ellaOne

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



 2 

1. NAME OF THE MEDICINAL PRODUCT 
 
ellaOne 30 mg tablet 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 30 mg ulipristal acetate. 
 
Excipients with known effect   
 
Each tablet contains 237 mg of lactose (as monohydrate). 
 
For the full list of excipients, see section 6.1 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
White to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive 
failure. 
 
4.2 Posology and method of administration 
 
Posology 
 
The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours 
(5 days) after unprotected intercourse or contraceptive failure.  
 
The tablet can be taken at any time during the menstrual cycle.  
If vomiting occurs within 3 hours of the tablet intake, another tablet should be taken. 
 
If a woman’s menstrual period is late or in case of symptoms of pregnancy, pregnancy should be 
excluded before the tablet is administered. 
 
Special populations 
 
Renal impairment 
No dose adjustment is necessary. 
 
Hepatic impairment  
In the absence of specific studies, no alternate dose recommendations for ulipristal acetate can be 
made. 
 
Severe hepatic impairment 
In the absence of specific studies, ulipristal acetate is not recommended. 
 
Paediatric population 
There is no relevant use of ulipristal acetate for children of prepubertal age in the indication 
emergency contraception. 



 3 

 
Adolescents: 
ulipristal acetate for emergency contraception is suitable for any woman of child bearing age, 
including adolescents. No differences in safety or efficacy have been shown compared to adult women 
aged 18 and older (see section 5.1).  
 
Method of administration 
 
Oral use. 
The tablet can be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
 
4.4 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 case 
 
In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in 
character 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 be 
considered. 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 be 
taken 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 body 
weight 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 not 
recommended (see section 4.5). 
 
Contraception after ellaOne intake 
 
Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected 
intercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore, 



 4 

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 the 
continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (see 
section 4.5). Therefore, if a woman wishes to start or continue using hormonal contraception, she can 
do so after using ellaOne, however, she should be advised to use a reliable barrier method until the 
next 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 medicinal product contains lactose. Patients with rare hereditary problems of galactose 
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 
medicinal product.   
 
4.5 Interaction 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 and 
decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold 
decrease 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- and 
5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinical 
consequences.   
 
The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is 
used 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 
(from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of this 



 5 

interaction for single dose administration of ulipristal acetate as emergency contraception is not 
known. 
 
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 with 
the 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 products 
that 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 to 
www.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 not 
been 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 is 
recommended 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 of 
intercourse until the next menstrual period.  
 



 6 

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 to 
moderate 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 and 
dysmenorrhea. 
 
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 table 
below.  
 
Adverse reactions listed below are classified according to frequency and system organ class using the 
following 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 from 
the available data). 



 7 

 
 
MedDRA Adverse reactions (frequency) 
System organ class Common Uncommon Rare 
Infections and 
infestations  

 Influenza    

Metabolism and 
nutrition disorders  

 Appetite disorders  

Psychiatric disorders  Mood disorders Emotional disorder  
Anxiety  
Insomnia  
Hyperactivity disorder  
Libido changes  

Disorientation 

Nervous system 
disorders  

Headache 
Dizziness 

Somnolence 
Migraine  

Tremor  
Disturbance in attention  
Dysgueusia  
Syncope  

Eye disorders   Visual disturbance Abnormal sensation in eye  
Ocular hyperaemia  
Photophobia  

Ear and labyrinth 
disorders  

  Vertigo 

Respiratory, thoracic 
and mediastinal 
disorders  

  Dry throat 
 

Gastrointestinal 
disorders  
 

Nausea* 
Abdominal pain* 
Abdominal discomfort 
Vomiting*  

Diarrhoea 
Dry mouth 
Dyspepsia  
Flatulence 

 

Skin and 
subcutaneous tissue 
disorders  

 Acne 
Skin lesion 
Pruritus  

Urticaria 
 

Musculoskeletal and 
connective tissue 
disorders  

Myalgia  
Back pain 

  

