MERCILON TABLETS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ETHINYLOESTRADIOL; DESOGESTREL

Available from:

ORGANON MALAYSIA SDN. BHD.

INN (International Name):

ETHINYLOESTRADIOL; DESOGESTREL

Units in package:

21 Tablet Tablets; 63 Tablet Tablets

Manufactured by:

N.V. ORGANON

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MERCILON
® TABLETS
Ethinylestradiol/Desogestrel (0.020mg/0.150mg)
1
Copyright 2021 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What MERCILON is used for
2.
How MERCILON works
3.
Before you use MERCILON
4.
How to use MERCILON
5.
While you are using MERCILON
6.
Side effects
7.
Storage and Disposal of
MERCILON
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MERCILON IS USED FOR
MERCILON is used to prevent
pregnancy. When taken correctly
(without missing tablets), the
chance of becoming pregnant is
very low.
HOW MERCILON WORKS
MERCILON releases two female
sex hormones that prevents the
release of an egg cell from the
ovaries. If no egg is released you
cannot become pregnant.
BEFORE YOU USE MERCILON
_-_
_ _
_When you must not use it _
Do not use the MERCILON if you
have any of the conditions listed
below. If anything on this list
applies to you, tell your doctor
before starting to use MERCILON.
Your doctor may advise you to use
a different type of Pill or an entirely
different (non-hormonal) method of
birth control.
•
If you have, or have had in the
past a blood clot (thrombosis) in
a blood vessel of the leg, lung
(embolus) or other organs (see
section ‘
THE PILL AND
THROMBOSIS
’).
•
If you have or have had in the
past a heart attack or stroke.
•
If you have or have ever had a
condition that may be a first sign
of a heart attack (such as chest
pain) or stroke (such as small
reversible stroke).
•
If you have diabetes with blood
vessel damage.
•
If you have a serious risk
factor, or several risk factors
for developing thrombosis,
this may also be a reason
why you cannot use
MERCILON (See also ‘
THE
PILL AND THROMBOSIS
’).
•
If you have or have had a
pancreatitis (an inflammation of
the pancreas) associated with
high levels of fatty substances
in your blood.
•
If you have jaundice (yellowing
of the skin) or have (had) severe
liver disease and your liver is
not yet work

Summary of Product characteristics

MERCILON
LPC-OG8276A-MCL21-TB-112021
TABLET
1.
NAME OF THE MEDICINAL PRODUCT
Mercilon tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.150mg desogestrel and 0.020mg ethinylestradiol.
Excipient: lactose < 80 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Tablets for oral use
Tablets are round, biconvex and 6 mm in diameter. They are coded on
one side TR above 4
and on the reverse side Organon*.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral Contraception.
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 TAKING MERCILON
_No preceding hormonal contraceptive use [in the past month]_
_ _
_ _
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e.
the first day of her
menstrual bleeding). Starting on days 2-5 is allowed, but during the
first cycle a barrier method
is recommended in addition for the first 7 days of tablet-taking.
_ _
_Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), _
_vaginal ring, or transdermal patch) _
The woman should start with Mercilon preferably on the day after the
last active tablet (the last
tablet containing the active substances) of her previous COC, but at
the latest on the day
following the usual tablet-free interval or following the last placebo
tablet of her previous COC.
In case a vaginal ring or transdermal patch has been used, the woman
should start using
Mercilon preferably on the day of removal, but at the latest when the
next application would
have been due.
If the woman has been using her previous method consistently and
correct