Terbinafine Hydrochloride 1% Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
Terbinafine Hydrochloride 1% Cream
Terbinafine hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
■ 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Terbinafine Hydrochloride 1 % Cream (hereafter Terbinafine) is and what it is used for
2. What you need to know before you use Terbinafine
3. How to use Terbinafine
4. Possible side effects
5. How to store Terbinafine
6. Contents of the pack and other information
1. 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.
Terbinafine should NOT be used for fungal infections of the nail.
For external use only.
2. What you need to know before you use Terbinafine
DO NOT USE Terbinafine:
■ If you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
■ The use of Terbinafine is not recommended for children.
Warnings and Precautions:
Talk to your doctor or pharmacist before you use Terbinafine:
■ For external use only.
■ Avoid contact of the cream with your eyes as it may be irritating to the eyes. If it gets into the eyes accidentally, the eyes should be washed with plenty of water and the patient should consult a doctor or ophthalmologist if necessary.
■ After application, you should always wash your hands. Other medicines and Terbinafine
Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including medicines obtained without a prescription. Do not use other medicines on the area you treat with Terbinafine cream.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Ask your doctor or pharmacist for advice before using Terbinafine.
If you do become pregnant whilst using Terbinafine, tell your doctor. Terbinafine is not recommended for use during pregnancy.
Breast-feeding
Terbinafine Cream should not be used whilst breastfeeding. Infants should not come into contact with any treated skin, including the breast.
Driving and using machines
Terbinafine Cream does not affect your ability to drive or operate machinery when used as directed and only externally.
Terbinafine contains cetyl alcohol and stearyl alcohol
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
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Usage of the cream
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.
Usually improvement is seen in a few days. Irregular use or prematurely stopping the cream increases the recurrence of symptoms.
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. Do not use a double dose to make up for a forgotten dose.
If you STOP using Terbinafine
If you suddenly stop using Terbinafine, your old symptoms may return.
If you have any further questions on the use of this medicine, contact your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the Terbinafine cream and seek medical help immediately if you experience any of the following symptoms which may indicate an allergic reaction:
■ Difficulty breathing or difficulty swallowing;
■ Swelling of the mounth, face, lips, tongue or throat;
■ Severe itching of the skin with a red rash or raised lumps, hives or blisters.
Other side effects
Some side effects are common (may affect up to 1 in 10 people): Peeling of the skin, itching.
Some side effects are uncommon (may affect up to 1 in 100 people): Injury skin, crusting, skin disorder, change in skin color, redness, burning, pain, pain at the site of administration, irritation at the site of administration.
Some side effects are rare (may affect up to 1 in 1,000 people): Irritation of the eyes, dry skin, inflammation of the skin, eczema, aggravation of the condition.
If Terbinafine cream is applied accidentally in the eyes it can cause irritation.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov. u k/ve llowcard.
By reporting side effects you can help provide more information of the safety of this medicine.
5. How to store Terbinafine
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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.
If your doctor decides to stop your treatment, return any leftover medicine to the pharmacist. Only keep it if your doctor tells you to.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other 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 Application held by:
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts, SG4 0TW, United Kingdom.
Manufactured by:
Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary.
This leaflet was last revised in: 07/2013