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 medicinal product.
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 contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions 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 of the leaflet

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, consult your doctor or pharmacist.
Avoid contact of the cream with the eyes.
In cases of prior topical treatment of seborrhoeic dermatitis with corticosteroids, corticosteroid therapy should be gradually discontinued over a period of 2 weeks before starting treatment with Nizoral cream, as abrupt cessation has been associated with exacerbation of disease symptoms.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a 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 regarding 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 mechanical vehicles and operate machinery have not been conducted.

Nizoral cream contains propylene glycol (E 1520), cetyl alcohol and stearyl alcohol
The cream 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 your 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 and tinea pedis, pityriasis versicolor:
Apply Nizoral cream to the affected skin areas and to the immediately surrounding 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), apply Nizoral cream once or twice daily. Symptoms usually resolve within 2–4 weeks.
Improvement is usually visible after 4 weeks of treatment. If no improvement is observed, consult your doctor.
Continue using the medicine for several days after complete resolution 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, skin burning, and swelling.
If such symptoms occur, consult your doctor.
In case of accidental ingestion of Nizoral cream, contact your doctor for appropriate treatment.
Missed dose 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 will get them.
The following adverse reactions may occur:

Common (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,
Uncommon (in more than 1 in 1,000 and less than 1 in 100 patients): bleeding at the application site, discomfort and dryness, inflammation, irritation, paraesthesia (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, skin peeling and stickiness of the skin may occur. After introduction of Nizoral cream to the market, 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 or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions enables better assessment of 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 are required.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Nizoral cream contains

The active substance is ketoconazole. 1 g of cream contains 20 mg of ketoconazole.
The other ingredients are: propylene glycol (E 1520), 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 medicine is packed in an aluminium tube with a polypropylene cap, containing 30 g of cream, placed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Spain, the country of export: 977314.4
Parallel Import Licence Number: 375/25