DERMAX THERAPEUTIC SHAMPOO - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Dermax Therapeutic Shampoo

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzalkonium Chloride 0.5% w/w

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

4.   CLINICAL PARTICULARS

4.1.   Therapeutic indications

4.2 Posology and method of administration

For adults, children and the elderly.

Use as a shampoo, daily if necessary, reducing the frequency of use to once or twice a week as the condition improves. Thereafter, occasional use may be necessary. Wet the hair. Apply a sufficient quantity of the shampoo to the scalp to produce a rich lather (approximately a quantity the size of a fifty pence piece for short hair, adjusting up depending on length/thickness of hair) and, with the tips of the fingers, rub in thoroughly. Rinse. If necessary, repeat the application and massage to produce a rich lather. Remove as much lather as possible with the hands, before rinsing thoroughly under running water.

4.3. Contraindications

Not to be used in cases of sensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Keep away from the eyes.

In case of irritation, or if there is no improvement after 4 weeks, or the scalp condition seems to look or feel worse, discontinue treatment and tell your doctor, pharmacist or nurse.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

No special precautions.

4.7. Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

None known.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

There are no known toxic effects resulting from excessive use of Dermol Shampoo.

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Medicated Shampoos. ATC code: D11AC.

The surface active cationic germicide, benzalkonium chloride, is adsorbed on to dry skin scales, which are a feature of pityriasis capitis and other seborrhoeic scalp conditions. The scales are thereby loosened and attain a net positive charge. In the presence of the anionic foaming agent, sodium lauryl ether sulfate, the dandruff scales are then levitated into the negatively charged surface of the foam, and are thus washed from the hair.

The benzalkonium chloride also acts as a mild antiseptic which improves clinical performance where the condition is exacerbated by the presence of microbes. The major site of action against micro-organisms appears to be the cell membrane, where permeability is altered.

5.2. Pharmacokinetic properties

The effect of Dermol Shampoo is entirely superficial since it acts on the outer surface of the stratum corneum, treating the external manifestations of the recommended clinical indications. For this reason, no pharmacokinetic studies have been undertaken.

5.3 Preclinical safety data

6   PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium lauryl ether sulfate

Coconut diethanolamide

Dilute hydrochloric acid

Phenoxyethanol

Sodium chloride

Lauryldimonium hydroxypropyl hydrolyzed collagen

Coconut oil

Purified water

6.2 Incompatibilities

Not applicable.

6.3. Shelf life

36 months in unopened container.

6.4. Special precautions for storage

Do not store above 25°C.

Keep bottle in outer carton.

6.5 Nature and contents of container

100 or 250 ml white high density polyethylene bottle with a polypropylene dispensing screw cap.

25 or 30 ml white high density polyethylene bottle with a polypropylene screw cap.

Not all pack sizes may be marketed.

6.6. Instructions for use and handling

Not applicable.

7. MARKETING AUTHORISATION HOLDER

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place,

Gosmore

Hitchin,

Herts,

SG4 7QR, UK

8. MARKETING AUTHORISATION NUMBER

PL 00173/0198