Reproductive system 
and breast disorders  

Dysmenorrhea 
Pelvic pain  
Breast tenderness  
 

Menorrhagia  
Vaginal discharge 
Menstrual disorder  
Metrorrhagia 
Vaginitis  
Hot flush 
Premenstrual syndrome 

Genital pruritus  
Dyspareunia  
Ruptured ovarian cyst  
Vulvovaginal pain 
Hypomenorrhea* 

General disorders 
and administration 
site conditions  

Fatigue 
 

Chills  
Malaise 
Pyrexia 

Thirst 

*Symptom which could also be related to an undiagnosed pregnancy (or related complications)  
 
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.  
 



 8 

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 
differences in 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 in 
women without safety concern.  Such high doses were well-tolerated; however, these women had a 
shortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and in 
some 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 the 
mechanism 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 is 
scheduled 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). 
 



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Prevention of ovulation1,§ 
 Placebo 

n=50 
Levonorgestrel  

n=48 
Ulipristal acetate 

n=34 
Treatment before LH 
surge 

n=16 
0.0% 

n=12 
25.0% 

n=8 
100%  

p<0.005* 
Treatment after LH 
surge but before LH peak 

n=10 
10.0% 

n=14 
14.3% 
NS† 

n=14 
78.6%  

p<0.005* 
Treatment after LH peak n=24 

4.2% 
n=22 
9.1% 
NS† 

n=12 
8.3% 
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 of 
ulipristal 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 the 
data 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 

Pregnancy rate (%) 
within 72h of unprotected intercourse or 

contraceptive failure2 

Odds ratio [95% CI] of 
pregnancy risk, ulipristal 
acetate vs levonorgestrel2 

• Ulipristal 
acetate 

• Levonorgestrel 

HRA2914-507 0.91  
(7/773) 

1.68 
(13/773) 

0.50 [0.18-1.24] 

HRA2914-513 1.78 
(15/844) 

2.59 
(22/852) 

0.68 [0.35-1.31] 

Meta- analysis 1.36 
(22/1617) 

2.15 
( 35/1625) 

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 were 
treated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rate 
of 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 unprotected 
intercourse, 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 the 
four clinical studies conducted with ulipristral acetate presented below excluded women who had 
further acts of unprotected intercourse. 

 

BMI (kg/m2) Underweight 0 - 18.5 
Normal 
18.5-25 

Overweight 
25-30 

Obese 
30- 

N total 128 1866 699 467 



 10 

BMI (kg/m2) Underweight 0 - 18.5 
Normal 
18.5-25 

Overweight 
25-30 

Obese 
30- 

N pregnancies 0 23 9 12 
Pregnancy rate 0.00% 1.23% 1.29% 2.57% 
Confidence 
interval 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 a 
peak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) after 
ingestion, 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-acid 
glycoprotein, 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 Resistance 
Protein) transporters at the intestinal level. The effects of ulipristal acetate on BCRP are unlikely to 
have 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 indicate 
that 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 renal 
or hepatic function. 
 
5.3 Preclinical safety data 
 
Non-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 were 



 11 

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 measurement 
in 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 were 
observed. 
 
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 in 
the 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 HOLDER 
 
LABORATOIRE HRA PHARMA 
200 avenue de Paris 
92320 CHATILLON 
France 
 
 



 12 

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 
 
<{DD/MM/YYYY}>  
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.  



 13 

1. NAME OF THE MEDICINAL PRODUCT 
 
ellaOne 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 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. 



 14 

 
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 case 
 
In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in 
character 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 be 
considered. 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 be 
taken 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 body 
weight 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 not 
recommended (see section 4.5). 
 
