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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nystatin/Chlorhexidine hydrochloride/ Hydrocortisone 100,000 units/g/1%/0.5% Cream

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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream is and what it is used for

2.    What you need to know before you use Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream

3.    How to use Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream

4.    Possible side effects

5.    How to store Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream

6.    Contents of the pack and other information

1.    WHAT NYSTATIN/CHLORHEXIDINE HYDROCHLORIDE/HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR

Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream is a light yellow oream for application to the skin. It is used to treat skin infections caused by either fungi and/or bacteria, suoh as ringworm, athlete's foot and infected nappy rash.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE NYSTATIN/CHLORHEXIDINE HYDROCHLORIDE/HYDROCORTISONE CREAM

Do not use Nystatin/Chlorhexidine hydrochloride/Hydrocortisone Cream

•    If you are allergic to nystatin, ohlorhexidine hydrochloride, hydrocortisone or any of the other ingredients of this medicine (listed in section 6).

•    If you have tuberculosis of the skin.

Warnings and precautions

Talk to your doctor or pharmacist before using Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream. Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream may in rare oases oause severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness. Early symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop using Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream and oontaot your doctor as soon as possible (see under section 4).

Take special care with Nystatin/Chlorhexidine hydrochloride/Hydrocortisone Cream

•    Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream is for external use only and should not be used near your eyes, mouth or be swallowed.

•    If swallowed accidentally, seek medioal advioe immediately.

•    If Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream gets in your eyes accidentally, you should rinse your eyes immediately and oontaot your doctor.

•    Use Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream on large areas of your skin only if told to do so by your doctor, as the hydrocortisone (steroid) may be absorbed into your bloodstream.

•    Take care not to cover the treated area of skin with tight clothes or bandages, as this may also oause the hydrocortisone (steroid) to be absorbed into your bloodstream.

Children

•    Use Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream with care in infants.

As Nystatin/Chlorhexidine hydroohloride/Hydrooortisone Cream contains hydrocortisone (steroid), long term continuous use in infants should be avoided.

Other medicines and Nystatin/Chlorhexidine hydrochloride/Hydrocortisone Cream

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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Pregnancy and breast-feeding

Do not use Nystatin/Ohlorhexidine hydroohloride/Hydrooortisone Cream if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

important information about some of the ingredients of Nystatin/Ohlorhexidine hydrochloride/Hydrocortisone Cream Nystatin/Chlorhexidine hydrochloride/Hydrocortisone Cream contains cetostearyl alcohol

Nystatin/Ohlorhexidine hydrochloride/Hydrocortisone Cream contains the ingredient cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) in some patients.

3.    how to use nystatin/chlorhexidine hydrochloride/Hydrocortisone cream

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For application to the skin only.

Apply the cream to the infected area two or three times daily.

Continue treatment for a maximum of seven days.

if you forget to use Nystatin/Ohlorhexidine hydrochloride/Hydrocortisone Cream

Apply the cream as soon as you remember and then continue the rest of your treatment as usual.

If you have any further Questions on the use of this medicine, ask your doctor or pharmacist.

4.    possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following reactions stop using Nystatin/Chlorhexidine hydrochloride/Hydrocortisone Cream and get immediate medical help:

Swelling of the face, lips, tongue or throat; a red itchy skin rash; wheezing or difficulty breathing; feeling faint and dizzy; a strange metallic taste in the mouth; collapse. You may be having an allergic reaction.

If you develop a rash or your skin becomes itchy, red, dry or inflamed where you have used the product, stop using it and talk to your doctor or pharmacist.

If a new infection appears, stop using Nystatin/Chlorhexidine hydrochloride/Hydrocortisone Cream and consult your doctor. An alternative treatment may need to be used.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Nystatin/Ohlorhexidine hydrochloride/Hydrocortisone cream

Keep this medicine out of the sight and reach of children.

Do not store above 25⁰C.

Do not use this medicine after the expiry date which is stated on the tube and on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    contents of the pack and other information

What Nystatin/Ohlorhexidine hydrochloride/Hydrocortisone Cream contains

-    The active substances are nystatin (100,000 units/g), chlorhexidine hydrochloride (1% w/w) and hydrocortisone (0.5% w/w).

-    The other ingredients are cetostearyl alcohol, octyldodecanol, polysorbate 60, sorbitan stearate, cetyl esters wax, benzyl alcohol and purified water.

What Nystatin/Ohlorhexidine hydrochloride/Hydrocortisone Cream looks like and contents of the pack

Nystatin/Chlorhexidine hydrochloride/Hydrocortisone Cream is a light yellow cream which comes in aluminium tubes of 15g and 30g. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Typharm Ltd, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH.

Manufacturer

Pharmaserve Ltd, Clifton Technology Park, Wynne Avenue, Swinton, Manchester, M27 8FF.

This leaflet was last revised in November 2015.