Package Leaflet: Information for the User

ellaOne 30 mg Film-Coated Tablet

Ulipristal Acetate

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this package leaflet or those given 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 any side effects, consult your doctor, pharmacist or other healthcare professional, even if they appear in this package leaflet. See section 4.

- Useful information related to contraception

ellaOne is an emergency contraceptive

ellaOne is an emergency contraceptive designed to prevent pregnancy after unprotected sex or failure of the used contraceptive method. For example:

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

You should take the tablet as soon as possible after having unprotected sex, and at most within 5 days (120 hours) afterwards.

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

This medication is suitable for any fertile woman, 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 menstrual period, you may be pregnant. If your period is delayed or you have symptoms of pregnancy (enlarged 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 prevent you from becoming pregnant.

Unprotected sex can result in 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 ingredientulipristal acetate, which acts by modifying the activity of the natural hormone progesterone necessary for ovulation to occur. As a result, this medication works by delaying ovulation. Emergency contraception is not effective in all cases. Approximately two out of 100 women who take this medication will become pregnant.

This medication 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 medication 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 this concerns you.

You will find 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).

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 (swollen breasts, morning sickness), because you may already be pregnant (see section «Pregnancy, breastfeeding and fertility»);
• if you have severe asthma;
• if you have a severe liver disease.

Emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that this medicine may be less effective with increased weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, ellaOne is recommended for all women regardless of their weight or BMI.

We recommend that you consult a healthcare professional if you are concerned about any problem related to emergency contraception.

If you become pregnant despite taking this medicine, it is essential that you see your doctor. See section «Pregnancy, breastfeeding and fertility» for more information.

Use of ellaOne with other contraceptives

This medicine may temporarily reduce the effectiveness of regular hormonal contraceptives, such as pills or patches. If you are currently using hormonal contraceptives, continue to use them as usual after taking the tablet, but make sure to use condoms whenever you have sex until your next period.

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

Other medicines and ellaOne

Inform your doctor, pharmacist, or other healthcare professional if you are taking or have recently taken any other medicine, including medicines 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. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e., a copper intrauterine device (IUD-Cu):

• 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 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 the medicines listed.

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 ensure you are not already pregnant (see section «Warnings and precautions»).

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

If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, it is essential that you see 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 a previous ectopic pregnancy, a tubal ligation, or a long-standing (chronic) genital infection.

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. Sharing this information may help future women understand the safety or risks of ellaOne during pregnancy.

Breastfeeding

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

Fertility

This medicine does not affect your future fertility. If you have sex without protection after taking this medicine, it will not prevent you from becoming pregnant. Therefore, it is essential that you use condoms until your next period.

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

Driving and operating machines

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

ellaOne contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor, pharmacist, or other healthcare professional. In case of doubt, consult your doctor or pharmacist again.

How to take the ellaOne coated tablet

• Take one tablet orally as soon as possible, but no later than 5 days (120 hours) after unprotected sex or a failure in the contraceptive method used. 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 the day, either before, during, or after a meal.
• If you are using one of the medications that may prevent ellaOne from working correctly (see section 2 "What you need to know before starting ellaOne") or if you have used one of these medications in the last 4 weeks, ellaOne may be less effective for you. Consult your doctor or pharmacist before using ellaOne. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is, a copper IUD.

If you vomit after taking ellaOne

If you vomit (regurgitate) 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 again after taking the tablet, it will not prevent pregnancy. 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 for a few days. However, if your period is delayed more than 7 days, is lighter or heavier than usual, or if you experience symptoms such as abdominal pain, breast pain, vomiting, or nausea, you may be pregnant. You must do a pregnancy test immediately. If you are pregnant, it is essential that you see your doctor (see section "Pregnancy, breastfeeding, and fertility").

If you take more ellaOne than you should

No adverse effects have been reported from taking a higher dose than recommended of this medication. However, consult your doctor, pharmacist, or other healthcare professional.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or other healthcare professional.

Like all medications, this medication may cause side effects, although not everyone will experience them. Some symptoms, such as breast tenderness (breast pain) and abdominal pain (stomach pain), vomiting (returning) and nausea (dizziness), are also possible signs of pregnancy. If you do not have your period and experience these symptoms after taking ellaOne, you should have a pregnancy test (see section "Pregnancy, breastfeeding and fertility").

Frequent side effects(may affect up to 1 in 10 patients):

• nausea, abdominal pain (stomach pain), vomiting
• painful periods, pelvic pain, breast tenderness
• headache, dizziness, changes in mood
• muscle pain, back pain, fatigue

Less frequent side effects(may affect up to 1 in 100 patients):

• diarrhea, stomach burning, flatulence, dry mouth
• irregular or unusual vaginal bleeding, heavy or prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased sex drive
• migraines
• changes in appetite, emotional disorders, anxiety, agitation, difficulty sleeping, drowsiness, migraines, visual disorders
• flu
• acne, skin lesions, itching
• fever, chills, discomfort

Rare side effects(may affect up to 1 in 1,000 patients):

• genital pain or itching, pain during sex, ovarian cyst rupture, lighter periods than usual
• loss of concentration, vertigo, tremors, disorientation, fainting
• strange sensation in the eyes, red eyes, light sensitivity
• dry throat, taste disorders
• allergic reactions such as rashes, hives or facial swelling
• feeling of thirst

Reporting side effects

If you experience any type of side effect,consult your pharmacist, doctor or healthcare professional, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the blister after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of ellaOne

• The active ingredient is ulipristal acetate. Each film-coated tablet contains 30 milligrams of ulipristal acetate.
• The other components are:
• Tablet core: lactose monohydrate, polyvidone, croscarmellose sodium, magnesium stearate.
• Film coating: polyvinyl alcohol (E1203), macrogol (E1521), talc (E553b), titanium dioxide (E171), polisorbate 80 (E433), iron oxide yellow (E172), potassium and aluminium silicate (E555).

Appearance of the product and contents of the ellaOne pack

ellaOne is a yellow film-coated tablet, shield-shaped (approximately 10.8 mm in diameter) with "ella" engraved on both sides.

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

Marketing Authorisation Holder

LABORATOIRE HRA PHARMA

200 avenue de Paris

92320 CHATILLON

France

Email:[email protected]

Responsible Person for Manufacturing

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 more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Last update of the summary of product characteristics:

For more detailed information about this medicinal product, please visit the website of the European Medicines Agency: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 prevent pregnancy. Emergency contraception does not affect your fertility.

Emergency contraception may delay ovulation within a menstrual cycle, but it will not prevent pregnancy if you have sex again without protection. 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 do not use a regular contraceptive method (or do not have a 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 are:

Daily methods

Oral contraceptive pill

Weekly or monthly methods

Contraceptive patchVaginal ring

Long-acting methods

Implantable contraceptiveIntrauterine device (IUD)