EBERNET 10 MG/G CREAM

Introduction

Package Leaflet: Information for the User

Ebernet 10 mg/g Cream

Eberconazole

Read the 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 or pharmacist.

??This medication has been prescribed to you, 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 or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ebernet 10 mg/g Cream and what is it used for
2. What you need to know before using Ebernet 10 mg/g Cream
3. How to use Ebernet 10 mg/g Cream
4. Possible side effects
5. Storage of Ebernet 10 mg/g Cream
6. Contents of the pack and further information

1. What is Ebernet 10 mg/g Cream and what is it used for

This medication belongs to a group of antifungal medications known as imidazole derivatives.

It is indicated for the cutaneous treatment of the following fungal infections: such as Tinea corporis (body ringworm), Tinea cruris (jock itch)and Tinea pedis (athlete's foot).

2. What you need to know before using Ebernet 10 mg/g Cream

Do not use Ebernet 10 mg/g Cream

??If you are allergic to eberconazole, other antifungal medications of the same class, or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Ebernet 10 mg/g Cream.

??If the cream comes into contact with your eyes when applying it, rinse them with plenty of water.

??If you experience skin irritation after using the cream, consult your doctor in this case.

Do not use non-breathable bandages on the infected area, as this may increase skin irritation. Do not apply this medication to mucous membranes.

Using Ebernet 10 mg/g Cream with other medications

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

Do not use Ebernet 10 mg/g Cream with other topical preparations without consulting your doctor or pharmacist.

Pregnancy and Breastfeeding

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. Your doctor will determine whether it is appropriate to use this medication during pregnancy or breastfeeding.

Driving and Using Machines

Using Ebernet 10 mg/g Cream does not affect your ability to drive or operate machinery.

Ebernet 10 mg/g Cream contains methylparaben (E-218) and cetearyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E218).

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

3. How to use Ebernet 10 mg/g Cream

Follow your doctor's or pharmacist's instructions for using this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Administration: Topical use.

The recommended dose is:

Adults and Elderly Patients

It should be applied twice a day for 4 weeks. The cream should be applied in sufficient quantity to cover the lesion and surrounding area and spread with a gentle massage. For lesions located in skin folds, a small amount of cream should be applied to avoid skin maceration.

It is necessary to close the tube tightly after each application.

Adequate hygiene is recommended to prevent the possibility of a new infection.

Your doctor will indicate the duration of treatment with this medication. Do not stop treatment prematurely, as the infection may recur. If you do not observe clinical improvement after 4 weeks, consult your doctor.

Renal and Hepatic Impairment

No dose adjustment is necessary.

If you use more Ebernet 10 mg/g Cream than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Ebernet 10 mg/g Cream

If you have missed an application, apply the cream as soon as you remember. If it is almost time for the next application, wait until then. Do not use a double amount of cream to make up for the missed application.

If you have any other questions about using this product, ask your doctor or pharmacist.

4. Possible Side Effects

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

The most common side effects are mild and transient and occur at the application site. The following side effects have been reported frequently: redness and itching. Less frequently reported side effects include: eczema, skin peeling, folliculitis (inflammation of the hair follicles), and pustules.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects 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 Ebernet 10 mg/g Cream

Store below 30°C.

Keep this medication out of the sight and reach of children.

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Ebernet 10 mg/g Cream

The active ingredient is eberconazole. Each gram of cream contains 10 mg of eberconazole (as nitrate).

The other components are methylparaben (E-218), cetearyl alcohol, polyglycolic acid esters, decyl oleate, propylene glycol, formaldehyde-releasing glycerol, glycerol (E-422), polyacrylamide, tromethamine, and purified water.

Appearance of the Product and Packaging Contents

Ebernet 10 mg/g Cream has a viscous appearance and is white in color. It is available in 30-gram and 60-gram tubes.

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

SPAIN

Date of the Last Revision of this Package Leaflet: March 2004

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/