EllaOne: detailed information

Package leaflet: Information for the user

ellaOne 30 mg tablet

Ulipristal acetate
Please read all of this leaflet carefully before you use 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 advised you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, contact your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your pharmacist, doctor or other healthcare professional. See section 4.

Contents of this leaflet:

What ellaOne is and what it is used for
What you need to know before taking 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 sexual intercourse
or following failure of a contraceptive method. For example:
- if you had unprotected sexual intercourse;
- if you or your partner’s condom broke, slipped, came off, or was not used;
- if you missed taking your contraceptive pill as instructed.
You must take the tablet as soon as possible after intercourse, and no later than
5 days (120 hours).
This is because it is more effective the sooner it is taken after unprotected sexual intercourse.
This medicine is suitable for any woman of reproductive age, including adolescents.
The tablet can be taken at any time during the menstrual cycle.
ellaOne does not work if pregnancy is already established
If your period is late, there is a possibility of pregnancy. If your period is delayed or if you have symptoms of pregnancy (breast tenderness, morning nausea), 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 during the cycle can result in pregnancy.
ellaOne must not be used as a regular contraceptive
If you are not using a regular contraceptive method, speak to a doctor or healthcare professional to choose one that is suitable for you.
How ellaOne works
ellaOne contains the active substance ulipristal acetate, which works by altering the activity of the natural hormone progesterone, required for ovulation to occur. As a result, this medicine acts by delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women who take this medicine, approximately 2 will become pregnant.
This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, ellaOne will not terminate the existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections.
Only the use of a condom provides protection against sexually transmitted infections. This
medicine does not protect against HIV infection or other sexually transmitted diseases
(for example, Chlamydia, genital Herpes, genital warts, gonorrhoea, hepatitis B and syphilis). If you are concerned about this, consult a healthcare professional.
At the end of this leaflet you will find further information on contraception.

2. What you need to know before taking ellaOne

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

Warnings and precautions
Talk to your pharmacist, doctor, or another healthcare provider before taking this medicine
if your menstrual period is late or if you have symptoms of pregnancy (heavy breasts, morning
nausea), as you may already be pregnant (see section “Pregnancy, breastfeeding and fertility”);
if you have severe asthma;
if you have severe liver disease.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. According to some data, this medicine may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive. Therefore, ellaOne is recommended for all women regardless of weight or BMI.
If you are concerned about potential problems related to taking emergency contraception, speak with a healthcare provider.
If pregnancy occurs despite taking the tablet, it is important that you consult your doctor. See section “Pregnancy, breastfeeding and fertility” for further information.

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

Other medicines and ellaOne
Tell your pharmacist, doctor, or another healthcare provider if you are taking or have recently taken any other medicines, including those obtained without a prescription or herbal medicines.
Some medicines may prevent ellaOne from working effectively. If you have taken any of the medicines listed below during the past 4 weeks, ellaOne may be less suitable for you. Your doctor may prescribe another type (non-hormonal) of emergency contraception, namely a copper intrauterine device (Cu-IUD):
medicines used to treat epilepsy (e.g. primidone, phenobarbital, phenytoin,
fosphenytoin, carbamazepine, oxcarbazepine, and barbiturates)
medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
HIV treatment (ritonavir, efavirenz, nevirapine)
a medicine used to treat fungal infections (griseofulvin)
herbal preparations containing St John’s wort (Hypericum perforatum)

Please consult your doctor or pharmacist before using ellaOne if you are currently taking (or have recently taken) any of the medicines listed above.

Pregnancy, breastfeeding and fertility
Pregnancy
Before taking this medicine, if your period is late, inform your pharmacist, doctor, or another healthcare provider, or perform 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 from occurring. If you are already pregnant, it will not terminate the existing pregnancy.
If pregnancy occurs despite taking this medicine, there is no evidence that it negatively affects the pregnancy. However, it is important that you consult your doctor. As with any pregnancy, your doctor may decide to check that the pregnancy is not ectopic (occurring outside the uterus). This check is particularly important if you experience severe abdominal pain (stomach ache) or bleeding, or if you have previously had an ectopic pregnancy, undergone tubal surgery, or had a long-term (chronic) genital infection.
If you become pregnant despite taking ellaOne, please ask your doctor to report your pregnancy to an official registry. You may also report this information directly at www.hra-pregnancy-registry.com. Your data will remain anonymous – no one will know the information refers to you. Sharing your data may help other women in the future 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, you are advised to express milk to maintain milk production, but discard it. The effects of breastfeeding during the week following intake of this medicine are unknown.

