ELLAONE 30 mg TABLETS

Introduction

Package Leaflet: Information forthe user

ellaOne 30 mg tablet

Ulipristal acetate

Read this package leaflet carefully before starting to use this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or other healthcare professional.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or other healthcare professional, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is ellaOne and what is it used for
2. What you need to know before taking ellaOne
3. How to take ellaOne
4. Possible side effects
5. Storage of ellaOne
6. Contents of the pack and further information

• Useful information about contraception

1. What is ellaOne and what is it used for

ellaOne is an emergency contraceptive

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

• if you have had unprotected sex;
• if the condom used by you or your partner breaks, slips, or is not used;
• if you did not take your contraceptive pill as recommended.

You should take the tablet as soon as possible after having unprotected sex, and no later than 5 days (120 hours) after.

This is because it is more effective the sooner you take it after having unprotected sex.

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

You can take the tablet at any time during your menstrual cycle.

ellaOne does not work if you are already pregnant

If you have a delayed period, you may be pregnant. If your period is delayed or you have symptoms of pregnancy (breast tenderness, 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 prevent you from becoming pregnant.

Unprotected sex can lead to pregnancy at any time during your menstrual cycle.

ellaOne should not be used as a regular contraceptive method

If you do not have a regular contraceptive method, talk to your doctor or other healthcare professional to help you choose the most suitable one for you.

How ellaOne works

ellaOne contains the active substance ulipristal acetate, which works by modifying the activity of the natural hormone progesterone necessary for ovulation to occur. As a result, this medicine works by delaying ovulation. Emergency contraception is not effective in all cases. Out of 100 women taking this medicine, about two will become pregnant.

This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not interrupt an existing pregnancy.

Emergency contraceptives do not protect against sexually transmitted infections.

Only the use of a condom can protect you from sexually transmitted infections. This medicine will not protect you from HIV or any other sexually transmitted disease (e.g., chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, or syphilis). Consult a healthcare professional if you are concerned.

You will find more information about contraception at the end of this package leaflet.

2. What you need to know before taking 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).

Warnings and precautions

Consult your doctor, pharmacist, or other healthcare professional before starting to take this medicine

• if your period is delayed or you have symptoms of pregnancy (breast tenderness, morning sickness), 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 having unprotected sex. 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 not conclusive. Therefore, ellaOne is recommended for all women, regardless of their weight or BMI.

You are advised to consult a healthcare professional if you are concerned about any issues related to emergency contraception.

If you become pregnant despite taking the tablet, it is important that you consult your doctor. See the section "Pregnancy, breastfeeding, and fertility" for more information.

Using ellaOne with other contraceptives

This medicine may temporarily reduce the effectiveness of your regular hormonal contraceptives, such as the pill or patch. If you are currently using hormonal contraceptives, continue to use them as usual after taking this medicine, but make sure to use a condom every time you have sex until your next period.

Do not take this medicine with another emergency contraceptive pill that contains levonorgestrel. Taking them together may reduce the effectiveness of this medicine.

Other medicines and ellaOne

Tell your doctor, pharmacist, or other 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 used any of the following medicines in the last 4 weeks, ellaOne may be less effective for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), i.e., a copper intrauterine device (IUD):

• Medicines used to treat epilepsy (e.g., primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, and barbiturates).
• Medicines used to treat tuberculosis (e.g., rifampicin and rifabutin).
• A treatment for HIV (ritonavir, efavirenz, nevirapine).
• A medicine used to treat fungal infections (griseofulvin).
• Herbal medicines containing St. John's Wort (Hypericum perforatum).

Consult your doctor or pharmacist before using ellaOne if you are using (or have recently used) any of these medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy

Before taking this medicine, if your period is delayed, talk to your doctor, pharmacist, or other healthcare professional or have 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 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 consult your doctor. As with any pregnancy, your doctor may want to check that the pregnancy is not ectopic. This is especially important if you have severe abdominal pain or bleeding or if you have had an ectopic pregnancy, tubal surgery, or a long-standing genital infection in the past.

If you become pregnant despite taking ellaOne, we encourage you to talk to your doctor to register your pregnancy in an official registry. You can also report the information yourself at www.hra-pregnancy-registry.com. Your information will be kept anonymous; no one will know that the information refers to you. By sharing this information, you can help other women understand the safety or risks of ellaOne during pregnancy in the future.

