CANESPOR

Package leaflet: Information for the patient

Warning! Please keep this 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 medicinal product.
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet, or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If your condition does not improve or worsens, consult your doctor.

Table of contents of the leaflet

1. What Canespor is and what it is 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 pack and other information

1. What Canespor is and what it is used for

Canespor is an antifungal medicine available as a cream. It contains the active substance
bifonazole, which has a broad spectrum of antifungal activity.
Canespor is indicated for the topical treatment of fungal skin infections such as tinea manuum and tinea pedis (fungal infections of the hands and feet), tinea corporis (fungal infection of the body), tinea intertriginosa (fungal infection of skin folds), pityriasis versicolor, superficial fungal infections of the skin, and for the topical treatment of pityriasis erythrosquamous.

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 treatment with Canespor, discuss it with your doctor or pharmacist.
Patients who have previously experienced hypersensitivity reactions to other imidazole-derived antifungals (e.g. econazole, clotrimazole, miconazole) should use bifonazole-containing medicines with caution.
If symptoms persist or do not improve after stopping treatment, consult your doctor.
Avoid contact of the medicine with the eyes. 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 occurs only during treatment.

Children and adolescents
Canespor may be used in infants and young children (from 28 days to 23 months of age) only on a doctor's prescription and under medical supervision. There is no data available on the use of this medicine in newborns.

Canespor and other medicines
Concomitant use of Canespor with warfarin may increase the risk of bleeding. If Canespor and warfarin are used together, the patient must be under close medical supervision.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Canespor should not be used during the first trimester of pregnancy.
If a doctor decides that treatment with Canespor is necessary during breastfeeding, breastfeeding should be discontinued.

Driving and operating machinery
Canespor has no effect or has a negligible effect on the ability to drive and operate machinery.

Canespor contains cetostearyl alcohol.
This 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 use Canespor

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Recommended dose
The medicine should be applied once daily, preferably in the evening before bedtime. A small amount of the medicine is usually sufficient to cover an affected skin area the size of the palm of the hand.
Method of administration
Apply a thin layer of the medicine to the affected area and gently massage it in.
Duration of treatment
Treatment with Canespor should be continued for an appropriately long period. The medicine is usually used as shown in the table below.

Use in children and adolescents
The medicine may be used in infants and young children (from 28 days to 23 months of age) only
on a doctor's prescription and under medical supervision. There is no data available on the use of the medicine in newborns.
Use of a higher than recommended dose of Canespor
There is no risk of acute poisoning.
Missed dose of Canespor
Do not use a double dose to make up for the missed dose.
Apply the next dose as soon as possible.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Canespor may cause adverse reactions, although not everyone experiences them.
Frequency unknown (cannot be estimated from available data):
pain at application site, local swelling (at application site), contact dermatitis, allergic dermatitis, erythema, pruritus, rash, urticaria, vesicles, skin desquamation, eruption, dry skin, skin irritation, skin maceration, burning sensation on skin.

Adverse reactions usually resolve after discontinuation of treatment.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Canespor

Keep this medicine 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 stated month.
Medicines must 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 package 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, cetostearyl alcohol, cetyl palmitate, polysorbate 60,
octyldodecanol, purified water, sorbitan stearate.

What Canespor looks like and contents of the pack
Canespor is a cream.
The available pack is an aluminium tube with a PE cap containing 15 g of cream, placed in a cardboard box.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Portugal, the country of export:
Bayer Portugal, Lda.
Avenida Vítor Figueiredo n°4, 4° piso
2790-255 Carnaxide
Portugal

Manufacturer:
Kern Pharma, S.L.
C/ Venus, 72 - Polígono Industrial Colon 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
Poland

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

Portugal, country of export, Marketing Authorisation Number: 9627307
Parallel Import Licence Number: 83/16