Ulipristal acetate: package leaflet

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 it is more effective if you take it as soon as possible after unprotected sex.

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.

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 that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

ellaOne contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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.

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 ­ allergic reactions such as rash, hives or swelling of the face ­ 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.

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.

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

What ellaOne looks like and contents of the pack ellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.

ellaOne is available in a carton containing one blister of 1 tablet.

Marketing Authorisation Holder
LABORATOIRE HRA PHARMA
200 avenue de Paris
92320 CHATILLON
France

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
Perrigo Belgium NV
+32 (0)9 381 04 30
Lietuva
Perrigo Poland Sp. z o.o.
Tel: +371 660 916 05
България
Perrigo Bulgaria OOD
Tel: +359 2805 7108
Luxembourg/Luxemburg
Perrigo Belgium NV
+32 (0)9 381 04 30
Česká republika
Omega Pharma a.s.
Tel : +420 603 407 623
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
Perrigo Deutschland GmbH
+49 7032 9154 200

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

Eesti
Perrigo Poland Sp. z o.o.
Tel: +371 660 916 05
Norge
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Ελλάδα
Perrigo Hellas A.E.
Τηλ: +30 2108188900

Österreich
Perrigo Deutschland GmbH
+49 7032 9154 200
España
Perrigo España, S.A.
Tel: +34 902 889 010
Polska
Perrigo Poland Sp. z o.o.
Tel: +48 (22) 852 55 51

France
Laboratoire Perrigo France
Tél/Tel: + 33-(0) 1 55 48 18 00

Portugal
Perrigo Portugal Lda.
Tel: +351 214 167 610

Hrvatska
Makpharm d.o.o.
Tel: + 385-(0)1 4678 688

România
Perrigo Romania S.R.L.
Tel: +40 213 150 344
Ireland
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30

Slovenija
Perrigo Bulgaria OOD
Tel: +386 1 23 22 095

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

Slovenská republika
Omega Pharma a.s.
Tel : +420 603 407 623
Italia
Perrigo Italia S.r.l
Tel: + 39 06 90250333

Suomi/Finland
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741741

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

Latvija
Perrigo Poland Sp. z o.o.
Tel: +371 660 916 05

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)

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 it is more effective if you take it as soon as possible after unprotected sex.

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.

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 that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

ellaOne contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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.

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 ­ allergic reactions such as rash, hives or swelling of the face ­ 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.

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.

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
200 avenue de Paris
92320 CHATILLON
France

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
Perrigo Belgium NV
+32 (0)9 381 04 30
Lietuva
Perrigo Poland Sp. z o.o.
Tel: +371 660 916 05

България
Perrigo Bulgaria OOD
Tel: +359 2805 7108

Luxembourg/Luxemburg
Perrigo Belgium NV
+32 (0)9 381 04 30
Česká republika
Omega Pharma a.s.
Tel: +420 603 407 623
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
Perrigo Deutschland GmbH
+49 7032 9154 200

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

Eesti
Perrigo Poland Sp. z o.o.
Tel: +371 660 916 05
Norge
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Ελλάδα
Perrigo Hellas A.E.
Τηλ: +30 2108188900

Österreich
Perrigo Deutschland GmbH
+49 7032 9154 20
España
Perrigo España, S.A.
Tel: +34 902 889 010
Polska
Perrigo Poland Sp. z o.o.
Tel: +48 (22) 852 55 51

France
Laboratoire Perrigo France
Tél/Tel: + 33-(0) 1 55 48 18 00

Portugal
Perrigo Portugal Lda.
Tel: +351 214 167 610

Hrvatska
Makpharm d.o.o.
Tel: + 385-(0)1 4678 688

România
Perrigo Romania S.R.L.
Tel: +40 213 150 344
Ireland
Laboratoire HRA Pharma
Tel: + 33-(0)1 40 33 11 30

Slovenija
Perrigo Bulgaria OOD
Tel: +386 1 23 22 095
Ísland
Laboratoire HRA Pharma
Sími: + 33-(0)1 40 33 11 30

Slovenská republika
Omega Pharma a.s.
Tel : +420 603 407 623
Italia
Perrigo Italia S.r.l
Tel: + 39 06 90250333

Suomi/Finland
Perrigo Sverige AB
Tel: +46 8 59 00 29 00

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741741

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

Latvija
Perrigo Poland Sp. z o.o.
Tel: +371 660 916 05

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)