LEVELINA 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Levelina 10 mg/g cream

Bifonazole

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 use 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

Bifonazole 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 used to treat 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(a condition characterized by the appearance of patches on the skin)
• Cutaneous candidiasis (infections that affect moist and warm areas of the skin, such as the groin and armpits)
• Candidal balanitis (inflammation of the glans penis)

You should consult a doctor if your symptoms worsen or do not improve after completing the treatment.

2. What you need to know before you use Levelina

Do not use Levelina

• if you are allergic (hypersensitive) to bifonazole, imidazoles in general, or any of the other ingredients 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 the eyes. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.

If an allergic reaction occurs during use, treatment should be discontinued and your doctor consulted 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 or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

It is not known whether bifonazole passes into breast milk. Your doctor will decide whether you should stop breastfeeding or stop treatment, considering the benefit of breastfeeding for the baby and the benefit of treatment for the mother.

Driving and using machines

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

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

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl stearyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to use Levelina

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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. 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 hospital casualty department or call the National Poison Information Service on 91 562 04 20, quoting the medicine and the amount taken.

If you forget to use Levelina

Do not apply a double dose to make up for forgotten doses.

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

If you stop using Levelina

Do not stop treatment without consulting your doctor, as your symptoms 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 not known (cannot be estimated 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)
• Dryness of the skin
• Skin irritation
• Maceration of the skin
• Burning sensation
• Pain and edema (swelling) at the application site

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 precautions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month stated.

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 bifonazole. Each gram of cream contains 10 milligrams of bifonazole.
• The other ingredients (excipients) are macrogol 400, polyoxyethylene stearyl ether 40 (E-431), cetyl stearyl alcohol, liquid paraffin, white petrolatum, carbomer, sodium hydroxide (E-524), disodium edetate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and purified water.

Appearance and packaging of the product

Homogeneous, white or yellowish-white cream.

This medicine is available in 30-gram tubes.

Marketing authorization holder

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturer

Laboratorios ERN, S.A.

C/ Gorgs Lladó, 188

Polígono Industrial Can Salvatella

08210 Barberá del Vallés - Barcelona

Spain

Date of last revision of this leaflet: November 2013.

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