KETOCONAZOL ABAMED 20 mg/g CREAM

Introduction

Patient Information Leaflet

Ketoconazol Abamed 20 mg/g Cream

Ketoconazol

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

• Keep this 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 only, 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 not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Ketoconazol Abamed and what is it used for
2. What you need to know before using Ketoconazol Abamed
3. How to use Ketoconazol Abamed
4. Possible side effects
5. Storage of Ketoconazol Abamed
6. Package contents and additional information

1. What is Ketoconazol Abamed and what is it used for

Ketoconazol belongs to the group of medications known as antifungals (medications used to treat infections caused by fungi and yeast).

Ketoconazol Abamed is indicated for the treatment of the following superficial skin infections:

• Tinea: a disease that can affect the trunk (tinea corporis), groin (tinea cruris), feet (tinea pedis), and hands (tinea manuum).
• Cutaneous candidiasis: infections that typically affect moist and warm areas of the skin and mucous membranes.
• Pityriasis versicolor: a disease characterized by the appearance of spots on the skin.
• Seborrheic dermatitis: a disease that mainly affects the face and chest, causing redness and scaling of the skin.

You should consult a doctor if your condition worsens or does not improve after 4 weeks of treatment.

2. What you need to know before using Ketoconazol Abamed

Do not use Ketoconazol Abamed:

• If you are allergic to ketoconazol 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 Ketoconazol Abamed.

Do not ingest.

For external use only. Avoid contact with the eyes. In case of accidental contact, rinse your eyes with water.

If you are being treated or have recently been treated with topical corticosteroids, consult your doctor, as the corticosteroid treatment should be discontinued 2 weeks before starting the use of this medication.

Using Ketoconazol Abamed with other medications

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

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.

As a precautionary measure, it is preferable to avoid the use of ketoconazol during pregnancy or breastfeeding, although this medication is not absorbed through the skin after application.

Driving and using machines

The influence of this medication on the ability to drive or use machines is negligible.

Ketoconazol Abamed contains bronopol

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

3. How to use Ketoconazol Abamed

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

This medication should be applied once a day (preferably at night). In severe cases, and according to medical criteria, the dosage may be increased to twice a day (morning and night).

The recommended treatment duration will depend on the type and severity of the infection:

• Body ringworm: 3-4 weeks
• Groin ringworm: 2-4 weeks
• Foot and hand ringworm: 4-6 weeks
• Cutaneous candidiasis: 2-3 weeks
• Pityriasis versicolor: 2-3 weeks
• Seborrheic dermatitis: 2-4 weeks

Your doctor will indicate the duration of treatment with this medication. Do not stop treatment before the recommended duration, as the infection may recur.

Method of use

For cutaneous use.

After applying general hygiene measures to avoid reinfection, apply this medication to the affected skin area and surrounding skin in sufficient quantity to cover it.

If you use more Ketoconazol Abamed than you should

If you apply more Ketoconazol Abamed than your doctor has indicated, you may feel a burning sensation, redness, or swelling that will disappear after stopping treatment.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested. Do not induce vomiting or perform gastric lavage to avoid aspiration.

If you forget to use Ketoconazol Abamed

Do not apply a double dose to make up for forgotten doses. Continue with your usual routine, and if you have forgotten many doses, consult your doctor or pharmacist immediately.

4. Possible side effects

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

Side effects occur in the application area and may include a burning sensation on the skin, itching, localized eczema (contact dermatitis), and allergic reactions (hypersensitivity).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance 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 Ketoconazol Abamed

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

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

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Ketoconazol Abamed

• The active ingredient is ketoconazol. Each gram of cream contains 20 mg of ketoconazol.
• The other components (excipients) are: polyglycol stearate (polyethylene glycol-6 stearate, glycerol 40-55 monostearate, keto-stearic ether of macrogol, and stearic ether of macrogol), glycerol stearate (glycerol 40-55 monostearate (type I), mono- and diglycerides), disodium edetate, sodium metabisulfite, sorbitol, bronopol, 2,4-dichlorobenzyl alcohol, tromethamine, and purified water.

Appearance of the product and package contents

White and homogeneous cream.

This medication is available in 30 g tubes.

Marketing authorization holder

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908- L’Hospitalet de Llobregat

Barcelona

Spain

Manufacturer

FARMASIERRA MANUFACTURING, S.L.

Carretera de Irún, km 26,200

28700 - San Sebastián de los Reyes

Madrid

Date of the last revision of this leaflet: October 2013

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/.