PACKAGE LEAFLET: INFORMATION FOR THE USER

Tinaderm Cream

TOLNAFTATE

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

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

-    Ask your pharmacist if you need more information or advice.

-    You must contact your doctor if your symptoms worsen or do not improve after a few days.

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

In this leaflet:

1.    What Tinaderm is and what it is used for

2.    Before you use Tinaderm

3.    How to use Tinaderm

4.    Possible side effects

5.    How to store Tinaderm

6.    Further information

1.    WHAT TINADERM IS AND WHAT IT IS USED FOR

Tinaderm Cream is used on the surface of the skin to kill certain types of fungi which cause skin infections, such as Athlete’s Foot. It contains Tolnaftate which is a topical (on the skin) fungicide.

2.    BEFORE YOU USE TINADERM Do not use Tinaderm

If you are allergic (hypersensitive) to tolnaftate or any of the other ingredients in the cream.

Important information about some of the ingredients of Tinaderm

The cream contains chlorocresol, cetostearyl alcohol and butylhydroxytoluene, which may cause skin reactions such as contact dermatitis, allergic reactions or irritation to the eyes and mucous membranes.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant or breast-feeding, before you start using TINADERM.

3. HOW TO USE TINADERM

For adults and children: Thoroughly wash and dry the areas of skin you are treating, then rub in the cream. You should do this twice a day.

You should see an improvement within two to three days of starting to use the cream and the infection should clear up within two to three weeks. Infections on the soles of the feet may take longer to clear up and it may help to remove any hard skin before rubbing in the cream.

If you forget to use Tinaderm

If you miss a dose, use the cream as soon as you remember and then carry on using it as before.

4.    POSSIBLE SIDE EFFECTS

The cream may cause slight irritation of the skin in some people. If this happens to you, stop using the cream and see your doctor.

5.    HOW TO STORE TINADERM

The cream should be stored in a cool place. Keep out of reach and sight of children.

Do not use the cream after the expiry date stamped on the container.

6.    FURTHER INFORMATION What Tinaderm contains

-    The active substance is tolnaftate 1.0% w/w.

-    The other ingredients are chlorocresol; sodium acid phosphate; white soft paraffin; cetomacrogol 1000; cetostearyl alcohol; mineral oil; butylated hydroxytoluene and purified water.

What Tinaderm looks like and contents of the pack

The cream comes in a tube containing 15g.

Marketing Authorisation Holder and Manufacturer

The holder of the Marketing Authorisation is:

Merck Sharp & Dohme Limited Hertford Road,

Hoddesdon,

Hertfordshire,

EN11 9BU,

UK

The manufacturer is:

Schering-Plough Labo NV,

Heist-op-den-berg, Belgium.

This leaflet was last approved in June 2010

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