ellaOne

Main information

  • Trade name:
  • ellaOne
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ellaOne
    European Union
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Sex hormones and modulators of the genital system, , Emergency contraceptives
  • Therapeutic area:
  • Contraception, Postcoital
  • Therapeutic indications:
  • Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.,
  • Product summary:
  • Revision: 18

Other information

Status

  • Source:
  • EMA - European Medicines Agency
  • Authorization status:
  • Authorised
  • Authorization number:
  • EMEA/H/C/001027
  • Authorization date:
  • 15-05-2009
  • EMEA code:
  • EMEA/H/C/001027
  • Last update:
  • 12-01-2019

Public Assessment Report

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United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

EMA/764301/2014

EMEA/H/C/001027

EPAR summary for the public

ellaOne

ulipristal acetate

This document is a summary of the European public assessment report (EPAR) for ellaOne. It explains

how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its

opinion in favour of granting a marketing authorisation and its recommendations on the conditions of

use for ellaOne.

What is ellaOne?

EllaOne is a medicine that contains the active substance ulipristal acetate. It is available as tablets

(30 mg).

What is ellaOne used for?

EllaOne is a female emergency contraceptive to be taken within 120 hours (five days) of unprotected

sex or contraceptive failure (such as a tear in a condom during sex).

The medicine can be obtained without a prescription.

How is ellaOne used?

EllaOne is taken as one tablet by mouth as soon as possible, but no later than 120 hours, after

unprotected sex or contraceptive failure. If the woman vomits within three hours of taking the

medicine she should take another tablet. EllaOne can be taken at any time during the menstrual cycle.

If a woman’s menstrual period is late or in case of symptoms of pregnancy, pregnancy should be

excluded before ellaOne is taken.

ellaOne

EMA/764301/2014

Page 2/3

How does ellaOne work?

For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the

egg (fusion with a sperm) and implantation in the womb. The sex hormone progesterone plays a role

in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg.

The active substance in ellaOne, ulipristal acetate, acts as a progesterone receptor modulator. This

means that it attaches to the receptors that progesterone normally attaches to, preventing the

hormone from having its effect. Through its actions on the progesterone receptors, ellaOne prevents

pregnancies mainly by preventing or delaying ovulation. If ovulation has already occurred, ellaOne is

no longer effective.

How has ellaOne been studied?

In one main study, ellaOne was given to 1,533 women (aged on average 24 years) who had requested

emergency contraception between two and five days after unprotected sex or contraceptive failure.

The main measure of effectiveness was the number of women who did not become pregnant. This

number was then compared with the number of women who would have been expected to become

pregnant if they had not taken a contraceptive. This number was calculated from published pregnancy

rates.

An additional study compared ellaOne with levonorgestrel (another medicine used in emergency

contraception). This study included women who took the medicine within two days of unprotected sex

or contraceptive failure.

What benefit has ellaOne shown during the studies?

EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies.

Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant. This is less

than the 5.5% of women who would have been expected to become pregnant if they had not taken

any contraceptive. EllaOne therefore prevented about three-fifths of the pregnancies.

The additional study, which included women who took the medicine within two days of unprotected sex

or contraceptive failure, supported the effectiveness of ellaOne. In this study, ellaOne was as effective

as levonorgestrel at preventing pregnancies.

What is the risk associated with ellaOne?

The most common side effects with ellaOne are headache, nausea (feeling sick), abdominal pain

(stomach ache) and dysmenorrhea (period pains). For the full list of all side effects and restrictions,

see the package leaflet.

Why has ellaOne been approved?

The CHMP decided that ellaOne’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

ellaOne

EMA/764301/2014

Page 3/3

What measures are being taken to ensure the safe and effective use of

ellaOne?

A risk management plan has been developed to ensure that ellaOne is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for ellaOne, including the appropriate precautions to be followed by healthcare

professionals and patients.

Other information about ellaOne:

The European Commission granted a marketing authorisation valid throughout the European Union for

ellaOne on 15 May 2009.

The full EPAR for ellaOne can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with ellaOne,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 12-2014.

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

B. PACKAGE LEAFLET

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

What ellaOne is and what it is used for

What you need to know before you take ellaOne

How to take ellaOne

Possible side effects

How to store ellaOne

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.

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.

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.

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

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”

both sides.

ellaOne is available in a 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

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

A&D Pharma Bulgaria

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)234 516 592-0

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

Sanova Pharma GesmbH

Tel: + 43-(0)1 801 040

España

HRA Pharma Iberia S.L.

Tel: + 34-(0)902 107 428

Polska

A&D Pharma Poland Sp. z o. o.

Tel: + 48-(0)22 570 27 00

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

A&D Pharma Romania

Tel: + 40-(0)372 072 219

Ireland

HRA Pharma UK & Ireland Limited

Tel: 1800 812 984

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.

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)

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

What ellaOne is and what it is used for

What you need to know before you take ellaOne

How to take ellaOne

Possible side effects

How to store ellaOne

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.

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.

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.

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

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.

Marketing Authorisation Holder

Laboratoire HRA Pharma

15, rue Béranger

F-75003 Paris

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

A&D Pharma Bulgaria

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)234 516 592-0

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

Sanova Pharma GesmbH

Tel: + 43-(0)1 801 040

España

HRA Pharma Iberia S.L.

Tel: + 34-(0)902 107 428

Polska

A&D Pharma Poland Sp. z o. o.

Tel: + 48-(0)22 570 27 00

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

A&D Pharma Romania

Tel: + 40-(0)372 072 219

Ireland

HRA Pharma UK & Ireland Limited

Tel: 1800 812 984

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.

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)

11-1-2019

Health Canada safety review finds possible link between Fibristal and risk of liver injury

Health Canada safety review finds possible link between Fibristal and risk of liver injury

OTTAWA – Health Canada is informing Canadians that its safety review of Fibristal (ulipristal acetate) found a possible link between its use and the risk of a rare but serious liver injury.

Health Canada

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

29-5-2018

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous ...

FDA - U.S. Food and Drug Administration

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

15-3-2018

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

OTTAWA - Health Canada is advising Canadians that it will be conducting a safety review of Fibristal (ulipristal acetate), a medication used to treat uterine fibroids in women. Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver.

Health Canada

15-2-2018

Be aware of rare but possible risk of liver injury in medical treatment of fibroids

Be aware of rare but possible risk of liver injury in medical treatment of fibroids

The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.

Danish Medicines Agency

20-12-2018


Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt, Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate) - Orphan designation - Commission Decision (2018)7795 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/106/18

Europe -DG Health and Food Safety

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

29-8-2018

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Active substance: Ulipristal Acetate) - Centralised - Authorisation - Commission Decision (2018)5779 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/5017

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

6-8-2018

Cetrotide (Merck Europe B.V.)

Cetrotide (Merck Europe B.V.)

Cetrotide (Active substance: Cetrorelix (as acetate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5373 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/233/T/67

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

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EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

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Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety

17-4-2018

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Active substance: Ornithine phenylacetate) - Transfer of orphan designation - Commission Decision (2018)2355 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/11/T/03

Europe -DG Health and Food Safety