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 the patient leaflet or as directed by
a physician or pharmacist.
- Keep this leaflet for future reference.
- If advice or additional information is needed, consult a pharmacist.
- If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
- If there is no improvement or if the patient feels worse, contact a 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 in 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 medicine with the eyes.
In case of prior local treatment of seborrhoeic dermatitis with corticosteroids, corticosteroid therapy should be gradually withdrawn over a period of 2 weeks before applying Nizoral cream, as abrupt discontinuation has been associated with worsening of disease symptoms.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 taking, has recently taken, or might take 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 prescribed 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
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
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 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), apply Nizoral cream once or twice daily. Symptoms usually resolve within 2 to 4 weeks.
Improvement is usually 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 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 effects
Like all medicines, this medicinal product may cause adverse effects, although not everybody will experience them.
The following adverse effects may occur:
- Common (in more than 1 in 100 and less than 1 in 10 patients): erythema and itching at the site of application; burning sensation of the skin,
- Uncommon (in more than 1 in 1,000 and less than 1 in 100 patients): bleeding at the site of application, discomfort, dryness, inflammation, irritation, paraesthesia (unpleasant sensation of tingling, numbness, or changes in skin temperature, i.e. feeling of intense heat or cold), and local reactions at the site of application. Uncommonly, hypersensitivity, blistering, 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the medicine.
5. How to store Nizoral cream
Keep the medicine out of the sight and reach of children.
Store below 30°C, 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will 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, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, isopropyl myristate, anhydrous 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 packaging consists of an aluminium tube containing 15 g of cream, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Romania, the country of export:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse, Belgium
Manufacturer:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse, Belgium
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 Romania, the country of export: 3804/2011/01
Parallel Import Licence Number: 394/22