Breastfeeding

If you take this medicine while breastfeeding, do not breastfeed your baby for the week after taking this medicine. We recommend that, during this week, you use a breast pump to maintain milk production but discard the expressed milk. The effect on the baby of breastfeeding in the week after taking this medicine is unknown.

Fertility

This medicine does not affect your future fertility. If you have unprotected sex after taking the tablet, it will not prevent you from becoming pregnant. Therefore, it is important that you use condoms until your next period.

If you want to start using or continue using a conventional contraceptive method after using this medicine, you can do so, but you must also use condoms until your next period.

Driving and using machines

After taking this medicine, some women may experience dizziness, drowsiness, blurred vision, or loss of concentration (see section 4). If you experience these symptoms, do not drive or use machines.

ellaOne contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take ellaOne

Follow exactly the administration instructions of this medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or other healthcare professional. If you are unsure, consult your doctor or pharmacist again.

How to take the ellaOne tablet

• Take one tablet by mouth as soon as possible, but no later than 5 days (120 hours) after having unprotected sex or when a contraceptive method has failed. Take the tablet without delay.
• You can take the tablet at any time during your menstrual cycle.
• You can take the tablet at any time of day, either before, during, or after a meal.
• If you are using one of the medicines that may prevent ellaOne from working correctly (see section 2 "What you need to know before taking ellaOne") or if you have used one of these medicines in the last 4 weeks, ellaOne may be less effective for you. Consult your doctor or pharmacist before using ellaOne. Your doctor may prescribe a different type of emergency contraception (non-hormonal), i.e., a copper IUD.

If you vomit after taking ellaOne

If you vomit (throw up) within 3 hours of taking the tablet, take another tablet as soon as possible.

If you have unprotected sex again after taking ellaOne

If you have unprotected sex after taking the tablet, it will not prevent you from becoming pregnant. After taking the tablet and until your next period, you must use condoms every time you have sex.

If your next period is delayed after taking ellaOne

After taking the tablet, it is normal for your next period to be delayed by a few days. However, if your period is delayed by more than 7 days, is shorter or longer than usual, or if you experience symptoms such as abdominal pain, breast tenderness, vomiting, or nausea, you may be pregnant. You should have a pregnancy test immediately. If you are pregnant, it is important that you consult your 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. However, consult your doctor, pharmacist, or other healthcare professional.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, 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 pain, vomiting, and nausea, are also possible signs of pregnancy. If your period does not arrive and you experience these symptoms after taking ellaOne, you should have a pregnancy test (see section 2 "Pregnancy, breastfeeding, and fertility").

Common side effects (may affect up to 1 in 10 people):

• nausea, abdominal pain or discomfort, vomiting
• painful periods, pelvic pain, breast tenderness
• headache, dizziness, mood changes
• muscle pain, back pain, fatigue

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

• diarrhea, stomach upset, flatulence, dry mouth
• irregular or unusual vaginal bleeding, heavy or prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido
• hot flashes
• changes in appetite, emotional disorders, anxiety, agitation, sleep disorders, drowsiness, migraines, 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 sex, rupture of an ovarian cyst, lighter than usual periods
• loss of concentration, vertigo, tremors, disorientation, fainting
• strange sensation in the eyes, red eyes, sensitivity to light
• dry throat, taste disorders
• allergic reactions such as rash, hives, or swelling of the face
• feeling of thirst

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or other healthcare professional, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ellaOne

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

Appearance of the Product and Package Contents of ellaOne

ellaOne is a curved, round tablet, 9 mm in diameter, white to cream marbled in color, with «ella» engraved on both sides.

ellaOne is marketed in a box containing a blister pack with 1 tablet.

Marketing Authorization Holder

LABORATOIRE HRA PHARMA

200 avenue de Paris

92320 CHATILLON

France

Email: 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/.

USEFUL INFORMATION ABOUT CONTRACEPTION

MORE ABOUT EMERGENCY CONTRACEPTION

The sooner you take emergency contraception, the more likely you are to avoid pregnancy. Emergency contraception does not affect your fertility.

Emergency contraception may delay ovulation within a given menstrual cycle, but it will not prevent you from getting pregnant if you have unprotected sex again. After taking emergency contraception and until your next period, you should use condoms every time you have sex.

MORE ABOUT REGULAR CONTRACEPTION

If you have taken emergency contraception and are not using a regular contraceptive method (or do not have a contraceptive method that suits you), consult your doctor or a family planning clinic. There are many different types of contraceptives, and you should be able to find one that is suitable for you.

Examples of regular contraceptive methods include: