CANESTEN 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Canesten 10 mg/g Cream

Clotrimazole

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this 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 you start using Canesten
3. How to use Canesten
4. Possible side effects
5. Storage of Canesten
6. Contents of the pack and other information

1. What is Canesten and what is it 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 of the body, tinea cruris (jock itch), pityriasis versicolor (tinea versicolor), candidal balanitis (inflammation of the glans) and vulvovaginal candidiasis (thrush with itching usually accompanied by an increase in vaginal discharge, inflammation of the vaginal mucosa and vulvar area, burning and sensation of burning when urinating).

2. What you need to know before you start 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.

Avoid contact with the 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.

The use of additional contraceptive methods to condoms and diaphragms is recommended during treatment, as this medicine may affect latex. This effect on latex is temporary and only occurs during treatment.

Your doctor will assess the most appropriate treatment based on the infection, if you have certain diseases, such as a weakened immune system or diabetes.

Using Canesten with other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or 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 evaluate the benefit 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.

Canesten contains cetyl stearyl alcohol and benzyl alcohol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl stearyl alcohol.

This medicine contains 20 mg of benzyl alcohol in each gram.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to use Canesten

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist or nurse. If you are unsure, consult your doctor, pharmacist, or nurse again.

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

The recommended dose is:

Apply a thin layer of cream to the affected area and surrounding areas, massaging gently 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 the hand (back and palm). As a guide, 2 cm is equivalent to the length of the last phalange of the index finger.

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

Vaginal candidiasis or candidal balanitis 1 to 2 weeks

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

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

If you use more Canesten than you should

Accidental ingestion may cause gastrointestinal upset and/or vomiting. Accidental administration in the eyes may cause burning and eye irritation without gravity.

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 fungi may not have disappeared. If you have any other 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 (elevated red patches that cause itching), burning/pinging sensation of the skin, exfoliation (peeling of the skin), and 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 it is a side effect not listed in this leaflet.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) 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 special storage conditions.

Keep out of the sight and reach of children.

Do not use Canesten after the expiry date which is stated on the packaging after the abbreviation EXP. The expiry date is the last day of the month indicated.

This medicine must be used within 3 months after opening.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Canesten

• The active substance is clotrimazole. Each gram of cream contains 10 mg of clotrimazole.
• The other ingredients (excipients) are: sorbitan stearate, polysorbate 60, cetyl palmitate, cetyl stearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

Appearance and packaging of the product:

This medicine is a white cream. It is available in aluminum tubes with a screw cap containing 30 grams of cream.

Marketing authorization holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

GP Grenzach Produktions GmbH

Emil-Barell-Str. 7

79639 Grenzach-Wyhlen

Germany

Date of last revision of this leaflet: July 2021

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