Fertility
This medicine will not have negative effects on your future fertility. If you have unprotected sexual intercourse after taking the tablet, the medicine will not prevent pregnancy. It is therefore important to use a condom until your next menstrual period.
If you wish to start or continue using a regular contraceptive method after using this medicine, you may do so, but you must also use a condom until your next menstrual period.

Driving and using machines
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 and do not operate machinery.

ellaOne contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 exactly as described in this leaflet, or as directed by your pharmacist, doctor, or other healthcare professional. If you have any doubts, consult your pharmacist or doctor.

How to take the ellaOne tablet

Take one tablet orally as soon as possible, and in any case within and no later than 5 days (120 hours) after unprotected sexual intercourse or contraceptive failure. Do not delay taking the tablet.
The tablet may be taken at any time during the menstrual cycle.
The tablet may be taken at any time of day, before, during, or after a meal.
If you are taking any medicines that may reduce the effectiveness of ellaOne (see section 2 “What you need to know before taking ellaOne”), or if you have taken any of these medicines within the last 4 weeks, ellaOne may be less effective for you. Consult your doctor or pharmacist before using ellaOne. Your doctor may prescribe another type of emergency contraception (non-hormonal), such as a copper intrauterine device (Cu-IUD).

If you vomit after taking ellaOne
If you vomit within 3 hours after taking the tablet, take another tablet as soon as possible.

If you have 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 menstrual period, you must always use a condom for every sexual intercourse.

If your next menstrual period is delayed after taking ellaOne
It is normal for your next menstrual period to be delayed by a few days after taking the tablet. However, if your period is more than 7 days late, or if the bleeding is unusually light or unusually heavy, or if you experience symptoms such as abdominal pain, breast tenderness, vomiting, or nausea, you may be pregnant. You should immediately perform a pregnancy test. If 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 following an overdose of this medicine. Nevertheless, consult your pharmacist, doctor, or other healthcare professional for advice.

If you have any further questions about the use of this medicine, consult your pharmacist, doctor, or other healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some symptoms, such as breast pain and abdominal pain, vomiting and feeling unwell (nausea), may
also be possible signs of pregnancy. If you miss a period and experience these symptoms after taking
ellaOne, you should carry out a pregnancy test (see section 2 “Pregnancy, breast-feeding 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 pain, 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 or prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido (sex drive)
hot flushes
changes in appetite, emotional disturbances, anxiety, restlessness, difficulty sleeping, drowsiness, migraine, visual disturbances
influenza-like symptoms
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
difficulty concentrating, vertigo, tremors, disorientation, fainting
abnormal sensation in the eye, redness of the eyes, light sensitivity
dry throat, taste disturbances
allergic reactions such as skin rash, hives or swelling of the face
feeling thirsty

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your pharmacist, doctor or another healthcare professional. You can also report side effects directly via 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 carton and on the blister after
"Exp." The expiry date refers to the last day of that month.
Store below 25 °C. Keep in the original packaging to protect the medicine from moisture. Keep the blister in the outer carton to protect the medicine from light.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ellaOne contains

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

Description of the appearance of ellaOne and contents of the pack
ellaOne is a round, convex, white marbled tablet 9 mm in diameter, with “еllа”
imprinted on both sides.
ellaOne is available in a cardboard box containing a blister pack 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

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

България Luxembourg/Luxemburg
MagnaPharm Bulgaria EAD. Omega Pharma Belgium NV
Teл.: + 359 800 12 400 Tél/Tel : +32 (0)9 381 04 30

Česká republika Magyarország
Akacia Group, s.r.o. Zentiva Pharma Kft.
Tel: + 420-(0)220 610 491 Tel.: + 36 1 299 1058

Danmark Malta
Perrigo Sverige AB Laboratoire HRA Pharma
Tel: +46 8 59 00 29 00 Tel: + 33-(0)1 40 33 11 30

Deutschland Nederland
HRA Pharma Deutschland GmbH Omega Pharma Nederland BV
Tel: + 49-(0) 611 890777-0 Tel: +31 (0) 10 2211007

