Psoriderm Cream
PACKAGE LEAFLET Information for the user
Psoriderm™
cream
distilled coal tar 6% w/w, lecithin 0.4% 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. If any of the side effects get serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet:
1. What Psoriderm Cream is and what it is used for
2. Before you use Psoriderm Cream
3. How to use Psoriderm Cream
4. Possible side effects
5. How to store Psoriderm Cream
6. Further information
1. WHAT PSORIDERM CREAM IS AND WHAT IT IS USED FOR
• Psoriderm Cream is a treatment for application to areas of your skin and scalp affected by a particular type of psoriasis that doctors refer to as sub-acute
or chronic plaque psoriasis.
• This type of psoriasis involves areas of raised, red, sometimes itchy, patches of skin, covered with silvery scales (without any blistering or tenderness). The patches often occur on the elbows, knees, lower back and scalp.
• Psoriderm Cream is recommended for use by adults, the elderly and children.
• This product contains two active ingredients:
• lecithin, which softens the skin, helping to increase the action of the distilled coal tar;
• distilled coal tar, which stops itching and restores normal skin development.
2. BEFORE YOU USE PSORIDERM CREAM Do not use Psoriderm Cream:
• i f you are allergic (hypersensitive)
to distilled coal tar, lecithin or any of the other ingredients of Psoriderm Cream listed in section 6;
• 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);
• on infected skin.
Take special care when using this product: Keep the cream away from:
• the eyes;
• your mouth;
• the inside of your nose;
• your genital (sex) or rectal (bottom) areas;
• cuts and grazes.
Using other medicines
This product is not known to affect, or to be affected by, any other medicines.
Pregnancy and breast-feeding
This product 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 one of the ingredients of Psoriderm Cream
The product contains a small amount of propylene glycol. This ingredient may cause skin irritation in a small number of people who are intolerant to it. If your doctor has told you that you have an intolerance to propylene glycol, please talk to your doctor before using this product.
3. HOW TO USE PSORIDERM CREAM
Use this cream only to treat the particular type of psoriasis that it is recommended for.
For adults, children and the elderly:
• Apply the cream to the affected areas once or twice daily, or as often as advised by your doctor.
• Always wash your hands after use.
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If the cream gets into the eyes, nose or mouth
The product may cause irritation if it gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist.
If you apply too much cream
Do not worry if you apply too much cream, simply remove any excess with a tissue.
If you forget to use this product
Do not worry if you occasionally forget to use this product, 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this product can cause side effects, although not everybody gets them.
• The following can occur rarely, in which case you should stop using the product:
• skin irritation;
• acne-like eruptions;
• skin photo-sensitivity (sensitivity to sunlight).
• In rare cases, it may stain the skin, hair or fabric.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 PSORIDERM CREAM
• Keep it out of the reach and sight of children.
• Always replace the cap tightly after use.
• Do not store the product above 25°C.
• Do not use after the expiry date shown on the jar and the carton. The expiry date refers to the last day of that month.
• Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION ABOUT PSORIDERM CREAM
What Psoriderm Cream contains:
The active ingredients are distilled coal tar (6.0% w/w) and lecithin (0.4% w/w).
The other ingredients are stearic acid, isopropyl palmitate, propylene glycol, trolamine, phenoxyethanol and purified water.
What Psoriderm Cream looks like and contents of the pack
• The product is a buff-coloured cream.
• The cream is available in amber glass jars containing 225ml. The jars are fitted with screw caps.
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 reviewed in May 2015.
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: Psoriderm Cream, 00173/5000.
This is a service provided by the Royal National Institute of Blind People (RNIB).
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