Nizoral
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Nizoral (Fungoral)
20 mg/g (2%) cream
Ketoconazolum
Nizoral and Fungoral are different trade names for the same medicine.
Please read this leaflet carefully 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
the doctor 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 reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If your symptoms do not improve 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 (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 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, because abrupt withdrawal has been associated with worsening of disease symptoms.
Nizoral cream and other medicines
No data available.
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines planned for future 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 a doctor or pharmacist before using this medicine.
Nizoral cream should only be used during pregnancy and breastfeeding if specifically prescribed by a doctor, as there are no data on 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 or operate machinery have not 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 information 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, tinea pedis, pityriasis versicolor:
Apply Nizoral cream to the affected areas of the skin and to the 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 yellowish scales (seborrhoeic dermatitis), Nizoral cream should be applied once or twice daily. Symptoms usually resolve within 2 to 4 weeks.
Improvement is usually noticeable after 4 weeks of treatment. If no improvement is observed, consult your doctor.
The medicine should be continued for several days after complete disappearance of infection symptoms.
Even after complete 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 medicinal product may cause adverse reactions, although not everybody experiences 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): at the application site bleeding, discomfort and dryness, inflammation, irritation, paresthesia (unpleasant sensations of tingling, numbness, or temperature changes of the skin, i.e. sensation of intense heat or cold), reactions at the application site may occur. Uncommonly, hypersensitivity, vesicular changes, contact dermatitis, rash, desquamation and stickiness of the skin may occur. After administration of Nizoral cream, urticaria very rarely (in less than 1 in 10,000 patients) occurred.
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, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows collecting further information on the safety of the medicine.
5. How to store Nizoral cream
Keep this medicine out of the 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 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.
- 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 in the form of a cream.
The packaging consists of an aluminium tube with a plastic 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 Greece, country of export:
Karo Healthcare AB
Box 16184
103 24 Stockholm
Sweden
Manufacturer:
Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.
Estrada Consiglieri Pedroso 69 B
Queluz de Baixo
2730-055 Barcarena
Portugal
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
Marketing authorisation numbers in Greece, country of export: 113698/20/04-03-2021
57756/10-08-2018
44567/07/9-5-2008
Parallel import authorisation number: 169/21