GYNOFLOR VAGINAL TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ESTRIOL; LACTOBACILLUS ACIDOPHILUS LYOPHILISATE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

ESTRIOL; LACTOBACILLUS ACIDOPHILUS LYOPHILISATE

Unit dalam pakej:

6Tablet Tablets; 12Tablet Tablets

Dikeluarkan oleh:

Haupt. Pharma. Amareg .GmbH...

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
GYNOFLOR VAGINAL TABLETS
®
_ _
_Lactobacillus acidophilus/_
Estriol (100 million viable/0.03mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_Gynoflor _
is used for
2.
How
_Gynoflor _
works
3.
Before you use
_Gynoflor _
4.
How to use
_Gynoflor _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Gynoflor _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _GYNOFLOR _IS USED FOR
Gynoflor is used for restoration of the
vaginal lactobacilli flora after treatment
with certain medicines (e.g. anti-
infective or chemotherapy), treatment of
atrophic vaginitis (thinning, drying and
inflammation of vaginal walls) due to
your body having less estrogen hormone
during and after menopause as well as
for co-medication to systemic hormone
replacement therapy. It is also used for
treatment of vaginal discharge of
unknown origin or mild to intermediate
cases of vaginal infections, where the use
of anti-infective or chemotherapy agents
is not absolutely necessary. It can be
used for preventive treatment of
recurrent vaginal infections.
HOW _GYNOFLOR _WORKS
Gynoflor contains active substances that
are identical to substances found
naturally in the human vagina. The
healthy vagina is in a state of biological
equilibrium and possesses a natural
protection mechanism against infections.
The lactobacilli bacteria (e.g.
Lactobacillus acidophilus) constitute a
main part of this protection mechanism
by producing lactic acid and other
substances which have an anti-infective
activity. The production of lactic acid
results in an acidic environment,
favouring the growth of the lactobacilli
bacteria but inhibiting the growth of
pathogenic micro-organisms.
Disturbance or destruction of the vaginal
lactobacilli flora can be caused by
treatment with certain medicines (e.g.
antibiotics), local infections, serious
general illnesses or improper hygienic
measures (vaginal rinses and douches).
Gynoflor contains viable lactobacilli
bacteria in a hig

Ciri produk

new article-no.: 806515/40022322-05/15 – old article-no.: 806187/29741 – Code-No.: 45 – Code: dDDDd \
– Plant: Haupt Pharma
Format 170 x 292 mm – Font: Helvetica Neue – Font-Size: 8 pt – \
Creation-Date: 26.05.15 – Version 1
GYNOFLOR ®vaginal tablets
NAME OF T\bE MEDICINAL PRODUCT
Gynoflor vaginal tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains 100 million viable
Lactobacillus acidophilusand 0.03 mg Estriol
For excipients, see “List of Excipients”.
P\bARMACEUTICAL FORM
Vaginal tablets. The vaginal tablets are slightly beige,
spotted, oval and biconvex.
CLINICAL PARTICULARS
Therapeutic indications
• restoration of the Lactobacillus flora after local and/or systemic treatment with anti-infective or
chemotherapeutic agents;
• atrophic vaginitis due to estrogen deficiency during menopause and post-menopause, or as
comedication to systemic hormone replacement
therapy;
• vaginal discharge of unknown origin or mild to intermediate cases of bacterial vaginosis and
candidiasis, where use of anti-infective therapy is
not absolutely necessary.
A further possible application is the prophylactic
treatment of recidive vaginal infections.
Posology and method of administration
Restoration therapy, vaginal discharge of un\bnown


 1 – 2 vaginal tablets daily for 6 – 12 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.
Treatment should be interrupted during menstrua -
tion and resumed afterwards.
Atrophic vaginitis:
In cases of atrophic vaginitis, a dose of 1 vaginal
tablet daily is recommended for 6 – 12 days, fol -
lowed by a maintenance dose of 1 vaginal tablet at
1 – 2 days per week.
Instructions for use / handling
Gynoflor 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 o