Prospect: Patient Information

CanesMycospor 10 mg/g cream

Bifonazol

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

This medication belongs to a group of medications called antifungals (medications 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, hand tinea, body tinea, groin tinea, pityriasis versicolor (a condition characterized by the appearance of patches on the skin) and cutaneous candidiasis (infections that typically affect warm and moist areas of the skin).

No use CanesMycospor:

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use CanesMycospor.

• This medication is only forexternal use. Avoid contact with the eyes and mucous membranes, and in case of contact, rinse with cold water,
• do not ingest,

• if a hypersensitivity reaction or allergic reaction occurs during treatment, discontinue treatment and consult your doctor,
• do not recommend covering the affected area with bandages after applying the medication, as it promotes systemic absorption.
• Some of the excipients in this medication 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 have not been established in the pediatric population.

Use of CanesMycospor with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications or may need to take any other medication.

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

Do not recommend using, at the same time, other medications in the same areas where this medication is applied.

Pregnancy and breastfeeding

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

Pregnancy

This medication is not recommended during pregnancy or in fertile women who are not using contraceptive methods.

Breastfeeding

Caution should be exercised during breastfeeding, as bifonazol may be excreted in breast milk. In the event of administration, natural breastfeeding should be interrupted and replaced.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

CanesMycospor contains cetoestearic alcohol and benzyl alcohol

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of cetoestearic alcohol.

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

Benzyl alcohol may cause allergic reactions

Benzyl alcohol may cause moderate local irritation.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

1 application on the affected area once a day, preferably before going to bed.

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

Do not recommend occlusion with bandages, see sectionWarnings and precautions.

The duration of treatment will depend on the indication to be 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 all symptoms have disappeared.

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 medication 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use CanesMycospor

If you forgot to use this medication when it was due, apply the cream as soon as you remember and continue with your regular treatment regimen. Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with CanesMycospor

Do not stop treatment before your doctor indicates, as irregular use or premature interruption of treatment carries the risk of relapse.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been described, but their frequency cannot be estimated from the available data (unknown frequency).

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication 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 container is opened, do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of CanesMycospor

- The active principle is bifonazole. Each gram of cream contains 10 mg of bifonazole.

- The other components (excipients) are: benzyl alcohol, cetoestearic alcohol, cetyl palmitate, octyldodecanol, polisorbate 60, sorbitan monostearate, and purified water.

Appearance of the product and contents of the packaging

CanesMycospor is a white, odorless cream. It is presented in a cardboard box containing an aluminum tube with a HDPE screw cap that contains 20 g of cream.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing

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

Revision date of this leaflet: February 2022

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/