Ketoconazole Korhispana 20 mg/g gel EFG

Package leaflet: Information for the user

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 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. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any serious adverse reactions or any adverse reaction not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Ketoconazol Korhispana 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).

Ketoconazole has antifungal activity against dermatophytes such as Trichophyton rubrum, T. mentagrophytes and T. tonsurans, Epidermophyton floccosum and Microsporum canis, against yeasts such as Candida albicans and C. tropicalis, and against Malassezia ovale and 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 using Ketoconazole Korhispana

Do not use Ketoconazole Korhispana

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 Korhispana.

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

Children

The safety and efficacy of ketoconazole gel in children has not been established.

Other medicines and Ketoconazol Korhispana

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

If you are or have been receiving treatment with a topical corticosteroid, it is recommended to discontinue the corticosteroid two weeks before starting treatment with Ketoconazol Korhispana to prevent steroid-induced allergies.

Pregnancy and lactation

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.

Since ketoconazole is not absorbed through the skin following topical application, pregnancy and lactancia do not constitute a contraindication for the use of ketoconazole gel. However, caution is recommended in its use.

Driving and operating machinery

Since ketoconazole is not absorbed through the skin following topical application, effects on the ability to drive and operate machinery are not expected.

3. How to use Ketoconazol Korhispana

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

Remember to use your medicine.

Your doctor will indicate how long your treatment with Ketoconazol Korhispana should last. Do not stop treatment early, as the infection may return.

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

Ketoconazol Korhispana is applied to the skin or scalp.

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

For the treatment of pityriasis versicolor, apply once daily 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 the doctor who prescribed the treatment.

It is essential to maintain general hygiene measures to prevent reinfection.

If you use more Ketoconazol Korhispana than you should

If you have used more Ketoconazol Korhispana than recommended, consult your doctor or pharmacist immediately. Poisoning is unlikely because ketoconazole 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested. Do not induce vomiting or perform gastric lavage, as this may cause aspiration.

If you forget to use Ketoconazol Korhispana

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.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. Since ketoconazole is not absorbed after application to the skin, any possible adverse effects occur only at the site of application and may include local burning sensation, pruritus, or contact dermatitis (due to irritation or allergy). Rarely, oily or dry hair has been observed.

Increased hair shedding is often associated with seborrheic dermatitis and dandruff, and only rarely associated with the use of ketoconazole.

Discoloration of hair has been observed rarely, mainly in hair that has been chemically damaged or in grey hair.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Korhispana

Keep this medicine out of the 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 in household waste. Dispose of unused medicines and their containers at the SIGRE point located at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ketoconazol Korhispana

• 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; fatty acid monoethanolamide of ethoxylated rapeseed oil; hydrolyzed collagen; polyethylene glycol 120 methyl glucose dioleate; hydrochloric acid; imidazolidinyl urea; fragrance; erythrosine (E127); sodium chloride; purified water.

Appearance of the product and contents of the pack

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)

Telephone: 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 the most recent review of this leaflet: August 2024