CANESPOR 10 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
3. Canespor (Canesten Unidia)
   1. Read the leaflet carefully before using the medicine, as it contains
   2. Table of Contents of the Leaflet
4. What is Canespor and what is it used for
5. Important information before taking Canespor
   1. When not to use Canespor:
   2. Warnings and precautions
   3. Children and adolescents
   4. Canespor and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Canespor contains cetearyl alcohol.
   8. Canespor contains benzyl alcohol
6. How to take Canespor
   1. Use in children and adolescents
   2. Overdose of Canespor
   3. Missed dose of Canespor
7. Possible side effects
   1. Reporting side effects
8. How to store Canespor
9. Contents of the pack and other information
   1. What Canespor contains
   2. What Canespor looks like and contents of the pack
   3. Marketing authorization holder in Portugal, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 83/16
   8. Date of approval of the leaflet: 15.02.2024

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Canespor (Canesten Unidia)

10 mg/g, cream
Bifonazolum
Canespor and Canesten Unidia are different trade names for the same medicine.

Read the 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 patient leaflet, or according to the doctor's or pharmacist's instructions.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, talk to a pharmacist.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Canespor and what is it used for
• 2. Important information before taking Canespor
• 3. How to take Canespor
• 4. Possible side effects
• 5. How to store Canespor
• 6. Contents of the pack 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 active substance is bifonazole, with a broad spectrum of antifungal activity.
Canespor is indicated for the local treatment of fungal skin infections, such as: athlete's foot, including interdigital athlete's foot (Tinea pedis, tinea pedum interdigitalis), corporal ringworm, hand and skin fold ringworm (Tinea corporis, tinea manuum, tinea inguinalis), pityriasis versicolor, and superficial skin candidiasis, as well as for the local treatment of pityriasis rubra.

2. Important information before taking Canespor

When not to use Canespor:

Warnings and precautions

Before starting treatment with Canespor, you should discuss it with your doctor or pharmacist.
Patients who have had hypersensitivity reactions to other 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.
Eye contact with the medicine 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 a doctor's prescription and under their control. There is no data on the use of the medicine in newborns.

Canespor and other medicines

Taking Canespor with warfarin increases the risk of bleeding. If Canespor and warfarin are used together, the patient should be under close medical supervision.
Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do 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 cetearyl alcohol.

The medicine may cause local skin reactions (e.g., contact dermatitis).

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 take Canespor

This medicine should always be taken exactly as described in this patient leaflet, or according to the doctor's or pharmacist's instructions. If you are unsure, talk to 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 enough 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 affected area and gently rubbed in.
Duration of treatment
Treatment with Canespor should be continued for a sufficient period. The medicine is usually used as described 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 a doctor's prescription and under their control. There is no data on the use of the medicine in newborns.

Overdose of Canespor

There is no risk of acute overdose.

Missed dose of Canespor

Do not take a double dose to make up for a missed dose.
Take the next dose as soon as possible.
If you have any further questions about the use of this medicine, talk to 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, erythema, pruritus, rash, urticaria, vesicles, desquamation, eczema, skin irritation, maceration, burning sensation on the skin.
Side effects usually disappear after the end of treatment.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. Side effects can also 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, phone: +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

Keep the medicine out of the 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. 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 Canespor contains

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

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, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Bayer Portugal, Lda.
Avenida Vitor Figueiredo n°4 - 4° piso
2790-255 Carnaxide
Portugal

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portuguese marketing authorization number: 9627307

Parallel import authorization number: 83/16

Date of approval of the leaflet: 15.02.2024

[Information about the trademark]