ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS

1

1.

NAME OF THE MEDICINAL PRODUCTellaOne 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

TabletWhite 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.
2

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

Special warnings and precautions for use

ellaOne 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 not be taken by any woman
suspected or known to be pregnant. However, it does not interrupt an existing pregnancy (see section
4.6).
ellaOne does not prevent pregnancy in every caseIn case the next menstrual period is more than 7 days late, if the menstrual period is abnormal incharacter or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test
should be performed. As with any pregnancy, the possibility of an ectopic pregnancy should beconsidered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic
pregnancy. Women who become pregnant after taking ulipristal acetate should contact their doctor(see section 4.6).
ulipristal acetate inhibits or postpones ovulation (see section 5.1). If ovulation has already occurred, it
is no longer effective. The timing of ovulation cannot be predicted and therefore the tablet should betaken as soon as possible after unprotected intercourse.
No data are available on the efficacy of ulipristal acetate when taken more than 120 hours (5 days)
after unprotected intercourse.
Limited and inconclusive data suggest that there may be reduced efficacy of ellaOne with increasing
body weight or body mass index (BMI) (see section 5.1). In all women, emergency contraception
should be taken as soon as possible after unprotected intercourse, regardless of the woman’s bodyweight or BMI.
After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected.
In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected.
In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than
20 days.
Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is notrecommended (see section 4.5).
Contraception after ellaOne intake
Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotectedintercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore,
3

after using emergency contraception, women should be advised to use a reliable barrier method until
her next menstrual period.
Although the use of ulipristal acetate for emergency contraception does not contraindicate thecontinued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (seesection 4.5). Therefore, if a woman wishes to start or continue using hormonal contraception, she cando so after using ellaOne, however, she should be advised to use a reliable barrier method until thenext menstrual period.
Specific populations
Concomitant use of ellaOne with CYP3A4 inducers is not recommended due to interaction (e.g.
barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine,
oxcarbazepine, herbal medicinal products containing Hypericum perforatum (St. John’s wort),
rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine and long term use of ritonavir).
Use in women with severe asthma treated by oral glucocorticoid is not recommended.
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total
lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.
4.5Interaction with other medicinal products and other forms of interaction

Potential for other medicinal products to affect ulipristal acetate
Ulipristal acetate is metabolised by CYP3A4 in vitro.
CYP3A4 inducers
In vivo results show that the administration of ulipristal acetate with a strong CYP3A4 inducer
such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or more anddecreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-folddecrease of ulipristal acetate exposure. Concomitant use of ellaOne with CYP3A4 inducers (e.g.
barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine,
oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John’s wort),
rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces plasma
concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne. For
women who have used enzyme-inducing drugs in the past 4 weeks, ellaOne is not recommended(see section 4.4) and non-hormonal emergency contraception (i.e. a copper intrauterine device(Cu-IUD)) should be considered.
-

CYP3A4 inhibitors
In vivo results show that administration of ulipristal acetate with a potent and a moderate
CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinicalconsequences.
The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir isused for a longer period. In such cases ritonavir might reduce plasma concentrations of ulipristal
acetate. Concomitant use is therefore not recommended (see section 4.4). Enzyme induction
wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if
a woman has stopped taking an enzyme inducer in the past 4 weeks.

Medicinal products affecting gastric pH
Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor
esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed Tmax
4

(from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of thisinteraction for single dose administration of ulipristal acetate as emergency contraception is notknown.
Potential for ulipristal acetate to affect other medicinal products
Hormonal contraceptives
Because ulipristal acetate binds to the progesterone receptor with high affinity, it may interfere withthe action of progestogen-containing medicinal products:
Contraceptive action of combined hormonal contraceptives and progestogen-only contraception
may be reduced
Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is
not recommended (see section 4.4).
In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit
CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations. After single dose
administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not
likely. Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal productsthat are metabolised by these enzymes.
P-glycoprotein (P-gp) substrates
In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant
concentrations. Results in vivo with the P-gp substrate fexofenadine were inconclusive. The effects of
the P-gp substrates are unlikely to have any clinical consequences.
4.6

Fertility, pregnancy and lactation

Pregnancy
ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or
known to be pregnant (see section 4.2).
Ulipristal acetate does not interrupt an existing pregnancy.
Pregnancy may occasionally occur after ulipristal acetate intake. Although no teratogenic potential has
been observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Limited human data regarding pregnancy exposure to ellaOne do not suggest any safety concern.
Nevertheless it is important that any pregnancy in a woman who has taken ellaOne be reported towww.hra-pregnancy-registry.com. The purpose of this web-based registry is to collect safety
information from women who have taken ellaOne during pregnancy or who become pregnant after
ellaOne intake. All patient data collected will remain anonymous.
Breast-feeding
Ulipristal acetate is excreted in breast milk (see section 5.2). The effect on newborn/infants has notbeen studied. A risk to the breastfed child cannot be excluded. After intake of ulipristal acetate for
emergency contraception, breast-feeding is not recommended for one week. During this time it isrecommended to express and discard the breast milk in order to stimulate lactation.
Fertility
A rapid return of fertility is likely following treatment with ulipristal acetate for emergency
contraception. Women should be advised to use a reliable barrier method for all subsequent acts ofintercourse until the next menstrual period.

5

4.7

Effects on ability to drive and use machines

Ulipristal acetate has minor or moderate influence on the ability to drive or use machines: mild tomoderate dizziness is common after ellaOne intake, somnolence and blurred vision are uncommon;
disturbance in attention has been rarely reported. The patient should be informed not to drive or use
machines if they are experiencing such symptoms (see section 4.8).
4.8

Undesirable effects

Summary of the safety profile
The most commonly reported adverse reactions were headache, nausea, abdominal pain anddysmenorrhea.
Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development
program.
Tabulated list of adverse reactions
The adverse reactions reported in the phase III program of 2,637 women are provided in the tablebelow.
Adverse reactions listed below are classified according to frequency and system organ class using thefollowing convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated fromthe available data).

6

MedDRA
System organ class
Infections andinfestations
Immune systemdisordersAdverse reactions (frequency)
CommonUncommonInfluenza

Metabolism andnutrition disorders
Psychiatric disorders Mood disorders

Nervous systemdisorders

HeadacheDizziness

Eye disorders

General disorders
and administrationsite conditions

Emotional disorderAnxiety
Insomnia
Hyperactivity disorder
Libido changes
Somnolence
Migraine
Visual disturbance

Ear and labyrinth
disorders
Respiratory, thoracic
and mediastinal
disorders
Gastrointestinal
Nausea*disorders
Abdominal pain*
Abdominal discomfort
Vomiting*
Skin andsubcutaneous tissue
disorders
Musculoskeletal andconnective tissue
disorders
Reproductive systemand breast disorders

Appetite disorders

Myalgia
Back pain
Dysmenorrhea
Pelvic pain
Breast tenderness

FatigueRarehypersensitivity reactions
including rash, urticaria,
angioedema**
Disorientation

TremorDisturbance in attention
Dysgueusia
SyncopeAbnormal sensation in eye
Ocular hyperaemia
Photophobia
VertigoDry throat

Diarrhoea
Dry mouth
Dyspepsia
Flatulence
Acne
Skin lesion
Pruritus

Menorrhagia
Genital pruritus
Vaginal discharge
Dyspareunia
Menstrual disorder
Ruptured ovarian cyst
Metrorrhagia
Vulvovaginal pain
Vaginitis
Hypomenorrhea*
Hot flush
Premenstrual syndrome
ChillsThirstMalaisePyrexia*Symptom which could also be related to an undiagnosed pregnancy (or related complications)**Adverse reaction from spontaneous reporting

Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing
is similar to the safety profile in adults during the phase III program (see section 4.2).
Post-marketing experience: the adverse reactions spontaneously reported in post-marketing experience
were similar in nature and frequency to the safety profile described during the phase III program.
7

