Package Leaflet: Information for the User

Ketoisdin 20 mg/g Cream

ketoconazole

Read 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 others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Ketoisdin and what it is used for

2. What you need to know before using Ketoisdin

3. How to use Ketoisdin

4. Possible side effects

5. Storage of Ketoisdin

6. Contents of the pack and additional information

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

This medication is indicated for adults in thetreatmentof the following superficial skin infections:

• Cutaneous candidiasis, infections that normally affect moist and warm areas of the skin and mucous membranes.
• Pityriasis versicolor, a disease characterized by the appearance of patches on the skin.
• Seborrheic dermatitis, a disease that primarily affects the face and chest and causes redness and skin peeling.
• Tinea, a disease that can affect the trunk (body tinea), groin (inguinal tinea), feet (foot tinea), and hands (hand tinea).

No use Ketoisdin

• If you are allergic to ketoconazole 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 Ketoisdin.

For external use only. Avoid contact with the eyes. If accidental contact with the eyes occurs, rinse with abundant water and consult an ophthalmologist if necessary.

If you are using corticosteroids in cream, lotion, or ointment, inform your doctor or pharmacist before starting treatment with this medication. You can start your treatment with this medication, but do not stop applying the corticosteroid from one day to the next. The skin may react and cause redness or itching. Continue your treatment as follows:

• Apply a mild corticosteroid to the skin in the morning and Ketoisdin cream in the evening for one week;
• Subsequently, apply the corticosteroid in the morning every two or three days and this medication in the evening for 1 to 2 weeks;
• Stop using the corticosteroid completely and if necessary, continue only with this medication.

In case of allergic reaction, you must clean the cream from the skin, interrupt treatment, and immediately visit your doctor.

Children

The safety and efficacy of ketoconazole cream in children have not been established.

Other medications and Ketoisdin

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

Pregnancy and breastfeeding

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

As a precaution, it is recommended to avoid using this medication during pregnancy and breastfeeding.

Driving and operating machinery

Given the characteristics of this medication, no effect on driving or operating machinery is expected.

Ketoisdincontains propylene glycol, cetyl alcohol, and stearic alcohol.

This medication contains 200 mg of propylene glycol in each gram.
Propylene glycol may cause skin irritation.
This medication contains propylene glycol, do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearic alcohol.

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

This medication will be applied one or two times a day depending on the type of infection.

The recommended dose is:

• Cutaneous candidiasis:2 to 3 weeks
• Pityriasis versicolor:2 to 3 weeks
• Body lice:3 to 4 weeks
• Ingrown pubic lice:2 to 4 weeks
• Foot lice:4 to 6 weeks
• Hand lice, your doctor will indicate how and for how long to apply this medication.

For skin infections with brownish-red patches and yellow or white peeling (seborrheic dermatitis), apply Ketoisdin creamone or two times a day.Skin infections usually improve after 2 to 4 weeks.

Normally, you will see signs of improvement after 4 weeks. If not, talk to your doctor.

Continue using the cream until a few days after all symptoms have disappeared.

Occasionally, it is necessary to apply the cream once a week or once every two weeks, even after the skin is fully cured. This prevents symptoms from reappearing.

Patients with advanced age

No specific dosage recommendations are available for these patients.

Form of use

Cutaneous use.

Wash and dry the infected skin before applying the medication. Gently rub the cream into the skin with your fingertips. Do not treat only the infected area, apply the cream to the surrounding area as well. Wash your hands carefully after applying the cream (this is important to avoid infecting other parts of the body or other people).

To open the tube, unscrew the cap and with the top of the cap pierce the tube seal.

If you use more Ketoisdin than you should

If you apply more Ketoisdin than your doctor has indicated, you may feel a burning sensation, redness, or swelling that will disappear after stopping treatment.

This medication should not be ingested. If ingested accidentally, contact your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Ketoisdin

Do not apply a double dose to compensate for the missed doses.

If you interrupt the treatment with Ketoisdin

Do not stop treatment without consulting your doctor, as symptoms of your disease may reappear or worsen.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Frequent Adverse Effects (may affect up to 1 in 10 patients)

• Burning sensation on the skin.
• Redness of the skin at the application site.
• Itching at the administration site.

Less Frequent Adverse Effects (may affect up to 1 in 100 patients)

• Allergic reactions (hypersensitivity).
• Localized eczema (contact dermatitis).
• Skin rash.
• Hives.
• Exfoliation of the skin (peeling).
• Oily sticky skin.
• Other reactions at the administration site: bleeding, discomfort, dryness, inflammation, irritation, paresthesia (tingling, numbness).

Adverse Effects of Unknown Frequency (cannot be estimated from available data)

• Urticaria.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the tube after CAD. The expiration date is the last day of the month indicated.

Store below25°C

Do not use this medication if you observe signs of deterioration.

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

Composition ofKetoisdin

• The active ingredient is ketoconazole. Each gram of cream contains 20 mg of ketoconazole.

• The other components (excipients) are:
• propylene glycol,
• stearic alcohol,
• cetyl alcohol,
• sorbitan monostearate,
• polysorbate 60,
• polysorbate 80,
• isopropyl myristate,
• sodium sulfite (E-221) and
• purified water.

Appearance of the product and contents of the packaging

White and homogeneous cream.

This medication is presented in tubes of30 grams.

Holder of the Marketing Authorization

Isdin S.A.

Provençals, 33

08019-Barcelona

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa- Barcelona

Spain

Last review date of this leaflet: March 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/