LEVELINA 10 mg/g CUTANEOUS POWDER

Introduction

Package Leaflet: Information for the User

Levelina 10 mg/g Cutaneous Powder

Bifonazole

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package 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 starting to use Levelina
3. How to use Levelina
4. Possible side effects
5. Storage of Levelina
6. Package Contents and Additional Information

1. What is Levelina and what is it used for

Bifonazole belongs to the group of medications called antifungals (imidazole derivatives), which are used to treat skin infections caused by fungi and yeast.

This medication is indicated for the treatmentof the following superficial skin infections:

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

You should consult a doctor if your condition worsens or does not improve after completing the 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 any of the other components of this medication (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 with plenty of water and consult an ophthalmologist if necessary.

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

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

Children

No data are available.

Using Levelina with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications or may need to use any other medication.

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 medication.

As a precautionary measure, it is preferable to avoid using this medication during pregnancy.

It is not known whether bifonazole passes into breast milk; therefore, your doctor will decide whether it is necessary 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

The influence of Levelina on the ability to drive or use machines is negligible or insignificant.

3. How to use Levelina

Follow the administration instructions for this medication exactly 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.
• Candidal balanitis: 2 to 4 weeks.

Method of Use

For cutaneous use.

Wash and dry the infected skin carefully before each application. Sprinkle a thin layer of this medication over the affected area.

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 medication 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 for the next application is near, skip the forgotten dose and apply the next dose.

If you interrupt treatment with Levelina

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effectshave been reported with an unknown frequency (cannot be estimated from the available data):

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

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levelina

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levelina

• The active ingredient is bifonazole. Each gram of cutaneous powder contains 10 milligrams of bifonazole.
• The other components (excipients) are colloidal silica, zinc oxide, and talc (E-553b).

Appearance of the Product and Package Contents

White powder.

This medication is presented in a 20-gram spray container.

Marketing Authorization Holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturers

Laboratorios ERN, S.A.

Gorgs Lladó, 188.

08210 - Barberá del Vallés

Barcelona

Spain

Date of the Last Revision of this Package Leaflet: November 2013.

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