Levelina 10 mg/g cream
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Levelina 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, pharmacist, or nurse.
- 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, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Levelina is and what it is used for
- What you need to know before using Levelina
- How to use Levelina
- Possible side effects
- How to store Levelina
- Contents of the pack and other information
1. What Levelina is and what it is used for
Bifonazole belongs to a group of medicines called antifungal agents (imidazole derivatives), which are indicated for the treatment of skin infections caused by fungi and yeasts.
This medicine is indicated for the treatment of the following superficial skin infections:
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Athlete's foot (tinea pedis) and tinea of the hands
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Tinea corporis and tinea cruris (jock itch)
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Pityriasis versicolor (tinea versicolor, characterized by the appearance of discolored patches distributed across the skin)
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Cutaneous candidiasis (infections affecting warm, moist, and folded areas of the skin, such as groin and armpits)
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Candidal balanitis (inflammation of the glans penis)
You should consult a doctor if your condition worsens or does not improve after completing treatment.
2. What you need to know before starting to use Levelina
Do not use Levelina
- if you are allergic (hypersensitive) to bifonazole, imidazoles in general, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Levelina.
Do not ingest.
For external use only. Avoid contact with the eyes. If accidental contact with the eyes occurs, rinse thoroughly with plenty of water and consult an ophthalmologist if necessary.
If an allergic reaction occurs during use, treatment must be discontinued and you should seek immediate medical advice.
Concurrent treatment of the affected area with other topical skin medications is not recommended.
Children
No data are available.
Use of Levelina with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy, breast-feeding, and fertility
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.
As a precautionary measure, it is preferable to avoid using this medicine during pregnancy.
It is unknown whether bifonazole passes into breast milk; therefore, your doctor will decide whether it is necessary to discontinue breastfeeding or to discontinue treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and using machines
The effect of Levelina on the ability to drive or use machines is negligible or none.
Levelina contains cetostearyl alcohol, methyl parahydroxybenzoate (E-218), and propyl parahydroxybenzoate (E-216)
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
3. How to use Levelina
Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Levelina should be applied once daily, preferably at night, before going to bed.
The recommended duration of treatment is:
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Athlete's foot and hand fungus: 3 weeks.
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Ringworm of the body and groin: 2 to 3 weeks.
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Pityriasis versicolor: 2 weeks.
-
Cutaneous candidiasis: 2 to 4 weeks.
-
Candidal balanitis: 2 to 4 weeks.
Instructions for use
For topical use only.
Wash and dry the infected skin carefully before each application. Apply a sufficient amount of cream to cover the affected area and massage gently until completely absorbed.
If you use more Levelina than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center immediately, or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Levelina
Do not apply a double dose to make up for missed doses.
If you have missed a dose, apply it as soon as possible and continue with your new schedule. If the time for your next dose is approaching, skip the missed dose and apply the next one as scheduled.
If you stop using Levelina
Do not stop treatment without consulting your doctor, as symptoms of your condition may return or worsen.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
The following adverse effects have been reported with unknown frequency (cannot be estimated from the available data):
- Localized eczema (contact dermatitis)
- Allergic reaction
- Erythema (inflammation and redness of the skin)
- Itching
- Rash (skin eruption)
- Urticaria (itchy wheals or hives)
- Blisters
- Skin exfoliation (peeling of the skin)
- Dry skin
- Skin irritation
- Skin maceration
- Burning sensation
- Pain and edema (fluid retention) at the application site
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Levelina
Keep out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or in household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Levelina
- The active substance is bifonazole. Each gram of cream contains 10 milligrams of bifonazole.
- The other components (excipients) are macrogol 400, polyoxyethylene 40 stearate (E-431), cetostearyl alcohol, liquid paraffin, white soft paraffin, carbomer, sodium hydroxide (E-524), disodium edetate, methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216) and purified water.
Appearance of the product and contents of the pack
Homogeneous cream, white or yellowish-white.
This medicine is available in 30-gram tubes.
Marketing Authorization Holder
Laboratorios ERN, S.A.
Perú, 228 - 08020 Barcelona, Spain
Manufacturer
Laboratorios ERN, S.A.
C/ Gorgs Lladó, 188
Polígono Industrial Can Salvatella
08210 Barberà del Vallès - Barcelona
Spain
Date of the most recent review of this leaflet: November 2013.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/