Eesti Norge
Orivas OÜ Perrigo Sverige AB
Tel: +372 639 8845 Tel: +46 8 59 00 29 00

Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. HRA Pharma Deutschland GmbH
Τηλ: + 30 210 8009111-120 Tel: + 49-(0) 611 890777-0

España Polska
HRA Pharma Iberia S.L. MagnaPharm Poland Sp. z o. o.
Tel: + 34-(0)902 107 428 Tel: + 48 (22) 570 27 00

France Portugal
Laboratoires Omega Pharma France HRA Pharma Iberia S.L.
Tél/Tel: + 33-(0) 1 55 48 18 00 sucursal em Portugal
Tel: +351 707 501 996

Hrvatska România
Arenda d.o.o. MagnaPharm Marketing & Sales Romania S.R.L.
Tel: + 385-(0)1 644 44 80 Tel: + 40 372 502 221

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

Ísland Slovenská republika
Laboratoire HRA Pharma Liek, s.r.o.
Sími: + 33-(0)1 40 33 11 30 Tel: + 421-(0)905 667 410

Italia Suomi/Finland
HRA Pharma Italia srl, società unipersonale Perrigo Sverige AB
Tel: + 39 06 59 60 09 87 Tel: +46 8 59 00 29 00

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

Latvija United Kingdom (Northern Ireland)
Orivas SIA Laboratoire HRA Pharma
Tel: +371 676 124 01 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 ON CONTRACEPTION

ADDITIONAL INFORMATION ON EMERGENCY CONTRACEPTION
The shorter the time between sexual intercourse and taking emergency contraception, the greater the chance of avoiding pregnancy.
Emergency contraception will not have any negative effects on your fertility.
Emergency contraception may delay ovulation within a menstrual cycle, but it will not prevent pregnancy if you have another unprotected sexual intercourse. After taking emergency contraception and until your next menstrual period, you must always use a condom for every sexual intercourse.

ADDITIONAL INFORMATION ON REGULAR CONTRACEPTION
If you have taken emergency contraception and you do not use a regular contraceptive method (or have not found a contraceptive method suitable for you), speak to your doctor or visit 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
Oral contraceptive pill

Weekly or monthly methods
Contraceptive patch Vaginal ring

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

Package leaflet: Information for the user

ellaOne 30 mg film-coated tablet

Ulipristal acetate
Please read this entire 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 instructed you.

Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If you experience any adverse reactions, including those not listed in this leaflet, contact your pharmacist, doctor, or other healthcare professional. See section 4.

Contents of this leaflet:

What ellaOne is and what it is used for
What you need to know before taking 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

How ellaOne works
ellaOne contains the active substance ulipristal acetate, which works by altering the activity of the natural hormone progesterone, necessary for ovulation to occur. As a result, this medicine acts by delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women who take this medicine, approximately 2 will become pregnant.
This medicine is a contraceptive used to prevent a pregnancy from occurring. If you are already pregnant, ellaOne will not terminate the existing pregnancy.
Emergency contraception does not protect against sexually transmitted infections.
Only the use of a condom provides protection against sexually transmitted infections. This medicine does not protect against HIV infection or other sexually transmitted diseases (for example, Chlamydia, genital Herpes, genital warts, gonorrhoea, hepatitis B and syphilis). If you are concerned about this, consult a healthcare professional.
Further information about contraception can be found 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 to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your pharmacist, doctor or another healthcare professional before taking this medicine
if your period is late or if you have symptoms of pregnancy (heavy breasts, morning nausea), 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.

If you are concerned about potential problems related to taking emergency contraception, speak with a healthcare professional.
If you become pregnant despite taking the tablet, it is important that you see a doctor. See section “Pregnancy, breastfeeding and fertility” for further information.

Other contraceptives and ellaOne
Taking this medicine may temporarily reduce the effectiveness of regular hormonal contraceptives, such as pills and patches. If you are taking a hormonal contraceptive, continue using it regularly after taking this medicine, but use a condom every time you have sexual intercourse until your next period.

Do not take this medicine together with another emergency contraceptive pill containing levonorgestrel. Taking both medicines together could reduce the effectiveness of this medicine.

