Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dithranol
Dermal Laboratories Ltd
D05AC01
Dithranol
20mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050200; GTIN: 5016379185007
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 • Dithrocream is a treatment for careful application to localised areas of your skin and scalp affected by a particular type of psoriasis that doctors refer to as sub-acute or chronic psoriasis. • This type of psoriasis involves areas of raised, 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. • Dithrocream is recommended for use by adults, the elderly and children. • The active ingredient in this product is dithranol. It helps to clear patches of psoriasis by restoring normal skin development. • Dithrocream is available in five 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: • on psoriasis that feels and looks sore and angry, or on pustular psoriasis (which is very tender, inflamed, and involves small blisters filled with pus); • to treat areas of psoriasis on your face; • if you are allergic (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 e Read the complete document
OBJECT 1 DITHROCREAM Summary of Product Characteristics Updated 13-Nov-2014 | Dermal Laboratories Limited 1. Name of the medicinal product DITHROCREAM™ 2. Qualitative and quantitative composition Dithranol 0.1%, 0.25%, 0.5%, 1.0% or 2.0% w/w. 3. Pharmaceutical form Yellow aqueous cream. 4. Clinical particulars 4.1 Therapeutic indications For the topical treatment of subacute and chronic psoriasis including psoriasis of the scalp. 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 packs are colour coded as follows: 0.1% pale blue 0.25% red 0.5% purple 1.0% brown 2.0% yellow 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 1.0% and finally the 2.0% 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 should be applied sparingly, and only to the affected areas, once every 24 hours, at any convenient time of the day or evening. Rub the cream gently and carefully into the skin until completely absorbed. For use on the scalp, first comb the hair to remove scalar debris and, after suitably parting, rub the cream well into the affected areas. Remove by washing off the skin or scalp, usually no more than one hour after application (Short Contact Therapy). Alternatively, it may be applied at night before retiring and Read the complete document