Description of selected adverse reactions
The majority of women (74.6%) in the phase III studies had their next menstrual period at the
expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than
expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses. The
delay was greater than 20 days in 4 % of the women.
A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days. In a
majority of cases (88.2%), this bleeding was reported as spotting. Among the women who received
ellaOne in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.
In the phase III studies, 82 women entered a study more than once and therefore received more than one
dose of ellaOne (73 women enrolled twice and 9 enrolled three times). There were no safety differencesin these subjects in terms of incidence and severity of adverse reactions, change in duration or volume
of menses or incidence of intermenstrual bleeding.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
4.9

Overdose

Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg have been used inwomen without safety concern. Such high doses were well-tolerated; however, these women had ashortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and insome women, the duration of bleeding was prolonged, although not excessive in amount (spotting).
There are no antidotes and further treatment should be symptomatic.
5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency
contraceptives. ATC code: G03AD02.
Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via
high-affinity binding to the human progesterone receptor. When used for emergency contraception themechanism of action is inhibition or delay of ovulation via suppression of the luteinising hormone(LH) surge. Pharmacodynamic data show that even when taken immediately before ovulation isscheduled to occur (when LH has already started to rise), ulipristal acetate is able to postpone
follicular rupture for at least 5 days in 78.6% of cases (p<0.005 vs. levonorgestrel and vs. placebo)(see table).

8

Treatment before LH
surge

Prevention of ovulation1,§
Placebo
Levonorgestrel
n=50
n=48
n=16
n=12
0.0%
25.0%

Treatment after LH
surge but before LH peak

n=10
10.0%

Treatment after LH peak

n=24
4.2%

Ulipristal acetate
n=34
n=8
100%
p<0.005*
n=14
78.6%
p<0.005*
n=12
8.3%
NS*

n=14
14.3%
NS†
n=22
9.1%
NS†

1: Brache et al, Contraception 2013§: defined as presence of unruptured dominant follicle five days after late follicular-phase treatment*: compared to levonorgestrel
NS: non statistically significant†: compared to placebo

Ulipristal acetate also has high affinity for the glucocorticoid receptor and in vivo, in animals,
antiglucocorticoid effects have been observed. However, in humans, no such effect has been observed
even after repeat administration at the daily dose of 10 mg. It has minimal affinity to the androgen
receptor and no affinity for the human estrogen or mineralocorticoid receptors.
Results from two independent randomised controlled trials (see Table) showed the efficacy ofulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency
contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure. When thedata from the two trials were combined via meta- analysis, the risk of pregnancy with ulipristal acetate
was significantly reduced compared to levonorgestrel (p=0.046).
Randomised
controlled trial
HRA2914-507
HRA2914-513
Meta- analysis

Pregnancy rate (%)
within 72h of unprotected intercourse orcontraceptive failure2• Ulipristal• Levonorgestrel
acetate
0.91
1.68(7/773)(13/773)
1.78
2.59(15/844)(22/852)
1.36
2.15(22/1617)( 35/1625)

Odds ratio [95% CI] of
pregnancy risk, ulipristal
acetate vs levonorgestrel2
0.50 [0.18-1.24]
0.68 [0.35-1.31]
0.58 [0.33-0.99]

2: Glasier et al, Lancet 2010

Two trials provide efficacy data on ellaOne used up to 120 hours after unprotected intercourse. In an
open-label clinical trial, which enrolled women who presented for emergency contraception and weretreated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rateof 2.1% (26/1241) was observed. In addition, the second comparative trial described above also
provides data on 100 women treated with ulipristal acetate from 72 to 120 hours after unprotectedintercourse, in whom no pregnancies were observed.
Limited and inconclusive data from clinical trials suggest a possible trend for a reduced contraceptive
efficacy of ulipristal acetate with high body weight or BMI (see section 4.4). The meta-analysis of thefour clinical studies conducted with ulipristral acetate presented below excluded women who had
further acts of unprotected intercourse.
BMI (kg/m2)
N totalUnderweight Normal
0 - 18.5
18.5-25128
1866
9Overweight
25-30
699

Obese
30467

BMI (kg/m2)
N pregnancies
Pregnancy rate
Confidence
interval

Underweight0 - 18.50
0.00%

Normal18.5-25
23
1.23%

Overweight
25-30
9
1.29%

Obese
3012
2.57%

0.00 – 2.84

0.78 – 1.84

0.59 – 2.43

1.34 - 4.45

A post-marketing observational study evaluating efficacy and safety of ellaOne in adolescents aged 17
and younger showed no difference in the safety and efficacy profile compared to adult women aged 18
and older.
5.2

Pharmacokinetic properties

Absorption
Following oral administration of a single 30 mg dose, ulipristal acetate is rapidly absorbed, with apeak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) afteringestion, and with an AUC0-∞ of 556 ± 260 ng.h/ml.
Administration of ulipristal acetate together with a high-fat breakfast resulted in approximately 45%
lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean
AUC0-∞ compared with administration in the fasted state. Similar results were obtained for the active
mono-demethylated metabolite.
Distribution
Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acidglycoprotein, and high density lipoprotein.
Ulipristal acetate is a lipophilic compound and is distributed in breast milk, with a mean daily
excretion of 13.35 µg [0-24 hours], 2.16 µg [24-48 hours], 1.06 µg [48-72 hours], 0.58 µg[72-96 hours], and 0.31 µg [96-120 hours].
In vitro data indicate that ulipristal acetate may be an inhibitor of BCRP (Breast Cancer ResistanceProtein) transporters at the intestinal level. The effects of ulipristal acetate on BCRP are unlikely tohave any clinical consequences.
Ulipristal acetate is not a substrate for either OATP1B1 or OATP1B3.
Biotransformation/elimination
Ulipristal acetate is extensively metabolised to mono-demethylated, di-demethylated and hydroxylated
metabolites. The mono-demethylated metabolite is pharmacologically active. In vitro data indicatethat this is predominantly mediated by CYP3A4, and to a small extent by CYP1A2 and CYP2A6. The
terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ±6.3 hours, with a mean oral clearance (CL/F) of 76.8 ± 64.0 L/h.
Special populations
No pharmacokinetic studies with ulipristal acetate have been performed in females with impaired renalor hepatic function.
5.3

Preclinical safety dataNon-clinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeated dose toxicity, and genotoxicity. Most findings in general toxicity studies were10

related to its mechanism of action as a modulator of progesterone and glucocorticoid receptors, with
antiprogesterone activity observed at exposures similar to therapeutic levels.
Information from reproductive toxicity studies is limited due to the absence of exposure measurementin these studies. Ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1
mg/kg) and in monkeys. At these repeated doses, the safety for a human embryo is unknown. At doses
which were low enough to maintain gestation in the animal species, no teratogenic effects wereobserved.
Carcinogenicity studies (in rats and mice) showed that ulipristal acetate is not carcinogenic.
6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate
Povidone
Croscarmellose sodium
Magnesium stearate
6.2

Incompatibilities

Not applicable
6.3

Shelf life

3 years
6.4

Special precautions for storage

Store below 25°C. Store in the original package in order to protect from moisture. Keep the blister inthe outer carton in order to protect from light.
6.5

Nature and contents of container

PVC-PE-PVDC-Aluminium blister of 1 tablet.
PVC-PVDC-Aluminium blister of 1 tablet.
Each carton contains one blister.
Not all pack sizes may be marketed.
6.6

Special precautions for disposal

No special requirements.
7.

MARKETING AUTHORISATION HOLDERLABORATOIRE HRA PHARMA
200 avenue de Paris92320 CHATILLONFrance11

8.

MARKETING AUTHORISATION NUMBER(S)EU/1/09/522/001
EU/1/09/522/002
9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 May 2009
Date of latest renewal: 21 March 2014
10.

DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu.

12

1.