Contraception after ellaOne intake 
 
Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected 
intercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore, 



 15 

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 the 
continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (see 
section 4.5). Therefore, if a woman wishes to start or continue using hormonal contraception, she can 
do so after using ellaOne, however, she should be advised to use a reliable barrier method until the 
next 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 medicinal product contains lactose. Patients with rare hereditary problems of galactose 
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 
medicinal product.   
 
4.5 Interaction 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 and 
decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold 
decrease 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- and 
5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinical 
consequences.   

 
The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is 
used 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 
(from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of this 



 16 

interaction for single dose administration of ulipristal acetate as emergency contraception is not 
known. 
 
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 with 
the 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 products 
that 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 to 
www.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 not 
been 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 is 
recommended 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 of 
intercourse until the next menstrual period.  
 



 17 

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 to 
moderate 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 and 
dysmenorrhea. 
 
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 table 
below.  
 
Adverse reactions listed below are classified according to frequency and system organ class using the 
following 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 from 
the available data).  
 
 



 18 

MedDRA Adverse reactions (frequency) 
System organ class Common Uncommon Rare 
Infections and 
infestations  

 Influenza    

Metabolism and 
nutrition disorders  

 Appetite disorders  

Psychiatric disorders  Mood disorders Emotional disorder  
Anxiety  
Insomnia  
Hyperactivity disorder  
Libido changes  

Disorientation 

Nervous system 
disorders  

Headache 
Dizziness 

Somnolence 
Migraine  

Tremor  
Disturbance in attention  
Dysgueusia  
Syncope  

Eye disorders   Visual disturbance Abnormal sensation in eye  
Ocular hyperaemia  
Photophobia  

Ear and labyrinth 
disorders  

  Vertigo 

Respiratory, thoracic 
and mediastinal 
disorders  

  Dry throat 
 

Gastrointestinal 
disorders  
 

Nausea* 
Abdominal pain* 
Abdominal discomfort 
Vomiting*  

Diarrhoea 
Dry mouth 
Dyspepsia  
Flatulence 

 

Skin and 
subcutaneous tissue 
disorders  

 Acne 
Skin lesion 
Pruritus  

Urticaria 
 

Musculoskeletal and 
connective tissue 
disorders  

Myalgia  
Back pain 

  

Reproductive system 
and breast disorders  

Dysmenorrhea 
Pelvic pain  
Breast tenderness  
 

Menorrhagia  
Vaginal discharge 
Menstrual disorder  
Metrorrhagia 
Vaginitis  
Hot flush 
Premenstrual syndrome 

Genital pruritus  
Dyspareunia  
Ruptured ovarian cyst  
Vulvovaginal pain 
Hypomenorrhea* 

General disorders 
and administration 
site conditions  

Fatigue 
 

Chills  
Malaise 
Pyrexia 

Thirst 

*Symptom which could also be related to an undiagnosed pregnancy (or related complications)  
 
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.  
 
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 



 19 

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 
differences in 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 in 
women without safety concern.  Such high doses were well-tolerated; however, these women had a 
shortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and in 
some 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 the 
mechanism 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 is 
scheduled 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). 
 



 20 

Prevention of ovulation1,§ 
 Placebo 

n=50 
Levonorgestrel  

n=48 
Ulipristal acetate 

n=34 
Treatment before LH 
surge 

n=16 
0.0% 

n=12 
25.0% 

n=8 
100%  

p<0.005* 
Treatment after LH 
surge but before LH peak 

n=10 
10.0% 

n=14 
14.3% 
NS† 

n=14 
78.6%  

p<0.005* 
Treatment after LH peak n=24 

4.2% 
n=22 
9.1% 
NS† 

n=12 
8.3% 
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 of 
ulipristal 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 the 
data 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 

Pregnancy rate (%) 
within 72h of unprotected intercourse or 

contraceptive failure2 

Odds ratio [95% CI] of 
pregnancy risk, ulipristal 
acetate vs levonorgestrel2 

• Ulipristal 
acetate 

• Levonorgestrel 

HRA2914-507 0.91  
(7/773) 

1.68 
(13/773) 

0.50 [0.18-1.24] 

HRA2914-513 1.78 
(15/844) 

2.59 
(22/852) 

0.68 [0.35-1.31] 

Meta- analysis 1.36 
(22/1617) 

2.15 
( 35/1625) 

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 were 
treated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rate 
of 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 unprotected 
intercourse, 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 the 
four clinical studies conducted with ulipristral acetate presented below excluded women who had 
further acts of unprotected intercourse. 

