NIZORAL CREAM

Země: Malajsie

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivní složka:

Ketoconazole

Dostupné s:

JOHNSON & JOHNSON SDN BHD

INN (Mezinárodní Name):

Ketoconazole

Jednotky v balení:

15gm15 mcg/mL

Výrobce:

JANSSEN PHARMACEUTICA N.V.

Informace pro uživatele

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NIZORAL
®
CREAM
Ketoconazole (2% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What NIZORAL
®
Cream is used
for
2.
How NIZORAL
®
Cream works
3.
Before you use NIZORAL
®
Cream
4.
How to use NIZORAL
®
Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
NIZORAL
®
Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT NIZORAL
® CREAM IS USED
FOR
NIZORAL
®
Cream is a medicine for
treating skin infections caused by
fungi or yeasts.
It is used for treating skin infections
on the trunk, groin, feet or hands.
NIZORAL
®
Cream is also used to
treat skin infections that usually occur
on the face and on the chest with
reddish brown patches and yellow or
white scaling (seborrheic dermatitis).
HOW NIZORAL
® CREAM WORKS
NIZORAL
®
cream works by killing
the fungus that causes the infection.
BEFORE YOU USE NIZORAL
® CREAM
-
_When you must not use it _
Do not use NIZORAL
®
Cream if
you know you are hypersensitive
(allergic) to it. Symptoms of
hypersensitivity include itching and
red skin which may occur after you
have applied NIZORAL
®
Cream.
-
_Before you start to use it _
Talk to your doctor or pharmacist
before using this medicine:
•
If you have recently used a cream,
ointment or lotion on your skin
infection that contains a steroid:
You should continue to apply a
mild steroid (such as
hydrocortisone) cream, ointment
or lotion in the morning whilst
applying NIZORAL
®
cream in the
evening. The mild steroid
treatment can then be gradually
stopped over a period of 2-3
weeks.
If you have any questions about
stopping your steroid cream,
ointment or lotion, ask your
doctor or pharmacist.
-
_Pregnancy and breast-feeding _
There are no known risks with the
use of NIZORAL
®
Cream in
pregnancy or breast-feeding.
-
_Children and adolescents _
NIZORAL
®
Cream is not
recommended for use in children
under 18 years of age.
-
_Taking other medicines _
If you are also using corticosteroids
(cortisone-type medicines in

Charakteristika produktu

1
NIZORAL ™®
CREAM
PRODUCT NAME TRADE NAME OF TH E
MEDICINAL PRODUCT
NIZORAL 2% Cream
QUALITATIVE AND QUANTI TATIVE
COMPOSITION DOSAGE FORMS AND STRENGTHS
Cream for topical application to the skin.
Each gram contains 20 mg ketoconazole.
For excipients, see List of Excipients .
PHARMACEUTICAL FORM
Cream for topical app lication to the skin.
CLINICAL PART IC ULARS INFORMATION
Therapeutic Indications
NIZORAL 2% Cream is indicated for topical application in the treat ment of der matophyte
infections of the skin: tinea corporis, tinea cruris, tinea manus and tinea pedis due to Trichophyton
rubru m, Trichophyton mentagrophytes , Microsporum canis and Epidermophyton floccosu m, as
well as in the treat ment of cutaneous candidosis and ti nea (pity riasis) versic olor.
NIZORAL 2% Cream is also indicated for the treat ment of seborrhoeic der matitis, a skin
condition related associated with the pre sence of Pityrosporum ovale Malassezia furfur .
Posology and Method of
Administration Dosage and
Administration
Dosage
Cutaneous candidosis, tinea corporis, tinea cru ris, tinea manus, tinea pedis and tinea (pity riasis)
versicolor: it is recommended that NIZORAL 2% Cream be applied once daily to cover the
affected and im mediate surrounding area.
Seborrh oeic der matitis: NIZORAL 2% Cream shou ld be applied to the affected area once or
twice daily depending on the severity of infection .
Treat ment should be continued for a sufficient period, at least until a few days after disappearance
of all sympto ms. The diagnosis should be reconside red if no clinical improv ement is noted after 4
weeks of treat ment. General measures in regard to hygiene should be observed to control sources of
infection or reinfection.
The usual duration of treat ment is: tinea versico lor 2 - 3 weeks, yea st infections 2 - 3 weeks,
tinea cruris 2 - 4 weeks, tinea corporis 3 - 4 weeks, tinea pedis 4 - 6 weeks.
Commented [LMc[1]: To update the trademark.
Commented [LMc[2]: To align with CCDS vDec2011 .
Commented [KS[3]: To align with CCDS vOct2017 .
C