SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Aquadrate 10% w/w Cream Hydromol Intensive

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Aquadrate/Hydromol Intensive 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, iasteatosis and other chronic dry skin conditions.

4.2 Posology and method of administration

Aquadrate/Hydromol Intensive 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 selfocclusive 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.

4.5 Interaction with other medicinal products and other forms of interaction

Aquadrate/Hydromol Intensive may increase the penetration through the skin barrier of other topically applied medicaments.

4.6 Pregnancy and lactation

Animal reproduction studies have not been conducted with Aquadrate/Hydromol Intensive. Aquadrate/Hydromol Intensive should only be used if the anticipated benefits outweigh the risks.

4.7 Effects on ability to drive and use machines

Aquadrate/Hydromol Intensive 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

Topical applications of excessive amounts of Aquadrate/Hydromol Intensive might cause skin irritation but no other effects would be expected. Ingestion of a large amount of Aquadrate/Hydromol Intensive 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.

5.1 Pharmacodynamic properties

Urea has a therapeutic effect in chronic dry skin conditions through its hydrating, keratolytic and anti-pruritic properties.

5.2 Pharmacokinetic properties

There 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.

Nature and contents of container

Aquadrate/Hydromol Intensive is available in tubes of 30g and 100g.

Special precautions for disposal

A patient leaflet is provided with details of use and handling of the product

7 MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 16853/0061

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

20 June 2002

10 DATE OF REVISION OF THE TEXT

10/03/2015