SODIUM PYRROLIDONE CARBOXYLATE 2.5% CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Sodium pyrrolidone carboxylate 2.5% Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Pyrrolidone Carboxylate 2.5%.

Excipients: Cetomacrogol emulsifying wax contains cetostearyl alcohol.

For full list of excipients see Section 6.1.

3 PHARMACEUTICAL FORM

4.1.   Therapeutic Indications

4.2 Posology and method of administration

Route of administration

For topical use only.

Adults, Children and the Elderly:

Apply liberally to the affected area and massage well into the skin. Sodium pyrrolidone carboxylate 2.5% Cream may be used as often as required.

Sodium pyrrolidone carboxylate 2.5% Cream is especially beneficial when used immediately after washing or bathing, when the resultant warmth of the skin enhances absorption.

4.3. Contra-Indications

There are no contraindications except true hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

The formulation is not designed for use as a diluent.

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. Interactions with other Medicinal Products and other Forms of Interaction

None known.

4.6 Fertility, pregnancy and lactation

Sodium pyrrolidone carboxylate 2.5% Cream is not contra-indicated in pregnancy or lactation.

4.7. Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable effects

Rarely a non serious allergic reaction may be experienced, e.g. rash.

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 at: www.mhra.gov.uk/yellowcard.

Not applicable. Sodium pyrrolidone carboxylate 2.5% Cream is for topical use only.

5.1 Pharmacodynamic properties

The combination of oils used in Sodium pyrrolidone carboxylate 2.5% Cream helps to lubricate and hydrate the skin. Moisture loss from the stratum corneum is reduced by the formation of an occlusive film by liquid paraffin on the surface of the skin. Isopropyl myristate, a fatty acid ester, is easily absorbed into the skin and helps to improve skin softness

5.2. Pharmacokinetic Properties

Sodium pyrrolidone carboxylate positively aids the hydration of the skin.

5.3. Pre-clinical Safety Data

None stated.

6.1 List of Excipients

Liquid Paraffin

Isopropyl Myristate

Sodium Lactate Solution

Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol)

Myristyl Myristate

Macrogol Cetostearyl Ether

Hydroxybenzoates (Parabens)

Phenoxyethanol

Purified Water.

6.2 Incompatibilities

Not applicable. Sodium pyrrolidone carboxylate 2.5% Cream is for topical use only.

6.4 Special precautions for storage

Sodium pyrrolidone carboxylate 2.5% Cream should be stored in a dry place avoiding extremes of temperature ie not less than 5°C and not more than 30°C.

6.5 Nature and contents of container

Sodium pyrrolidone carboxylate 2.5% Cream is packed in low density polyethylene tubes of 10 g, 50 g and 100 g with a flush fitting cap. It is also available in polypropylene tubs containing 500 g with pump dispenser.

Not all pack sizes may be marketed.

6.6. Instruction for Use, Handling and Disposal

No special instructions.

7. MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PL 16853/0089

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

29/05/2008