Ebernet 10 mg/g crema

Product Information for the User

Ebernet 10 mg/g Cream

Eberconazol

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

Keep this product information, 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 other people who have the same symptoms as you, as it may harm them.

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

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

2. What you need to know before starting to use 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 package and additional information

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

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

Do not use Ebernet 10 mg/g cream

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

Warnings and precautions

Consult your doctor or pharmacistbefore starting to use Ebernet 10 mg/g cream.

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

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

Do not use bandagesthat do not allow the infected area to breathe, as this could increase skin irritation. Do not apply this medication to mucous membranes.

Using Ebernet 10 mg/g cream with other medications

Inform your doctor or pharmacist if you are using, have used recently 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, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will determine on a case-by-case basis whether it is advisable to use this medication during pregnancy or breastfeeding.

Driving and operating machinery

The use of Ebernet 10 mg/g cream does not affect your ability to drive vehicles or operate machines.

Ebernet 10 mg/g cream contains phenoxyethanol (E 218) and cetearyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains phenoxyethanol (E 218).

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, 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 will be applied in sufficient quantity to cover the lesion and surrounding area, and will be spread with the help of a gentle massage. In localized lesions on skin folds, a small amount of cream will be applied to avoid skin maceration.

The tube must be closed tightly after each application.

It is recommended to maintain good hygiene to prevent the possibility of a new infection.

Your doctor will indicate the duration of treatment with this medication. Do not discontinue treatment as the infection may recur. If no clinical improvement is observed after 4 weeks, consult your doctor.

Renal and hepatic insufficiency

No dose adjustment is required.

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

If you forgot to use Ebernet 10 mg/g cream

If you have forgotten a dose, apply the cream as soon as you remember. If there is little time left for the next application, wait until then. Do not use double the amount of cream to compensate for the missed dose.

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

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

The most common ones are mild and transient and occur at the skin level, in the application area. The following adverse effects have been described frequently: redness and itching. Also, the following adverse effects have been described infrequently: eczema, skin peeling, folliculitis (inflammation of the follicles) and pustules

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System of 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.

Store below 30°C.

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

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

Do not dispose of medications through the drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

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), cetoestearic alcohol, polyglycolic esters of fatty acids, decylo oleate, propylene glycol, glycerol formaldehyde, glycerol (E-422), polyacrylamide, triethanolamine, and purified water.

Appearance of the product and content of the packaging

Ebernet 10 mg/g cream has a viscous and white appearance. It is presented in tubes of 30 and 60 grams.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

SPAIN

Last review date of this leaflet: March 2004

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