Ketoconazole Abamed 20 mg/g gel EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Ketoconazol Abamed 20 mg/g Gel EFG
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 you should not give it 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.
Leaflet contents
- What Ketoconazol Abamed is and what it is used for
- What you need to know before using Ketoconazol Abamed
- How to use Ketoconazol Abamed
- Possible side effects
- How to store Ketoconazol Abamed
- 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 (used to treat infections caused by fungi and yeasts).
Ketoconazol Abamed is indicated for the treatment of the following skin infections:
- Seborrheic dermatitis, a condition affecting mainly the face and chest, causing redness and flaking of the skin.
- Pityriasis versicolor, a condition characterized by small, irregular, brownish or whitish patches appearing across the trunk.
- Pityriasis capitis (dandruff), which is characterized by flaking of the scalp.
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 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 gel.
If you are or have been undergoing treatment with a topical corticosteroid, it is recommended to discontinue the corticosteroid two weeks before starting this medicine to prevent steroid-induced allergies.
For external use only. Contact with the eyes should be avoided. In case of accidental contact, wash eyes thoroughly with water.
Using Ketoconazole Abamed with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may 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 using this medicine during pregnancy or breastfeeding, although ketoconazole is not absorbed through the skin following topical application.
Driving and using machines:
The effect of this medicine on the ability to drive and use machines is negligible or none.
3. How to use Ketoconazole Abamed
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the duration of treatment with this medicine. Do not stop treatment early, as the infection may recur.
The recommended frequency of application and duration of treatment is as follows:
- Pityriasis versicolor: once daily for 5 days.
- Seborrheic dermatitis and Pityriasis capitis: twice weekly for 2-4 weeks.
Method of use
For topical use.
After applying general hygiene measures to prevent reinfection, wash the affected skin or scalp areas, leaving the medicine to act for 3 to 5 minutes before rinsing.
If you use more Ketoconazole Abamed than you should
If more Ketoconazole Abamed is applied 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Ketoconazole Abamed
Do not use 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 cause adverse effects, although not everyone will experience them.
Possible adverse effects occur at the site of application 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. In rare cases, oily or dry hair has been observed.
Rarely, mainly in chemically damaged hair or grey hair, hair discoloration has been observed.
Hair loss is often associated with seborrheic dermatitis and dandruff, and is rarely associated with the use of this medicine.
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 Medicinal Products: 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 store above 30 °C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to 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 Ketoconazol Abamed
- The active substance is Ketoconazole. Each gram of gel contains 20 mg of ketoconazole.
- The other components (excipients) are: sodium laureth sulfate, disodium laureth sulfosuccinate, monoethanolamide of fatty acids from rapeseed oil ethoxylates, hydrolyzed collagen, methylglucose dioleate macrogol 120, hydrochloric acid, imidourea, perfume PLB 176, erythrosine (E-127), and purified water.
Appearance of the medicine and contents of the pack
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 most recent review of this leaflet: August 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/