Loceryl® 0.25% w/w Cream

a m o r o l f i n e

CREAM

PACKAGE LEAFLET: INFORMATION FOR THE USER Loceryl 0.25% w/w Cream

amorolfine

Read all of this leaflet carefully before you start using this medicine.

-    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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1.    What Loceryl is and what it is used for

2.    Before you use Loceryl

3.    How to use Loceryl

4.    Possible side effects

5.    How to store Loceryl

6.    Further information

1.    What Loceryl is and what it is used for

•    Loceryl is used to treat certain fungal infections of the skin (e.g. athlete's foot).

•    Loceryl contains the active substance amorolfine (as the hydrochloride), which belongs to a group of medicines known as antifungals.

2.    Before you use Loceryl

Do not use Loceryl

•    If you are allergic (hypersensitive) to amorolfine or any of the other ingredients of Loceryl (see section 6 for other ingredients).

•    If you are pregnant, planning to become pregnant, or are breast-feeding.

Take special care with Loceryl

•    Avoid the cream coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils).

Using other medicines

There are no known interactions with other medicines.

Nail varnish or artificial nails should not be used while using Loceryl.

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

You should not use Loceryl and tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Your doctor will then decide whether you should use Loceryl.

Do not apply Loceryl to your chest if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Loceryl

This medicinal product contains stearyl alcohol which may cause local skin reaction (e.g. contact dermatitis).

3.    How to use Loceryl

•    Always use Loceryl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    The cream should be rubbed gently into the infected skin area each evening after washing. It is important to continue using the cream until the infection clears up and for about 3 to 5 days after that. This generally means that you will need to use the cream for at least 2 to 3 weeks, but for some foot infections up to 6 weeks treatment may be needed.

If you get Loceryl in your eyes or ears

If you get Loceryl in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.

If you accidently swallow Loceryl

If you, or anyone else, accidentally swallows the cream contact your doctor, pharmacist or nearest hospital straight away.

If you forget to use Loceryl

If you miss a treatment one evening, do not worry. Apply the cream the next evening and continue as directed by your doctor. If you stop using Loceryl

Do not stop using Loceryl before your doctor tells you to or your infection could come back.

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

4.    Possible side effects

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

In addition to the beneficial effects of Loceryl, it is possible that unwanted effects will occur during treatment, even when it is used as directed.

Rare side effects (occurring in less than 1 in 1000 people)

Loceryl may cause skin irritation (redness, itching or a burning feeling).

Very rare side effects (occurring in less than 1 in 10,000 people)

An allergic skin reaction (contact dermatitis) may occur

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

5.    How to store Loceryl

•    Keep out of the reach and sight of children.

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

•    Keep the pack away from heat (store below 30°C).

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

What Loceryl contains

Loceryl contains 0.25% w/w of the active substance amorolfine (as the hydrochloride) The other ingredients are 2-phenoxy ethanol, polyoxyl 40 stearate, stearyl alcohol, liquid paraffin, white soft paraffin, carbomer, sodium hydroxide, disodium edetate and purified water.

What Loceryl looks like and contents of the pack

Loceryl is available in a tube with a screw cap. Each tube contains 20 g of cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS. UK. (PL 10590/0041)

Manufacturer: Laboratoires Galderma, ZI- Montdesir, 74540 Alby-sur-Cheran, France.

Further information

You can get more information on Loceryl Cream from your doctor or pharmacist.

This leaflet was last approved in 04/2010.

GALDERMA