NAME OF THE MEDICINAL PRODUCTellaOne 30 mg film-coated 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

Film-coated tablet
Golden film-coated tablet of shield shape (around 10,8 mm diameter) with “ella” engraved on bothsides.
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.
13

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

Special warnings and precautions for use

ellaOne 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 not be taken by any woman
suspected or known to be pregnant. However, it does not interrupt an existing pregnancy (see section
4.6).
ellaOne does not prevent pregnancy in every caseIn case the next menstrual period is more than 7 days late, if the menstrual period is abnormal incharacter or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test
should be performed. As with any pregnancy, the possibility of an ectopic pregnancy should beconsidered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic
pregnancy. Women who become pregnant after taking ulipristal acetate should contact their doctor(see section 4.6).
Ulipristal acetate inhibits or postpones ovulation (see section 5.1). If ovulation has already occurred, it
is no longer effective. The timing of ovulation cannot be predicted and therefore the tablet should betaken as soon as possible after unprotected intercourse.
No data are available on the efficacy of ulipristal acetate when taken more than 120 hours (5 days)
after unprotected intercourse.
Limited and inconclusive data suggest that there may be reduced efficacy of ellaOne with increasing
body weight or body mass index (BMI) (see section 5.1). In all women, emergency contraception
should be taken as soon as possible after unprotected intercourse, regardless of the woman’s bodyweight or BMI.
After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected.
In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected.
In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than
20 days.
Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is notrecommended (see section 4.5).
Contraception after ellaOne intake
Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotectedintercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore,
14

after using emergency contraception, women should be advised to use a reliable barrier method until
her next menstrual period.
Although the use of ulipristal acetate for emergency contraception does not contraindicate thecontinued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (seesection 4.5). Therefore, if a woman wishes to start or continue using hormonal contraception, she cando so after using ellaOne, however, she should be advised to use a reliable barrier method until thenext menstrual period.
Specific populations
Concomitant use of ellaOne with CYP3A4 inducers is not recommended due to interaction (e.g.
barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine,
oxcarbazepine, herbal medicinal products containing Hypericum perforatum (St. John’s wort),
rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine and long term use of ritonavir).
Use in women with severe asthma treated by oral glucocorticoid is not recommended.
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total
lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.
4.5Interaction with other medicinal products and other forms of interaction

Potential for other medicinal products to affect ulipristal acetate
Ulipristal acetate is metabolised by CYP3A4 in vitro.
CYP3A4 inducers
In vivo results show that the administration of ulipristal acetate with a strong CYP3A4 inducer
such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or more anddecreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-folddecrease of ulipristal acetate exposure. Concomitant use of ellaOne with CYP3A4 inducers (e.g.
barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine,
oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John’s wort),
rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces plasma
concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne. For
women who have used enzyme-inducing drugs in the past 4 weeks, ellaOne is not recommended(see section 4.4) and non-hormonal emergency contraception (i.e. a copper intrauterine device(Cu-IUD)) should be considered.
-

CYP3A4 inhibitors
In vivo results show that administration of ulipristal acetate with a potent and a moderate
CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinicalconsequences.
The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir isused for a longer period. In such cases ritonavir might reduce plasma concentrations of ulipristal
acetate. Concomitant use is therefore not recommended (see section 4.4). Enzyme induction
wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if
a woman has stopped taking an enzyme inducer in the past 4 weeks.

Medicinal products affecting gastric pH
Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor
esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed Tmax
15

(from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of thisinteraction for single dose administration of ulipristal acetate as emergency contraception is notknown.
Potential for ulipristal acetate to affect other medicinal products
Hormonal contraceptives
Because ulipristal acetate binds to the progesterone receptor with high affinity, it may interfere withthe action of progestogen-containing medicinal products:- Contraceptive action of combined hormonal contraceptives and progestogen-only
contraception may be reduced- Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel
is not recommended (see section 4.4).
In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit
CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations. After single dose
administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not
likely. Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal productsthat are metabolised by these enzymes.
P-glycoprotein (P-gp) substrates
In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant
concentrations. Results in vivo with the P-gp substrate fexofenadine were inconclusive. The effects of
the P-gp substrates are unlikely to have any clinical consequences.
4.6

Fertility, pregnancy and lactation

Pregnancy
ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or
known to be pregnant (see section 4.2).
Ulipristal acetate does not interrupt an existing pregnancy.
Pregnancy may occasionally occur after ulipristal acetate intake. Although no teratogenic potential has
been observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Limited human data regarding pregnancy exposure to ellaOne do not suggest any safety concern.
Nevertheless it is important that any pregnancy in a woman who has taken ellaOne be reported towww.hra-pregnancy-registry.com. The purpose of this web-based registry is to collect safety
information from women who have taken ellaOne during pregnancy or who become pregnant after
ellaOne intake. All patient data collected will remain anonymous.
Breast-feeding
Ulipristal acetate is excreted in breast milk (see section 5.2). The effect on newborn/infants has notbeen studied. A risk to the breastfed child cannot be excluded. After intake of ulipristal acetate for
emergency contraception, breast-feeding is not recommended for one week. During this time it isrecommended to express and discard the breast milk in order to stimulate lactation.
Fertility
A rapid return of fertility is likely following treatment with ulipristal acetate for emergency
contraception. Women should be advised to use a reliable barrier method for all subsequent acts ofintercourse until the next menstrual period.

16

4.7

Effects on ability to drive and use machines

Ulipristal acetate has minor or moderate influence on the ability to drive or use machines: mild tomoderate dizziness is common after ellaOne intake, somnolence and blurred vision are uncommon;
disturbance in attention has been rarely reported. The patient should be informed not to drive or use
machines if they are experiencing such symptoms (see section 4.8).
4.8

Undesirable effects

Summary of the safety profile
The most commonly reported adverse reactions were headache, nausea, abdominal pain anddysmenorrhea.
Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development
program.
Tabulated list of adverse reactions
The adverse reactions reported in the phase III program of 2,637 women are provided in the tablebelow.
Adverse reactions listed below are classified according to frequency and system organ class using thefollowing convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated fromthe available data).

17

MedDRA
System organ class
Infections andinfestations
Immune systemdisordersAdverse reactions (frequency)
CommonUncommonInfluenza

Metabolism andnutrition disorders
Psychiatric disorders Mood disorders

Nervous systemdisorders

HeadacheDizziness

Eye disorders

General disorders
and administrationsite conditions

Emotional disorderAnxiety
Insomnia
Hyperactivity disorder
Libido changes
Somnolence
Migraine
Visual disturbance

Ear and labyrinth
disorders
Respiratory, thoracic
and mediastinal
disorders
Gastrointestinal
Nausea*disorders
Abdominal pain*
Abdominal discomfort
Vomiting*
Skin andsubcutaneous tissue
disorders
Musculoskeletal andconnective tissue
disorders
Reproductive systemand breast disorders

Appetite disorders

Myalgia
Back pain
Dysmenorrhea
Pelvic pain
Breast tenderness

FatigueRarehypersensitivity reactions
including rash, urticaria,
angioedema**
Disorientation

TremorDisturbance in attention
Dysgueusia
SyncopeAbnormal sensation in eye
Ocular hyperaemia
Photophobia
VertigoDry throat

Diarrhoea
Dry mouth
Dyspepsia
Flatulence
Acne
Skin lesion
Pruritus

Menorrhagia
Genital pruritus
Vaginal discharge
Dyspareunia
Menstrual disorder
Ruptured ovarian cyst
Metrorrhagia
Vulvovaginal pain
Vaginitis
Hypomenorrhea*
Hot flush
Premenstrual syndrome
ChillsThirstMalaisePyrexia*Symptom which could also be related to an undiagnosed pregnancy (or related complications)**Adverse reaction from spontaneous reporting

Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing
is similar to the safety profile in adults during the phase III program (see section 4.2).
Post-marketing experience: the adverse reactions spontaneously reported in post-marketing experience
were similar in nature and frequency to the safety profile described during the phase III program.

