PRIMOLUT-NOR

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

NORETHISTERONE ACETATE

متاح من:

BAYER ISRAEL LTD

ATC رمز:

G03DC02

الشكل الصيدلاني:

TABLETS

تركيب:

NORETHISTERONE ACETATE 5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

المجموعة العلاجية:

NORETHISTERONE

المجال العلاجي:

NORETHISTERONE

الخصائص العلاجية:

Oral progestron for: Dysfunctional bleeding, primary and secondary amenorrhea, premenstrual syndrome, timing of mensturation and endometriosis.

تاريخ الترخيص:

2021-03-31

نشرة المعلومات

PACKAGING TECHNOLOGY BERLIN SGQCL
page 2
Bayer AG
client: JS86
material-no.: 87205878
PZ: 2589W-3B
code-no.:
name: LF-INS-PRIMOLUT NOR 5MG TAB IL
country: IL/-/BAG
colors: BLACK
version: 21.05.2020/01
Restricted Document
dimension: 297 X 594 MM
PRIMOLUT®-NOR
TABLETS
Each tablet contains:
Norethisterone acetate 5 mg
Inactive and allergenic ingredients: see section 6 “Further
Information”.
READ THE 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 for 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?
Primolut-Nor is intended for use in several circumstances:
Progestogenic treatment of dysfunctional menstrual
cycles, primary and secondary amenorrhea, pre-menstrual
syndrome, menstrual cycle regulation and inflammation
of the endometrium (endometriosis).
THERAPEUTIC GROUP: Primolut-Nor belongs to a group of
medicines called progestogens, which are female hormones.
2) BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to norethisterone acetate or
to any of the additional ingredients contained in the
medicine. For the list of inactive ingredients, see section
6 “Further Information”.
• You are pregnant or think you may be pregnant.
• You are breastfeeding.
• You have ever suffered from a blood circulation
problem, including a blood clot (thrombosis) in the
legs (deep vein thrombosis), in the lungs (pulmonary
embolism), in the heart (heart attack), in the brain
(stroke), or any other part of your body.
• You have any symptoms of a blood clot, such as chest
pain, shortness of breath and/or sudden, unexplained
cough.
• You have any condition which raises your risk for a
blood clot (thrombosis).
• You have ever suffered from a migraine with visual
disturbances.
• You are suffering (or recoveri

خصائص المنتج

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Primolut-Nor
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 milligrams of norethisterone acetate.
Excipient with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM.
Tablets.
White tablets with cross-score on one side and "AP" in regular hexagon
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dysfunctional bleeding, primary and secondary amenorrhea, premenstrual
syndrome, timing
of menstruation and endometriosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The following dosage schemes are recommended:
•
DYSFUNCTIONAL BLEEDING
The administration of 1 tablet Primolut Nor 5 mg twice daily over 10
days leads to the arrest
of uterine bleeding not associated with organic lesions within 1-4
days. In individual cases,
bleeding diminishes during the first few days after the commencement
of tablet-taking and
does not stop until about 5-7 days later. For the treatment to be
successful, Primolut Nor
administration must be continued regularly even after arrest of
bleeding (up to a total of 20
tablets Primolut Nor 5 mg).
About 2-4 days after discontinuation of treatment a withdrawal
bleeding will occur resembling
a normal menstruation in intensity and duration.
•
SLIGHT BLEEDING DURING TABLET-TAKING
Occasionally slight bleeding may occur after initial arrest of
bleeding. In these cases tablet-
taking must not be interrupted.
•
MISSING ARREST OF HAEMORRHAGE, HEAVY BREAKTHROUGH BLEEDING
If the bleeding does not stop in spite of regular tablet-taking, an
organic cause or an extra-
genital factor (e.g. polyps, high-situated carcinoma of the cervix
uteri or endometrium,
myoma, residua of abortion, extra-uterine pregnancy, thrombopenia,
thrombasthenia) must
be assumed, so that other measures are called for. This applies also
in cases where, after
initial arrest of haemorrhage, fairly heavy bleeding recurs within a
few days even during
tablet-taki