ellaOne 30 mg. 1 tablet

What is ellaOne is and what it is used
ellaOne is an emergency contraceptive
ellaOne is a contraceptive that is designed to prevent pregnancy after unprotected sexual intercourse or failure you are using a contraceptive method. For example:
if you had sexual intercourse without protection;
if your or your partner's condom tore, slipped or came off, or if you forgot to use a condom;
if you take the contraceptive pill as recommended.
You should take ellaOne as quickly as possible after intercourse and no later than 5 days (120 hours).
This is because sperm survive in your body up to five days after intercourse. ellaOne is suitable for every woman of childbearing potential, including in adolescence. You can take ellaOne at any time during the menstrual cycle.

ellaOne does not work if you are already pregnant.
If your period is late, it is likely that you are pregnant. If your period is late, or if you have symptoms of pregnancy (breast tenderness, morning sickness), you should consult your doctor or other healthcare professional before taking ellaOne.
If you have unprotected intercourse after taking ellaOne, will not prevent pregnancy. Unprotected intercourse at any time during the menstrual cycle can lead to pregnancy.

ellaOne should not be used for regular contraception.
If you do not have a regular method of contraception, talk to your doctor or health care professional to select the one that is right for you.

How does ellaOne
ellaOne contains a substance ulipristalov acetate that acts by altering the activity of the natural hormone progesterone, which is necessary for the occurrence of ovulation. So ellaOne works by delaying ovulation. Emergency contraception is not always effective. Of the 100 women who took ellaOne, approximately 2 pregnant.
ellaOne a contraceptive, which is used to prevent pregnancy. If you are already pregnant, the drug will not interrupt the pregnancy.

Emergency contraception does not protect against sexually transmitted infections.
Only condoms can protect you from sexually transmitted infections. ellaOne will not protect you from HIV infection or other sexually transmitted diseases (eg. chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis). If you have any concerns, talk to your healthcare professional.
At the end of this leaflet contains additional information on contraception.

2. What you should know before using ellaOne
Do not take ellaOne:
if you are allergic to ulipristalov acetate or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your pharmacist, doctor or other healthcare professional before taking ellaOne:
If your period is late, or if you have symptoms of pregnancy (breast tenderness, morning sickness), as can 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 used as soon as possible after intercourse unprotected. There is some evidence that ellaOne may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive. Therefore ellaOne is still recommended for all women, regardless of their body weight or BMI.
You are advised to speak with a medical professional if you are worried about problems related to the implementation of emergency contraception.
If you become pregnant despite taking ellaOne, it's important to go to the appointment with your doctor. For more information, see section "Pregnancy, breast-feeding and fertility."

Other contraceptives, ellaOne
EllaOne is possible to temporarily reduce the efficacy of the usual hormonal contraceptives such as birth control pills and patches. If you are currently taking hormonal contraceptives, continue to use them as usual after taking ellaOne, but be sure to use condoms during every sexual intercourse until your next period.
Do not use ellaOne with another pill emergency contraceptive containing levonorgestrel. If you take them together may impair the effectiveness of ellaOne.

Other medicines and ellaOne
Tell your pharmacist, doctor or other healthcare professional if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking any of the following medicines as they reduce the effects of ellaOne:
Phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine (medicines used to treat epilepsy);
Ritonavir, efavirenz, nevirapine (used to treat HIV infection);
Rifampicin, rifabutin (used to treat tuberculosis);
St. John's wort (Hypericum Perforatum) or herbal medicines containing St. John's wort (used for depression or anxiety).
Pregnancy, lactation and fertility
pregnancy
If your period is late before taking ellaOne you should tell your pharmacist, doctor or other medical professional or to take a pregnancy test to make sure that you are not already pregnant (see section "Warnings and Precautions") .
ellaOne a contraceptive, which is used to prevent pregnancy. If you are already pregnant, the drug will not interrupt the pregnancy.
If you become pregnant despite applying to ellaOne, there is no evidence that ellaOne intake will affect your pregnancy. It is important to go to the appointment with your doctor. As with any pregnancy, your doctor may wish to determine whether 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, surgery of fallopian tube or long term (chronic) infection but genitals.
If you become pregnant despite the application of ellaOne, we encourage you to ask your doctor to register your pregnancy in an official register. You yourself can report this information to the web address www.hra-pregnancy-registry.com. Your information will remain confidential - no one will know that this information applies to you. Sharing information on your part may in the future help women learn about safety or risks of ellaOne during pregnancy.

breastfeeding
If you take ellaOne while breast-feeding, you should stop breastfeeding for a week after taking ellaOne. During this time, it is recommended to use a breast pump to maintain lactation, but to dispose of expressed milk. The effect of breastfeeding your baby in the first week after taking ellaOne is not known.

Fertility
ellaOne does not affect your fertility future. If you have unprotected intercourse after taking ellaOne, will not prevent pregnancy. It is therefore important to use condoms until your next menstrual period.
If after ellaOne intake you want to start or continue with any of the usual methods of contraception can do it, but with it must use condoms until your next menstrual period.

