Esmya 5mg Tablets

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

Ulipristal Acetate

Tilgjengelig fra:

ZUELLIG PHARMA SDN BHD

INN (International Name):

Ulipristal Acetate

Enheter i pakken:

28tablet Tablets

Produsert av:

CENEXI

Informasjon til brukeren

ESMYA
®
TABLETS
Ulipristal Acetate 5mg
_Consumer Medication Information Leaflet (RiMUP)_
1
WHAT IS IN THIS LEAFLET

What Esmya is used for

How Esmya works

Before you use Esmya

How to use Esmya

While you are using Esmya

Side effects

Storage and disposal of Esmya

Product description

Manufacturer
and product
registration holder

Date of revision
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 the
menopause who need an operation for
their fibroids.
In some women, uterine fibroids may
cause heavy menstrual bleeding (your
‘period’), pelvic pain (discomfort in
the belly) and create pressure on other
organs.
HOW ESMYA WORKS
This medicine acts by modifying the
activity of progesterone, a naturally
occuring hormone in the body. It is
used
either
before
an
operation
of
your
fibroids
or
for
long
term
treatment
of
your
fibroids
for
a
maximum of 3 months continuously
(this
3-month
treatment
can
be
repeated once) to reduce their size of
fibroids, to stop or reduce bleeding
and to increase your red blood cell
count., before the operation.
BEFORE YOU USE ESMYA
WHEN YOU MUST NOT USE IT
DO NOT TAKE ESMYA:
-
if you are allergic to ulipristal
acetate
or
any
of
the
other
ingredients of Esmya.
-
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.
or breast
.
CHILDREN AND ADOLESCENTS
Esmya
should
not
be
taken
by
children under 18 years of age since
safety
and
efficacy
of
ulipristal
acetate has not been established in this
age group.
BEFORE YOU START TO USE IT
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breastfeeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or

Preparatomtale

1
1. NAME OF THE MEDICINAL PRODUCT
Esmya 5 mg tablets
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 one treatment course of pre-operative treatment of moderate to severe
symptoms of uterine fibroids in adult women of reproductive age.
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 Posology and method of administration
Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and
treatment of uterine fibroids.
Posology
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.
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 population
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 (see sectio