ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
ellaOne 30 mg tablet
2.
Each tablet contains 30 mg ulipristal acetate.
Excipients: each tablet contains 237 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
Tablet
White to off-white, round curved tablet engraved with code
“еllа”
on both faces
4.
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive
failure.
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 with or without food.
If vomiting occurs within 3 hours of ellaOne intake, another tablet should be taken.
ellaOne can be taken at any moment during the menstrual cycle.
Pregnancy should be excluded before ellaOne is administered.
Renal or hepatic impairment
:
In the absence of specific studies, no specific dose recommendations for
ellaOne can be made.
Severe hepatic impairment
:
In the absence of specific studies, ellaOne is not recommended.
Children and adolescents
: A limited number of women under 18 years were included in clinical trials
of ellaOne.
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy.
2
Concomitant use with an emergency contraceptive containing levonorgestrel is not recommended (see
section 4.5).
Use in women with severe asthma insufficiently controlled by oral glucocorticoid is not
recommended
.
Emergency contraception with ellaOne is an occasional method. It should in no instance replace a
regular contraceptive method. In any case, women should be advised to adopt a regular method of
contraception.
Although the use of ellaOne does not contraindicate the continued use of regular hormonal
contraception, ellaOne may reduce its contraceptive action (see section 4.5). Therefore, after using
emergency contraception, it is recommended that subsequent acts of intercourse be protected by a
reliable barrier method until the next menstrual period starts.
Repeated administration of ellaOne within the same menstrual cycle is not advisable, as safety and
efficacy of ellaOne after repeated administration within the same menstrual cycle has not been
investigated.
Emergency contraception with ellaOne does not prevent pregnancy in every case. No data is available
on the efficacy of ellaOne for women who have had unprotected intercourse more than 120 hours
before ellaOne intake. In case of doubt, delay of more than 7 days in next menstrual period, abnormal
bleeding at the expected date of menses, or symptoms of pregnancy, pregnancy should be excluded by
a pregnancy test.
If pregnancy occurs after treatment with ellaOne, as for all pregnancies, the possibility of an ectopic
pregnancy should be considered. Ectopic pregnancy may continue, despite the occurrence of uterine
bleeding.
After ellaOne intake menstrual periods can sometimes occur earlier or later than expected by a few
days. 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.
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take
this medicine.
Ulipristal acetate is metabolized by CYP3A4
in vitro
. No specific drug interaction studies have been
performed
in vivo
.
•
Potential for other medicinal products to affect ulipristal acetate:
CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, ritonavir, St John’s
wort/Hypericum perforatum) may reduce plasma concentrations of ulipristal acetate and may result in
decrease in efficacy. Concomitant use is therefore not recommended. 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 within the last 2-3 weeks.
Concomitant administration of medicinal products that increase gastric pH (e.g. proton pump
inhibitors, antacids and H2-receptor antagonists) may reduce plasma concentrations of ulipristal
acetate and may result in decrease in efficacy. Concomitant use is therefore not recommended.
3
Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, telithromycin, clarithromycin, nefazodone)
may increase exposure to ulipristal acetate. The clinical relevance is unknown.
•
Potential for ulipristal acetate to affect other medicinal products:
Because ulipristal acetate binds 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.
ellaOne is contra-indicated during an existing or suspected pregnancy (see section 4.3).
Extremely limited data are available on the health of the foetus/new-born in case a pregnancy is
exposed to ulipristal acetate. Although no teratogenic potential was observed, animal data are
insufficient with regard to reproduction toxicity (see section 5.3).
HRA Pharma maintains a pregnancy registry to monitor outcomes of pregnancy in women exposed to
ellaOne. Patients and health care providers are encouraged to report any exposure to ellaOne by
contacting the Marketing Authorisation Holder (see section 7).
It is unknown whether ulipristal acetate is excreted in human or animal breast milk. Ulipristal acetate
is a lipophilic compound and may theoretically be excreted in breast milk. A risk to the breast-fed
child cannot be excluded. After intake of ellaOne breastfeeding is not recommended for at least
36 hours.
No studies on the effect on the ability to drive and use machines have been performed.
ellaOne may have 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.
Adverse events reported in more than 10 percent of subjects treated with ulipristal were headache,
nausea and abdominal pain
Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development
program.
