Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Nizoral, 20 mg/g (2%) cream
Ketoconazole
Please read this leaflet carefully before using the medicine because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If symptoms do not improve or if you feel worse, contact your doctor.

Table of contents

What Nizoral cream is and what it is used for
Important information before using Nizoral cream
How to use Nizoral cream
Possible side effects
How to store Nizoral cream
Contents of the pack and other information

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

Nizoral cream contains the active substance ketoconazole, which has strong antifungal activity. Ketoconazole acts against dermatophytes of the genera Trichophyton, Epidermophyton, Microsporum, as well as yeasts of the genera Candida and Malassezia (Pityrosporum).
Indications
Topical treatment of fungal infections of the trunk, groin, hands, and feet caused by the following dermatophytes:
Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis, Epidermophyton floccosum,
as well as cutaneous candidiasis and pityriasis versicolor (Pityriasis versicolor).
Nizoral cream is also indicated for the treatment of seborrhoeic 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Nizoral cream, discuss this with your doctor or pharmacist.
Avoid contact of the medicine with the eyes.
In case of prior topical treatment of seborrhoeic dermatitis with corticosteroids, corticosteroid treatment should be gradually withdrawn over a period of 2 weeks before using Nizoral cream, as worsening of symptoms has been observed following abrupt discontinuation of corticosteroid therapy.

Nizoral cream and other medicines
No data available.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Nizoral cream should only be used during pregnancy and breastfeeding if prescribed by a doctor, as there are no data on the safety of the medicine during pregnancy and breastfeeding.

Driving and operating machinery
Studies on the influence of the medicine on the ability to drive vehicles and operate machinery have not been conducted.

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 local skin reactions (e.g. contact dermatitis).
Page 1 of 4

3. How to use Nizoral cream

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Nizoral cream is intended for topical use on the skin in adults.
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea manuum, tinea pedis, pityriasis versicolor:
Apply Nizoral cream to the affected areas of skin and to adjacent skin once daily.
Average duration of treatment:

Pityriasis versicolor: 2 to 3 weeks,
Cutaneous candidiasis: 2 to 3 weeks,
Tinea cruris: 2 to 4 weeks,
Tinea corporis: 3 to 4 weeks,
Tinea pedis: 4 to 6 weeks.

Seborrhoeic dermatitis:
For skin infections presenting with brownish-red patches or white and yellow scales (seborrhoeic dermatitis), Nizoral cream should be applied once or twice daily. Symptoms usually resolve within 2–4 weeks.
Improvement is typically noticeable after 4 weeks of treatment. If no improvement occurs, consult your doctor.
The medicine should be continued for several days after complete disappearance of infection symptoms.
Even after full recovery, to prevent recurrence of the disease, the patient should continue using Nizoral cream once a week or once every two weeks.
During treatment, to prevent reinfection, basic hygiene measures should be observed.
Use of more than the recommended dose of Nizoral cream
Significant overdose may cause erythema, burning sensation, and swelling of the skin.
If such symptoms occur, consult your doctor.
In case of accidental ingestion of Nizoral cream, contact your doctor for appropriate treatment.
Missed application of Nizoral cream
If a dose is missed, apply the cream as soon as possible. Do not use a double amount to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone gets them.
The following adverse reactions may occur:

Common (in more than 1 in 100 and less than 1 in 10 patients): erythema and itching at the application site; sensation of burning of the skin;
Uncommon (in more than 1 in 1,000 and less than 1 in 100 patients): at the application site there may occur bleeding, discomfort and dryness, inflammation, irritation, paresthesia (unpleasant sensation of tingling, numbness, or changes in skin temperature, i.e. feeling of intense heat or cold), application site reactions. Uncommonly, hypersensitivity, vesicular changes, contact dermatitis, rash, desquamation, and stickiness of the skin may occur. After administration of Nizoral cream, urticaria occurred very rarely (in less than 1 in 10,000 patients).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
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
Reporting adverse reactions allows more information on the safety of the medicine to be collected.

5. How to store Nizoral cream

Keep the medicine out of sight and reach of children.
Store below 25°C.
Page 3 of 4
Shelf life after first opening the container: 6 months.
The tube should be kept closed.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Nizoral cream contains

The active substance is ketoconazole. Each 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 sulfite, polysorbate 80, purified water.

What Nizoral cream looks like and contents of the pack
The medicine is a cream.
The pack contains 15 g of cream in one tube or 30 g of cream in two tubes of 15 g each, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Bulgaria, the country of export: 20010017
Parallel import licence number: 37/25
Page 4 of 4