Zole Topical Solution (Clotrimazole 1% wv)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOTRIMAZOLE

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

CLOTRIMAZOLE

Unit dalam pakej:

15 ml

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ZOLE TOPICAL SOLUTION (CLOTRIMAZOLE 1% W/V)
Clotrimazole (1% w/v)
1
WHAT IS IN THIS LEAFLET
1.
What Zole is used for
2.
How Zole works
3.
Before you use Zole
4.
How to use Zole
5.
While you are using Zole
6.
Side effects
7.
Storage and disposal of Zole
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ZOLE IS USED FOR
To treat cutaneous candidiasis (red, itchy
rash), tinea corporis (ringworm), tinea
cruris (jock itch), tinea pedis (Athlete's
foot)
and
tinea
versicolor
(small,
discolored patches).
HOW ZOLE WORKS
Clotrimazole has an anti-fungal activity
which helps to treat fungal infection.
BEFORE YOU USE ZOLE
_- When you must not use it _
Do not use it when you have sensitivity
to Clotrimazole.
_-Before you start to use it_
To be used under medical advice and as
directed by the attending physician.
_-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.
Not known drug interaction.
HOW TO USE ZOLE
_-How much to use _
Apply
gently
onto
affected
and
surrounding skin area 2 or 3 times daily
continuing for 2-4 weeks.
_-When to use it _
Use
as
directed
by
your
doctor
or
pharmacist.
Apply thinly to the affected
areas 2-3 times daily and rub in.
_-How long to use it _
Continue
taking
Zole
as
your
doctor
recommended.
_ _
_ _
_ _
_ _
_ _
_-If you forget to use it _
Consult your doctor or pharmacist on
what you should do if you forget to use
it.
_ _
_-If you use too much (overdose) _
Acute overdose with topical application
of Clotrimazole is unlikely and would
not
be
expected
to
lead
to
a
life-
threatening situation.
WHILE YOU ARE USING ZOLE
_-Things you must do _
•
Tell
all
the
doctors,
dentists
and
pharmacists treating you that you are
using Zole.
_ _
•
Tell your doctor immediately if you
become
pregnant
while
taking
this
medication.
_ _
_-Things you must not do _
•
Do
not
take
more
than
the
rec

Ciri produk

ZOLE TOPICAL SOLUTION (CLOTRIMAZOLE 1% W/V)
Name and Strength of Active Substance:
Clotrimazole ………………………….. 1% w/v
DESCRIPTION:
PRODUCT DESCRIPTION
Clear, colourless viscous liquid.
PHARMACODYNAMICS
The antifungal activity of imidazoles is due to their ability to
increase fungal cell membrane
permeability by interfering with the biosynthesis of sterols,
particularly ergosterol.
PHARMACOKINETICS
When applied topically Clotrimazole penetrates the epidermis but there
is little if any systemic
absorption. Clotrimazole is metabolised in the liver to inactive
compounds and excreted in the
faeces and urine.
INDICATIONS
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis and
tinea versicolor.
RECOMMENDED DOSE
Apply gently onto affected and surrounding skin area 2 or 3 times
daily continuing for 2-4
weeks.
ROUTE OF ADMINISTRATION
Topical
CONTRAINDICATIONS
Hypersensitivity to Clotrimazole.
WARNING AND PRECAUTIONS
If
irritation
or
sensitivity
develops
with
the
use
of
Clotrimazole,
treatment
should
be
discontinued and appropriate therapy instituted.
INTERACTIONS WITH OTHER MEDICAMENTS
Not known.
PREGNANCY & LACTATION
There are, no adequate and well controlled studies in pregnant women
during the first trimester
of pregnancy because animal reproduction studies are not always
predictive of human response,
this drug should be used only if clearly indicated during the first
trimester of pregnancy.
Nursing Mothers: It is not known whether this drug is excreted in
human milk. Because many
drugs are excreted in human milk, caution should be exercised when
clotrimazole is used by a
nursing woman.
ADVERSE EFFECTS / UNDESIRABLE EFFECTS
Local reactions include irritation, burning sensation, contact
dermatitis, blister, peeling of skin,
pruritus, urticaria and stinging of skin.
SYMPTOMS AND TREATMENT OF OVERDOSE
Acute overdosage with topical application of Clotrimazole is unlikely
and would not be
expected to lead to a life-threatening situation.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINE
Not Applicabl