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1. Psorin Scalp Gel
2. Psorin Scalp Gel

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Psorin scalp gel

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Dithranol 0.25% w/w, salicylic acid 1.6% w/w.

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Gel.

Pale yellow, opaque gel

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the topical treatment of psoriasis of the scalp.

4.2 Posology and method of administration

Before beginning regular treatment a small area of affected skin should be treated. The gel should be left on the skin for 20 minutes and then washed off with an appropriate shampoo. If there is no major reaction within 24 hours the full treatment can be instituted.

Psorin Scalp Gel is applied to areas of the scalp affected by psoriasis avoiding spread to healthy skin. Wash hands after use or use disposable gloves. The gel should be left on the affected area for 10 - 20 minutes and then removed with an appropriate shampoo. Treatment should be repeated initially on alternate days and then daily until the lesions have resolved. As treatment progresses, the gel can be left on the scalp for periods of up to one hour. Several weeks of treatment may be necessary.

Psorin Scalp Gel should not be used in patients who are known to be sensitive to dithranol, salicylic acid or any of the excipients. It should not be used in acute or pustular psoriasis, or unstable psoriasis where the skin is hot to touch, itchy and deteriorates in the sun.

4.4 Special warnings and precautions for use

Avoid contact with the eyes, mucous membranes 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

Dithranol preparations should not be used within two weeks of withdrawing potent topical steroids.

4.6 Fertility, Pregnancy and lactation

Although there is no experimental evidence to support the safety of the product in pregnancy, the active ingredients have been in widespread use for many years without apparent ill-effects.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

The treatment may induce a feeling of warmth. If there is a prolonged or severe burning sensation the contact time should be reduced. Normally this sensation resolves within 3-4 days and the full treatment regime can be resumed. In extreme cases it may be necessary to stop treatment.

Dithranol causes staining of skin, hair and clothing. Staining of healthy skin will be more marked and will resolve after cessation of treatment.

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

If excess gel is applied, it should be removed with a neutral or slightly acidic shampoo.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

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

Dithranol has antimicrobial properties and reduces the rate of epidermal mitosis in psoriatic lesions.

Salicylic acid is a keratolytic agent which may aid penetration of the dithranol into the epidermis.

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

None other than those described in other sections of the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methyl salicylate; white soft paraffin; paraffin, light liquid.

6.2 Incompatibilities

Not applicable.

Shelf life

3 years.

17/07/2015