Norix 1 Tablet

1.5 mg: Each tablet contains 1.5 mg levonorgestrel. Levonorgestrel belongs to a group of medicines called progestogen. Each pack contains 1 round white tablet.
0.75 mg: Each tablet contains 0.75 mg of levonorgestrel. Levonorgestrel belongs to a group of medicines called progestogen. Each pack contains 2 round white tablets.

Norix 1 is an emergency contraceptive for women. This should be used within 72 hours of unprotected intercourse. It should not be taken as a regular birth control pill. This medicine is also known as Post Coital Pill and Morning After Pill. The active substance in this medicine is Norix 1.

Some information about the menstrual cycle and contraception:

The menstrual cycle is the time elapsed between two menstrual periods. Normally, the cycle lasts for 28 days but its length can vary noticeably from one woman to another.

Menstrual periods occur when a woman is not pregnant. At the middle of the cycle, an ovum is expelled by one of the 2 ovaries (this moment is called "ovulation"). Usually, ovulation takes place in the middle of the cycle, but it can occur at any moment during the cycle.

If sperms are near the ovum, fertilization (i.e. the merge between the ovum and a sperm cell in order to create an embryo) can take place. After a few days, the fertilized ovum implants in the womb and the pregnancy starts.

Contraceptive methods are aimed to prevent:

• either the ovulation: this is the case for the contraceptive pill,
• either the fertilization (merge of the sperm with the ovum): this is the case for condoms,
• or the implantation of a fertilized ovum: this is the case for intrauterine devices.

Emergency contraception aims to block ovulation or prevent implantation if the sexual intercourse has taken place in the hours or days preceding ovulation, i.e. at a time when the likelihood of fertilization is the highest. It could also prevent implantation. It becomes inefficient as soon as implantation has started.

Without a contraceptive method, a woman cannot exclude the possibility of becoming pregnant after sexual intercourse.

If you have taken this medicine and that you do not use regular contraception, it is highly recommended to visit your doctor in order to obtain advice on a method of contraception suitable to you.

The advice in case of risk of transmission of sexually transmitted disease:

If you fear a pregnancy, this can mean that you have not used a condom (or that you have used it improperly) during sexual intercourse. You may therefore have contracted a sexually transmitted disease or the AIDS virus, if you are not aware of your partner's health status, or if you have several partners. You should ask for advice from your doctor as soon as possible for early detection and, if necessary, early treatment. During your next sexual intercourse, it is recommended to take the appropriate measures in order to prevent unwanted pregnancy and/or a sexually transmitted disease and to avoid AIDS contamination. If you need further information about Norix 1, ask your doctor, or a family planning center.

Oral contraceptives containing levonorgestrel suppress gonadotropins, inhibiting ovulation. Specifically, levonorgestrel binds to progesterone and androgen receptors and slows the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. This process results in the suppression of the normal physiological luteinizing hormone (LH) surge that precedes ovulation. It inhibits the rupture of follicles and viable egg release from the ovaries. Levonorgestrel has been proven to be more effective when administered before ovulation.

1.5 mg Tablet: The treatment necessitates the intake of one tablet. The Levonorgestrel tablet must be taken as soon as possible, preferably within 12 hours, after the unprotected intercourse, and no longer than within 72 hours (3 days) after the intercourse. Levonorgestrel can be taken at any moment during the menstrual cycle.

0.75 mg Tablet: The first Levonorgestrel tablet must be taken within 72 hours of the intercourse and the second tablet should be taken after 12 hours of the intake of the first tablet. Levonorgestrel must be taken within 48 hours of unprotected intercourse and in no way after 72 hours because the effectiveness of the medicine starts reducing after 48 hours of intercourse. Levonorgestrel can be taken at any moment during the menstrual cycle.

After using emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, and cervical cap) until the next menstrual period resumes. The use of Levonorgestrel does not contraindicate the continuation of regular hormonal contraception. If you have used this medicine while you were using oral contraception (contraceptive pill), you should carry on taking the usual tablets until the end of the treatment. In case no menstrual period occurs in the next pill-free period following the use of Levonorgestrel a pregnancy test should be performed to rule out a pregnancy.

Oral use. The tablet should be taken with a glass of water.

Interactions with other medicines and other forms of interaction: Simultaneous administration of certain anticonvulsant agents (phenobarbitone, phenytoin, primidone, carbamazepine), also other medications such as rifampicin, and griseofulvin can reduce or suppress the effectiveness of this emergency contraception.

If you have hypersensitivity to levonorgestrel or any of the excipients of Levonorgestrel.

Undesirable effects which have been observed are:

• Nausea and vomiting
• Dizziness, fatigue, headache
• Abdominal pain
• A feeling of breast tenderness
• Bleeding can occur after taking this medicine

Inform the doctor of any unwanted effect which is not mentioned here.

This medicine is not indicated in case of pre-existing pregnancy and cannot interrupt it. In case of failure of this contraceptive mean persisting pregnancy, epidemiological studies indicate no adverse effects of progestogen on the malformation of a fetus. Lactation is possible. However, since levonorgestrel is secreted into breast milk, it is suggested that you breastfeed immediately before taking each Levonorgestrel tablet and that you skip the nursing following each Levonorgestrel administration.

Emergency contraception must be used exceptionally, since:

• It does not allow to prevent a pregnancy in every instance:
• The associated hormonal overdosing is not advisable in the case of regular intake.
• It cannot replace regular contraception.

After taking Norix 1, the menstrual period usually occurs at the expected date nevertheless, it can occur earlier or later by a few days. After taking this medicine, it is therefore mandatory to check the absence of pregnancy by performing a pregnancy test in case of abnormal bleeding at the date of excepted menses or in case of menstrual delay of more than 5 days.

The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases and the measures to be taken in case of risk of transmission.

Taking this medicine is not recommended if you have had an ectopic pregnancy or if you have had salpingitis or if you have a severe digestive disease that impairs the absorption of medications.

If vomiting would occur within three hours after taking this medicine, it is recommended to take immediately another Norix 1 tablet.

No acute toxicity has been demonstrated with this medicine in the case of intake of several doses. The efficacy of this medicine is not guaranteed if the dose has been omitted.

Emergency Contraceptive Pill, Oral Contraceptive preparations

Do not exceed the expiry date printed on the outer packaging. Keep the tablet in the outer carton. Keep the medicine away from children. Store in cool dry conditions (below 30° C).