CANESMYCOSPOR 10 mg/g CREAM

Introduction

Patient Information Leaflet

CanesMycospor 10 mg/g cream

Bifonazole

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is CanesMycospor and what is it used for
2. What you need to know before using CanesMycospor
3. How to use CanesMycospor
4. Possible side effects
5. Storage of CanesMycospor
6. Package contents and additional information

1. What is CanesMycospor and what is it 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 the following superficial skin infections in adults: athlete's foot or tinea pedis, tinea manuum, tinea corporis, tinea cruris, pityriasis versicolor (a disease characterized by the appearance of scattered patches on the skin) and cutaneous candidiasis (infections that normally affect humid and warm areas of the skin).

2. What you need to know before using CanesMycospor

Do not use CanesMycospor:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use CanesMycospor.

• This medicine is for external use only. Avoid contact with the eyes and mucous membranes, and if it occurs, rinse with cold water,
• do not ingest,

• it is not recommended to cover the affected area with bandages after applying the medicine, as it promotes systemic absorption.
• Some of the excipients in this medicine may reduce the effectiveness of latex products, such as condoms and diaphragms, when applied to the genital area. The effect is temporary and only occurs during treatment.

Children

The safety and efficacy in the pediatric population have not been established.

Using CanesMycospor with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines or may need to take any other medicine.

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

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

Pregnancy and breastfeeding

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

Pregnancy

This medicine should not be used during pregnancy or in women of childbearing age who are not using contraceptive methods.

Breastfeeding

Cautious use is recommended during breastfeeding, as bifonazole may be excreted in breast milk. If administered, breastfeeding should be interrupted and substituted.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or nonexistent.

CanesMycospor contains cetyl stearyl alcohol and benzyl alcohol

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

This medicine contains 20 mg of benzyl alcohol per gram of cream.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to use CanesMycospor

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

1 application to the affected area once a day, preferably before bedtime.

Apply and spread a small amount of cream to completely cover the affected area and rub in until fully absorbed. It is recommended to wash your hands after each application.

It is not recommended to cover the affected area with bandages, see section Warnings and precautions.

The duration of treatment will depend on the indication being treated:

If symptoms do not improve after 4 weeks of treatment, you should consult your doctor. Treatment should be continued for at least a few days after the disappearance of all symptoms.

If you use more CanesMycospor than you should

If you apply more cream than your doctor has indicated, you may feel a burning sensation, redness, or swelling that will disappear after stopping treatment.

This medicine should not be ingested. If ingested accidentally, contact your doctor.

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

If you forget to use CanesMycospor

If you forget to use this medicine when you should, apply the cream as soon as you remember and continue with your usual treatment regimen. Do not use a double dose to make up for forgotten doses.

If you stop using CanesMycospor

Do not stop treatment before your doctor indicates, as irregular use or premature discontinuation of treatment may lead to relapse.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

Contact dermatitis, allergic dermatitis, erythema, pruritus, exanthema, urticaria, blisters, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, burning sensation in the skin, pain at the application site, and peripheral edema at the application site.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of CanesMycospor

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

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

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

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the Sigre collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of CanesMycospor

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

Appearance of the product and package contents

CanesMycospor is a white, odorless cream. It comes in a cardboard box containing an aluminum tube with a HDPE screw cap that contains 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)

Manufacturer

Kern Pharma, S.L.

Polígono Industrial Colón II

Venus, 72

08228 Terrassa (Barcelona)

Spain

or

GP Grenzach Produktions GmbH

Emil-Barell-Str. 7

D-79639 Grenzach-Wyhlen

Germany

Date of revision of this leaflet: February 2022

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/