Terbinafine Pensa 10 mg/g cream EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terbinafina pensa 10 mg/g cream EFG

Terbinafine (as hydrochloride)

Read the entire leaflet carefully before you start using this 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Terbinafina Pensa 10 mg/g cream is and what it is used for
2. Before using Terbinafina Pensa 10 mg/g cream
3. How to use Terbinafina Pensa 10 mg/g cream
4. Possible side effects
5. How to store Terbinafina Pensa 10 mg/g cream
6. Further information

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

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

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

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

2. Before using Terbinafine Pensa 10 mg/g cream

Do not use Terbinafine Pensa

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

Take special care with Terbinafine Pensa

• This medicine is for topical use only. It may be irritating to the eyes, so contact should be avoided. In case of accidental contact, rinse thoroughly with tap water.
• If you experience any reaction at the application site, you may need to discontinue treatment. Consult your doctor if this occurs.

Use of other medicines

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

The simultaneous use of other products on the areas where terbinafine cream is applied is not recommended.

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; therefore, its use is not recommended.

Driving and operating machinery

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

Important information about some of the components of Terbinafine Pensa

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

3. How to use Terbinafina Pensa 10 mg/g cream

This medicine is for external use on the skin only.

Follow exactly the dosing instructions for terbinafine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

Remember to use your medicine regularly.

If you use more Terbinafina Pensa than you should:

If you have applied more cream than recommended, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount used. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to use Terbinafina Pensa:

If you forget to apply the cream, do so as soon as you remember. However, if it is almost time for the next application, wait until then. Never apply a double amount of cream to make up for a missed dose.

If you stop using Terbinafina Pensa:

Do not stop treatment with terbinafine before the time indicated by your doctor, as the infection may recur.

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

4. Possible adverse effects

Like all medicines, Terbinafina Pensa 10 mg/g cream may produce adverse effects, although not everybody gets them.

Uncommon adverse effects, affecting 1 or more of every 1,000 patients but less than 100, who receive this medicine are: irritation or burning sensation at the site of application.

Very rare adverse effects, affecting fewer than 1 in every 10,000 patients who receive this medicine, affecting the skin and tissue beneath it, are: allergic reactions, itching, urticaria, and blistering.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Information for the user

Composition of Terbinafina Pensa 10 mg/g cream

• The active substance 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, polysorbate 60, isopropyl myristate, sodium hydroxide and purified water.

Appearance of the medicinal product and contents of the pack

Terbinafina Pensa 10 mg/g cream is a cream, shiny, uniform and white in colour. It is supplied in containers containing 30 g of cream.

Marketing Authorisation 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/