Nizoral

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Nizoral, 20 mg/g (2%), cream

Ketoconazole

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If you do not improve or feel worse, contact your 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. Contents of the pack and other information

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

Nizoral cream contains the active substance ketoconazole, with a strong antifungal effect. Ketoconazole acts on 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).

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, discuss it with your doctor or pharmacist.
Avoid contact of the medicine with the eyes.
In the case of previous local treatment of seborrheic dermatitis with corticosteroids, before using Nizoral cream, you should gradually - over 2 weeks - discontinue corticosteroid treatment, as sudden discontinuation of their use has been observed to exacerbate the symptoms of the disease.

Nizoral Cream and Other Medicines

No data available.
Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to use.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your 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 193 mg of propylene glycol in each 1 g of cream. Propylene glycol may cause skin irritation.
Due to the presence of auxiliary substances - 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 leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your 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):
Apply the medicine to the affected areas on the skin and the surrounding skin once a day.
Average treatment duration:

• 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 with brown-red spots or white and yellow scales (seborrheic dermatitis), apply Nizoral cream once or twice a day. The symptoms of the infection usually disappear after 2-4 weeks.
Improvement is usually visible after 4 weeks of treatment. If there is no improvement, contact your doctor.
Continue using the medicine for a few days after the symptoms of the infection have completely disappeared.
Even after complete healing, to prevent relapse of the disease, you should use Nizoral cream once a week or once every 2 weeks.
During treatment, to prevent re-infection, follow basic hygiene rules.

Using More Than the Recommended Dose of Nizoral Cream

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

Missing a Dose of Nizoral Cream

If you miss a dose, use it as soon as possible. Do not use a double dose 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., sensation of strong heat or cold), reactions at the application site. Not very often, hypersensitivity, blistering, contact dermatitis, rash, peeling, and stickiness of the skin may occur. After the introduction of Nizoral cream to the market, very rarely (in less than 1 in 10,000 patients) hives have occurred.

Reporting Side Effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your 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, you can help gather more information on the safety of the medicine.

5. How to Store Nizoral Cream

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening the package: 6 months.
The tube should be closed.
Do not use this medicine after the expiry date stated on the package.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack 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 Pack Contains

The medicine is a cream.
The pack contains 15 g of cream in 1 tube or 30 g of cream in two tubes of 15 g each, in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Bulgaria, the Country of Export:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer:

Janssen Pharmaceutica N.V., Turnhoutseweg 30, B-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
Number of the permit in Bulgaria, the country of export: 20010017

Number of the Parallel Import Permit: 37/25

Date of Approval of the Leaflet: 29.01.2025

[Information about the trademark]
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