Ketoconazole Abamed 20 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ketoconazol Abamed 20 mg/g Cream

 Ketoconazol

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any 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

1. What Ketoconazol Abamed is and what it is used for
2. What you need to know before using Ketoconazol Abamed
3. How to use Ketoconazol Abamed
4. Possible side effects
5. How to store Ketoconazol Abamed
6. Contents of the pack and other information

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

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

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

• Tinea infections: a condition that may affect the trunk (tinea corporis), groin (tinea cruris), feet (tinea pedis), and hands (tinea manuum).
• Cutaneous candidiasis: infections that usually affect warm, moist areas of the skin and mucous membranes.
• Pityriasis versicolor: a condition characterized by the appearance of discolored patches on the skin.
• Seborrheic dermatitis: a condition that mainly affects the face and chest, causing redness and flaking 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 starting to use Ketoconazole Abamed

Do not use Ketoconazole Abamed:

• If you are allergic to ketoconazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ketoconazole Abamed.

Do not ingest.

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

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

Use of Ketoconazole Abamed with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid the use of ketoconazole during pregnancy or breastfeeding, although this medicine is not absorbed following application to the skin.

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is none or negligible.

Ketoconazole Abamed contains bronopol

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

3. How to use Ketoconazole Abamed

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine should be applied once daily (preferably at night). In severe cases, and according to medical judgment, the dosage may be increased to twice daily (morning and night).

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

• Tinea corporis (body ringworm): 3–4 weeks
• Tinea cruris (jock itch): 2–4 weeks
• Tinea pedis (athlete’s foot) and tinea manuum (hand ringworm): 4–6 weeks
• Cutaneous candidiasis: 2 to 3 weeks
• Pityriasis versicolor: 2 to 3 weeks
• Seborrheic dermatitis: 2 to 4 weeks

Your doctor will determine the appropriate duration of treatment with this medicine. Do not stop treatment early, as the infection may recur.

Method of use

For cutaneous use only.

After applying general hygiene measures to prevent reinfection, apply the medicine to the skin in sufficient quantity to cover the affected area and surrounding skin.

If you use more Ketoconazole Abamed than you should

If more Ketoconazole Abamed is applied than prescribed by your doctor, you may experience a burning sensation, redness, or swelling, which will resolve once treatment is discontinued.

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

If you forget to use Ketoconazole Abamed

Do not apply a double dose to make up for missed doses. Continue with your usual dosing schedule. If you have missed several doses, consult your doctor or pharmacist immediately.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

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

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 may 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 Ketoconazole Abamed

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the tube following EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ketoconazole Abamed

• The active substance is ketoconazole. Each gram of cream contains 20 mg of ketoconazole.
• The other components (excipients) are: polyglycol stearate palmitate (polyethylene glycol-6 stearate, glyceryl monostearate 40-55, macrogol cetyl ether, and macrogol stearyl ether), glyceryl stearate palmitate (glyceryl monostearate 40-55 (type I), mono- and diglycerides), disodium edetate, sodium metabisulfite, sorbitol, bronopol, 2,4-dichlorobenzyl alcohol, triethanolamine, and purified water.

Appearance of the medicine and contents of the pack

White, homogeneous cream.

This medicine 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

28706 - San Sebastián de los Reyes

Madrid

Date of the most recent revision of this leaflet: October 2013

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.