EC PRODUCTS

Produits NorLevoHRA-Pharma has developed
Emergency Contraceptive Pills.

NorLevo®, also known as Vikela®, Unofem®, Vika®, is an Emergency Contraceptive Pill.

It is sold as a package with one blister containing 1.5 mg of levonorgestrel, a progestin.

This new product does not contain estrogens and its side-effect profile is therefore better.

 
 
Here is a list of Frequently Asked Questions
We hope that you will find all the information you need about Emergency Contraception.
If you wish to ask another question, find the local distributor in your country.
 
  • It is a method which prevents an unwanted pregnancy after unprotected intercourse (see question #3).

  • No. Pregnancy is prevented in 70 to 90 % of cases when emergency contraception is used within 72 hours after intercourse. Efficacy is higher when emergency contraception is used sooner rather than later.

  • It is any sexual intercourse without contraception, or when your contraceptive method is likely to have failed. Here are some examples of unprotected intercourse:

    • Unplanned sexual intercourse, using no contraceptive method
    • A condom which breaks, has been displaced, has been improperly removed, has slipped, or simply has been forgotten…
    • A forgotten pill
    • Your diaphragm or your cervical cap has been improperly placed or has slipped during intercourse
    • Your partner has withdrawn too late if you use the coitus interruptus (withdrawal) method
    • You have been raped

    Remember that if sexual intercourse has occurred without a condom, you may also have been exposed to infectious agents, such as bacteria or virus (gonorrhea, AIDS, hepatitis): if you have any question, ask your doctor or a health care provider.

  • No. Without contraception, sexual intercourse has been known to result in pregnancy at all times in the menstrual cycle.

  • Here are some examples :

    • After sexual intercourse using no contraceptive method,
    • A condom broke, or was displaced, or slipped, or was improperly removed
    • A pill was forgotten
    • Vomiting occurred within an hour following your regular pill intake.
    • In case of rape
  • Our current understanding is that several mechanisms could be involved such as impairment of ovulation, or modification of the uterine lining. In any case, emergency contraception takes effect before the implantation of the egg in the uterus.
    If you are already pregnant before using emergency contraception, the pregnancy will continue normally.

  • NO.
    Emergency contraception is an occasional “back-up” method. It cannot replace regular contraceptive methods. If you have used emergency contraception, you should discuss with your doctor or your health care provider the most suitable contraceptive method for you.

  • One menstrual cycle is the time elapsed between the beginning of one menstrual period (bleeding) and the next one. Menstrual periods occur when a woman is not pregnant. Usually, the menstrual cycle lasts for 28 days, but it can vary widely from one woman to another.
    By definition, the first day of the menstrual cycle is the first day of bleeding. Usually, at the middle of the cycle, an egg (or ovum) is released by one of the two ovaries. (This event is called “ovulation”). If, at that time, sperm cells (which can fertilize the egg up to 7 days after being deposited in the vagina) are around the egg, “fertilization” (i.e. the fusion of the egg with one sperm) can take place. After a few days, the fertilized egg is anchored (or implanted) in the womb, and pregnancy starts.  Therefore, fertilization can occur only at the time of ovulation. Although, on average, ovulation takes place at the middle of the cycle (usually 14 days after the first day of the last menstrual period), it can actually take place at other times in the cycle.
    Therefore, without a contraceptive method, a woman can never be sure that she is not pregnant after sexual fertilization, either by blocking ovulation (as with the contraceptive pill), or by preventing the sperm from meeting the egg (as with the condom).

  • At the latest, 72 hours after an unprotected sexual intercourse, whatever the date in the cycle.

  • NO. Neither the use of spermicide after ejaculation, nor water and soap an prevent the occurrence of pregnancy. The reason is that sperm cells are immediately taken up by the cervical mucus, allowing them to penetrate in the womb and protecting them from external damage.

  • Yes. Since the date of ovulation is not exactly predictable, you should use emergency contraception after any unprotected intercourse. Indeed, since the ovulation date is unknown, in order to be as sure as possible of avoiding an unwanted pregnancy, you should use an emergency contraception after an unprotected intercourse at any time of the cycle.

  • No. It is therefore strongly recommended to use a barrier method (condom, spermicide, cervical cap) at each intercourse until the next menstrual period. Then, you should use a regular contraceptive method that is suitable for you.

  • Yes, NorLevo® is equally effective after one or several acts of intercourse in a row, provided that all the acts have taken within the 72 hours preceding the intake of the drug. The risk of unwanted pregnancy occurs when several unprotected acts of intercourse have taken place at various times in the same cycle. Therefore, remember that after having used an emergency contraceptive pill, you must use a barrier contraceptive method (condom, spermicide, cervical cap) until the next menstrual period.

  • It will usually occur at the expected date, although in some women, it can occur either earlier or later, by a few days. If it is delayed more than 5 days after the expected time, you should do a pregnancy test in order to check if you are pregnant.

  • No, there is no interference between Norlevo® and pregnancy tests.

  • Regarding the contraceptive pill: you should discuss this with your doctor. Regarding the IUD, it can be inserted during the next menstrual cycle. In any case, barrier contraceptive methods (condom, spermicide, diaphragm, cervical cap) should be used as soon as you have taken NorLevo®.

  • Fertility remains completely unchanged and therefore you should immediately use a contraceptive method (barrier method) until the next menstrual period, then adopt a regular contraceptive method suitable for you.

  • No. The use of emergency contraception does not protect against STDs and therefore precautions need to be taken to prevent them.

