Prospect: Information for the user

Levelina 10 mg/g topical powder

Bifonazol

Read this prospect carefullybefore starting to use this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they do not appear in this prospect. See section 4.

1.What is Levelina and how is it used

2.What you need to know before starting to useLevelina

3.How to use Levelina

4.Possible adverse effects

5.Storage of Levelina

6.Contents of the package and additional information

Bifonazol belongs to a group of medications called antifungals (imidazolic derivatives), medications indicated for the treatment of skin infections caused by fungi and yeasts.

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

• Athlete's foot (tinea pedis) and hand tinea
• Body tinea and inguinal tinea (inguinal itch)
• Pityriasis versicolor(tinea versicolor, characterized by the appearance of patches distributed over the skin)
• Cutaneous candidiasis (infections affecting moist and warm areas of the skin and folds (inguinal and axillary areas)
• Candidal balanitis (inflammation of the glans)

Consult a doctor if it worsens or does not improve after completing the treatment.

Do not use Levelina

• if you are allergic (hypersensitive) to bifonazole, imidazoles in general, or to 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 abundant water and consult an ophthalmologist if necessary.

In case of an allergic reaction during its use, treatment should be suspended and your doctor should be consulted immediately.

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

Children

No data available.

Use of Levelina with other medications

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant,consult your doctor or pharmacist before using this medication.

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

The passage of bifonazole into breast milk is unknown, so your doctor will decide whether to interrupt breastfeeding or interrupt treatment after considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machines

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

Follow exactly the administration instructions for this medication 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 going to bed.

The recommended duration of treatment is:

• Ringworm of the foot and hand ringworm: 3 weeks.
• Body ringworm and inguinal ringworm:2 to 3 weeks.

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

Form of use

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Levelina

Do not use a double dose to compensate for the missed 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 very close, skip the missed dose and apply the next dose.

If you interrupt the treatment with Levelina

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The followingadverse effectsof unknown frequency(cannot be estimated from available data):

• Localized eczema (contact dermatitis)
• Allergic reaction
• Erythema (inflammation and redness of the skin)
• Itching
• Rash (exanthema)
• Urticaria (hives accompanied by itching)
• Blisters
• Epidermal exfoliation (skin peeling)
• Dry skin
• Dermatitis
• Skin maceration
• Burning sensation
• Pain and edema (fluid retention) at the application site

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and unused medicines at the SIGREpointofthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Levelina

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

Appearance of the product and content of the container

White powder.

This medication is presented in a 20-gram powder shaker container.

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturing responsible parties

Laboratorios ERN, S.A.

Gorgs Lladó, 188.

08210 - Barberá del Vallés

Barcelona

Spain

Last review date of this leaflet: November 2013.

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