EU pack leaflet

Package leaflet: Information for the user

EUROPEAN UNION

ellaOne 30 mg tablet

Ulipristal acetate

ML-ELA-EU-GP-1214

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you.

–                 Keep this leaflet. You may need to read it again.

–                 Ask your pharmacist if you need more information or advice.

–                 If you get any side effects, talk to your pharmacist, doctor,  or other healthcare  professional. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.         What ellaOne is and what it is used for

2.         What you need to know before you use ellaOne

3.         How to use ellaOne

4.         Possible side effects

5.         How to store ellaOne

6.         Contents of the pack and other information

– Useful information about contraception

  1. 1.             What ellaOne is and what it is used for

ellaOne is an emergency contraceptive

ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed. For example:

  • if  you had sex without protection;
  • if your or your partner’s condom tore, slipped or came off, or if you forgot to use one;
  • if you did not take your contraceptive pill as recommended.

You should take ellaOne as soon as possible after sex, and within a maximum of 5 days (120 hours).

This is because the sperm can survive up to 5 days in your body after intercourse.

ellaOne is suitable for any woman of childbearing age, including adolescents.

You can take ellaOne 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 ellaOne.

If you have unprotected sex after taking ellaOne, 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, ellaOne works by postponing ovulation. Emergency contraception is not effective in every case. Of 100 women who take ellaOne approximately 2 will become pregnant.

ellaOne is a contraceptive used to prevent a pregnancy from starting. If you are already pregnant, itwill not interrupt an existing pregnancy.

Emergency contraception does not protect against sexually transmitted infections

Only condoms can protect you from sexually transmitted infections. ellaOne 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.

  1. 2.             What you need to know before you use ellaOne

Do not take ellaOne

  • If you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).

Warning and precautions

Talk to your pharmacist, doctor or other healthcare professional before taking ellaOne

  • 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 ellaOne 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 ellaOne, it is important that you see your doctor. See section “Pregnancy, breast-feeding and fertility” for more information.

Other contraceptives and ellaOne

ellaOne 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 ellaOne, but be sure to use condoms every time you have sex until your next period.

Do not use ellaOne together with another emergency contraceptive pill that contains levonorgestrel. By taking them both together, you might make ellaOne less effective.

Other medicines and ellaOne

Tell your pharmacist, doctor or other healthcare professional if you are taking, have recently taken or might take any other medicines.

This is especially important if you are taking any of the medicines listed below since they make ellaOne work less well:

  • Phenytoin, fosphenytoine, phenobarbital, primidone, carbamazepine, oxcarbazepine (used  to treat epilepsy)
  • Ritonavir, efavirenz, nevirapine (used to treat HIV infection)
  • Rifampicin, rifabutin (used to treat tuberculosis)
  • St John’s wort (Hypericum perforatum) or herbal medicines that contain it (used for depression or anxiety).

Pregnancy, breast-feeding and fertility

Pregnancy

Before taking ellaOne, 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”).

ellaOne 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 ellaOne, there is no evidence that ellaOne 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 ellaOne while you are
breastfeeding a baby, do not breast-feed for one week after taking ellaOne. 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 breastfeeding your baby in the week after taking ellaOne is not known.

Fertility

ellaOne will not affect your future fertility. If you have unprotected sex after taking ellaOne, 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 ellaOne, you can do so but you should also use condoms until your next period.

Driving and using machines

After taking ellaOne, some women experience dizziness, drowsiness, blurred vision and/or loss of concentration (see section 4 “Possible side effects”). If you experience these symptoms, do not drive or use machines

ellaOne contains lactose

If you have been told by your doctor or other healthcare professional that you have an intolerance to some sugars, tell your pharmacist before taking this medicine.

  1. 3.             How to use ellaOne

Always use 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 ellaOne at any time in your cycle.
  • You can take ellaOne at any time of the day either before, during or after a meal.

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 ellaOne, it will not stop you from becoming pregnant. After you take ellaOne 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 ellaOne, 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.

  1. 4.               Possible side effects

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

Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting), feeling sick (nausea) are also possible signs of pregnancy. If you miss your period and experience such symptoms after taking ellaOne, you should do a pregnancy test (See section “Pregnancy, breast-feeding and fertility”).

Common side effects (these 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 (these 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 (these may affect up to 1 in 1,000 people)

  • genital pain or itching, pain during sex, rupture of an ovarian cyst, unusually light period
  • loss of concentration, vertigo, shaking, disorientation, fainting
  • unusual sensation in eye, red eye, sensitivity to light
  • dry throat, disturbance in taste
  • hives (itchy rash), feeling thirsty

Reporting of side effects

If you get any side effects, talk to your pharmacist, doctor or other healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V – Adverse-drug-reaction reporting details available on the website of the European Medicines Agency (EMA):

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59.