The adverse reactions reported in the phase III program of 2,637 women are provided in the table
below. The vast majority of adverse reactions were mild or moderate and resolved spontaneously.
Adverse reactions listed below are classified according to frequency and system organ class. Within
each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4
MedDRA
Adverse reactions (frequency)
System Organ Class
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
Infections and infestations
Vaginitis
Nasopharyngitis
Influenza
Urinary tract
infection
Conjonctivitis infective
Hordeolum
Pelvic inflammatory disease
Metabolism and nutrition
disorders
Appetite disorders
Dehydration
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
Poor quality of sleep
Parosmia
Syncope
Eye disorders
Visual disturbance Abnormal sensation in eye
Ocular hyperaemia
Photophobia
Ear and labyrinth disorders
Vertigo
Vascular disorders
Hot flush
Haemorrhage
Respiratory, thoracic and
mediastinal disorders
Upper respiratory tract
congestion
Cough
Dry throat
Epistaxis
Gastrointestinal disorders
Nausea
Abdominal pain
(NOS)
Abdominal pain upper
Abdominal discomfort
Vomiting
Abdominal pain
lower Diarrhoea
Dry mouth
Constipation
Dyspepsia
Flatulence
Gastro-oesophageal reflux
disease
Toothache
Skin and subcutaneous tissue
disorders
Acne
Skin lesion
Pruritus
Urticaria
Genital pruritus
Musculoskeletal and
connective tissue disorders
Myalgia
Back pain
Pain in extremity
Arthralgia
Renal and urinary disorders
Urinary tract disorder
Chromaturia
Nephrolithiasis
Renal Pain
Bladder pain
Reproductive system and
breast disorders
Dysmenorrhea
Pelvic pain
Breast tenderness
Menorrhagia
Vaginal discharge
Menstrual disorder
Metrorrhagia
Vaginal
haemorrhage
Hot flush
Premenstrual
syndrome
Genital pruritus
Dysfunctional uterine
bleeding
Dyspareunia
Ruptured ovarian cyst
Vulvovaginal pain
Menstrual discomfort
Hypomenorrhea
General disorders and
administration site conditions
Fatigue
Pain
Irritability
Chills
Malaise
Pyrexia
Chest discomfort
Inflammation
Thirst
5
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 events, change in duration
or volume of menses or incidence of intermenstrual bleeding.
Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg were administered to
a limited number of subjects, and no severe or serious adverse reactions were reported.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other sex hormones and modulators. ATC code: Not yet assigned.
Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via
high-affinity binding to the human progesterone receptor. The primary mechanism of action is
inhibition or delay of ovulation. Pharmacodynamic data show that even when taken immediately
before ovulation is scheduled to occur, ulipristal acetate is able to postpone follicular rupture in some
women.
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 randomized 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).
Randomized
controlled trial
Pregnancy rate (%)
within 72h of unprotected intercourse or contraceptive
failure
1
Odds ratio [95% CI] of pregnancy
risk, ulipristal acetate vs
levonorgestrel
1
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]
1 – Glasier et al, Lancet 2010
6
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.
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 AUC
0-∞
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
AUC
0-∞
compared with administration in the fasted state. Similar results were obtained for the active
mono-demethylated metabolite.
The absorption of ulipristal acetate is pH-dependent and may be reduced in situations where gastric
pH is increased irrespective of cause.
Distribution
Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid
glycoprotein, and high density lipoprotein.
Ulipristal acetate is extensively metabolized 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 CYP2D6. 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
related to its mechanism of action as a modulator of progesterone and glucocorticoid receptors, with
antiprogesterone activity observed at exposures similar to therapeutic levels.
Reproduction toxicity data are insufficient due to lack of human and animal pharmacokinetic data.
Due to its mechanism of action, ulipristal acetate has an embryolethal effect in rats, rabbits (at
repeated doses above 1 mg/kg) and in monkeys. The safety for a human embryo is unknown. At doses
which were low enough to maintain gestation in the animal species, no teratogenic potential was
observed.
Carcinogenicity studies with ulipristal acetate have not been conducted.
6.
6.1
List of excipients
7
Metabolism/elimination
Lactose monohydrate
Povidone K30
Croscarmellose sodium
Magnesium stearate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
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.
The carton contains one blister of one tablet.
6.6
Special precautions for disposal
No special requirements
7.
