ELLA TABLET 30MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ulipristal acetate

Available from:

HYPHENS PHARMA PTE. LTD.

ATC code:

G03AD02

Dosage:

30.00 mg

Pharmaceutical form:

TABLET

Composition:

Ulipristal acetate 30.00 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

CENEXI

Authorization status:

ACTIVE

Authorization date:

2011-06-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELLA 30 MG TABLET
Ulipristal acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, healthcare
provider or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their problem is the same as yours.
-
If you get any side effects, talk to your doctor, healthcare provider
or pharmacist. This includes
any possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Ella is and what it is used for
2.
What you need to know before you use Ella
3.
How to use Ella
4.
Possible side effects
5.
How to store Ella
6.
Contents of the pack and other information
1.
WHAT ELLA IS AND WHAT IT IS USED FOR
Ella is an oral emergency contraceptive, which means that it can be
used to prevent pregnancy after
unprotected sex or if your contraceptive method has failed, for
example:
-
if your or your partner’s condom tore, slipped or came off, or if
you forgot to use one;
-
if you forgot to take your birth control pill on time (consult the
information leaflet that comes with
your contraceptive pill pack).
You can use Ella up to 120 hours (5 days) after unprotected sex or
failure of a contraceptive method.
Ella acts by modifying the activity of the natural hormone
progesterone. Ella is thought to work by
stopping your ovaries from releasing an egg. Ella is not effective in
every case: of 100 women
receiving Ella up to 5 days after unprotected sex, approximately 2
will become pregnant.
Ella is not suitable as a regular method of contraception.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ELLA
DO NOT USE ELLA
-
if you are allergic to ulipristal acetate or any of the other
ingredients of this medicine (listed in
section 6)
-
if you know or suspect that you are pregnant
WARNINGS AND PRECAUTIONS
_ _
Emergency contraception is a ba

Summary of Product characteristics

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 tablet contains 237 mg 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.
The tablet can be taken with or without food.
If vomiting occurs within 3 hours of Ella intake, another tablet
should be taken.
Ella can be taken at any moment during the menstrual cycle.
Pregnancy should be excluded before Ella is administered.
_Special populations _
_Renal or hepatic impairment: _
In the absence of specific studies, no specific dose recommendations
for Ella can be made.
_Severe hepatic impairment: _
In the absence of specific studies, Ella is not recommended.
_Children and adolescents: _
A limited number of women under 18 years were included in clinical
trials of Ella.
Method of administration
Oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Pregnancy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Concomitant use of ulipristal acetate with an emergency contraceptive
containing levonorgestrel is not
recommended (see section 4.5).
Use in women with severe asthma insufficiently controlled by oral
glucocorticoid is not recommended
.
Emergency contraception with Ella is an occasional method. It should
in no instance replace a regular
contraceptive
method.
In
any
case,
women
should
be
advised
to
adopt
a
regular
method
of
contraception.
Although the use of Ella