EllaOne 30 mg film-coated tablet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ellaOne 30 mg film-coated tablet

Ulipristal acetate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for taking the medicine contained in this leaflet or those provided by your doctor, pharmacist, or other healthcare professional.

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

Leaflet contents:

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

• Useful information regarding 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 there has been a failure of the contraceptive method used. For example:

• if you had unprotected sex;
• if the condom used by you or your partner broke, slipped, or was not used;
• if you did not take your contraceptive pill as recommended.

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

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

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

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

ellaOne does not work if you are already pregnant

If your menstrual period is delayed, you may be pregnant. If your period is late or you have symptoms of pregnancy (swollen 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 the menstrual cycle.

ellaOne must not be used as a regular contraceptive method

If you do not have a regular contraceptive method, speak with your doctor or another 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 every 100 women who take this medicine, approximately two will become pregnant.

This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not interrupt the 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 becoming infected with HIV or any other sexually transmitted disease (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, or syphilis). Please consult a healthcare professional if you are concerned about this.

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

2. What you need to know before taking ellaOne

Do not take ellaOne

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

Warnings and precautions

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

• if your period is delayed or you have symptoms of pregnancy (swollen breasts, morning sickness), because you might already be pregnant (see section "Pregnancy, breastfeeding and fertility");
• if you have severe asthma;
• if you have severe liver disease.

For all women, emergency contraception should be taken as soon as possible after 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 inconclusive. Therefore, ellaOne is recommended for all women regardless of their weight or BMI.

You are advised to consult a healthcare professional if you have any concerns regarding emergency contraception.

If you become pregnant despite taking this medicine, it is important that you see your doctor. See section "Pregnacy, 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 using them as usual after taking the tablet, but make sure to use condoms every time you have sex until your next period.

Do not take ellaOne together with another emergency contraceptive pill containing levonorgestrel. Taking them together could 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 medicines obtained without a prescription or herbal medicines.

Some medicines may prevent ellaOne from working effectively. If you have taken any of the following medicines within the last 4 weeks, ellaOne may be less effective. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is, a copper intrauterine device (Cu-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 taking (or have recently taken) any of the medicines listed above.

Pregnancy, breastfeeding and fertility

Pregnancy

Before taking this medicine, if your period is delayed, speak to your doctor, pharmacist, or other healthcare professional or take 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. 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 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 previously had an ectopic pregnancy, tubal surgery, or a chronic genital infection.

If you become pregnant after taking ellaOne, you are encouraged to speak with your doctor so that your pregnancy can be registered in an official registry. You may also report the information yourself at www.hra-pregnancy-registry.com. Your information will remain anonymous; no one will know the information refers to you. By sharing this information, you can 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 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 of breastfeeding during the week after taking this medicine is unknown.

Fertility

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

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

Driving and use of machines

After taking this medicine, some women may experience dizziness, drowsiness, blurred vision, or difficulty concentrating (see section 4). If you experience these symptoms, do not drive or operate machinery.

ellaOne contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take ellaOne

Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor, pharmacist, or other healthcare professional. If in doubt, consult your doctor or pharmacist again.

How to take the ellaOne film-coated tablet

• Take one tablet orally as soon as possible, but no later than 5 days (120 hours) after unprotected intercourse or contraceptive failure. Take the tablet without delay.
• You may take the tablet at any time during your menstrual cycle.
• You may take the tablet at any time of day, either before, during, or after a meal.
• If you are taking any of the medicines that may reduce the effectiveness of ellaOne (see section 2 "What you need to know before taking ellaOne"), or if you have taken any of these medicines within 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), i.e., a copper IUD.

If you vomit after taking ellaOne

If you vomit (regurgitate) within 3 hours after taking the tablet, take another tablet as soon as possible.

If you have unprotected intercourse again after taking ellaOne

If you have unprotected intercourse 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 intercourse.

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 lighter or heavier than usual, or if you experience symptoms such as abdominal pain, breast tenderness, vomiting, or nausea, you may be pregnant. You should take a pregnancy test immediately. If you are pregnant, it is important that you see a doctor (see section "Pregnancy, breastfeeding and fertility").

If you take more ellaOne than you should

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them. Some symptoms, such as breast tenderness (breast pain) and abdominal pain (stomach pain), vomiting, and nausea (feeling sick), may also be possible signs of pregnancy. If your period does not come and you experience these symptoms after taking ellaOne, you should take a pregnancy test (see section "Pregnancy, breastfeeding and fertility").

Frequent adverse effects (may affect up to 1 in 10 people ):

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

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

• diarrhoea, heartburn, flatulence, dry mouth
• irregular or unusual vaginal bleeding, heavy or prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased sexual desire
• hot flushes
• changes in appetite, emotional disturbances, anxiety, restlessness, difficulty sleeping, drowsiness, migraine, visual disturbances
• flu-like symptoms
• acne, skin lesions, itching
• fever, chills, malaise

Rare adverse 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
• difficulty concentrating, dizziness, tremors, disorientation, fainting
• unusual sensation in the eyes, red eyes, light sensitivity
• dry throat, taste disturbances
• allergic reactions such as rashes, hives, or facial swelling
• feeling thirsty

Reporting of adverse effects

If you experience any type of adverse effect, talk to your pharmacist, doctor, or healthcare professional, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of ellaOne

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

Appearance of the product and contents of the pack of ellaOne

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

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

Marketing Authorisation Holder

LABORATOIRE HRA PHARMA

200 avenue de Paris

92320 CHATILLON

France

Email: [email protected]

Manufacturer

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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent revision of this leaflet:

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

USEFUL INFORMATION ON 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 becoming pregnant if you have unprotected sex again. After taking emergency contraception and until your next period starts, you must use condoms every time you have sex.

MORE ABOUT ROUTINE CONTRACEPTION

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

Examples of routine contraceptive methods include:

Daily methods

Oral contraceptive pill

Weekly or monthly methods

Contraceptive patch
Vaginal ring

Long-term methods

Contraceptive implant
IUD (intrauterine device)