)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
_____________19.8.09__________ ‫תאריך‬
______ Ovestin_____________‫שם תכשיר באנגלית‬
_________________ 656021266___________‫מספר רישום‬
____________.‫ ג'י‬.‫פלאו ישראל איי‬-‫שם בעל הרישום___ שרינג‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
Ovestin, 1 mg vaginal
cream.
Homogeneous, smooth,
white to nearly white mass
of creamy consistency
‫טקסט נוכחי‬
Ovestin, vaginal cream.
‫פרק בעלון‬
NAME OF THE
MEDICINAL
PRODUCT
Pharmaceutical form
Instructions for use for the
patient
1. Remove cap from the
tube, invert it, and use
the sharp point to open
the tube.
2. Screw the end of the
applicator onto the
tube.
Posology and
method of adminis
3. Squeeze tube to fill the
applicator with the
cream until the plunger
stops.
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4.
5.
6.
Unscrew applicator
from tube and replace
cap on tube.
To apply cream, lie
down and insert end of
applicator deep into
the vagina.
Slowly push plunger
all the way in until
applicator is empty.
After use, pull plunger out
of barrel and wash both in
warm, soapy water.
Do not use detergents.
Rinse well afterwards.
DO NOT PUT THE
APPLICATOR IN HOT OR
BOILING WATER.
In women not taking HRT
or in women who switch
from a continuous
combined HRT product,
treatment with Ovestin may
be started on any day.
Women who switch from
cyclic HRT regimen should
start Ovestin treatment one
week after completion of
the cycle.
In women not taking HRT
or in women who switch
from a continuous
combined HRT product,
treatment may be started
on any day. In Women
who switch from a cyclic
or a continuous sequential
HRT product, treatment
should start Ovestin
treatment the day after
completion of the previous
cycle.
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Breast cancer

HRT may increase
mammographic
density. This may
complicate the
radiological detection
of breast cancer.
Clinical studies
reported that the
likelihood of developing
increased
mammographic
densitiy was lower in
subjects treated with
estriol than in subjects
treated with other
estrogens.
Special warnings
and precautions for
use
.


It is unknown whether
Ovestin carries the
same risk. Therefore, it
is important that the
risk of being diagnosed
with breast cancer is
discussed with the
patient and weighed
against the known
benefits of HRT.

The limited available
data do not contain
indications that the
use of Ovestin vaginal
cream increases the
risk of breast cancer.
Other conditions
Ovestin cream contains cetyl
alcohol and stearyl alcohol.
This may cause local skin
reactions (e.g. contact
dermatitis).
No examples of
interactions between
Ovestin and other
medicines have been
reported in clinical practice.
Although data are limited,
interactions between
Interaction with
other medicinal
products and other
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Ovestin and other
medicinal products may
occur. The following
interactions have been
described with use of
combined oral
contraceptives which may
also be relevant for
Ovestin.
forms of interaction
The metabolism of
estrogens (and
progestogens) may be
increased by concomitant
use of substances known
to induce drugmetabolizing enzymes,
specifically cytochrome
P450 enzymes, such as
anticonvulsants (e.g.
hydantoins,
barbiturates,phenobarbital,
phenytoin, carbamazepin)
and ,antiinfectives/antivirals (e.g.
griseofulvin, rifamycins
rifampicin, rifabutin, the
antiretroviral agents
nevirapine and efavirenz)
and herbal preparations
containing St John’s wort
(Hypericum Perforatum).
Ritonavir and nelfinavir,
although known as strong
inhibitors of the
metabolism, by contrast
exhibit inducing properties
when used concomitantly
with steroid hormones.
Fytotherapeutic
preparations containing St
John's wort (Hypericum
perforatum) may induce
the metabolism of
estrogens and
progestogens. Clinically,
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an increased metabolism
of estrogens and
progestogens may lead to
decreased effectiveness of
Ovestin efficacy and
changes in uterine
bleeding profile.
Estriol may possibly
increase the
pharmacological effects of
corticosteroids,
succinylcholine,
theophyllines and
troleandomycin.
From literature and safety
surveillance monitoring,
the following adverse
reactions have been
reported:
( ‫(טבלה המפרטת שכיחות תופעות‬
‫הלוואי‬
As with any product that is
to be applied to mucosal
surfaces, Ovestin may
cause local irritation or
itching. Breast tension or
pain may occasionally
occur, and this may be
indicative of too high a
dosage. These adverse
reactions usually
disappear after the first
weeks of treatment.
Undesirable effects
*MedDRA version 9.1
These adverse reactions
are usually transient, but
may also be indicative of
too high a dosage.
The acute toxicity of estriol
in animals is very low.
Overdose with Ovestin
after vaginal administration
is unlikely.
Overdose
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Pharmacotherapeutic
group: natural and
semisynthetic estrogens
Ovestin contains the
natural female hormone
estriol. Unlike other
estrogens, estriol is short
acting since it has only a
short retention time in the
nuclei of endometrial cells.
It substitutes for the loss of
estrogen production in
menopausal women and
alleviates menopausal
symptoms. Estriol is
particularly effective in the
treatment of urogenital
symptoms. In case of
atrophy of the lower
urogenital tract estriol
induces the normalization
of the urogenital epithelium
and helps to restore the
normal microflora and the
physiological pH in the
vagina. As a result, it
increases the resistance of
the urogenital epithelial
cells to infection and
inflammation reducing
vaginal complaints such as
dyspareunia, dryness,
itching, vaginal and urinary
infections, miction
complaints and mild
urinary incontinence.
The active ingredient of
Ovestin is estriol. Estriol
is chemically and
biologically identical to
the natural female sex
hormone estriol. After the
menopause the body does
not produce estrogens
anymore. This can lead to
atrophic changes in the
vaginal epithelium. As a
consequence, urogenital
complaints can develop,
like atrophic vaginitis.
Estriol can reduce those
symptoms.
Unlike other estrogens,
estriol is short acting.
Since it has only a short
retention time in the
nuclei of endometrial
cells, no endometrial
proliferation is to be
expected if the total
recommended daily
dose is taken at one
time. Hence cyclic
administration of a
progestogen is not
necessary, and
withdrawal bleedings do
not occur.
Pharmacodynamic
properties
clinical trial infromation:

Vaginal bleeding after
treatment with Ovestin
has only rarely been
reported.
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Store at 2 - 25°C. Do not freeze.
Store below 25°C, do not
allow to freeze
Special precautions
for storage
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