DEFUNGO 0.1G (VAGINAL TABLET)

Country: Malaysia

Language: English

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

Active ingredient:

CLOTRIMAZOLE

Available from:

SPG PHARMA (MALAYSIA) SDN BHD

INN (International Name):

CLOTRIMAZOLE

Units in package:

1 x 6's vaginal Tablets

Manufactured by:

SIAM BHEASACH CO LTD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DEFUNGO (VAGINAL TABLET)
Clotrimazole (0.1 g)
_______________________________________________________________________________________________
1/2
WHAT IS IN THIS LEAFLET
1.
What DEFUNGO is used for
2.
How DEFUNGO works
3.
Before you use DEFUNGO
4.
How to use DEFUNGO
5.
While you are using
DEFUNGO
6.
Side effects
7.
Storage and Disposal of
DEFUNGO
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT DEFUNGO IS USED FOR
DEFUNGO is an antifungal agent
used to treat infections vaginal
discharge.
HOW DEFUNGO WORKS
DEFUNGO belongs to a class of
medicines known as azoles.
It works by preventing the growth
of fungi which causes your
infection.
BEFORE YOU USE DEFUNGO
_- When you must not use it _
Do not use DEFUNGO if you:
▪
are allergic to clotrimazole or
any other ingredients listed at the
end of this leaflet
▪
are having your menstrual period
_- Before you start to use it _
Tell your doctor or pharmacist
before using DEFUNGO if you:
▪
have known hypersensitivity to
imidazoles or other vaginal
antifungal product
_- Taking other medicines _
Tell your doctor or pharmacist if
you are taking or have recently
taken any medicines, including
traditional products bought without
a prescription.
Some medicines may interact with
DEFUNGO such as tacrolimus or
sirolimus (used after organ
transplant).
For pregnant and/or breastfeeding
mother, please consult your doctor
before using DEFUNGO.
HOW TO USE DEFUNGO
_- How much to use _
For vaginal use only.
The medicine should be inserted as
deeply as possible into the vagina,
best achieved when lying back with
legs bent up.
_DEFUNGO 0.1G (VAGINAL _
_TABLET): _
First infection
Insert 2 Defungo 0.1g (vaginal
tablet) into the vagina for three
consecutive nights.
Reinfection
Insert 1 Defungo 0.1g (vaginal
tablet) into the vagina for six
consecutive nights.
If necessary, 2 Defungo 0.1g
(vaginal tablet) can be used, 1 in
the morning and 1 in the evening
for 6-12 days.
_- When t

Summary of Product characteristics

PRODUCT NAME
DEFUNGO 0.1G (VAGINAL TABLET)
NAME AND STRENGTH OF ACTIVE SUBSTANCE
DEFUNGO 0.1G: Each vaginal tablet contains 0.1 g Clotrimazole
PRODUCT DESCRIPTION
DEFUNGO 0.1G: White, oblong and biconvex tablet engraved with the “
” logo on one side and the letter “0.1”
on the other side
PHARMACODYNAMICS
Pharmacotherapeutic group: gynaecological anti-infective and
antiseptics - imidazole derivatives
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 which includes dermatophytes, yeasts, moulds, etc.
PHARMACOKINETICS
Clotrimazole applied intravaginally does not lead to measurable
systemic effects or side effects. Pharmacokinetic
investigations have shown that only a small amount of clotrimazole,
about 3-10% of the dose is absorbed after
vaginal application.
INDICATION
Infections of the genital region (vaginitis) caused by fungi (usually
Candida) and superinfections caused by
Clotrimazole-sensitive bacteria.
DOSAGE AND ADMINISTRATION
DEFUNGO 0.1G (VAGINAL TABLET):
First infection
Insert 2 Defungo 0.1g (vaginal tablet) into the vagina for three
consecutive nights.
Reinfection
Insert 1 Defungo 0.1g (vaginal tablet) into the vagina for six
consecutive nights. If necessary, 2 Defungo 0.1g (vaginal
tablet) daily, 1 in the morning and 1 in the evening for 6-12 days.
Instruction for use
█
For vaginal use only. The medicine should be inserted as deeply as
possible into the vagina, best achieved when
lying back with the legs bent up
█
Treatment should be timed so as to avoid the menstrual period and be
finished before the onset of menstruation
█
Do not use tampons, intravaginal douches, spermicides or other vaginal
products while using this product
█
Avoidance of vaginal intercourse is recommended in case of vaginal
infection and while using this product the
partner could become infected
CONTRAINDICATI