ELLAONE 30 mg Tablet

Зміст інструкції

1. ellaOne 30 mg tablet
   1. What ellaOne is and what it is used for
   2. What you need to know before taking ellaOne
   3. How to take ellaOne
   4. Possible side effects
   5. How to store ellaOne
   6. Contents of the pack and other information
2. ellaOne 30 mg film-coated tablet
   1. What ellaOne is and what it is used for
   2. What you need to know before taking ellaOne
   3. How to take ellaOne
   4. Possible side effects
   5. How to store ellaOne
   6. Package contents and other information

ellaOne 30 mg tablet

Ulipristal acetate

Read this leaflet carefully before using this medicine as 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.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your pharmacist, doctor or other healthcare professional. See section 4.

Contents of 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 sexual intercourse
or following the failure of a contraceptive method. For example:
- if you have had unprotected sexual intercourse;
- in the event that your condom or your partner's condom has broken, slipped or leaked, or if you
forgot to use it;
- if you have not taken the contraceptive pill according to the instructions.
You should take the tablet as soon as possible after sexual intercourse, and in any case within
a maximum of 5 days (120 hours).
This is because it is more effective if taken as soon as possible after unprotected sexual intercourse.
This medicine is suitable for any woman of childbearing age, including adolescents.
The tablet can be taken at any time of the menstrual cycle.
ellaOne does not work if a pregnancy is already in progress
If your period is delayed, there is a possibility of pregnancy. If your period is delayed or if you have symptoms of pregnancy (heavy breasts, morning sickness), you should consult a
doctor or healthcare professional before taking the tablet.
If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent
pregnancy.
Unprotected sexual intercourse at any time of the cycle can cause a pregnancy.
ellaOne should not be used as a regular contraceptive
If you are not using a regular contraceptive method, talk to a doctor or healthcare professional to
choose one that is suitable for you.
How ellaOne works
ellaOne contains the substance ulipristal acetate,which works by modifying the activity of the natural hormone
progesterone, necessary for ovulation to occur. Consequently, this medicine works by
delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women
who take this medicine, a pregnancy occurs in approximately 2 cases.
This medicine is a contraceptive used to prevent a pregnancy from establishing. If you are already
pregnant, ellaOne will not interrupt an existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections.
Only the use of a condom guarantees protection against sexually transmitted infections. This
medicine does not offer protection against HIV infection or other sexually transmitted diseases
(for example, Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis). If you
are concerned about this, consult a healthcare professional.
You will find further information on contraception at the end of this leaflet.

2. What you need to know before taking 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).

Warnings and precautions
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine
if your period is late or if you have symptoms of pregnancy (tender breasts, morning sickness), as you may already be pregnant (see section “Pregnancy, breastfeeding and fertility”);
if you suffer from severe asthma;
if you suffer from a severe liver disease.
In all women, emergency contraception should be taken as soon as possible after unprotected sex. According to some data, this medicine may be less effective with increasing body weight or body mass index (BMI), but this data is limited and inconclusive.
Therefore, ellaOne is recommended for all women regardless of weight or BMI.
If you are concerned about problems related to taking emergency contraception, talk to a healthcare professional.
If you become pregnant despite taking the tablet, it is important that you see your doctor. See section “Pregnancy, breastfeeding and fertility” for further information.

Other contraceptives and ellaOne
The use of this medicine may temporarily reduce the effectiveness of regular hormonal contraceptives, such as pills and patches. If you are taking a hormonal contraceptive, continue to use it regularly after taking this medicine, but use a barrier method each time you have sexual intercourse until your next period.
Do not take this medicine together with another emergency contraceptive pill containing levonorgestrel. Taking the two medicines together may reduce the effectiveness of this medicine.

