COMOZOL CREAM 2% ww

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

KETOCONAZOLE

זמין מ:

EUCOGEN SDN BHD

INN (שם בינלאומי):

KETOCONAZOLE

יחידות באריזה:

1 tube x 10 gm

תוצרת:

DAE HWA PHARMACEUTICAL CO., LTD.

עלון מידע

COMOZOL CREAM 2%W/W
_Ketoconazole_
(20mg per gram)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Comozol cream is used for
2.
How Comozol cream works
3.
Before you use Comozol cream
4.
How to use Comozol cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Comozol
cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT COMOZOL CREAM IS USED FOR
Comozol cream is used for fungal and
yeast infections of the skin in adults.
Infections may appear on the:
•
Trunk, chest or back
•
Hands or feet
•
Scalp or face
•
Groin or genitals
HOW COMOZOL CREAM WORKS
Comozol cream works by killing the
fungus that causes the infection.
BEFORE YOU USE COMOZOL CREAM
-
_When you must not use it _
_ _
•
If you are allergic to anything in
Comozol cream
•
For eye infections
Do not use this medicine if the above
applies to you. If you are not sure, talk to
your doctor or pharmacist before using
Comozol cream.
_ _
Pregnancy and breast-feeding
There are no known risks with the use of
COMOZOL cream in pregnancy or
breast-feeding.
_ _
_ _
-
_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
COMOZOL 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.
•
Preparing your skin
Wash the infected skin and dry it
well
-
_Taking other medicines _
Comozol cream does not normally
react with other medicines. However,
tell your doctor or pharmacist if you
are taking or have recently taken any
other medicines. This includes
medicines that you buy without a
prescription or herbal medici

מאפייני מוצר

COMOZOL CREAM
1.
NAME OF THE MEDICAL PRODUCT
COMOZOL cream 2% w/w
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
Ketoconazole…………………… 20mg
3.
PHARMACEUTICAL FORM
White and homogeneous cream
4.
CLINICAL PARTICULARS
4.1 INDICATIONS
Comozol Cream 2% is indicated for topical application in the treatment
of dermatophyte
infections
of the
skin:
tinea
corporis,
tinea
cruris,
tinea
manus,
and
tinea
pedis
due
to
_Trichophyton rubrum_
,
_Trichophyton mentagrophytes_
,
_Microsporum canis_
, and
_Epidermophyton _
_floccosum_
, as well as in the treatment of cutaneous candidosis and tinea
(pityriasis) versicolor.
- Comozol Cream 2% is also indicated for the treatment of seborrhoeic
dermatitis, a skin
condition associated with the presence of
_Malassezia furfur_
.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
-
Cutaneous
candidosis,
tinea
corporis,
tinea
cruris,
tinea
manus,
tinea
pedis
and
tinea
(pityriasis) versicolor: it is recommended that Comozol Cream 2% be
applied once daily to
cover the affected and immediate surrounding area.
- Seborrheic dermatitis: Comozol Cream 2% should be applied to the
affected area once or
twice daily.
- The usual duration of treatment is: tinea versicolor 2 - 3 weeks,
yeast infections 2 - 3 weeks,
tinea cruris 2 - 4 weeks, tinea corporis 3 - 4 weeks, tinea pedis 4 -
6 weeks.
- The usual initial duration of treatment in seborrheic dermatitis is
2 to 4 weeks. Maintenance
therapy is applied once or twice weekly in seborrheic dermatitis.
- Treatment should be continued, until a few days after disappearance
of all symptoms. The
diagnosis should be reconsidered if no clinical improvement is noted
after 4 weeks of treatment.
Special populations
Paediatrics
There are limited data on the use of ketoconazole 2% cream in
paediatric patients.
Administration
Topical administration to the skin.
For External Use Only.
4.3 CONTRAINDICATIONS
COMOZOL Cream is contra-indicated in patients with a known
hypersensitivity to any of
the ingredients or to ketoconazole itself.
4.4 SPECIAL W