Search for:

Search Medicine or Company Name Search Full Document

Advanced Search

Alliance Pharmaceuticals
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB Telephone: +44 (0)1249 466 966 Fax: +44 (0)1249 466 977 WWW: http://www.alliancepharma.co.uk Medical Information e-mail: medinfo@alliancepharma.co.uk Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 03/11/2009

SPC	Aquadrate 10% w/w Cream

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Aquadrate 10% w/w Cream

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Aquadrate contains urea Ph Eur 10% w/w.

Go to top of the page

3. PHARMACEUTICAL FORM

A smooth, unperfumed, non greasy, off white cream for topical administration.

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

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.

Go to top of the page

4.2 Posology and method of administration

Aquadrate 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.

Go to top of the page

4.3 Contraindications

Known hypersensitivity to the product.

Go to top of the page

4.4 Special warnings and precautions for use

Avoid application to moist or broken skin.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

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

Go to top of the page

4.6 Pregnancy and lactation

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

Go to top of the page

4.7 Effects on ability to drive and use machines

Aquadrate does not interfere with the ability to drive or use machines.

Go to top of the page

4.8 Undesirable effects

May produce local irritations (including erythema, burning or pruritus) and oedema when applied to sensitive, moist or fissured skin.

Go to top of the page

4.9 Overdose

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

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

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

Go to top of the page

5.2 Pharmacokinetic properties

There is no information available on the pharmacokinetics of urea.

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients