Prospect: Information for the Patient

Canespie Bifonazol 10 mg/g Cream

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

Follow exactly the administration instructions of 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.
• If you 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.

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" (a 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, scaling, 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 to 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 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,
• do not recommend covering the affected area with bandages after applying the medication, as it favors systemic absorption.

Children and Adolescents

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

For adolescents 12 years old and above, see the sectionHow to use Canespie Bifonazol.

Use of Canespie Bifonazol with other medications

Inform your doctor or pharmacist if you are using or have used recently 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 modified 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, or think you may be 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

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 machines

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

Canespie Bifonazol 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 2 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions and moderate local irritation.

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 form:

This medication is administered viatopical application.

Apply a sufficient amount of cream to completely cover the affected area, paying special attention to the areas between the toes, and massage until complete absorption.It is recommended to wash your hands after each application.

Container with applicator

For the container with the built-in applicator, follow the following instructions:

1. Clean and dry your feet well, especially between the toes, before applying the cream.
2. Remove the cap from the applicator.
3. To open the tube, turn the base of the applicator in the ON direction.
4. Press 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 massage with the help of the soft part of the applicator and let it dry.
6. To close the tube, turn the base of the applicator in the OFF direction.
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 chemicals to clean the applicator.
8. Replace the cap on the applicator.

If you use more Canespie Bifonazol than you should

If you apply more cream than your pharmacist 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 forget to use Canespie Bifonazol

If you forget to use this medication when 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 treatment with Canespie Bifonazol

Do not stop treatment before the indicated time in the leaflet, as irregular use or premature interruption of treatment may lead to relapse.

If you have any other doubts 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 peeling), eczema, dry skin, skin irritation, skin maceration, sensation of burning on the skin, pain at the site of administration, and peripheral edema (fluid retention) at the site of administration.

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.

Container with applicator (15 g):

After the first opening,the cream is stable for6months.

Container without applicator (20g):

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 Canespie Bifonazol after the expiration date that appears on the container, 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 containers and medicines you no longer need at the Punto Sigreof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Canespie Bifonazol

- The active ingredient is bifonazol. Each gram of cream contains 10 mg of bifonazol.

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

Appearance of the product and contents of the packaging

Canespie Bifonazol is a white and odorless cream.

Container with applicator (15 g):It is presented in a cardboard box containing a polyethylene/aluminum tube containing 15 g of cream with an integrated applicator.

Container without applicator (20 g): It is presented in a cardboard box containing an aluminum tube with a closed mouth and a HDPE screw cap containing 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)

Spain

Responsible for manufacturing

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

Revision date of this leaflet:

June 2019

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/