Driving and using machines
After ellaOne intake some women experience dizziness, drowsiness, blurred vision and / or loss of concentration (see "Possible side effects"). If you experience these symptoms, you should not drive or operate machinery.

ellaOne contains lactose
If your doctor or other healthcare professional tells you that you have an intolerance to some sugars, contact your pharmacist before taking this medicine.

3. How to use ellaOne
Always use this medicine exactly as described in this leaflet or as you have been told your pharmacist, doctor or other medical professional. If you're not sure, ask your pharmacist or doctor.

How to take the tablet ellaOne
Take one tablet by mouth as soon as possible and not later than five days (120 hours) after unprotected intercourse or contraceptive failure. Take the tablet immediately;
You can take ellaOne at any time during your menstrual cycle;
You can take ellaOne at any time of the day, both before and during meals or after meals.
If you vomit after taking ellaOne
If you vomit within 3 hours after taking the tablet, take a second tablet as soon as possible.

If you have intercourse again after taking ellaOne
If you have unprotected intercourse after taking ellaOne, will not prevent pregnancy. After taking ellaOne and it took until your next period, you should use condoms anyway intercourse.
If you vomit after taking ellaOne
If you vomit within 3 hours after taking the tablet, take a second tablet as soon as possible.

If you have intercourse again after taking ellaOne
If you have unprotected intercourse after taking ellaOne, will not prevent pregnancy. After taking ellaOne and it took until your next period, you should use condoms anyway intercourse.

If your next period is late after taking ellaOne
After ellaOne intake is normal for your next period to be delayed for several days.
However, if your period is late by more than 7 days, if unusually weak or unusually strong; or if you develop symptoms of pregnancy, such as abdominal pain, breast tenderness, nausea or vomiting, you may be pregnant. You should make a pregnancy test. If you are pregnant, it is important to go to the appointment with your doctor. (See section "Pregnancy, breast-feeding and fertility").

If you take more dose of ellaOne
No reports of adverse effects from taking higher than recommended dose of this medicine. However, ask your pharmacist, doctor or other medical professional.

If you have any further questions on the use of this medicine, ask your pharmacist, doctor or other medical 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, nausea, and possible signs of pregnancy. If you skip your period and feel similar symptoms after taking ellaOne, you should perform a pregnancy test (see section "Pregnancy, breast-feeding and fertility").

Common side effects (may affect up to 1 in 10 people):
nausea, abdominal pain or discomfort, vomiting;
painful menstruation, pain in the pelvic region, breast tenderness;
headache, dizziness, mood swings;
muscle pain, back pain, fatigue.
Uncommon side effects (may affect up to 1 in 100 people):
diarrhea, heartburn, flatulence, dry mouth;
unusual or irregular vaginal bleeding, severe / prolonged menstruation, premenstrual syndrome, vaginal irritation or discharge, reduced or increased sexual desire;
hot flashes;
changes in appetite, emotional disturbances, restlessness, anxiety, insomnia, somnolence, migraine, visual disturbances;
flu;
acne, skin lesions, itching;
fever, chills, malaise
Rare side effects (may affect up to 1 in 1,000 people):
pain in the genitals or itching, pain during intercourse, burst ovarian cyst, unusually light period;
loss of concentration, dizziness, tremors, disorientation, fainting;
abnormal sensations in the eyes, red eyes, sensitivity to light;
dry mouth, taste disturbance;
hives (itchy rash), thirst.
Adverse event reporting
If you get any side effects, contact your doctor, pharmacist or other health care specialist. This includes any possible effects not listed in this leaflet. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can do your bit for getting more information on the safety of this medicine.

5. How to store ellaOne
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 25 ° C. Store in the original container to protect from moisture. Keep the blister in the original package to protect from light.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What ellaOne
The active substance is ulipristalov acetate. One tablet contains 30 milligrams ulipristalov acetate.
The other ingredients are lactose, povidone K30, croscarmellose sodium, magnesium stearate.

EllaOne looks like and contents of the pack
ellaOne is a white to creamy marble, round curved tablet engraved with code "ella" on both sides.
ellaOne is available in a cardboard box containing one blister of 1 tablet.
INFORMATION ON contraception
More information on emergency contraception
The sooner you take emergency contraception, the more chances to avoid pregnancy.
Emergency contraception will not affect your fertility.
Emergency contraception can delay ovulation within a given menstrual cycle but will not protect you from getting pregnant again if you have unprotected intercourse. After taking emergency contraception and while waiting to start your next period, you should use condoms anyway intercourse.

MORE INFORMATION usual CONTRACEPTION
If you take emergency contraception and not using common contraceptive method (or if there is no method that is suitable for you), talk to your doctor or family planning clinic to give you advice. There are many different types of contraception and should be able to find such a method that is suitable for you.

Examples of common methods of contraception:
Methods with daily administration:
Contraceptive pill.
Methods for weekly or monthly administration:
Contraceptive patch;
Vaginal ring.
Methods of continuous operation:
Contraceptive implant;
IUD (intrauterine device - IUD).

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