Canesten 10 mg/ml cutaneous spray solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Canestén 10 mg/ml cutaneous spray solution

Clotrimazole

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

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

Leaflet contents:

1. What Canestén is and what it is used for

2. What you need to know before using Canestén

3. How to use Canestén

4. Possible side effects

5. How to store Canestén

6. Contents of the pack and other information

1. What Canestén is and what it is used for

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

This medicine is indicated for the treatment of superficial skin infections: athlete's foot (tinea pedis), tinea of the hands, tinea corporis (ringworm), tinea cruris (jock itch), and pityriasis versicolor (tinea versicolor).

2. What you need to know before starting to use Canestén

Do not use Canestén

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

For external use only. Contact with mucous membranes and eyes should be avoided, as it may cause stinging. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary. Do not ingest.

If a hypersensitivity reaction occurs during use, treatment must be discontinued and you should seek immediate medical advice.

Use of Canestén with other medicines

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Breastfeeding

Clotrimazole may be used during breastfeeding. If applied topically to the nipple area, wash the area thoroughly before feeding the infant.

Driving and using machines

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

Canestén contains propylene glycol

This medicine contains 546 mg of propylene glycol per ml.

Propylene glycol may cause skin irritation.

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

3. How to use Canesten

Follow exactly the instructions for use of this medicine given 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 the solution to the affected area and surrounding skin, 2–3 times daily. 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 infection. 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 application into the eyes may cause mild burning and eye irritation.

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

If you forget to use Canesten

If you miss a dose, wait until the next scheduled dose. Do not apply a double dose to make up for the missed dose.

If you stop using Canesten

If you stop treatment, the fungi may not have been completely eradicated. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, Canestén may produce adverse effects, although not everyone will experience 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 (skin redness after direct contact with a substance), erythema, tingling sensation, pruritus, urticaria (raised, red, itchy rashes), burning/itching sensation of the skin, exfoliation (skin peeling), and skin rash.

General and application site conditions:

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

These symptoms usually do not require discontinuation of treatment and are more common during the first days of treatment.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Canesten

This medicine does not require any special storage conditions.

Keep out of the sight and reach of children.

Do not use Canesten after the expiry date stated on the packaging, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Canesten

• The active substance 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 medicine and contents of the pack

This medicine is a colourless or slightly yellowish solution. It is supplied in a spray container containing 30 ml of solution.

Marketing Authorisation 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 most recent review of this leaflet: February 2021

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