18

Description of selected adverse reactions
The majority of women (74.6%) in the phase III studies had their next menstrual period at the
expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than
expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses. The
delay was greater than 20 days in 4 % of the women.
A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days. In a
majority of cases (88.2%), this bleeding was reported as spotting. Among the women who received
ellaOne in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.
In the phase III studies, 82 women entered a study more than once and therefore received more than one
dose of ellaOne (73 women enrolled twice and 9 enrolled three times). There were no safety differencesin these subjects in terms of incidence and severity of adverse reactions, change in duration or volume
of menses or incidence of intermenstrual bleeding.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
4.9

Overdose

Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg have been used inwomen without safety concern. Such high doses were well-tolerated; however, these women had ashortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and insome women, the duration of bleeding was prolonged, although not excessive in amount (spotting).
There are no antidotes and further treatment should be symptomatic.
5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency
contraceptives. ATC code: G03AD02.
Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via
high-affinity binding to the human progesterone receptor. When used for emergency contraception themechanism of action is inhibition or delay of ovulation via suppression of the luteinising hormone(LH) surge. Pharmacodynamic data show that even when taken immediately before ovulation isscheduled to occur (when LH has already started to rise), ulipristal acetate is able to postpone
follicular rupture for at least 5 days in 78.6% of cases (p<0.005 vs. levonorgestrel and vs. placebo)(see table).

19

Treatment before LH
surge

Prevention of ovulation1,§
Placebo
Levonorgestrel
n=50
n=48
n=16
n=12
0.0%
25.0%

Treatment after LH
surge but before LH peak

n=10
10.0%

Treatment after LH peak

n=24
4.2%

Ulipristal acetate
n=34
n=8
100%
p<0.005*
n=14
78.6%
p<0.005*
n=12
8.3%
NS*

n=14
14.3%
NS†
n=22
9.1%
NS†

1: Brache et al, Contraception 2013§: defined as presence of unruptured dominant follicle five days after late follicular-phase treatment*: compared to levonorgestrel
NS: non statistically significant†: compared to placebo

Ulipristal acetate also has high affinity for the glucocorticoid receptor and in vivo, in animals,
antiglucocorticoid effects have been observed. However, in humans, no such effect has been observed
even after repeat administration at the daily dose of 10 mg. It has minimal affinity to the androgen
receptor and no affinity for the human estrogen or mineralocorticoid receptors.
Results from two independent randomised controlled trials (see Table) showed the efficacy ofulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency
contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure. When thedata from the two trials were combined via meta- analysis, the risk of pregnancy with ulipristal acetate
was significantly reduced compared to levonorgestrel (p=0.046).
Randomised
controlled trial
HRA2914-507
HRA2914-513
Meta- analysis

Pregnancy rate (%)
within 72h of unprotected intercourse orcontraceptive failure2• Ulipristal• Levonorgestrel
acetate
0.91
1.68(7/773)(13/773)
1.78
2.59(15/844)(22/852)
1.36
2.15(22/1617)( 35/1625)

Odds ratio [95% CI] of
pregnancy risk, ulipristal
acetate vs levonorgestrel2
0.50 [0.18-1.24]
0.68 [0.35-1.31]
0.58 [0.33-0.99]

2: Glasier et al, Lancet 2010

Two trials provide efficacy data on ellaOne used up to 120 hours after unprotected intercourse. In an
open-label clinical trial, which enrolled women who presented for emergency contraception and weretreated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rateof 2.1% (26/1241) was observed. In addition, the second comparative trial described above also
provides data on 100 women treated with ulipristal acetate from 72 to 120 hours after unprotectedintercourse, in whom no pregnancies were observed.
Limited and inconclusive data from clinical trials suggest a possible trend for a reduced contraceptive
efficacy of ulipristal acetate with high body weight or BMI (see section 4.4). The meta-analysis of thefour clinical studies conducted with ulipristral acetate presented below excluded women who had
further acts of unprotected intercourse.
BMI (kg/m2)
N totalUnderweight Normal
0 - 18.5
18.5-25
128
1866
20

Overweight
25-30
699

Obese
30467

BMI (kg/m2)
N pregnancies
Pregnancy rate
Confidence
interval

Underweight0 - 18.50
0.00%

Normal18.5-25
23
1.23%

Overweight
25-30
9
1.29%

Obese
3012
2.57%

0.00 – 2.84

0.78 – 1.84

0.59 – 2.43

1.34 - 4.45

A post-marketing observational study evaluating efficacy and safety of ellaOne in adolescents aged 17
and younger showed no difference in the safety and efficacy profile compared to adult women aged 18
and older.
5.2

Pharmacokinetic properties

Absorption
Following oral administration of a single 30 mg dose, ulipristal acetate is rapidly absorbed, with apeak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) afteringestion, and with an AUC0-∞ of 556 ± 260 ng.h/ml.
Administration of ulipristal acetate together with a high-fat breakfast resulted in approximately 45%
lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean
AUC0-∞ compared with administration in the fasted state. Similar results were obtained for the active
mono-demethylated metabolite.
Distribution
Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acidglycoprotein, and high density lipoprotein.
Ulipristal acetate is a lipophilic compound and is distributed in breast milk, with a mean daily
excretion of 13.35 µg [0-24 hours], 2.16 µg [24-48 hours], 1.06 µg [48-72 hours], 0.58 µg[72-96 hours], and 0.31 µg [96-120 hours].
In vitro data indicate that ulipristal acetate may be an inhibitor of BCRP (Breast Cancer ResistanceProtein) transporters at the intestinal level. The effects of ulipristal acetate on BCRP are unlikely tohave any clinical consequences.
Ulipristal acetate is not a substrate for either OATP1B1 or OATP1B3.
Biotransformation/elimination
Ulipristal acetate is extensively metabolised to mono-demethylated, di-demethylated and hydroxylated
metabolites. The mono-demethylated metabolite is pharmacologically active. In vitro data indicatethat this is predominantly mediated by CYP3A4, and to a small extent by CYP1A2 and CYP2A6. The
terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ±6.3 hours, with a mean oral clearance (CL/F) of 76.8 ± 64.0 L/h.
Special populations
No pharmacokinetic studies with ulipristal acetate have been performed in females with impaired renalor hepatic function.
5.3

Preclinical safety dataNon-clinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeated dose toxicity, and genotoxicity. Most findings in general toxicity studies were21

related to its mechanism of action as a modulator of progesterone and glucocorticoid receptors, with
antiprogesterone activity observed at exposures similar to therapeutic levels.
Information from reproductive toxicity studies is limited due to the absence of exposure measurementin these studies. Ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1
mg/kg) and in monkeys. At these repeated doses, the safety for a human embryo is unknown. At doses
which were low enough to maintain gestation in the animal species, no teratogenic effects wereobserved.
Carcinogenicity studies (in rats and mice) showed that ulipristal acetate is not carcinogenic.
6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablet core:
Lactose monohydrate
Povidone
Croscarmellose sodium
Magnesium stearate
Film-coating:Poly(vinyl alcohol) (E1203)
Macrogol (E1521)
Talc (E553b)
Titanium dioxide (E171)
Polysorbate 80 (E433)
Iron oxide yellow (E172)
Potassium aluminium silicate (E555)
6.2

Incompatibilities

Not applicable
6.3

Shelf life

3 years
6.4

Special precautions for storage

This medicinal product does not require any special storage conditions.
6.5

Nature and contents of container

PVC-PVDC (with UV filter) / Aluminium blister of 1 tablet.
The carton contains one blister.
6.6

Special precautions for disposal

No special requirements.
7.

MARKETING AUTHORISATION HOLDERLABORATOIRE HRA PHARMA
22

200 avenue de Paris92320 CHATILLONFrance8.

MARKETING AUTHORISATION NUMBER(S)EU/1/09/522/003
9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 May 2009
Date of latest renewal: 21 March 2014
10.

DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines
Agency) http://www.ema.europa.eu.

23

ANNEX IIA.

MANUFACTURERS RESPONSIBLE FOR BATCH
RELEASEB.

CONDITIONS OR RESTRICTIONS REGARDING SUPPLYAND USEC.

OTHER CONDITIONS AND REQUIREMENTS OF THE
MARKETING AUTHORISATION

D.

