Fluomizin 10mg vaginal tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dequalinium chloride

Available from:

Gedeon Richter (UK) Ltd

ATC code:

G01AC05

INN (International Name):

Dequalinium chloride

Dosage:

10mg

Pharmaceutical form:

Vaginal tablet

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020200; GTIN: 5391500440348

Patient Information leaflet

new article-no.: 380225 / 316944 – old article-no.: 380902 / 310424
– Code: dDDdDdDd – Plant: Rottendorf
Format 148 x 330 mm – Font: Helvetica Neue 55 Roman – Font-Size: 9
pt – Creation-Date: 25.11.22 – Version 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOMIZIN® 10 MG VAGINAL TABLETS
DEQUALINIUM CHLORIDE
WHAT IS IN THIS LEAFLET:
1.
What Fluomizin is and what it is used for
2.
What
you
need
to
know
before
you
use
Fluomizin
3.
How to use Fluomizin
4.
Possible side effects
5.
How to store Fluomizin
6.
Contents of the pack and other information
1.
WHAT FLUOMIZIN IS AND WHAT
IT IS USED FOR
Dequalinium chloride, the active ingredient in
Fluomizin, belongs to the family of anti-infective
and antiseptic drugs. Dequalinium chloride is
active against the bacteria which cause bacterial
vaginosis.
Fluomizin is used for the treatment of bacterial
vaginosis.
It is inserted into the vagina for treatment at the
site of infection.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU USE FLUOMIZIN
DO NOT USE FLUOMIZIN:
•
if you are allergic to the active substance
dequalinium
chloride
or
any
of
the
other
ingredients of this medicine (listed in section 6).
•
if you have ulcers on your vagina or cervix.
•
if you have not yet had your first period.
WARNINGS AND PRECAUTIONS
Intravaginal
use
of
soaps,
spermicides
and
vaginal
douches
(vaginal
washes)
is
not
recommended during treatment with Fluomizin.
As with all vaginal infections, unprotected sexual
intercourse du
ring treatment with Fluomizin is not
re
commended.
Fluomizin does not reduce the effectiveness of
latex condoms.
This product may reduce the effectiveness of
non-latex condoms or diaphragms. Consequently,
you should use alternative methods of contracep -
tion for at least 12 hours following the treatment.
Do not use Fluomizin within 12 hours before birth
to
minimize
exposure
of
the
newborn
to
dequalinium ch
lori
de. Please inform your doctor
otherwise.
You should stop the treatment during the heavy
bleeding period of your menstruation and resume
afterwards.
You should

Summary of Product characteristics

1
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS
2
1
NAME OF THE MEDICINAL PRODUCT
Fluomizin 10 mg vaginal tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains 10 mg dequalinium chloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Vaginal tablet
The vaginal tablets are white or almost white, oval and biconvex with
approximate dimension
of length: 19 mm, width: 12 mm, and thickness: 6.3 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluomizin 10 mg vaginal tablets are indicated for the treatment of
Bacterial vaginosis (see
section 4.4)
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
Although relief of discharge and inflammation generally occurs within
24 to 72 hours, 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.
Fluomizin contains excipients which do not dissolve completely, such
that remains of the tablet
are occasionally found in the underwear. 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. 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.
_Women more than 55 years and elderly _
3
There is a lack of data on the efficacy and safety of dequalinium
chloride in women above 55
years of age.
_ _
_