Canesten Control

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Canesten Control, 10 mg/g, cream

Clotrimazole

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, tell your doctor or pharmacist. This also includes any possible side effects not listed in the leaflet. See section 4.
• If the condition does not improve or worsens after the recommended treatment period, consult a doctor. See section 3.

Table of contents of the leaflet

• 1. What is Canesten Control and what is it used for
• 2. Important information before using Canesten Control
• 3. How to use Canesten Control
• 4. Possible side effects
• 5. How to store Canesten Control
• 6. Contents of the pack and other information

1. What is Canesten Control and what is it used for

Canesten Control contains the active substance clotrimazole. Clotrimazole belongs to a group of medicines called imidazole derivatives, which combat the cause of fungal skin infections. Canesten Control is used in adults, adolescents, and children for the treatment of:

• fungal skin infections, including athlete's foot, dermatophytosis, diaper rash, and candidal intertrigo
• fungal inflammation of the external genitalia in women or the glans penis in men.

If you are unsure whether you (or your child, in the case of diaper rash) have one of the above-mentioned skin infections, consult a doctor or pharmacist.

2. Important information before using Canesten Control

When not to use Canesten Control

• If you (or your child, in the case of diaper rash) are allergic to clotrimazole or any of the other ingredients of the medicine (listed in section 6).

Warnings and precautions

Before starting to use Canesten Control, discuss it with your doctor or pharmacist.

• Canesten Control may reduce the effectiveness and safety of latex products (condoms, diaphragms) if used in the genital area (vulva and around the vulva in women; glans penis in men). This effect is temporary and only occurs during treatment. Therefore, during treatment, an alternative method of contraception and protection against sexually transmitted diseases should be used.
• Avoid contact with the eyes.
• Do not insert the cream into the mouth or swallow it.
• There may be cross-sensitivity to clotrimazole with similar antifungal medicines, such as itraconazole, fluconazole, ketoconazole, and miconazole.
• Patients taking immunosuppressive medicines, undergoing chemotherapy, suffering from diabetes, or infected with HIV should consult a doctor before using Canesten Control.

Children, adolescents, and the elderly

The medicine can be used in children (under 12 years) and the elderly only under medical supervision. Long-term treatment of large areas of skin should be avoided, especially in infants and children. In the case of vulvar inflammation, patients under 16 years of age should consult a doctor before using Canesten Control.

Canesten Control and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use. Canesten Control may reduce the effectiveness of topical polyene antibiotics (nystatin, natamycin). The effect of clotrimazole may be weakened by the local use of glucocorticosteroids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medicine.

• Pregnancy Before using Canesten Control during the first 3 months of pregnancy, consult a doctor.
• Breastfeeding Canesten Control can be used during breastfeeding. When applied to the nipple area, wash and rinse the breast before feeding the child.

Driving and using machines

No effects of Canesten Control on the ability to drive or use machines have been observed.

Canesten Control contains cetostearyl alcohol and benzyl alcohol

• Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
• The medicine contains 2 g of benzyl alcohol per 100 g. Benzyl alcohol may cause allergic reactions or mild local skin irritation.

3. How to use Canesten Control

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.

• Before using the medicine, pierce the membrane of the tube with the reverse side of the cap.
• If the infection affects the feet, wash and dry them thoroughly, especially between the toes, before applying the cream.
• Apply a thin layer of cream evenly to the affected areas of skin 2-3 times a day.
• A 0.5 cm strip of cream is enough to cover an area of skin the size of the palm of your hand.

Duration of treatment

The duration of treatment depends on the type of infection. To ensure complete recovery, Canesten Control should be used for the period specified in the table below, even if symptoms disappear.

Symptoms of skin infection (itching, pain) should disappear within a few days of starting treatment, but the disappearance of redness and scaling may take longer. If symptoms persist after the recommended treatment period, consult a doctor.

4. Possible side effects

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

• Severe allergic reaction (which can be life-threatening)
• Rash
• Swelling
• Shortness of breath
• Low blood pressure
• Loss of consciousness
• Dizziness

If an allergic reaction occurs, stop using the medicine and seek medical advice immediately. After applying the cream, the following may occur:

• Blisters
• Skin rash
• Burning/stinging/tingling sensation
• Redness
• Hives
• Itching
• Peeling of the skin
• Pain
• Swelling
• Irritation at the application site
• Reaction at the application site

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist. This also includes any possible side effects not listed in the leaflet. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Canesten Control

Keep the medicine out of the sight and reach of children. Do not use the medicine after the expiry date stated on the carton and tube after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. After opening the tube, use the medicine within 3 months, but before the expiry date. 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 other information

What Canesten Control contains

• The medicine contains the active substance clotrimazole.
• 1 g of cream contains 10 mg of clotrimazole.
• Other ingredients: benzyl alcohol, cetostearyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60, purified water, sorbitan stearate.

What Canesten Control looks like and contents of the pack

Canesten Control is a white cream in an aluminum tube with a PE cap. The tube is internally coated with an epoxy-phenolic lacquer and sealed with a membrane, which should be pierced before the first use. The cap contains a spike to pierce the membrane. Canesten Control is available in a 20 g tube in a carton.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer Sp. z o.o. Al. Jerozolimskie 158 02-326 Warsaw tel. +48 22 5723500

Manufacturer

GP Grenzach Produktions GmbH Emil-Barell-Strasse 7 D-79639 Grenzach-Wyhlen Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland: Canesderm 10mg/g emulsiovoide Estonia: Canesten Latvia: Canesten 10 mg/g krēms Lithuania: Canesten 10 mg/g kremas Poland: Canesten Control

Date of last revision of the leaflet: 09.2022