Nizoral

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language

Nizoral

20 mg/g, cream

Ketoconazole

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
The medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor or pharmacist.

• The leaflet should be kept, so that it can be re-read if necessary.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including all possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

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 packaging 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 candidiasis and pityriasis versicolor.
Nizoral cream is also recommended for the treatment of seborrheic dermatitis associated with the presence
of the yeast 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 doctor or pharmacist should be consulted.
Contact of the medicine with 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 their use has been observed to exacerbate the symptoms of the disease.

Nizoral cream and other medicines

No data available.
The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient,
as well as about medicines that the patient plans to use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should
consult a 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 excipients - cetyl alcohol and stearyl alcohol, the medicine may cause a local skin reaction
(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 advised by the doctor or
pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Nizoral cream is intended for use on the skin in adults.
Skin candidiasis, fungal infections of the torso, groin, fungal infections of the hands and feet, pityriasis versicolor:
The medicine should be applied to the affected areas on the skin and the surrounding skin once a day.
Average treatment duration:

• pityriasis versicolor: 2 to 3 weeks,
• skin candidiasis: 2 to 3 weeks,
• groin fungal infections: 2 to 4 weeks,
• fungal infections of the torso: 3 to 4 weeks,
• fungal infections of the feet: 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.
Improvement is usually visible after 4 weeks of treatment. If there is no improvement, the doctor should be contacted.
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, basic hygiene rules should be followed.

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 doctor should be contacted.
In case of accidental ingestion of Nizoral cream, the doctor should be contacted to apply appropriate treatment.

Missing a dose of Nizoral cream

In case of missing a dose, 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 of the skin, i.e., sensation of strong heat or cold), reactions at the application site. Not very often, hypersensitivity, blistering changes, contact dermatitis, rash, scaling, and skin stickiness may occur. After the introduction of Nizoral cream to the market, very rarely (in less than 1 in 10,000 patients) hives occurred.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed.
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,
Phone: +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 collected on the safety of the medicine.

5. How to store Nizoral cream

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Store in the original packaging.
The tube should be closed.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the
specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose
of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging 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 (E 221), polysorbate 80, purified water.

What Nizoral cream looks like and what the packaging containsThe medicine is a cream.
The packaging of the medicine is a tube containing 15 g or 30 g of cream, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Romania, the country of export:

Janssen Pharmaceutica NV
Turnhoutseweg 30, B-2340 Beerse
Belgium

Manufacturer:

Janssen Pharmaceutica NV
Turnhoutseweg 30, B-2340 Beerse
Belgium

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
02-234 Warsaw
Marketing authorization number in Romania, the country of export: 3804/2011/01
3804/2011/02
Parallel import authorization number: 75/24

Date of approval of the leaflet: 26.02.2024

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