DERMOL WASH CUTANEOUS EMULSION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Dermol Wash Cutaneous Emulsion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Liquid paraffin

2.5% w/w

2.5% w/w

0.1% w/w

Isopropyl myristate

Benzalkonium chloride

Chlorhexidine dihydrochloride 0.1% w/w

Excipients with known effect:

Cetostearyl alcohol

For the full list of excipients, see Section 6.1

3 PHARMACEUTICAL FORM

Cutaneous emulsion

White, non-greasy cutaneous emulsion.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

An antimicrobial emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. Dermol Wash Cutaneous Emulsion is suitable for direct application and for use as a soap substitute.

4.2 Posology and method of administration

For adults, children and the elderly. For cutaneous use only.

For use as a soap substitute

Use as a cleanser at the sink or to wash with in the bath or shower, instead of ordinary soap or shower gel. Pat the skin dry using a soft towel (avoid rubbing as this can irritate the skin).

The product may also be used in a similar way for frequent hand washing.

For application to the skin (eg after washing)

Apply to the affected areas as required.

4.3 Contraindications

Do not use in cases of known sensitivity (especially generalised allergic reaction) to any of the ingredients (see sections 4.4 and 4.8).

4.4 Special warnings and precautions for use

Avoid contact with the eyes.

Local skin reactions (e.g. contact dermatitis) to any of the ingredients are rare but possible in sensitive people.

There are literature reports of chlorhexidine compounds inducing hypersensitivity, including anaphylactic shock. The prevalence of this is not known, but is likely to be very rare. Dermol Wash Cutaneous Emulsion should not be administered to anyone with a possible history of allergic reaction to a chlorhexidine compound (see sections 4.3 and 4.8).

Dermol Wash Cutaneous Emulsion contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

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 known.

4.6 Pregnancy and lactation

No special precautions.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Although the product has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction, discontinue treatment.

These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area.

Very rarely, hypersensitivity including anaphylactic reaction (see sections 4.3 and 4.4) is possible (based on literature for chlorhexidine-containing products).

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: D02 AX, emollients and protectives.

Bacteria (especially Staphylococcus aureus) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema and dermatitis.

Dermol Wash contains 5% of emollient oils in a non-greasy aqueous system which also contains the well-known and effective antiseptics benzalkonium chloride and chlorhexidine dihydrochloride. Its antimicrobial properties assist in overcoming infection, whether from Staph aureus, the pathogen which often complicates eczema and associated pruritus, or secondary infection caused by scratching.

Massaged into the skin, the emollients, liquid paraffin and isopropyl myristate, permit rehydration of dry skin by forming an occlusive barrier within the skin surface, thus reducing drying from evaporation of water that diffuses from the underlying layers.

5.2 Pharmacokinetic properties

The active ingredients are presented in an aqueous emulsion system and so are readily absorbed into the stratum corneum when the product is gently massaged over the areas of dry skin. The antiseptic ingredients are in intimate contact with the skin, and as they are in solution, their availability is optimal.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6.1 List of excipients

Macrogol cetostearyl ether (cetomacrogol 1000)

Cetostearyl alcohol

Phenoxyethanol

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

30 months in unopened container

In-use – 18 months (container sizes greater than 250 ml)

6.4 Special precautions for storage

Do not store above 25°C.

Replace cap after use.

6.5 Nature and contents of container

High density polyethylene bottle (50, 200 or 500 ml) with either a white polypropylene metering pump or a white polypropylene dispensing stopper/screw cap.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place

Gosmore

Hitchin

Hertfordshire, SG4 7QR UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 00173/0407

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

30/04/2010