Laboratoire HRA Pharma
15, rue Béranger
F-75003 Paris
France
8.
EU/1/09/522/001
9.
15/05/2009
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
.
8
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
B. CONDITIONS OF THE MARKETING AUTHORISATION
9
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Osny Pharma S.A.S.
17 Rue de Pontoise
FR-95520 Osny
France
or
León Farma SA
Pol. Ind. Navatejera
La Vallina s/n, Navatejera
24008 León, Spain
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to medical prescription.
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version 6 presented in
Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and
whilst the product is on the market.
Risk Management plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in
Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP
agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the
updated RMP should be submitted at the same time as the next Periodic Safety Update Report
(PSUR).
10
In addition, an updated RMP should be submitted
•
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
reached
•
At the request of the EMEA
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A. LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON BOX
1.
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 monohydrate.
See leaflet for further information.
4.
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 REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Keep the blister in the outer carton in order to protect from light.
14
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.
Laboratoire HRA Pharma
15 rue Béranger
F-75003 Paris
France
12.
EU/1/09/522/001
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
ellaOne
15
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
ALU BLISTER
1.
ellaOne 30 mg tablet
Ulipristal acetate
2.
HRA Pharma
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
OTHER
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
ellaOne 30 mg tablet
Ulipristal acetate
Read all of this leaflet carefully before you start using this medicine.
-
If you have any further questions, ask your doctor, healthcare provider or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their problem is the same as yours.
-
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or your pharmacist.
In this leaflet
:
1.
What ellaOne is and what it is used for
2.
Before you use ellaOne
4.
Possible side effects
5.
How to store ellaOne
6.
Further information
1.
WHAT ELLAONE IS AND WHAT IT IS USED FOR
ellaOne is an oral emergency contraceptive, which means that it can be used to prevent pregnancy
after unprotected sex or if your contraceptive method has failed, for example:
-
if you or your partner’s condom tore, slipped or came off, or if you forgot to use one;
-
if you forgot to take your birth control pill on time (consult the information leaflet that comes with
your contraceptive pill pack).
You can use ellaOne up to 120 hours (5 days) after unprotected sex or failure of a contraceptive
method.
ellaOne acts by modifying the activity of the natural hormone progesterone. ellaOne is thought to
work by stopping your ovaries from releasing an egg. ellaOne is not effective in every case: of 100
women receiving ellaOne up to 5 days after unprotected sex, approximately 2 will become pregnant.
ellaOne is not suitable as a regular method of contraception.
2.
BEFORE YOU USE ELLAONE
Do not use ellaOne
-
if you are allergic (hypersensitive) to ulipristal acetate or any of the other ingredients of ellaOne
Take special care with ellaOne
Emergency contraception is a backup method for preventing pregnancy and should only be used
occasionally. Only limited information is available concerning the safety and efficacy of repeated use
of ellaOne; therefore, you are advised not to use ellaOne more than once in the same menstrual cycle.
Your doctor or healthcare provider can tell you about long-term methods of contraception that may be
appropriate for you.
18
-
Keep this leaflet. You may need to read it again.
3.
How to use ellaOne
-
if you suspect that you are pregnant
Tell your doctor, healthcare provider or pharmacist if you have liver disease. It is not recommended to
use ellaOne in case of severe liver disease.
Tell your doctor if you have severe asthma.
After using ellaOne, if you want to have sex, you should use a reliable barrier contraceptive method
such as condom. This is because ellaOne will not work if you have unprotected sex again.
If you are currently taking hormonal contraception (for example birth control pills), you can continue
as usual immediately after taking ellaOne but you should use a reliable barrier contraceptive method
such as condom until your next period (see “Taking other medicines”)
After taking ellaOne, most women have a normal period at the expected time, but some may have their
period later or earlier than normal (see paragraph 4 “POSSIBLE SIDE EFFECTS”). If your period is
more than 7 days late or is unusually light or unusually heavy or if you experience symptoms such as
abdominal pain, nausea, vomiting or breast pain or if you have any doubt about being pregnant, you
should perform a pregnancy test to make sure you are not pregnant.
If you do become pregnant after taking ellaOne, it is important to contact your doctor. Your doctor
may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the
womb). This is especially important if you develop severe abdominal pain or bleeding after taking
ellaOne or if you have previously had an ectopic pregnancy, Fallopian tube surgery or long term
(chronic) genital infection (pelvic inflammatory disease).