CONDITIONS OR RESTRICTIONS WITH REGARD TO
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
PRODUCT24

A.

MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release
Tablet and film-coated tablet:
Cenexi17 Rue de Pontoise
95520 Osny
FranceDelpharm Lille S.A.S.
Parc d’activités Roubaix-Est
22, rue de Toufflers
CS 50070
59452 Lys-Lez-Lannoy
FranceTablet only:
Laboratorios León Farma S.A.
C/ La Vallina, s/n Pol. Ind. Navatejera
24008 Navatejera, León
Spain

The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.

B.

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product not subject to medical prescription.
C.

OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
AUTHORISATION•

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of
Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
D.

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT•Risk Management Plan (RMP)

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of theMarketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:• At the request of the European Medicines Agency;25• Whenever the risk management system is modified, especially as the result of new information
being received that may lead to a significant change to the benefit/risk profile or as the result of
an important (pharmacovigilance or risk minimisation) milestone being reached.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same
time.

26

ANNEX III
LABELLING AND PACKAGE LEAFLET

27

A. LABELLING

28

PARTICULARS TO APPEAR ON THE OUTER PACKAGINGOUTER CARTON
1.

NAME OF THE MEDICINAL PRODUCTellaOne 30 mg tablet
Ulipristal acetate
2.

STATEMENT OF ACTIVE SUBSTANCE(S)Each tablet contains 30 mg ulipristal acetate
3.

LIST OF EXCIPIENTSContains lactose. See leaflet for further information
4.

PHARMACEUTICAL FORM AND CONTENTS

1 tablet.
5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use.
6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.
7.

OTHER SPECIAL WARNING(S), IF NECESSARY

If you have used certain other medicines in the last 4 weeks, in particular for epilepsy, tuberculosis,
HIV infection or herbal medicines containing St. John´s wort (see leaflet), ellaOne may work lesseffectively. Talk to your doctor or pharmacist before using ellaOne.
8.

EXPIRY DATEEXP
9.

SPECIAL STORAGE CONDITIONSStore below 25°C. Store in the original package in order to protect from moisture. Keep the blister inthe outer carton in order to protect from light.
29

10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDERLABORATOIRE HRA PHARMA
200 avenue de Paris92320 CHATILLONFrance12.

MARKETING AUTHORISATION NUMBER(S)EU/1/09/522/001
EU/1/09/522/002
13.

BATCH NUMBER

Lot
14.

GENERAL CLASSIFICATION FOR SUPPLY

15.

INSTRUCTIONS ON USE

Emergency contraception
Take one tablet as soon as possible after unprotected sex or contraceptive failure.
You must take this medicine within 120 hours (5 days) of unprotected sex or contraceptive failure.
QR code linking to package leaflet to be included
Package leaflet online at
COUNTRY
AUSTRIABELGIUM
BULGARIA
CROATIACYPRUSCZECH REPUBLIC
DENMARKESTONIAFINLANDFRANCEGERMANYGREECEHUNGARIAICELAND

URL
www.hra-pharma.com/PIL/AT
www.hra-pharma.com/PIL/BE
www.hra-pharma.com/PIL/BG
www.hra-pharma.com/PIL/HR
www.hra-pharma.com/PIL/GR
www.hra-pharma.com/PIL/CZ
www.hra-pharma.com/PIL/DK
www.hra-pharma.com/PIL/LT
www.hra-pharma.com/PIL/FI
www.hra-pharma.com/PIL/FR
www.hra-pharma.com/PIL/DE
www.hra-pharma.com/PIL/GR
www.hra-pharma.com/PIL/HU
www.hra-pharma.com/PIL/IS
30

IRELANDITALYLATVIALITUANIALUXEMBOURG
MALTA
NETHERLANDSNORWAYPOLANDPORTUGALROUMANIASLOVAK REPUBLICSLOVENIASPAIN
SWEDEN
UNITED-KINGDOM
16.

www.hra-pharma.com/PIL/UK
www.hra-pharma.com/PIL/IT
www.hra-pharma.com/PIL/LT
www.hra-pharma.com/PIL/LT
www.hra-pharma.com/PIL/BE
Not applicable
www.hra-pharma.com/PIL/NL
www.hra-pharma.com/PIL/NO
www.hra-pharma.com/PIL/PL
www.hra-pharma.com/PIL/PT
www.hra-pharma.com/PIL/RO
www.hra-pharma.com/PIL/SK
www.hra-pharma.com/PIL/SI
www.hra-pharma.com/PIL/ES
www.hra-pharma.com/PIL/SE
www.hra-pharma.com/PIL/UK

INFORMATION IN BRAILLE

ellaOne tablet
17.

UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.
Not applicable.
18.

UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}
SN: {number}
NN: {number}
Not applicable.

31

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPSBLISTER
1.

NAME OF THE MEDICINAL PRODUCTellaOne 30 mg tablet
Ulipristal acetate
2.

NAME OF THE MARKETING AUTHORISATION HOLDERHRA Pharma
3.

EXPIRY DATEEXP
4.

BATCH NUMBER

Lot
5.

OTHER

32

PARTICULARS TO APPEAR ON THE OUTER PACKAGINGOUTER CARTON
1.

NAME OF THE MEDICINAL PRODUCTellaOne 30 mg film-coated tablet
Ulipristal acetate
2.

STATEMENT OF ACTIVE SUBSTANCE(S)Each film-coated tablet contains 30 mg ulipristal acetate
3.

LIST OF EXCIPIENTSContains lactose. See leaflet for further information.
4.

PHARMACEUTICAL FORM AND CONTENTS

1 film-coated tablet.
5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use.
6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.
7.

OTHER SPECIAL WARNING(S), IF NECESSARY

If you have used certain other medicines in the last 4 weeks, in particular for epilepsy, tuberculosis,
HIV infection or herbal medicines containing St. John´s wort (see leaflet), ellaOne may work lesseffectively. Talk to your doctor or pharmacist before using ellaOne.
8.

EXPIRY DATEEXP
9.

SPECIAL STORAGE CONDITIONS<Not applicable.>
33

10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDERLABORATOIRE HRA PHARMA
200 avenue de Paris92320 CHATILLONFrance12.

MARKETING AUTHORISATION NUMBER(S)EU/1/09/522/003
13.

BATCH NUMBER

Lot
14.

GENERAL CLASSIFICATION FOR SUPPLY

15.

INSTRUCTIONS ON USE

Emergency contraception
Take one tablet as soon as possible after unprotected sex or contraceptive failure.
You must take this medicine within 120 hours (5 days) of unprotected sex or contraceptive failure.
QR code linking to package leaflet to be included
Package leaflet online at
COUNTRY
AUSTRIABELGIUM
BULGARIA
CROATIACYPRUSCZECH REPUBLIC
DENMARKESTONIAFINLANDFRANCEGERMANYGREECEHUNGARIAICELANDIRELAND

URL
www.hra-pharma.com/PIL/DE/AT/GS
www.hra-pharma.com/PIL/BE/GS
www.hra-pharma.com/PIL/BG/GS
www.hra-pharma.com/PIL/HR/GS
www.hra-pharma.com/PIL/GR/GS
www.hra-pharma.com/PIL/CZ/SK/GS
www.hra-pharma.com/PIL/DK/GS
www.hra-pharma.com/PIL/LT/GS
www.hra-pharma.com/PIL/FI/GS
www.hra-pharma.com/PIL/FR/GS
www.hra-pharma.com/PIL/DE/AT/GS
www.hra-pharma.com/PIL/GR/GS
www.hra-pharma.com/PIL/HU/GS
www.hra-pharma.com/PIL/IS/GS
www.hra-pharma.com/PIL/UK/GS
34

ITALYLATVIALITUANIALUXEMBOURG
MALTA
NETHERLANDSNORWAYPOLANDPORTUGALROUMANIASLOVAK REPUBLICSLOVENIASPAIN
SWEDEN
UNITED-KINGDOM
16.

www.hra-pharma.com/PIL/IT/GS
www.hra-pharma.com/PIL/LT/GS
www.hra-pharma.com/PIL/LT/GS
www.hra-pharma.com/PIL/BE/GS
Not applicable
www.hra-pharma.com/PIL/NL/GS
www.hra-pharma.com/PIL/NO/GS
www.hra-pharma.com/PIL/PL/GS
www.hra-pharma.com/PIL/PT/GS
www.hra-pharma.com/PIL/RO/GS
www.hra-pharma.com/PIL/CZ/SK/GS
www.hra-pharma.com/PIL/SI/GS
www.hra-pharma.com/PIL/ES/GS
www.hra-pharma.com/PIL/SE/GS
www.hra-pharma.com/PIL/UK/GS

INFORMATION IN BRAILLE

ellaOne film-coated tablet
17.

UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.
Not applicable.
18.

UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}
SN: {number}
NN: {number}
Not applicable.

35

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPSBLISTER
1.

NAME OF THE MEDICINAL PRODUCTellaOne 30 mg film-coated tablet
Ulipristal acetate
2.

NAME OF THE MARKETING AUTHORISATION HOLDERHRA Pharma
3.

EXPIRY DATEEXP
4.

BATCH NUMBER

Lot
5.

OTHER

36

B. PACKAGE LEAFLET37

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 for2.
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 islate or when you have symptoms of pregnancy (heavy breasts, morning sickness) you should consult adoctor 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.
ellaOne is not to be used for regular contraception
If you do not have a regular method of contraception, talk to your doctor or healthcare professional tochoose one that is suitable for you.

38

How ellaOne works
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, this medicine works bypostponing 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 alreadypregnant, it will not interrupt an existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections
Only condoms can protect you from sexually transmitted infections. This medicine will not protect
you against HIV infection or any other sexually transmitted diseases (e.g. chlamydia, genital herpes,
genital warts, gonorrhoea, hepatitis B and syphilis). Ask a healthcare professional for advice if you areworried about this.
There is more information about contraception at the end of this leaflet.
2.

What you need to know before you take ellaOne

Do not take ellaOne
if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in
section 6).

­

Warning and precautions
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine­
if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as
you may already be pregnant (see section “Pregnancy, breast-feeding and fertility”);­
if you suffer from severe asthma;­
if you suffer from severe liver disease.
In all women, emergency contraception should be taken as soon as possible after unprotectedintercourse. There is some evidence that this medicine may be less effective with increasing bodyweight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ellaOne isstill recommended for all women regardless of their weight or BMI.
You are advised to speak to a healthcare professional if you are concerned about any problems related
to taking emergency contraception.
If you become pregnant despite taking the tablet, it is important that you see your doctor. See section“Pregnancy, breast-feeding and fertility” for more information.
Other contraceptives and ellaOne
This medicine may make regular hormonal contraceptives, like pills and patches, temporarily lesseffective. If you are currently taking hormonal contraception, continue to use it as usual after taking
this medicine, but be sure to use condoms every time you have sex until your next period.
Do not take this medicine together with another emergency contraceptive pill that contains
levonorgestrel. By taking them both together, you might make this medicine less effective.
Other medicines and ellaOne
Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription or herbal medicines.

39Some medicines may prevent ellaOne from working effectively. If you have used any of the medicineslisted below during the last 4 weeks, ellaOne may be less suitable for you. Your doctor may prescribe
another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD):­
medicines used to treat epilepsy (for example, primidone, phenobarbital, phenytoin,fosphenytoine, carbamazepine, oxcarbazepine and barbiturates)­
medicines used to treat tuberculosis (for example, rifampicin, rifabutin)­a treatment for HIV (ritonavir, efavirenz, nevirapine)­
a medicine used to treat fungal infections (griseofulvin)­herbal remedies containing St John's wort (Hypericum perforatum).
Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any ofthe medicines stated above.
Pregnancy, breast-feeding and fertility
Pregnancy
Before taking this medicine, if your period is late, tell your pharmacist, doctor or other healthcare
professional, or do a pregnancy test in order to make sure you are not already pregnant (see section“Warning and precautions”).
This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant
it will not interrupt an existing pregnancy.
If you become pregnant despite taking this medicine, there is no evidence that it will affect yourpregnancy. However, it is important that you see your doctor. As for any pregnancy, your doctor may
want to check that the pregnancy is not outside the womb. This is especially important if you havesevere abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside thewomb, tubal surgery or long term (chronic) genital infection.
If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register yourpregnancy in an official registry. You can also report this information on your own at
www.hra-pregnancy-registry.com.Your information will remain anonymous – nobody will know it isinformation about you. Sharing your information may help women in the future understand the safetyor risks of ellaOne during a pregnancy.
Breast-feeding
If you take this medicine while you are breast-feeding a baby, do not breast-feed for one week after
taking this medicine. During this time, it is recommended to use a breast pump in order to maintainmilk production, but throw away your breast milk. The effect of breast-feeding your baby in the week
after taking this medicine is not known.
Fertility
This medicine will not affect your future fertility. If you have unprotected sex after taking the tablet, it
will not stop you from becoming pregnant. Therefore it is important you use condoms until your next
period.
If you wish to start or continue with a regular method of contraception after using this medicine, you
can do so but you should also use condoms until your next period.
Driving and using machines
After taking this medicine, some women experience dizziness, drowsiness, blurred vision and/or lossof concentration (see section 4). If you experience these symptoms, do not drive or use machines
ellaOne contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
40

ellaOne contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3.

How to take ellaOne

Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other
healthcare professional has told you. Check with your pharmacist or doctor if you are not sure.
How to take the ellaOne tablet­­­­

Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after
unprotected sex or contraceptive failure. Take the tablet without delay.
You can take the tablet at any time in your cycle.
You can take the tablet at any time of the day either before, during or after a meal.
If you are using one of the medicines that may prevent ellaOne from working properly (seesection 2 “What you need to know before you take ellaOne”) or if you have used one of these
medicines in the past 4 weeks, ellaOne may work less effectively for you. Speak to your doctor
or pharmacist before using ellaOne. Your doctor may prescribe another type of (non-hormonal)
emergency contraceptive, i.e. a Cu-IUD.

If you vomit after taking ellaOne
If you vomit (be sick, throw up) within 3 hours of taking the tablet, take another tablet as soon as
possible.
If you have sex again after taking ellaOne
If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. Afteryou take the tablet and until your next period comes, you should use condoms every time you havesex.
If your next period is late after taking ellaOne
After taking the tablet, it is normal for your next period to be a few days late.
However, if your period is more than 7 days late; if it is unusually light or unusually heavy; or if you
experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea, you
may be pregnant. You should do a pregnancy test right away. If you are pregnant, it is important thatyou see your doctor. (See section “Pregnancy, breast-feeding and fertility”)
If you take more ellaOne than you should
There have been no reports of harmful effects from taking a higher dose than recommended of thismedicine However do ask your pharmacist, doctor or other healthcare professional for advice.
If you have any further questions on the use of this medicine, ask your pharmacist, doctor or other
healthcare professional.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting),
feeling sick (nausea) are also possible signs of pregnancy. If you miss your period and experience such
symptoms after taking ellaOne, you should do a pregnancy test (see section 2 “Pregnancy, breastfeeding and fertility”).
Common side effects (may affect up to 1 in 10 people)­­

nausea, abdominal (stomach) pain or discomfort, vomiting
painful periods, pelvic pain, breast tenderness
41

­
­

headache, dizziness, mood swings
muscle pain, back pain, tiredness

Uncommon side effects (may affect up to 1 in 100 people)
­
­
­
­
­
­
­

diarrhoea, heartburn, wind, dry mouth
unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal
irritation or discharge, lesser or greater sex drive
hot flushes
appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine
visual disturbances
influenzaacne, skin lesions, itching
fever, chills, malaise

Rare side effects (may affect up to 1 in 1,000 people)
­
­
­
­
­
­

genital pain or itching, pain during sex, rupture of an ovarian cyst, unusually light period
loss of concentration, vertigo, shaking, disorientation, fainting
unusual sensation in eye, red eye, sensitivity to light
dry throat, disturbance in taste
allergic reactions such as rash, hives or swelling of the facefeeling thirsty

Reporting of side effects
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. You can also report side effects directly via
the national reporting system listed in Appendix V. By reporting side effects you can provide more
information on the safety of this medicine.
5.

