TERBINAFINE COMBIX 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Terbinafine Combix 10 mg/g Cream EFG

Contents of the Package Leaflet:

1. What is Terbinafine Combix and what is it used for
2. What you need to know before you use Terbinafine Combix
3. How to use Terbinafine Combix
4. Possible side effects
5. Storage of Terbinafine Combix

Contents of the pack and further information

1. What is Terbinafine Combix and what is it used for

Terbinafine is an antifungal medicine, which belongs to the group of allylamines, and works by preventing the growth of fungi.

This medicine is used to treat the following superficial skin infections:

• Tinea pedis, Tinea cruris, and Tinea corporis(caused by a type of fungus called dermatophytes).
• Cutaneous candidiasis (caused by yeast of the genus Candida).
• Pityriasis (tinea) versicolor.

2. What you need to know before you use Terbinafine Combix

Do not use Terbinafine Combix

If you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before you start using Terbinafine Combix.

• This medicine is for use on the skin only. It may be irritating to the eyes, so contact with them should be avoided. In case of accidental contact, they should be rinsed thoroughly with tap water.
• If after administration you experience any reaction in the treated area, you may need to interrupt treatment. Consult your doctor if this is the case.

Using Terbinafine Combix with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is not recommended to use other products on the areas where the terbinafine cream is applied at the same time.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Do not use this medicine if you are breastfeeding, as terbinafine passes into breast milk.

Use in children

Experience with the use of terbinafine in children is limited, so its use is not recommended.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

Important information about some of the ingredients of Terbinafine Combix 10 mg/g cream

This medicine may cause local skin reactions (such as contact dermatitis) because it contains stearyl alcohol and cetyl alcohol.

This medicine contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions.

3. How to use Terbinafine Combix

This medicine should be used exclusively on the skin.

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor again.

The cream can be applied once or twice a day, for one week (in the treatment of Tinea pedis, Tinea cruris, Tinea corporis, and cutaneous candidiasis) or two weeks (for the treatment of Pityriasis versicolor). Your doctor will indicate the duration of your treatment.

Before applying the cream, clean and dry the affected areas carefully. Apply a thin layer of cream to the affected skin and surrounding areas, and gently massage. If the infection is between the fingers of the hands or feet, under the breasts, or in the groin, it is advisable to cover the area with a gauze, especially at night.

Remember to use your medicine.

If you use more Terbinafine Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Terbinafine Combix

If you forget to apply the cream, apply it as soon as you remember, although if it is almost time for the next application, it is best to wait until then. You should never use a double dose of cream to make up for the forgotten dose.

If you stop using Terbinafine Combix

Do not stop using Terbinafine Combix cream before your doctor indicates, as it is possible that the infection may reappear.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects, which affect 1 or more of every 1000 patients but less than 100, who receive this medicine are: irritation or burning sensation at the application site.

Very rare side effects, which affect less than 1 in every 10,000 patients who receive this medicine, occur in the skin and subcutaneous tissue and are: allergic reactions, itching, urticaria, and blistering.

If you think any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Terbinafine Combix

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month stated.

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 protect the environment.

6. Contents of the pack and further information

Composition of Terbinafine Combix 10 mg/g cream

• The active substance is terbinafine hydrochloride. Each gram of cream contains 10 mg of terbinafine hydrochloride.
• The other ingredients (excipients) are benzyl alcohol (E1519), sorbitan monostearate (E491), cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60 (E435), isopropyl myristate, sodium hydroxide (E524), and purified water.

Appearance of the product and contents of the pack

Terbinafine Combix 10 mg/g cream is shiny, uniform, and white. It is available in packs containing 30 g of cream.

Marketing Authorisation Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of last revision of this leaflet:January 2007

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.