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PSORIN SCALP GEL

Active substance(s): DITHRANOL / SALICYLIC ACID / DITHRANOL / SALICYLIC ACID / DITHRANOL / SALICYLIC ACID

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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.

4.3

Contraindications
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

4.9

Overdose
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.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Do not store above 25°C. Store in the original container in order to protect
from light.

6.5

Nature and contents of container
Psorin Scalp Gel is supplied in 9g, 25g & 50g epoxy lined aluminium tubes.
Not all pack sizes may be marked.

6.6

Special precautions for disposal
None other than specified in Section 4.2, 4.4 and 4.5 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 39974/0008

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/05/2006

10

DATE OF REVISION OF THE TEXT

17/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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