). Symptomatic and supportive care should be given. Liberal oral administration of milk or water may be helpful. PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties Urea has a therapeutic effect in chronic dry skin conditions through its hydrating, keratolytic and anti-pruritic properties. Pharmacokinetic properties There is no information available on the pharmacokinetics of urea. PHARMACEUTICAL PARTICULARS List of excipients The cream also contains: White bees wax, Cetyl alcohol, Glycerin, Tween 80 (Polysorbate 80), Methyl paraben, Propyl paraben, liquid paraffin, Deionized water. Incompatibilities None Known. Shelf life Three years. Special precautions for storage Store at a temperature not exceeding 30°C. Nature and contents of container Carbamide Cream is available in tubes of 30g and 50g. Package: Carton box contains aluminium tube of 30g or 50g and inner leaflet.
