Prospect: Information for the Patient

Canespie Bifonazol 10 mg/ml Cutaneous Spray Solution

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

Follow exactly the administration instructions for the medication contained in this prospect or those indicated by your doctor or pharmacist.

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

6. Contents of the package and additional information

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 "athlete's foot" (superficial skin infection caused by fungi and located between the toes of the feet) in adults and adolescents 12 years of age and older.

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

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

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 useCanespie Bifonazol.

• 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 you develop any hypersensitivity reaction or allergic reaction during treatment, discontinue treatment and consult your doctor.

Children and adolescents

Do not administer this medication to children under 12 years old.

For adolescents 12 years and older, see belowHow to use Canespie Bifonazol.

Use ofCanespie Bifonazolwith 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.

It is not recommended to use, at the same time, other medications in the same areas where this medication is applied.

Pregnancy and lactation

If you are pregnant or breastfeeding, or 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.

Lactation

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.

Canespie Bifonazol contains alcohol (ethanol)

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

It may cause a burning sensation on injured skin.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

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

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

Administration method:

This medication is administered topically.

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, about 20 cm away from the treatment area.It is recommended to wash your hands after each application.

If you use more Canepie Bifonazol than you should

If you apply more solution than indicated by your pharmacist, 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 Canepie Bifonazol

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

If you interrupt treatment with Canespie Bifonazol

Do not discontinue treatment before the indicated duration in the leaflet, as irregular use or premature interruption of treatment may lead to 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 (inflammation and redness of the skin), pruritus, exanthema (rash), 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 of 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.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer needat thePharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Canespie Bifonazol

- The active ingredient is bifonazol. Each ml of solution contains 10 mg of bifonazol.

- The other components (excipients) are: ethanol at 96 percent and isopropyl myristate.

Appearance of the product and contents of the packaging

Canespie Bifonazol is a colourless or slightly yellow solution. It is presented in a cardboard box containing a glass bottle with a spray pump containing 30 ml of solution.

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)

Spain

Responsible for manufacturing

KVP Pharma + Veterinär Produkte GmbH

Projendsdorfer Strasse 324

24106 Kiel, Germany

Date of review of this leaflet:

October 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/