Canespie Bifonazol 10 mg/ml cutaneous spray solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Canespie Bifonazole 10 mg/ml cutaneous spray solution

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

• Keep this leaflet, 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 adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Leaflet contents:

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

2. What you need to know before using Canespie Bifonazole

3. How to use Canespie Bifonazole

4. Possible adverse effects

5. How to store Canespie Bifonazole

6. Contents of the container and other information

1. What Canespie Bifonazole is and what it is 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 athlete's foot (a superficial fungal skin infection located between the toe folds) in adults and adolescents aged 12 years and older.

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

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

2. What you need to know before using Canespie Bifonazol.

Do not use Canespie Bifonazol:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Canespie Bifonazol.

• This medicine is for external use only. Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with cool water.
• Do not ingest.
• If any hypersensitivity reaction or allergic reaction develops during treatment, discontinue use and consult your doctor.

Children and adolescents

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

For adolescents aged 12 years and older, see section How to use Canespie Bifonazol below.

Using Canespie Bifonazol with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, or if you might need to take any other medicines.

If you are being treated with warfarin (an 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 simultaneously on the same areas where this medicine is applied.

Pregnancy and breastfeeding

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

Pregnancy

The use of this medicine 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 bifonazole may be excreted in breast milk. If administration is necessary, breastfeeding should be discontinued and replaced.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

Canespie Bifonazol contains alcohol (ethanol)

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

It may cause a burning sensation on damaged skin.

3. How to use Canespie Bifonazole

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 12 years and older: 1 application to the affected area once daily, preferably before going to bed. The treatment duration 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 medicine is administered topically.

Apply 1 or 2 sprays, covering the affected area completely, and rub in until fully absorbed. During application, hold the spray bottle in an upright position, approximately 20 cm from the area to be treated. It is recommended to wash your hands after each application.

If you use more Canespie Bifonazole than you should

If you apply more solution than prescribed by your pharmacist, you may experience a sensation of burning, redness, or swelling, which will disappear once you stop treatment.

This medicine must not be ingested. If accidentally swallowed, contact your doctor immediately.

In case of overdose or accidental ingestion, seek immediate advice from your doctor or pharmacist, go to a medical center immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Canespie Bifonazole

If you forget to use this medicine at the scheduled time, apply the solution as soon as you remember, and then continue with your usual treatment regimen. Do not use a double dose to make up for missed doses.

If you stop using Canespie Bifonazole

Do not discontinue treatment earlier than indicated in the leaflet, as irregular use or premature interruption of treatment may increase the risk of relapse.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported, for which the frequency cannot be estimated from the available data (frequency not known):

Contact dermatitis (inflammation of the skin), allergic dermatitis, erythema (inflammation and redness of the skin), itching, rash, urticaria (hives accompanied by itching), blisters, skin exfoliation (peeling of the skin), eczema, dry skin, skin irritation, skin maceration, burning sensation in the skin, pain at the application site, and peripheral edema (fluid retention) at the application site.

Reporting of 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 leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Canespie Bifonazole

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

This medicine does not require any special storage temperature. Store in the original packaging to protect it from light. The solution is flammable due to its ethanol content. Keep away from sources of ignition.

After opening, this medicine is stable for 28 days and should be stored below 25°C. This medicine should be discarded at the end of treatment.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Canespie Bifonazole

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

Appearance of the medicinal product and contents of the pack

Canespie Bifonazole is a colorless or slightly yellow solution. It is presented in a cardboard box containing a glass bottle with a spray pump, holding 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

Projendsdorfer Strasse 324

24106 Kiel, Germany

Date of revision of this leaflet:

October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/