 

BMI (kg/m2) Underweight 0 - 18.5 
Normal 
18.5-25 

Overweight 
25-30 

Obese 
30- 

N total 128 1866 699 467 



 21 

BMI (kg/m2) Underweight 0 - 18.5 
Normal 
18.5-25 

Overweight 
25-30 

Obese 
30- 

N pregnancies 0 23 9 12 
Pregnancy rate 0.00% 1.23% 1.29% 2.57% 
Confidence 
interval 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 a 
peak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) after 
ingestion, 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-acid 
glycoprotein, 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 Resistance 
Protein) transporters at the intestinal level. The effects of ulipristal acetate on BCRP are unlikely to 
have 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 indicate 
that 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 renal 
or hepatic function. 
 
5.3 Preclinical safety data 
 
Non-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 were 



 22 

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 measurement 
in 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 were 
observed. 
 
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 HOLDER 
 
LABORATOIRE HRA PHARMA 



 23 

200 avenue de Paris 
92320 CHATILLON 
France 
 
 
8. 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 
 
<{DD/MM/YYYY}> 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency) http://www.ema.europa.eu.  



 24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS  OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



 25 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  
 
Name and address of the manufacturers responsible for batch release  
 
Cenexi 
17 Rue de Pontoise  
95520 Osny 
France 
 
Laboratorios 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 
France 
 
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 web-
portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency;  
• 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. 

 



 26 

If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same 
time. 

  



 27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



 28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 29 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ellaOne 30 mg tablet 
Ulipristal acetate 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 30 mg ulipristal acetate 
 
 
3. LIST OF EXCIPIENTS 
 
Contains 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 less 
effectively. Talk to your doctor or pharmacist before using ellaOne. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C. Store in the original package in order to protect from moisture. Keep the blister in 
the outer carton in order to protect from light. 
 



 30 

 
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 HOLDER 
 
LABORATOIRE HRA PHARMA 
200 avenue de Paris 
92320 CHATILLON 
France 
 
 
12. 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 URL 
AUSTRIA www.hra-pharma.com/PIL/AT 
BELGIUM www.hra-pharma.com/PIL/BE 
BULGARIA www.hra-pharma.com/PIL/BG 
CROATIA www.hra-pharma.com/PIL/HR 
CYPRUS www.hra-pharma.com/PIL/GR 
CZECH REPUBLIC  www.hra-pharma.com/PIL/CZ 
DENMARK www.hra-pharma.com/PIL/DK 
ESTONIA www.hra-pharma.com/PIL/LT 
FINLAND www.hra-pharma.com/PIL/FI 
FRANCE www.hra-pharma.com/PIL/FR 
GERMANY www.hra-pharma.com/PIL/DE 
GREECE www.hra-pharma.com/PIL/GR 
HUNGARIA www.hra-pharma.com/PIL/HU 
ICELAND www.hra-pharma.com/PIL/IS 



 31 

IRELAND www.hra-pharma.com/PIL/UK 
ITALY www.hra-pharma.com/PIL/IT 
LATVIA www.hra-pharma.com/PIL/LT 
LITUANIA www.hra-pharma.com/PIL/LT  
LUXEMBOURG www.hra-pharma.com/PIL/BE 
MALTA Not applicable 
NETHERLANDS www.hra-pharma.com/PIL/NL 
NORWAY www.hra-pharma.com/PIL/NO 
POLAND www.hra-pharma.com/PIL/PL 
PORTUGAL www.hra-pharma.com/PIL/PT 
ROUMANIA www.hra-pharma.com/PIL/RO 
SLOVAK REPUBLIC  www.hra-pharma.com/PIL/SK 
SLOVENIA www.hra-pharma.com/PIL/SI 
SPAIN www.hra-pharma.com/PIL/ES 
SWEDEN www.hra-pharma.com/PIL/SE 
UNITED-KINGDOM www.hra-pharma.com/PIL/UK 

 
 
16. 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.  



