PACKAGE LEAFLET: INFORMATION FOR THE USER

TERBINAFINE HYDROCHLORIDE 1% CREAM

(Terbinafine Hydrochloride)

Read all of this leaflet carefully before you start using this medicine. This medicine is available without prescription. Nevertheless you still need to use Terbinafine cream carefully to get the best results from it • Keep this leaflet. You may want to read it again • Ask your pharmacist if you need more information or advice • You must see a doctor if your symptoms worsen or do not improve within two weeks of starting treatment.

In this leaflet:

1.    What Terbinafine Hydrochloride 1% Cream (hereafter Terbinafine) is and what it is used for

2.    Before you use Terbinafine

3.    How to use Terbinafine

4.    Possible side effects

5.    How to store Terbinafine

6.    Further information.

2. BEFORE YOU USE TERBINAFINE

Do not use Terbinafine if:

•    you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other inqredients of Terbinafine

•    you are not sure about the nature of your skin problems, you should consult your doctor before starting to use Terbinafine Cream

•    you are younger than 16 years of age.

Take special care with Terbinafine:

•    for external use only

•    avoid contact of the cream with your eyes. If it gets into the eyes accidentally, the eyes should be washed with plenty of water and the patient should consult an ophthalmologist if necessary

•    after application you should always wash your hands.

Taking or using other medicines - Please tell our doctor or pharmacist if you are taking/using or ave recently taken/used any other medicines,

including medicines obtained without a prescription.

1. WHAT TERBINAFINE IS AND WHAT IT IS USED FOR

Terbinafine Cream is an anti-fungal preparation. It kills fungi, which cause skin infections. Terbinafine cream is used for the local treatment of fungal infections such as Athlete's foot and jock itch. You can treat mild, transient complaints before seeking medical attention or supervision. To achieve optimal effect you should use this medicine carefully and expertly. For external use only.

Fungal infections can develop in the following areas of the body:

•    fungal infection of the foot (Athlete's foot) appears on the feet, mainly between the toes. It can spread to the soles, edges or the instep of the feet. It may affect one or both feet. The most common symptoms can be inflammation, cracking or scaling of the skin, unpleasant itching. In more severe cases, small weeping blisters, peeling skin and painful, deep cracks can appear

•    Terbinafine is not for nail infections.

Pregnancy and breast-feeding: Pregnancy -

Ask your doctor or pharmacist for advice before using Terbinafine. if you do become pregnant whilst using Terbinafine, tell your doctor.

Breast-feeding - Ask your doctor or pharmacist for advice before using Terbinafine.

Driving and using machines - Terbinafine does not affect your ability to drive or operate machinery when used as directed and only externally.

Important information about some of the ingredients of Terbinafine - Cetylalcohol and cetostearyl alcohol, which are among the other ingredients of the cream, may causelocal skin reactions (eg. contact dermatitis).

3. HOW TO USE TERBINAFINE

You can open the sealed tube by using the spike at the top of the cap. Always clean and dry your hands before using the cream.

Usage of the cream: The cream should be applied once or twice daily on the previously cleansed and dried area. The cream should be applied to the affected skin and surrounding area in a thin layer and rubbed in lightly.

Duration of treatment according to types of infections:

Fungal infection of the foot: 1 week/once or twice daily. Treatment should be continued for one week even if the affected area starts healing earlier. This way you can avoid the return of infection and treatment will be successful. The effect of use of the cream will stop the infection quickly due to the killing of the pathogenic fungus. However, complete healing may take longer depending on the extent of inflammation. The effect of Terbinafine Cream persists after treatment, even when you have finished using the preparation. If there are no signs of improvement after two weeks of therapy, consult your doctor.

To avoid re-infection it is important to take the following hygienic measures: The affected area should be kept clean; after use of the cream you should always wash your hands; you should use your own towel; you should frequently change underwear; you should wear cotton socks and it is advised to disinfect footwear. Avoid scratching the affected area, although it may be itchy, because it can cause further damage to the skin and slow down the healing process or spread the infection.

If you use more terbinafine than you should - If you or someone else including a child, accidentally swallow the cream, contact your doctor immediately.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Terbinafine can have side effects, although not everybody gets them.

Redness, itching or stinging occasionally occur at the site of application. If these side effects occur, contact your doctor.

Hypersensitivity reactions may develop with any medicine.

Therefore, if you experience any of the following symptoms, such as swelling of the treated area, pain

and redness, you should stop treatment and contact your doctor.

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

5.    HOW TO STORE TERBINAFINE

Do not use after the expiry date stated on the pack. The expiry date refers fo the last day of that month. No special precautions for storage. Store in original container. Do not use Terbinafine if you notice visible signs of deterioration. Keep out of the reach and sight of children. Only keep it if your doctor tells you to. If your doctor decides to stop your treatment, return any left over medicine to the pharmacist.

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 Terbinafine contains: The active substance is terbinafine hydrochloride. The other ingredients are sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, cetostearyl alcohol, polysorbate 60, isopropyl myristate, water purified.

What Terbinafine looks like and contents of the pack: White or almost white cream, with slight almond odour. Packs contain 1 tube of cream (7.5 g and 15 g).

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Application held by:

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL.

Manufactured by: Gedeon Richter Pic. 1103 Budapest, Gydmrdi ut 19-21, Hungary.

Date of revision: November 2008