ELLAONE 30MG TBL

ATC code: Eiropas c 

Active substances: Ulipristalum

Vendor, principal: Laboratoire Hra Pharma. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ELLAONE 30MG

Package leaflet: Information for the user

ellaOne 30 mg tablet

Ulipristal acetate

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

Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your pharmacist, doctor, or other healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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. 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, 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. 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.

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.

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.

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, breastfeeding 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 www.ravimiamet.ee . 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 marble creamy, round curved tablet engraved with code “ella” on both faces. ellaOne is available in carton containing one blister of 1 tablet.

Marketing Authorisation Holder

Laboratoire HRA Pharma 15, rue Beranger F-75003 Paris France
E-mail: [email protected]

Manufacturer

Cenexi

17, rue de Pontoise 95520 Osny France or

Leon Farma SA

Pol. Ind. Navatejera La Vallina s/n, Navatejera 24008 Leon, Spain
or

Delpharm Lille S.A.S.

Parc d’activites Roubaix-Est 22, rue de Toufflers CS 50070
59452 Lys-Lez-Lannoy France

contact the local representative of the Marketing

Lietuva
Takeda UAB
Tel: + 370-(0)5 210 90 70
Luxembourg/Luxemburg
HRA Pharma Benelux Tel/Tel: +32 2 709 2295
Magyarorszag Aramis Pharma Kft.
Tel.: + 36-(0) 1 219 0775

For any information about this medicine, please Authorisation Holder

Belgie/Belgique/Belgien

HRA Pharma Benelux Tel/Tel: +32 2 709 2295

Etarapun

A&D Pharma Bulgaria Tea.: + 359 800 12 400

Česka republika

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

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 GmbH Tel: + 49-(0)234 516 592-0	Nederland HRA Pharma Benelux Tel: +32 2 709 2295
Eesti Takeda SEFA AS Tel: + 372-(0)6177 669	Norge Takeda Nycomed AS Tlf: + 47-(0) 6676 3030
EXldda APPIANI OAPMAKEYTIKH AE Tņk: + 30-(0)210 66 83 000	Österreich Sanova Pharma GesmbH Tel: + 43-(0)1 801 040
Espana HRA Pharma Iberia S.L. Tel: + 34-(0)902 107 428	Polska A&D Pharma Poland Sp. z o. o. Tel: + 48-(0)22 570 27 00
France HRA Pharma France Tel/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	Romania A&D Pharma Romania Tel: + 40-(0)372 072 219
Ireland HRA Pharma UK & Ireland Limited Tel: 1800 812 984	Slovenija Dr. Gorkič d.o.o. Tel: + 386-(0)1 7590 251
^sland Laboratoire HRA Pharma Simi: + 33-(0)1 40 33 11 30	Slovenska republika Liek, s.r.o. Tel: + 421-(0)905 667 410
Italia HRA Pharma Italia srl, societa unipersonale Tel: + 39 06 59 60 09 87	Suomi/Finland Takeda Oy Puh/Tel: + 358-(0)20 746 50 00
Khnpoq APPIANI OAPMAKEYTIKH AE TpA.: + 30-(0) 210 66 83 000	Sverige Takeda Pharma AB Tel: + 46-(0)8 731 28 00
Latvija Takeda Latvia SIA Tel: + 371-(0)67840082 This leaflet was last revised in	United Kingdom HRA Pharma UK & Ireland Limited Tel: 0800 917 9548

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)