 32 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ellaOne 30 mg tablet 
Ulipristal acetate 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
HRA Pharma 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 



 33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ellaOne 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 EXCIPIENTS 
 
Contains 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 less 
effectively. Talk to your doctor or pharmacist before using ellaOne. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
<Not applicable.>  
 



 34 

 
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 HOLDER 
 
LABORATOIRE HRA PHARMA 
200 avenue de Paris 
92320 CHATILLON 
France 
 
 
12. 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 URL 
AUSTRIA www.hra-pharma.com/PIL/DE/AT/GS 
BELGIUM www.hra-pharma.com/PIL/BE/GS 
BULGARIA www.hra-pharma.com/PIL/BG/GS 
CROATIA www.hra-pharma.com/PIL/HR/GS 
CYPRUS www.hra-pharma.com/PIL/GR/GS 
CZECH REPUBLIC  www.hra-pharma.com/PIL/CZ/GS 
DENMARK www.hra-pharma.com/PIL/DK/GS 
ESTONIA www.hra-pharma.com/PIL/LT/GS 
FINLAND www.hra-pharma.com/PIL/FI/GS 
FRANCE www.hra-pharma.com/PIL/FR/GS 
GERMANY www.hra-pharma.com/PIL/DE/AT/GS 
GREECE www.hra-pharma.com/PIL/GR/GS 
HUNGARIA www.hra-pharma.com/PIL/HU/GS 
ICELAND www.hra-pharma.com/PIL/IS/GS 
IRELAND www.hra-pharma.com/PIL/UK/GS 



 35 

ITALY www.hra-pharma.com/PIL/IT/GS 
LATVIA www.hra-pharma.com/PIL/LT/GS 
LITUANIA www.hra-pharma.com/PIL/LT/GS  
LUXEMBOURG www.hra-pharma.com/PIL/BE/GS 
MALTA Not applicable 
NETHERLANDS www.hra-pharma.com/PIL/NL/GS 
NORWAY www.hra-pharma.com/PIL/NO/GS 
POLAND www.hra-pharma.com/PIL/PL/GS 
PORTUGAL www.hra-pharma.com/PIL/PT/GS 
ROUMANIA www.hra-pharma.com/PIL/RO/GS 
SLOVAK REPUBLIC  www.hra-pharma.com/PIL/SK/GS 
SLOVENIA www.hra-pharma.com/PIL/SI/GS 
SPAIN www.hra-pharma.com/PIL/ES/GS 
SWEDEN www.hra-pharma.com/PIL/SE/GS 
UNITED-KINGDOM www.hra-pharma.com/PIL/UK/GS 

 
 
16. 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. 
  



 36 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ellaOne 30 mg film-coated tablet 
Ulipristal acetate 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
HRA Pharma 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 
  



 37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
  



 38 

Package leaflet: Information for the user 
 

ellaOne 30 mg tablet 
Ulipristal acetate 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
 
Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other 
healthcare professional has told you. 
- Keep this leaflet. You may need to read it again. 
- Ask your pharmacist if you need more information or advice. 
- If you get any side effects, talk to your pharmacist, doctor,  or other healthcare  professional. 

This includes any possible side effects not listed in this leaflet. See section 4.  
 