If you are worried about sexually transmitted diseases: ellaOne will not protect you against HIV
infection (AIDS) or any other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital
warts, gonorrhoea, hepatitis B and syphilis). Only condoms can protect you from these diseases. Ask
your doctor or healthcare provider for advice if you are worried about this.
Taking other medicines
Please tell your doctor, healthcare provider or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Be sure to tell your doctor or pharmacist if you are taking any of the medicines listed below, as these
medicines can make ellaOne less effective in preventing pregnancy:
-
Certain medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine)
-
Certain medicines used to treat HIV infection (ritonavir)
-
Medicines used to treat certain bacterial infections (for example rifampicin)
-
Herbal remedies containing St John's wort (
Hypericum perforatum
) used for depression or anxiety
-
Certain medicines used to treat acidity of the stomach or ulcers (for example omeprazole)
ellaOne may also make regular hormonal contraceptives less effective. Therefore you should use a
reliable barrier contraceptive method such as condom until your next period.
ellaOne should not be used together with emergency contraceptives containing levonorgestrel.
The activity of ellaOne may be increased if you are taking certain medicines such as medicines to treat
fungal infections (for example, ketoconazole, itraconazole), or certain infections (for example,
telithromycin, clarithromycin) as they may increase the amount of ellaOne in your body.
Pregnancy and breast-feeding
ellaOne is not to be taken if you are already pregnant. Using ellaOne while pregnant might affect your
pregnancy. In case of doubt about a pregnancy, you should perform a pregnancy test (see ”Take
special care with ellaOne”).
19
If you do become pregnant after taking this medicine, it is important that you contact your doctor,
healthcare provider or pharmacist.
If you are breast-feeding
Breast-feeding is not recommended in the 36 hours following ellaOne intake: if you take ellaOne
while breast-feeding, you should breast-feed your baby immediately before taking the ellaOne tablet,
then pump and discard your milk for 36 hours after ellaOne intake. Breast-feeding can be resumed
after 36 hours.
Driving and using machines
After ellaOne intake, some women experience dizziness, drowsiness, blurred vision and/or disturbance
in attention (see paragraph 4 “POSSIBLE SIDE EFFECTS”): do not drive or use machines if you
experience these symptoms.
Important information about some of the ingredients of ellaOne
ellaOne contains lactose monohydrate. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
3.
HOW TO USE ELLAONE
Always use ellaOne exactly as your doctor, healthcare provider or pharmacist has told you. You
should check with your doctor, healthcare provider or pharmacist if you are not sure.
-
Take one tablet by mouth
as soon as possible
and no later than 120 hours (5 days) after you have
had unprotected sex or contraceptive failure. Do not delay taking the tablet.
-
You can take ellaOne either before, during or after a meal.
-
You can take ellaOne at any moment in your cycle.
-
If you vomit within 3 hours of taking an ellaOne tablet, you should consult your doctor in order to
take another tablet.
-
If you become pregnant after taking ellaOne, it is important to contact your doctor, healthcare
provider or pharmacist (see “Take special care with ellaOne” for further information).
If you use more ellaOne than you should
There have been no reports of serious harmful effects from taking several doses of this medicine at
once. You should nonetheless ask your doctor, healthcare provider or pharmacist for advice.
If you have any further questions on the use of this product, ask your doctor, healthcare provider or
pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, ellaOne can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
20
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
Common side effects:
-
nausea, abdominal pain, upper abdominal pain, abdominal discomfort, vomiting
-
headache, dizziness
-
painful menses, pelvic pain, breast tenderness
-
tiredness
-
mood swings
-
muscle pain, back pain
Uncommon side effects:
-
lower abdominal pain, diarrhoea, dry mouth, constipation, heartburn, intestinal gases
-
abnormal vaginal bleeding and menstrual disorder (prolonged periods, light unexpected vaginal
bleeding, vaginal bleeding, heavy/prolonged periods, premenstrual syndrome)
-
vaginal inflammation, vaginal discharge
-
hot flushes
-
urinary tract infection
-
nose/throat infection, influenza, fever, chills
-
pain, feeling sick
-
appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, irritability,
decreased / increased libido
-
acne, skin lesion, itching
-
migraine
-
visual disturbances
Rare side effects:
-
genital itching, pain during sexual intercourse, rupture of a pre-existing ovarian cyst, genital pain,
abnormal sensation during menses, abnormal light periods, pelvic inflammatory disease
-
urinary tract disorders, coloured urine, kidney stones, renal and bladder pain
-
acid reflux, toothache
-
attention deficit, vertigo, shaking, disorientation, smell and taste disturbance, poor quality of sleep,
fainting
-
abnormal sensation in eye, red eye, eye sensitivity to light, eye infection, stye
-
chest discomfort, inflammation, thirst feeling
-
nose and throat congestion, cough, dry throat, dehydration
-
nose bleeds
-
hives
-
bleeding
-
pain in arms/legs, joint pain
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor, healthcare provider or pharmacist.
