Leaflet: information for the user

Terbinafine Combix 10 mg/g cream EFG

Contents of the pack and additional information

Terbinafine is an antifungal medication, belonging to the group of allylamines, which acts by preventing the growth of fungi.

This medication is used in the treatment of the following superficial skin infections:

• Foot athlete's foot,groin athlete's footandbody ringworm(caused by a type of fungi called dermatophytes).
• Cutaneous candidiasis (caused by fungi of the genusCandida).
• Pityriasis (tinea) versicolor.

Do not use Terbinafina Combix

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Terbinafina Combix.

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

Use of Terbinafina Combix with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Use in children

The experience of using terbinafine in children is limited, so it is not recommended for use.

Driving and operating machinery

This medication does not affect the ability to drive or operate machinery.

Important information about some of the components of Terbinafina Combix 10 mg/g cream

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

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

This medication should be used exclusively on the skin.

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

The cream can be applied one or two times a day, for one week (in the treatment ofTinea pedis, Tinea cruris, Tinea corporisand 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 over the affected skin and surrounding areas and gently massage. If the infection is located 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 medication.

If you use more Terbinafina Combix than you should

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

If you forgot to use Terbinafina Combix

If you forgot to apply the cream, apply it as soon as you remember, although if there is little time left for the next application, it is advisable to wait until then. At no time should you use double the amount of cream to compensate for the missed dose.

If you interrupt the treatment withTerbinafina Combix

Do not interrupt the treatment with Terbinafina Combix cream before the indicated time by your doctor, as it is possible that the infection will recur.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The rare adverse effects, which affect 1 or more of every 1000 patients but less than 100, who receive this medication are: irritation or burning sensation at the application site

The very rare adverse effects, which affect less than 1 in every 10,000 patients who receive this medication, occur on the skin and the tissue beneath it and are: allergic reactions, itching, urticaria, and blister formation.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date indicated on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Terbinafina Combix 10 mg/g cream

• The active ingredient is hydrochloride of terbinafine. Each gram of cream contains 10 mg of hydrochloride of terbinafine.
• The other components (excipients) are benzyl alcohol(E1519), sorbitan monoestearate(E491), cetomacrogol, cetyl alcohol, stearyl alcohol, polisorbate 60(E435), isopropyl myristate, sodium hydroxide(E524), and purified water.

Appearance of the product and contents of the packaging

Terbinafina Combix 10 mg/g cream is bright, uniform, and white in color. It is presented in containers containing 30 g of cream.

Holder of the marketing authorization:

Combix, S.L.U. Laboratories

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

Laboratories Liconsa, S.A.

Avenida Miralcampo, No. 7, Miralcampo Industrial Estate

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the last review of this leaflet:January 2007

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.