What is in this leaflet:  
1. What ellaOne is and what it is used for 
2. What you need to know before you take ellaOne 
3. How to take ellaOne 
4. Possible side effects 
5. How to store ellaOne 
6. Contents of the pack and other information 

- Useful information about contraception 
 
1. What ellaOne is and what it is used for 
 
ellaOne is an emergency contraceptive 
 
ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive 
method has failed. For example: 
- if you had sex without protection;  
- if your or your partner’s condom tore, slipped or came off, or if you forgot to use one; 
- if you did not take your contraceptive pill as recommended.  
 
You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours). 
This is because the sperm can survive up to 5 days in your body after intercourse. 
 
This medicine is suitable for any woman of childbearing age, including adolescents.  
 
You can take the tablet at any time in the menstrual cycle. 
 
ellaOne does not work if you are already pregnant   
 
If your menstrual period is late, there is a possibility that you may be pregnant. When your period is 
late or when you have symptoms of pregnancy (heavy breasts, morning sickness) you should consult a 
doctor or other healthcare professional before taking the tablet.  
 
If you have unprotected sex after 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 to 
choose one that is suitable for you. 



 39 

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 by 
postponing 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 already 
pregnant, 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 are 
worried 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 unprotected 
intercourse. There is some evidence that this medicine may be less effective with increasing body 
weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ellaOne is 
still 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 less 
effective. 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. 
 



 40 

Some medicines may prevent ellaOne from working effectively. If you have used any of the medicines 
listed 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 of 
the 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 your 
pregnancy. 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 have 
severe abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside the 
womb, tubal surgery or long term (chronic) genital infection.  
 
If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register your 
pregnancy 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 is 
information about you. Sharing your information may help women in the future understand the safety 
or 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 maintain 
milk 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 loss 
of 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 or other healthcare professional that you have an intolerance to 
some sugars, tell your pharmacist before taking this medicine. 



 41 

 
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 (see 

section 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. After 
you take the tablet and until your next period comes, you should use condoms every time you have 
sex.  
 
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 that 
you 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 this 
medicine 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, breast-
feeding 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 
- headache, dizziness, mood swings  



 42 

- 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 
- influenza 
- acne, 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 
- hives (itchy rash), feeling 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 in 
the 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 pack 
ellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on 
both sides. 
 
ellaOne is available in a carton containing one blister of 1 tablet. 
 
Marketing Authorisation Holder  
LABORATOIRE HRA PHARMA 
200 avenue de Paris 



 43 

92320 CHATILLON 
France 
E-mail: info-ella@hra-pharma.com  
 
Manufacturer 
Cenexi 
17, rue de Pontoise 
95520 Osny 
France 
 
Laboratorios 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 
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder  
 
België/Belgique/Belgien 
HRA Pharma Benelux 
Tél/Tel: +32 2 709 2295 
 

Lietuva 
Orivas UAB 
Tel: +370 5 252 6570 

България 
MagnaPharm Bulgaria EAD. 
Teл.: + 359 800 12 400 
 

Luxembourg/Luxemburg 
HRA Pharma Benelux 
Tél/Tel: +32 2 709 2295 
 

Česká republika 
Akacia Group, s.r.o. 
Tel: + 420-(0)220 610 491 
 

Magyarország 
Aramis Pharma Kft. 
Tel.: + 36-(0)1 219 0775 
 

Danmark 
Midsona Danmark A/S 
Tlf: + 45 98 54 22 88 

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

Deutschland 
HRA Pharma Deutschland GmbH 
Tel: + 49-(0) 611 890777-0 
 

Nederland 
HRA Pharma Benelux 
Tel: +32 2 709 2295 
 

Eesti 
Orivas OÜ 
Tel: +372 639 8845 

Norge 
Midsona Norge AS 
Tlf: + 47 24 11 01 00 
 

Ελλάδα 
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ 
Τηλ: + 30-(0)210 66 83 000 
 

