ATHLETE FOOT CREAM 1%

Active substance: TERBINAFINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Athlete Foot Cream 1%
Terbinafine hydrochloride

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.






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.

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.

4. Possible side effects

Only keep it if your doctor tells you to.

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

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.

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).




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, Gyömrõi út 19-21,
Hungary.
Leaflet revised in: October 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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