Psorin Ointment
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.
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
None stated.
5 PHARMACOLOGICAL PROPERTIES
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
17/07/2015