FLUOMIZIN VAGINAL TABLETS

Country: Malaysia

Language: English

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

Active ingredient:

Dequalinium chloride

Available from:

DKSH MALAYSIA SDN. BHD.

INN (International Name):

Dequalinium chloride

Units in package:

6Capsule Capsules

Manufactured by:

ROTTENDORF PHARMA GMBH

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FLUOMIZIN
® VAGINAL TABLETS
Dequalinium chloride (10mg)
1
WHAT IS IN THIS LEAFLET:
1.
What
Fluomizin
®
vaginal
tablets is used for
2.
How
Fluomizin
®
vaginal
tablets work
3.
Before
you
use
Fluomizin
®
vaginal tablets
4.
How to use Fluomizin
®
vaginal
tablets
5.
While
you
are
using
Fluomizin
®
vaginal tablets
6.
Side effects
7.
Storage
and
disposal
of
Fluomizin
®
vaginal tablets
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT FLUOMIZIN
®
VAGINAL TABLETS ARE
USED FOR
Fluomizin
®
vaginal tablets is used for
treatment of vaginal infections, which
caused by bacteria (bacterial vaginosis),
yeast (Candida infections) and parasite
(trichomoniasis).
It
is
also
used
for
preparation of aseptic condition before
gynecological operation or deliveries.
HOW FLUOMIZIN
®
VAGINAL TABLETS WORK
After
insertion
into
the
vagina,
Fluomizin
®
vaginal tablets dissolve and
release the active substance dequalinium
chloride.
Dequalinium
chloride
effective
against
a
wide
range
of
bacteria,
fungi
(yeasts)
and
protozoa
(Trichomonas), which can be the cause
of vaginal infections.
Fluomizin
®
vaginal tablets acts locally
within
the
vagina.
Marked
relief
of
discharge and inflammation generally
occurs within 24 to 72 hours.
BEFORE
YOU
USE
FLUOMIZIN
®
VAGINAL
TABLETS
_-When you must not use it _
You must not use Fluomizin
®
vaginal
tablets if you have:
-
Hypersensitivity to the ingredients
listed in Product Description
-
Ulceration of the vaginal lining or
neck of the uterus
-
not
yet
reached
sexual
maturity
(young
girls
should
not
use
this
preparation)
_-Before you start to use it _
Please tell your doctor or pharmacist if
you are allergic to any medicines, food,
preservatives or dye.
During
pregnancy
and
breastfeeding,
Fluomizin
®
vaginal tablets can be used
after
consulting
a
medical
doctor
or
pharmacist.
However, as in general, caution should
be exercised when using Fluomizin by
pregnant women in the first trimester.
_-Taking other

Summary of Product characteristics

New article-no.: 380706 / 306087, Plant: ROT, Format: 148x210mm, Code:
DddDddDD, Code-No.: 402,
Font: Arial, Font-size: 7pt., Creation-date: 09/10/13, Version-no: 1
FLUOMIZIN
®
vaginal tablets
NAME OF THE MEDICINAL PRODUCT
Fluomizin 10 mg vaginal tablets.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each
tablet
contains
10
mg
dequalinium
chloride.
For excipients, see “List of Excipients”.
PHARMACEUTICAL FORM
Vaginal tablets
The vaginal tablets are white or almost white,
oval and biconvex.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
•
Vaginal infection of bacterial and mycotic
origin
(e.g.
bacterial
vaginosis
and
candidiasis)
•
Trichomoniasis
•
Achievement of asepsis before gynaeco-
logical operations and deliveries
POSOLOGY AND METHOD OF ADMINISTRATION
One vaginal tablet daily for six days.
The vaginal tablets should be inserted deeply
into the vagina in the evenings before retiring.
This is best performed in a reclining position with
the legs slightly bent.
The
treatment
should
be
interrupted
during
menstruation and resumed afterwards.
The treatment should be continued even when
there
is
no
subjective
discomfort
(itching,
discharge,
smell)
anymore.
A
treatment
less
than six days could result in a relapse.
INSTRUCTIONS FOR USE / HANDLING
Fluomizin
contains
excipients
which
do
not
dissolve completely, such that remains of the
tablet could occasionally be found in the panties.
This
is
of
no
importance
for
the
efficacy
of
Fluomizin.
In rare cases of a very dry vagina, it is possible
that the vaginal tablet does not dissolve and is
discharged by the vagina as intact tablet. As
consequence,
the
treatment
is
not
optimal.
However, this is not harmful to the vagina. For
prevention, the vaginal tablet can be moistened
with a drop of water before insertion into a very
dry vagina.
Patients
should
use a sanitary towel or panty
liner.
There
is
no
change
in
colour
of
the
underwear.
Patients
should
be
instructed
to
change their underwear and flannel daily and
launder them at a temperature of at least 80 °C.
Patients
sh