Esmya

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Ulipristal acetate 5mg

Mevcut itibaren:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Adı):

Ulipristal acetate 5 mg

Doz:

5 mg

Farmasötik formu:

Tablet

Kompozisyon:

Active: Ulipristal acetate 5mg Excipient: Croscarmellose sodium Magnesium stearate Mannitol Microcrystalline cellulose Purified talc

Reçete türü:

Prescription

Tarafından üretildi:

Crystal Pharma SA

Terapötik endikasyonlar:

Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Ürün özeti:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC, PVC/PVDC blister packs, Al foil closure - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/PE/PVDC, PVC/PVDC blister packs, Al foil closure - 84 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Yetkilendirme tarihi:

2017-03-27

Bilgilendirme broşürü

Esmya
®
_Version 3.0 - January 2019_
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 have an underlying hepatic
disorder.
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 th

Ürün özellikleri

NEW ZEALAND DATA SHEET_ - ESMYA_
®
_ _
V2.0 January 2019
Page 1 of 21
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Esmya
®
5 mg ulipristal acetate tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of ulipristal acetate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off white, round biconvex tablet of 7 mm engraved with
“ES5” on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ulipristal acetate is indicated for intermittent treatment of moderate
to severe symptoms of
uterine fibroids in adult women of reproductive age who are not
eligible for surgery.
4.2
DOSE AND METHOD OF ADMINISTRATION
Esmya treatment is to be initiated and supervised by physicians
experienced in the diagnosis
and treatment of uterine fibroids.
DOSE
The treatment consists of one tablet of 5 mg to be taken once daily
for treatment courses of
up to 3 months each. Tablets may be taken with or without food.
Treatments should only be initiated when menstruation has occurred:
•
The first treatment course should start during the first week of
menstruation.
•
Re-treatment courses should start at the earliest during the first
week of the second
menstruation following the previous treatment course completion.
NEW ZEALAND DATA SHEET_ - ESMYA_
®
_ _
V2.0 January 2019
Page 2 of 21
The treating physician should explain to the patient the requirement
for treatment free
intervals.
Repeated intermittent treatment has been studied up to 4 intermittent
courses.
If a patient misses a dose, the patient should take ulipristal acetate
as soon as possible. If the
dose was missed by more than 12 hours, the patient should not take the
missed dose and
simply resume the usual dosing schedule.
_SPECIAL POPULATIONS _
_Renal impairment:_
No dose adjustment is recommended in patients with mild or moderate
renal impairment. In the absence of specific studies, ulipristal
acetate is not recommended in
patients with severe renal impairment unless the patient is closely
monitored.
_Paediatric pop