KETOCONAZOL SANDOZ 20 mg/g GEL EFG

Introduction

Package Leaflet: Information for the Patient

Ketoconazol Sandoz 20 mg/g gel EFG

Read the entire 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 Sandoz and what is it used for
2. What you need to know before starting to use Ketoconazol Sandoz
3. How to use Ketoconazol Sandoz
4. Possible side effects
5. Storage of Ketoconazol Sandoz
6. Package Contents and Additional Information

1. What is Ketoconazol Sandoz and what is it used for

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

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

• Pityriasis versicolor,a disease characterized by the appearance of small, irregular, brown or whitish areas on the trunk.
• Seborrheic dermatitis, a disease that primarily affects the face and chest, causing redness and skin peeling.
• Pityriasis capitis(dandruff), characterized by the appearance of scalp peeling.

2. What you need to know before starting to use Ketoconazol Sandoz

Do not use Ketoconazol Sandoz:

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.

If you are using corticosteroids in cream, ointment, or lotion, inform your doctor or pharmacist before starting treatment. You can start your treatment with this medication, but you should not stop applying corticosteroids abruptly, 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, treatment should be discontinued and your doctor should be consulted immediately.

For external use only. Contact with the eyes should be avoided. If this occurs, rinse your eyes with water and, if necessary, consult an ophthalmologist.

Children

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

Other Medications and Ketoconazol Sandoz

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, although no risks associated with this medication during pregnancy and breastfeeding are known.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is negligible or insignificant.

Ketoconazol Sandoz contains laureth-7 sulfate and laureth-7 sulfosuccinate and fragrance with allergens

This medication contains 0.26 g of laureth-7 sulfate and 0.19 g of laureth-7 sulfosuccinate per gram of gel. Laureth-7 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.

This medication contains 2 mg of fragrance that contains traces of benzyl alcohol and benzyl benzoate per gram of gel. Benzyl alcohol may cause allergic reactions and moderate local irritation. Benzyl benzoate may cause local irritation. It also contains citral, hexylcinnamaldehyde, and isoeugenol, which may cause allergic reactions.

3. How to use Ketoconazol Sandoz

Follow your doctor's instructions for using this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

The frequencyof application and durationof treatment recommended for this medication depend on the type of infection and whether you are treating or preventing it, and are 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 to 4 weeks consecutively.To avoidthe appearance of relapses after treatment, you can use it 1 time every 1 or 2 weeks.

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

Advanced Age

The dosage will be the same as for adults.

Method of Use

For cutaneous use.

You can treat both the scalp and more extensive areas of the chest and face with the gel.

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 well.

If you use more Ketoconazol Sandoz than you should

This medication should not be ingested. If ingested accidentally, contact your doctor. Do not induce vomitingto avoid possible aspiration.

If you have taken more ketoconazol than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to use Ketoconazol Sandoz

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

If you interrupt treatment with Ketoconazol Sandoz

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

If you have any other questions about using 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.

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

• inflammation of the hair follicles,
• increased tearing,
• hair loss,
• dry skin,
• changes in hair texture,
• rash,
• burning sensation on the skin,
• red skin,
• skin irritation,
• itching at the application site,
• reaction at the application site.

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

• allergic reactions (hypersensitivity),
• distorted taste perception,
• eye irritation,
• acne,
• localized eczema,
• skin sensitivity,
• skin peeling,
• allergic reaction (hypersensitivity) at the application site,
• pustules (pimples containing pus).

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

• sudden swelling of the skin or mucous membranes, usually on the face, eyes, or lips,
• changes in hair color,
• urticaria (hives).

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 Pharmacovigilance 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 Sandoz

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

Store below 30 °C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ketoconazol Sandoz

• The active ingredient is Ketoconazol. Each gram contains 20 mg of ketoconazol.
• The other ingredients (excipients) are: laureth-7 sulfate, laureth-7 sulfosuccinate, monoethanolamide of fatty acids of ethoxylated rapeseed oil, hydrolyzed collagen, polyethylene glycol 120 methylglucose dioleate, hydrochloric acid, imidazolidinyl urea, perfume (contains benzyl alcohol, benzyl benzoate, citral, hexylcinnamaldehyde, isoeugenol), erythrosine (E-127), sodium chloride, and purified water.

Appearance of the Product and Package Contents

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

High-density white polyethylene container with a polypropylene cap. It is packaged in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Feltor, S.A.

Polígono Industrial Moli de les Planes

C/ Roques Blanques, 3-5

08470 Sant Celoni

Barcelona

or

Inibsa, S.A.

Ctra Sabadell-Granollers, km 14,5

08185 Llissa de Vall

Barcelona

Date of the Last Revision of this Package Leaflet: December 2021

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/