Patient Leaflet Updated 04-Jun-2018 | Dermal Laboratories Limited
PACKAGE LEAFLET Information for the user
Available in five different strengths containing dithranol 0.1% w/w; 0.25% w/w; 0.5% w/w; 1% w/w and 2% w/w.
Read all of this leaflet carefully before using this product.
Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more information or advice. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Dithrocream is and what it is used for
2. Before you use Dithrocream
3. How to use Dithrocream
4. Possible side effects
5. How to store Dithrocream
6. Further information
1. WHAT DITHROCREAM IS AND WHAT IT IS USED FOR
2. BEFORE YOU USE DITHROCREAM
Do not use this product:
Take special care when using this product:
Dithranol can cause skin burning and excessive soreness if not used correctly. It is therefore very important that you:
Dithranol causes staining:
For children, use with extra caution and with regular supervision.
Using other medicines
If you have been regularly using topical corticosteroids to treat your psoriasis it is important that you allow yourself a treatment-free interval of at least one week before starting to use Dithrocream. You can use a plain emollient (skin moisturiser) on your skin in the meantime.
Pregnancy and breast-feeding
Dithrocream can be used during pregnancy and whilst breast-feeding. The ingredients have been in widespread use in this and similar preparations for many years, without reports of problems. However, safety trials have not been conducted.
Driving and using machinery
Using this product is not known to affect your ability to drive or use machinery.
Important information about two of the ingredients of Dithrocream
This cream contains a small amount of cetostearyl alcohol. This ingredient may cause local skin reactions (e.g. contact dermatitis) in a small number of people who are sensitive to it.
The cream also contains chlorocresol. This ingredient may cause allergic reactions in rare cases. If you have been told by your doctor that you are sensitive to cetostearyl alcohol or chlorocresol, please talk to your doctor before using this product.
3. HOW TO USE DITHROCREAM
Use Dithrocream only on patches of skin affected by the particular type of psoriasis that it is recommended for. Before using this tube for the first time, open it as follows:
Unscrew the cap, turn it upside down and then use the sharp point of the cap to pierce the membrane in the neck of the tube.
To use the cream (for adults, the elderly and children):
Follow instructions a) to d) below carefully otherwise the cream may cause skin burning and excessive soreness:
a) Make sure that you start treatment with the correct strength of Dithrocream:
b) Make sure that you always apply Dithrocream carefully as follows:
c) Make sure that you apply the cream only once a day, and always limit the ‘contact’ time with your skin, using one of the following methods to stop it working for too long:
either use ‘short contact treatment’, in which case:
or after you have gradually built up the contact time as described above, use ‘overnight treatment’, in which case:
Because using it ‘overnight’ involves a longer contact time, this option is only advised when using Dithrocream 0.1%, Dithrocream 0.25% or Dithrocream 0.5%.
Always make sure you start treatment with the correct strength of Dithrocream (see Section 3a).
d) For use on scalp psoriasis:
To avoid unnecessary staining to clothing and bed linen etc, you could wear an old pair of pyjamas and / or dressing gown and, when treating the scalp, use an old pillowcase.
Carry on using Dithrocream for long enough:
If the cream or rinse gets into your eyes, nose or mouth (e.g. when shampooing or washing it off), it may be strongly irritant. If this happens, rinse the affected areas with plenty of water for several minutes.
In the case of any eye contamination, take care not to wash the rinse from one eye to the other eye. We recommend that you then go without undue delay to a Hospital Accident & Emergency department for further assessment and possibly more thorough eye irrigation.
If the cream accidentally gets onto normal skin, wipe it off straight away with a tissue, and wash the area with soap and warm water.
If the cream is accidentally swallowed, go to a hospital Accident & Emergency department straight away because it is a strong laxative and you may need a stomach washout.
If you use too high a strength or leave it in contact with your skin for too long, it may cause skin burning and excessive soreness, in which case the dosage should be reviewed by your doctor.
If you occasionally forget to use this product, do not worry. Just carry on using it when you remember.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Look after your bath or shower to prevent the possibility of staining, particularly where Dithrocream 1% or 2% has been used. Always rinse the bath or shower with hot water immediately after washing or showering, and then use a suitable detergent to remove any deposit from the surface of the bath or shower. Wear protective gloves to avoid irritating your hands.
4. POSSIBLE SIDE EFFECTS
While Dithrocream is working, some skin redness and a feeling of mild ‘sunburn’ at the site of application is quite normal, indicating that it is working. If excessive burning or soreness occurs, this usually means that the strength being used is too high or that the cream is being left in contact with the skin for too long. If this happens, treatment should be stopped at once and the dosage reviewed by your doctor. Your doctor may advise you to use a lower strength, to apply it for shorter contact periods or to apply it less often.
Like all medicines, Dithrocream can cause other side effects, although not everybody gets them:
Any staining caused by getting the cream on your clothes, bed linen, fabrics, plastics or other materials is likely to be permanent.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
5. HOW TO STORE DITHROCREAM
6. FURTHER INFORMATION ABOUT DITHROCREAM
What Dithrocream contains:
The active ingredient in the Dithrocream range is dithranol, at five different strengths comprising 0.1% w/w, 0.25% w/w, 0.5% w/w, 1% w/w and 2% w/w.
The other ingredients are white soft paraffin, cetostearyl alcohol, salicylic acid, ascorbic acid, sodium laurilsulfate, chlorocresol and purified water.
Dithrocream 2% w/w also contains liquid paraffin.
What Dithrocream looks like and contents of the pack
The Marketing Authorisation holder is
The Manufacturer is
This leaflet was last revised in November 2014.
To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information: Dithrocream, 00173/0029.
This is a service provided by the Royal National Institute of Blind People (RNIB).
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866
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