  • Yes.
    Any woman, from puberty to menopause can use NorLevo® in order to prevent an unwanted pregnancy in case of unprotected intercourse.

  • NO.
    Every emergency contraceptive pill, including NorLevo® - has to remain occasional. It cannot replace regular contraception. Indeed, one must remember that emergency contraception cannot prevent an unwanted pregnancy in 100 percent of cases.

  • NO. Read carefully the Norlevo leaflet to know hot to take Norlevo® while breastfeeding.
    Remember that breastfeeding is not a 100 percent effective contraceptive and that you may need to use emergency contraception while you are breastfeeding.

  • Adverse events observed during the various clinical trials have been: nausea and vomiting, dizziness, fatigue, headache, lower abdominal pain, breast tenderness, vaginal bleeding.

  • Menstrual bleeding after NorLevo® is comparable to your usual periods. However it can come earlier or later than expected by a few days. The quantity can be slightly modified.
    If you have any doubt about whether your period is normal, you should perform a pregnancy test. We do not know if this emergency contraceptive can prevent an ectopic pregnancy (a pregnancy which develops outside of the womb). One of the main symptoms of ectopic pregnancy is vaginal bleeding more or less similar to menstrual bleeding.
    In case of questions, do not hesitate to call your doctor, or your health care provider.

  • Ask your doctor, your health care provider or a family planning center. NorLevo® is not effective in case of existing pregnancy. However, if you take NorLevo® while already pregnant, don't be anxious: to date, the data of many epidemiological reviews indicate that progestins (the active principle of Norlevo®) are not harmful for the fetus.

  • It is difficult to evaluate because the likelihood of being pregnant depends on several factors the time of intercourse with respect to the timing of ovulation the usual length of the cycle the occurrence of other acts of unprotected intercourse in the same cycle. In general, the risk of pregnancy is higher if the unprotected intercourse took place on the day of ovulation, or on the 4 to 5 days preceding ovulation.   However, since the date of ovulation is unpredictable, any unprotected intercourse, at any time of the cycle, can lead to a pregnancy. Therefore if you have the slightest doubt, and you don't wish to become pregnant, do not hesitate to use emergency contraception without delay.

  • For optimal efficacy, the Norlevo® tablet must be taken as soon as possible after unprotected intercourse, and no later than 72 hours (3 days) afterwards. In case of vomiting in the 2 hours following the tablet intake, take an extra tablet immediately .
    Norlevo® can be taken at any time in the cycle.
    After using Norlevo® , it is necessary to use a barrier contraceptive method (condoms, spermicides, cervical cap) during every act of intercourse until the next menstrual period. Menstrual periods generally come at the expected date, sometimes earlier or later by a few days.

    If your period is late by more than 5 days, perform a pregnancy test.

    Emergency contraceptive pills are not 100 percent effective and a failure is always possible. Also remember that if you don't know the health status of your partner, STD exposure is always possible: don't hesitate to ask your doctor, a health care provider or a family planning center what to do.

  • No, to date NorLevo® has no known contraindication. However, since Norlevo® is ineffective if a pregnancy has already started, it is useless to use it if you have good reason to think that you are already pregnant (for example if you have not had your periods for more than 28 days if you have regular cycles) If you are already pregnant, NorLevo® will not be able to interrupt your pregnancy. Should you have taken NorLevo® while you were pregnant, don't be anxious: to date, the data of many epidemiological reviews indicate that progestins (which constitute the active principle of Norlevo®)are not harmful for the fetus.

  • It prevents pregnancy in 7 to 9 cases out of 10: it is therefore not 100 percent effective. It should not be used as a regular contraceptive method because it would be much less effective than methods that exist for regular contraception. It also means that if your period has not come 5 days after the expected date after having taken NorLevo® , you should perform a pregnancy test to be sure that you are not pregnant. Also, remember that no emergency contraceptive method prevents STDs, including AIDS.

  • Use a barrier contraceptive method (condoms, spermicides, cap, diaphragm) at each intercourse until the next menstrual period Perform a pregnancy test if your menstrual period is more than 5 days late. Ask your doctor, your pharmacist, your health care provider in case of any question about exposure to an infection. See your doctor, your health care provider, or family planning center in order to start a regular contraceptive method suitable for you.

  • Yes, if necessary.
    However, remember that the multiplication of unprotected acts of intercourse increase the risk of unwanted pregnancy even if you use emergency contraception each time.
    After having taken an emergency contraceptive pill, you should use a barrier contraceptive method (condom, spermicide, cap, diaphragm) for each act of intercourse until the next menstrual period.
    You should then ask your doctor, your health care provider, or a family planning center in order about starting a regular contraceptive method suitable for you.

  • No.
    Levonorgestrel contained in Norlevo® blocks ovulation, and hence prevents fertilization. If the embryo has already implanted in the womb, levonorgestrel cannot dislodge it.

  • No.
    This is why, after having used emergency contraception, it is necessary that you use a barrier contraceptive method (condoms, spermicides, diaphragm, cap) for each sexual intercourse until you use the regular contraceptive method most suitable to you.

  • Data currently available indicate that levonorgestrel contained in Norlevo® does not induce fetal harm. Note : remember that in this case, emergency contraception with Norlevo® will not work, since it cannot dislodge an embryo which has already implanted.

  • No.
    It is not advised to use emergency contraception repeatedly because it is not efficient enough to make it a regular contraceptive method, and not because there are concerns about its safety.