PSORIDERM CREAM - patient leaflet, side effects, dosage

Psoriderm™ cream

distilled coal tar 6% 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 the active ingredient distilled coal tar, which stops itching and restores normal skin development.

2. before you use psoriderm cream do not use psoriderm cream:

• if you are allergic (hypersensitive) to distilled coal tar, 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.

Warnings and precautions

Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

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.

Psoriderm Cream contains propylene glycol (E 1520)

This medicine contains 50 mg propylene glycol in each gram.

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.

continued…

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.

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: yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. how to store psoriderm cream

• Keep it out of the sight and reach 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 of via 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 ingredient is distilled coal tar (6.0% w/w).

The other ingredients are lecithin, stearic acid, isopropyl palmitate, propylene glycol (E 1520), 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.