MARVELON TABLET

국가: 말레이시아

언어: 영어

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

유효 성분:

DESOGESTREL; ETHINYLOESTRADIOL

제공처:

ORGANON MALAYSIA SDN. BHD.

INN (International Name):

DESOGESTREL; ETHINYLOESTRADIOL

패키지 단위:

21 Tablet Tablets

Manufactured by:

N.V. ORGANON

환자 정보 전단

_Consumer Medication Information Leaflet (RiMUP) _
MARVELON
®
Ethinylestradiol/Desogestrel (0.030mg/0.150mg)
1
Copyright 2021 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What MARVELON is used for
2.
How MARVELON works
3.
Before you take MARVELON
4.
How to take MARVELON
5.
While you are taking MARVELON
6.
Side effects
7.
Storage and Disposal of
MARVELON
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.Serial number
WHAT MARVELON IS USED FOR
MARVELON is a combined oral
contraceptive (‘the combined Pill’).
Each tablet contains a small amount of
two different female hormones. These
are desogestrel (a progestogen) and
ethinylestradiol (an estrogen).
Because of the small amounts of
hormones, MARVELON is
considered a low-dose oral
contraceptive. As all tablets in the
pack combine the same hormones in
the same dose, it is considered a
monophasic combined oral
contraceptive.
MARVELON is used to prevent
pregnancy. When taken correctly
(without missing tablets), the chance
of becoming pregnant is very low.
HOW MARVELON WORKS
MARVELON 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 TAKE MARVELON
_-_
_ _
_When you must not use it _
_ _
Do not use the MARVELON if you
have any of the conditions listed
below. If anything on this list applies
to you, tell your doctor before starting
to use MARVELON. 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.
•
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 angina
pectoris or chest pain) or stroke
(such as transient ischaemic
attack or small reversible
stroke).
•
If you have a disturbance of

제품 특성 요약

MARVELON
LPC-OG8276A -TB-112021
TABLET
1.
NAME OF THE MEDICINAL PRODUCT
MARVELON, tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.150 mg desogestrel and 0.030 mg
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 5 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 MARVELON
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 2-3 days after the last tablet and may not have finished before
the next
pack is started.
4.2.2
HOW TO START TAKING MARVELON
_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 MARVELON 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
MARVELON 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 consistentl