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DITHROCREAM 0.1% W/W

Active substance: DITHRANOL

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PACKAGE LEAFLET Information for the user
TM

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.

•  ithrocream is a treatment for careful application to
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localised areas of your skin and scalp affected by a
particular type of psoriasis that doctors refer to as
sub-acute or chronic psoriasis.
•  his type of psoriasis involves areas of raised, red
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patches of skin, covered with silvery scales (without
any blistering or tenderness). The patches often occur
on the elbows, knees, lower back and scalp.
•  ithrocream is recommended for use by adults,
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the elderly and children.
•  he active ingredient in this product is dithranol.
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It helps to clear patches of psoriasis by restoring
normal skin development.
•  ithrocream is available in five strengths that have
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colour coded packs, as follows:
– 0.1% - in a pale blue pack
– 0.25% - in a red pack
– 0.5% - in a purple pack
– 1% - in a brown pack
– 2% - in a yellow pack

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.

2. BEFORE YOU USE DITHROCREAM

3. HOW TO USE DITHROCREAM

1.  HAT DITHROCREAM IS AND WHAT
W
IT IS USED FOR

Do not use this product:
•  n psoriasis that feels and looks sore and angry, or
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on pustular psoriasis (which is very tender, inflamed,
and involves small blisters filled with pus);
•  o treat areas of psoriasis on your face;
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• f you are allergic (hypersensitive) to dithranol or
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any of the other ingredients of Dithrocream listed in
section 6.
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:
•  se the correct strength of Dithrocream for your
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particular requirements (see Section 3a below);
•  pply it carefully, only to the patches of psoriasis
a
(see Section 3b below), and;
• imit the contact time on your skin (see Section
l
3c below);
•  nly use the three highest strengths, Dithrocream
o
0.5% w/w, 1% w/w and 2% w/w, if recommended
by a doctor and if you have failed to respond to the
lower strengths;
•  void using this product (unless advised by your
a
doctor) to treat psoriasis on areas of folded skin,
such as the groin or underneath the breasts. This is
because the skin’s response to Dithrocream tends
to be stronger in these areas. If you have been given
a high strength of Dithrocream (0.5% w/w, 1% w/w
or 2% w/w) to use on areas of folded skin, return
to your doctor for further advice;
•  eep the cream away from your eyes, nose and
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mouth;
•  lways wash your hands thoroughly after use.
a
Dithranol causes staining:
•  void contact with fabrics, plastics and other
a
materials, such as bedclothes, furnishings and bath
and shower fittings, because this is likely to cause
permanent staining which cannot be removed;
•  reated areas of skin may gradually become stained
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purple or brown. This is harmless, and will gradually
disappear within a few days after the end of your
treatment;
•  londe or fair hair may take on a pinkish tinge when
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treating the scalp. This will grow out after treatment
stops.
Dithrocream PIL DIP1_14_3.indd 1

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)  ake sure that you start treatment with the
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correct strength of Dithrocream:
• f you have not used Dithrocream before, or if you
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are about to use it on patches of psoriasis on areas
of your body where you have not used it previously,
always start treatment with the lowest strength
of Dithrocream, 0.1% w/w. Use this strength for at
least a week and then, only if recommended by your
doctor or pharmacist, increase at weekly intervals to
the 0.25% w/w, followed by the 0.5% w/w, the 1%
w/w, and possibly the 2% w/w strength.
•  he aim is to start with the lowest strength and
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build up gradually over approximately 4 weeks to
the highest, optimum strength that does not cause
excessive sensation of skin warmth.
•  his optimum strength differs for each of us, and
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may also depend upon the thickness and location
of your psoriatic patches. Your doctor should help
you decide which strength is best for your particular
circumstances.
b)  ake sure that you always apply Dithrocream
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carefully as follows:
•  pply it thinly and only to the patches of psoriasis.
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•  ub the cream gently into the psoriasis patches until
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completely absorbed, otherwise any excess cream
may spread onto normal skin areas (where the skin
reaction is much stronger), or spread onto clothing
or bedding, causing staining.
•  lways wash your hands immediately after use.
A

continued…

Prints: Black

DIP1/14/3 201226

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

04/11/2014 12:12
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Dithrocream PIL DIP1_14_3.indd 2

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:
• f you mistakenly allow the cream to spread onto,
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and remain in contact with, areas of normal skin
(see precautions in section 3b), it is more likely to
cause burning and soreness.
•  emporary staining of the skin or hair can occur.
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However, this will gradually go away after treatment
has stopped.
•  n very rare occasions allergic reactions to the
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ingredients can occur. These may result in local skin
inflammation, itching and redness, in which case
treatment with Dithrocream should be stopped.
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.
United Kingdom
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

5. HOW TO STORE DITHROCREAM





K
 eep it out of the reach and sight of children.
A
 lways replace the cap tightly after use.
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 o not store the product above 25°C.
D
 o not use after the expiry date shown on the fold
of the tube and the carton. The expiry date refers to
the last day of that month.
•  edicines should not be disposed of via wastewater
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or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6.  URTHER INFORMATION ABOUT
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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
•  he product is a pale yellow/yellow cream.
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•  he cream is available in tubes containing 50g.
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The Marketing Authorisation holder is Dermal
Laboratories, Tatmore Place, Gosmore, Hitchin,
Herts, SG4 7QR, UK.
The Manufacturer is Fleet Laboratories Ltd, 94
Rickmansworth Road, Watford, Herts, WD18 7JJ, UK.
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).

DIP1/14/3 201226

c)  ake sure that you apply the cream only once
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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:
•  pply the cream at any convenient time of the day
a
or evening;
•  tart with a contact time of 10 minutes, then;
s
• bathe or shower to wash the cream off;
•  nd over the following days, gradually increase
a
the contact time to no more than one hour, washing
off the cream as previously.
or after you have gradually built up the contact
time as described above, use ‘overnight treatment’,
in which case:
•  pply the cream at night before going to bed, then;
a
•  he following morning, bathe or shower to wash
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the cream off.
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:
•  efore use on the scalp, carefully read the section
B
below, with the subheading “If the cream or rinse
gets into your eyes, nose or mouth...”
•  irst comb the hair to remove any loose scales,
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then, after suitably parting the hair, massage the
cream well into the affected areas.
•  se it only once a day, and stop the cream working
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after the required contact time on the scalp by
shampooing the hair as normal (use either the ‘short
contact’ or ‘overnight’ method, as described under
section 3c above).
•  ake great care when washing out the shampoo
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(which may contain some Dithrocream residue)
to avoid getting it into the eyes or on the face.
This is particularly important when using the higher
strengths of Dithrocream.
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:
•  ontinue this daily treatment, using the highest
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strength of Dithrocream that does not cause
excessive sensation of skin warmth, until your
skin is completely better, ie when there is nothing to
feel with the fingers and the skin texture is normal.
•  y gradually increasing the strength of Dithrocream
B
applied, it should be possible to clear psoriasis
patches within 4 to 6 weeks.
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.

Prints: Black

04/11/2014 12:12
Flat size: 180mm x 354mm

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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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