Psoriderm

Psoriderm Cream

Distilled coal tar 6.0% w/w

Excipients with known effect:

1g of cream contains 50 mg of propylene glycol (E 1520)

For the full list of excipients, see section 6.1.

Buff coloured Cream

For the topical treatment of sub-acute and chronic psoriasis, including psoriasis of the scalp and flexures.

For adults, children and the elderly

Apply to the affected area once or twice daily, or as recommended by the physician. Wash hands after use.

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.

Keep away from the eyes, mucous membranes, genital or rectal areas. Avoid cuts and grazes or infected skin.

Propylene glycol may cause skin irritation.

Replace cap after use.

Avoid spillage.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

None known.

No special precautions.

None known.

Local side-effects do not normally occur. In rare cases of skin irritation, acne-like eruptions or photosensitivity, discontinue treatment. Rarely, Psoriderm Cream 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

There are no known toxic effects resulting from excessive use of Psoriderm Cream.

Coal tar has been used dermatologically for hundreds of years and has been shown to be safe and effective in the treatment of scaly scalp 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 Cream 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 10 000 components. There is evidence that topical application of coal tar improves psoriasis by reducing the excessive rate of mitotic epidermal cell division.

Lecithin is added to Psoriderm Cream to soften psoriasis scales and thereby enhance the absorption of the coal tar.

Not applicable.

No relevant information additional to that contained elsewhere in the SPC.

Lecithin

Stearic acid

Isopropyl palmitate

Propylene glycol (E 1520)

Trolamine

Phenoxyethanol

Purified water

None known.

36 months in unopened container.

Do not store above 25°C.

225 ml amber glass JAR with black bakelite SCREWCAP incorporating a Steran liner.

This is supplied as an original pack (OP).

Not applicable.

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place

Gosmore

Hitchin

Herts SG4 7QR

UK

PL 00173/5000R

18 September 1990 / 16 February 2006

27/01/2020