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FUNGSTER 10MG/G CREAM

Active substance(s): TERBINAFINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FUNGSTER 10 mg/g cream
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.
2.
3.
4.
5.
6.

1.

What FUNGSTER 10mg/g cream (thereafter FUNGSTER) is and what it is used for
Before you use FUNGSTER
How to use FUNGSTER
Possible side effects
How to store FUNGSTER
Further information

WHAT FUNGSTER IS AND WHAT IT IS USED FOR

FUNGSTER is an anti-fungal preparation. It kills fungi, which cause skin infections.
FUNGSTER is used for the local treatment of fungal infections of the skin.

2.

BEFORE YOU USE FUNGSTER

Do not use FUNGSTER
- if you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of
FUNGSTER
Take special care with FUNGSTER
- 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.
- The use of FUNGSTER is not recommended for children.
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 FUNGSTER .
If you do become pregnant whilst using FUNGSTER, tell your doctor.
Driving and using machines
FUNGSTER will not affect your ability to drive or operate machinery when used as directed and only
externally.

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Important information about some of the ingredients of FUNGSTER
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 FUNGSTER

Your doctor will decide the right amount of FUNGSTER for you to use and will tell you how long to
use your medicine. Follow your doctor’s instructions exactly.
Unless otherwise instructed by your doctor, apply the cream once or twice daily. The cream is
generally used for 1 to 2 weeks, but this will depend upon the type and area of infection.
Method and route of administration
Cutaneous use.
Make sure that you have cleaned and dried the affected skin and surrounding areas thoroughly before
applying FUNGSTER cream in a thin layer. The cream should be rubbed in gently and the affected
areas may be covered with a gauze dressing, especially at night.
If there are no signs of improvement after two weeks of therapy, consult your doctor.
If you use more FUNGSTER than you should
If you or someone else including a child, accidentally swallow the cream, contact your doctor
immediately.
If you forget to use FUNGSTER
If you forget to use your cream, apply the cream as soon as possible, and then continue the rest of your
treatment as usual.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, FUNGSTER can have side effects, although not everybody gets them.
Very common side effects (occurring in more than 1 in 10 people treated):
- Irritation (burning sensation) at the site of application.
Common side effects (occurring in less than 1 in 10 people but more than 1 in 100 treated):
- Redness, itching or stinging 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 FUNGSTER

Keep out of the reach and sight of children.

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UK_FUNGSTER 10mg/g cream: PL 20693/0008
Last approved: 25/04/2012

Do not use FUNGSTER after the expiry date which is stated on the label and carton. The expiry date
refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the
original package.
Do not use FUNGSTER if you notice visible signs of deterioration.
You can use FUNGSTER 1 month after first opening of the tube.
If you 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 FUNGSTER contains
The active substance is terbinafine hydrochloride. 1g cream contains 10mg 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 FUNGSTER 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 Holder and Manufacturer
Marketing Authorisation Application held by:
Pierre Fabre Dermatologie, 45 place Abel Gance, 92100 Boulogne, France
Manufactured by:
Gedeon Richter Ltd. 1103 Budapest, Gyömrői út 19-21, Hungary
This medicinal product is authorised in the Member States under the following names:
In the United Kingdom: FUNGSTER
In Spain: FONGEAL
This leaflet was last approved in April 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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