Summary of Product Characteristics (SmPC) - Psoriderm cream
1 NAME OF THE MEDICINAL PRODUCT
PSORIDERM CREAM
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3 PHARMACEUTICAL FORM
Buff coloured CREAM
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the topical treatment of sub-acute and chronic psoriasis, including psoriasis of the scalp and flexures.
4.2 Posology and method of administration
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.
4.3 Contraindications
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
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.
4.5 Interaction 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 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.
4.9 Overdose
There are no known toxic effects resulting from excessive use of Psoriderm Cream.
5 PHARMACOLOGICAL PROPERTIES
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 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.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lecithin
Stearic acid
Isopropyl palmitate
Propylene glycol (E 1520)
Trolamine
Phenoxyethanol
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°
6.5 Nature and contents of container
225 ml amber glass JAR with black bakelite SCREWCAP incorporating a Steran liner. This is supplied as an original pack (OP).
6.6 Special precautions for disposal
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(S)
PL 0173/5000R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24 November 1972 / 18 September 2000
10 DATE OF REVISION OF THE TEXT
27/01/2020