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Psorin Ointment

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Psorin ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Dithranol 0.11 %w/w, salicylic acid 1.6 %w/w, coal tar 1.0 %w/w For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Yellow/beige ointment for topical administration.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

The topical treatment of sub-acute and chronic (stable) psoriasis.

4.2 Posology and method of administration

Method of administration: Topical

Adults, children and elderly:

Following a 24-hour skin test, a small quantity of Psorin should be applied to the affected areas morning and evening for seven days. If no redness occurs, it may then be applied more liberally twice daily. The ointment should be rubbed well into the skin.

4.3 Contraindications

Psorin should not be used to treat patients with acute or pustular psoriasis, or unstable psoriasis which tends to deteriorate in the sunlight and where the skin is hot to touch and itchy.

Patients sensitive to dithranol, coal tar, salicylic acid or any of the excipients should not be treated with Psorin; a 24-hour skin test is recommended prior to treatment.

Patients using Psorin should not spend long periods in direct sunlight.

4.4 Special warnings and precautions for use

A 24-hour skin sensitivity test should be carried out prior to commencing treatment.

Avoid contact with the eyes and sensitive areas of skin such as the face, skin flexures and genitals.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6    Fertility, Pregnancy and lactation

There is no evidence to support the safety in pregnant or lactating women.

4.7    Effects on ability to drive and use machines

Psorin ointment is not expected to affect ability to drive or use machines.

4.8 Undesirable effects

There may be a local burning sensation and treatment should be discontinued if irritation occurs. Psorin may stain the skin, hair or fabrics.

4.9 Overdose

None stated.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antipsoriatics for topical use: anthracin derivatives, ATC code: D05AC.

Dithranol and coal tar both suppress the proliferation of psoriatic tissue. Salicylic acid acts as a keratolytic. The emollient base helps to promote healing of psoriatic areas.

5.2 Pharmacokinetic properties

Not relevant for this type of preparation when used as recommended.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin; beeswax, yellow; wool fat; cod liver oil type B; wheat starch, zinc oxide.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

Sealed epoxy resin lined aluminium tubes fitted with a screw cap containing 5 g, 9 g, 10 g, 25 g, 50 g or 100 g of ointment.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

None other than specified in Section 4.2 and 4.4 above.

7    MARKETING AUTHORISATION HOLDER

Boston Healthcare Limited Unit 6, Navigation Court Calder Park Wakefield

West Yorkshire WF2 7BJ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 39974/0007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22nd April 2002

10 DATE OF REVISION OF THE TEXT

04/02/2012