Nizoral

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Ketoconazole 200mg

Tilgængelig fra:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Ketoconazole 200 mg

Dosering:

200 mg

Lægemiddelform:

Tablet

Sammensætning:

Active: Ketoconazole 200mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Povidone

Enheder i pakken:

Blister pack, 30 tablet pack, 30 tablets

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Janssen Pharmaceutica NV

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

1982-04-07

Indlægsseddel

CONSUMER MEDICINE INFORMATION 
NIZORAL™

ketoconazole 
200 mg tablets 

WHAT IS IN THIS LEAFLET 
This leaflet answers some of the common questions about NIZORAL
tablets. It does not 
contain all the available information. It does not take the place of
talking to your doctor or 
pharmacist. 
All medicines have risks and benefits.  Your doctor has weighed the
risks of you taking 
NIZORAL tablets against the benefits this medicine is expected
to have for you. 
If you have any concerns about using NIZORAL tablets ask
your doctor or pharmacist.  
Keep this leaflet with your medicine.  You may need to read it
again. 
WHAT NIZORAL TABLETS ARE USED FOR 
NIZORAL tablets are used to treat: 
•  fungal infections of the skin, hair and  mucous membrane that
cannot be treated by 
applying a medicine directly to the infected area 
•  persistent fungal infections of the vagina 
•  fungal infections of the mouth, throat and stomach,
intestines or other internal organs. 
NIZORAL contains ketoconazole, which belongs to a group of
medicines called antifungals.  It 
works by killing or stopping the growth of certain types of fungi
or yeasts that cause the 
infection. 
Your doctor may have prescribed NIZORAL tablets for another reason.
 Ask your doctor if you 
have any questions about why this medicine has been prescribed for
you. 
BEFORE YOU TAKE NIZORAL TABLETS 
_WHEN YOU MUST NOT TAKE IT _
Do not take NIZORAL tablets if: 
•  you have an allergy to NIZORAL or any of the ingredients.
 See PRODUCT DESCRIPTION at 
the end of this leaflet for a list of ingredients 
•  you have liver diseases or are recovering from hepatitis 
•  you are pregnant. 

 Do not use NIZORAL tablets with any of the following: 

•  certain medicines for allergy or hayfever (terfenadine,
mizolastine or astemizole) 
•  cisapride or domperidone (used to treat certain digestive
problems) 
•  certain medicines used to produce calmness or to help

Produktets egenskaber

_CCDS100528 _
NIZORALTAB(120215)ADS 
1
 DATA SHEET  
NAME OF MEDICINE 
NIZORAL™ ketoconazole 200 mg tablet 
PRESENTATION 
White, scored, tablet marked with ‘K/200’ and ‘Janssen’ on
reverse. 
INDICATIONS 
Because of the risk for serious hepatotoxicity, NIZORAL tablets should
be used only when 
the potential benefits are considered to outweigh the potential risks,
taking into 
consideration the availability of other effective antifungal
therapy. 

NIZORAL tablets are indicated for the treatment of the following
mycoses that cannot be 
treated topically due to the site or extent of the lesions, in
patients resistant to, or intolerant 
of other effective antifungal agents: 
• Dermatophytosis 
• Pityriasis 
versicolor 
• Malassezia 
folliculitis 
•  Chronic mucocutaneous candidosis 
• Cutaneous 
candidosis 
•  Oropharyngeal and oesophageal candidosis 
•  Chronic, recurrent vaginal candidosis. 

Ketoconazole does not penetrate well in the CNS.  Therefore, fungal
meningitis should not 
be treated with oral ketoconazole. 

NIZORAL tablets are also indicated for the treatment of the following
systemic fungal 
infections in patients resistant to, or intolerant of other effective
antifungal agents: 
• Histoplasmosis 
• Blastomycosis 
• Coccidioidomycosis 
• Paracoccidioidomycosis. 
DOSAGE AND ADMINISTRATION 
DOSAGE 
ADULTS  
The recommended dose of NIZORAL tablets for all indications

is one tablet (200 mg) once 
daily with a meal, with the exception of vaginal candidosis (see
below).  
If no adequate response is obtained with this dose after a reasonable
trial period,

the 
dosage may be increased to two tablets (400 mg) once daily with a
meal 
For vaginal candidosis, the recommended dose of NIZORAL tablets is
two tablets (400 
mg) once daily with a meal. 
_Children _
Children weighing more than 30mg: same as that for adults. 
Children weighing 15-30kg: half a tablet (100mg) once daily with a
meal. 
_CCDS10052