Nizoral
Poland
Table of Contents
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, cream
Ketoconazole
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your 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 side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement or if the patient feels 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 properties. Ketoconazole acts against dermatophytes of the genera Trichophyton, Epidermophyton, and 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, and Epidermophyton floccosum; also for the treatment of 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, discuss this with your doctor or pharmacist.
Avoid contact of the medicine with the eyes.
In case of previous topical treatment of seborrhoeic dermatitis with corticosteroids, treatment with corticosteroids should be gradually discontinued over a period of 2 weeks before starting treatment with Nizoral cream, as abrupt discontinuation has been observed to exacerbate symptoms of the disease.
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 child, she should consult her doctor or pharmacist before using this medicine.
Nizoral cream may be used during pregnancy and breastfeeding only if prescribed by a doctor, as there is no data regarding the safety of using 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).
3. How to use Nizoral cream
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician 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 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 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 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 experience 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, discomfort and dryness, inflammation, irritation, paresthesia (unpleasant sensations of tingling, numbness, or temperature changes in the skin, such as intense heat or cold), and reactions at the application site may occur. Hypersensitivity, blistering, contact dermatitis, rash, skin desquamation, and skin stickiness may occur uncommonly. Following 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland.
Tel.: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store Nizoral cream
Keep the medicine out of the sight and reach of children.
Store below 30°C.
Store in the original packaging.
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 in use. Such measures help protect the environment.
6. Contents of the packaging 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 (E 221), 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 or 30 g of cream, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Romania, 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
02-234 Warszawa
Marketing Authorisation numbers in Romania, country of export: 3804/2011/01
3804/2011/02
Parallel import licence number: 75/24