Other medicines and ellaOne
Tell your pharmacist, doctor or another healthcare professional if you are taking or have recently taken any other medicines, including those obtained without a prescription or herbal medicines.

Some medicines may prevent ellaOne from working effectively. If you have taken any of the medicines listed below during the past 4 weeks, ellaOne may be less suitable for you. Your doctor may prescribe another type (non-hormonal) of emergency contraception, namely a copper intrauterine device (Cu-IUD):
medicines used to treat epilepsy (e.g. primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine and barbiturates)
medicines used to treat 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 currently taking (or have recently taken) any of the medicines listed above.

Pregnancy, breastfeeding and fertility

Pregnancy
Before taking this medicine, if your period is late, inform your pharmacist, doctor or another healthcare professional, or perform 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 from occurring. If you are already pregnant, it will not terminate the existing pregnancy.

If you become pregnant despite taking this medicine, there is no evidence that it negatively affects the pregnancy. However, it is important that you see a doctor. As with any pregnancy, your doctor may decide to check that the pregnancy is not ectopic (outside the uterus). This check is particularly important if you experience severe abdominal pain or bleeding, or if you have previously had an ectopic pregnancy, tubal surgery, or a long-term (chronic) genital infection.

If you become pregnant despite taking ellaOne, please ask your doctor to enter your pregnancy data into an official registry. You may also report this information directly at www.hra-pregnancy-registry.com. Your data will remain anonymous – no one will know the information refers to you. Sharing your data may help other women in the future 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, you are advised to express milk to maintain milk production, but discard the milk. The effects of breastfeeding during the week following intake of this medicine are unknown.

Fertility
This medicine will not have negative effects on your future fertility. If you have unprotected sexual intercourse after taking this medicine, it will not prevent pregnancy. It is therefore important to use a condom until your next period.

If you wish to start or continue using a regular contraceptive method after using this medicine, you may do so, but you must also use a condom until your next period.

Driving and use of machines
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 and do not operate machinery.

ellaOne contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 exactly as described in this leaflet or as directed by your pharmacist, doctor, or other healthcare professional. If you have any doubts, consult your pharmacist or doctor.

How to take the ellaOne film-coated tablet

Take one tablet orally as soon as possible, and in any case within and no later than 5 days (120 hours) after unprotected sexual intercourse or contraceptive failure. Do not delay taking the tablet.
The tablet can be taken at any time during the 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 taking ellaOne”), or if you have taken any of these medicines within 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), such as a Cu-IUD.

In case of vomiting after taking ellaOne

If you vomit (regurgitate) within 3 hours after taking the tablet, take another tablet 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 menstrual period, you must always use a condom for every sexual intercourse.

If your next menstrual period is delayed after taking ellaOne

It is normal for your next menstrual period to be delayed by a few days after taking the tablet. However, if your period is more than 7 days late, or if bleeding is unusually light or unusually heavy, or if you experience symptoms such as abdominal pain, breast tenderness, vomiting, or nausea, you may be pregnant. You should perform a pregnancy test immediately. If pregnancy occurs, it is important that you see a doctor (see section “Pregnancy, breastfeeding and fertility”).

If you take more ellaOne than you should

No harmful effects have been reported with taking a higher dose of this medicine than recommended. Nevertheless, consult your pharmacist, doctor, or other healthcare professional for advice.

If you have any doubts about how to use this medicine, consult your pharmacist, doctor, or other healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Some symptoms, such as breast pain and abdominal pain (stomach ache), vomiting and feeling unwell (nausea), may also be possible signs of pregnancy. If you miss a period and experience these symptoms after taking ellaOne, you should carry out a pregnancy test (see section “Pregnancy, breast-feeding 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 pain, back pain, tiredness

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

diarrhoea, heartburn, flatulence (intestinal gas), dry mouth
unusual or irregular vaginal bleeding, heavy or prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido (sex drive)
hot flushes
changes in appetite, emotional disturbances, anxiety, restlessness, difficulty sleeping, drowsiness, migraine, visual disturbances
flu-like symptoms
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
difficulty concentrating, vertigo, tremors, disorientation, fainting
abnormal sensation in the eyes, redness of the eyes, light sensitivity
dry throat, taste disturbances
allergic reactions such as skin rash, hives or facial swelling
feeling thirsty

