Ebernet 10 mg/g cream
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Ebernet 10 mg/g cream is and what it is 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 adverse effects
- 5. Storage of Ebernet 10 mg/g cream
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ebernet 10 mg/g cream
Eberconazole
Read the entire 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 questions, ask your doctor or pharmacist.
??This medicine has been prescribed for you; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ebernet 10 mg/g cream is and what it is used for
- What you need to know before using Ebernet 10 mg/g cream
- How to use Ebernet 10 mg/g cream
- Possible adverse effects
- Storage of Ebernet 10 mg/g cream
- Contents of the pack and other information
1. What Ebernet 10 mg/g cream is and what it is used for
This medicine belongs to a group of antifungal medicines known as imidazole derivatives.
It is indicated for the cutaneous treatment of the following fungal infections: such as Tinea corporis (ringworm of the body), 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, to other antifungal agents of the same class, or to any of the other components of this medicine (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, rinse them thoroughly with plenty of water.
??If you experience skin irritation after using the cream, consult your doctor.
Do not use occlusive dressings (non-breathable) on the infected area, as this may increase skin irritation. Do not apply this medicine to mucous membranes.
Use of Ebernet 10 mg/g cream with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will determine whether it is appropriate for you to use this medicine during pregnancy or breastfeeding.
Driving and use of machines
The use of Ebernet 10 mg/g cream does not affect the ability to drive or operate machinery.
Ebernet 10 mg/g cream contains methyl parahydroxybenzoate (E-218) and cetostearyl alcohol.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218).
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
3. How to use Ebernet 10 mg/g cream
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Administration: Cutaneous use
Recommended dose:
Adults and elderly patients
Apply twice daily for 4 weeks. Apply a sufficient amount of cream to cover the lesion and surrounding area, spreading it gently with light massage. For lesions located in skin folds, apply a small amount of cream to avoid skin maceration.
It is necessary to close the tube tightly after each application.
Maintain adequate hygiene to help prevent the possibility of a new infection.
Your doctor will determine the duration of treatment with this medicine. Do not stop treatment prematurely, as the infection may recur. If no clinical improvement is observed after 4 weeks, consult your doctor.
Renal and hepatic impairment
No dose adjustment is required.
If you use more Ebernet 10 mg/g cream than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Ebernet 10 mg/g cream
If you miss a dose, apply the cream as soon as you remember. If it is almost time for your next dose, wait until then. Do not use a double amount of cream to make up for the missed dose.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The most common are mild and transient and occur at the site of application on the skin. The following adverse effects have been frequently reported: redness and itching. Less frequently reported effects include: eczema, skin peeling, folliculitis (inflammation of the follicles), and pustules.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ebernet 10 mg/g cream
Store below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point 
in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Ebernet 10 mg/g cream
The active substance is eberconazole. Each gram of cream contains 10 mg of eberconazole (as nitrate).
The other components are methyl parahydroxybenzoate (E-218), cetostearyl alcohol, polyglycolyzed fatty acid esters, decyl oleate, propylene glycol, glycerol formaldehyde, glycerol (E-422), polyacrylamide, tromethamine and purified water.
Appearance of the medicinal product and contents of the pack
Ebernet 10 mg/g cream is a viscous, white cream. It is supplied in tubes of 30 and 60 grams.
Marketing Authorization Holder and Manufacturer
Laboratorios Salvat, S.A.
C/ Gall, 30-36 - 08950
Esplugues de Llobregat (Barcelona)
SPAIN
Date of the most recent review of this summary: March 2004
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/