Levelina 10 mg/ml solution for cutaneous spray
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Levelina 10 mg/ml cutaneous spray solution
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 others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions 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 adverse 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 known as antifungal agents (imidazole derivatives), which are indicated for the treatment of fungal and yeast skin infections.
This medicine is indicated for the treatment of the following superficial skin infections:
- Athlete's foot (tinea pedis) and tinea of the hands
- Tinea corporis, tinea cruris (jock itch)
- Pityriasis versicolor (tinea versicolor, characterized by the appearance of discolored patches on the skin)
- Cutaneous candidiasis (infections affecting warm, moist, and skin-fold areas such as groin and armpits)
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 components 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. Contact with eyes or mucous membranes must be avoided, as it may cause irritation. If accidental contact occurs with eyes or mucous membranes, wash thoroughly with plenty of water.
If an allergic reaction occurs during use, treatment must be discontinued and you should immediately consult your doctor.
It is not recommended to treat the affected area simultaneously with other topical skin medications.
Children
No data 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, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 breastfeeding should be interrupted or treatment discontinued, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.
Driving and using machines
The influence of Levelina on the ability to drive or use machines is none or negligible.
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.
Levelina should be applied once daily, preferably at night before going to bed.
The recommended duration of treatment is:
- Athlete's foot and tinea of the hands: 3 weeks.
- Tinea corporis and tinea cruris: 2 to 3 weeks.
- Pityriasis versicolor: 2 weeks.
- Cutaneous candidiasis: 2 to 4 weeks.
Method of administration
For cutaneous use only.
Wash and carefully dry the infected skin area before each application. Apply a few drops of the solution to the affected area and spread gently by rubbing.
If you use more Levelina than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, 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 Levelina
Do not use a double dose to make up for missed doses.
If you forget a dose, apply it as soon as possible and then continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and apply the next one at the regular time.
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 cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported with frequency not known (cannot be estimated from the available data):
- Localised eczema (contact dermatitis)
- Allergic reaction
- Erythema (inflammation and redness of the skin)
- Itching
- Exanthema (rash)
- Urticaria (hives accompanied by itching)
- Blisters
- Skin exfoliation (skin peeling)
- Dry skin
- Skin irritation
- Skin maceration
- Burning sensation
- Pain and oedema (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 the 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the package and other information
Composition of Levelina
- The active substance is bifonazole. Each millilitre of cutaneous spray solution contains 10 milligrams of bifonazole.
- The other components (excipients) are ethanol and isopropyl myristate.
Appearance of the product and contents of the pack
Colourless, transparent solution.
This medicine is supplied in a 30-millilitre spray container with spray device.
Marketing Authorisation Holder
LABORATORIOS ERN, S.A.
Perú, 228 - 08020 Barcelona, Spain
Manufacturers
Laboratorios ERN, S.A.
Gorcs Lladó, 188
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 Medical Devices (AEMPS) http://www.aemps.gob.es