Dithrocream 2% w/w

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Dithranol

Saatavilla:

Dermal Laboratories Ltd

ATC-koodi:

D05AC; D05AC01

INN (Kansainvälinen yleisnimi):

Dithranol

Annos:

2 percent weight/weight

Lääkemuoto:

Cream

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Antracen derivatives; dithranol

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

1987-07-03

Pakkausseloste

PACKAGE LEAFLET _Information for the user_
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
s$ITHROCREAMISATREATMENTFORCAREFULAPPLICATIONTO
localised areas of your skin and scalp affected by a
particular type of psoriasis that doctors refer to as
sub-acute or chronic psoriasis.
s4HISTYPEOFPSORIASISINVOLVESAREASOFRAISEDRED
patches of skin, covered with silvery scales (without
any blistering or tenderness). The patches often occur
on the elbows, knees, lower back and scalp.
s$ITHROCREAMISRECOMMENDEDFORUSEBYADULTS,
THE ELDERLY AND CHILDREN.
s4HEACTIVE INGREDIENT in this product is dithranol.
It helps to clear patches of psoriasis by restoring
normal skin development.
s$ITHROCREAMISAVAILABLEINFIVE STRENGTHS that have
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
2. BEFORE YOU USE DITHROCREAM
DO NOT USE this product:
sONPSORIASISTHATFEELSANDLOOKSSOREANDANGRYOR
on pustular psoriasis (which is very tender, inflamed,
and involves small blisters filled with pus);
sTOTREATAREASOFPSORIASISONYOURFACE
sIFYOUAREALLERGIC (hypersensitive) to dithranol or
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
importa

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dithrocream 2% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dithranol 2.0% w/w.
Excipients: Cetostearyl alcohol
7.00 % w/w
Chlorocresol
0.10 % w/w
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Smooth, yellow, aqueous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of subacute and chronic psoriasis, including
psoriasis of the scalp.
Dithrocream 0.5%, Dithrocream 1% and Dithrocream 2% should only be
used for those patients who have failed to
respond to lower strengths of dithranol (see section 4.2 below).
Dithrocream 1% and 2% should normally only be applied
for 'short contact' periods.
Dithrocream has been developed as a cream formulation of dithranol for
particular convenience for home treatment, and is
especially suitable for the exposed surfaces and hairy regions of the
body.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dithranol therapy customarily involves titrating the concentration
applied to skin to suit individual patient’s
circumstances. Dithrocream is, therefore, available in five strengths.
The different strengths are colour coded as
follow:
_For adults and the elderly_
It is important to determine each patient's optimal treatment
strength, as too high a strength may induce a burning
sensation. Where the response to Dithrocream has not previously been
established, always commence with Dithrocream
0.1%, continuing for at least one week and then, if necessary,
increase to the 0.25% followed by the 0.5%, the 1% and
finally the 2% strength. The aim should be to build up gradually over
approximately 4 weeks to the highest tolerated
strength to produce the optimum therapeutic effect. This optimum
concentration will depend upon such factors as the
thickness and location of the psoriatic plaques, as well as the
variation between individual patients in their reaction to
dithranol. Dithrocream 0.5%, Dithrocream 1% and Dithrocream 2% should
always be used under medical supervision.
D