SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Dermol 500 Lotion

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Liquid Paraffin 2.5% w/w Isopropyl Myristate 2.5% w/w Benzalkonium Chloride 0.1% w/w Chlorhexidine Dihydrochloride 0.1% w/w

Excipient:

Cetostearyl Alcohol 5.0% w/w For full list of excipients see 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. The lotion 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 application to the skin

Apply the lotion to the affected areas as required.

Massage into the skin, until absorbed.

For use as a soap substitute

Use as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.

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, in particular cetostearyl alcohol, 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 500 Lotion should not be administered to anyone with a possible history of allergic reaction to a chlorhexidine compound (see sections 4.3 and 4.8).

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

Local skin reactions

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.

Serious generalised allergic reactions

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

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

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 or dermatitis.

Dermol 500 Lotion contains 5% of emollient oils in a non-greasy aqueous lotion 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.

Pharmacokinetic properties

The active ingredients are presented in an aqueous lotion 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

No special information.

6    PHARMACEUTICAL PARTICULARS

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, 75, 100, 125, 150, 200, 300, 350 or 500 ml) with either a white polypropylene METERING PUMP or a white polypropylene dispensing STOPPER/CAP as appropriate.