MINULET

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

ETHINYLESTRADIOL; GESTODENE

Disponibil de la:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Codul ATC:

G03CA01

Forma farmaceutică:

TABLETS

Compoziție:

GESTODENE 0.075 MG; ETHINYLESTRADIOL 0.030 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

PFIZER IRELAND PHARMACEUTICALS

Grupul Terapeutică:

ETHINYLESTRADIOL

Zonă Terapeutică:

ETHINYLESTRADIOL

Indicații terapeutice:

Contraception.

Data de autorizare:

2015-10-31

Prospect

Minulet PIL CC 260723 Technical change
1
2023-0087005
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
MINULET
®
COATED TABLETS
Each coated tablet contains:
Ethinylestradiol 0.03 mg
Gestodene 0.075 mg
INACTIVE INGREDIENTS AND ALLERGENS IN THIS MEDICINE: see section 6.
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 a 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?
Minulet is intended for birth control and belongs to a group of
medicines called
“contraceptive pills”.
Each tablet contains two female hormones, estrogen (ethinylestradiol)
and
progestogen (gestoden).
THERAPEUTIC GROUP: combined oral contraceptive pills, an estrogen and
progestogen
combination.
A FEW IMPORTANT THINGS TO KNOW ABOUT COMBINED PILLS:
•
When used correctly, they are one of the most reliable reversible
methods of
contraception.
•
They slightly increase the risk of having a thrombosis (blood clots)
in the veins
and arteries, especially in the first year or when restarting after a
break of 4 or
more weeks.
•
Please be alert and see your doctor if you think you may have symptoms
of a
blood clot (see section 2 “Minulet and thrombosis (blood clots)”).
•
Like other contraceptive pills, Minulet does not protect you against
HIV infection
(AIDS) or other sexually transmitted diseases. If you think you are at
risk, you
should use a condom as well as the Pill.
2.
BEFORE USING THE MEDICINE
Before you start taking Minulet 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 “Minulet and thrombosis (blood clots)”).
DO NOT USE THE

Caracteristicilor produsului

Minulet LPD CC 020423
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MINULET
®
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Minulet
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 micrograms gestodene and 30 micrograms
ethinylestradiol.
Excipients with known effect:
Also includes lactose monohydrate 37.43 mg and sucrose 19.66 mg per
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets.
White, round, biconvex, sugar-coated tablets, with a shiny surface.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Minulet should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE
with Minulet compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE MINULET
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 MINULET
No hormonal contraceptive use within the preceding month
The user should begin taking Minulet on Day 1 of her natural menstrual
cycle (i.e. the first day
of menstrual bleeding). Beginning Minulet use on days 2-7 of the
menstrual cycle is allowed;
however a non-hormonal back-up method of birth control [e.g. condoms
and spermicide] is
recommended during the first 7 days of Minulet use.
_Switching from another combined hormonal contraceptive (CHC) _
_ _
Minulet LPD CC 020423
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Minulet use should begin preferably on the day after t