Terbinafine Hydrochloride 1% Cream
TERBINAFINE HYDROCHLORIDE 1 % CREAM
Terbinafine hydrochloride
PACKAGE LEAFLET: INFORMATION FORTHE USER
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.
INTHIS LEAFLET:
1. What Terbinafine Hydrochloride
1 % cream (thereafterTerbinafine) 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
O WHAT TERBINAFINE IS AND WHAT IT IS USED FOR
Terbinafine is an anti-fungal preparation. It kills fungi, which cause skin infections.
Terbinafine is used for the local treatment of fungal infections of the skin.
For external use only.
0 BEFOREYOU USE TERBINAFINE
DO NOT USE Terbinafine
• If you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients ofTerbinafine • The use ofTerbinafine is not recommended for children.
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 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 Pregnancy
Ask your doctor or pharmacist for advice before usingTerbinafine.
If you do become pregnant whilst using Terbinafine, tell your doctor.
Breast-feeding
Ask your doctor or pharmacist for advice before usingTerbinafine.
Driving and using machines
Terbinafine 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 ofTerbinafine
Cetyl alcohol and cetostearyl alcohol, which are among the other ingredients of the cream, may cause local skin reactions (e.g. contact dermatitis).
HOWTO USE TERBINAFINE
Your doctor will decide the right amount ofTerbinafine 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. Make sure that you have cleaned and dried the affected skin and surrounding areas thoroughly before applyingTerbinafine 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 MORETerbinafine than you should
If you or someone else including a child, accidentally swallow the cream, contact your doctor immediately.
If you FORGETTO 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.
Q 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.
Do not useTerbinafine if you notice visible signs of deterioration.
Keep out of the reach and sight of children.
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.
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, 15 g or 30 g).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Application held by:
Gedeon Richter Pic., 1103 Budapest, Gyomroi ut 19-21, Hungary.
HOWTO STORE TERBINAFINE
Do not use after the expiry date stated on the pack.The expiry date refers to the last day of that month.
Manufactured by:
Gedeon Richter Pic., 1103 Budapest, Gyomroi ut 19-21, Hungary.
Leaflet revised in November 2006.
No special precautions for storage.
Store in original container.
TEUZD
TEVA UK LIMITED