GRACIAL TABLET

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DESOGESTREL (in blue tablet); DESOGESTREL (in white tablet); ETHINYLESTRADIOL (in blue tablet); ETHINYLESTRADIOL (in white tablet)

Available from:

DCH AURIGA SINGAPORE

ATC code:

G03AA09

Dosage:

25 mcg

Pharmaceutical form:

TABLET

Composition:

DESOGESTREL (in blue tablet) 25 mcg; DESOGESTREL (in white tablet) 125 mcg; ETHINYLESTRADIOL (in blue tablet) 40 mcg; ETHINYLESTRADIOL (in white tablet) 30 mcg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

ORGANON (IRELAND) LTD

Authorization status:

ACTIVE

Authorization date:

2004-02-10

Patient Information leaflet

Gracial
®
 Tablet 

1. NAME OF THE MEDICINAL PRODUCT 
Gracial tablets. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Gracial is a combiphasic oral contraceptive of which: 
•
each blue tablet contains 0.025mg desogestrel and 0.040mg ethinylestradiol. 
•
each white tablet contains 0.125mg desogestrel and 0.030mg ethinylestradiol. 
Excipient: lactose <100mg 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 
Tablets for oral use. 

Tablets are round, flat with beveled edges, and 6 mm in diameter. Tablets are coded on 
one side Organon* and on the reverse side TR above 8 (white tablets) or TR above 9 
(blue tablets). 

4. CLINICAL PARTICULARS 
4.1 Therapeutic indications 
Contraception. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
4.2.1 HOW TO TAKE GRACIAL 
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 tablet 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. 

4.2.2 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 transd

Summary of Product characteristics

Gracial
®
Tablet
1. NAME OF THE MEDICINAL PRODUCT
Gracial tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gracial is a combiphasic oral contraceptive of which:
• each blue tablet contains 0.025mg desogestrel and 0.040mg
ethinylestradiol.
• each white tablet contains 0.125mg desogestrel and 0.030mg
ethinylestradiol.
Excipient: lactose <100mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets for oral use.
Tablets are round, flat with beveled edges, and 6 mm in diameter.
Tablets are coded on
one side Organon* and on the reverse side TR above 8 (white tablets)
or TR above 9
(blue tablets).
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1 HOW TO TAKE GRACIAL
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 tablet 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.
4.2.2 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