Österreich 
HRA Pharma Deutschland GmbH 
Tel: + 49-(0) 611 890777-0 
 

España 
HRA Pharma Iberia S.L. 
Tel: + 34-(0)902 107 428 
 

Polska 
MagnaPharm Poland Sp. z o. o. 
Tel: + 48 (22) 570 27 00 
 



 44 

France 
HRA Pharma France 
Tél/Tel: + 33-(0) 1 53 24 81 00 
 

Portugal 
HRA Pharma Iberia S.L. 
sucursal em Portugal 
Tel: +351 707 501 996 
 

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

România 
MagnaPharm Marketing & Sales Romania S.R.L. 
Tel: + 40 372 502 221  

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

Slovenija 
Dr. Gorkič d.o.o. 
Tel: + 386-(0)1 7590 251 
 

Ísland 
Laboratoire HRA Pharma 
Sími: + 33-(0)1 40 33 11 30 
 

Slovenská republika 
Liek, s.r.o. 
Tel: + 421-(0)905 667 410 
 

Italia 
HRA Pharma Italia srl, società unipersonale 
Tel: + 39 06 59 60 09 87 

Suomi/Finland 
Midsona Finland Oy 
Puh/Tel: + 358-(0) 20 743 4755 
 

Κύπρος 
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ 
Τηλ: + 30-(0) 210 66 83 000 
 

Sverige 
Midsona Sverige AB 
Tel: + 46-(0) 20 78 88 01 
 

Latvija 
Orivas SIA 
Tel: +371 676 124 01 

United Kingdom 
HRA Pharma UK & Ireland Limited 
Tel: 0800 917 9548 
 

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 CONTRACEPTION 
 
MORE 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. 
 



 45 

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. There are many different types of contraception available, and you should be able to find the 
right method 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) 

 
  



 46 

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 for 
2. What you need to know before you take ellaOne 
3. How to take ellaOne 
4. Possible side effects 
5. How to store ellaOne 
6. Contents of the pack and other information 

- Useful information about contraception 
 
1. What ellaOne is and what it is used for 
 
ellaOne is an emergency contraceptive 
 
ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive 
method has failed. For example: 
- if you had sex without protection;  
- if your or your partner’s condom tore, slipped or came off, or if you forgot to use one; 
- if you did not take your contraceptive pill as recommended.  
 
You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours). 
This is because the sperm can survive up to 5 days in your body after intercourse. 
 
This medicine is suitable for any woman of childbearing age, including adolescents.  
 
You can take the tablet at any time in the menstrual cycle. 
 
ellaOne does not work if you are already pregnant.   
 
If your menstrual period is late, there is a possibility that you may be pregnant. When your period is 
late or when you have symptoms of pregnancy (heavy breasts, morning sickness) you should consult a 
doctor or other healthcare professional before taking the tablet.  
 
If you have unprotected sex after 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 to 
choose one that is suitable for you. 



 47 

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 by 
postponing 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 already 
pregnant, 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 are 
worried 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 unprotected 
intercourse. There is some evidence that this medicine may be less effective with increasing body 
weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ellaOne is 
still 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 less 
effective. 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. 
 



 48 

Some medicines may prevent ellaOne from working effectively. If you have used any of the medicines 
listed 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 of 
the 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 your 
pregnancy. 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 have 
severe abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside the 
womb, tubal surgery or long term (chronic) genital infection.  
 
If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register your 
pregnancy 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 is 
information about you. Sharing your information may help women in the future understand the safety 
or 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 maintain 
milk 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 this 
medicine, 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 loss 
of 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 or other healthcare professional that you have an intolerance to 
some sugars, tell your pharmacist before taking this medicine. 



 49 

 
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 (see 

section 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. After 
you take the tablet and until your next period comes, you should use condoms every time you have 
sex.  
 
