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ZOELY
®
1
ZOELY
®
_Nomegestrol Acetate and Oestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZOELY. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ZOELY
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS INFORMATION CAREFULLY
BEFORE YOU START TAKING ZOELY
TABLETS.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ZOELY IS USED
FOR
ZOELY is an oral contraceptive,
commonly known as a "Birth Control
Pill" or "The Pill" that has been
prescribed to prevent you from
getting pregnant.
ZOELY prevents pregnancy in
several ways:
· It inhibits the egg release by
stopping it maturing.
· Changing the cervical mucus
consistency making it difficult for
the sperm to reach the egg.
· Changing the lining of the uterus
making it less suitable for
implantation.
ZOELY consists of 24 white tablets,
each containing 2 active ingredients:
2.5 milligrams of nomegestrol
acetate (a progestogen) and 1.5
milligrams of oestradiol (the natural
oestrogen) and 4 yellow inactive
tablets. ZOELY contains oestradiol,
the natural oestrogen, compared with
most Pills which contain the
synthetic oestrogen ethinyloestradiol.
Oral contraceptives are an effective
method of birth control. When taken
correctly (without missing tablets)
the chance of becoming pregnant is
very low.
The following non-contraceptive
health benefits have been associated
with the combined Pill:
· Your periods may be lighter and
shorter. As a result,
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製品の特徴
1
PRODUCT INFORMATION
ZOELY
®
NAME OF THE MEDICINE
ZOELY
Each blister strip consists of 24 white active tablets each containing 2.5mg
nomegestrol acetate and 1.5 mg oestradiol (as hemihydrate) and 4 yellow placebo
tablets that do not contain active substances.
NOMEGESTROL ACETATE
O
CH
3
CH
3
O
H
C
CH
3
O
C
H
3
O
H
H
H
Chemical name: 17
-acetoxy-6-methyl-19-norpregna-4,6-dien-3,20-dione
Molecular formula: C
23
H
30
O
4
Molecular mass: 370.48
CAS No.: 58652-20-3
OESTRADIOL
Chemical name: estra-1,3,5(10)-triene-3,17
-diol
Molecular formula: C
18
H
24
O
2
Molecular mass: 281.4
CAS No.: 50-28-2
DESCRIPTION
ZOELY is a combined oral contraceptive (COC) preparation containing the
progestogen nomegestrol acetate and the natural oestrogen 17
-oestradiol as the
active substances.
H
CH
3
OH
O
H
H
H
H
1/2 H
2
O
2
Nomegestrol acetate: a white to off white crystalline powder that is freely soluble in
methylene chloride, acetone and ethyl acetate, soluble in dioxane and acetonitrile and
sparing soluble in methanol and ethanol. Melting range is between
177 and 180
o
C.
Oestradiol: a white to almost white, crystalline powder and is practically insoluble in
water. Melting range is between 173 and 179
o
C.
PHARMACOLOGY
Nomegestrol acetate is a highly selective progestogen derived from, and structurally
similar to, the naturally occurring steroid hormone, progesterone. Nomegestrol acetate
has a strong affinity for the human progesterone receptor and has strong anti-
gonadotropic activity, moderate anti-androgenic activity, and is devoid of any
oestrogenic, androgenic, glucocorticoid or mineralocorticoid
activit
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