PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Nizoral (Fungarest)
20 mg/g, cream
Ketoconazolum
Nizoral and Fungarest are different trade names for the same medicine
Please read the entire 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
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement 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 properties. 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.
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 treatment with Nizoral cream, consult your doctor or pharmacist.
Avoid contact of the medicine with the eyes.
In cases of prior topical treatment of seborrheic dermatitis with corticosteroids, corticosteroid therapy should be gradually discontinued over a period of 2 weeks before applying Nizoral cream, as abrupt discontinuation has been associated with worsening of disease symptoms.

Nizoral cream and other medicines
No data available.
Tell your doctor or pharmacist if the patient is currently using, has recently used, or plans to use any other medicines.

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

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

Nizoral cream contains propylene glycol, cetyl alcohol, and stearyl alcohol
This medicine contains 200 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).

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 in doubt, consult your doctor or pharmacist.
Nizoral cream is intended for topical use in adults.
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea manuum, tinea pedis, pityriasis versicolor:
Apply Nizoral cream to the affected skin areas and the 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, basic hygiene measures should be followed to prevent reinfection.
Use of a larger than recommended dose of Nizoral cream
Significant overdose may cause redness, skin burning, and swelling. If such symptoms occur, consult your doctor.
In case of accidental ingestion of Nizoral cream, contact a doctor to initiate appropriate treatment.
Missed application of Nizoral cream
If a dose is missed, apply the cream as soon as possible. Do not use a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody 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): bleeding, discomfort and dryness, inflammation, irritation, paraesthesia (unpleasant sensation of tingling, numbness or changes in skin temperature, i.e. feeling of intense heat or cold), reactions at the application site. Uncommonly, hypersensitivity, blistering, contact dermatitis, rash, desquamation and stickiness of the skin may occur. After administration of Nizoral cream for external use, 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 Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail:
https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nizoral cream

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
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 your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Nizoral cream contains

The active substance is ketoconazole. 1 g of cream contains 20 mg of ketoconazole.
Other ingredients are: propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan stearate, polysorbate 60, isopropyl myristate, sodium sulfite (E 221), polysorbate 80, purified water.

What Nizoral cream looks like and contents of the pack
The medicine is in the form of a cream.
The pack consists of a tube containing 30 g of cream, in a cardboard box.
For more detailed information, please 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 NV
Turnhoutseweg 30
2340 Beerse
Belgium
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
02-234 Warsaw
Spain marketing authorization number in the country of export: 977314.4
Parallel import authorization number: 258/25