Canespro Once Daily Bifonazole Anti-fungal Cream 1% ww

Country: Malaysia

Language: English

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

Active ingredient:

BIFONAZOLE

Available from:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (International Name):

BIFONAZOLE

Units in package:

15 gm

Manufactured by:

GP GRENZACH PRODUKTIONS GMBH

Patient Information leaflet

1
CANESPRO
ONCE DAILY
BIFONAZOLE ANTI-FUNGAL CREAM 1% W/W
Bifonazole 1%
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
WHAT IS IN THIS LEAFLET
1.
What Canespro Once Daily
Bifonazole Anti-fungal Cream is
used for
2.
How Canespro Once Daily
Bifonazole Anti-fungal
Creamworks
3.
Before you use Canespro Once
Daily Bifonazole Anti-fungal
Cream
4.
How to use Canespro Once Daily
Bifonazole Anti-fungal Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Canespro
Once Daily Bifonazole Anti-fungal
Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CANESPRO ONCE DAILY BIFONAZOLE
ANTI-FUNGAL CREAM IS USED FOR
Canespro Once Daily Bifonazole Anti-
fungal Cream is used to treat athlete’s
foot, fungal infection of the hand,
ringworks, jock
itch,
white
spots,
erythrasma (skin redness) & fungal
infection of the skin.
HOW CANESPRO ONCE DAILY BIFONAZOLE
ANTI-FUNGAL CREAM WORKS
The active substance in Canespro Once
Daily
Bifonazole
Anti-fungal
Cream
is
bifonazole.
Bifonazole
belongs
to
a
group
of
medicines
called
imidazoles.
The
primary
mechanism
of
action
of
bifonazole
is
against
the
division
and
growing
of
fungi
,
on
two
different
levels,
thereby
distinguishing
bifonazole
both
from
other
azole
derivatives
and
from other anti-fungals which act only
on
a
single level. Bifonazole
alters
the
permeability of the fungal cell wall and
inhibits the activity of enzymes within
the
cell.
It
specifically
inhibits
the
biosynthesis
of
ergosterol
required
for
cell membrane production.
BEFORE YOU USE CANE
SPRO ONCE DAILY
BIFONAZOLE ANTI-FUNGAL CREAM
_When you must not use it_
If
you
are
allergic
(hypersensitive)
to
bifonazole or any of the other ingredients
of .
If you have ever had an allergic reaction to
any antifungal product. Patients on warfarin
therapy should be monitored when bifonazole
is used concomitantly. Some of the excipients
may reduce the effectiveness of latex products
such as condoms and diaphragms when
applied to genital area. The effect is
temporary and

Summary of Product characteristics

Once Daily Bifonazole
Anti-Fungal cream 1%w/w
For external use only
Canespro
PRODUCT INSERT FOR MALAYSIA MARKET
ACTIVE INGREDIENTS
Canespro
®
Once Daily Bifonazole Anti-Fungal Cream 1%w/w contains:
Bifonazole 1%
PRODUCT DESCRIPTION
White & soft cream.
PHARMACODYNAMIC
Pharmacotherapeutic group: Anti-fungals for dermatological use
-Bifonazole ATC Code: DD1AC10
MODE OF ACTION
Bifonazole is an imidazole derivative with a broad antimycotic
spectrum, which includes dermatophytes, yeasts, moulds and other
fungi such as _Malassezia furfur_. It is also effective against
_Corynebacterium minutissimum_. Bifonazole exerts its anti-fungal
action by inhibiting the biosynthesis of ergosterol on two different
levels, thereby distinguishing bifonazole both from other azole
derivatives and from other anti-fungals which act only on a single
level. Inhibition of ergosterol synthesis leads to structural and
functional impairment of the cytoplasmic membrane. The resistance
situation for bifonazole is favorable. Primary resistant variants of
sensitive fungal species are very rare. Investigations so far did not
provide any evidence of a development of secondary resistance in
primarily sensitive strains.
PHARMACOKINETIC
Absorption
Bifonazole penetrates well into infected skin layers. 6 hours after
administration concentrations in the various skin layers reach from
1000 µg/cm
3
in the top layer of the epidermis (stratum corneum) to
5 µg/cm
3
in the stratum papillare. All concentrations determined are
thus within a range of reliable antimycotic activity.
INDICATIONS
•
Treatment of skin mycoses caused by dermatophytes, yeasts,
moulds, and other fungi (e.g. athlete’s foot, fungal infection of
the
hand, ringworms, jock itch, white spots, superficial fungal skin
infections & other tinea conditions).
•
Treatment of erythrasma (skin redness).
DOSAGE & APPLICATION
Posology
To achieve a lasting cure, treatment with bifonazole must be carried
out reliably and over an adequate period. The usual periods of
treatment are summarized in the tab