SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

HYDROMOL 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

Hydromol Cream is a soft, white, oil-in-water cream which can be massaged easily into the skin.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Any condition in which "dry skin" is a feature, including all forms of dermatitis / eczema and all degrees of icthyosis and senile pruritus.

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. Hydromol Cream may be used as often as required.

Hydromol 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 Special Precautions for Use

The formulation is not designed for use as a diluent.

4.5. Interactions with other Medicinal Products and other Forms of Interaction

None known.

4.6.    Pregnancy and Lactation

Hydromol 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.

4.9. Overdose

Not applicable. Hydromol Cream is for topical use only.

5.    PHARMACOLOGICAL PROPERTIES

5.1.    Pharmacodynamic Properties

The combination of oils used in Hydromol 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.

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, Hydromol Cream is for topical use only.

6.3.    Shelf-Life

2 years.

6.4.    Special Precautions for Storage

Hydromol Cream should be stored in a dry place avoiding extremes of temperature i.e. not less than 5°C and not more than 30°C.

6.5 Nature and contents of container

Hydromol 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 THE

AUTHORISATION

29/05/2008

10 DATE OF REVISION OF THE TEXT

21/04/2015