Giane 35 Tablet

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

Ethinylestradiol; CYPROTERONE ACETATE

Saatavilla:

Vitamode Sdn.bhd

INN (Kansainvälinen yleisnimi):

Ethinylestradiol; CYPROTERONE ACETATE

Kpl paketissa:

21 Tablets

Valmistaja:

RENATA LIMITED

Pakkausseloste

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
GIANE 35 TABLET
Ethinylestradiol / Cyproterone Acetate (0.035mg/2mg)
1
WHAT IS IN THIS LEAFLET
1.
What GIANE 35 is used for
2.
How GIANE 35 works
3.
Before you use GIANE 35
4.
How to use GIANE 35
5.
While you are using GIANE 35
6.
Side effects
7.
Storage and Disposal of GIANE
35
8.
Product Description
9.
Manufacturer and product
registration holder
10.
Date of Revision
WHAT GIANE 35 IS USED FOR
GIANE
35
is
used
to
treat
the
following
androgen-dependent
conditions in women of reproductive
age:
• moderate to severe acne when other
treatments have failed
• mild to moderate increased growth
of facial or body hair (hirsutism)
Since Giane 35 is also a hormonal
contraceptive, it should not be used in
combination
with
other
hormonal
contraceptives.
HOW GIANE 35 WORKS
Ethinyl
estradiol:
Estrogens
are
responsible for the development and
maintenance
of
the
female
reproductive
system
and
secondary
sexual characteristics. Androgens are
male
sex
hormones,
produced
by
women
in
small
amounts.
If
a
woman's body produces too much of
these hormones or is overly sensitive,
then
androgen-dependent
conditions
occur. Giane 35 works by blocking the
action of these hormones.
BEFORE YOU USE GIANE 35
-
_When you must not use it _
You should not use this medicine if
you have:
•
Hypersensitivity to any
ingredients of Giane 35 tablet
•
Unexplained vaginal bleeding
•
Cancer that may grow under the
influence of sex hormones (e.g.
cancer of the breast or genital
organs)
•
Severe liver disease including
yellowing of skin and eyes or
liver tumor
•
Have or previously have blood
clot in the leg, lung, heart attack
or stroke
•
Diabetes involving blood vessels
•
Having severe or multiple risk
factor for blood clot in blood
vessels
•
Migraine or severe headache
•
Disturbance of visual or hearing
•
Chest pain or tightness
•
Pending
operations
(6
weeks
beforehand)
•
Immobilization
(eg.
following
accidents)
•
Hepatitis (liver inflammation)
•
Itchiness
•
Increases in seizur

Valmisteyhteenveto

PRODUCT DESCRIPTION
6.0 mm, white, round biconvex tablet, one side having ‘R’ logo and
other side contains break line.
PHARMACODYNAMICS
Mode of Action: Ethinyl estradiol: Estrogens are responsible for the
development and maintenance of the
female reproductive system and secondary sexual characteristics.
Estrogens modulate the pituitary secretion
of gonadotropins, luteinizing hormone, and follicle-stimulating
hormone through a negative feedback system.
Estrogen increases levels of sex hormone-binding globulin (SHBG) and
may reduce unbound androgen levels.
Ethinyl estradiol is a synthetic derivative of estradiol. The addition
of the ethinyl group prevents rapid
degradation by the liver.
Cyproterone: Steroidal compound with antiandrogenic, antigonadotropic
and progestin-like activity
PHARMACOKINETICS CYPROTERONE ACETATE
Following oral administration cyproterone acetate is completely
absorbed in a wide dose range. The ingestion
of GIANE-35 effects a maximum serum level of 15mg cyproterone
acetate/ml at 1.6 hours. Thereafter, drug
serum levels decrease in two disposition phases characterized by
half-lives of 0.8 hours and 2.3 days. The total
clearance of cyproterone acetate from serum was determined to 3.6
ml/min/kg. Cyproterone acetate is
metabolized by various pathways including hydroxylations and
conjugations. The main metabolite in human
plasma is the 15ß-hydroxy derivative. Some dose parts are excreted
unchanged with bile fluid. Most of the dose
is excreted in form of metabolites at a urinary to biliary ratio of
3:7. The renal and biliary excretion was
determined to proceed with a half-life of 1.9 days. Metabolites from
plasma were eliminated at a similar rate
(half-life of 1.7 days).
Cyproterone acetate is almost exclusively bound to plasma albumins.
About 3.5-4.0 % of total drug levels are
present unbound. Because protein binding is non-specific, changes in
SHBG (sex hormone binding globulin)
levels do not affect the pharmacokinetics of cyproterone acetate.
Due
to
the
long
half-life
of
the
terminal
disposi