How to store ellaOne

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is on the carton and on the blister after EXP. The
expiry date refers to the last day of that month.
Store below 25°C. Store in the original package in order to protect from moisture. Keep the blister inthe outer carton in order to protect from light.
Do not throw away any medicines via waste water. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What ellaOne contains­
The active substance is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate.
­
The other ingredients are lactose monohydrate, povidone, croscarmellose sodium, magnesium
stearate.
What ellaOne looks like and contents of the packellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” onboth sides.
ellaOne is available in a carton containing one blister of 1 tablet.

42

Marketing Authorisation Holder
LABORATOIRE HRA PHARMA
200 avenue de Paris92320 CHATILLONFranceE-mail: info-ella@hra-pharma.com
Manufacturer
Cenexi17, rue de Pontoise
95520 Osny
FranceLaboratorios León Farma S.A.
C/ La Vallina, s/n Pol. Ind. Navatejera
24008 Navatejera, León
Spain
Delpharm Lille S.A.S.
Parc d’activités Roubaix-Est
22, rue de Toufflers
CS 50070
59452 Lys-Lez-Lannoy
FranceFor any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder
België/Belgique/Belgien
Perrigo Belgium NV+32 (0)9 381 04 30

Lietuva
Orivas UAB
Tel: +370 5 252 6570

България
Perrigo Bulgaria OOD
Tel: +359 2805 7108

Luxembourg/Luxemburg
Perrigo Belgium NV+32 (0)9 381 04 30

Česká republika
Omega Pharma a.s.
Tel : +420 603 407 623

Magyarország
Zentiva Pharma Kft.
Tel.: + 36 1 299 1058

Danmark
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Malta
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30

Deutschland
Perrigo Deutschland GmbH+49 7032 9154 200

Nederland
Omega Pharma Nederland BV
Tel: +31 (0) 10 2211007

Eesti
Orivas OÜ
Tel: +372 639 8845

Norge
Perrigo Sverige AB
Tel: +46 8 59 00 29 00ΕλλάδαΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111-120

Österreich
Perrigo Deutschland GmbH+49 7032 9154 200

EspañaPerrigo España, S.A.

PolskaPerrigo Poland Sp. z o.o.
43Tel: +34 902 889 010

Tel: +48 (22) 489 54 51

FranceLaboratoire Perrigo France
Tél/Tel: + 33-(0) 1 55 48 18 00

Portugal
Perrigo Portugal Lda.
Tel: +351 214 167 610

Hrvatska
Arenda d.o.o.
Tel: + 385-(0)1 644 44 80

România
Perrigo Romania S.R.L.
Tel: +40 213 150 344

IrelandLaboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30

Slovenija
Dr. Gorkič d.o.o.
Tel: + 386-(0)1 7590 251ÍslandLaboratoire HRA Pharma
Sími: + 33-(0)1 40 33 11 30

Slovenská republika
Omega Pharma a.s.
Tel : +420 603 407 623

ItaliaPerrigo Italia S.r.l
Tel: + 39 06 90250333

Suomi/Finland
Perrigo Sverige AB
Tel: +46 8 59 00 29 00Κύπρος
ΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111-120

Sverige
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Latvija
Orivas SIA
Tel: +371 676 124 01

United Kingdom (Northern Ireland)Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30

This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/.
USEFUL INFORMATION ABOUT CONTRACEPTIONMORE ABOUT EMERGENCY CONTRACEPTION
The sooner you take emergency contraception, the better the chance of avoiding pregnancy.
Emergency contraception will not affect your fertility.
Emergency contraception can delay ovulation within a given menstrual cycle, but it will not stop you
from becoming pregnant if you have unprotected sex again. After you take emergency contraception
and until your next period comes, you should use a condom every time you have sex.
MORE ABOUT REGULAR CONTRACEPTION
If you have taken emergency contraception and you do not use a regular contraceptive method (or do
not have a contraceptive method that suits you), talk to your doctor or family planning clinic for advice.

44

There are many different types of contraception available, and you should be able to find the rightmethod for you.
Examples of regular contraception methods:
Daily methods
Contraceptive pill
Weekly or monthly methods
Contraceptive patch
Vaginal Ring
Long lasting methods
Contraceptive implant
IUD (intrauterine device)45

Package leaflet: Information for the user
ellaOne 30 mg film-coated 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 for2.
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 islate or when you have symptoms of pregnancy (heavy breasts, morning sickness) you should consult adoctor 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.
ellaOne is not to be used for regular contraception
If you do not have a regular method of contraception, talk to your doctor or healthcare professional tochoose one that is suitable for you.

46

How ellaOne works
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, this medicine works bypostponing 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 alreadypregnant, it will not interrupt an existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections
Only condoms can protect you from sexually transmitted infections. This medicine will not protect
you against HIV infection or any other sexually transmitted diseases (e.g. chlamydia, genital herpes,
genital warts, gonorrhoea, hepatitis B and syphilis). Ask a healthcare professional for advice if you areworried about this.
There is more information about contraception at the end of this leaflet.
2.

What you need to know before you take ellaOne

Do not take ellaOne
if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in
section 6).

­

Warning and precautions
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine­
if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as
you may already be pregnant (see section “Pregnancy, breast-feeding and fertility”);­
if you suffer from severe asthma;­
if you suffer from severe liver disease.
In all women, emergency contraception should be taken as soon as possible after unprotectedintercourse. There is some evidence that this medicine may be less effective with increasing bodyweight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ellaOne isstill recommended for all women regardless of their weight or BMI.
You are advised to speak to a healthcare professional if you are concerned about any problems related
to taking emergency contraception.
If you become pregnant despite taking this medicine, it is important that you see your doctor. See
section “Pregnancy, breast-feeding and fertility” for more information.
Other contraceptives and ellaOne
This medicine may make regular hormonal contraceptives, like pills and patches, temporarily lesseffective. If you are currently taking hormonal contraception, continue to use it as usual after taking
the tablet, but be sure to use condoms every time you have sex until your next period.
Do not take ellaOne together with another emergency contraceptive pill that contains levonorgestrel.
By taking them both together, you might make this medicine less effective.
Other medicines and ellaOne
Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription or herbal medicines.

47

Some medicines may prevent ellaOne from working effectively. If you have used any of the medicineslisted below during the last 4 weeks, ellaOne may be less suitable for you. Your doctor may prescribe
another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD):­
medicines used to treat epilepsy (for example, primidone, phenobarbital, phenytoin,fosphenytoine, carbamazepine, oxcarbazepine and barbiturates)­
medicines used to treat tuberculosis (for example, rifampicin, rifabutin)­a treatment for HIV (ritonavir, efavirenz, nevirapine)­
a medicine used to treat fungal infections (griseofulvin)­herbal remedies containing St John's wort (Hypericum perforatum).
Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any ofthe medicines stated above.
Pregnancy, breast-feeding and fertility
Pregnancy
Before taking this medicine, if your period is late, tell your pharmacist, doctor or other healthcare
professional, or do a pregnancy test in order to make sure you are not already pregnant (see section“Warning and precautions”).
This medicine is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant
it will not interrupt an existing pregnancy.
If you become pregnant despite taking this medicine, there is no evidence that it will affect yourpregnancy. However, it is important that you see your doctor. As for any pregnancy, your doctor may
want to check that the pregnancy is not outside the womb. This is especially important if you havesevere abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside thewomb, tubal surgery or long term (chronic) genital infection.
If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register yourpregnancy in an official registry. You can also report this information on your own at
www.hra-pregnancy-registry.com.Your information will remain anonymous – nobody will know it isinformation about you. Sharing your information may help women in the future understand the safetyor risks of ellaOne during a pregnancy.
Breast-feeding
If you take this medicine while you are breast-feeding a baby, do not breast-feed for one week after
taking this medicine. During this time, it is recommended to use a breast pump in order to maintainmilk production, but throw away your breast milk. The effect of breast-feeding your baby in the week
after taking this medicine is not known.
Fertility
This medicine will not affect your future fertility. If you have unprotected sex after taking thismedicine, it will not stop you from becoming pregnant. Therefore it is important you use condoms
until your next period.
If you wish to start or continue with a regular method of contraception after using this medicine, you
can do so but you should also use condoms until your next period.
Driving and using machines
After taking this medicine, some women experience dizziness, drowsiness, blurred vision and/or lossof concentration (see section 4). If you experience these symptoms, do not drive or use machines
ellaOne contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
48

ellaOne contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3.

