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Crystacide Cream 1%

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Patient Information Leaflet

Crystacide Cream 1% Lipid stabilized Hydrogen Peroxide 1% w/w

Crystacide®

Read all of this leaflet carefully because it contains important information for you.

This medicine is available with and without a prescription. However, you still need to use Crystacide 1% w/w Cream carefully to obtain the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your doctor or pharmacist if you need more information or advice.

•    This medicine is only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    You must contact a doctor if your symptoms worsen or do not improve after 3 weeks.

•    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Crystacide Cream 1% is and what it is used for 4. Possible side effects

2. Before you use Crystacide Cream 1%    5. How to store Crystacide Cream 1%

3. How to use Crystacide Cream 1%    6. Further information

1.    WHAT CRYSTACIDE CREAM 1% IS AND WHAT IT IS USED FOR

Crystacide is used for the treatment of superficial skin infections caused by organisms sensitive to hydrogen peroxide, which is a potent medicine that is active against many types of bacteria, and some fungi and viruses. It acts by destroying the cells of these organisms.

2.    BEFORE YOU USE CRYSTACIDE CREAM 1%

Do not use Crystacide Cream 1%:

•    If you know you are sensitive or allergic to any of the ingredients (see section 6).

Make sure your doctor or pharmacist knows if this affects you.

Take special care with Crystacide Cream 1%:

Crystacide should not be used on large or deep wounds and should not be applied to healthy skin. Take care to avoid contact with the eyes. If Crystacide should accidentally get into your eyes, wash it out immediately with plenty of cold water.

Hydrogen peroxide, the active substance in your cream, can bleach fabrics.

Taking or using other medicines

Crystacide should not be used in the presence of iodine, permanganate and other strong oxidising agents.

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using this, or any other medicine when you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding.

Driving and using machines

Crystacide should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Crystacide Cream

Salicylic acid may cause allergic dermatitis which is an itchy red rash. Another ingredient in your cream, propylene glycol, may also cause skin irritation.

3. HOW TO USE CRYSTACIDE CREAM 1%

Follow the instructions of your doctor or pharmacist. Always check the label for directions on how to use your medicine. Your pharmacist will help if you are not sure.

Crystacide is for external use only.

It is usually applied 2-3 times a day, or when needed, to the affected areas. If a waterproof plaster is used, one application a day may be sufficient. A dry film may appear on the skin after application; this can easily be washed off with water.

Do not use continuously for more than 3 weeks.

What to do if you accidentally swallow Crystacide Cream 1%

If you accidentally swallow the cream, contact your doctor or local hospital.

If you forget to use Crystacide Cream 1%

If you forget to apply a dose, do so as soon as you remember and then go on as before.

If you have any further questions on the use of this product ask your doctor of pharmacist.

4.POSSIBLE SIDE EFFECTS

Like all medicines Crystacide Cream 1% can sometimes cause side effects, although not everybody has them. Crystacide is generally well tolerated however, and not associated with any serious side effects.

The following side effects have been reported but how often they occur is not known:

• You may notice a mild burning feeling for a short time after application.

If you feel that your skin remains irritated for a long time or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist and ask if you should continue with your medication.

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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.HOW TO STORE CRYSTACIDE CREAM 1%

Keep out of the reach and sight of children. Your medicine could harm them.

Once you have opened the tube, do not keep it for more than 28 days.

Do not use any medicine after the expiry date stated on the packaging.

Keep your medicine at room temperature below 25°C, in a dry place.

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

The active ingredient is hydrogen peroxide in a concentration of 1% w/w.

The other ingredients are glyceryl monolaurate, glyceryl monomyristate, Macrogol stearate 5000, propylene glycol, anhydrous citric acid, sodium hydroxide, sulphuric acid, sodium oxalate, salicylic acid, disodium edetate, sodium pyrophosphate, sodium stannate and purified water.

What Crystacide Cream 1% looks like and contents of pack

Crystacide 1% w/w Cream is a smooth pearly white cream.

Crystacide cream may be available in tubes of 5g, 10g, 25g and 40g.

Marketing authorization holder

Reig Jofre UK Ltd, 10 The Barns, Farm Road, Caddsdown Industrial Park,

Bideford, Devon, EX39 3BT, UK

Manufacturer

Bioglan AB, PO Box 50310, S-202 13 Malmo, Sweden. This leaflet was last revised in March 2015

910562

Printed in Sweden BERGSTENS, HBG 150202