Psoriderm Cream

1. Name Of The Medicinal Product

PSORIDERM™ CREAM

2. Qualitative And Quantitative Composition

Distilled Coal Tar 6.0% w/w; Lecithin 0.4% w/w.

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 and mucous membranes, genital or rectal areas. Avoid cuts and grazes or infected skin. The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people. Replace cap after use. Avoid spillage.

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.

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 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 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 a well known phospholipid which is present in foodstuffs. It 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

Stearic Acid; Isopropyl Palmitate; Propylene Glycol; Triethanolamine; 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°C.

6.5 Nature And Contents Of Container

Amber glass jar containing 225 ml. This is supplied as an original pack (OP).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/5000R.

9. Date Of First Authorisation/Renewal Of The Authorisation

16 February 2006.

10. Date Of Revision Of The Text

February 2006.