PACKAGE LEAFLET: INFORMATION FOR THE USER

TERBINAFINE HYDROCHLORIDE 1% CREAM

Read all of this leaflet carefully before you start to use Terbinafine Hydrochloride 1% Cream

•    Keep this leaflet in case you want to refer to it again.

•    If you want to know more about your medicine or have any questions, you should 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Terbinafine hydrochloride 1% cream will be referred to as Terbinafine Cream throughout this leaflet.

In this leaflet:

1.    What Terbinafine cream is and what it is used for

2.    Before you use Terbinafine cream

3.    How to use Terbinafine cream

4.    Possible side effects

5.    How to store Terbinafine cream

6.    Further information

Important information about some of the ingredients of Terbinafine cream.

The cream contains cetyl alcohol and steryl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. HOW TO USE TERBINAFINE CREAM

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

Terbinafine cream belongs to a group of medicines called antifungals which are used to treat fungal infections, especially of the skin. It can be used in the treatment of infections, such as Athlete's foot, ringworm, itchy rash of the groin and fungal infections of the skinfolds (intertrigo).

2. BEFORE YOU USE TERBINAFINE CREAM

Do NOT use Terbinafine cream if:

•    you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of the cream (listed in Section 6 Further Information)

•    you are under 16 years of age

•    you are breast-feeding.

Pregnancy and breast-feeding

If you are pregnant or trying for a baby, tell your doctor before using the cream. If you have already informed your doctor, follow his/her instructions carefully. Do not use Terbinafine cream if you are breastfeeding.

Driving and using machines

Using Terbinafine cream does not affect your ability to drive or use machinery.

Take special care with Terbinafine cream as:

•    your Terbinafine cream is for external use only and should not be put in the mouth or swallowed. If swallowed accidentally, seek medical advice immediately and take this leaflet with you.

•    you must keep the cream away from your eyes. If the cream gets in your eyes wipe the cream from around the eye and then rinse with clean water. Seek medical advice immediately.

Before use, invert the cap over the end of the

tube and press to pierce the tube seal.

Adults including the elderly

Your doctor will tell you how much cream to use

and how long to use it for. Always follow his/her

instructions carefully.

•    Wash your hands and wash and dry the affected areas thoroughly before applying the cream.

•    Apply the cream thinly and evenly to the affected and surrounding area once or twice daily and rub in gently, unless directed otherwise by your doctor.

•    It may be helpful to cover the treated area with a gauze strip, especially at night.

•    The cream should normally be used for 1 to 2 weeks, but this will depend on the type and location of the infection.

•    Once opened, the cream should be used within 2 weeks.

Continued overleaf...

•    If symptoms do not improve after 2 weeks consult your doctor.

The symptoms of your skin infection, such as itching or soreness should improve within a few days, although signs such as redness and scaling of the skin may take longer to disappear. Your symptoms should continue to improve after the end of the treatment period.

You can help the treatment to work if you follow these self-help tips:

•    Although the infected area will itch, try not to scratch. Scratching will damage the surface of the skin and cause the infection to spread.

•    Keep the affected area clean and dry, but avoid excessive rubbing.

•    To protect yourself from further re-infection, it may be helpful to regularly wash your own towels and clothes and not share them with others.

Children

The cream is not recommended for use in children under 16 years of age.

If you use more Terbinafine cream than you should

Do not worry just continue as previously instructed by your doctor. If you do have any concerns discuss them with your doctor or pharmacist. Seek medical advice immediately if the cream is accidentally swallowed.

If you forget to use Terbinafine cream

If you forget to use your cream, apply the cream as soon as possible and then continue your treatment as usual.

If you stop using Terbinafine cream

Do not stop using the cream before the recommended time as your infection may not have been fully treated and the infection may re-occur. It is therefore important to complete the course of treatment as stated by your doctor.

You may experience redness, stinging and itching at the site of application after using the cream. If the symptoms get worse or persist, or if you notice any symptoms not mentioned above contact your doctor.

5. HOW TO STORE TERBINAFINE CREAM

Keep out of reach and sight of children.

There are no special storage instructions.

The cream should be used within 2 weeks of opening.

Do not use unopened cream after the expiry date which is printed at one end of the carton and on the end of the tube. This date refers to the last day of the month. Return any unused cream or expired medicine to your pharmacist for safe disposal.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, this cream may cause side effects, although not everyone will get them. Rarely, people may be allergic to the cream. Stop using the cream and contact your doctor IMMEDIATELY if any of the following occur, as you may require urgent medical attention:

•    wheezing or difficulty in breathing

•    pain, swelling of skin (hives), red itchy rash.

What Terbinafine cream contains:

•    Terbinafine cream contains 1% w/w of the active ingredient terbinafine hydrochloride.

•    The other ingredients are sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristrate and purified water.

What Terbinafine cream looks like and the contents of the pack:

Terbinafine cream is a smooth white cream.

It is available in aluminium tubes containing 7.5 g, 15 g or 30 g of cream.

Not all pack sizes may be marketed.

Manufacturer:

GP Grenzach Produktions GmbH,

Grenzach- Wyhlen,

Germany

Marketing Authorisation Holder:

Activase Pharmaceuticals Limited,

11 Boumpoulinas, 3rd floor,

P.C. 1060, Nicosia,

Cyprus

For more information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 07/2012