Canespor

Package Leaflet: Information for the Patient

CANESPOR, 10 mg/g, cream

Bifonazole

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this package leaflet for the patient, or according to the doctor's or pharmacist's instructions.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

Package Leaflet Contents

• 1. What is Canespor and what is it used for
• 2. Important information before using Canespor
• 3. How to use Canespor
• 4. Possible side effects
• 5. How to store Canespor
• 6. Package contents and other information

1. What is Canespor and what is it used for

Canespor is an antifungal medicine, in the form of a cream. The medicine contains the active substance bifonazole with a broad spectrum of antifungal activity.
Canespor is indicated for the local treatment of fungal skin infections, such as: athlete's foot and hands, body ringworm, skin fold ringworm, pityriasis versicolor, superficial skin fungal infections, and for the local treatment of seborrheic dermatitis.

2. Important information before using Canespor

When not to use Canespor:

• if the patient is allergic to the active substance - bifonazole - or to any of the other ingredients of this medicine, listed in section 6.

Warnings and precautions

Before starting to use Canespor, the doctor or pharmacist should be consulted.
Patients who have previously experienced hypersensitivity reactions to other antifungal imidazole derivatives (e.g., econazole, clotrimazole, miconazole) should use bifonazole-containing medicines with caution.
If the symptoms of the disease persist or do not improve after stopping treatment, the doctor should be contacted.
Contact with the eyes should be avoided. Do not swallow.
Some excipients in Canespor may reduce the effectiveness of latex-containing products, such as condoms and diaphragms, when applied to the genital area.
This effect is temporary and only occurs during treatment.

Children and adolescents

In infants and young children (from 28 days to 23 months), the medicine can only be used on the doctor's prescription and under their control. There is no data on the use of the medicine in newborns.

Canespor and other medicines

Using Canespor with warfarin increases the risk of bleeding. When using Canespor and warfarin at the same time, the patient should be under close medical supervision.
The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Canespor should not be used during the first trimester of pregnancy.
If the doctor decides that Canespor needs to be used during breastfeeding, breastfeeding should be stopped.

Driving and using machines

Canespor has no influence or negligible influence on the ability to drive and use machines.

Canespor contains benzyl alcohol

1 g of Canespor cream contains 20 mg of benzyl alcohol.
Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Canespor

This medicine should always be used exactly as described in this package leaflet for the patient or according to the doctor's or pharmacist's instructions. In case of doubt, the doctor or pharmacist should be consulted.
Recommended dose
The medicine should be used once a day, preferably in the evening, before bedtime. A small amount of medicine is usually sufficient to cover the skin with lesions the size of a hand.
Method of administration
A thin layer of the medicine should be applied to the area affected by the lesions and gently massaged in.
Duration of treatment
Treatment with Canespor should be carried out for a sufficient period. The medicine is usually used as presented in the table below.

Use in children and adolescents

In infants and young children (from 28 days to 23 months), the medicine can only be used on the doctor's prescription and under their control. There is no data on the use of the medicine in newborns.

Using more than the recommended dose of Canespor

There is no risk of acute overdose.

Missing a dose of Canespor

A double dose should not be used to make up for a missed dose.
The next dose should be used as soon as possible.
In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Canespor can cause side effects, although not everybody gets them.
Frequency not known (cannot be estimated from the available data):
pain at the application site, peripheral edema (at the application site), contact dermatitis, allergic dermatitis, erythema, pruritus, rash, urticaria, vesicles, skin exfoliation, eczema, skin dryness, skin irritation, skin maceration, burning sensation on the skin.
Side effects usually disappear after the end of treatment.

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, the doctor or pharmacist should be informed. 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.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Canespor

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
This medicine should not be used after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Canespor contains

The active substance of Canespor is bifonazole: 1 g of cream contains 10 mg of bifonazole.
The other ingredients are: benzyl alcohol, cetylstearyl alcohol, cetyl palmitate, polysorbate 60, octyldodecanol, purified water, sorbitan stearate.

What Canespor looks like and contents of the pack

Canespor is a cream.
The marketing authorization holder's package of the medicine is an aluminum tube containing 15 g of cream, placed in a cardboard box.

Marketing authorization holder

Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw

Manufacturer

GP Grenzach Produktions GmbH
Emil-Barell-Str. 7
D-79639 Grenzach-Wyhlen
Germany
To obtain more detailed information, the local representative of the marketing authorization holder should be contacted:

Poland

Bayer Sp. z o.o.
Aleje Jerozolimskie 158
02-326 Warsaw
Phone number: +48 22 572 35 00
Fax number: +48 22 572 35 00

Date of last revision of the package leaflet: