KETOCONAZOL CINFA 2% GEL

Introduction

Package Leaflet: Information for the User

ketoconazol cinfa 2% gel EFG

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is ketoconazol cinfa and what is it used for
2. What you need to know before starting to use ketoconazol cinfa
3. How to use ketoconazol cinfa
4. Possible side effects
5. Storage of ketoconazol cinfa
6. Package Contents and Additional Information

1. What is ketoconazol cinfa and what is it used for

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

This medication is indicated in adolescents and adults for the treatment and prevention of the following skin infections caused by fungi and yeasts:

• Pityriasis versicolor, a disease characterized by the appearance of small, irregular, brown or whitish patches on the trunk.

• Seborrheic dermatitis, a disease that primarily affects the face and chest, causing redness and scaling of the skin.
• Pityriasis capitis(dandruff), characterized by the appearance of scalp scaling.

2. What you need to know before starting to use ketoconazol cinfa

Do not use ketoconazol cinfa

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

After application, some symptoms of allergy may be itching and irritation.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use ketoconazol cinfa.

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 form, inform your doctor or pharmacist before starting treatment. You can start your treatment with this medication, but do not interrupt the application of corticosteroids from one day to the next, as the skin may react and cause redness or itching. Continue your treatment with corticosteroids as follows:

• apply the same amount during the first week, gradually reduce the frequency over the second to third week,
• completely stop using corticosteroids.

In case of an allergic reaction, wash the gel off the skin, interrupt treatment, and immediately consult your doctor.

Children

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

Other medications and ketoconazol cinfa

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

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 medication.

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

Driving and Using Machines

Given the characteristics of this medication, no effects on driving or using machines are expected.

ketoconazol cinfa contains sodium lauryl sulfate

This medication contains 480 mg of sodium lauryl sulfate per ml.

Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase skin reactions caused by other medications when applied to the same area.

ketoconazol cinfa contains ethanol

This medication contains 26.3 mg of alcohol (ethanol) per ml.

It may cause a burning sensation on damaged skin.

3. How to use ketoconazol cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The frequencyof application and durationof treatment recommended for this medication will depend on the type of infection and whether it is intended to treat or prevent it, and is as follows:

• Pityriasis versicolor:apply once a day for 5 days. To prevent, apply once a year and before summer, for 3 consecutive days.

• Pityriasis capitis(dandruff) and seborrheic dermatitis: apply 2 times a week, for 2-4 weeks. To avoid the appearance of relapses after treatment, apply the gel once a week or once every 2 weeks. This prevents the symptoms from reappearing.

If the symptoms do not improve after 4 weeks of treatment, consult your doctor.

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

Elderly Patients

There are no specific dosage recommendations for these patients.

Method of Use

For cutaneous use.

The gel can be used to treat both the scalp and more extensive areas of the chest and face.

Wash the infected skin or scalp areas, allowing the medication to act for 3 to 5 minutes before rinsing. Make sure to wash both the skin and hair thoroughly. Normally, a palmful of gel is sufficient for one wash.

If you use more ketoconazol cinfa 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 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use ketoconazol cinfa

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

If you interrupt treatment with ketoconazol cinfa

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 area of administration.

Uncommon Side Effects(may affect up to 1 in 100 patients)

• Inflammation of the hair follicles.
• Allergic reactions (hypersensitivity).
• Increased tearing.
• Hair loss.
• Changes in hair texture.
• Localized eczema (contact dermatitis).
• Rash.
• Urticaria.
• Exfoliation of the skin (scaling).
• Sticky, oily skin.
• Other reactions at the application site: bleeding, discomfort, dryness, inflammation, irritation, paresthesia (tingling, numbness).

Rare Side Effects(may affect up to 1 in 1,000 patients)

• Distorted taste perception.
• Irritation in the eyes.
• Acne.
• Sensitive skin.

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

• Sudden swelling of the skin or mucous membranes, usually of the face, eyes, or lips.
• Changes in hair color.
• Urticaria.

Interrupt treatment in case of intolerance to the gel.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of ketoconazol cinfa

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

After the first opening, the contents must be used within 28 days.

After the first opening, do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ketoconazol cinfa

• The active ingredient is ketoconazol. Each milliliter of gel contains 20 mg of ketoconazol.
• The other components are: sodium lauryl sulfate, sodium lauryl sulfosuccinate, monoethanolamide of ethoxylated colza oil fatty acids, hydrolyzed collagen, macrogol 120 methylglucose dioleate, hydrochloric acid (E-507), imidazolidinylurea, summer perfume, erythrosine (E-127), sodium chloride, and purified water.

Appearance of the Product and Package Contents

ketoconazol cinfa is presented as a liquid gel with a red, viscous color.

It is packaged in high-density polyethylene (HDPE) bottles, white, opaque, with a polypropylene (PP) cap.

Each package contains a 100 ml bottle.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet:May 2022

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66052/P_66052.html

QR code at: https://cima.aemps.es/cima/dochtml/p/66052/P_66052.html