LEVELINA 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Levelina 10 mg/ml cutaneous spray solution

Bifonazol

Read all of this 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Levelina and what is it used for
2. What you need to know before you start using Levelina
3. How to use Levelina
4. Possible side effects
5. Storage of Levelina
6. Contents of the pack and further information

1. What is Levelina and what is it used for

Bifonazol belongs to a group of medicines called antifungals (imidazole derivatives), which are used to treat skin infections caused by fungi and yeasts.

This medicine is indicated for the treatment of the following superficial skin infections:

• Athlete's foot (tinea pedis) and tinea of the hands
• Tinea of the body, tinea inguinal (jock itch)
• Pityriasis versicolor(tinea versicolor, characterized by the appearance of scattered patches on the skin)
• Cutaneous candidiasis (infections that affect humid and warm areas of the skin with folds (jock itch and axillae)

2. What you need to know before you start using Levelina

Do not use Levelina

• if you are allergic (hypersensitive) to bifonazol, imidazoles in general, or 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. Avoid contact with eyes or mucous membranes, as it may cause irritation. If accidental contact occurs, rinse with plenty of water.

In case of an allergic reaction during use, treatment should be discontinued and medical attention sought immediately.

It is not recommended to treat the affected area with other skin medicines at the same time.

Children

No data are available.

Using Levelina with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines or if you might use any other medicine.

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 not known whether bifonazol passes into breast milk; therefore, your doctor will decide whether to interrupt breastfeeding or treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using machines

Levelina has no or negligible influence on the ability to drive or use machines.

3. How to use Levelina

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

Levelina should be applied once a day, preferably at night before bedtime.

The recommended durationof treatmentis:

• Athlete's foot and tinea of the hands: 3 weeks.
• Tinea of the body and tinea inguinal: 2 to 3 weeks.

• Pityriasis versicolor: 2 weeks.
• Cutaneous candidiasis: 2 to 4 weeks.

Method of use

For cutaneous use.

Wash and dry the infected skin carefully before each application. Apply a few drops of solution to the affected area and spread by rubbing.

If you use more Levelina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicology Information Service, phone 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 forgotten doses.

If you have forgotten a dose, apply another as soon as possible and continue with the new schedule. If the time of the next application is very close, skip the forgotten dose and apply the next dose.

If you stop using Levelina

Do not stop treatment without consulting your doctor, as the symptoms of your disease may reappear or worsen.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effectshave been reported with a frequency that cannot be estimated (cannot be determined from the available data):

• Localized eczema (contact dermatitis)
• Allergic reaction
• Erythema (inflammation and redness of the skin)
• Itching
• Exanthema (rash)
• Urticaria (hives with itching)
• Blisters
• Exfoliation of the skin (peeling of the skin)
• Dryness of the skin
• Skin irritation
• Maceration of the skin
• Burning sensation
• Pain and edema (fluid retention) at the application site

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Levelina

• The active substance is bifonazol. Each milliliter of cutaneous spray solution contains 10 milligrams of bifonazol.
• The other components (excipients) are ethanol and isopropyl myristate.

Appearance and packaging of the product

Transparent and colorless solution.

This medicine is presented in a 30-milliliter spray container with a spray device.

Marketing authorization holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturers

Laboratorios ERN, S.A.

Gorcs Lladó, 188.

08210 - Barberá del Vallés

Barcelona

Spain

Date of last revision of this leaflet: November 2013.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es