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please consult your pharmacist, doctor or other healthcare professional. You can also report side effects directly via 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 stated on the carton 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 medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ellaOne contains
The active substance is ulipristal acetate. Each film-coated tablet contains
30 milligrams of ulipristal acetate.
The other components 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 golden, shield-shaped film-coated tablet (approximately 10.8 mm in diameter),
with "еllа" engraved on both sides.
ellaOne is available in a cardboard box containing a blister pack with 1 film-coated tablet.
Marketing Authorization 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, please contact the local representative of the Marketing Authorization Holder
België/Belgique/Belgien Lietuva
Omega Pharma Belgium NV Orivas UAB
Tél/Tel : +32 (0)9 381 04 30 Tel: +370 5 252 6570
България Luxembourg/Luxemburg
MagnaPharm Bulgaria EAD. Omega Pharma Belgium NV
Teл.: + 359 800 12 400 Tél/Tel : +32 (0)9 381 04 30
Česká republika Magyarország
Akacia Group, s.r.o. Zentiva Pharma Kft.
Tel: + 420-(0)220 610 491 Tel.: + 36 1 299 1058
Danmark Malta
Perrigo Sverige AB Laboratoire HRA Pharma
Tel: +46 8 59 00 29 00 Tel: + 33-(0)1 40 33 11 30
Deutschland Nederland
HRA Pharma Deutschland GmbH Omega Pharma Nederland BV
Tel: + 49-(0) 611 890777-0 Tel: +31 (0) 10 2211007
Eesti Norge
Orivas OÜ Perrigo Sverige AB
Tel: +372 639 8845 Tel: +46 8 59 00 29 00
Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. HRA Pharma Deutschland GmbH
Τηλ: + 30 210 8009111-120 Tel: + 49-(0) 611 890777-0
España Polska
HRA Pharma Iberia S.L. MagnaPharm Poland Sp. z o. o.
Tel: + 34-(0)902 107 428 Tel: + 48 (22) 570 27 00
France Portugal
Laboratoires Omega Pharma France HRA Pharma Iberia S.L.
Tél/Tel: + 33-(0) 1 55 48 18 00 sucursal em Portugal
Tel: +351 707 501 996
Hrvatska România
Arenda d.o.o. MagnaPharm Marketing & Sales Romania S.R.L.
Tel: + 385-(0)1 644 44 80 Tel: + 40 372 502 221
Ireland Slovenija
Laboratoire HRA Pharma Dr. Gorkič d.o.o.
Tel: + 33-(0)1 40 33 11 30 Tel: + 386-(0)1 7590 251
Ísland Slovenská republika
Laboratoire HRA Pharma Liek, s.r.o.
Sími: + 33-(0)1 40 33 11 30 Tel: + 421-(0)905 667 410
Italia Suomi/Finland
HRA Pharma Italia srl, società unipersonale Perrigo Sverige AB
Tel: + 39 06 59 60 09 87 Tel: +46 8 59 00 29 00
Κύπρος Sverige
ΒΙΑΝΕΞ Α.Ε. Perrigo Sverige AB
Τηλ: + 30 210 8009111-120 Tel: +46 8 59 00 29 00
Latvija United Kingdom (Northern Ireland)
Orivas SIA Laboratoire HRA Pharma
Tel: +371 676 124 01 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 ON CONTRACEPTION
ADDITIONAL INFORMATION ON EMERGENCY CONTRACEPTION
The shorter the time between sexual intercourse and taking emergency contraception,
the greater the likelihood of avoiding pregnancy.
Emergency contraception will not have any negative effects on your fertility.
Emergency contraception may delay ovulation within a menstrual cycle, but it will not
prevent pregnancy if you have another unprotected sexual intercourse. After taking
emergency contraception and until your next menstrual period, you must always use a condom for every sexual intercourse.
ADDITIONAL INFORMATION ON REGULAR CONTRACEPTION
If you have taken emergency contraception and do not use a regular contraceptive method (or have not found a contraceptive method suitable for you), speak with your doctor or visit a clinic.
There are many different types of contraceptives available, and you should be able to find one that suits you.
Examples of regular contraceptive methods:
Daily methods
Oral contraceptive pill
Weekly or monthly methods
Contraceptive patch Vaginal ring
Long-acting methods
Contraceptive implant IUD (intrauterine device)