ELLA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ULIPRISTAL ACETATE

Available from:

CTS LTD

ATC code:

G03AD02

Pharmaceutical form:

TABLETS

Composition:

ULIPRISTAL ACETATE 30 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

LABORATOIRE HRA PHARMA , FRANCE

Therapeutic group:

ULIPRISTAL

Therapeutic area:

ULIPRISTAL

Therapeutic indications:

Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Authorization date:

2016-05-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a doctor’s prescription
ELLA
TABLET
Each tablet contains: Ulipristal Acetate 30 mg
Inactive ingredients – see section 6.
Patient safety information card:
In addition to the leaflet, there is a patient safety information card
for Ella.
This card contains important safety information you should know before
and after taking
Ella, as well as act according to it.
Please review the patient safety information card and the patient
leaflet before taking the
medicine. You should keep the leaflet and the card for further review,
if necessary.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, refer to the
doctor or the pharmacist.
THE MEDICINE IS DISPENSED WITHOUT A DOCTOR’S PRESCRIPTION FOR WOMEN
AND GIRLS
ABOVE THE AGE OF 14. FOR GIRLS UNDER THE AGE OF 14, THE MEDICINE IS
DISPENSED WITH A
DOCTOR’S PRESCRIPTION ONLY.
Take the product according to the instructions in the dosage section
of this leaflet. Consult
the pharmacist if you need further information.
The medicine should be taken immediately after sexual intercourse but
no later than 120
hours (5 days), since the efficacy of the medicine is higher the
closer it is taken to the time
of unprotected sexual intercourse. Ella is not effective in every
case: out of 100 women who
take this medicine, approximately 2 may become pregnant.
Ella may be taken in any stage of the menstrual cycle (every day of
the month).
ELLA IS NOT INTENDED TO BE A CONTRACEPTIVE FOR ROUTINE USE.
Consult a doctor in order to
determine a regular method for preventing pregnancy.
Ella does not work if you are already pregnant.
Ella is ineffective in cases of unprotected intercourse after it has
been taken.
1.
WHAT IS ELLA INTENDED FOR?
Ella is an emergency contraceptive for up to 120 hours (5 days) after
unprotected
intercourse or failure of the contraceptive that w

Summary of Product characteristics

1
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 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 code
_“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.
2
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
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ella is for occasional use only. It should in no instance replace a
regular contraceptive method. In any
case, women should be advised to adopt a regular method of
contraception.
Ulipristal acetate is not intended for use during pregnancy and should
n