Canesmycospor 10 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
CanesMycospor 10 mg/g cream
Bifonazole
Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What CanesMycospor is and what it is used for
- What you need to know before using CanesMycospor
- How to use CanesMycospor
- Possible side effects
- How to store CanesMycospor
- Contents of the pack and other information
1. What CanesMycospor is and what it is used for
This medicine belongs to the group of medicines known as antifungals (medicines used to treat infections caused by fungi and yeasts).
It is indicated for the treatment of the following superficial skin infections in adults: athlete's foot or tinea pedis, tinea manuum, tinea corporis, tinea cruris, pityriasis versicolor (a condition characterized by the appearance of discolored patches on the skin), and cutaneous candidiasis (infections that usually affect warm, moist areas of the skin).
2. What you need to know before using CanesMycospor
Do not use CanesMycospor:
- if you are allergic to bifonazole, imidazoles in general, or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use CanesMycospor.
-
This medicine is for external use only. Avoid contact with the eyes and mucous membranes. If contact occurs, rinse thoroughly with cool water.
-
Do not ingest.
-
If any hypersensitivity reaction or allergic reaction occurs during treatment, discontinue use and consult your doctor.
-
It is not recommended to cover the treated area with dressings after applying the medicine, as this may enhance systemic absorption.
-
Some of the excipients in this medicine may reduce the effectiveness of latex products, such as condoms and diaphragms, when applied in the genital area. This effect is temporary and occurs only during treatment.
Children
The safety and efficacy in the pediatric population have not been established.
Use of CanesMycospor with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to take any other medicines.
If you are being treated with warfarin (an oral anticoagulant), your dose may need to be adjusted, as the effects of this medicine may be affected by the use of bifonazole.
It is not recommended to use other medicines simultaneously on the same areas where this medicine is applied.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Use of this medicine 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 bifonazole may be excreted in breast milk. If administration is necessary, breastfeeding should be interrupted and replaced.
Driving and using machines
The influence of this medicine on the ability to drive and operate machinery is none or negligible.
CanesMycospor contains cetostearyl alcohol and benzyl alcohol
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
This medicine contains 20 mg of benzyl alcohol per gram of cream.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause moderate local irritation.
3. How to use CanesMycospor
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
1 application to the affected area once daily, preferably before going to bed.
Apply and spread a small amount of cream to completely cover the affected area, and rub in until fully absorbed. It is recommended to wash your hands after each application.
Occlusion with dressings is not recommended; see section Warnings and precautions.
The duration of treatment will depend on the indication being treated:
Indication | Duration of treatment |
Ringworm of the body, jock itch | 2-3 weeks |
Athlete's foot | 3 weeks |
Ringworm of the hands | 2-4 weeks |
Pityriasis versicolor | 2 weeks |
Cutaneous candidiasis | 2-4 weeks |
If symptoms do not improve after 4 weeks of treatment, you should consult your doctor. Treatment should continue for at least several days after all symptoms have disappeared.
If you use more CanesMycospor than you should
If you apply more cream than your doctor has prescribed, you may experience a burning sensation, redness, or swelling, which will disappear once you stop treatment.
This medicine must not be ingested. If accidentally swallowed, contact your doctor.
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist, go to a medical center immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use CanesMycospor
If you forget to use this medicine at the scheduled time, apply the cream as soon as you remember and then continue with your usual treatment regimen. Do not use a double dose to make up for a missed dose.
If you stop treatment with CanesMycospor
Do not stop treatment earlier than instructed by your doctor, as irregular use or premature discontinuation of treatment may carry a risk of relapse.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported, whose frequency cannot be estimated from the available data (frequency not known):
Contact dermatitis (inflammation of the skin), allergic dermatitis, erythema (redness and inflammation of the skin), itching, rash, urticaria (hives accompanied by itching), blisters, skin exfoliation (peeling of the skin), eczema, dry skin, skin irritation, skin maceration, burning sensation at the application site, pain at the application site, and peripheral edema (fluid retention) at the application site.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of CanesMycospor
Keep this medicine out of the sight and reach of children.
Store in the original packaging. No special storage conditions are required.
After first opening, the cream is stable for 6 months. Once the container is opened, do not store at temperatures above 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of CanesMycospor
- The active substance is bifonazole. Each gram of cream contains 10 mg of bifonazole.
- The other components (excipients) are: benzyl alcohol, cetyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60, sorbitan monostearate, and purified water.
Appearance of the product and contents of the pack
CanesMycospor is a white, odorless cream. It is supplied in a cardboard box containing a lacquered aluminum tube with a blind mouth and a high-density polyethylene (HDPE) screw cap, containing 20 g of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bayer Hispania, S.L.
Av. Baix Llobregat, 3 – 5
08970 Sant Joan Despí (Barcelona)
Manufacturer
Kern Pharma, S.L.
Polígono Industrial Colón II
Venus, 72
08228 Terrassa (Barcelona)
Spain
or
GP Grenzach Produktions GmbH
Emil-Barell-Str. 7
D-79639 Grenzach-Wyhlen
Germany
Date of revision of this leaflet: February 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/