Canesmycospor onicoset 10mg/ g + 400mg/g pomada

Label: Patient Information

CanesMycospor Onicoset 10 mg/g + 400 mg ointment

Bifonazol / urea

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of the package and additional information

This medication has two active ingredients, bifonazole (an antifungal) used for the treatment of superficial skin infections caused by fungi and yeast, and urea, an emollient used for the softening of the infected nail.

It is used to remove infected nails in a non-traumatic (non-bleeding) manner, and simultaneously eliminates the infection caused by fungi.

Do not use CanesMycospor Onicoset:

• if you are allergic to bifonazol, imidazoles in general, or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use CanesMycospor Onicoset.

• this medication is only forexternal use. Avoid contact with the eyes and mucous membranes, and in case of contact, rinse them with cold water,
• do not ingest,

• if a hypersensitivity reaction or allergic reaction develops during treatment, discontinue treatment and consult your doctor,
• in rare cases, the dressing may cause an allergic reaction; in that case, switch to another type of dressing or use a rubber glove.

Children

The safety and efficacy have not been established in the pediatric population.

Using CanesMycospor Onicoset with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications or may need to take any other medication.

If you are being treated with warfarin (oral anticoagulant), your dose may need to be adjusted as the effects of this medication may be affected by the use of bifonazol.

It is not recommended to use other medications in the same areas where this medication is applied.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

This medication is not recommended during pregnancy or in women of childbearing age who are not using contraceptive methods.

Breastfeeding

Caution should be exercised during breastfeeding, as bifonazol or urea may be excreted in breast milk. In the event of administration, natural breastfeeding should be interrupted and replaced.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

CanesMycospor Onicoset contains lanolin

This medication may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Recommended dose:

Apply once a day to the infected nail, in sufficient quantity to cover the entire surface of the nail with a thin layer of ointment.

The treatment with the ointment should be applied carefully every day and should continue until no more fungus-infected nail substance can be lifted.

Usually, treatment lasts from 7 to 14 days, depending on the extent of the infection and the thickness of the nail.

Administration form:

Cutaneous use

Before the first application of the ointment, soak the infected nail in warm water for a few minutes to slightly soften the nail to be treated, and then dry it well. Apply the ointment to the infected nail, covering its surface with a thin layer. Then, the treated finger or toe will be covered with a dressing that will be left in place for 24 hours. After these 24 hours, the dressing will be removed and the affected finger will be washed for 10 minutes in warm water. After this wash, the softened part of the treated nail will be removed with the scraper included in the package; the treated nail will be dried and the ointment will be reapplied as described before, covering the nail with a new dressing until the next day.

No need to cover the skin around the nail. However, if irritation is observed, which is exceptional, before placing the dressing, the skin around the nail can be covered with an appropriate product such as zinc paste.

Once the nail is removed, the treatment should continue with another antifungal product to eliminate the fungus from the skin layer located under the nail. Before this, the doctor should evaluate if the infected part of the nail has been completely removed and, if necessary, perform a final cleaning of the area.

It is recommended to wash your hands after each application.

General hygiene measures should be taken to avoid the appearance of other infections or recurrences.

Usage instructions

If you use more CanesMycospor Onicoset than you should

If you apply more ointment than your doctor has indicated, you may feel a burning sensation, redness, or swelling that will disappear after stopping treatment.

This medication should not be ingested. If ingested accidentally, contact your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use CanesMycospor Onicoset

If you forgot to use this medication when it was due, apply the ointment as soon as you remember and continue with your usual treatment regimen. Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with CanesMycospor Onicoset

Do not stop treatment before your doctor indicates, as irregular use or premature interruption of treatment carries the risk of recurrence.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been described, whose frequency cannot be estimated from the available data (unknown frequency):Contact dermatitis (skin inflammation), erythema (skin inflammation and redness), pruritus, exanthema (rash), skin exfoliation (skin peeling), skin irritation, skin maceration, nail disorders or changes in color, pain at the application site, and pain in the extremity.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:https://notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 86°F (30°C). Store in the original packaging.

The remaining medication in the tube should be discarded once the treatment period set by the doctor is completed, and in any case, within 3 months after opening. Once the container is opened, do not store at a temperature above 77°F (25°C).

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through drains or in the trash. Dispose of the containers, medical devicesand medications that you no longer need at the Sigre Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers,medical devicesand medications that you no longer need. In this way, you will help protect the environment.

Composition of CanesMycospor Onicoset

- The active principles are bifonazole and urea. Each gram of ointment contains 10 mg of bifonazole and 400 mg of urea.

- The other components (excipients) are: lanolin, white beeswax, and white petrolatum.

Appearance of the product and contents of the packaging

CanesMycospor Onicoset is a yellowish-colored ointment with no odor. It is presented in a cardboard box that contains inside: a cardboard box with a lacquered aluminum tube with a closed mouth and an HDPE screw cap containing 10 g of ointment, a package of hydrophobic (waterproof) adhesive dressings, and a nail scraper.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

GP Grenzach Produktions GmbH

Emil-Barell-Str. 7

D-79639 Grenzach-Wyhlen

Germany

Revision date of this leaflet: April 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/