Norix Tablet

Emergency contraception is a rescue method that is aimed to prevent fertilization in case of unprotected intercourse.

This contraception must be used as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after the unprotected sexual intercourse, particularly;

• if you have had sexual intercourse whereas either yourself or your partner did not use a contraceptive method;
• if you have forgotten to take consecutive 3 contraceptive pills;
• if your partner's condom has broken, slipped, or been improperly removed, or if he has forgotten to use it;
• if you fear that your intrauterine device has been expelled;
• if your vaginal diaphragm or your contraceptive cap has moved or if you have removed it too early;
• if you are afraid that the method of coitus interruptus has failed or if you have had sexual intercourse during the period when you are supposed to be fertile while using the rhythm method;
• in the event of rape.

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.

Administration

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 Levonorgestrel, 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 Levonorgestrel 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).