Label: Information for the User

Levelina 10 mg/g Cream

Bifonazole

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

• Keep this label, 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 alone, 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 any adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this label. See section 4.

1.What is Levelina and how is it used

2.What you need to know before starting to use Levelina

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 (jock 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)
• Balanitis candidiásica (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 bifonazol, 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, wash 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 used recently ormay have 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 the use of this medication during pregnancy.

The passage of bifonazol to breast milk is unknown, therefore your doctor will decide if it is necessary 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.

Levelina contains cetoestearic alcohol, methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)

This medication may produce local skin reactions (such as contact dermatitis) because it contains cetoestearic alcohol.

It may produce allergic reactions (possibly delayed) because it containsmethyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

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

Levelina should be applied once a day, preferably at night, before going to bed.

Therecommended durationoftreatmentis:

• Ringworm of the foot and hand ringworm: 3 weeks.
• Body ringworm and inguinal ringworm:2 to3 weeks.

• Pityriasis versicolor: 2 weeks.
• Cutaneous candidiasis:2 to4 weeks.
• Candidal balanitis:2 to4 weeks.

Form of use

Cutaneous use.

Wash and dry the infected skin carefully before each application. Apply a sufficient amount of cream to cover the affected area and massage until fully absorbed.

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 apply 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 next application time 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 may 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
• Skin exfoliation (peeling of the skin)
• 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 about 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 principle is bifonazol. Each gram of cream contains 10 milligrams of bifonazol.
• The other components (excipients) are macrogol 400, stearate of polyoxyethylene 40 (E-431), cetearyl alcohol, liquid paraffin, white vaseline, carbomer, sodium hydroxide (E-524), disodium edetate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216) and purified water.

Appearance of the product and content of the packaging

Homogeneous cream, white or light yellowish.

This medicine is presented in tubes of 30 grams.

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Responsible for manufacturing

Laboratorios ERN, S.A.

C/ Gorgs Lladó, 188

Polígono Industrial Can Salvatella

08210 Barberá del Vallés - Barcelona

Spain

Last review date of this leaflet: November 2013.

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