How to take ellaOne

Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other
healthcare professional has told you. Check with your pharmacist or doctor if you are not sure.
How to take the ellaOne film-coated tablet­­­­

Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after
unprotected sex or contraceptive failure. Take the tablet without delay.
You can take the tablet at any time in your cycle.
You can take the tablet at any time of the day either before, during or after a meal.
If you are using one of the medicines that may prevent ellaOne from working properly (seesection 2 “What you need to know before you take ellaOne”) or if you have used one of these
medicines in the past 4 weeks, ellaOne may work less effectively for you. Speak to your doctor
or pharmacist before using ellaOne. Your doctor may prescribe another type of (non-hormonal)
emergency contraceptive, i.e. a Cu-IUD.

If you vomit after taking ellaOne
If you vomit (be sick, throw up) within 3 hours of taking the tablet, take another tablet as soon as
possible.
If you have sex again after taking ellaOne
If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant. Afteryou take the tablet and until your next period comes, you should use condoms every time you havesex.
If your next period is late after taking ellaOne
After taking the tablet, it is normal for your next period to be a few days late.
However, if your period is more than 7 days late; if it is unusually light or unusually heavy; or if you
experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea, you
may be pregnant. You should do a pregnancy test right away. If you are pregnant, it is important thatyou see your doctor. (See section “Pregnancy, breast-feeding and fertility”)
If you take more ellaOne than you should
There have been no reports of harmful effects from taking a higher dose than recommended of thismedicine However do ask your pharmacist, doctor or other healthcare professional for advice.
If you have any further questions on the use of this medicine, ask your pharmacist, doctor or other
healthcare professional.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting),
feeling sick (nausea) are also possible signs of pregnancy. If you miss your period and experience such
symptoms after taking ellaOne, you should do a pregnancy test (See section “Pregnancy, breastfeeding and fertility”).
Common side effects (may affect up to 1 in 10 people)­­

nausea, abdominal (stomach) pain or discomfort, vomiting
painful periods, pelvic pain, breast tenderness
49

­
­

headache, dizziness, mood swings
muscle pain, back pain, tiredness

Uncommon side effects (may affect up to 1 in 100 people)
­
­
­
­
­
­
­

diarrhoea, heartburn, wind, dry mouth
unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal
irritation or discharge, lesser or greater sex drive
hot flushes
appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine
visual disturbances
influenzaacne, skin lesions, itching
fever, chills, malaise

Rare side effects (may affect up to 1 in 1,000 people)
­
­
­
­
­
­

genital pain or itching, pain during sex, rupture of an ovarian cyst, unusually light period
loss of concentration, vertigo, shaking, disorientation, fainting
unusual sensation in eye, red eye, sensitivity to light
dry throat, disturbance in taste
allergic reactions such as rash, hives or swelling of the facefeeling thirsty

Reporting of side effects
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. You can also report side effects directly via
the national reporting system listed in Appendix V. By reporting side effects you can provide more
information on the safety of this medicine.
5.

How to store ellaOne

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is on the carton and on the blister after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via waste water. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What ellaOne contains­
The active substance is ulipristal acetate. Each film-coated tablet contains 30 milligrams ofulipristal acetate.
­
The other ingredients are:­Tablet core: lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate­
Film coating: poly(vinyl alcohol) (E1203), macrogol (E1521), talc (E553b), titanium dioxide(E171), polysorbate 80 (E433), iron oxide yellow (E172), potassium aluminium silicate(E555)
What ellaOne looks like and contents of the packellaOne is a golden film-coated tablet of shield shape (around 10.8 mm diameter) with “ella” engraved
on both sides.

50

ellaOne is available in a carton containing one blister of 1 film-coated tablet.
Marketing Authorisation Holder
LABORATOIRE HRA PHARMA
200 avenue de Paris92320 CHATILLONFranceE-mail: info-ella@hra-pharma.com
Manufacturer
Cenexi17, rue de Pontoise
95520 Osny
FranceDelpharm Lille S.A.S.
Parc d’activités Roubaix-Est
22, rue de Toufflers
CS 50070
59452 Lys-Lez-Lannoy
FranceFor any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder
België/Belgique/Belgien
Perrigo Belgium NV+32 (0)9 381 04 30
България
Perrigo Bulgaria OOD
Tel: +359 2805 7108

Lietuva
Orivas UAB
Tel: +370 5 252 6570
Luxembourg/Luxemburg
Perrigo Belgium NV+32 (0)9 381 04 30

Česká republika
Omega Pharma a.s.
Tel: +420 603 407 623

Magyarország
Zentiva Pharma Kft.
Tel.: + 36 1 299 1058

Danmark
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Malta
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30

Deutschland
Perrigo Deutschland GmbH+49 7032 9154 200

Nederland
Omega Pharma Nederland BV
Tel: +31 (0) 10 2211007

Eesti
Orivas OÜ
Tel: +372 639 8845

Norge
Perrigo Sverige AB
Tel: +46 8 59 00 29 00ΕλλάδαΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111-120

Österreich
Perrigo Deutschland GmbH+49 7032 9154 200

EspañaPerrigo España, S.A.

PolskaPerrigo Poland Sp. z o.o.
51

Tel: +34 902 889 010

Tel: +48 (22) 489 54 51

FranceLaboratoire Perrigo France
Tél/Tel: + 33-(0) 1 55 48 18 00

Portugal
Perrigo Portugal Lda.
Tel: +351 214 167 610

Hrvatska
Arenda d.o.o.
Tel: + 385-(0)1 644 44 80

România
Perrigo Romania S.R.L.
Tel: +40 213 150 344

IrelandLaboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30

Slovenija
Dr. Gorkič d.o.o.
Tel: + 386-(0)1 7590 251ÍslandLaboratoire HRA Pharma
Sími: + 33-(0)1 40 33 11 30

Slovenská republika
Omega Pharma a.s.
Tel : +420 603 407 623

ItaliaPerrigo Italia S.r.l
Tel: + 39 06 90250333

Suomi/Finland
Perrigo Sverige AB
Tel: +46 8 59 00 29 00Κύπρος
ΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111-120

Sverige
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Latvija
Orivas SIA
Tel: +371 676 124 01

United Kingdom (Northern Ireland)Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30

This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/.
USEFUL INFORMATION ABOUT CONTRACEPTIONMORE ABOUT EMERGENCY CONTRACEPTION
The sooner you take emergency contraception, the better the chance of avoiding pregnancy.
Emergency contraception will not affect your fertility.
Emergency contraception can delay ovulation within a given menstrual cycle, but it will not stop you
from becoming pregnant if you have unprotected sex again. After you take emergency contraception
and until your next period comes, you should use a condom every time you have sex.
MORE ABOUT REGULAR CONTRACEPTION
If you have taken emergency contraception and you do not use a regular contraceptive method (or do
not have a contraceptive method that suits you), talk to your doctor or family planning clinic for advice.

52

There are many different types of contraception available, and you should be able to find the rightmethod for you.
Examples of regular contraception methods:
Daily methods
Contraceptive pill
Weekly or monthly methods
Contraceptive patch
Vaginal Ring
Long lasting methods
Contraceptive implant
IUD (intrauterine device)53