Patient Information Leaflet

Ketoconazole Abamed 20 mg/g Cream

Ketoconazole

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, ask 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 Ketoconazole Abamed and what it is used for

2.What you need to know before using Ketoconazole Abamed

3.How to use Ketoconazole Abamed

4.Possible side effects

5.Storage of Ketoconazole Abamed

6.Contents of the pack and additional information

Ketoconazol belongs to a group of medications known as antifungals (medications that are used to treat infections caused by fungi and yeasts).They are used to treat infections produced by fungi and yeasts).

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

• Dandruff: a disease that can affect the trunk (body dandruff), groin (inguinal dandruff), feet (foot dandruff) and hands (hand dandruff).
• 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 patches on the skin.
• Seborrheic dermatitis: a disease that primarily affects the face and chest and causes redness and skin peeling.

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.

Do not ingest.

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

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

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 ketoconazole during pregnancy or breastfeeding, although this medication is not absorbed after its application to the skin.

Driving and operating machines

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

Ketoconazol Abamed contains bronopol

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

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.

This medication will be applied once a day (preferably at night). In severe cases, and according to medical criteria, this 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
• Ingrown ringworm: 2-4 weeks
• Ringworm of the feet and hands: 4-6 weeks
• Cutaneous candidiasis: 2 to 3 weeks
• Pityriasis versicolor : 2 to 3 weeks
• Seborrheic dermatitis: 2 to 4 weeks

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

Form of use

Cutaneous use.

After applying general hygiene measures to prevent re-infection, apply this medication to the skin in sufficient quantity to cover the affected area and the surrounding skin.

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 Toxicological 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 forgot to use Ketoconazol Abamed

Do not apply 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 all people will experience them.

Adverse effects occur at the application site, and may include a sensation of burning on the skin, itching, localized eczema (contact dermatitis), and allergic reactions (hypersensitivity).

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 the Spanish 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 use this medication after the expiration date that appears on the tube after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Ketoconazole Abamed Composition

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

Appearance of the product and contents of the packaging

White and homogeneous cream.

This medication is presented in 30 g tubes.

Marketing Authorization Holder

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908- L’Hospitalet de Llobregat

Barcelona

Spain

Responsible for Manufacturing

FARMASIERRA MANUFACTURING, S.L.

Carretera de Irún, km 26,200

28700 - San Sebastián de los Reyes

Madrid

Last review date of this leaflet: October 2013

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