Other medicines and ellaOne
Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently taken any other medicines, including those obtained without a prescription or herbal medicines.
Some medicines can 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 you another type (non-hormonal) of emergency contraception, such as a copper intrauterine device (Cu-IUD):
– medicines used for the treatment of epilepsy (e.g. primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine and barbiturates)
– medicines used in the treatment of tuberculosis (e.g. rifampicin, rifabutin)
– a treatment for HIV (ritonavir, efavirenz, nevirapine)
– a medicine used to treat fungal infections (griseofulvin)
– herbal preparations containing St John's Wort ( Hypericum perforatum)
Ask your doctor or pharmacist before using ellaOne if you are using (or have recently used) any of the medicines listed above.

Pregnancy, breastfeeding 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 to make sure you are not already pregnant (see section “Warnings and precautions”).
This medicine is a contraceptive used to prevent pregnancy. 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 negatively affect the pregnancy. However, it is still important that you see your doctor. As with any pregnancy, your doctor may decide to check that the pregnancy is not outside the uterus (ectopic). This check is particularly important if you have severe abdominal pain (stomach pain) or bleeding, or if you have had an ectopic pregnancy in the past, have had surgery on your fallopian tubes, or have had a long-lasting (chronic) genital infection.
If you should become pregnant despite taking ellaOne, ask your doctor to enter the details of your pregnancy into an official registry. You can also report this information directly on www.hra-pregnancy-registry.com. Your data will remain anonymous – no one will know that the information relates to you. Sharing your data can help other women in the future to understand the safety or risks of ellaOne during pregnancy.

Breastfeeding
If you take this medicine while breastfeeding, do not breastfeed for one week after taking it. During this period it is recommended to express and discard your milk to maintain and preserve your milk production. The effects of breastfeeding in the week following taking this medicine are unknown.

Fertility
This medicine will not have any negative effects on your subsequent fertility. If you have unprotected sex after taking the tablet, the medicine will not prevent pregnancy. It is therefore important to use a barrier method until your next period.
If you wish to start or continue using a regular method of contraception after using this medicine, you can do so, but you should also use a barrier method until your next period.

Driving and operating machinery
After taking this medicine, some women report dizziness, drowsiness, blurred vision and/or difficulty concentrating (see section 4). If you experience these symptoms, do not drive or operate machinery.

ellaOne contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
ellaOne contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take ellaOne

Take this medicine following exactly what is stated in this leaflet or the instructions of your pharmacist, doctor or other healthcare professional. If you have any doubts, ask your pharmacist or doctor.
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 sexual intercourse or failure of your contraceptive method. Do not delay taking the tablet.
• The tablet can be taken at any time of your menstrual cycle.
• The tablet can be taken at any time of the day, before, during or after a meal.
• If you are taking any 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 any of these medicines in the last 4 weeks, ellaOne may be less effective for you. Consult your doctor or pharmacist before using ellaOne. Your doctor may prescribe you another type of emergency contraception (non-hormonal), namely a Cu-IUD.

