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Athlete Foot Cream 1%

Informations for option: Athlete Foot Cream 1%, show other option

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.


PACKAGE LEAFLET:

INFORMATION FOR THE USER

Athlete Foot Cream 1%

Terbinafine hydrochloride

In this leaflet:

1.    What Terbinafine hydrochloride 1% cream (there after Athlete Foot Cream) is and what it is used for

2.    Before you use Athlete Foot Cream

3.    How to use Athlete Foot Cream

4.    Possible side effects

5.    How to store Athlete Foot Cream

6.    Further information

1. What Athlete Foot Cream is and what it is used for

Athlete Foot Cream is an anti-fungal preparation. It kills fungi, which cause skin infections.

Athlete Foot Cream is used for the local treatment of fungal infections of the skin such as Athlete's foot and Jock itch (an infection in the groin area, characterised by red ring like areas, sometimes with small blisters, and itching).

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

•    A superficial fungal infection of the skin can appear anywhere on the body surface. As the fungus grows, it spreads out in a circle, leaving normal looking skin in the middle. This makes it look like a ring. At the edge of the ring, the skin is lifted up by the irritation and looks red and scaly.

2.    Before you use Athlete Foot Cream

Do not use Athlete Foot Cream

•    if you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of Athlete Foot Cream

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

•    if you are under 16 years of age

•    for nail infections.

Take special care with Athlete Foot Cream

•    For external use only

•    Avoid getting the cream in your eyes. However if this should accidentally happen rinse your eyes thoroughly with plenty of clean water. If eye irritation continues please see your doctor

•    After application you should always wash your hands.

Taking or using other medicines

Please tell your doctor or pharmacist if you are taking/ using or have recently taken/used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using Athlete Foot Cream if you are pregnant or breast-feeding. If you do become pregnant whilst using Athlete Foot Cream tell your doctor.

Driving and using machines

Athlete Foot Cream will not affect your ability to drive or operate machinery when used as directed and only externally.

Important information about some of the ingredients of Athlete Foot Cream

Cetyl alcohol and cetostearyl alcohol, which are among the other ingredients of the cream, may cause local skin reactions (e.g. contact dermatitis).

3.    How to use Athlete Foot Cream

Open the sealed tube 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 a day on the previously cleansed and dried area. A thin layer of cream should be applied to the affected skin and surrounding area and gently rubbed in.

Duration of treatment according to types of infections:

   Athletes foot: 1 week/once or twice daily.

   Jock itch: 1-2 weeks/once or twice daily.

Treatment should be continued for the duration above, even if the affected area starts healing earlier. This way you can avoid the return of infection and treatment will be successful.

Using Athlete Foot Cream will help stop the infection quickly by killing the pathogenic fungus (disease producing). However, complete healing may take longer depending on the extent of inflammation. The effect of Athlete Foot Cream continues after treatment, even when you have finished using the cream.

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 or someone else including a child, accidentally swallow the cream, contact your doctor immediately.

If you forget to use Athlete Foot Cream

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, Athlete Foot Cream can have side effects, although not everybody gets them.

Redness, itching or stinging occasionally occur at the site of application. Allergic (hypersensitive) 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 you experience any of the following while you are using Athlete Foot Cream, stop using this medicine and tell your doctor as soon as possible:

These side effects may occur with certain frequencies, which are defined as follows:

Common: affects 1 to 10 users in 100.

Uncommon: affects 1 to 10 users in 1,000.

Rare: affects 1 to 10 users in 10,000.

Not Known: frequency cannot be estimated with the available data.

Common

•    Skin exfoliation, itching, inflammatory skin eruption (erythema).

Uncommon

•    Skin problems such as superficial growth or patch of the skin that does not resemble the area surrounding it (skin lesion), pigmentation, burning sensation of the skin

•    Irritation and pain at the site of application.

Rare

•    Eye irritation

•    Dry skin, inflammation of the outer layer of the skin

(eczema).

Not known

•    Rash

•    Hypersensitivity reaction.

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 Athlete Foot Cream

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the pack. The expiry date refers to the last day of that month.

No special precautions for storage.

Store in original container.

Do not use Athlete Foot Cream if you notice visible signs of deterioration.

Only keep it if your doctor tells you to.

If your doctor decides to stop your treatment, return any leftover medicine to the pharmacist.

Only keep it if your doctor tells you to.

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 Athlete Foot Cream 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 Athlete Foot Cream 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, 15 g or 30 g).

Marketing Authorisation Application held by:

ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany.

Manufactured by: Merckle GmbH, Ludwig Merckle strasse 3, 89143 Blaubeuren, Germany.

Or Gedeon Richter Ltd. 1103 Budapest, Gyomroi ut 19-21, Hungary.

Leaflet revised in: October 2012

ratiophann