PATIENT INFORMATION LEAFLET

CANESPIE CLOTRIMAZOL 10 mg/g cream

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 10 days.

In this leaflet:

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

6. Contents of the pack and additional information

Clotrimazol is an antifungal (medication used to treat infections caused by fungi).

It is indicated for the treatment of "athlete's foot," which is a superficial skin infection caused by fungi and located between the toes of the foot.

The main symptoms of athlete's foot are: itching, redness (erythema), cracks between the toes, peeling, and 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 10 days of treatment.

No use Canespie Clotrimazol

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Canespie Clotrimazol.

• Do not apply non-breathable dressings over the affected area.
• Consult your doctor if irritation appears on the treated area and discontinue treatment.
• Do not ingest.

• Apply the medication only on the skin and exclusively for the treatment of athlete's foot.
• Discontinue treatment if symptoms do not improve after 10 days of treatment.
• Avoid contact with the eyes and mucous membranes. If accidental contact with the eyes occurs, rinse with abundant water and consult an ophthalmologist if necessary.
• It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid cotton socks, and change socks after each application.
• Appropriate hygiene measures should be followed to prevent contagion, do not share towels, socks, footwear, or walk barefoot in pools, locker rooms, and collective bathrooms.

Children and adolescents

Use in children under 12 years old under medical supervision.

Use of Canespie Clotrimazol with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

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

Pregnancy

No risks are expected for the mother and child after topical use of clotrimazol during pregnancy, however, the doctor will evaluate the benefit of using the medication before administering it.

Breastfeeding

Clotrimazol can be used during breastfeeding.

Driving and operating machines

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

Canespie Clotrimazol contains cetoestearic alcohol and benzyl alcohol

This medication may produce local skin reactions (such as contact dermatitis) because it contains 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 contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.contenidas en este prospecto o lasindicadas por su médico o farmacéutico. En caso de duda, consulte de nuevo a su médico o farmacéutico.

Skin use.

The recommended dose is:

One application on the affected area of the feet 2-3 times a day. The treatment should last 3 to 4 weeks.

Apply and spread a small amount of the product to cover the affected area and the surrounding area completely, paying special attention between the toes of the feet. Rub until complete absorption.

A strip of cream, approximately 2 cm long, is sufficient to treat an area the size of a hand (back and palm). As a guide, 2 cm is equivalent to the length of the last phalanx of the index finger.

To prevent relapses in these infections, it is recommended to continue treatment for 2 weeks after all symptoms have disappeared.

Recommendations for the use of the cream:

To apply correctly, follow the steps indicated:

1. Before applying the product, wash the feet with water and soap to remove scaly skin and any remaining residue from the last treatment. After washing, they must be thoroughly dried, especially between the toes.
2. Apply a small amount of the product and spread it to cover the affected area and the surrounding area completely until complete absorption, especially between the toes of the feet.
3. Close the tube well after use.
4. Wash your hands after each application.

It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid fiber socks, and change socks after each application due to the possibility of re-infection. To avoid contagion, do not share towels, socks, or shoes with other people, and do not walk barefoot in pools, locker rooms, and public baths.It is recommended to wash your hands after each application.

If, after 10 days of use, you do not observe an improvement in your symptoms, consult your doctor.

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

Skin use in children and adolescents

Use in children under 12 years old under medical supervision. No dose adjustment is required.

If you use more Canespie Clotrimazol than you should

If you have applied too much, you can remove it by washing the affected area with warm water or simply removing a part.

Given the concentration of the active principle and the application route, it is not possible to have an overdose or in the case of accidental ingestion.

In case of overdose or accidental ingestion, go immediately to your doctor or pharmacist 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. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

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

If you forgot to use Canespie Clotrimazol

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 apply a double dose to compensate for the missed doses.

Like all medications,Canespie Clotrimazolmay cause adverse effects, although not everyone will experience them.

Adverse reactions withunknown frequency (cannot be estimated from available data)are:

Immune System Disorders:

Angioedema (swelling under the skin), allergic reaction, hypersensitivity.

Vascular Disorders:

Syncope (sudden loss of consciousness, fainting), hypotension (low blood pressure).

Respiratory, Thoracic, and Mediastinal Disorders:

Difficulty breathing.

Skin and Subcutaneous Tissue Disorders

Blisters, contact dermatitis (skin redness after direct contact with a substance), erythema, tingling sensation, urticaria (raised, red, itchy patches), exfoliation (skin peeling), skin rash, pruritus, skin burning/itching sensation.

General and Localized Disorders:

Application site irritation, application site reaction, edema, pain.

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: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medicationout of the sight and reach of children.

No special storage conditions are required.

This medication should be used within 3 months of opening.

Do not use Canespie Clotrimazol after the expiration date that appears on the packaging, after the abbreviation 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 packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Canespie Clotrimazol

• The active ingredient is clotrimazol. Each gram of cream contains 10 mg of clotrimazol.
• The other components (excipients) are: sorbitan stearate, polisorbate 60, cetyl palmitate, cetoestearic alcohol, octyldodecanol, benzyl alcohol, purified water.

Appearance of the product and content of the packaging

This medication is a white cream. It is presented in aluminum tubes with a screw cap containing 30 grams of cream packaged in a cardboard box.

Holder of the marketing authorization

Bayer Hispania, S.L

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

GP Grenzach Produktions GmbH

Emil-Barell-Str. 7

79639 Grenzach-Wyhlen

Germany

Last review date of this leaflet: July 2021

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 /