30 mg film-coated tablet
ulipristal acetate
1. What ellaOne is and what it is used for
ellaOne is an emergency – the pill.
ellaOne is a contraceptive pill intended to prevent pregnancy after unprotected intercourse or if you have failed your contraceptive method, for example
- if you had unprotected intercourse,
- if your or your partner’s condom broke or slipped off or if you forgot to use a condom,
- if you have not taken your contraceptive pill according to the recommendations.
Take the tablet as soon as possible after intercourse and no later than 5 days (120 hours) afterward.
This is because sperm can survive in your body up to 5 days after intercourse.
This medicine is suitable for all women of childbearing potential, including adolescents.
You can take the tablet at any time during the menstrual cycle.
ellaOne does not work if you are already pregnant.
If your period is delayed, you may be pregnant. If your period is delayed or if you have symptoms of pregnancy (soreness in the breasts, nausea especially in the morning), you should consult a midwife or doctor before taking the tablet.
If you have unprotected intercourse after taking the tablet, it does not prevent you from getting pregnant.
Unprotected intercourse at any time during your cycle can lead to pregnancy.
ellaOne should not be used regularly as a contraceptive.
If you are not using a regular method of contraception, you should talk to your doctor or midwife to choose a method that suits you.
How ellaOne works
ellaOne contains the substance ulipristal acetate which acts by altering the activity of the natural hormone et progesterone, which is necessary for ovulation to take place. As a result, this drug works by delaying ovulation. Emergency contraceptives do not always affect. Out of 100 women who take this medicine, about 2 become pregnant.
This medicine is a contraceptive that is used to prevent the onset of pregnancy. If you are already pregnant, it does not terminate the ongoing pregnancy.
Acute contraceptives do not protect against sexually transmitted diseases.
Only condoms can protect you from sexually transmitted diseases. This medicine will not protect you against HIV – infection or any other sexually transmitted disease (eg chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis ). If you are concerned about this, ask your midwife or caregiver for advice.
There is more information on contraceptive methods at the end of this brochure.
2. What you need to know before using ellaOne
Do not use ellaOne
– if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your pharmacist, doctor, or midwife before taking this medicine
- if your period is delayed or you have symptoms of pregnancy (breast tenderness, morning sickness) because 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.
All women should take emergency contraception as soon as possible after unprotected intercourse. There are data to suggest that this drug may be less effective with increasing body weight or Body Mass Index ( BMI ), but these data are limited and incomplete. Therefore, ellaOne is still recommended for all women, regardless of their weight or BMI.
You should talk to healthcare professionals if you are concerned about problems with taking oral contraceptives.
If you become pregnant even though you have taken this medicine, you must consult your midwife or doctor. See the section “Pregnancy, breast-feeding and fertility” for more information.
Other contraceptives and ellaOne
This drug may make other hormone-based contraceptives, e.g. birth control pills and birth control patches, less effective for a shorter time. If you are using hormone-based contraceptives, you should continue to take them as usual after taking the tablet, but be sure to use a condom every time you have intercourse until the next period.
Do not take this medicine with other emergency contraceptives that contain levonorgestrel. If taken together, the effect of this medicine may be reduced.
Other medicines and ellaOne
Tell your pharmacist, doctor, or midwife if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and (traditional) herbal medicines.
Some medicines may prevent ellaOne from working effectively. If you have been taking any of the medicines below for the past 4 weeks, ellaOne may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, ie copper coil.
- drugs against epilepsy (e.g., primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, and barbiturate s)
- drugs against tuberculosis (eg rifampicin, rifabutin)
- treatment of HIV (ritonavir, efavirenz, nevirapine)
- medicines for fungal infections (griseofulvin)
- (traditional) herbal medicines containing St. John’s wort ( Hypericum perforatum).
Talk to your doctor or pharmacist before taking ellaOne if you are taking (or have recently taken) any of the medicines listed above.
Pregnancy, breastfeeding, and fertility
Pregnancy
If your period is delayed, you should talk to your pharmacist, doctor, or midwife or take a pregnancy test before taking this medicine to make sure you are not already pregnant (see section “Warnings and precautions”).
