KETOCONAZOL KORHISPANA 20 mg/g GEL

Introduction

Package Leaflet: Information for the User

Ketoconazol Korhispana 20 mg/g Gel EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Ketoconazol has antifungal action against dermatophytes such as Trichophyton rubrum, T. mentagrophytesand T. tonsurans, Epidermophyton floccosumand Microsporum canis, against yeasts such as Candida albicansand C. tropicalisand against Malassezia ovaleand M. orbiculare.

Ketoconazol Korhispana is indicated for the topical treatment of seborrheic dermatitis, pityriasis capitis (dandruff) and pityriasis versicolor in localized areas of the body.

2. What you need to know before you use Ketoconazol Korhispana

Do not use Ketoconazol Korhispana

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ketoconazol Korhispana.

Avoid contact with the eyes. In case of accidental contact, rinse your eyes with water.

Children

The safety and efficacy of ketoconazol gel in children have not been established.

Other medicines and Ketoconazol Korhispana

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

If you are or have been treated with a topical corticosteroid. It is recommended to withdraw the corticosteroid 2 weeks before starting the use of Ketoconazol Korhispana, to prevent steroid-induced allergies.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Since ketoconazol is not absorbed through the skin after topical application, pregnancy and breast-feeding are not contraindications for the use of ketoconazol gel. However, caution is recommended.

Driving and using machines

Since ketoconazol is not absorbed through the skin after topical application, no effects on the ability to drive and use machines are expected.

3. How to use Ketoconazol Korhispana

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

Remember to use your medicine.

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

If you think that the action of Ketoconazol Korhispana is too strong or too weak, tell your doctor or pharmacist.

Ketoconazol Korhispana is applied to the skin or scalp.

Treat the affected areas of the skin or scalp by applying it and leaving it on for 3 to 5 minutes before rinsing. The scalp should be washed thoroughly, not just the hair. The amount of gel that fits in the palm of your hand is enough for one wash.

For the treatment of Pityriasis versicolor, apply once a day for 5 days.

For the treatment of Seborrheic dermatitis and pityriasis capitis (dandruff), apply twice a week for 2-4 weeks.

If no clinical improvement is observed after 4 weeks of treatment, consult your doctor.

It is essential that you maintain general hygiene measures to avoid reinfection.

If you use more Ketoconazol Korhispana than you should

If you have used Ketoconazol Korhispana more than you should, consult your doctor or pharmacist immediately. It is unlikely that intoxication will occur since ketoconazol is not absorbed through the skin.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Do not induce vomiting or perform gastric lavage to avoid aspiration.

If you forget to use Ketoconazol Korhispana

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.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Since ketoconazol is not absorbed through the skin after topical application, possible side effects only occur in the area of application, and may include a burning sensation, pruritus or contact dermatitis (due to irritation or allergy). Rarely, the appearance of greasy or dry hair has been observed.

It is often associated with seborrheic dermatitis and dandruff an increase in hair loss and rarely associated with the use of ketoconazol.

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

If you notice any other reaction not mentioned in this leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketoconazol Korhispana

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

Do not store above 30 ºC.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Ketoconazol Korhispana

• The active substance is ketoconazol. Each gram of gel contains 20 mg of ketoconazol.
• The other ingredients (excipients) are: sodium lauryl ether sulfate; disodium lauryl ether sulfosuccinate; monoethanolamide of colza oil fatty acids, ethoxylated; hydrolyzed collagen; methylglucoside dioleate polyethylene glycol 120; hydrochloric acid; imidazolidinyl urea; perfume; erythrosine (E127); sodium chloride and purified water.

Appearance and packaging of the product

Ketoconazol Korhispana is presented as a gel in 100 ml containers.

Marketing authorization holder and manufacturer

Marketing authorization holder

KORHISPANA, S.L.

Ctra. de Castellvell, 24

43206 Reus (Tarragona)

Phone: 977 333 211

Spain

Manufacturer

Laboratorios FELTOR, S.A.

Polígono Industrial Moli de les Planes

C/ Roques Blanques, 3-5

08470 Sant Celoni (BARCELONA)

Spain

Date of last revision of this leaflet: August 2024