EllaOne ulipristal acetate 30 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
05-10-2021
Summary of Product characteristics
(SPC)
16-11-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
ulipristal acetate, Quantity: 30 mg
Available from:
Orion Laboratories Pty Ltd T/A Perrigo Australia
INN (International Name):
ulipristal acetate
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: povidone; magnesium stearate; croscarmellose sodium; lactose monohydrate
Administration route:
Oral
Units in package:
1
Prescription type:
(S3) Pharmacist Only Medicine
Therapeutic indications:
EllaOne is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Product summary:
Visual Identification: Tablet is a white to marble creamy, round tablet engraved on both faces with the code "ella"; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2015-03-06
Patient Information leaflet
EllaOne
®
_Version–August 2019_
Page 1 of 3
ELLAONE
®
ULIPRISTAL ACETATE 30 MG TABLET
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some
common
questions about EllaOne
®
. It does not
contain all the available information.
It does not take the place of talking to
your pharmacist or doctor.
All medicines have risks and benefits.
Your
pharmacist
or
doctor
has
weighed the risks of you being given
EllaOne
®
against the expected benefits
it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET.
You may need to
read it again.
WHAT ELLAONE
® IS USED
FOR
EllaOne
®
is an oral emergency
contraceptive intended to prevent
pregnancy after unprotected sex or if
your contraceptive method has failed,
for example:
- if you had sex without protection;
- if your or your partner’s condom
tore, slipped or came off, or if you
forgot to use one;
- if you did not take your birth control
pill as recommended.
You should take EllaOne
®
as soon as
possible after sex, and within a
maximum of 5 days (120 hours).
This is because the sperm can survive
up to 5 days in your body after
intercourse.
EllaOne
®
is suitable for any woman
of child bearing age, including
adolescents.
You can take EllaOne
®
at any time in
the menstrual cycle.
EllaOne
®
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, EllaOne
®
works by
postponing ovulation.
Emergency contraception is not
effective in every case: of 100 women
who take EllaOne
®
, approximately 2
will become pregnant.
EllaOne
®
does not work if you are
already pregnant.
EllaOne
®
is not suitable as a regular
method of contraception.
After using EllaOne
®
, if you want to
have sex, you should use a reliable
barrier contraceptive method such as
condom. This is because EllaOne
®
will not work if you have unprotected
sex again.
EllaOne
®
does not protect against
HIV
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION –
ELLAONE
® ULIPRISTAL ACETATE 30 MG TABLET
vA12-15 Nov 2021
Page 1 of 14
1
NAME OF THE MEDICINE
Ulipristal acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of ulipristal acetate.
List of excipients with known effect: contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
EllaOne
®
is a white to marble creamy, round tablet engraved on both faces with
the code “еllа”.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Emergency contraception within 120 hours (5 days) of unprotected
sexual intercourse or
contraceptive failure.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
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.
EllaOne
®
can be taken at any time during the menstrual cycle.
If vomiting occurs within 3 hours of EllaOne
®
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 EllaOne
®
is administered.
EllaOne
®
is more effective if taken in the first 24 hours following unprotected
intercourse.
METHOD OF ADMINISTRATION
Oral use. The tablet can be taken with or without food.
DOSAGE ADJUSTMENT IN SPECIAL POPULATIONS
_Renal impairment_: No dose adjustment is necessary.
_Hepatic impairment_: EllaOne
®
is not recommended in severe hepatic impairment. No
alternate dose recommendations for EllaOne
®
can be made for mild or moderate hepatic
impairment in the absence of specific studies.
EllaOne
®
ulipristal acetate 30 mg tablet
vA12-15 Nov 2021
Page 2 of 14
_Paediatric population (Adolescents)_: adolescents of childbearing age
- no differences in safety
or efficacy have been shown compared to adult women aged 18 and older.
There is no relevant use of ulipristal acetate for children of
prepubertal age in emergency
contraception.
4.3
C
ONTRAINDICATIONS
Hypersensi
Read the complete document
