DITHROCREAM Cream Ref.[27607] Active ingredients: Dithranol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Diomed Developments Ltd, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR

4.3. Contraindications

Not to be used on the face, or for acute or pustular psoriasis.

Not to be used in cases of sensitivity to any of the ingredients.

4.4. Special warnings and precautions for use

Dithrocream 0.5%, Dithrocream 1.0% and Dithrocream 2.0% should only be used for those patients who have failed to respond to lower strengths of dithranol.

Dithrocream 1.0% and 2.0% should normally only be applied for ‘short contact’ periods.

Dithrocream 0.5%, Dithrocream 1.0% and Dithrocream 2.0% should always be used under medical supervision.

It is most important to avoid applying an excessive amount of the cream, which may cause unnecessary soiling and staining of the clothing and/or bed linen. After each period of treatment, a bath/shower should be taken to remove any residual cream. To prevent the possibility of discolouration, particularly where Dithrocream 1.0% or 2.0% has been used, always rinse the bath/shower with hot water immediately after washing/showering and then use a suitable cleanser to remove any deposit on the surface of the bath/shower.

After use on the scalp, a shampoo may be used to remove the Dithrocream residue. Great care must be taken when washing out the shampoo (which may contain some Dithrocream residue), to ensure that it does not get into the eyes or on the face. This is particularly important when the higher strengths of Dithrocream have been used.

Although a feeling of warmth at the application site is normal, if this amounts to a burning sensation, or if the lesions spread, treatment should be stopped at once, and the dosage re-evaluated by a doctor.

Dithrocream is not normally recommended for use on areas of folded skin such as the groin and beneath the breasts. Do not use high strengths on these sites.

Keep away from the eyes and mucous membranes.

Always wash the hands after use.

As long term use of topical corticosteroids is known to destabilise psoriasis, and withdrawal may give rise to a rebound phenomenon, an interval of at least one week should be allowed between the discontinuance of such steroids and the commencement of Dithrocream therapy. A suitably bland emollient may usefully be applied in the intervening period.

The excipients, chlorocresol and cetostearyl alcohol, may on rare occasions give rise to allergic or local skin reactions (e.g. contact dermatitis) in sensitive people.

Contact with fabrics, plastics and other materials may cause permanent staining and should be avoided.

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

Although there is no experimental evidence to support the safety of the drug in pregnancy or during lactation, no adverse effects have been reported.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Some skin irritation and/or a feeling of warmth at the site of application is normally associated with dithranol therapy. Dithrocream applied at too high a strength or left in contact with the skin for too long may induce a burning sensation.

Dithrocream may cause temporary staining of the skin and/or hair.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal products 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.

6.2. Incompatibilities

None known.

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