Nystatin Cream PIL 30g

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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 hydrochloride Cream is and what it is used for

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

3.    How to use Nystatin/Chlorhexidine hydrochloride Cream

4.    Possible side effects

5.    How to store Nystatin/Chlorhexidine hydrochloride Cream

6.    Contents of the pack and other information

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

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

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE NYSTATIN/CHLORHEXIDINE HYDROCHLORIDE CREAM Do not use Nystatin/Chlorhexidine hydrochloride Cream

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

Talk to your doctor or pharmacist before using Nystatin/Chlorhexidine hydrochloride Cream.

Nystatin/Chlorhexidine hydrochloride Cream may in rare cases cause 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 hydrochloride Cream and contact your doctor as soon as possible (see under section 4).

Take special care with Nystatin/Chlorhexidine hydrochloride Cream

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

•    If swallowed accidentally, seek medical advice immediately.

•    If Nystatin/Chlorhexidine hydrochloride Cream gets in your eyes accidentally, you should rinse your eyes immediately and contact your doctor.

If you are unsure about anything, please ask your doctor or pharmacist.

Other medicines and Nystatin/Chlorhexidine hydrochloride Cream

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

Pregnancy and breast-feeding

Do not use Nystatin/Chlorhexidine hydrochloride 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/Chlorhexidine hydrochloride Cream Nystatin/Chlorhexidine hydrochloride Cream contains cetostearyl alcohol

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

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3.    HOW TO USE NYSTATIN/CHLORHEXIDINE HYDROCHLORIDE 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.

The cream should be applied for one week after your infection has healed.

If the infected area has not improved within seven days of starting treatment, consult your doctor. If the condition does not improve within 14 days of starting treatment, or if a new infection appears, you should stop using Nystatin/Chlorhexidine hydrochloride Cream and consult your doctor. An alternative treatment may be needed.

If you forget to use Nystatin/Chlorhexidine hydrochloride 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 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 this medicine, stop using it and talk to your doctor or pharmacist.

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/CHLORHEXIDINE HYDROCHLORIDE 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/Chlorhexidine hydrochloride Cream contains

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

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

What Nystatin/Chlorhexidine hydrochloride Cream looks like and contents of the pack Nystatin/Chlorhexidine hydrochloride Cream is a light yellow cream which comes in 30g aluminium tubes.

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.