CANESPIE CLOTRIMAZOLE 10 MG/G CREAM

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANESPIE CLOTRIMAZOLE 10 mg/g cream

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

Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 10 days.

In this leaflet:

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

2. What you need to know before using Canespie Clotrimazole

3. How to use Canespie Clotrimazole

4. Possible adverse effects

5. How to store Canespie Clotrimazole

6. Contents of the pack and other information

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

Clotrimazole is an antifungal (a medicine used to treat infections caused by fungi).

It is indicated for the treatment of athlete's foot, which is a superficial fungal infection of the skin occurring between the toe folds.

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 begins between the toes, but may also spread to the soles and sides of the feet.

You should consult your doctor if your condition worsens or does not improve after 10 days of treatment.

2. What you need to know before using Canespie Clotrimazole

Do not use Canespie Clotrimazole

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

Warnings and precautions

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

• Do not apply occlusive (non-breathable) dressings over the affected area.

• Consult your doctor if irritation develops at the treated site and discontinue treatment.

• Do not ingest.

• This medicine should be applied only on the skin and exclusively for the treatment of athlete's foot.

• You should stop treatment if symptoms do not improve after 10 days of treatment.

• Avoid contact with eyes and mucous membranes. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.

• It is advisable to wear well-ventilated shoes, avoid shoes and rubber soles, avoid synthetic fiber socks, and change socks with each application.

• Appropriate hygiene measures should be followed to prevent transmission: do not share towels, socks, or footwear, and avoid walking barefoot in swimming pools, locker rooms, and communal bathrooms.

Children and adolescents

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

Use of Canespie Clotrimazole with other medicines

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

Pregnancy and breastfeeding

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

Pregnancy

No risks to mother or child are expected following topical use of clotrimazole during pregnancy; however, the doctor will assess the benefit of using the medicine before administration.

Breastfeeding

Clotrimazole may be used during breastfeeding.

Driving and using machines

The influence of Canespie Clotrimazole on the ability to drive and operate machinery is none or negligible.

Canespie Clotrimazole contains cetyl alcohol and benzyl alcohol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl 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 use of this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For topical use only.

Recommended dosage:

Apply to the affected area of the feet 2–3 times daily. Treatment should last for 3 to 4 weeks.

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

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

To prevent relapse of these infections, it is recommended to continue treatment for an additional 2 weeks after all symptoms have disappeared.

Recommendations for cream application:

For proper application, follow these steps:

1. Before applying the product, wash the feet with water and soap to remove skin scales and any residue from the previous 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 surrounding skin until fully absorbed, particularly between the toe folds.
3. Close the tube tightly after use.
4. Wash your hands after each application.

It is advisable to wear well-ventilated shoes, avoid rubber shoes and soles, avoid fiber socks, and change socks with each application to prevent reinfection. To avoid transmission, do not share towels, socks, or footwear with others, and avoid walking barefoot in pools, locker rooms, and public bathrooms. It is recommended to wash your hands after each application.

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

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

Use in children and adolescents

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

If you use more Canespie Clotrimazole than you should

If you have applied too much, remove the excess by washing the affected area with lukewarm water or simply wiping off part of the cream.

Due to the concentration of the active substance and the route of administration, intoxication is not possible, even in case of accidental ingestion.

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

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

If you forget to use Canespie Clotrimazole

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

4. Possible adverse effects

Like all medicines, Canespie Clotrimazole may cause adverse effects, although not everyone experiences 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 itchy rash), exfoliation (peeling of the skin), 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 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 Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse 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 stated on the packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over at a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Canespie Clotrimazole

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

Appearance of the medicine and contents of the pack

This medicine is a white cream. It is supplied in aluminum tubes with screw caps containing 30 grams of cream, packed 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 the most recent review of this leaflet: July 2021

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