KETOCONAZOL KERN PHARMA 20 mg/g CREAM

Introduction

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Read the entire leaflet carefully before starting to use 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Ketoconazol Kern Pharma and what is it used for

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

This medicine is indicated in adults for the treatment of the following superficial skin infections:

• Cutaneous candidiasis, infections that normally affect humid and warm areas of the skin and mucous membranes.
• Pityriasis versicolor, a disease characterized by the appearance of spots on the skin.
• Seborrheic dermatitis, a disease that mainly affects the face and chest, causing redness and peeling of the skin.
• Tinea, a disease that can affect the trunk (tinea corporis), groin (tinea cruris), feet (tinea pedis), and hands (tinea manuum).

2. What you need to know before using Ketoconazol Kern Pharma

Do not useKetoconazol Kern Pharma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ketoconazol Kern Pharma.

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

If you are using corticosteroids in cream, ointment, or lotion, inform your doctor or pharmacist before starting treatment with this medicine. You can start treatment with this medicine, but do not interrupt the application of 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 Ketoconazol cream in the evening for one week;
• then, apply the corticosteroid in the morning every two or three days and Ketoconazol cream in the evenings for 1 to 2 weeks;
• stop using the corticosteroid completely and, if necessary, continue only with this medicine.

In case of an allergic reaction, wash the cream off the skin, interrupt treatment, and go immediately to your doctor.

Children

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

Using Ketoconazol Kern Pharma with other medicines

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

Pregnancy and breastfeeding

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

As a precaution, it is preferable to avoid using this medicine during pregnancy and breastfeeding.

Driving and using machines

Given the characteristics of this medicine, no effect on driving or using machines is expected.

Ketoconazol Kern Pharma contains propylene glycol, cetyl alcohol, and stearyl alcohol

This medicine may cause skin irritation because it contains propylene glycol.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

3. How to use Ketoconazol Kern Pharma

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

This medicine will be applied once or twice a day, depending on the type and severity of the infection.

The recommended treatment durationis:

• Cutaneous candidiasis: 2 to 3 weeks
• Pityriasis versicolor: 2 to 3 weeks
• Seborrheic dermatitis: 2 to 4 weeks. After this, the medicine can be applied once or twice a week to maintain the treatment effect.
• Tinea corporis: 3-4 weeks
• Tinea cruris: 2-4 weeks
• Tinea pedis: 4-6 weeks
• Tinea manuum, your doctor will indicate how and for how long you should apply this medicine.

If the symptoms do not improve after 4 weeks of treatment, you should go to your doctor.

Treatment should be prolonged until at least a few days after the disappearance of all symptoms.

Elderly patients

There are no specific dosage recommendations for these patients.

Method of use

For cutaneous use.

Wash and dry the infected skin before applying the medicine. Gently rub the cream into the skin with your fingertips. Do not treat only the infected area; also apply the cream around the affected area. 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 use the top of the cap to pierce the seal of the tube.

If you use more Ketoconazol Kern Pharma than you should

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

This medicine 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Ketoconazol Kern Pharma

Do not apply a double dose to make up for forgotten doses.

If you interrupt treatment with Ketoconazol Kern Pharma

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects(may affect up to 1 in 10 patients)

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

Uncommon side effects(may affect up to 1 in 100 patients)

• Allergic reactions (hypersensitivity).
• Localized eczema (contact dermatitis).
• Rash.
• Hives.
• Peeling of the skin (desquamation).
• Sticky oily skin.
• Other reactions at the application site: bleeding, discomfort, dryness, inflammation, irritation, paresthesia (tingling, numbness).

Side effects of unknown frequency(cannot be estimated from the available data)

• Urticaria.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketoconazol Kern Pharma

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

Do not use this medicine after the expiration date stated on the carton and tube after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Discard the tube 6 weeks after the first opening.

Do not use this medicine if you notice signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Ketoconazol Kern Pharma

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

The other components (excipients) are:

• Propylene glycol (E-1520)
• Stearyl alcohol
• Cetyl alcohol
• Sorbitan stearate
• Polysorbate 60 (E-435)
• Polysorbate 80 (E-433)
• Isopropyl myristate
• Sodium sulfite anhydrous
• Purified water

Appearance of the product and contents of the pack

White and homogeneous cream.

This medicine is presented in 30-gram tubes.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet:December 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es