Summary of medicine characteristics - UREA10% W/W CREAM
1 NAME OF THE MEDICINAL PRODUCT
Urea 10% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Urea 10% w/w Cream contains urea Ph Eur 10% w/w.
3 PHARMACEUTICAL FORM
A smooth, unperfumed, non greasy, off white cream for topical administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of ichthyosis and hyperkeratotic skin conditions associated with atopic eczema, xeroderma, asteatosis and other chronic dry skin conditions.
4.2 Posology and method of administration
Urea 10% w/w 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.
4.3 Contraindications
Known hypersensitivity to the product.
4.4 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.
4.5 Interaction with other medicinal products and other forms of interaction
Urea 10% w/w Cream may increase the penetration through the skin barrier of other topically applied medicaments.
4.6 Fertility, pregnancy and lactation
Animal reproduction studies have not been conducted with Urea 10% w/w Cream. Urea 10% w/w Cream should only be used if the anticipated benefits outweigh the risks.
4.7 Effects on ability to drive and use machines
Urea 10% w/w Cream does not interfere with the ability to drive or use machines.
4.8 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 the Yellow Card Scheme. Tel: Freephone 0808 100 3352. Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
4.9 OverdoseTopical applications of excessive amounts of Urea 10% w/w Cream might cause skin irritation but no other effects would be expected. Ingestion of a large amount of Urea 10% w/w 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Urea has a therapeutic effect in chronic dry skin conditions through its hydrating, keratolytic and anti-pruritic properties.
5.2 Pharmacokinetic properties
5.2 Pharmacokinetic propertiesThere is no information available on the pharmacokinetics of urea.
5.3 Preclinical safety data None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
The cream also contains white soft paraffin, maize starch, isopropyl myristate, syncrowax HR-C, palmitic acid, sorbitan laurate, arlatone G.
6.2 Incompatibilities
None Known.
6.3 Shelf life
Two years.
6.4 Special precautions for storage Store below 30°C.
6.5 Nature and contents of container
Urea 10% w/w Cream is available in tubes of 30g and 100g.