Canespor onychoset

Poland
Brand name Canespor onychoset
Form ointment
Active substance / Dosage
bifonazole · 10 mg/g
urea · 400 mg/g
Prescription type Prescription only
ATC code
D01AC60
Registration number 100045057
Manufacturer GP Grenzach Produktions GmbH
Canespor onychoset ointment

Table of Contents

Package leaflet: Information for the user

CANESPOR ONYCHOSET, 10 mg + 400 mg/g, cream
(Bifonazole + Urea)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, please ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
  • If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

  1. What Canespor Onychoset is and what it is used for
  2. Important information before using Canespor Onychoset
  3. How to use Canespor Onychoset
  4. Possible side effects
  5. How to store Canespor Onychoset
  6. Contents of the pack and other information

1. What Canespor Onychoset is and what it is used for

Canespor Onychoset is an antifungal medicine, available as a cream. The medicine contains the active substance
bifonazole, which has a broad spectrum of antifungal activity, and urea, which facilitates penetration
of bifonazole into the nail and enhances its effect.
Canespor Onychoset is indicated for topical treatment of fungal infections of fingernails and toenails,
involving non-invasive removal of the nail and simultaneous antifungal treatment.

2. Important information before using Canespor Onychoset

When not to use Canespor Onychoset

  • if the patient is allergic to the active substances – bifonazole and urea – or to any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Before starting treatment with Canespor Onychoset, discuss this with your doctor or pharmacist. Patients who have previously experienced hypersensitivity reactions to other imidazole-derived antifungal agents, such as econazole, clotrimazole, miconazole, should use bifonazole-containing medicines with caution. If symptoms of the disease persist or do not improve after discontinuing treatment, consult your doctor. Avoid contact of the medicine with the eyes. Do not swallow.

Children and adolescents

Canespor Onychoset should be used in infants and young children only on medical advice and under medical supervision.

Canespor Onychoset and other medicines

Concomitant use of Canespor Onychoset with warfarin increases the risk of bleeding. If Canespor Onychoset and warfarin are used simultaneously, the patient must be under close medical supervision. Inform your doctor or pharmacist about all medicines currently used or recently used, 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.
Do not use Canespor Onychoset during the first trimester of pregnancy.
If the doctor decides that treatment with Canespor Onychoset is necessary during breastfeeding, breastfeeding should be discontinued.

Driving and operating machinery

Canespor Onychoset has no effect or has negligible effect on the ability to drive and operate machinery.

Canespor Onychoset contains lanolin and may cause local skin reactions, e.g. contact dermatitis.

3. How to use Canespor Onychoset

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
Apply Canespor Onychoset once daily, spreading a thin layer of the ointment over the entire surface of the affected nail.

Instructions for use

Illustration showing a foot with a diseased nail plate and a hand applying medication from a tube directly onto the toe
  1. Wash the foot or hand with warm water and dry thoroughly.
  2. Squeeze from the tube a strip of ointment long enough to cover the fungus-infected nail. Apply the ointment to the affected nails. Do not rub in.
Schematic drawing depicting the spine with labeled vertebrae and a human head and neck silhouette from the front or back view
  1. Cover the nail with half of the patch. (Illustrations show the sole of the foot.) Caution! For small nails, the patch may be divided into smaller pieces.
Schematic drawing showing four fingers placed side by side against a background resembling a dispenser or medication packaging Schematic drawing showing hands and fingers with two arrows indicating rotational movement around a circular device component
  1. Attach the adhesive side of the patch to the underside of the toe.
Schematic drawing of foot toes with black arrows indicating direction of pressure or massage on the sole and lateral sides of the toes
  1. Cover the bottom of the toe with the other half of the patch.
Line drawing showing three toes with clearly marked phalangeal segments and foot arch lines
  1. In this way, the nail will be completely sealed. Leave the dressing in place for 24 hours. (Illustration shows the top of the foot.)
Black-and-white drawing of a human foot showing a pathological lesion or skin condition on the big toe
  1. After 24 hours, remove the patch and soak the hand or foot in warm water for 10 minutes, then dry thoroughly.
A hand holding a small scalpel making an incision on the skin of the toe, exposing subcutaneous tissue for drug administration
  1. Using a scraper, gently remove the softened layer of infected nail.
  2. Then dry the nails thoroughly and reapply the medicine and dressing. The medicine acts only on infected areas of the nail, leaving healthy tissue unaffected. Therefore, it is usually not necessary to protect the surrounding healthy skin. However, if irritation occurs, protect the adjacent skin, for example by applying a zinc paste. The patch size provided in the package corresponds to nail dimensions.

Duration of treatment
Treatment with Canespor Onychoset should continue until all infected layers of the nail have been removed. This usually takes from 7 to 14 days. After removal of the infected nail layers, continue treatment with Canespor cream, applied once daily for an additional 4 weeks.

The amount of ointment in the package is sufficient for 30 applications, i.e., treatment of 3 infected nails for 10 days. If patches are used up before the ointment, you may purchase another waterproof patch and adjust its size to fit the nail.

Use in children and adolescents
Canespor Onychoset may be used in infants and young children only on medical advice and under medical supervision. There is no data available on use in newborns.

Use of more than the recommended dose of Canespor Onychoset
There is no risk of acute poisoning.

Missed dose
Do not use a double dose to make up for a missed dose. Apply the next dose as soon as possible.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Canespor Onychoset can cause adverse reactions, although not everyone experiences them.
Frequency unknown (cannot be estimated from available data):
contact dermatitis, skin maceration, skin desquamation, nail disorders, nail discoloration, erythema, irritation, pain at application site, limb pain, pruritus, rash.
Adverse symptoms usually resolve after discontinuation of treatment.

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

5. How to store Canespor Onychoset

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Canespor Onychoset contains

  • The active substances are bifonazole and urea.
  • The other ingredients are: white wax, white soft paraffin, lanolin.

What Canespor Onychoset looks like and contents of the pack
Canespor Onychoset is an ointment. The medicinal product is available in a set containing:

  • one tube with 10 g of ointment,
  • 15 patches,
  • one nail scraper.
    All components are packed in a cardboard box.

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

Manufacturer
GP Grenzach Produktions GmbH
Emil-Barell-Str. 7
79639 Grenzach-Wyhlen
Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:

Poland
Bayer Sp. z o.o.
Aleje Jerozolimskie 158
02-326 Warsaw
Telephone: +48 22 572 3500
Fax: +48 22 572 3500