Patient Information Leaflet

Ketoconazol Abamed 20 mg/g Gel EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they 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 leaflet. See section 4.

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

2.What you need to know before starting to use Ketoconazol Abamed

3.How to use Ketoconazol Abamed

4.Possible side effects

5.Storage of Ketoconazol Abamed

6.Contents of the pack and additional information

Ketoconazol belongs to a group of medications called antifungals (used to treat infections caused by fungi and yeasts).

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

• Dermatitis seborreica, a disease that primarily affects the face and chest and causes redness and skin peeling.
• Pityriasis versicolor, a disease characterized by the appearance of small, irregular, brownish or whitish areas on the trunk.
• Pityriasis capitis(dandruff), characterized by the appearance of skin flakes on the scalp.

Consult a doctor if it worsens or does not improve after 4 weeks of treatment.

Do not use Ketoconazol Abamed:

• If you are allergic to ketoconazole or to 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 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 medication to prevent steroid allergy.

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

Use of Ketoconazol Abamed with other medications

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machines:

The influence of this medication on the ability to drive and operate machines is negligible or insignificant.

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.

Your doctor will indicate the duration of treatment with this medication. Do not discontinue treatment beforehand, as the infection will recur.

The recommended frequency of application and duration of treatment is for:

• Pityriasis versicolor : once a day, for 5 days.
• Dermatitis seborreica and Pityriasis capitis : twice a week, for 2-4 weeks.

Form of use

Cutaneous use.

After applying general hygiene measures to prevent re-infection, wash the affected skin areas or scalp, allowing the medication 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 not induce vomiting or perform gastric lavage to avoid aspiration.

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 Ketoconazol Abamed

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

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

Adverse effects may occur at the application site, potentially resulting in a sensation of burning on the skin, itching at the application site (pruritus), or localized eczema (contact dermatitis), due to irritation or allergy. In rare cases, the appearance of greasy or dry hair has been observed.

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

Often associated with seborrheic dermatitis and dandruff, an increase in hair loss has been observed, and rarely associated with the use of this medication.

Reporting 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 prospectus. You can also report them directly through theSpanish System for 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.

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

Do not store at a temperature above 30 °C.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacyAsk your pharmacist how to dispose ofthe packaging and medicines you no longer need. In this way, you will help protect the environment.

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 sulfate, sodium lauryl sulfosuccinate, monoethanolamine oleate, ethoxylated, hydrolyzed collagen, macrogol 120 dioleate of methylglucoside, hydrochloric acid, imidurea, perfume PLB 176, erythrosine (E-127), and purified water.

Appearance of the product and contents of the packaging

Red gel.

This medication is presented in 100 ml bottles.

Holder of the marketing authorization

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908-L’Hospitalet de Llobregat

(Barcelona) Spain

Responsible for manufacturing

Laboratorios Feltor

Polígono Industrial Molí de les Planes

c/ Roques Blanques 3-5

08470 -Sant Celoni

(Barcelona)

Last review date of this leaflet: August 2013

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