CANESTEN 10 mg/g CUTANEOUS POWDER

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Canesten 10 mg/g cutaneous powder

Clotrimazole

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible 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
6. Contents of the pack and further information

1. What is Canesten and what is it used for

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

This medicine 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 ingredients of this medicine (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 sought immediately.

Using Canesten with other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 assess the benefits of using the medicine before it is administered.

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

Canesten has no or negligible influence on the ability to drive and use machines.

3. How to use Canesten

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

The recommended dose is:

Sprinkle the powder over the affected area and surrounding areas 2-3 times a day.

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

Fungal 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. Telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Canesten

If you forget a dose, wait for the next one. Do not apply a double dose to make up for the forgotten dose.

If you stop using Canesten

If you stop treatment, the fungus may not have disappeared. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

Adverse reactions with frequency not known (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, pruritus, urticaria (raised red itchy patches), burning/stinging 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, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this package 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 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, after the abbreviation CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Canesten

• The active substance is clotrimazole. Each gram of powder contains 10 mg of clotrimazole.
• The other ingredients (excipients) are: Rice starch.

Appearance and packaging of the product

This medicine is a fine white powder. It is presented in a spray container containing 30 grams of cutaneous powder.

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

or

Sigmar Italia S.p.A

Vía Sombreno, 11

24011 Almè (BG)

Italy

Date of last revision of this package leaflet: July 2021

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