MINESSE

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

ETHINYLESTRADIOL; GESTODENE

Tillgänglig från:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-kod:

G03AA10

Läkemedelsform:

FILM COATED TABLETS

Sammansättning:

ETHINYLESTRADIOL 0.015 MG; GESTODENE 0.06 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

PFIZER IRELAND PHARMACEUTICALS

Terapeutisk grupp:

GESTODENE AND ESTROGEN

Terapiområde:

GESTODENE AND ESTROGEN

Terapeutiska indikationer:

Contraceptive.

Tillstånd datum:

2021-05-31

Bipacksedel

Minesse PIL CC 290323
1
2022-0081366
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
Minesse
®
Film-coated tablets
Each blister pack contains 28 tablets:
•
24 pale yellow active tablets, each coated tablet contains:
ethinylestradiol 0.015 mg
gestodene 0.060 mg
•
4 white inactive tablets
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?
Minesse is a preparation for birth control that belongs to a group of
medicines called
“contraceptive pills”.
•
Each of the 24 pale yellow tablets contains two female hormones:
ethinylestradiol
and gestodene.
The 4 white tablets do not contain active ingredients.
Therapeutic group: combined oral contraceptive pills, a combination of
estrogen and
progestogen.
2. BEFORE USING THIS MEDICINE
Before you can begin taking Minesse, your doctor will ask you some
questions about
your personal health history and that of your close relatives. The
doctor will also
measure your blood pressure, and depending on your personal situation,
may also
carry out other tests.
Before you start using Minesse, you should read the information on
thrombosis
(blood clots) in section 2. It is particularly important to read the
part about symptoms
of thrombosis (see section 2 “Minesse and thrombosis (blood
clots)”).
In this leaflet, several situations are described where you should
stop using Minesse,
or situations where the reliability of Minesse may be decreased. In
such situations
you

Produktens egenskaper

Page 1 of 18
2022-0081366
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MINESSE
60 micrograms / 15 micrograms
film-coated tablets
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
Gestodene : ...... ........... ………60 micrograms
Ethinylestradiol: .......... ………15 micrograms
For one pale-yellow, film-coated tablet (active tablet)
Excipient with known effect: lactose
The white, film-coated tablets do not contain any active ingredients
(placebo).
Excipient with known effect: lactose
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The active tablet is a pale-yellow round tablet with convex faces
embossed with “60”on one side and
“15”on the other.
The placebo tablet is a white round tablet with convex faces.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral hormonal contraception.
The decision to prescribe Minesse should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with
Minesse compares with other combined hormonal contraceptives (CHCs)
(see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Take regularly and without omission, one tablet daily at the same time
of the day, for 28 consecutive
days (one pale-yellow, active tablet during the first 24 days, one
white, inactive tablet during the 4
following days) with no free interval between each blister pack. A
withdrawal bleed usually starts on
day 2-3 after the last active tablet and may not have finished before
the next pack is started.
How to start Minesse

No preceding hormonal contraceptive use in the past month:
Take the first tablet on the first day of menstrual bleeding.

Changing from another combined oral contraceptive (COC):
Page 2 of 18
2022-0081366
The woman should start Minesse
_ _
on the day after the last active tablet of her previous COC.

Changing from a progestin-only method (minipill, injection, implant):
The woman may switch any day