This medicine is a contraceptive that is used to prevent a pregnancy from developing. If you are already pregnant, the current pregnancy will not be terminated.
If you become pregnant even though you have taken this medicine, there is no indication that ellaOne will affect your pregnancy. But you must consult a doctor. As with all pregnancies, your doctor may want to check that you have not had an ectopic pregnancy (that the fetus is developing outside the womb). This is especially important if you suffer from severe abdominal pain or bleeding or if you have previously had an ectopic pregnancy, operated on the fallopian tubes, or had a long-term ( chronic ) genital infection.
If you become pregnant even though you have taken ellaOne, you are asked to ask your doctor to report your pregnancy to an official registry. You can also report this information to www.hra-pregnancy-registry.com. Your information remains anonymous – no one will know that the information applies to you. Sharing your information with you can help women understand the safety and risks of ellaOne during pregnancy in the future.
Breast-feeding
If you are taking this medicine while breast-feeding your baby, do not breast-feed for one week after taking this medicine. During this time it is recommended that you use a breast pump to keep milk production going, but that you discard the milk. The effect of breastfeeding your baby during the week after taking this medicine is not known.
Fertility
This medicine does not affect your future fertility. If you have had unprotected intercourse after taking this medicine, it will not prevent you from getting pregnant. It is therefore important to use a condom until the next period.
If you want to start or continue to use a regular method of contraception after using this medicine, you can do so, but you should also use a condom until the next period.
Driving and using machines
After taking this medicine, some women experience dizziness, drowsiness, blurred vision, and/or difficulty concentrating (see section “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 nurse that you have an intolerance to some sugars, contact your pharmacist before taking this medicine.
3. How to use ellaOne
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or midwife has told you. If you are not sure, talk to a pharmacist or doctor.
How to take the film-coated ellaOne tablet
- Take a tablet by mouth as soon as possible and no longer than 5 days (120 hours) after you have had unprotected intercourse or have failed a contraceptive method. Do not delay taking the tablet.
- You can take the tablet at any time during the menstrual cycle.
- You can take the tablet at any time of the day, either before, during, or after a meal.
- If you are taking any medicine that may prevent ellaOne from working effectively (see section 2 “What you need to know before you take ellaOne”) or if you have used any of these medicines in the last 4 weeks, ellaOne may be less effective for you. Talk to your doctor or pharmacist before using ellaOne. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, ie copper coil.
If you vomit after taking ellaOne
If you vomit within 3 hours after taking the tablet, take a new tablet as soon as possible.
If you have intercourse again after taking ellaOne
If you have unprotected intercourse after taking the tablet, it does not prevent you from getting pregnant. After taking the tablet and until the next period, you should use a condom 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 a few days late. However, if your period is more than 7 days late, if it is unusually sparse or abundant, if you experience symptoms such as pain in the abdomen (stomach), soreness in the breasts, vomiting, or nausea, you may be pregnant. You should do a pregnancy test immediately. If you are pregnant, you must consult your doctor. (See section “Pregnancy, breast-feeding and fertility”.)
If you use more ellaOne then you should
There have been no reports of serious side effects after taking a higher dose than recommended with this medicine. But still consult a pharmacist, doctor, or midwife.
If you have any further questions on the use of this product, ask your pharmacist, doctor, or midwife.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms, e.g. Soreness in the breasts and pain in the abdomen (stomach), vomiting, and nausea, are also possible signs of pregnancy. If you have not had your period and experience such symptoms after taking ellaOne, you should have a pregnancy test (see section “Pregnancy, breast-feeding and fertility”).
