Leaflet: information for the user

Terbinafine pensa 10 mg/g cream EFG

Terbinafine (as hydrochloride)

Read this leaflet carefully before you start using the medicine.

-Keep this leaflet as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.

-If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1. What isTerbinafine Pensa 10 mg/g creamand what it is used for

2. Before usingTerbinafine Pensa 10 mg/g cream

3. How to useTerbinafine Pensa 10 mg/g cream

4. Possible side effects

5. Storage ofTerbinafine Pensa 10 mg/g cream

6. Additional information

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

This medicationis used in the treatment of the following superficial skin infections:

• Tinea pedis(also known as athlete's foot or dermatophytosis of the foot),Tinea cruris(also known as jock itch or dermatophytosis of the inguinal region) andTinea corporis(also known as body ringworm), caused by a type of fungi called dermatophytes).
• Cutaneous candidiasis (caused by fungi of the genusCandida).
• Pityriasis(ringworm)versicolor.

Do not useTerbinafina Pensa

If you are allergic (hypersensitive) to terbinafine or to any of the other components of Terbinafina Pensa.

Be especially careful with Terbinafina Pensa

• 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, they must be thoroughly washed with tap water.
• If after administration you present any reaction in the treated area, it may be necessary to interrupt treatment. Consult your doctor if this were the case.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, even those acquired without a prescription.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication. This medication should only be used during pregnancy when clearly indicated.

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 machines

This medicationdoes not affect the ability to drive or operate machines.

Important information about some of the components of Terbinafina Pensa

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

This medication should be used exclusively on the skin.

Follow exactly the administration instructions for terbinafina indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 ofPityriasis 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 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 Pensa than you should:

If you have used more cream than you should, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to use Terbinafina Pensa:

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 a double dose of cream to compensate for the missed dose.

If you interrupt the treatment with Terbinafina Pensa:

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

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

Like all medications, Terbinafina Pensa 10 mg/g cream may produce adverse effects, although not all people will experience them.

The less common 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 the appearance of blisters.

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

No requires special conditions for conservation.

Keep out of reach and sight of children.

Do not use Terbinafine Pensa 10 mg/g cream after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Terbinafina Pensa 10 mg/g Cream

• The active ingredient is terbinafine (as hydrochloride). Each gram of cream contains 10 mg of terbinafine (as hydrochloride).
• The other components are:benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polisorbate 60, isopropyl myristate, sodium hydroxide, and purified water.

Appearance of the Product and Contents of the Package

Terbinafina Pensa 10 mg/g Cream is presented as a bright, uniform, and white cream. It is presented in packages containing30 gof cream.

Holder of the Marketing Authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing:

Laboratorios Liconsa, S.A

Avda. Miralcampo, nº 7. Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Madrid)

or

GP Grenzach Produktions GmbH

Emil-Barell-Strasse 7

79839 Grenzach-Wyhlen (Germany)

This leaflet was approved in JANUARY 2011

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/