Patient Information Leaflet

Strong cetrimide solution BP 0.75%w/w, ®    Dimeticone 1000 Ph Eur 10%w/w

Slope] Cream

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

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. 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 Siopel cream is and what it is used for

2.    Before you use Siopel cream

3.    How to use Siopel cream

4.    Possible side effects

5.    How to store Siopel cream

6.    Further information

1.    WHAT SIOPEL CREAM IS AND WHAT IT IS USED FOR

Siopel cream contains two active ingredients, cetrimide and dimeticone. Cetrimide is an antiseptic which destroys germs. Dimeticone protects the skin from water.

Siopel cream is used as a water repellent barrier cream with antiseptic properties. It is useful when the skin needs to be protected from water or external irritants.

2.    BEFORE YOU USE SIOPEL CREAM Do not use Siopel cream:

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

[Please note: Siopel cream contains Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Siopel cream.]

•    In body cavities or as an enema

•    On skin that is acutely inflamed (ie red and angry) or weeping

•    Before the skin has been cleansed of any irritants Take special care with Siopel cream:

•    Take care to avoid application to the ears and eyes, and any deep cuts involving the head or spine. Wash out with water if necessary

•    If mixed with soap or detergents its effectiveness may be reduced Taking or using other medicines

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

Siopel cream may be used during pregnancy and breast feeding.

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

Driving and using machines

Siopel cream should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Siopel cream

Siopel cream contains Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Siopel cream.

The ingredient cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis) which can cause an itchy rash. Methyl-parahydroxybenzoate may cause local skin reactions (possibly delayed).

3.    HOW TO USE SIOPEL CREAM

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.

Siopel cream is for external use only. Wash and dry the skin first. Then apply the cream sparingly and massage well into the skin.

For the first 3-4 days: apply three to five times a day.

After that: apply once or twice daily.

What to do if you accidentally swallow Siopel Cream

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

If you forget to use Siopel cream

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 Siopel cream can sometimes cause side effects, although not everybody has them. The following side effects have been reported but how often they occur is not known:

You may notice some irritation of the skin or allergic (itchy) reaction after repeated applications.

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

5.    HOW TO STORE SIOPEL CREAM

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

Do not use any cream 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 ingredients are cetrimide solution BP 0.75%w/w, and dimeticone 1000 Ph Eur 10% w/w. The other ingredients are arachis oil, butylated hydroxytoluene, cetostearyl alcohol, anhydrous citric acid, methyl-parahydroxybenzoate and water.

What Siopel cream looks like and contents of pack

Siopel cream is a white cream available in tubes of 50 grammes.

Marketing authorisation holder

Derma UK Ltd, ARC Progress, Mill Lane, Stotfold, Bedfordshire SG5 4NY, United Kingdom. Manufacturer

Pharmasol Ltd, Walworth Industrial Estate, Andover, Hants SP10 5AZ.

This leaflet was last approved in March 2012.