PATIENT INFORMATION LEAFLET

Canestén 10 mg/g topical powder

Clotrimazol

Read this 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet (See section 4).

1.What is Canestén and what it is used for

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

3.How to use Canestén.

4.Possible side effects

5.Storage of Canestén

6. Contents of the pack and additional information

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

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

Do not use Canestén

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

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 abundant water and consult an ophthalmologist if necessary. Do not ingest.

In case of an allergic reaction during its use, treatment should be suspended and you should immediately consult your doctor.

Use of Canestén with other medications

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

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

Driving and operating machines

The influence of Canestén on the ability to drive and operate machines is negligible or insignificant.

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

The recommended dose is:

Apply the powder to the affected area and surrounding areas 2-3 times a day.

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

Dermatophyte infections3 to 4 weeks

Pityriasis versicolor1 to 3 weeks

If you use more Canestén than you should

An accidental ingestion may cause gastrointestinal discomfort and/or vomiting. An accidental application to the eyes may cause burning and minor eye irritation.

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

If you forgot to use Canestén

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

If you interrupt the treatment with Canestén

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

Like all medications, Canestén can produce adverse effects, although not all people will experience them.

Adverse reactions withunknown 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, sensation of tingling, pruritus,urticaria (raised, red itchy patches),sensation of burning/itching of the skin, exfoliation (skin peeling)and skin rash.

General and Localized Disorders:

Site irritation, site reaction, edema, pain.

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

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special storage conditions.

Keep out of the sight and reach of children.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Canestén

• The active ingredient is clotrimazol. Each gram of powder contains 10 mg of clotrimazol.
• The other components (excipients) are: Rice starch.

Appearance of the product and contents of the packaging

This medication is a fine white powder.It is presented in a shaker container containing 30 grams of topical powder.

Holder of the marketing authorization

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

KVP Pharma + Veterinär Produkte GmbH,

Projensdorfer Straße 324,

24106 Kiel,

Germany

or

Sigmar Italia S.p.A

Vía Sombreno, 11

24011 Almè (BG)

Italy

Last review date of this leaflet: July 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/