Psoriderm Emulsion 40% W/V Bath Additive
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Psoriderm Emulsion 40% w/v Bath Additive
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Distilled Coal Tar 40.0% w/v
3. PHARMACEUTICAL FORM
Bath additive.
Buff coloured liquid emulsion
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For use topically as an aid in the treatment of subacute and chronic psoriasis.
4.2. Posology and method of administration
For adults, children and the elderly.
Add 30 ml of the emulsion to a standard bath of warm water. Soak for 5 minutes, pat dry.
4.3. Contra-indications
Not to be used for acute, sore or pustular psoriasis or in the presence of infection.
Not to be used in cases of sensitivity to any of the ingredients.
4.4. Special warnings and precautions for use
Do not use product undiluted
Keep away from the eyes and broken or inflamed skin. Replace cap after use.
Avoid spillage.
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
Local side effects do not normally occur. In rare cases of skin irritation, acne-like eruptions or photosensitivity, discontinue treatment. Rarely, Psoriderm bath additive may stain skin, hair or fabric.
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
There are no known toxic effects resulting from excessive use of Psoriderm bath additive. If accidentally swallowed, contact a doctor or hospital immediately.
5.1 Pharmacodynamic properties
Coal tar has been used dermatologically for hundreds of years and has been shown to be safe and effective in the treatment of scaly skin conditions such as psoriasis. The British Pharmacopoeia contains monographs on coal tar and coal tar solution, and many formulations of coal tar are used in hospitals throughout the country. The coal tar used in Psoriderm bath additive has been specially distilled and is based on a neutral fraction, which has been shown to be effective in the treatment of psoriasis.
The precise mechanism of action of coal tar is not understood, largely as a result of it comprising up to 10000 components. There is evidence that topical application of coal tar improves psoriasis by reducing the excessive rate of mitotic epidermal cell division.
5.2 Pharmacokinetic properties
Dry scales, which are a common feature of psoriasis, generally reduce the effectiveness of topically applied treatments by reducing absorption of the active ingredient. An established means of overcoming this problem is to add a mild softening agent such as lecithin. In the case of Psoriderm bath additive, however, no such softening agent is included because the dosage and administrative regime involves prolonged soaking (5 minutes) in a warm water emulsion which achieves a similar effect.
5.3. Preclinical safety data
None
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polysorbate 20 Trolamine Phenoxyethanol Water
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months in unopened container
6.4. Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
200 ml amber glass bottle and polypropylene screw cap with polyethylene liner, supplied as an original pack.
6.6. Instruction for use, handling and 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
PL 00173/5003R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/01/2007
10 DATE OF REVISION OF THE TEXT
19/10/2015