ellaOne - patient leaflet, side effects, dosage

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 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, itwill 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.

2. What you need to know before you take 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 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 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’.

3. How to take ellaOne

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.

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 2 “Pregnancy, breastfeeding 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

• – 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. 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 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.

6. Contents of the pack and other information

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

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 “ella ” 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

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

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

Authorisation Holder

België/Belgiqu­e/Belgien

HRA Pharma Benelux

Tél/Tel: +32 2 709 2295

Etnrapuu

MagnaPharm Bulgaria EAD.

Ten.: + 359 800 12 400

Česká republika

Akacia Group, s.r.o.

Tel: + 420-(0)220 610 491

Danmark

Midsona Danmark A/S

Tlf: + 45 98 54 22 88

Deutschland

HRA Pharma Deutschland GmbH

Tel: + 49-(0) 611 890777–0

Norge

Midsona Norge AS

Tlf: + 47 24 11 01 00

Österreich

HRA Pharma Deutschland GmbH

Tel: + 49-(0) 611 890777–0

Polska

MagnaPharm Poland Sp. z o. o.

Tel: + 34-(0)902 107 428	Tel: + 48 (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	România MagnaPharm Marketing & Sales Romania S.R.L. Tel: + 40 372 502 221
Ireland Laboratoire HRA Pharma Tel: + 33-(0)1 40 33 11 30	Slovenija Dr. Gorkič d.o.o. Tel: + 386-(0)1 7590 251
island Laboratoire HRA Pharma Simi: + 33-(0)1 40 33 11 30	Slovenská 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 Midsona Finland Oy Puh/Tel: + 358-(0) 20 743 4755
Kvnpog BLANES A.E. Tql: + 30 210 8009111–120	Sverige Midsona Sverige AB Tel: + 46-(0) 20 78 88 01
Latvija Orivas SIA Tel: +371 676 124 01	United Kingdom (Northern Ireland) Laboratoire HRA Pharma Tel: + 33-(0)1 40 33 11 30

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

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)