Nizoral

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nizoral (Fungarest)

20 mg/g, cream

Ketoconazole
Nizoral and Fungarest are different trade names for the same medicine.

Before using the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including all possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Nizoral cream and what is it used for
• 2. Important information before using Nizoral cream
• 3. How to use Nizoral cream
• 4. Possible side effects
• 5. How to store Nizoral cream
• 6. Package contents and other information

1. What is Nizoral cream and what is it used for

Nizoral cream contains the active substance ketoconazole, which has a strong antifungal effect. Ketoconazole works against dermatophytes of the genus: Trichophyton, Epidermophyton,
Microsporumand yeast of the genus Candidaand Malassezia( Pityrosporum).

Indications for use

Local treatment of skin fungal infections of the torso, groin, hands, and feet caused by the following dermatophytes:
Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis, Epidermophyton floccosum,
as well as skin yeast infections and pityriasis versicolor ( Pityriasis versicolor).
Nizoral cream is also recommended for the treatment of seborrheic dermatitis associated with the presence of Malassezia ovale( Pityrosporum ovale).

2. Important information before using Nizoral cream

When not to use Nizoral cream

• if the patient is allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Nizoral cream, the patient should discuss it with their doctor or pharmacist.
Contact between the medicine and the eyes should be avoided.
In the case of previous local treatment of seborrheic dermatitis with corticosteroids, before using Nizoral cream, the corticosteroid treatment should be gradually discontinued over a period of 2 weeks, as sudden discontinuation of corticosteroids may lead to worsening of symptoms.

Nizoral cream and other medicines

No data available.
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, Nizoral cream can only be used if prescribed by a doctor, as there is no data on the safety of using the medicine during pregnancy and breastfeeding.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive vehicles and operate machinery.

Nizoral cream contains propylene glycol, cetyl alcohol, and stearyl alcohol

The medicine contains 200 mg of propylene glycol in every 1 g of cream. Propylene glycol may cause skin irritation.
Due to the presence of excipients - cetyl alcohol and stearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Nizoral cream

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Nizoral cream is intended for use on the skin in adults.
Yeast infection of the skin, fungal infection of the torso, groin, fungal infection of the hands and feet, pityriasis versicolor ( Pityriasis
versicolor):
The medicine should be applied to the affected areas of the skin and the surrounding skin once a day.
The average duration of treatment:

• pityriasis versicolor: 2 to 3 weeks,
• yeast infection of the skin: 2 to 3 weeks,
• groin fungal infection: 2 to 4 weeks,
• torso fungal infection: 3 to 4 weeks,
• foot fungal infection: 4 to 6 weeks.

Seborrheic dermatitis:

In skin infections characterized by brown-red spots or white and yellow scales (seborrheic dermatitis), Nizoral cream should be applied once or twice a day. The symptoms of the infection usually disappear after 2-4 weeks.
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Improvement is usually visible after 4 weeks of treatment. If there is no improvement, the patient should contact their doctor.
The medicine should be used for a few more days after the complete disappearance of the infection symptoms.
Even after complete healing, to prevent relapse of the disease, the patient should use Nizoral cream once a week or once every 2 weeks.
During treatment, to prevent re-infection, the patient should follow basic hygiene rules.

Using a higher dose of Nizoral cream than recommended

Significant overdose of the medicine may cause redness, burning of the skin, and swelling.
If such symptoms occur, the patient should contact their doctor.
In case of accidental ingestion of Nizoral cream, the patient should contact their doctor to receive appropriate treatment.

Missing a dose of Nizoral cream

If a dose is missed, it should be applied as soon as possible. A double dose should not be applied to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• often (in more than 1 in 100 and less than 1 in 10 patients) redness and itching at the application site; burning sensation of the skin;
• not very often (in more than 1 in 1,000 and less than 1 in 100 patients) at the application site, bleeding, discomfort, dryness, inflammation, irritation, paresthesia (unpleasant sensation of tingling, numbness, or temperature change, i.e., a feeling of strong heat or cold), reactions at the application site. Not very often, hypersensitivity, blistering changes, contact dermatitis, rash, skin peeling, and stickiness may occur. After the introduction of Nizoral cream to the market, very rarely (in less than 1 in 10,000 patients) urticaria occurred.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Nizoral cream

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The medicine should be stored out of sight and reach of children.
There are no special storage precautions.
The tube should be closed.
This medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Nizoral cream contains

• The active substance of the medicine is ketoconazole. 1 g of cream contains 20 mg of ketoconazole.
• The other ingredients are: propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan stearate, polysorbate 60, isopropyl myristate, sodium metabisulfite, polysorbate 80, purified water.

What Nizoral cream looks like and what the package contains

The medicine is a cream.
The package is an aluminum tube with a PP cap, containing 30 g of cream, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Laboratorio STADA, S.L., Frederic Mompou, 5, 08960 Sant Just Desvern (Barcelona), Spain

Manufacturer:

JANSSEN PHARMACEUTICA, N.V., Turnhoutseweg, 30, 2340 Beerse, Belgium
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish export authorization number: 977314.4

Parallel import authorization number: 26/25

Date of leaflet approval: 22.01.2025

[Information about the trademark]
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