CANESPIE BIFONAZOL 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

Package Leaflet: Information for the Patient

Canespie Bifonazol 10 mg/ml Cutaneous Spray Solution

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

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

Contents of the Package Leaflet:

1. What Canespie Bifonazol is and what it is used for
2. What you need to know before starting to use Canespie Bifonazol
3. How to use Canespie Bifonazol
4. Possible side effects
5. Storage of Canespie Bifonazol

1. Package Contents and Additional Information

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

This medication belongs to the group of medications known as antifungals (medications used to treat infections caused by fungi and yeast).

It is indicated for the treatment of "athlete's foot" (superficial skin infection caused by fungi and localized between the folds of the toes) in adults and adolescents from 12 years of age.

The main symptoms of athlete's foot are: itching, redness (erythema), cracks between the toes, scaling that can lead to inflammation or pustules. It only appears on the feet. It usually starts between the toes, but can also spread to the sole and sides of the feet.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before starting to use Canespie Bifonazol

Do not use Canespie Bifonazol:

• 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 Canespie Bifonazol.

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

Children and Adolescents

Do not administer this medication to children under 12 years of age.

For adolescents from 12 years of age, see "How to use Canespie Bifonazol" below.

Using Canespie Bifonazol with other medications

Tell 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.

It is not recommended to use other medications on the same areas where this medication 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 medication.

Pregnancy

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

Breastfeeding

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

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

Canespie Bifonazol contains alcohol (ethanol)

This medication contains 300 mg of alcohol (ethanol) per ml.

It may cause a burning sensation on damaged skin.

3. How to use Canespie Bifonazol

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years of age: 1 application to the affected area 1 time a day, preferably before bedtime. The duration of treatment is 3 weeks.

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

Method of administration:

This medication is administered via the cutaneous route.

Apply 1 or 2 sprays to completely cover the affected area and rub until fully absorbed. During application, keep the spray bottle in a vertical position, at a distance of about 20 cm from the area to be treated. It is recommended to wash your hands after each application.

If you use more Canespie Bifonazol than you should

If you apply more solution than your pharmacist has indicated, you may feel a certain 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Canespie Bifonazol

If you forget to use this medication when it was due, apply the solution 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 interrupt treatment with Canespie Bifonazol

Do not stop treatment before the indicated time in the package leaflet, as irregular use or premature interruption of treatment carries the risk of relapse.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Canespie Bifonazol

Keep this medication out of sight and reach of children.

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

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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the Sigre Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Canespie Bifonazol

• The active ingredient is bifonazol. Each ml of solution contains 10 mg of bifonazol.
• The other components (excipients) are: ethanol 96 percent and isopropyl myristate.

Appearance of the Product and Package Contents

Canespie Bifonazol is a colorless or slightly yellowish solution. It is presented in a cardboard box containing a glass bottle with a spray pump that contains 30 ml of solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

KVP Pharma + Veterinär Produkte GmbH

Projensdorfer Strasse 324

24106 Kiel, Germany

Date of Revision of this Package Leaflet:

October 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/