CANDID V GEL

Land: Maleisië

Taal: Engels

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

Werkstoffen:

CLOTRIMAZOLE

Beschikbaar vanaf:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Algemene Internationale Benaming):

CLOTRIMAZOLE

Eenheden in pakket:

30gm mcg/mL

Geproduceerd door:

GLENMARK PHARMACEUTICALS LTD

Bijsluiter

Consumer Medication Information Leaflet (RiMUP)
1
Candid™ - V Gel
Clotrimazole USP 2% w/v
What is in this leaflet
1.
What CANDID V Gel is used for
2.
How CANDID V Gel works
3.
Before you use CANDID V Gel
4.
How to use CANDID V Gel
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of CANDID V
Gel
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
11.
Serial Number
WHAT IS CANDID V Gel AND WHAT
IS IT USED FOR?
Candid – V Gel relieves irritation of the
vulva (vulvitis) which is caused by vaginal
thrush
(candidiasis).
Although
this
gel
provides relief from the external irritation
caused by vaginal thrush, it cannot treat any
internal (vaginal) cause of the infection. Ask
your doctor or pharmacist to recommend a
treatment for this. Only use this product if
you have been previously diagnosed by your
doctor
as
having
vaginal
thrush.
Some
women
suffer
from
recurrent
attacks
of
thrush. To reduce the frequency of these
attacks, the sexual partner’s penis can be
treated with this gel to prevent re-infection,
even if they have no symptoms of thrush.
The active substance in Candid – V Gel is
clotrimazole.
Clotrimazole
belongs
to
a
group of medicines called azoles and is an
antifungal agent which fights the cause of
infections such as vaginal thrush.
HOW CANDID V Gel WORKS
Clotrimazole Vaginal Gel is recommended
for the treatment of candidal vulvitis. It
should be used as an adjunct to treatment of
candidal vaginitis.
It can also be used for treatment of the sexual
partner's penis to prevent re-infection.
BEFORE YOU USE CANDID V Gel
Do not use Candid – V Gel
If
you
are
allergic
(hypersensitive)
to
clotrimazole or any of the other ingredients,
including chlorocresol, cetyl alcohol, and
propylene glycol, of Candid – V Gel (see
Section 6. Further Information).
Before using Candid – V Gel, you should
see your doctor if:

You are unsure whether you have
thrush or this is the first time you have
had these symptoms.

You have had more than two infections
of

Productkenmerken

COMPOSITION:
Clotrimazole USP
2%
PRESERVATIVES:
Benzyl Alcohol USP-NF
2%
Chlorocresol USP-NF
0.1%
THERAPEUTIC CLASS: T0130
DESCRIPTION:
A
printed
carton
with
an
insert,
applicator and a printed aluminium collapsible tube
containing white, smooth, semi-solid gel.
ACTIONS AND MODE OR MECHANISM OF ACTION :
The active substance of CANDID is Clotrimazole which
is bis-phenyl-(2-chlorophenyl)-1-dazolylmethane.
CANDID
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 ).
CANDID acts on the cell membrane of the fungus. It
appears that it inhibits protein synthesis and influences
the utilisation and incorporation of the acylated amino
acids essential to fungi.
P H A R M A C O L O G Y
( S U M M A R Y
O F
PHARMACODYNAMICS AND
PHARMACOKINETICS) :
PHARMACODYNAMICS:
Clotrimazole is a broad-spectrum antifungal agent that is
used for treatment of dermal infections caused by
various species of pathogenic dermatophytes, yeasts
and
Malassezia
furfur.
The
primary
action
of
Clotrimazole is against dividing any growing organisms.
In vitro Clotrimazole exhibits fungistatic and fungicidal
activity
against
isolates
Trichophytonrubrum,
Trichophyton
mentagrophytes,
Epidermophyton
flocossum, Microsporum canis and Candida species
including Candida albicans. In general, the in vitro
activity of Clotrimazole corresponds to that of tolnaftate
and griseofulvin against the mycelia of dermatophytes
INSERTION CAN BE CARRIED OUT MORE EASILY WHEN LYING
ON THE BACK WITH THE KNEES BENT AND SPREAD OUT.
6. The Applicator after each use should be taken apart
for cleaning by holding the cylinder with one hand and
pulling out the plunger with slight force. Wash with soap
and
luke