VISABELLE

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

DIENOGEST

Διαθέσιμο από:

BAYER ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

G03FA15

Φαρμακοτεχνική μορφή:

TABLETS

Σύνθεση:

DIENOGEST 2 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

Θεραπευτική ομάδα:

DIENOGEST AND ESTROGEN

Θεραπευτική περιοχή:

DIENOGEST AND ESTROGEN

Θεραπευτικές ενδείξεις:

Treatment of endometriosis.

Ημερομηνία της άδειας:

2016-06-30

Φύλλο οδηγιών χρήσης

PACKAGING TECHNOLOGY BERLIN SGQCL
page 1
Bayer AG
client: JS86
material-no.: 88544374
PZ: 2599F-4A
code-no.: 616
name: LF-VISABELLE TABL IL
country: IL/-/BPH
colors: BLACK
version: 15.12.2021/01
Restricted Document
dimension: 160 X 594 MM
VISABELLE
®
TABLETS
Each tablet contains:
Dienogest 2 mg
Inactive ingredients and allergens: See section 6 “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others.
It may harm them even if it seems to you that their medical condition
is
similar.
1) WHAT IS THE MEDICINE INTENDED FOR?
Visabelle is intended for the treatment of endometriosis (symptoms of
pain
due to displaced tissue of the lining of the womb).
THERAPEUTIC GROUP: Visabelle belongs to a group of hormonal medicines
called progestogens.
2) BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙ You are pregnant or breastfeeding.
∙ You are SENSITIVE (ALLERGIC) to dienogest or to any of the other
ingredients contained in the medicine. For the list of inactive
ingredients,
see section 6 “Further Information”.
∙ You suffer from a BLOOD CLOT (venous thrombosis) in the veins, for
example, in the blood vessels of the legs (deep vein thrombosis) or in
the lungs (pulmonary embolism). See “Visabelle and blood clots in
the
vein” in section 2.
∙ You suffer, or have suffered in the past, from a SEVERE ARTERIAL
DISEASE,
including a cardiovascular disease such as HEART ATTACK, STROKE or a
HEART DISEASE which causes a reduced blood supply (angina pectoris).
See “Visabelle and blood clots in the artery” in section 2.
∙ You suffer from DIABETES with vascular damage.
∙ You suffer, or have suffered in the past, from a SEVERE LIVER
DISEASE (and
liver function values are still not normal). Symptoms of liver disease
may be yellowing of the skin and/or itching all over the bod

Αρχείο Π.Χ.Π.

RESTRICTED
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Visabelle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dienogest.
Excipient with known effect: each tablet contains 62.8 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat-faced, bevelled-edge tablets with a
debossed “B” on one
side and a diameter of 7 mm
.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of endometriosis
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration: _
For oral use.
_ _
_Posology _
_ _
The dosage of Visabelle is one tablet daily
without any break, taken preferably at the same time
each day with some liquid as needed. The tablet can be taken with or
without food.
Tablets must be taken continuously without regard to vaginal bleeding.
When a pack is finished
the next one should be started without interruption.
Treatment can be started on any day of the menstrual cycle.
Any hormonal contraception needs to be stopped prior to initiation of
Visabelle. If contraception
is required, non-hormonal methods of contraception should be used
(e.g. barrier method).
RESTRICTED
Management of missed tablets:
The efficacy of Visabelle may be reduced in the event of missed
tablets,
vomiting and/or diarrhea
(if occuring within 3-4 hours after tablet taking). In the event of
one or more missed tablets, the
woman should take one tablet only, as soon as she remembers, and
should then continue the next
day at her usual time. A tablet not absorbed due to vomiting or
diarrhea should likewise be
replaced by one tablet.
_ADDITIONAL INFORMATION ON SPECIAL POPULATIONS _
_Paediatric population: _
Visabelle is not indicated in children prior to menarche.
The safety and efficacy of Visabelle was investigated in an
uncontrolled clinical trial over 12
months in 111 adolescent women (12-<18) with clinically suspected or
confirmed endometriosis
(see sections 4.4 and 5.1).
_Geriatric population: _
There i