In case of vomiting after taking ellaOne
If you vomit (reject) within 3 hours of taking the tablet, take another one as soon as possible.
If you have another sexual intercourse after taking ellaOne
If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent pregnancy. After taking the tablet and until your next period, you should always use a condom for each sexual intercourse.
If your next period is delayed after taking ellaOne
After taking the tablet, it is normal for your next period to be delayed by a few days.
However, if your period does not occur after more than 7 days or if the bleeding is unusually light or unusually heavy or if you experience symptoms such as abdominal pain (stomach ache), breast pain, vomiting or nausea, you may be pregnant. You should perform a pregnancy test immediately. If a pregnancy occurs, it is important that you see your doctor (see
section “Pregnancy, breastfeeding and fertility”).
If you take more ellaOne than you should
No harmful effects have been reported in case of taking a higher dose of this medicine than
recommended. However, ask for advice from your pharmacist, doctor or other healthcare professional.
If you have any questions about 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 everyone will experience them.
Some symptoms, such as breast pain and abdominal pain (stomach ache), vomiting and feeling unwell (nausea)
are also possible signs of pregnancy. If you miss a period and experience these symptoms after
taking ellaOne, you should perform a pregnancy test (see section 2 “Pregnancy, breastfeeding and
fertility”).
Common side effects (may affect up to 1 in 10 people)
­ nausea, abdominal pain (stomach ache) or discomfort, vomiting
­ painful periods, pelvic pain, breast pain
­ headache, dizziness, mood swings
­ muscle aches, back pain, fatigue
Uncommon side effects (may affect up to 1 in 100 people)
­ diarrhea, heartburn, flatulence (intestinal gas), dry mouth
­ unusual or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal
irritation or discharge, decreased or increased libido (sexual desire)
­ hot flushes
­ changes in appetite, emotional disturbances, anxiety, agitation, difficulty sleeping,
drowsiness, migraine, visual disturbances
­ flu
­ 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 sexual intercourse, rupture of ovarian cyst, unusually light
periods
­ loss of concentration, vertigo, tremors, disorientation, fainting
­ abnormal eye sensation, redness of the eyes, sensitivity to light
­ dry throat, taste disturbances
­ allergic reactions such as rash, hives or swelling of the face
­ feeling thirsty

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
pharmacist, doctor or other healthcare professional. You can also report side effects directly through
the national reporting system listed in Annex V.
By reporting side effects you can help 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 stated on the package and on the blister after
“Exp.” The expiry date refers to the last day of that month.
Store at a temperature below 25 °C. Store in the original package to protect the
medicine from humidity. Keep the blister in the outer carton to protect the medicine from light.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ellaOne contains

• The active ingredient is ulipristal acetate. Each tablet contains 30 milligrams of ulipristal acetate.
• The other ingredients are lactose monohydrate, povidone, sodium croscarmellose, magnesium stearate.

Description of the appearance of ellaOne and contents of the pack
ellaOne is a round, curved tablet of marble-white colour with a diameter of 9 mm, with “еllа”
imprinted on both sides.
ellaOne is available in a cardboard box containing a blister with 1 tablet.

Marketing Authorisation Holder
LABORATOIRE HRA PHARMA
200 avenue de Paris
92320 CHATILLON
France
E-mail: [email protected]

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 further information on this medicinal product, contact the local representative of the marketing
authorisation holder

België/Belgique/BelgienLietuva
Omega Pharma Belgium NV
Tél/Tel : +32 (0)9 381 04 30
Orivas UAB
Tel: +370 5 252 6570

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

Luxembourg/Luxemburg
Omega Pharma Belgium NV
Tél/Tel : +32 (0)9 381 04 30

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

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

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

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

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

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

Eesti
Orivas OÜ
Tel: +372 639 8845

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

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111-120

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

France
Laboratoires Omega Pharma France
Tél/Tel: + 33-(0) 1 55 48 18 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
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Κύπρος
ΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111-120

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

Latvija
Orivas SIA
Tel: +371 676 124 01

United Kingdom (Northern Ireland)
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/.

USEFUL INFORMATION ABOUT CONTRACEPTION
FURTHER INFORMATION ABOUT EMERGENCY CONTRACEPTION
The less time that passes between sexual intercourse and taking emergency contraception,
the greater the chances of avoiding pregnancy.
Emergency contraception will not have any adverse effects on your fertility.
Emergency contraception may delay ovulation within a menstrual cycle, but will not
prevent pregnancy if you have another unprotected sexual intercourse. After taking
emergency contraception and until your next menstrual period, you should always use a condom for
every sexual intercourse.

FURTHER INFORMATION ABOUT REGULAR CONTRACEPTION
If you have taken emergency contraception and do not use a regular method of contraception (or
have not found a method of contraception suitable for you), talk to your doctor or go to a family planning
clinic. There are many different types of contraceptives, and you should be able to find one that is suitable
for you. Examples of regular contraceptive methods:

Daily methods
Contraceptive pill

Weekly or monthly methods
Contraceptive patch Vaginal ring

Long-acting methods
Contraceptive implant IUD (intrauterine device).

ellaOne 30 mg film-coated tablet

Ulipristal acetate

Read this leaflet carefully before you use this medicine as 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.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your pharmacist, doctor or other healthcare professional. See section 4.

