HARMONET

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ETHINYLESTRADIOL; GESTODENE

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

G03AA10

الشكل الصيدلاني:

COATED TABLETS

تركيب:

ETHINYLESTRADIOL 0.020 MG; GESTODENE 0.075 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER IRELAND PHARMACEUTICALS

المجموعة العلاجية:

GESTODENE AND ESTROGEN

المجال العلاجي:

GESTODENE AND ESTROGEN

الخصائص العلاجية:

Contraceptive.

تاريخ الترخيص:

2021-04-30

نشرة المعلومات

Harmonet PIL CC Technical change 130723
2023-0086959
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
HARMONET
®
COATED TABLETS
Each coated tablet contains:
ethinylestradiol 0.02 mg
gestodene 0.075 mg
INACTIVE INGREDIENTS AND ALLERGENS: See section 2 under "Important
information about some
of this medicine’s ingredients" and section 6 “Further
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your 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 to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Harmonet is a preparation for birth control that belongs to a group of
medicines called
“contraceptive pills”.
Each tablet contains two female hormones, estrogen (ethinylestradiol)
and progestogen
(gestodene).
THERAPEUTIC GROUP: Combined oral contraceptive pills, a combination of
estrogen and
progestogen.
SEVERAL IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL
CONTRACEPTIVES:
•
When used correctly, combined hormonal contraceptives are one of the
most reliable
reversible contraceptive method.
•
They slightly increase the risk of thrombosis (blood clots) in the
veins and arteries,
especially during the first year or upon resuming intake after
stopping for 4 weeks or
more.
•
Be vigilant and contact your doctor if you are concerned that you
suffer from any
symptoms of a blood clot (see section 2, “Harmonet and thrombosis
(blood clots)”).
2. BEFORE USING THIS MEDICINE
Before you start taking Harmonet, you should read the information
about thrombosis (blood
clots) in section 2. It is especially important to read the part about
the symptoms of
thrombosis (see section 2, “Harmonet and thrombosis (blood
clots)”).
DO NOT USE THIS MEDICINE IF:
You are in

خصائص المنتج

Harmonet LPD CC 220323
Page 1 of 17
2022 -0075978, 2022-0081366
HARMONET
®
1.
NAME OF THE MEDICINAL PRODUCT
Harmonet
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.075 mg of gestodene and 0.02 mg of
ethinylestradiol
Excipients with known effect : lactose and sucrose (each tablet
contains 37.505 mg lactose hydrouse
and 19.66 mg sucrose; see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets
White, sugar coated tablets with a shiny surface.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Oral hormonal contraception
The decision to prescribe Harmonet
®
should take into consideration the individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Harmonet
®
compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
PAEDIATRIC POPULATION
_ _
Paediatric data are not available. Safety and efficacy of CHCs have
been established in adult women
of reproductive age.
GERIATRIC POPULATION
_ _
CHCs are not indicated for use in postmenopausal women.
HOW TO TAKE HARMONET
®
Regular daily intake of tablets for 21 consecutive days is important
for the preservation of
contraceptive efficacy.
Tablets must be taken in the order directed on the package every day
at about the same time with
some liquid as needed. One tablet is to be taken daily for 21
consecutive days. Each subsequent
pack is started after a 7-day tablet-free interval during which time a
withdrawal bleed occurs. This
usually starts on day 2-3 after the last tablet and may not have
finished before the next pack is
started.
HOW TO START HARMONET
®
No hormonal contraceptive use within the preceding month
_ _
Harmonet LPD CC 220323
Page 2 of 17
2022 -0075978, 2022-0081366
The user should begin taking Harmonet
®
on Day 1 of her natural menstrual cycle (i.e. the first day of
her menstrual bleeding). Beginning Harmonet
®
use on days 2-7 of the menstrual cycl