Label: information for the user

Ketoconazole Korhispana 20 mg/g gel EFG

Read this label carefully before starting to use the medicine, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

- If you experience severe side effects or any side effect not mentioned in this label, inform your doctor or pharmacist. See section 4.

1.Ketoconazole Korhispana and its use.

2.What you need to know before using Ketoconazole Korhispana.

3.How to use Ketoconazole Korhispana.

4.Possible side effects.

5.Storage of Ketoconazole Korhispana.

6.Contents of the package and additional information.

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

Ketoconazol has antifungal action against dermatophytes such asTrichophyton rubrum,T. mentagrophytesyT. tonsurans,Epidermophyton floccosumyMicrosporum canis,Candida albicansyC. tropicalis,Malassezia ovaleyM. orbiculare.

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

Do Not Use Ketoconazol Korhispana

If you are allergic to ketoconazol or 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 Korhispana.

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

Children

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

Other Medications and Ketoconazol Korhispana

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and Operating Machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse again.

Remember to use your medication.

Your doctor will indicate the duration of treatment with Ketoconazol Korhispana. Do not discontinue treatment beforehand, as the infection will recur.

If you estimate that the action 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 the skin or scalp by applying the medication, allowing it to act for 3 to 5 minutes before rinsing. The scalp must be washed completely, not just the hair. The amount of gel that fits in the palm of the hand is sufficient for a wash.

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

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

In case of no clinical improvement 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 Ketoconazol Korhispana more than you should, consult your doctor or pharmacist immediately. It is unlikely that you will experience toxicity due to the fact that ketoconazole does not absorb through the skin.

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

If you forgot to use Ketoconazol Korhispana

Do not use 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.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.Since ketoconazole is not absorbed through the skin after application, possible adverse effects occur only in the application area, and may include a burning sensation, itching, 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, and an increase in hair loss, and rarely associated with the use of ketoconazole.

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

If any other reaction not described in this prospectus is observed, consult a doctor or pharmacist.

Reporting Adverse Effects

If any type of adverse effect is experienced, consult a doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. Adverse effects can also be reported directly through the Spanish System of Pharmacovigilance of Medicines 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 store at a temperature above 30 °C.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Ketoconazol Korhispana Composition

- The active ingredient is ketoconazol. Each gram of gel contains 20 mg of ketoconazol.

- The other components (excipients) are: sodium lauryl sulfate; sodium lauryl sulfosuccinate; monoethanolamide of rapeseed oil fatty acids, ethoxylated; hydrolyzed collagen; polyethylene glycol 120 methylglucoside dioleate; hydrochloric acid; imidazolidinyl urea; perfume; erythrosine (E127); sodium chloride and purified water.

Product appearance and packaging content

Ketoconazol Korhispana is presented in the form of a gel in 100 ml containers.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

KORHISPANA, S.L.

Ctra. de Castellvell, 24

43206 Reus (Tarragona)

Phone:977 333 211

Spain

Responsible for Manufacturing

Laboratorios FELTOR, S.A.

Polígono Industrial Moli de les Planes

C/ Roques Blanques, 3-5

08470 Sant Celoni (BARCELONA)

Spain

Last review date of this leaflet: August 2024