CANDIGO (CLOTRIMAZOLE PESSARY 500MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOTRIMAZOLE

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

CLOTRIMAZOLE

Unit dalam pakej:

1 Units

Dikeluarkan oleh:

KUSUM HEALTHCARE PVT. LTD.

Risalah maklumat

CANDIGO
CLOTRIMAZOLE PESSARY 500 MG
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
_1._
_ _
What
_is Candigo used for _
2.
How
_Candigo _
works
_3._
_ _
Before you use
_Candigo _
_4._
_ _
How to use
_Candigo _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Candigo _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IS _CANDIGO _IS USED FOR
Clotrimazole belongs to a group of
medicines called azoles and is an
antifungal agent which fights the
infections such as vaginitis
(inflammation of vagina) caused by
certain types of fungi (usually
Candida) and superinfection caused
by Clotrimazole sensitive bacteria. It
is inserted into the vagina for
treatment at the site of infection.
HOW _CANDIGO _WORKS
Clotrimazole acts against fungi by
inhibiting ergosterol synthesis.
Inhibition of ergosterol synthesis
leads to structural and functional
impairment of the cytoplasmic
membrane of fungus
BEFORE YOU USE _CANDIGO _
_- When you must not use it _

If you are under 16 or over 60
years of age.

If you are in pain, feel sick, or
have diarrhoea or a fever.

Irregular vaginal bleeding.

Abnormal vaginal bleeding or a
blood-stained discharge.

Lower abdominal pain or dysuria.

Foul smelling vaginal discharge.
_PREGNANCY AND LACTATION _
If you are pregnant or trying for a
baby, tell your doctor or midwife
before using
_Candigo. _
If you have
informed your doctor or midwife
already, follow his/her instructions
carefully.
Do not use
_Candigo _
if you are breast-
feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
_-Before you start use it _
Confirm if you are not hypersensitive
to Clotrimazole or any of the
excipients used in
_Candigo_
.
-
_Taking other medicines _
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription. Inform your doctor if
you are taking tacrolimus or sirolimus
(used to reduc

Ciri produk

CANDIGO
®
CLOTRIMAZOLE PESSARY 500 MG
GENERAL CHARACTERISTICS
_GENERAL PHYSIO-CHEMICAL PROPERTIES:_
White to light yellow colour torpedo shaped pessary.
COMPOSITION:
Each pessary contains
Clotrimazole BP ….….. 500 mg
_EXCIPIENT _
Hard Fat
PHARMACODYNAMIC PROPERTIES:
PHARMACOTHERAPEUTIC GROUP:
Anti-infective
ATC CODE:
G01A F02
_MECHANISM OF ACTION _
Clotrimazole acts against fungi by inhibiting ergosterol synthesis.
Inhibition of ergosterol
synthesis leads to structural and functional impairment of the fungal
cytoplasmic membrane.
Clotrimazole has a broad antimycotic spectrum of action in vitro and
in vivo, which includes
dermatophytes, yeasts, moulds, etc.
Under appropriate test conditions, the MIC values for these types of
fungi are in the region of
less than 0.062-8.0 μg/ml substrate. The mode of action of
clotrimazole is fungistatic or
fungicidal depending on the concentration of clotrimazole at the site
of infection. In-vitro
activity is limited to proliferating fungal elements; fungal spores
are only slightly sensitive.
Primarily resistant variants of sensitive fungal species are very
rare; the development of
secondary resistance by sensitive fungi has so far only been observed
in very isolated cases
under therapeutic conditions
PHARMACOKINETICS PROPERTIES:
Pharmacokinetic investigations
after vaginal
application have shown
that only
a small
amount of clotrimazole (3- 10% of the dose) is absorbed. Due to the
rapid hepatic metabolism
of absorbed clotrimazole into pharmacologically inactive metabolites
the resulting peak
plasma concentrations of clotrimazole after vaginal application of a
500 mg dose were less
than 10 mg/ml, reflecting that clotrimazole applied intravaginally
does not lead to measurable
systemic effects or side effects.
INDICATIONS:
Infections
of
the
genital
region
(vaginitis)
caused
by
fungi
(usually
Candida)
and
superinfections caused by Clotrimazole-sensitive bacteria.
DOSAGE AND ADMINISTRATION:
Candigo
®
Pessary should be inserted into the vagina, as high as possible with
the help o