MERCILON

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DESOGESTREL; ETHINYLESTRADIOL

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

G03AC09

Pharmaceutical form:

TABLETS

Composition:

DESOGESTREL 150 MCG; ETHINYLESTRADIOL 20 MCG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

DESOGESTREL

Therapeutic area:

DESOGESTREL

Therapeutic indications:

Oral contraception

Authorization date:

2021-11-30

Patient Information leaflet

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
THIS MEDICINE IS MARKETED UPON DOCTOR'S PRESCRIPTION ONLY
MERCILON
®
Tablets
COMPOSITION:
EACH TABLET CONTAINS:
Desogestrel 0.15 mg
Ethinyl estradiol 0.02 mg
For a list of inactive ingredients see section 6.1 "WHAT MERCILON
CONTAINS".
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly.
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the
first year or when restarting a combined hormonal contraceptive
following 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, “BLOOD CLOTS”).
•
Some women should not take the Pill because of current medical
problems or illnesses. Please
read this leaflet to make sure MERCILON is right for you.
•
To prevent pregnancy it is important to take MERCILON as instructed
and to start each pack
on time. Please make sure that you understand what to do if you miss a
pill or if you think you
are pregnant.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
This leaflet contains concise information about MERCILON. If you have
any further questions,
ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their medical condition seems similar to yours.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions or need more advice, ask your
doctor, or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects
not listed in this leaflet. See section 4.
1.
WHAT MERCILON IS AND WHAT IT IS USED FOR?
1.1 WHAT IS MERCILON?
THERAPEUTIC GROUP: Estrogen-progestogen combination contraceptive.
1.2 WHAT I

Summary of Product characteristics

[Organon] Proprietary
1.
NAME OF THE MEDICINAL PRODUCT
MERCILON
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
desogestrel (a progestagen)
0.15 mg
ethinylestradiol (an estrogen)
0.02 mg
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
The tablets are white, round, biconvex and 6 mm in diameter. They are
coded on one side
“Organon*” and on the reverse side “TR” above “4”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Mercilon should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk of
VTE with Mercilon compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1
HOW TO TAKE MERCILON
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 usually occurs. This usually starts on day 2-3 after the last
tablet and may not have
finished before the next pack is started.
4.2.2
HOW TO START MERCILON
_No preceding hormonal contraceptive use [in the past month]: _
It is preferable that tablet intake from the first pack is started on
the first day of menstruation in
which case no extra contraceptive precautions are necessary.
If menstruation has already begun, (that is 2, 3, or 4 days
previously), tablet taking should
commence on day 5 of the menstrual period. In this case additional
contraceptive precautions
must be taken for the first 7 days of tablet taking.
If menstruation began more than 5 days previously then the patient
should be advised to wait
until her next menstrual period before starting to take Mercilon.
_Changing from a 21 day pill or another 22 day pill to Mercilon:_
[Organon] Proprietary
All tablets in the