Canespie Bifonazol 10 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Canespie Bifonazole 10 mg/g cream

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Leaflet contents:

1. What Canespie Bifonazole is and what it is used for
2. What you need to know before using Canespie Bifonazole
3. How to use Canespie Bifonazole
4. Possible adverse effects
5. How to store Canespie Bifonazole
6. Contents of the pack and other information

1. What Canespie Bifonazole is and what it is used for

This medicine belongs to a group of medicines called antifungals (medicines used to treat infections caused by fungi and yeasts).

It is indicated for the treatment of athlete's foot (a superficial fungal infection of the skin located between the folds of the toes) in adults and adolescents aged 12 years and older.

The main symptoms of athlete's foot are: itching, redness (erythema), skin fissures between the toes, scaling, and possibly inflammation or pustules. It occurs only on the feet. It usually starts between the toes, but may also spread to the soles and sides of the feet.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

2. What you need to know before using Canespie Bifonazole

Do not use Canespie Bifonazole

• if you are allergic to bifonazole, to imidazoles in general, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Canespie Bifonazole.

• This medicine is for external use only. Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with cool water.

• Do not ingest.

• If any hypersensitivity reaction or allergic reaction occurs during treatment, discontinue use and consult your doctor.

• It is not recommended to cover the treated area with bandages after applying the medicine, as this may enhance systemic absorption.

Children and adolescents

Do not give this medicine to children under 12 years of age.

For adolescents aged 12 years and older, see the section How to use Canespie Bifonazole below.

Using Canespie Bifonazole with other medicines

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

If you are being treated with warfarin (an oral anticoagulant), your dose may need to be adjusted, as the effects of warfarin may be affected by the use of bifonazole.

It is not recommended to use other medicines simultaneously on the same areas where this medicine is applied.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of this medicine is not recommended during pregnancy or in women of childbearing age who are not using contraceptive methods.

Breastfeeding

Caution should be exercised during breastfeeding, as bifonazole may be excreted in breast milk. If this medicine is administered, natural breastfeeding should be interrupted and replaced.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

Canespie Bifonazole contains cetostearyl alcohol and benzyl alcohol

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

This medicine contains 2 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Canespie Bifonazole

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents from 12 years of age:

1 application to the affected area once daily, preferably before going to bed. The duration of treatment is 3 weeks.

If after 7 days of use you do not notice an improvement in your symptoms, consult your doctor.

Method of administration:

This medicine is administered by cutaneous (topical) route.

Apply a sufficient amount of cream to completely cover the affected area, paying special attention to the folds between the toes, and rub in gently until fully absorbed. It is recommended to wash your hands after each application.

Pack with applicator

For the pack containing an integrated applicator, follow these instructions:

1. Before applying the cream, clean and thoroughly dry the feet, especially between the toes.
2. Remove the cap from the applicator.
3. To open the tube, turn the base of the applicator to the ON position.
4. Squeeze the tube until the cream comes out.
5. Apply and spread a thin layer of cream to the affected area of the foot and/or between the toes. Gently rub in using the soft part of the applicator and leave to dry.
6. To close the tube, turn the base of the applicator to the OFF position.
7. Clean the outer part of the applicator with a damp cloth, making sure no cream residue remains. Do not remove the soft part of the applicator. Do not use detergents or chemical products to clean the applicator.
8. Replace the cap on the applicator.

If you use more Canespie Bifonazole than you should

If you apply more cream than prescribed by your pharmacist, you may experience a burning sensation, redness, or swelling, which will disappear once you stop treatment.

This medicine must not be ingested. If accidentally swallowed, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Canespie Bifonazole

If you forget to use this medicine at the scheduled time, apply the cream as soon as you remember and continue with your regular treatment schedule. Do not use a double dose to make up for the missed dose.

If you interrupt treatment with Canespie Bifonazole

Do not stop treatment earlier than indicated in the leaflet, as irregular use or premature discontinuation of treatment may increase the risk of relapse.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported, whose frequency cannot be estimated from the available data (frequency not known):

Contact dermatitis (skin inflammation), allergic dermatitis, erythema (skin redness and inflammation), itching, rash, urticaria (itchy rash with hives), blisters, skin exfoliation (skin peeling), eczema, dry skin, skin irritation, skin maceration, skin burning sensation, pain at the site of administration, and peripheral edema (fluid retention) at the site of administration.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Canespie Bifonazole

Keep this medicine out of sight and reach of children.

Store in the original packaging. No special storage conditions are required.

Container with applicator (15 g):

After first opening, the cream is stable for 6 months.

Container without applicator (20 g):

After first opening, the cream is stable for 6 months. Once opened, do not store at temperatures above 25°C.

Do not use Canespie Bifonazole after the expiry date stated on the container, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Canespie Bifonazole

• The active substance is bifonazole. Each gram of cream contains 10 mg of bifonazole.
• The other components (excipients) are: benzyl alcohol, cetyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60, sorbitan stearate, and purified water.

Appearance of the product and contents of the pack

Canespie Bifonazole is a white, odorless cream.

Pack with applicator (15 g): Presented in a cardboard box containing a polyethylene/aluminum tube with 15 g of cream and an integrated applicator.

Pack without applicator (20 g): Presented in a cardboard box containing a lacquered aluminum tube with a blind mouth and a screw cap made of HDPE, containing 20 g of cream.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Kern Pharma, S.L.

Polígono Industrial Colón II

Venus, 72

08228 Terrassa (Barcelona)

Spain

GP Grenzach Produktions GmbH

Emil-Barell-Str. 7

D-79639 Grenzach-Wyhlen

Germany

Date of revision of this leaflet:

June 2019

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