TINAZOL CREAM 2%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MICONAZOLE NITRATE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

MICONAZOLE NITRATE

Unit dalam pakej:

15gm mcg/mL; 500 gm

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TINAZOL CREAM 2%
Miconazole nitrate (2% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Tinazol Cream is used for
2.
How Tinazol Cream works
3.
Before you use Tinazol Cream
4.
How to use Tinazol Cream
5.
While
you
are
using
Tinazol
Cream
6.
Side effects
7.
Storage
and
Disposal
of
Tinazol
Cream
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TINAZOL CREAM IS USED FOR
Tinazol
Cream
contains
a
medicine
called miconazole. This belongs to a
group
of
medicines
called
“antifungals”.
Tinazol Cream is used for infections of
the
skin
or
nails
caused
by
fungi
including
yeasts
and
some
bacteria.
Infections may appear on the:
•
hands or feet
•
Scalp or outer ear
•
Groin
Tinazol cream works by destroying the
fungus and associated bacteria which
may be present.
HOW TINAZOL CREAM WORKS
Miconazole
acts
as
an
antifungal
by
altering
cell
membrane
permeability,
resulting in the cell membrane being
unable to function as a selective barrier.
There is little systemic absorption when
miconazole is applied topically.
BEFORE YOU USE TINAZOL CREAM
_- When you must not use it _
_ _
Do not take this medicine if:
•
you are known to be hypersensitive
to any of the ingredients.
Do
not
take
this
medicine
after
the
expiry date printed on the pack or if the
packaging is damaged.
_ _
_Pregnancy and lactation _
_ _
Caution
is
recommended
during
pregnancy and lactation period.
_ _
_- Before you start use it _
Tell your doctor or pharmacist if:
•
you
are
allergic
to
any
of
the
ingredients in the cream.
•
you are on warfarin therapy.
_- Taking other medicines _
_ _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop.
HOW TO USE TINAZOL CREAM
_- How much to use _
Adults and children
-
Tinea
pedis,
Tinea
cruris
(fungal
infection that affects the skin of genital,
inner
thighs
and
buttocks),
Tinea
corporis,
cutaneous
candidiasis
(skin
fungal infectio

Ciri produk

DESCRIPTION
White cream with sheen.
COMPOSITION
Miconazole Nitrate 2.0% w/w
ACTIONS AND PHARMACOLOGY
Miconazole is an imidazole antifungal agent; it is fungicidal to
various
species
of
Trichophyton,
Epidermophyton,
Microsporum,
Candida,
Cryptococcus,
Asperqillus,
Coccodioides, Paracoccidioides, Cladosporium, Phialophora,
Madurella, Blastomyces and Histoplasma.
The
drug
permeates
the
chitin
of
the
fungal
wall
and
increases the membrane permeability to various intracellular
substances.
Miconazole
is
also
effective
against
gram-positive
bacteria. The
drug
readily
penetrates
the
stratum corneum of the skin and persists there for more than
4 days after application.
In the treatment of tinea pedis, topical miconazole relieves
itching within a few days; vesicles and fissures heal rapidly
but desquamation may continue for several weeks. In the
treatment of tines curis, the drug is comparably effective.
Tinea versicolor, ringworm, onychomycosis and cutaneous
candidiasis also repond to topical miconazole.
PHARMACOKINETICS
Absorption
Very little is absorbed systemically following topical application.
Excretion
Only trace amounts can be found in the urine.
CONTRAINDICATIONS
There are no data on contraindication for topical treatment in
human
INDICATIONS
For the topical treatment of tinea pedis, tinea cruris and tinea
corporis, and in topical treatment of cutaneous candidiasis,
tinea and pityriasis versicolor.
WARNINGS AND PRECAUTIONS
•
In patients on warfarin, caution should be exercised and
the
anticoagulant
effect
should
be
monitored
(see
Interactions).
TINAZOL CREAM 2%
VITINxx-0 (MY)2
xxx
•
Do not apply occlusive dressing over this medication
unless directed to do so by physician.
•
Avoid contact with the eyes.
•
If irritation occurs or if there is no improvement within 4
weeks, discontinue use and consult a doctor or pharmacist.
•
Do not use in children under 2 years of age except under
the advice and supervision of a doctor.
DRUG INTERACTIONS
Miconazole administered systemically is known to inhibit
CYP2C9 enzy