Summary of Product Characteristics (SmPC) - Dermax therapeutic shampoo
1 NAME OF THE MEDICINAL PRODUCT
Dermax Therapeutic Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzalkonium Chloride 0.5% w/w
Excipients with known effect:
Sodium benzoate (E 211)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
Clear, colourless to pale yellow viscous shampoo.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the topical treatment of pityriasis capitis and other seborrhoeic scalp conditions, where there is scaling and dandruff.
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 hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
This medicine contains 5mg of sodium benzoate (E 211) per gram of shampoo. Sodium benzoate (E 211) may cause local irritation.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
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 PHARMACOLOGICAL PROPERTIES
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
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Coconut oil
Dilute hydrochloric acid
Lauryldimonium hydroxypropyl hydrolysed collagen (contains phenoxyethanol and potassium sorbate)
Macrogol lauryl ether (4)
Sodium benzoate (E 211)
Sodium chloride
Sodium lauryl ether sulfate (contains sodium hydroxide as a pH adjuster) 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
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/11/2009
10 DATE OF REVISION OF THE TEXT
05/03/2024