Gracial Tablet

Country: Malaysia

Language: English

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

Active ingredient:

DESOGESTREL; Ethinylestradiol; DESOGESTREL; Ethinylestradiol

Available from:

Aspen Medical Products Malaysia Sdn Bhd

INN (International Name):

DESOGESTREL; Ethinylestradiol; DESOGESTREL; Ethinylestradiol

Units in package:

22 Tablets

Manufactured by:

CYNDEA PHARMA

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
GRACIAL TABLET
Desogestrel / Ethinylestradiol (25 mcg / 40 mcg & 125 mcg / 30 mcg)
WHAT IS IN THE LEAFLET
1.
What GRACIAL Tablet is
used for
2.
How GRACIAL Tablet works
3.
Before you take GRACIAL
Tablet
4.
How to take GRACIAL Tablet
5.
While you are taking it
6.
Side effects
7.
Storage and Disposal of
GRACIAL Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11. Serial Number
WHAT GRACIAL TABLET IS USED FOR
GRACIAL Tablet is used for
contraception, to prevent pregnancy.
When taken correctly (without missing
tablets), the change of becoming
pregnant is very low.
HOW GRACIAL TABLET WORKS
GRACIAL Tablet is a combined oral
contraceptive. Each tablet contains a
small amount of two different female
hormones. These are desogestrel (a
progestogen) and ethinylestradiol (an
estrogen). Because of small amounts of
hormones, GRACIAL Tablet is
considered a low-dose oral
contraceptive. As the two hormones in
the blue tablets are combined in a
different dose than in the white tablets,
it is considered a combiphasic oral
contraceptive.
GRACIAL Tablet prevents the
release of egg cell from the ovaries
and causes changes in the cervical
secretion, thus prevent pregnancy.
BEFORE YOU TAKE GRACIAL TABLET
-
_When you must not take it_
Do not take GRACIAL Tablet if you
have the following conditions listed
below. If anything on this list applies
to you, tell your doctor before
starting GRACIAL Tablet.
•
If you have or had in the past of
blood clots (thrombosis) in blood
vessel of the leg, lung (embolus)
or other organs.
•
If you have or had in the past a
heart attack or stroke.
•
If you have or 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 blood
clotting (e.g. protein C deficiency).
•
If you have major surgery (e.g. an
operation) and your ability to
move around is limited

Summary of Product characteristics

GRACIAL TABLET
QUANLITATIVE AND QUANTITATIVE COMPOSITION
•
Each blue tablet contains 25 mcg desogestrel and 40 mcg
ethinylestradiol.
•
Each white tablet contains 125 mcg desogestrel and 30 mcg
ethinylestradiol.
PHARMACEUTICAL FORM
Tablets for oral use.
Desogestrel/Ethinylestradiol 25mcg / 40mcg Tablets are blue, round and
flat tablets with
beveled edges with a diameter of 6 mm, coded TR / 9 on one side and
blank on the other side.
Desogestrel/Ethinylestradiol 125mcg / 30mcg Tablets are white, round
and flat tablets with
beveled edges with a diameter of 6 mm, coded TR / 8 on one side and
blank on the other side.
CLINICAL PARTICULARS
INDICATIONS
Contraception
DOSAGE AND ADMINISTRATION
METHOD OF ADMINISTRATION
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 22
consecutive days, starting with
the blue tablets for 7 days, followed by the white tablets for 15
days. Each subsequent pack is
started after a 6-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.
•
HOW TO START TAKING GRACIAL
_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 GRACIAL 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 or placebo tablet interval of her
previous COC. In case a vaginal
ring or transdermal patch has been used, the woman should start us