CANESTEN 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Canesten 10 mg/ml cutaneous spray solution

Clotrimazole

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4)

Contents of the package leaflet:

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

1. Package contents and additional information

1. What is Canesten and what is it used for

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

This medication is indicated for the treatment of superficial skin infections: athlete's foot (tinea pedis), tinea of the hands, tinea of the body, tinea inguinal (jock itch), and pityriasis versicolor (tinea versicolor).

2. What you need to know before using Canesten

Do not use Canesten

• If you are allergic (hypersensitive) to clotrimazole, imidazoles in general, or 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 Canesten.

For external use only. Avoid contact with mucous membranes and eyes, as it may cause irritation. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary. Do not ingest.

In case of a hypersensitivity reaction during use, treatment should be discontinued and medical attention should be sought immediately.

Using Canesten with other medications

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan 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 clotrimazole during pregnancy; however, the doctor will evaluate the benefits of using the medication before administration.

Breastfeeding

Clotrimazole can be used during breastfeeding. If used topically on the nipple area, wash the area well before feeding the baby.

Driving and using machines

The influence of Canesten on the ability to drive and use machines is negligible or nonexistent.

Canesten contains propylene glycol

This medication contains 546 mg of propylene glycol per ml.

Propylene glycol may cause skin irritation.

This medication contains propylene glycol; do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

3. How to use Canesten

Follow the administration instructions for this medication exactly as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is:

Apply a thin layer of solution to the affected area and its surroundings, 2-3 times a day. A few drops are sufficient to treat an area approximately the size of the hand.

The duration of treatment depends on the location and extent of the process. In general, it is recommended:

Dermatophyte infections 3 to 4 weeks

Pityriasis versicolor 1 to 3 weeks

If you use more Canesten than you should

Accidental ingestion may cause gastrointestinal discomfort and/or vomiting. Accidental administration in the eyes may cause burning and mild eye irritation.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to use Canesten

In case of a missed dose, wait for the next one. Do not apply a double dose to make up for the missed dose.

If you interrupt treatment with Canesten

If you interrupt treatment, the fungus may not have disappeared. If you have any other questions about using this medication, ask your doctor.

4. Possible side effects

Like all medications, Canesten can cause side effects, although not everyone experiences them.

Adverse reactions with unknown 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 (redness of the skin after direct contact with a substance), erythema, tingling sensation, pruritus, urticaria (elevated red patches that cause itching), burning/picking sensation of the skin, exfoliation (peeling of the skin), and skin rash.

General disorders and administration site conditions:

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

These symptoms usually do not determine the suppression of treatment and are more frequent during the first days of treatment.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Canesten

This medication does not require special storage conditions.

Keep out of sight and reach of children.

Do not use Canesten after the expiration date stated on the packaging, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the Sigre collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Canesten

• The active ingredient is clotrimazole. Each ml of solution contains 10 mg of clotrimazole.

• The other components (excipients) are: isopropyl alcohol, macrogol 400, propylene glycol.

Appearance of the product and package contents:

This medication is a colorless or slightly yellowish solution. It is presented in a spray container containing 30 ml of solution.

Marketing authorization holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

KVP Pharma + Veterinär Produkte GmbH

Projensdorfer Strasse 324

24106 Kiel, Germany

Date of the last revision of this package leaflet: February 2021

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