Terbinafine Hydrochloride 1% Cream

Document: leaflet PLIVA_PL 04854-0043 change

PACKAGE LEAFLET

Terbinafine Hydrochloride 1 % Cream

Terbinafine hydrochloride

Read all of this leaflet carefully before you start

using this medicine.

• Keep this leaflet. You may want to read it again.

• If you have any further questions, please 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 get 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 (hereafter Terbinafine) 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

[ft What Terbinafine is and what it is used for

Terbinafine cream is an anti-fungal preparation.

It kills fungi, which cause skin infections.

Terbinafine cream is used for the local treatment

of fungal infections of the skin.

For external use only.

[2 Before you use Terbinafine

Do not use Terbinafine

• if you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of Terbinafine.

• The use of Terbinafine 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 using Terbinafine. If you do become pregnant whilst using Terbinafine, tell your doctor.

Breast-feeding

Ask your doctor or pharmacist for advice before using Terbinafine.

Driving and using machines

Terbinafine will not affect your ability to drive or operate machinery when used in accordance to instructions and only externally.

Important information about some of the ingredients of Terbinafine

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 Terbinafine

Your doctor will decide the right amount of terbinafine 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 applying Terbinafine 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 Terbinafine than you should

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

If you FORGET TO 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.

[4 Possible side effects

Like all medicines, Terbinafine can have side effects, although not everybody gets them.

Terbinafine contains cetyl alcohol and cetostearyl alcohol as excipients which may cause skin reactions (e.g. contact dermatitis).

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.

[5 How to store Terbinafine

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 Terbinafine 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 left over 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 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 (7.5g, 15g or 30g)

Marketing Authorisation Holder

Gedeon Richter Plc. 1103 Budapest Gyomroi ut 19-21 Hungary

Manufacturer