CANESTEN CONTROL

Package leaflet: Information for the user

Canesten Control, 10 mg/g, cream
Clotrimazole
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed
by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, inform your doctor or pharmacist. This includes any possible adverse reactions not listed in this leaflet. See section 4.
• If there is no improvement after the recommended treatment period, or if symptoms worsen, consult your doctor. See section 3.

Contents of the leaflet

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

Canesten Control contains the active substance clotrimazole. Clotrimazole belongs to a group of medicines known as imidazole derivatives, which act against the cause of fungal skin infections.
Canesten Control is used in adults, adolescents, and children to treat:

• fungal skin infections, including athlete's foot, dermatophytosis, fungal diaper dermatitis, and candidal intertrigo
• fungal infection of the external genital organs in women or of the tip of the penis in men.

If you are unsure whether the patient (or child, in case of treating fungal diaper dermatitis) has one of the above-mentioned skin infections, you should consult your doctor or pharmacist.

2. Important information before using Canesten Control

When not to use Canesten Control

• If the patient (a child in the case of treatment of nappy area fungal dermatitis) is allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Canesten Control, discuss it with your doctor or pharmacist.

• Canesten Control may reduce the effectiveness and safety of latex products (e.g. condoms, vaginal diaphragms) when applied to the genital area (vulva and surrounding areas in women; on the tip of the penis in men). This effect is temporary and occurs only during treatment. Therefore, an alternative method of contraception and protection against sexually transmitted infections should be used during treatment.
• Avoid contact of the cream with the eyes.
• Do not apply the cream inside the mouth or swallow it.
• Cross-sensitivity between clotrimazole and other similar antifungal agents such as itraconazole, fluconazole, ketoconazole, and miconazole may occur.
• Patients taking immunosuppressive drugs, undergoing chemotherapy, patients with diabetes, or those infected with HIV should consult their doctor before using Canesten Control.

Children, adolescents, and elderly individuals
Canesten Control may be used in children (under 12 years of age) and elderly patients only under
medical supervision.
Prolonged treatment of large skin areas should be avoided, especially in infants and children.
In cases of vulvitis, female patients under 16 years of age should consult a doctor before using
Canesten Control.

Canesten Control and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Canesten Control may reduce the effectiveness of topically applied polyene antibiotics (e.g. nystatin, natamycin).
The action of clotrimazole may be diminished by local application of glucocorticosteroids.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.

• Pregnancy Consult your doctor before using Canesten Control during the first three months of pregnancy.
• Breastfeeding Canesten Control may be used during breastfeeding. If the medicine is applied locally to the nipple or areola area, the breast should be washed and rinsed thoroughly before feeding the baby.

Driving and operating machinery
No effects of Canesten Control on the ability to drive or operate machinery have been observed.

Canesten Control contains cetyl alcohol and benzyl alcohol

• Cetyl 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 this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

• Before starting to use the medicine, pierce the tube seal with the reverse side of the cap.
• If the feet are affected, wash and thoroughly dry them before applying the cream, especially the spaces between the toes.
• Apply a thin, even layer of cream evenly to the affected areas of skin 2–3 times daily.
• A 0.5 cm strip of cream is sufficient to cover an area of skin the size of the palm of the hand.

Duration of treatment
The duration of treatment depends on the type of infection.
To ensure complete cure, Canesten Control should be used for the period indicated in the table below, even if symptoms have subsided.

Skin infection symptoms (itching, pain) should subside within a few days of starting treatment, while resolution of redness and skin peeling may take longer. If symptoms persist after the recommended treatment period, consult a doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

• Severe allergic reaction (potentially 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 immediate medical advice.
After application of the cream, the following may occur:

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

Reporting of adverse reactions
If any adverse reactions occur, inform your doctor or pharmacist. This includes potential adverse reactions not listed in this leaflet. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Canesten Control

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and tube after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
After opening the tube, use the medicine within 3 months, but not beyond the expiry date.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains Canesten Control

• 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 contained in an aluminium tube with a polyethylene (PE) cap.
The tube is internally coated with an epoxy-phenolic lacquer and is sealed with a protective membrane
which must be pierced before first use of the medicine. A piercing device is integrated into the cap.
Canesten Control is available in a tube containing 20 g of cream, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area member states 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