Fungster 10mg/G Cream
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. What FUNGSTER 10mg/g cream (thereafter FUNGSTER) is and what it is used for
2. Before you use FUNGSTER
3. How to use FUNGSTER
4. Possible side effects
5. How to store FUNGSTER
6. Further information
1. 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.
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.
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, Gyomroi ut 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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