Canespor

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Canespor(Canesten Unidia)

10 mg/g, cream

Bifonazole
Canespor and Canesten Unidia are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 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. Contents of the packaging 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 fungal infections of the hands, body, skin folds, pityriasis versicolor, and superficial skin infections, as well as 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, you should discuss it with your doctor or pharmacist.
Patient 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, you should contact your doctor.
You should avoid contact of the medicine with the eyes. Do not swallow.
Some of the excipients of 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 advice of a doctor and under their supervision. 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.
You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, as well as any medicines you plan to use.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
You should not use Canespor during the first trimester of pregnancy.
If your doctor decides that you need to use Canespor during breastfeeding, you should stop breastfeeding.

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 the patient leaflet or according to
the doctor's or pharmacist's instructions. If you are unsure, you should consult your doctor or pharmacist.
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 the diseased area the size of the palm of your hand.
Method of administration
A thin layer of the medicine should be applied to the area affected by the disease and gently massaged in.
Duration of treatment
Treatment with Canespor should be carried out for a sufficient period of time. 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 advice of a doctor and under their supervision. There is no data on the use of the medicine in newborns.

Using a higher dose of Canespor than recommended

There is no risk of acute poisoning.

Missing a dose of Canespor

You should not use a double dose to make up for a missed dose.
You should use the next dose as soon as possible.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

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, redness, itching, rash, urticaria, blisters, peeling, eczema, dryness of the skin, skin irritation, maceration of the skin, burning sensation on the skin.
Side effects usually disappear after the end of treatment.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your doctor or pharmacist. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Canespor

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Canespor contains

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

What Canespor looks like and contents of the pack

Canespor is a cream.
The medicine is available in an aluminum tube with a PE cap, containing 15 g of cream, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Bayer Portugal, Lda.
Avenida Vítor Figueiredo nº4, 4º piso
2790-255 Carnaxide
Portugal

Manufacturer:

Kern Pharma, S.L.
C/ Venus, 72 - Polígono Industrial Colon II
E-08228 Terrasa - Barcelona
Spain
GP Grenzach Produktions GmbH
Emil-Barrel-Str. 7
D-79639 Grenzach-Wyhlen
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Portugal, the country of export: 9627307
Parallel import authorization number: 116/20

Date of approval of the leaflet: 04.04.2025

[Information about the trademark]