TERBINAFINE PENSA 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Terbinafine Pensa 10 mg/g Cream EFG

Terbinafine (as hydrochloride)

Read all of this leaflet carefully before you start using this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

1. What is Terbinafine Pensa 10 mg/g Cream and what is it used for
2. Before you use Terbinafine Pensa 10 mg/g Cream
3. How to use Terbinafine Pensa 10 mg/g Cream
4. Possible side effects
5. Storage of Terbinafine Pensa 10 mg/g Cream
6. Further information

1. What is Terbinafine Pensa 10 mg/g Cream and what is it used for

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

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

• Tinea pedis(known as athlete's foot or fungal/dermatophyte infection of the foot), Tinea cruris(known as jock itch or fungal/dermatophyte infection of the groin area) and Tinea corporis(known as ringworm of the body), caused by a type of fungus called dermatophytes.
• Cutaneous candidiasis (caused by yeasts of the genus Candida).
• Pityriasis(ringworm) versicolor.

2. Before you use Terbinafine Pensa 10 mg/g Cream

Do not useTerbinafine Pensa

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

Take special care with Terbinafine Pensa

• 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 other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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

Pregnancy and breastfeeding

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

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 Pensa

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

3. How to use Terbinafine Pensa 10 mg/g Cream

This medicine should be used exclusively on the skin.

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

The cream can be applied once or twice a day, for one week (in the treatment of Tinea 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 to the affected skin and surrounding areas, and massage gently. If the infection is between the fingers of the hands or feet, under the breasts, or in the groin area, it is advisable to cover the area with a gauze, especially at night.

Remember to use your medicine.

If you use more Terbinafine 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 Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the packaging and leaflet of the medicine to the healthcare professional.

If you forget to use Terbinafine Pensa:

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 amount of cream to make up for the forgotten dose.

If you stop using Terbinafine Pensa:

Do not stop treatment with terbinafine before your doctor indicates, as it is possible that the infection may recur.

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

4. Possible side effects

Like all medicines, Terbinafine Pensa 10 mg/g Cream 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, hives, and blistering.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Terbinafine Pensa 10 mg/g Cream

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Terbinafine Pensa 10 mg/g Cream after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

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. Further information

Composition of Terbinafine 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 ingredients are: benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, sodium hydroxide, and purified water.

Appearance and packaging of the product

Terbinafine Pensa 10 mg/g Cream is presented as a cream, shiny, uniform, and white in color. It is presented in containers containing 30 g of cream.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

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

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/