SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Dermol 200 Shower Emollient.

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

For excipients see section 6.1.

3. PHARMACEUTICAL FORM

White, non-greasy Cutaneous emulsion.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

An antimicrobial shower emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. Dermol 200 Shower Emollient is for direct application onto the skin and is suitable for use as a soap substitute.

4.2. Posology and method of administration

For adults, children and the elderly.

For application to the skin(eg after showering)

Apply to the affected areas as required.

Massage into the skin, until absorbed.

For use as a soap substitute in the shower

As required, use the shower emollient instead of ordinary shower gel or soap. Pat dry.

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, especially when used on the face.

Take care to avoid slipping in the shower or bath.

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 200 Shower Emollient 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. Interactions 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

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

Dermol 200 Shower Emollient 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.

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.

Patients with dry skin conditions have a deficiency of the natural oils which assist in the retention of moisture.

A non-ionic emollient soap substitute such as Dermol 200 Shower Emollient, will cleanse the skin, helping to remove surface debris without removing the skins natural oils.

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.

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.

6.5 Nature and contents of container

High density polyethylene bottle (30, 50, 75, 100, 125, 150, 200, 250, 300, 350 or 500 ml) with either a white polypropylene metering pump or a white polypropylene dispensing stopper/screw cap. A polypropylene hooked overcap is provided on some pack sizes.

Paper/polyethylene/foil/polyethylene laminate sachet (5 or 10 ml) packaged into unit cartons in appropriate multiples to match the above bottle capacities. Supplied as original packs (OP).

6.6 Special precautions for disposal

Not applicable.

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: 00173/0156.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21 February 1994.

10 DATE OF REVISION OF THE TEXT

16/10/2014