ellaOne

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ulipristal

Available from:

Laboratoire HRA Pharma

ATC code:

G03AD02

INN (International Name):

ulipristal acetate

Therapeutic group:

Sex hormones and modulators of the genital system, , Emergency contraceptives

Therapeutic area:

Contraception, Postcoital

Therapeutic indications:

Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.

Product summary:

Revision: 30

Authorization status:

Authorised

Authorization date:

2009-05-15

Patient Information leaflet

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELLAONE 30 MG TABLET
Ulipristal acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your pharmacist, doctor or other
healthcare professional has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your pharmacist, doctor, or other
healthcare professional.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What ellaOne is and what it is used for
2.
What you need to know before you take ellaOne
3.
How to take ellaOne
4.
Possible side effects
5.
How to store ellaOne
6.
Contents of the pack and other information
- Useful information about contraception
1.
WHAT ELLAONE IS AND WHAT IT IS USED FOR
ellaOne is an emergency contraceptive
ellaOne is a 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 contraceptive pill as recommended.
You should take the tablet as soon as possible after sex, and within a
maximum of 5 days (120 hours).
This is because it is more effective if you take it as soon as
possible after unprotected sex.
This medicine is suitable for any woman of childbearing age, including
adolescents.
You can take the tablet at any time in the menstrual cycle.
ellaOne 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 taki

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ellaOne 30 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg ulipristal acetate.
Excipients with known effect
Each tablet contains 237 mg 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 of 9 mm diameter engraved
with
_“еllа”_
on both sides.
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 at any time during the menstrual cycle.
If vomiting occurs within 3 hours of the tablet 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 the tablet is administered.
_Special populations_
_ _
_Renal impairment_
No dose adjustment is necessary.
_Hepatic impairment _
In the absence of specific studies, no alternate dose recommendations
for ulipristal acetate can be
made.
_Severe hepatic impairment_
In the absence of specific studies, ulipristal acetate is not
recommended.
_Paediatric population _
There is no relevant use of ulipristal acetate for children of
prepubertal age in the indication
emergency contraception
_. _
3
Adolescents:
ulipristal acetate for emergency contraception 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.
The 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
SPECI