Ella Tablet 30mg

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

Ulipristal Acetate; ULIPRISTAL ACETATE

Tillgänglig från:

HYPHENS PHARMA SDN. BHD.

INN (International namn):

Ulipristal Acetate; ULIPRISTAL ACETATE

Enheter i paketet:

1tablet Tablets

Tillverkad av:

CENEXI

Bipacksedel

ELLA
® 30MG TABLET
_Ulipristal acetate 30mg _
_Consumer Medication Information Leaflet (RiMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Ella is used for
2.
How Ella works
3.
Before you take Ella
4.
How to take Ella
5.
While you are taking Ella
6.
Side effects
7.
Storage and disposal of Ella
8.
Product description
9.
Manufacturer
&
Product
Registration Holder
10.
Date of revision
11.
Serial number
1.
WHAT ELLA IS USED FOR
Ella is an emergency contraceptive
intended to prevent pregnancy after
unprotected
sex
or
if
your
contraceptive method has failed. For
example:
-
if you or your partner’s condom
tore, slipped or came off, or if
you forgot to use one.
-
if
you
did
not
take
your
contraceptive
pill
as
recommended.
This
medicine
is
suitable
for
any
woman
of
childbearing
age,
including adolescents. You can take
the tablet at any time in the menstrual
cycle.
2.
HOW ELLA WORKS
Ella
30mg
tablet
contains
the
substance
_ulipristal _
_acetate_
which
acts by modifying the activity of the
natural hormone progesterone which
is necessary for ovulation to occur.
As a result, this medicine works by
postponing
ovulation.
Emergency
contraception
is
not
effective
in
every case. Of 100 women who take
this medicine, approximately 2 will
become pregnant.
This medicine is a contraceptive used
to prevent a pregnancy from starting.
If you are already pregnant, it will
not interrupt an existing pregnancy.
Ella does not work if you are already
pregnant.
If your menstrual period is late, there
is
a
possibility
that
you
may
be
pregnant. When your period is late or
when
you
have
symptoms
of
pregnancy (heavy breasts, morning
sickness) you should consult a doctor
or
other
healthcare
professional
before taking the tablet.
If you have unprotected sex after
taking the tablet, it will not stop you
from
becoming
pregnant.
Unprotected sex at any time during
your cycle can lead to pregnancy.
Ella
is
not
used
for
regular
contraception.
Emergency contraception does not
protect against sexually transmitted
infections. Only condoms can protect
you
from
sexual

Produktens egenskaper

D3,
PROPOSED PI FOR ELLA
(CLEAN COPY)
1.
NAME OF THE MEDICINAL PRODUCT
Ella 30 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
30
mg
ulipristal
acetate.
Excipients with known effect:
Each table contains 237mg of lactose(as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to marble creamy, round curved tablet engraved with code
_“еllа” _
on both faces
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emergency contraception within 120 hours (5 days) of unprotected
sexual intercourse or contraceptive
failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment consists of one tablet to be taken orally as soon as
possible, but no later than 120 hours
(5 days) after unprotected intercourse or contraceptive failure.
Ella can be taken at any time during the menstrual cycle
If vomiting occurs within 3 hours of Ella intake, another tablet
should be taken.
If a woman’s menstrual period is late or in case of symptoms of
pregnancy, pregnancy should be excluded
before Ella is administered.
_Special populations_
_ _
_Renal impairment: _
No dose adjustment is necessary
_ _
_Hepatic impairment _
In the absence of specific studies, no alternate dose recommendations
for Ella can be made.
_Severe hepatic impairment:_
In the absence of specific studies, Ella is not recommended.
_Paediatric population _
There is no relevant use of Ella for children of prepubertal age in
the indication emergency contraception
_._
Adolescents: Ella is suitable for any woman of child bearing age,
including adolescents. No differences
in safety or efficacy have been shown compared to adult women aged 18
and older (see section 5.1).
Method
of
administration
Oral use.
This tablet can be taken with or without food
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ella is for occasional use only. It should in no instance replace a
regular contraceptiv