5.
HOW TO STORE ELLAONE
Keep out of the reach and sight of children.
Do not use ellaOne after the expiry date which is stated on the carton and on the blister after EXP. The
expiry date refers to the last day of that month.
Keep the blister in the outer carton in order to protect from light.
21
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What ellaOne
contains
- The active substance is ulipristal acetate. One tablet contains 30 mg of ulipristal acetate.
- The other ingredients are lactose monohydrate, povidone K30, croscarmellose sodium, magnesium
stearate.
What ellaOne
looks like and contents of the pack
ellaOne is a white, round curved tablet engraved with code
“еllа”
on both faces.
ellaOne is available in the following pack size: carton containing one blister of 1 tablet.
Marketing Authorisation Holder
Laboratoire HRA Pharma
15, rue Béranger
F-75003 Paris
France
E-mail: info-ella@hra-pharma.com
Manufacturer
Osny Pharma S.A.S.
or
León Farma SA
17, rue de Pontoise
Pol. Ind. Navatejera
F-95520 Osny
La Vallina s/n, Navatejera
France
24008 León, Spain
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last approved in
{MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web
site:
http://www.emea.europa.eu
/
.
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
Besins Healthcare Benelux
Tél/Tel : + 32-(0)2 629 43 00
Luxembourg/Luxemburg
Besins Healthcare Benelux
Tel : + 32-(0)2 629 43 00
България
Gedeon Richter
Teл.: +359-(0)2 812 90 67
Magyarország
Richter Gedeon NyRt.
Tel.: + 36-(0)1 505 7032
Česká republika
Gedeon Richter Plc., zastoupení pro ČR
Tel: + 420-(0)26 114 1200
Malta
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30
22
Danmark
Nycomed Danmark ApS
Tlf: + 45-(0)46 77 11 11
Nederland
Apothecon B.V.
Tel: + 31-(0) 342 426120
Deutschland
HRA Pharma Deutschland GmbH
Tel: + 49-(0)234 516 592-0
Norge
Nycomed Pharma AS
Tlf: + 47-(0) 6676 3030
Eesti
Nycomed SEFA AS
Tel: + 372-(0)6177 669
Österreich
Sanova Pharma GesmbH
Tel: + 43-(0)1 801 040
Ελλάδα
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ
Τηλ: + 30-(0)210 66 83 000
Polska
Gedeon Richter Polska Sp. z o. o
.
Tel: + 48-(0)22 755 96 48
España
Laboratorios HRA Pharma España SL
Tel: + 34-(0)902 107 428
Portugal
Tecnifar Indústria Técnica Farmacêutica, S.A.
Tel: +351-(0)210 330 700
France
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30
România
Gedeon Richter Romania
Tel: + 40-(0)265 264 067
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
Gedeon Richter o.z.
Tel: + 421-(0)2 50 20 58 01
Italia
HRA Pharma Italia srl
Tel: + 39-(0) 06 541 44 60
Suomi/Finland
Oy Leiras Finland Ab
Puh/Tel: + 358-(0)20 746 5000
Κύπρος
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ
Τηλ: + 30 210 66 83 000
Sverige
Nycomed AB
Tel: + 46-(0)8 731 28 00
Latvija
SIA Nycomed Latvia
Tel: + 371-(0)67840082
United Kingdom
HRA Pharma UK Ltd.
Tel: + 44-(0)800 917 9548
Lietuva
Nycomed UAB
Tel: + 370-(0)5 210 90 70
23
Source: European Medicines Agency
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