Zoely

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Estradiol hemihydrate 1.55mg equivalent to Estradiol 1.5 mg;  ; Nomegestrol acetate 2.5mg;  ;  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Estradiol hemihydrate 1.55 mg (equivalent to Estradiol 1.5 mg)

Dosage:

2.5mg/1.5mg

Pharmaceutical form:

Tablet

Composition:

Active: Estradiol hemihydrate 1.55mg equivalent to Estradiol 1.5 mg   Nomegestrol acetate 2.5mg     Excipient: Colloidal silicon dioxide Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white 85F18422 Purified talc Colloidal silicon dioxide Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 85F32865 Purified talc

Units in package:

Blister pack, PVC/Al blister 1 x 28, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Therapeutic indications:

Oral contraception

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al blister 1 x 28 - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al blister 3 x 28 - 84 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2011-11-02

Patient Information leaflet

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, the risk of
anaemia may be lower.
•
Your period pains may become
less severe or may completely
disappear.
ZOELY is available only with a
doctor's prescription.
WHEN YOU MUST NOT
USE ZOELY
DO NOT TAKE ZOELY IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
nomegestrol acetate or oestradiol
•
any ingredients l

Summary of Product characteristics

NEW ZEALAND DATA SHEET
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
α
-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
β
-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
β
-oestradiol as the
active substances.
H
CH
3
OH
O
H
H
H
H
1/2 H
2
O
1
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 activity.
The oestrogen contained in ZOELY is 17β-oestradiol, a natural
oestrogen identical to
the endogenous human 17β-oestradiol (E2). This oestrogen differs from
the oestrogen
ethinyloestradiol used in other combined oral contraceptives (COC) by
the lack of the
ethinyl group in the 17alpha position. During use of ZOELY, the
average E2 levels
are comparable to the E2 levels during the early follicular and late
luteal ph