Ketoconazol sandoz 20 mg/g gel efg

Prospecto: Information for the Patient

Ketoconazole Sandoz 20 mg/g Gel EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to use Ketoconazole Sandoz

4.Possible adverse effects

5.Storage of Ketoconazole Sandoz

6.Contents of the package and additional information

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

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

• Pytiriasis versicolor,a condition characterized by the appearance of small, irregular, brownish or whitish patches on the trunk.
• Dermatitis seborreica, a condition that mainly affects the face and chest and causes redness and skin peeling.
• Pytiriasis capitis(dandruff), characterized by the appearance of skin flakes on the scalp.

No use Ketoconazol Sandoz:

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use ketoconazole.

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 do not stop applying corticosteroids from one day to the next, the skin may react and cause redness or itching. Continue your treatment with corticosteroids in the following way:

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

In case of an allergic reaction, treatment should be interrupted and your doctor should be consulted immediately.

Only for external use. Avoid contact with the eyes. If this occurs, wash your eyes with water and, if necessary, consult an ophthalmologist.

Children

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

Other medications and Ketoconazol Sandoz

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

As a precaution, it is preferable to avoid using this medication during pregnancy and breastfeeding, although there are no known risks associated with this medication during pregnancy and breastfeeding.

Driving and operating machines

The influence of this medication on the ability to drive and operate machines is negligible orinsignificant.

Ketoconazol Sandoz contains, laurilsulfate sodium and lauryl ether sulfosuccinate disodium and fragrance with allergens

This medication contains 0.26 g of laurilsulfate sodium and 0.19 g of lauryl ether sulfosuccinate disodium in each g of gel. Laurilsulfate sodium 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 in each g 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.

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

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

• Pytiriasis versicolor:Apply once a day for 5 days. Toprevent,apply a single cycle once a day for 3 consecutive days each year and before summer.
• Pytiriasis capitis(dandruff) and seborrheic dermatitis: Apply twice a week, for 2 to 4 weeksconsecutively. Toprevent the recurrence of symptoms after treatment, you can use it once every 1 or 2 weeks.

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

Advanced age

The dosage will be the same as for adults.

Form of use

Cutaneous use.

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

Wash the infected skin areas or scalp, allowing the medication to act for 3 to 5 minutes before rinsing. Make sure to wash both the skin and hair thoroughly.

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 immediately, your pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Ketoconazol Sandoz

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

If you interrupt the treatment with Ketoconazol Sandoz

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 medication may produce adverse effects, although not all people will experience them.

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

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

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

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

Adverse 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.

Discontinue treatment in case of intolerance to the gel.

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 theSpanish System for Pharmacovigilance of Medicines 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.

Store below 30 °C.

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

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

Composition of Ketoconazol Sandoz

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

-The other components (excipients) are:lauril ether sulfate of sodium, lauril ether sulfosuccinate disodium, monoethanolamide of fatty acids of rapeseed oil ethoxylated, hydrolyzed collagen, polyethylene glycol 120 methylglucoside 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 contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet: December 2021

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