Nizoral

Warning! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Nizoral, 20 mg/g, cream
Ketoconazole
Please 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
the physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, please consult the pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in the leaflet, inform the doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if the patient feels worse, contact the doctor.

Table of contents of the leaflet

1. What Nizoral cream is and what it is 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 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 body, 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 in the treatment of seborrhoeic dermatitis associated with 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 case of prior topical treatment of seborrhoeic dermatitis with corticosteroids, corticosteroid therapy should be gradually withdrawn over a period of 2 weeks before initiating treatment with Nizoral cream, as abrupt discontinuation has been associated with worsening of disease symptoms.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 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 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
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
The cream 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).
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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 skin areas and to the adjacent healthy 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 occurs, consult your doctor.
Continue using the medicine for several days after complete disappearance of symptoms.
Even after full recovery, to prevent recurrence of the disease, patients 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 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 dose to make up for the missed dose.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience 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; burning sensation 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 temperature changes of the skin, i.e. sensation of intense heat or cold), reactions at the application site. Uncommonly, hypersensitivity, vesicular changes, contact dermatitis, rash, desquamation, and stickiness of the skin may occur. Following the use 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 the leaflet, inform your doctor, pharmacist, or nurse. 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 helps to provide more information on the safety of the medicine.

5. How to store Nizoral cream

Keep the medicine out of sight and reach of children.
Store below 30°C. Keep in the original packaging.
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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 pack and other information

What Nizoral cream contains

• The active substance is ketoconazole. Each gram 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 consists of a tube containing 15 g of cream or 30 g of cream in two tubes of 15 g each,
in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, the exporting country:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Manufacturer:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
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 Romania, the exporting country: 3804/2011/01
Parallel import licence number: 212/24
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