Contents of 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 sexual intercourse
or following the failure of a contraceptive method. For example:
- if you have had unprotected sexual intercourse;
- in the event that your condom or your partner's condom has broken, slipped or leaked, or if you
forgot to use it;
- if you have not taken the contraceptive pill according to the instructions.
You should take the tablet as soon as possible after sexual intercourse, and in any case within
a maximum of 5 days (120 hours).
This is because it is more effective if taken as soon as possible after unprotected sexual intercourse.
This medicine is suitable for any woman of childbearing age, including adolescents.
The tablet can be taken at any time of the menstrual cycle.
ellaOne does not work if a pregnancy is already in progress.
If your period is delayed, there is a possibility of pregnancy. If your period is delayed or if you have symptoms of pregnancy (heavy breasts, morning sickness), you should consult a
doctor or healthcare professional before taking the tablet.
If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent
pregnancy.
Unprotected sexual intercourse at any time of the cycle can cause a pregnancy.
ellaOne should not be used as a regular contraceptive
If you are not using a regular contraceptive method, talk to a doctor or healthcare professional to
choose one that is suitable for you.
How ellaOne works
ellaOne contains the substance ulipristal acetate,which works by modifying the activity of the natural hormone
progesterone, necessary for ovulation to occur. Consequently, this medicine works by
delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women
who take this medicine, a pregnancy occurs in approximately 2 cases.
This medicine is a contraceptive used to prevent a pregnancy from occurring. If you are already
pregnant, ellaOne will not terminate an existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections.
Only the use of a condom guarantees protection against sexually transmitted infections. This
medicine does not offer protection against HIV infection or other sexually transmitted diseases
(for example, Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis). If you
are concerned about this, consult a healthcare professional.
You will find further information on contraception at the end of this leaflet.

2. What you need to know before taking 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).

Warnings and precautions
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine
if your period is delayed or if you have symptoms of pregnancy (tender breasts, morning sickness), as you may already be pregnant (see section “Pregnancy, breastfeeding 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 sex. According to some data, this medicine may be less effective with increasing body weight or body mass index (BMI), but this data is limited and inconclusive.
Therefore, ellaOne is recommended for all women regardless of weight or BMI.
If you are concerned about problems related to taking emergency contraception, talk to a healthcare professional.
If you become pregnant despite taking the tablet, it is important to see your doctor. See section “Pregnancy, breastfeeding and fertility” for more information.

Other contraceptives and ellaOne
The use of this medicine may temporarily reduce the effectiveness of regular hormonal contraceptives, such as pills and patches. If you are taking a hormonal contraceptive, continue to use it regularly after taking this medicine, but use a barrier method each time you have sexual intercourse until your next period.
Do not take this medicine together with another emergency contraceptive pill containing levonorgestrel. Taking the two medicines together may reduce the effectiveness of this medicine.

Other medicines and ellaOne
Tell your pharmacist, doctor or other healthcare professional if you are taking or have recently
taken any other medicines, including those obtained without a prescription or herbal medicines.
Some medicines can 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 you another type (non-hormonal) of emergency contraception, namely a copper intrauterine device (Cu-IUD):
medicines used for the treatment of epilepsy (e.g. primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine and barbiturates)
medicines used in the treatment of tuberculosis (e.g. rifampicin, rifabutin)
treatment for HIV (ritonavir, efavirenz, nevirapine)
a medicine used to treat fungal infections (griseofulvin)
herbal preparations containing St John's Wort ( Hypericum perforatum)
Talk to your doctor or pharmacist before using ellaOne if you are using (or have recently used) any of the medicines listed above.

