EUMOCREAM 25% W/W - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Eumocream 25% w/w

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Glycerol 25% w/w

For excipients, see 6.1

3 PHARMACEUTICAL FORM

Cream

Smooth, white cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

This product is indicated for the management of dry or flaky skin conditions which may also be pruritic such as eczema or dermatitis.

4.2 Posology and method of administration

For topical application to the skin.

Adults, the elderly, infants, babies and children:

The cream should be applied to the affected areas as often as required.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Avoid contact with the eyes, as the product may cause irritation to the epithelial cells of the cornea.

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 product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

None stated

4.6 Pregnancy and lactation

Animal studies are insufficient with respect to effects on pregnancy, foetal development, parturition or postnatal developments. The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

Hypersensitivity reactions have been rarely reported; they usually consist of localised skin 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

Eumocream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.

5.1 Pharmacodynamic properties

ATC Code: D02AX

When this product is applied to the skin it acts as an emollient and humectant.

5.2 Pharmacokinetic properties

Eumocream is for topical use only. There are no pharmacokinetic data for this product.

5.3 Preclinical safety data

There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.

6.1 List of excipients

Glycerol monostearate 40–55

Cetostearyl alcohol

Beeswax substitute 6621 (Paraffin wax, Vegetable Stearic acid, Prime Yellow Camauba wax)

Arlacel 165 (Glycerol Monostearate, Polyoxyethylene 100 Stearate) Dimeticone

Chlorocresol

Sodium citrate

Citric acid monohydrate

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25 °C. Do not freeze.

6.5 Nature and contents of container

Collapsible aluminium tube internally lacquered with an epoxy coat, with a latex band and a wadless polypropylene cap.

30 g and 100 g tubes.

6.6 Special precautions for disposal

None stated

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 44673/0040

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

03/04/2007