ESMYA ulipristal acetate 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ulipristal acetate

Available from:

Vifor Pharma Pty Ltd

INN (International Name):

ulipristal acetate

Authorization status:

Registered

Patient Information leaflet

Esmya
®
_Version 2.0 - December 2017_
Page 1 of 3
ESMYA
®
ULIPRISTAL ACETATE 5 MG TABLET
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some common
questions about Esmya
®
. 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 being given Esmya
®
against the
expected benefits it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to
read it again.
WHAT ESMYA
® IS USED
FOR
Esmya
®
contains the active substance
ulipristal acetate. It is used to treat
moderate to severe symptoms of
uterine fibroids (commonly known as
myomas), which are non-cancerous
tumours of the uterus (womb).
Esmya
®
is used in adult women (over
18 years of age) before they reach
menopause.
In some women, uterine fibroids may
cause heavy menstrual bleeding (your
‘period’), pelvic pain (discomfort in
the belly) and create pressure on other
organs.
This medicine acts by modifying the
activity of progesterone, a naturally
occurring hormone in the body. It is
used either before an operation on
your fibroids or for long term
treatment of your fibroids to reduce
their size, to stop or reduce bleeding
and to increase your red blood cell
count.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
ESMYA
®
You should know that most women
have no menstrual bleeding (period)
during the treatment and for a few
weeks afterwards.
_WHEN YOU MUST NOT TAKE IT _
- if you are allergic to ulipristal
acetate or any of the ingredients
listed at the end of this leaflet.
- if you are pregnant or if you are
breastfeeding.
- if you have vaginal bleeding not
caused by uterine fibroids.
- if you have cancer of the uterus
(womb), cervix (the neck of the
womb), ovary or breast.
You should not use this medicine
after the expiry date printed on the
Esmya
®
pack

Summary of Product characteristics

PRODUCT INFORMATION_ - ESMYA_
®
_ _
V01 June 2016
Page 1 of 19
NAME OF THE MEDICINE
Esmya
®
(5 mg ulipristal Acetate Tablet)
Australian Approved Name (AAN): ulipristal Acetate
Chemical name: 17α-acetoxy-11β
-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-
3,20-dione
Chemical structure:
Molecular formula: C
30
H
37
NO
4
Molecular weight: 475.619
CAS number: 126784-99-4
DESCRIPTION
Tablet is a white to off-white, round biconvex tablet engraved with
“ES5” on one face.
Each tablet contains 5 mg of ulipristal acetate. Ulipristal acetate is
a white to yellowish
crystalline powder. It is freely soluble in dichloromethane, soluble
in methanol, acetone and
ethanol and insoluble in water.
The tablet also contains the following inactive ingredients:
microcrystalline cellulose,
mannitol, croscarmellose sodium, talc and magnesium stearate.
PRODUCT INFORMATION_ - ESMYA_
®
_ _
V01 June 2016
Page 2 of 19
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic
group:
Sex
hormones
and
modulators
of
the
genital
system,
progesterone receptor modulators. ATC code: G03XB02.
Ulipristal acetate is an orally-active synthetic selective
progesterone receptor modulator
that
acts via high-affinity (nanomolar) binding to the human progesterone
receptor. Its major
metabolite, monodesmethyl ulipristal, has comparable affinity for the
progesterone receptor.
Ulipristal acetate also has high affinity for the glucocorticoid
receptor and antiglucocorticoid
effects have been observed
_in vivo _
in animals. However, in humans, no such effect has been
observed even after repeated administration at a daily dose of 10 mg.
Ulipristal acetate has weak
affinity for the androgen receptor and negligible affinity for the
human oestrogen or and
mineralocorticoid receptors.
Fibroids
Ulipristal acetate exerts a direct action on fibroids reducing their
size through inhibition of
cell proliferation and induction of apoptosis.
Pituitary
A daily dose of ulipristal acetate 5 mg inhibits ovulation in the
majority of patients as indicated
by progesteron