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 that 
you 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 this 
medicine 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, breast-
feeding 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 
- headache, dizziness, mood swings  



 50 

- 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 
- influenza 
- acne, 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 
- hives (itchy rash), feeling 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 of 

ulipristal 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 pack 
ellaOne is a golden film-coated tablet of shield shape (around 10.8 mm diameter) with “ella” engraved 
on both sides. 
 
 
ellaOne is available in a carton containing one blister of 1 film-coated tablet. 



 51 

 
Marketing Authorisation Holder  
LABORATOIRE HRA PHARMA 
200 avenue de Paris 
92320 CHATILLON 
France 
E-mail: info-ella@hra-pharma.com  
 
Manufacturer 
Cenexi 
17, rue de Pontoise 
95520 Osny 
France 
 
 
Delpharm Lille S.A.S. 
Parc d’activités Roubaix-Est 
22, rue de Toufflers 
CS 50070 
59452 Lys-Lez-Lannoy 
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder  
 
België/Belgique/Belgien 
HRA Pharma Benelux 
Tél/Tel: +32 2 709 2295 
 

Lietuva 
Orivas UAB 
Tel: +370 5 252 6570 

България 
MagnaPharm Bulgaria EAD. 
Teл.: + 359 800 12 400 
 

Luxembourg/Luxemburg 
HRA Pharma Benelux 
Tél/Tel: +32 2 709 2295 
 

Česká republika 
Akacia Group, s.r.o. 
Tel: + 420-(0)220 610 491 
 

Magyarország 
Aramis Pharma Kft. 
Tel.: + 36-(0)1 219 0775 
 

Danmark 
Midsona Danmark A/S 
Tlf: + 45 98 54 22 88 
 

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

Deutschland 
HRA Pharma Deutschland GmbH 
Tel: + 49-(0) 611 890777-0 
 

Nederland 
HRA Pharma Benelux 
Tel: +32 2 709 2295 
 

Eesti 
Orivas OÜ 
Tel: +372 639 8845 

Norge 
Midsona Norge AS 
Tlf: + 47 24 11 01 00 
 

Ελλάδα 
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ 
Τηλ: + 30-(0)210 66 83 000 
 

Österreich 
HRA Pharma Deutschland GmbH 
Tel: + 49-(0) 611 890777-0 
 

España 
HRA Pharma Iberia S.L. 
Tel: + 34-(0)902 107 428 
 

Polska 
MagnaPharm Poland Sp. z o. o. 
Tel: + 48 (22) 570 27 00 
 



 52 

France 
HRA Pharma France 
Tél/Tel: + 33-(0) 1 53 24 81 00 
 

Portugal 
HRA Pharma Iberia S.L. 
sucursal em Portugal 
Tel: +351 707 501 996 
 

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

România 
MagnaPharm Marketing & Sales Romania S.R.L. 
Tel: + 40 372 502 221  

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

Slovenija 
Dr. Gorkič d.o.o. 
Tel: + 386-(0)1 7590 251 
 

Ísland 
Laboratoire HRA Pharma 
Sími: + 33-(0)1 40 33 11 30 
 

Slovenská republika 
Liek, s.r.o. 
Tel: + 421-(0)905 667 410 
 

Italia 
HRA Pharma Italia srl, società unipersonale 
Tel: + 39 06 59 60 09 87 

Suomi/Finland 
Midsona Finland Oy  
Puh/Tel: + 358-(0) 20 743 4755 
 

Κύπρος 
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ 
Τηλ: + 30-(0) 210 66 83 000 
 

Sverige 
Midsona Sverige AB 
Tel: + 46-(0)20 78 88 01 
 

Latvija 
Orivas SIA 
Tel: +371 676 124 01 

United Kingdom 
HRA Pharma UK & Ireland Limited 
Tel: 0800 917 9548 
 

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 CONTRACEPTION 
 
MORE 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. 
 



 53 

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. There are many different types of contraception available, and you should be able to find the 
right method 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) 

 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT  
	A. LABELLING
	B. PACKAGE LEAFLET