PATIENT INFORMATION LEAFLET

Clotrimazol Canesmed 10 mg/g Cream

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 disease 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.

6.Contents of the pack and additional information

Clotrimazol 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), pityriasis versicolor (tinea versicolor), candidal balanitis (inflammation of the glans), and vulvovaginal candidiasis (characterized by itching, usually accompanied by increased vaginal discharge, vaginal mucosa inflammation, vulvar area inflammation, burning, and sensation of burning while urinating).

No use Clotrimazol Canesmed

• If you are allergic (hypersensitive) to clotrimazole, 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 Clotrimazol Canesmed.

Avoid contact with the eyes, as it would cause irritation. If accidental contact with the eyes occurs, wash 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.

It is recommended to use additional contraceptive methods in addition to the condom and diaphragm during treatment, as this medication may affect latex. This effect on latex is temporary and only occurs during treatment.

Your doctor will evaluate the most suitable treatment based on the infection, if you have certain diseases, such as having a depressed immune system or diabetes.

Use of Clotrimazol Canesmed 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, or 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 clotrimazole during pregnancy, however, the doctor will evaluate the benefit of using the medication before it is administered.

Breastfeeding

Clotrimazole 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 Clotrimazol Canesmed on the ability to drive and operate machines is negligible or insignificant.

Clotrimazol Canesmed contains cetoestearic alcohol and benzyl alcohol

This medication may produce local skin reactions (such as contact dermatitis) because it contains cetoestearic alcohol.

This medication contains 20 mg of benzyl alcohol in each gram of cream.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

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.

Clean and dry the affected areas thoroughly before applying the medication.

The recommended dose is:

Apply a thin layer of cream to the affected area and surrounding areas, massaging it in lightly until fully absorbed, 2-3 times a day. A strip of cream, approximately 2 cm long, is sufficient to treat an area the size of a hand (back and palm). As a guideline, 2 cm is equivalent to the length of the last phalanx of the index finger.

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

Fungal infections 3 to 4 weeks

Pityriasis versicolor 1 to 3 weeks

Vaginal candidiasis or balanitis candidiásica 1 to 2 weeks

In the case of vaginal candidiasis, apply this medication to the labia or adjacent areas.

There are other presentations available on the market for the treatment of vulvovaginitis, vaginal tablets and vaginal cream with applicator, depending on the location of the infection. Follow your doctor's recommendations.

If you use more Clotrimazol Canesmed than you should

An accidental ingestion may cause gastrointestinal discomfort and/or vomiting. An accidental administration in 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. Telephone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to use Clotrimazol Canesmed

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 Clotrimazol Canesmed

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

Like all medications, Clotrimazol Canesmed may produce adverse effects, although not everyone 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:

Application site irritation, reaction at the application site, 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 about the safety of this medication.

This medication does not require special conditions for conservation.

Keep out of the sight and reach of children.

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

This medication should be used within 3 months after opening.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Clotrimazol Canesmed

• The active ingredient is clotrimazol. Each gram of cream contains 10 mg of clotrimazol.
• The other components (excipients) are: sorbitan stearate, polisorbate 60, cetyl palmitate, cetoestearic alcohol, octyldodecanol, benzyl alcohol, purified water.

Appearance of the product and contents of the packaging:

This medication is a white cream. It is presented in aluminum tubes with a screw cap containing30 gramsof cream.

Holder of the marketing authorization

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

GP Grenzach Produktions GmbH

Emil-Barell-Str.7

79639 Grenzach-Wyhlen

Germany

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/