KETOCONAZOL ABAMED 20 mg/g GEL

Introduction

Patient Information Leaflet

Ketoconazol Abamed 20 mg/g Gel EFG

Read the entire leaflet carefully before starting to use this medicine, 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 medicine 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 medicines called antifungals (used to treat infections caused by fungi and yeasts).

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

• Seborrheic dermatitis, a disease that mainly affects the face and chest, causing redness and skin peeling.
• Pityriasis versicolor, a disease characterized by the appearance of small, irregular, brown or whitish patches on the trunk.
• Pityriasis capitis(dandruff), characterized by the appearance of scalp peeling.

You should consult a doctor if your symptoms worsen or do 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 medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ketoconazol Abamed gel.

If you are or have been treated with a topical corticosteroid, it is recommended to discontinue the corticosteroid 2 weeks before starting the use of this medicine to prevent steroid-induced allergies.

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

Using Ketoconazol Abamed with other medicines

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

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 medicine.

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

Driving and using machines:

The influence of this medicine on the ability to drive and use machines is negligible or non-existent.

3. How to use Ketoconazol Abamed

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with this medicine. Do not stop treatment before, as the infection will reappear.

The frequencyof application and durationof treatment recommended is:

• Pityriasis versicolor: once a day, for 5 days.
• Seborrheic dermatitis and Pityriasis capitis: 2 times a week, for 2-4 weeks.

Method of use

Topical use.

After applying general hygiene measures to avoid reinfection, wash the affected skin or scalp areas, allowing the medicine to act for 3 to 5 minutes before rinsing.

If you use more Ketoconazol Abamed than you should

If you apply more Ketoconazol Abamed than recommended, consult your doctor or pharmacist immediately.

In case of ingestion, do notinduce vomitingor perform gastric lavage to avoid aspiration.

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 medicine and the amount ingested.

If you forget to use Ketoconazol Abamed

Do not use a double dose to make up for forgotten doses, continue with the usual schedule, and if you have forgotten many doses, consult your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Possible side effects occur in the application area, and may include a burning sensation on the skin, itching at the application site (pruritus), or localized eczema (contact dermatitis), due to irritation or allergy. Rarely, the appearance of greasy or dry hair has been observed.

Rarely, mainly in chemically damaged or gray hair, hair discoloration has been observed.

Often associated with seborrheic dermatitis and dandruff is an increase in hair loss, and rarely associated with the use of this medicine.

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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ketoconazol Abamed

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

Do not store above 30°C.

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

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

6. Package contents and additional information

Composition of Ketoconazol Abamed

• The active ingredient is Ketoconazol. Each gram of gel contains 20 mg of ketoconazol.
• The other components (excipients) are: sodium lauryl ether sulfate, disodium lauryl ether sulfosuccinate, monoethanolamide of colza oil fatty acids, ethoxylated, hydrolyzed collagen, macrogol 120 dioleate, hydrochloric acid, imidurea, perfume PLB 176, erythrosine (E-127), and purified water.

Appearance and packaging of the product

Red-colored gel.

This medicine is available in 100 ml bottles.

Marketing authorization holder

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908-L’Hospitalet de Llobregat

(Barcelona) Spain

Manufacturer

Laboratorios Feltor

Polígono Industrial Molí de les Planes

c/ Roques Blanques 3-5

08470 -Sant Celoni

(Barcelona)

Date of the last revision of this leaflet: August 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es/