Pregnancy, breastfeeding and fertility

Pregnancy
Before taking this medicine, if your period is delayed, tell your pharmacist, doctor or other healthcare professional, or take a pregnancy test to make sure you are not already pregnant (see section “Warnings and precautions”).
This medicine is a contraceptive used to prevent pregnancy. 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 negatively affect the pregnancy. However, it is still important to see your doctor. As with any pregnancy, your doctor may decide to check that the pregnancy is not outside the uterus (ectopic). This check is particularly important if you have severe abdominal pain (stomach pain) or bleeding, or if you have had an ectopic pregnancy in the past, have had surgery on your tubes, or have had a long-lasting (chronic) genital infection.
If you should become pregnant despite taking ellaOne, ask your doctor to enter the details of your pregnancy into an official registry. You can also report this information directly on www.hra-pregnancy-registry.com. Your data will remain anonymous – no one will know that the information relates to you. Sharing your data can help other women in the future to understand the safety or risks of ellaOne during pregnancy.

Breastfeeding
If you take this medicine while breastfeeding, do not breastfeed for one week after taking it. During this period, it is recommended to express and discard milk to stimulate and maintain production. The effects of breastfeeding in the week following taking this medicine are unknown.

Fertility
This medicine will not have any negative effects on your subsequent fertility. If you have unprotected sex after taking this medicine, it will not prevent pregnancy. It is therefore important to use a barrier method until your next period.
If you wish to start or continue using a regular method of contraception after using this medicine, you can do so, but you should also use a barrier method until your next period.

Driving and operating machinery
After taking this medicine, some women report dizziness, drowsiness, blurred vision and/or loss of concentration (see section 4). If you experience these symptoms, do not drive or operate machinery.

ellaOne contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.
ellaOne contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take ellaOne

Take this medicine following exactly as indicated in this leaflet or the instructions of your pharmacist, doctor or other healthcare professional. If you have any doubts, ask your pharmacist or doctor.
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 sexual intercourse or failure of your contraceptive method. Do not wait to take the tablet.
- The tablet can be taken at any time of your menstrual cycle.
- The tablet can be taken at any time of the day, before, during or after a meal.
- If you are using any 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 any of these medicines in the last 4 weeks, ellaOne may be less effective for you. Consult your doctor or pharmacist before using ellaOne. Your doctor may prescribe you another type of emergency contraception (non-hormonal), namely a Cu-IUD.
If you vomit after taking ellaOne
If you vomit (reject) within 3 hours of taking the tablet, take another one as soon as possible.
If you have another sexual intercourse after taking ellaOne
If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent pregnancy. After taking the tablet and until your next menstruation, always use a condom for each sexual intercourse.
If your next menstruation is delayed after taking ellaOne
After taking the tablet, it is normal for your next menstruation to be delayed by a few days. However, if your period does not occur after more than 7 days or if the bleeding is unusually light or unusually heavy or if you experience symptoms such as abdominal pain (stomach ache), breast pain, vomiting or nausea, you may be pregnant. You should perform a pregnancy test immediately. If a pregnancy occurs it is important that you see your doctor (see section “Pregnancy, breastfeeding and fertility”).
If you take more ellaOne than you should
No harmful effects have been reported in case of taking a higher dose of this medicine than recommended. However, ask for advice from your pharmacist, doctor or other healthcare professional.
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 pain and abdominal pain (stomach ache), vomiting and feeling unwell (nausea)
are also possible signs of pregnancy. If you miss a period and experience these symptoms after
taking ellaOne, you should take a pregnancy test (see section “Pregnancy, breastfeeding and
fertility”).
Common side effects (may affect up to 1 in 10 people)
­ nausea, abdominal pain (stomach ache) or discomfort, vomiting
­ painful periods, pelvic pain, breast pain
­ headache, dizziness, mood swings
­ muscle aches, back pain, fatigue
Uncommon side effects (may affect up to 1 in 100 people)
­ diarrhoea, heartburn, flatulence (intestinal gas), dry mouth
­ unusual or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal
irritation or discharge, decreased or increased libido (sexual desire)
­ hot flushes
­ changes in appetite, emotional disturbances, anxiety, agitation, difficulty sleeping,
drowsiness, migraine, visual disturbances
­ flu
­ acne, skin lesions, itching
­ fever, chills, feeling unwell
Rare side effects (may affect up to 1 in 1,000 people)
­ genital pain or itching, pain during sexual intercourse, ovarian cyst rupture, unusually light
periods
­ loss of concentration, vertigo, tremors, disorientation, fainting
­ abnormal eye sensation, redness of the eyes, sensitivity to light
­ dry throat, taste disturbances
­ allergic reactions such as rash, hives or facial swelling
­ feeling thirsty

