MICANOL CREAM 3% - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Micanol Cream 3%

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

Dithranol BP 3% w/w

3 PHARMACEUTICAL FORM

Cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of sub-acute and chronic psoriasis, including psoriasis of the scalp, by the short contact therapy method.

4.2 Posology and method of administrationAdults including the elderly

Apply Micanol cream only to the affected areas being careful to avoid contact with normal skin. Use only a small amount, rubbing it in gently and thoroughly until it no longer smears.

Micanol cream should be applied once every 24 hours and removed by washing off usually no more than 30 minutes after application. The cream must be washed off using plenty of lukewarm water only. This may be easiest in a bath or shower, particularly if the treated area is extensive.

When removing the cream, it is important that the water is not too hot and soap is not used, as these can damage the Micanol cream base and cause increased staining of the skin. Soap may be used for washing after the Micanol cream has been rinsed off.

The treatment should start with 1% cream on a limited surface. Where the response to dithranol has not been previously established, contact with 1% cream should initially be not greater than 10 minutes. This may gradually be increased to 30 minutes over a period of about seven days depending on the individual response.

After 1–2 weeks patients may progress to Micanol 3% if necessary provided they do not show any sign of skin irritation.

If the skin is irritated, patients should revert to 1% cream. Treatment should be continued until the skin is clear of psoriasis.

For use on the scalp, first wash the hair with shampoo, rinse and then apply Micanol cream while the hair is still damp. Leave in contact for up to 30 minutes and then rinse off using plenty of lukewarm water only. Further shampoo may be used after the cream has been removed.

Micanol 3% cream should always be used under medical supervision.

Micanol cream may cause staining of clothing and bed linen. To remove staining on clothing or bed linen rinse in lukewarm water only (not more than 30°C). To prevent the possibility of discolouration to the bath or shower always rinse with lukewarm water. Should any deposit be left on the surface a suitable cleanser may be used.

Children

There is no evidence of adverse effects in children. However, caution should be exercised and the treatment supervised regularly.

Micanol is not suitable for the treatment of infants and young children.

4.3 Contraindications

Acute pustular psoriasis or presence of inflammation of skin, including folliculitis; erythroderma; hypersensitivity to Dithranol or any other component of Micanol®

4.4 Special warnings and precautions for use

Use with caution if potent steroids have been administered recently. Do not apply to the face and keep away from eyes; if accidentally applied to the eyes, severe conjunctivitis, keratinitis, or corneal opacity may result. If accidental contact occurs, wash with plenty of lukewarm water.

Do not apply to mucous membrane, genitalia or intertriginous skin, do not apply to blistered, raw or oozing area of the skin.

When excessive redness or burning is observed, reduce frequency or concentration, or discontinue application. Such irritation is more likely with higher concentrations.

If sensitivity reactions occur, especially on the normal skin surrounding the plaque site, discontinue use.

Wash hands thoroughly after use.

4.5 Interaction with other medicinal products and other forms of interaction

Photosensitising medications (concurrent use of these medications with Dithranol may enhance their photosensitising effects).

Propylene glycol containing drugs (Dithranol would be oxidised and inactivated).

Withdrawal of long term steroids in psoriasis may cause a rebound phenomenon. An interval of one to two weeks should therefore be left between stopping long term steroids and starting Micanol treatment. A bland emollient may be used in the intervening period.

4.6 Fertility, Pregnancy and lactation

There is no experimental evidence to support the safety of dithranol in pregnancy. Micanol cream should be given to pregnant women only if clearly needed.

Nursing mother should not apply Micanol on the breast area, and avoid accidental contamination of the skin or mouth of the baby.

4.7 Effects on ability to drive and use machines

None reported and none expected

4.8 Undesirable effects

Frequent:     Perilesional erythema and burning, lesional burning (usually

mild or moderate). These reactions usually lessen after one or two weeks of treatment.

Rare:         Allergic reaction (skin rash).

Staining of the treated and surrounding skin may appear. It will disappear within 1 to 2 weeks after the end of the treatment.

May temporarily discolour fingernails or grey or white hair; may stain 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 national reporting system in the United Kingdom: Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

Excessive application of the cream and prolonged usage causes burning and deep staining of the skin.

The skin should be rinsed firstly with water only and then washed, never wash at a temperature exceeding 30°C.

Dithranol is a cathartic (laxative) and if accidentally swallowed, should be removed by gastric lavage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Dithranol belongs to the family of Hydroxyanthrones, which have been used in the treatment of psoriasis for more than a century.

The therapeutic action of dithranol has been linked to its ability to generate free radicals.

Dithranol has been shown to accumulate in the mitochondria where it induces morphological and functional changes. This affects the cellular energy supply which, in turn, results in inhibition of energy dependent process such as DNA replication which slows down excessive cell division as seen in psoriasis plaque. Cyclic nucleosides are important in the regulation of epidermal cell division.

The psoriatic hyperproliferative epidermis contains elevated levels of cyclic guanosine monophosphate. As dithranol has been shown to reduce the elevated level of cGMP back to normal, this could represent an additional mechanism of action.

5.2 Pharmacokinetic propertiesAbsorption and distribution

In vitro studies with human skin showed that more dithranol penetrates into skin with impaired stratum corneum barrier in 30 minutes than into intact skin during about 16 hours. The concentration reaches its maximum after 30–60 minutes contact time and remains rather constant thereafter. In intact skin, however, the concentration continues to increase with time.

The highest concentration of unchanged dithranol is found in the horny layer where it can be detected for 24–48 hours, even after the skin has been washed. In deeper dermal layers relatively small amounts of unoxidised dithranol are detected whereas higher concentrations of the dithranol dimer are found.

Metabolism: The unstable dithranol is oxidised to danthron, to dithranol dimer and to further insoluble polymerisation products.

Elimination: There are no studies which indicate that unchanged dithranol is absorbed through the human skin. However, small quantities of oxidation products have been detected in the urine of patients after topical application.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glyceryl Monolaurate

Glyceryl Monomyristate

Anhydrous Citric Acid Ph. Eur

Sodium Hydroxide Ph. Eur

Purified Water Ph. Eur

6.2 Incompatibilities

Oxidants (like Propylene glycol)

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store below 25°C, in a dry place.

6.5 Nature and contents of container

Micanol cream is packed in aluminium tubes lined internally with a protective lacquer and sealed at the nozzle end with an aluminium membrane, and fitted with polypropylene caps.

The tubes are subsequently packed, together with the patient information leaflet, in unit, printed boxboard cartons in pack sizes of 5g and 50g.

6.6 Special precautions for disposal

Micanol may stain fabrics and contact should be avoided if possible. It is especially formulated so that it is easily washed off using lukewarm water only. Do not use very hot water or soap as these may increase the staining from Micanol.

7 MARKETING AUTHORISATION HOLDER

Northumbria Pharma Ltd.

NetPark Incubator

Thomas Wright Way

Sedgefield

County Durham

TS21 3FD

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 48259/0036

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

04/08/2008