By reporting side effects you can provide more information on the safety of this medicine.

5.       How to store ellaOne

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is on the carton and on the blister after marked EXP. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original packaging to protect from moisture. Keep the blister in the outer carton to protect from light.

Do not throw away any medicines via waste water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.       Contents of the pack and other information

What ellaOne contains

  • The active substance is ulipristal acetate. One tablet contains 30 milligrams of ulipristal acetate.
  • The other ingredients are lactose, povidone K30, croscarmellose sodium, magnesium stearate.

What ellaOne looks like and contents of the pack

ellaOne is a white to off-white, round curved tablet engraved with code “еllа” on both faces.

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

Marketing Authorisation Holder

Laboratoire HRA Pharma

15, rue Béranger

F-75003 Paris

France

E-mail: info-ella@hra-pharma.com

Manufacturer

Cenexi

17, rue de Pontoise

95520 Osny

France

or

León Farma SA

Pol. Ind. Navatejera

La Vallina s/n, Navatejera

24008 León, Spain

or

Delpharm Lille S.A.S.

Z.I. de Roubaix-Est

Rue de Toufflers

59390 Lys-Lez-Lannoy

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder

 

België/Belgique/Belgien

Laboratoire HRA Pharma

Tél/Tel: + 33-(0)1 40 33 11 30
Lietuva

Takeda UAB

Tel: + 370-(0)5 210 90 70
България

Pharma Bulgaria

Teл.: +   359 800 12 400
Luxembourg/Luxemburg

Laboratoire HRA Pharma                              

Tél/Tel: + 33-(0)1 40 33 11 30
Česká republika

Akacia   Group, s.r.o.

Tel: + 420-(0)220 610 491
Magyarország

Aramis   Pharma Kft.

Tel.: + 36-(0)1 219 0775
Danmark

Takeda Pharma A/S

Tlf: + 45-(0)46 77 11 11
Malta

Laboratoire HRA Pharma

Tel: +   33-(0)1 40 33 11 30
Deutschland

HRA Pharma Deutschland

GmbHTel: +   49-(0)234 516 592-0
Nederland

WeCare Pharmaceuticals B.V.

Tel: +31 (0) 75 612 05 11
Eesti

Takeda SEFA AS

Tel: + 372-(0)6177 669
Norge

Takeda Nycomed AS

Tlf: + 47-(0) 6676 3030
Ελλάδα

ΑΡΡΙΑΝΙ   ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ

Τηλ: + 30-(0)210   66 83 000
Österreich

Sanova Pharma GesmbH

Tel: + 43-(0)1   801 040
España

HRA Pharma Iberia

S.L.Tel: +   34-(0)902 107 428
Polska

D Pharma Poland Sp. z o. o.

Tel: + 48-(0)22 570 27 00
France

HRA Pharma France

Tél/Tel: + 33-(0) 1 53 24 81 00
Portugal

HRA Pharma   Iberia S.L.sucursal em Portugal

Tel: +351 707 501 996 
Hrvatska

Arenda d.o.o.

Tel: + 385-(0)1   644 44 80
România

D Pharma Romania

Tel: + 40-(0)372 072 219
Ireland

HRA Pharma UK & Ireland Limited

Tel: 1800   812 984
Slovenija

Dr.Gorkič d.o.o.

Tel: +   386-(0)1 7590 251
Ísland

Laboratoire HRA Pharma

Sími:   + 33-(0)1 40 33 11 30
Slovenská republika

Liek, s.r.o.

Tel: + 421-(0)905 667 410 
Italia

HRA Pharma Italia srl, società unipersonale

Tel: + 39-(0)   06 541 44 60
Suomi/Finland

Takeda Oy

Puh/Tel:   + 358-(0)20 746 50 00
Κύπρος

ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ

ΑΕΤηλ: + 30-(0) 210 66 83 000
Sverige

Takeda Pharma

ABTel: + 46-(0)8   731 28 00
Latvija

Takeda Latvia SIA

Tel: +   371-(0)67840082
United Kingdom

HRA Pharma UK & Ireland Limited

Tel:   0800 917 9548

This leaflet was last revised in January 2015

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 methodsContraceptive pill
Weekly or monthly methods
    Contraceptive patch     Vaginal Ring
Long lasting methods
    Contraceptive implant     IUD (intrauterine device)