Common side effects ( may affect up to 1 in 10 people):
- nausea, pain or discomfort in the abdomen (stomach), vomiting
- painful menstruation, pain in the pelvis, tenderness in the breasts
- headache, dizziness, mood swings
- muscle aches, back pain, fatigue
Uncommon side effects ( may affect up to 1 in 100 people):
- diarrhea, heartburn, flatulence, dry mouth
- abnormal or irregular vaginal bleeding, heavy/prolonged menstruation, premenstrual syndrome, irritation of the vagina or vaginal discharge, decreased/increased sexual desire
- hot flashes
- appetite changes, emotional disturbances, anxiety, worry, difficulty sleeping, drowsiness, migraines, visual disturbances
- influenza
- acne, skin problems, itching
- fever, chills, malaise
Rare side effects ( may affect up to 1 in 1,000 people ):
- genital pain or itching, pain during intercourse, rupture of an ovarian cyst, abnormally sparse menstruation
- difficulty concentrating, dizziness (dizziness), tremors, confusion, fainting
- abnormal sensation in the eyes, red eyes, photosensitivity
- pharyngeal dryness, taste disturbances
- hives (itchy rash), thirst.
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 stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is ulipristal acetate. Each film-coated tablet contains 30 milligrams of ulipristal acetate.
The other ingredients are Tablet core: lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate. (E555).
What the medicine looks like and the contents of the pack
ellaOne is a gold-colored, film-coated, shield-shaped tablet (approximately 10.8 mm in diameter) marked with “Ella” on both sides.
ellaOne is available in a carton containing a blister with 1 film-coated tablet.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Laboratory HRA Pharma
200 avenue de Paris
92320 Chatillon
France
Email: info-ella@hra-pharma.com
Manufacturer
Cenexi
17, rue de Pontoise
F-95520 Osny
France
Delpharm Lille SAS
Roubaix-Est Activity Park
22, rue de Toufflers
CS 50070
59452 Lys -Lez-Lannoy
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienHRA Pharma BeneluxTel: +32 2 709 2295 | LithuaniaOrivas UABTel: +370 5 252 6570 |
| BulgariaA&D Pharma BulgariaTel: + 359 800 12 400 | Luxembourg / LuxemburgHRA Pharma BeneluxTel: +32 2 709 2295 |
| Czech RepublicAkacia Group, sroTel: + 420- (0) 220 610 491 | HungaryAramis Pharma Kft.Tel .: + 36- (0) 1 219 0775 |
| DenmarkMidsona Danmark A / STel: + 45 98 54 22 88 | MaltaLaboratory HRA PharmaTel: + 33- (0) 1 40 33 11 30 |
| GermanyHRA Pharma Deutschland GmbHTel: + 49- (0) 234 516 592-0 | The NetherlandsHRA Pharma BeneluxTel: +32 2 709 2295 |
| EestiOrivas OÜTel: +372 639 8845 | NorwayMidsona Norge ASTel: + 47 24 11 01 00 |
| GreeceΑΕ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ:Ηλ: + 30- (0) 210 66 83 000 | AustriaSanova Pharma GesmbHTel: + 43- (0) 1 801 040 |
| SpainHRA Pharma Iberia SLTel: + 34- (0) 902 107 428 | PolandA&D Pharma Poland Sp. z ooTel: + 48- (0) 22 570 27 00 |
| FranceHRA Pharma FranceTel: + 33- (0) 1 53 24 81 00 | PortugalHRA Pharma Iberia SLsucursal in PortugalTel: +351 707 501 996 |
| CroatiaArenda dooTel: + 385- (0) 1 644 44 80 | RomaniaA&D Pharma RomaniaTel: + 40- (0) 372 072 219 |
| IrelandLaboratory HRA PharmaTel: + 33- (0) 1-40 33 11 30 | SloveniaDr. Gorkič dooTel: + 386- (0) 1 7590 251 |
| IcelandLaboratory HRA PharmaPhone: + 33- (0) 1 40 33 11 30 | Slovak RepublicLiek, sroTel: + 421- (0) 905 667 410 |
| ItalyHRA Pharma Italia srl, unipersonal companyTel: + 39 06 59 60 09 87 | Finland / FinlandMidsona Finland OyPuh / Tel: + 358- (0) 20 743 4755 |
| LatviaOrivas SIATel: +371 676 124 01 | United KingdomHRA Pharma UK & Ireland Limited |