Canesmycospor onicoset 10mg/ g + 400mg/g pomada
Como utilizar Canesmycospor onicoset 10mg/ g + 400mg/g pomada
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Introduction
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
1. What is CanesMycospor Onicoset and what is it used for
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.
2. What you need to know before starting to use CanesMycospor Onicoset
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.
3. How to Use CanesMycospor Onicoset
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
1. Soak the foot or hand in warm water and dry well. | 2. Squeeze the tube slowly until a portion of ointment of the same length as the affected nail comes out. Apply the portion of ointment to the nail without pressing or massaging. | 3. Place half of the dressing under the finger. The dressings can be cut to the size of the nail. |
4. Fold the sides of the dressing upwards and press them well against the finger. | 5. Then, place the remaining half of the dressing over the nail, folding the adhesive surfaces downwards and pressing. | 6. Now the dressing is placed as a protective covering over the affected nail. Thus, the nail is kept for 24 hours with the dressing. |
7. After 24 hours, the dressing is removed, the foot or hand is soaked in warm water for 10 minutes, and then washed and dried well. | 8. With the scraper included, the softened nail is carefully removed. | |
The treatment following these instructions carefully should be repeated daily until all the infected nail is removed, which usually occurs within 7-14 days. CanesMycospor Onicoset acts only on the infected nail, without affecting unaffected areas. Once the nail is removed, treatment should continue with an appropriate antifungal product. |
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.
4. Possible Adverse Effects
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.
5. Conservation of CanesMycospor Onicoset
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.
6. Contents of the packaging and additional information
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/
- País de registo
- Substância ativa
- Requer receita médicaSim
- Fabricante
- Esta informação é apenas para fins informativos e não constitui aconselhamento médico. Consulte sempre um médico antes de tomar qualquer medicamento.
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