Azalia 0.075 mg film-coated tablet

Country: Malaysia

Language: English

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

Active ingredient:

DESOGESTREL

Available from:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

DESOGESTREL

Units in package:

28 Tablets

Manufactured by:

Gedeon Richter Plc

Patient Information leaflet

AZALIA 0.075 MG FILM-COATED TABLETS
Desogestrel (0.075 mg)
_Consumer Medication Information Leaflet (RiMUP)_
_ _
1
WHAT IS IN THIS LEAFLET
1.
What _Azalia _is used for
2.
How _Azalia_ works
3.
Before you use _Azalia_
4.
How to use _Azalia_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Azalia_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _AZALIA_ IS USED FOR
This medicine is for the prevention of
pregnancy.
HOW _AZALIA_ WORKS
Azalia contains a small amount of one
type
of
female
sex
hormone,
the
progestogen
,
desogestrel.
For
this
reason Azalia is called a progestogen-
only pill (POP) or mini-pill. Unlike the
combined
pill,
the
POP
or
mini-pill
does not contain an oestrogen hormone,
but only a progestogen. Most POPs or
mini-pills work primarily by preventing
the sperm cells from entering the womb
but do not always prevent the egg cell
from ripening which is the primarily
action of combined pills.
Azalia is distinct from other mini-pills
in having a dose that in most cases is
high
enough
to
prevent
the
egg
cell
from
ripening.
As
a
result,
Azalia
provides high contraceptive efficacy.
In contrast to the combined pill, Azalia
can
be
used
by
women
who
do
not
tolerate oestrogens and by women who
are breast feeding. A disadvantage is
that
vaginal
bleeding
may
occur
at
irregular
intervals
during
the
use
of
Azalia.
You
also
may
not
have
any
bleeding at all.
BEFORE YOU USE _AZALIA _
-
_When you must not use it _

If you are allergic to desogestrel
or any of the other ingredients of
this medicine (listed in section 6).

If you have thrombosis.
Thrombosis is the formation of
blood clot in a blood vessel, which
may lead to obstruction of this
blood vessel {e.g. of the legs,
(deep venous thrombosis), the
lungs (pulmonary embolism), the
heart (heart attack) or brain
(stroke)}.

If you have or have had a severe
liver disease and the function of
your liver (as determined by
laboratory investigation of the
blood) has not returned to normal.

If y

Summary of Product characteristics

PACKAGE INSERT
BRAND OR PRODUCT NAME
Azalia 0,075 mg film-coated tablets
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each film-coated tablet contains 75 microgram desogestrel.
Excipient with known effect: 52.34 mg lactose (as lactose
monohydrate).
PRODUCT DESCRIPTION
Film-coated tablet.
White or almost white, round, biconvex film-coated tablets of about
5.5 mm in diameter, with a sign
“D” on one side and “75” on the other side.
Tablet core:
Lactose monohydrate,
Potato starch,
Povidone K-30,
Silica, colloidal anhydrous,
Stearic acid,
all-rac-

-Tocopherol
Tablet coat:
Poly[vinyl alcohol];
Titanium dioxide, E171;
Macrogol 3000;
Talc
PHARMACODYNAMICS/ PHARMACOKINETICS
_PHARMACODYNAMIC PROPERTIES_
Pharmacotherapeutic group: Hormonal contraceptives for systemic use,
Progestogens, ATC code:
G03AC09
Mechanism of action
Azalia is a progestogen-only pill, which contains the progestogen
desogestrel. Like other progestogen-
only pills, Azalia is best suited for use during breast feeding and
for women who may not or do not
want to use oestrogens. In contrast to traditional progestogen-only
pills, the contraceptive effect of
Azalia is achieved primarily by inhibition of ovulation. Other effects
include increased viscosity of the
cervical mucus.
The Pearl-Index for desogestrel is comparable to the one historically
found for COCs in the general
COC-using population.
Treatment with desogestrel leads to decreased estradiol levels, to a
level corresponding to the early
follicular phase. No clinically relevant effects on carbohydrate
metabolism, lipid metabolism and
haemostasis have been observed.
Paediatric population
No clinical data on efficacy and safety are available in adolescents
below 18 years.
_PHARMACOKINETIC PROPERTIES_
Absorption
After oral dosing of Azalia desogestrel (DSG) is rapidly absorbed and
converted into etonogestrel.
Under steady-state conditions, peak serum levels are reached 1.8 hours
after tablet-intake and the
absolute bioavailability of etonogestrel is approximately 70%.
Distribution
Etonogestrel