Desolon Tablet (Desogestrel 0.15 mg + Ethinylestradiol 0.03 mg)

País: Malàisia

Idioma: anglès

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

ingredients actius:

DESOGESTREL; Ethinylestradiol

Disponible des:

Vitamode Sdn.bhd

Designació comuna internacional (DCI):

DESOGESTREL; Ethinylestradiol

Unidades en paquete:

21Tablet Tablets

Fabricat per:

RENATA LIMITED

Informació per a l'usuari

DESOLON TABLET
Desogestrel/ Ethinylestradiol (0.15mg/0.03mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Desolon _
is used for
2.
How
_Desolon _
works
3.
Before you use
_Desolon _
4.
How to use
_Desolon _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Desolon _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _DESOLON _IS USED FOR
_Desolon_
is an estrogen and progestin
combination pill used for the prevention
of pregnancy.
HOW _DESOLON _WORKS
Combined oral contraceptives like
Desolon Tablet work mainly by tricking
your body into thinking that ovulation
has already happened. This prevents an
egg from ripening and being released
from the ovaries each month.
The hormones also increase the thickness
of the natural mucus at the neck of the
womb, which makes it more difficult for
sperm to cross from the vagina into the
womb and reach an egg. They also
change the quality of the womb lining
(endometrium), making it less likely that
a fertilised egg can implant there.
BEFORE YOU USE _DESOLON _
-
_When you must not use it _
Do not use this medication if you are
allergic to any of the ingredients of
_Desolon_
Tablet or are pregnant. Tell your
doctor right away if you become
pregnant during treatment. You should
not use this medicine if you have:
•
Unexplained vaginal bleeding
•
History or suspected cancer that
may grow under the influence of
sex hormones (breast,
endometrium)
•
Liver disease or tumor
•
History of disorder affecting the
blood circulation.
•
Severe high blood pressure
•
Diabetes with blood vessel damage
•
Severe headache with impairments
of nerve, spinal cord, or brain
function
•
Major surgery with prolonged
inability to move around
•
Heavy smoking (15 cigarettes/day)
in individuals >35 years of age
•
History of blood clots or blood
clotting problems (such as stroke,
heart attack).
Do not use
_Desolon_
if you have Hepatitis
C and are taking the medicinal products
containing ombit

Fitxa tècnica

PRODUCT DESCRIPTION
6.0 mm, White, Round Biconvex tablet, One side having logo "D" and
other side is
plain.
PHARMACODYNAMICS
Mode of Action: Combination hormonal contraceptives inhibit ovulation
via a negative
feedback mechanism on the hypothalamus, which alters the normal
pattern of
gonadotropin
secretion
of
a
follicle-stimulating
hormone
(FSH)
and
luteinizing
hormone by the anterior pituitary. The follicular phase FSH and
midcycle surge of
gonadotropins
are
inhibited.
In
addition,
combination
hormonal
contraceptives
produce alterations in the genital tract, including changes in the
cervical mucus,
rendering it unfavorable for sperm penetration even if ovulation
occurs. Changes in the
endometrium may also occur, producing an unfavorable environment for
nidation.
Combination hormonal contraceptive drugs may alter the tubal transport
of the ova
through the fallopian tubes. Progestational agents may also alter
sperm fertility.
PHARMACOKINETICS
Ethinyloestradiol
Absorption: Ethinyloestradiol (EE) is rapidly and completely absorbed
from the
intestine with an absorption half-life of 0.2-0.4 hours. After oral
administration of 50
mcg EE, the plasma peak time was approximately 1-2 hours, whereas
plasma peak
height amounted to 0.12 ± 0.03 mcg/l and the area under curve to 1048
± 247 pg/ml/h.
With EE, a great inter- and intra-population variability of plasma
levels has been
reported. As a result of gut wall metabolism during absorption and the
effect of
first-pass metabolism, the absolute bioavailability of EE after
single-dose administra-
tion is approx. 45%. The absolute bioavailability of EE calculated on
the basis of
repeated measurements after administration of DSG (desogestrel)/EE
150/30 mcg/d
for 21 days is 74 ± 25%. The reason for this figure being higher than
the average figure
of 45% mentioned above, probably has to do with the fact that the
former figure is
based on single-dose administration and single measurements. A
possible explanation
for the higher absolute bioavailability of EE upon repeated
measureme