Ketoconazole Sandoz 20 mg/g gel EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ketoconazol Sandoz 20 mg/g gel EFG

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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

This medicine is indicated in adolescents and adults for the treatment and prevention of the following fungal and yeast skin infections:

• Pityriasis versicolor, a condition characterized by the appearance of small, irregular, brownish or whitish patches distributed across the trunk.
• Seborrheic dermatitis, a condition affecting mainly the face and chest, causing redness and skin scaling.
• Pityriasis capitis (dandruff), characterized by scalp scaling.

2. What you need to know before using Ketoconazol Sandoz

Do not use Ketoconazol Sandoz:

If you are allergic to ketoconazole or to any of the other ingredients of this medicine (listed in section 6).

After application, some allergic symptoms may include itching and irritation.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use ketoconazole.

If you are using corticosteroid creams, ointments, or lotions, inform your doctor or pharmacist before starting treatment. You may begin treatment with this medicine, but you should not abruptly stop applying corticosteroids, as your skin may react, causing redness or itching. Continue your corticosteroid treatment as follows:

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

In case of an allergic reaction, treatment must be discontinued and you should contact your doctor immediately.

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

Children

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

Other medicines and Ketoconazol Sandoz

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Pregnancy and breastfeeding

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

As a precautionary measure, it is preferable to avoid using this medicine during pregnancy and breastfeeding, although no risks associated with this medicine during pregnancy and breastfeeding are currently known.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is none or negligible.

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

This medicine contains 0.26 g of laureth sulfate sodium and 0.19 g of disodium lauryl ether sulfosuccinate in each gram of gel. Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or may increase skin reactions caused by other medicines when applied to the same area.

This medicine contains 2 mg of fragrance containing traces of benzyl alcohol and benzyl benzoate in each gram of gel. Benzyl alcohol may cause allergic reactions and moderate local irritation. Benzyl benzoate may cause local irritation. It also contains citral, hexyl cinnamaldehyde, and isoeugenol, which may cause allergic reactions.

3. How to use Ketoconazole Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended frequency of application and duration of treatment for this medicine depend on the type of infection and whether it is intended to treat or prevent it, and are as follows:

• Pityriasis versicolor: apply once daily for 5 days. For prevention, once a year and before summer, apply one course once daily for 3 consecutive days.
• Pityriasis capitis (dandruff) and seborrheic dermatitis: apply twice a week for 2 to 4 consecutive weeks. To prevent recurrences after treatment, it may be used once every 1 or 2 weeks.

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

Elderly patients

The dosage is the same as for adults.

Method of administration

For cutaneous use only.

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

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

If you use more ketoconazole Sandoz than you should

This medicine must not be ingested. If accidentally swallowed, contact your doctor. Do not induce vomiting in order to avoid possible aspiration.

If you have taken more ketoconazole than you should, consult your doctor, pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Ketoconazole Sandoz

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

If you stop using Ketoconazole Sandoz

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• inflammation of hair follicles,
• increased tearing,
• hair loss,
• dry skin,
• changes in hair texture,
• rash,
• burning sensation on the skin,
• redness of the 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,
• pus-filled pimples (pustules).

Adverse 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,
• hives.

Discontinue treatment in case of intolerance to the gel.

Reporting of 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 leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketoconazole Sandoz

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

Store below 30 ºC.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ketoconazol Sandoz

• The active substance is Ketoconazole. Each gram contains 20 mg of ketoconazole.
• The other components (excipients) are: sodium laureth sulfate, disodium laureth sulfosuccinate, monoethanolamide of ethoxylated rapeseed oil fatty acids, hydrolyzed collagen, polyethylene glycol 120 methyl glucose dioleate, hydrochloric acid, imidazolidinyl urea, fragrance (contains benzyl alcohol, benzyl benzoate, citral, hexyl cinnamaldehyde, isoeugenol), erythrosine (E-127), sodium chloride and purified water.

Appearance of the product and contents of the container

Ketoconazol Sandoz is presented as a gel in 100 ml containers.

White high-density polyethylene container with a polypropylene cap. Packaged in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Feltor, S.A.

Moli de les Planes Industrial Estate

C/ Roques Blanques, 3-5

08470 Sant Celoni

Barcelona

or

Inibsa, S.A.

Sabadell-Granollers Road, km 14.5

08185 Llissa de Vall

Barcelona

Date of the most recent revision of this leaflet: December 2021

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