Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Dithranol
Dermal Laboratories Ltd
D05AC; D05AC01
Dithranol
0.5 percent weight/weight
Cream
Product subject to prescription which may be renewed (B)
Antracen derivatives; dithranol
Not marketed
1980-12-01
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$ITHROCREAMISATREATMENTFORCAREFULAPPLICATIONTO localised areas of your skin and scalp affected by a particular type of psoriasis that doctors refer to as sub-acute or chronic psoriasis. s4HISTYPEOFPSORIASISINVOLVESAREASOFRAISEDRED patches of skin, covered with silvery scales (without any blistering or tenderness). The patches often occur on the elbows, knees, lower back and scalp. s$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: sONPSORIASISTHATFEELSANDLOOKSSOREANDANGRYOR 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 Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dithrocream 0.5%w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dithranol 0.5% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream Pale yellow 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%w/w, Dithrocream 1.0%w/w and Dithrocream 2.0%w/w should only be used for those patients who have failed to respond to lower strengths of dithranol (see section 4.2 below). Dithrocream 1.0%w/w and 2.0%w/w 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%w/w, continuing for at least one week and then, if necessary, increase to the 0.25%w/w followed by the 0.5%w/w, the 1.0%w/w and finally the 2.0%w/w 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%w/w, Dithrocream 1.0%w/w and Dithrocream 2.0%w/w should always be used under medical supervision. Dithrocream should be applied once every 24 h Przeczytaj cały dokument