Reporting of side effects
If you get any side effects, talk to your pharmacist, doctor or other healthcare professional. You can also
report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help 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 stated on the box and 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 dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What ellaOne contains
The active ingredient is ulipristal acetate. Each film-coated tablet contains
30 milligrams of ulipristal acetate.
The other ingredients are:
Tablet core: lactose monohydrate, povidone, sodium croscarmellose, magnesium
stearate.
Film coating: polyvinyl alcohol (E1203), macrogol (E1521), talc (E553b), titanium
dioxide (E171), polysorbate 80 (E433), yellow iron oxide (E172), aluminium and
potassium silicate (E555).

Description of the appearance of ellaOne and contents of the pack
ellaOne is a film-coated tablet, golden in colour and shield-shaped (approximately 10.8 mm in diameter),
with “еllа” embossed on both sides.
ellaOne is available in a cardboard box containing a blister pack with 1 film-coated
tablet.

Marketing Authorisation Holder
LABORATOIRE HRA PHARMA
200 avenue de Paris
92320 CHATILLON
France
E-mail: [email protected]

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 further information on this medicinal product, contact the local representative of the marketing
authorisation holder

België/Belgique/Belgien
Omega Pharma Belgium NV

Lietuva
Orivas UAB
Tel/Tel : +32 (0)9 381 04 30 Tel: +370 5 252 6570

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

Luxembourg/Luxemburg
Omega Pharma Belgium NV
Tél/Tel : +32 (0)9 381 04 30

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

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

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

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

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

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

Eesti
Orivas OÜ
Tel: +372 639 8845

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

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111-120

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

France
Laboratoires Omega Pharma France
Tél/Tel: + 33-(0) 1 55 48 18 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
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Κύπρος
ΒΙΑΝΕΞ Α.Ε.
Τηλ: + 30 210 8009111-120

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

United Kingdom (Northern Ireland)
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu /.

Latvija
Orivas SIA
Tel: +371 676 124 01

USEFUL INFORMATION ABOUT CONTRACEPTION
FURTHER INFORMATION ABOUT EMERGENCY CONTRACEPTION
The less time that passes between sexual intercourse and taking emergency contraception,
the greater the chances of avoiding pregnancy.
Emergency contraception will not have any adverse effects on your fertility.
Emergency contraception can delay ovulation within a menstrual cycle, but will not
prevent pregnancy if you have another unprotected sexual intercourse. After taking
emergency contraception and until your next menstrual period, always use a condom for
every sexual intercourse.

FURTHER INFORMATION ABOUT REGULAR CONTRACEPTION
If you have taken emergency contraception and do not use a regular method of contraception (or
have not found a method of contraception suitable for you), talk to your doctor or go to a family
planning clinic.
There are many different types of contraceptives, and you should be able to find one that suits you.
Examples of regular contraceptive methods:

Daily methods
Contraceptive pill

Weekly or monthly methods
Contraceptive patch Vaginal ring

Long-acting methods
Contraceptive implant IUD (intrauterine device).