CANESPIE CLOTRIMAZOL 10 mg/g CREAM

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANESPIE CLOTRIMAZOLE 10 mg/g cream

Read all of this 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, pharmacist, or nurse.

• Keep this leaflet, 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, 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 is Canespie Clotrimazole and what is it used for
2. What you need to know before you start using Canespie Clotrimazole
3. How to use Canespie Clotrimazole
4. Possible side effects
5. Storage of Canespie Clotrimazole

1. Contents of the pack and further information

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

Clotrimazole is an antifungal (a medicine used to treat fungal infections).

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

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 10 days of treatment.

2. What you need to know before you start using Canespie Clotrimazole

Do not use Canespie Clotrimazole

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

Warnings and precautions

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

• Do not apply non-breathable bandages over the affected area.
• Consult your doctor if irritation occurs in the treated area and discontinue treatment.
• Do not ingest

• You should apply the medicine only to the skin and exclusively for the treatment of athlete's foot.
• You should 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 plenty of water and consult an ophthalmologist if necessary.
• It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid fiber socks, and change socks with each application.
• Adequate hygiene measures should be taken to avoid contagion, do not share towels, socks, or footwear, and do not walk barefoot in swimming pools, dressing rooms, and collective bathrooms.

Children and adolescents

Use in children under 12 years of age under medical supervision.

Using Canespie Clotrimazole with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

No risks are expected for the mother and child after topical use of clotrimazole during pregnancy; however, the doctor will evaluate the benefit of using the medicine before it is administered.

Breastfeeding

Clotrimazole can be used during breastfeeding.

Driving and using machines

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

Canespie Clotrimazole contains cetyl stearyl alcohol and benzyl alcohol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl stearyl alcohol.

This medicine contains 20 mg of benzyl alcohol in each gram of cream.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to use Canespie Clotrimazole

Follow exactly the instructions for administration of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Topical use.

The recommended dose is:

One application to the affected area of the feet 2-3 times a day. Treatment should last for 3 to 4 weeks.

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

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

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

Recommendations for using the cream:

For correct application, follow the indicated steps:

1. Before applying the product, wash your feet with water and soap to remove skin scales and any remaining treatment. After washing, dry thoroughly, especially the interdigital spaces.
2. Apply a small amount of the product and spread it to completely cover the affected area and the area around the infection until completely absorbed, especially between the folds of the toes.
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 with each application due to the possibility of reinfection. To avoid contagion, do not share towels, socks, or footwear with others, and do not walk barefoot in swimming pools, dressing rooms, and collective bathrooms. 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 doubts about the use of this product, ask your doctor or pharmacist.

Use in children and adolescents

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

If you use more Canespie Clotrimazole than you should

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

Given the concentration of the active ingredient and the route of administration, it is not possible to overdose, even 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

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

If you forget to use Canespie Clotrimazole

If you forget to use this medicine when you should, apply the cream as soon as you remember and continue with your usual treatment regimen. Do not apply a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, Canespie Clotrimazole can cause side effects, although not everybody gets them.

Adverse reactions with unknown frequency (cannot be estimated from the 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 (redness of the skin after direct contact with a substance), erythema, tingling sensation, urticaria (raised red patches that itch), exfoliation (scaling of the skin) and skin rash, pruritus, sensation of itching/burning of the skin.

General disorders and administration site conditions:

Irritation at the application site, reaction at the application site, edema, pain.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Canespie Clotrimazole

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

No special storage conditions are required.

This medicine should be used within 3 months of opening.

Do not use Canespie Clotrimazole after the expiry date which is stated on the packaging, after the abbreviation EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Canespie Clotrimazole

• The active ingredient is clotrimazole. Each gram of cream contains 10 mg of clotrimazole.
• The other ingredients (excipients) are: sorbitan stearate, polysorbate 60, cetyl palmitate, cetyl stearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

Appearance of the product and pack contents

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

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

GP Grenzach Produktions GmbH

Emil-Barell-Str. 7

79639 Grenzach-Wyhlen

Germany

Date of last revision of this leaflet: July 2021

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