Candid V3 Vaginal Insert

Country: Malaysia

Language: English

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

Active ingredient:

CLOTRIMAZOLE

Available from:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (International Name):

CLOTRIMAZOLE

Units in package:

0.2gm3Tablet Tablets

Manufactured by:

GLENMARK PHARMACEUTICALS LTD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CANDID V3 VAGINAL INSERT
Clotrimazole (200mg)
Page 1 of 2
WHAT IS IN THIS LEAFLET
1.
What Candid V3 is used for
2.
How Candid V3 works
3.
Before you use Candid V3
4.
How to use Candid V3
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Candid V3
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CANDID V3 IS USED FOR
Candid V3 is indicated for the
treatment of vaginal thrush.
It is inserted into the vagina for
treatment at the site of infection.
Only use this product if you have
been diagnosed by your doctor as
having vaginal thrush.
HOW CANDID V3 WORKS
The active substance in Candid V3
is clotrimazole. Clotrimazole
belongs to a group of medicines
called azoles which is an
antifungal agent that fights the
infections causing vaginal thrush.
BEFORE YOU USE CANDID V3
_-_
_ _
_When you must not use it _

If you are allergic
(hypersensitive) to
clotrimazole or any of the
other ingredients of Candid
V3.
_-_
_ _
_Before you start to use it _
Tell your pharmacist or doctor if:

You are unsure whether you
have thrush or this is the first
time you have had these
symptoms.

You have ever had an allergic
reaction or sensitivity caused
with the use of Candid V3 or
other vaginal antifungal
products.

Please consult your doctor or
pharmacist if you are
pregnant, planning for
pregnancy or breast-feeding
before using any medicine
This is because Candid V3 may
not be the right treatment for you.
_-_
_ _
_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 CANDID V3
_-_
_ _
_How much to use _
Non-pregnant women: Insert one
tablet into vagina once a day.
Pregnant women: Intravaginal,
100mg once a day.
_-_
_ _
_When to use it _
If Candid V3 has been prescribed
for you by your doctor, follow any
instructions he/she may have given
you. If you purchased this product
withou

Summary of Product characteristics

SAME SIZE ARTWORK
LEAFLET SIZE: 88 mm x 186 mm
SAME SIZE ARTWORK
LEAFLET SIZE: 88 mm x 186 mm
Manufactured by:
Plot no. E-37, 39, D-Road,
MIDC, Satpur, Nashik - 422 007,
Maharashtra State, India.
Trade Mark
PRODUCT REGISTRATION HOLDER:
Glenmark Pharmaceuticals
(Malaysia) Sdn Bhd (660397-W)
D-31-02, Menara Suezcap 1,
No. 2, Jalan Kerinchi,
59200 Kuala Lumpur, Malaysia
PE00000 MY
PE56459 MY
24 mm
COMPOSITION
Each uncoated tablet contains:
Clotrimazole USP
200 mg
PRESERVATIVES:
Methyl Paraben USP NF
0.8 mg
Propyl Paraben USP NF
0.2 mg
THERAPEUTIC CLASS
T0130
DESCRIPTION
A printed carton with an insert, an applicator (s) and a printed
aluminium strip (s)
containing 3 white, biconvex vaginal, uncoated tablets with monogram
on one
side and V3 on the other side.
ACTIONS AND MODE OR MECHANISM OF ACTION
Clotrimazole is an imidazole antifungal agent. Clotrimazole exerts its
activity on
the cell membrane of the fungus. It appears that the drug inhibits
protein
synthesis and so influences the utilisation and the incorporation of
the acylated
amino acids essential for fungi.
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS)
PHARMACODYNAMICS
Clotrimazole
has
a
wide
spectrum
of
activity
against
Dermatophytes
(Trichophyton,
Microsporum,
Epidermophyton),
Yeasts
(Candida
sp.,
Torulopsis sp.), Mould fungi and other fungi (Aspergilus
sp.,Malassezia furfur,
Nocardia sp., etc.). It also has action against Trichomonas and some
strains of
Gram - positive bacteria (Streptococci, Staphylococci and
Corynebacterium
minitissimum) and Gram - negative bacteria (Bacteroides and
Haemophilus
vaginalis).
PHARMACOKINETICS
Following topical and vaginal administration , however, Clotrimazole
appears to
14
be minimally absorbed . Following intravaginal administration of 100
mg
C-
Clotrimazole vaginal inserts to nine adult females, an average peak
serum level,
corresponding to only 0.03 µg equivalents/mL of Clotrimazole, was
reached 1 to
2 days after application.
INDICATIONS
Vulvoginal Candidiasis.
CONTRAINDICATIONS
Except for possible h