Emergency contraception within 72 hours after an unprotected sexual intercourse or in case of failure of a contraceptive method.
What is it?
NorLevo is an oral emergency contraceptive.
What is emergency contraception?
- Emergency contraception is a rescue method intended to prevent pregnancy after unprotected intercourse or in case of failure of a contraceptive method.
When should emergency contraception be used?
This contraceptive method should be used as soon as possible, preferably within 12 hours and no later than a period of 72 hours (3 days), after unprotected sexual intercourse or failure of a contraceptive method. It is more effective if you take it as soon as possible after unprotected sex. Norlevo can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Norlevo, it will not stop you from becoming pregnant.
Norlevo has been shown to prevent 52% to 85% of expected pregnancies.
Studies suggest that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg.
Ask your doctor or pharmacist for advice on alternative methods of emergency contraception.
If you suspect that you might be pregnant for one of the following reasons:
- if you have had sexual intercourse without contraception;
- if you have forgotten to take your contraceptive pill on time;
- if your partner’s condom has broken, slipped or came off;
- 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 early;
- if you are afraid of the method of coitus interruptus or the rhythm method has failed;
- in the event of rape.
NorLevo works by stopping your ovaries from releasing an egg. It cannot stop a fertilized egg from attaching to the womb.
This tablet is only for emergency contraception, not for a regular contraception as it is less effective than the regular contraceptive pill (“the pill”).
Before you use Norlevo
Do not use NorLevo 1.5 mg tablet:
- if you are allergic (hypersensitive) to levonorgestrel or to any of the other ingredients of NorLevo
Take special care with NorLevo 1.5 mg tablet
The use of Norlevo is not recommended in the following cases:
- if you have had a tubal (ectopic) pregnancy,
- or an infection in your fallopian tubes (salpingitis),
- if you have personal or family history of known risk factor for thrombosis (blood clotting).
- or if you have a severe digestive disease which impairs absorption of food and medications,
- or if you have severe liver problems or severe disease of the small bowel, such as Crohn’s disease.
- if you weigh 75 kg or more
A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy. Therefore, if you have had an ectopic pregnancy or an infection of the fallopian tubes you should contact your doctor before taking Norlevo.
Emergency contraception must be used only occasionally and should not replace a regular contraceptive method because:
- it does not prevent pregnancy in every instance;
- of the risk of hormonal overdose which may cause disturbance to your menstrual cycle
Emergency contraception cannot interrupt a pregnancy.
If you have had another act of unprotected intercourse more than 72 hours ago, conception may have occurred. Treatment with NorLevo following the second act of intercourse may therefore be ineffective in preventing pregnancy.
Repeated administration of Norlevo within a menstrual cycle is not advisable because it may upset your cycle.
Norlevo does not work as well as regular methods of contraception. Your doctor can tell you about long-term methods of contraception which are more effective in preventing from getting pregnant.
After taking this medicine:
It is mandatory to exclude pregnancy by performing a pregnancy test:
- if your next menstrual period is delayed more than five days,
- in case of abnormal bleeding even at the date of expected menstrual period.
If you did not use a condom (or if it split or slipped off) during intercourse, it might be possible that you have contracted a sexually transmitted disease or the HIV virus. The use of emergency contraception does not protect against sexually transmitted diseases and cannot replace the necessary precautions and measures to be taken in case of risk of transmission (see National Information).
Taking other medicines: The medicines listed below, including medicines obtained without prescription, can reduce or suppress the effectiveness of Norlevo:
- Certain medicines used to treat epilepsy (phenobarbital, phenytoin, primidone, carbamazepin),
- Certain medicines used to treat HIV infection (ritonavir),
- Certain medicines to treat certain infections (rifabutin, rifampicin, griseofulvin),
- Herbal medicines containing St. John’s Wort (Hypericum perforatum).
Norlevo should not be used together with drugs containing ulipristal acetate.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant:
This medication does not end an ongoing pregnancy.
- If you take this medication and you still become pregnant, studies to date have not shown any risk of malformation for the developing foetus. However this medication should not be taken if you are pregnant.
- If you do become pregnant after taking NorLevo, you should contact your doctor. Your doctor might want to check whether the pregnancy is not ectopic (the baby develops somewhere outside your womb). This is especially important if you develop severe pain in your abdomen after taking Norlevo or if you ever had an ectopic pregnancy, surgery to your fallopian tubes or pelvic inflammation disease.
If you are breast-feeding:
- Breast-feeding is possible. However, since levonorgestrel is excreted into breast milk, it is suggested that you breastfeed immediately before taking the Norlevo, tablet and refrain from nursing for at least 8 hours following Norlevo administration
- Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
- After Norlevo intake, some women experienced fatigue and dizziness: do not drive or use machines if you experience these symptoms.
- No studies on the effect on the ability to drive and use machines have been reported.
How to use Norlevo Tablets
- Always use NorLevo 1.5 mg tablet exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
- Norlevo is for oral use. The tablet should be taken with a glass of water and should not be chewed.
- The tablet should be taken as soon as possible, preferably within 12 hours, after unprotected intercourse and no longer than 72 hours (3 days) after intercourse.
- NorLevo can be taken at any time during the menstrual cycle.
- If you vomit within three hours of taking the tablet, you should take another tablet immediately. Contact your pharmacist or doctor to obtain another tablet.
- After using emergency contraception, you should use a local contraceptive method (condom, spermicide, cervical cap) until your next menstrual period. If another unprotected intercourse takes place after the use of Norlevo (also if this is during the same menstrual cycle), the tablets will not exert its contraceptive effect and there is again the risk of pregnancy. If you are using a regular method of contraceptive such as the oral contraceptive pill, you should continue to take this as normal.
- If you take oral contraception (birth control pills), you should carry on taking your birth control pills as usual after using NorLevo. In case you do not have menstrual bleeding in the next pill-free period, perform a pregnancy test to exclude pregnancy.
- Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.
- If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.
- Your next period after you took Norlevo
- After the use of Norlevo, your period is usually normal and will start on the expected day; however sometimes, this will be a few days later or earlier.
- If your period is more than 5 days late or is unusually light or unusually heavy, or if you think that you might be pregnant for any reason, you should check whether you are pregnant by performing a pregnancy test. If you do become pregnant even after taking this medicine, it is important that you see your doctor.
- If you use more NorLevo 1.5 mg tablet than you should
- No acute toxicity or serious harmful effects has been demonstrated with this medicine in case of intake of several doses. However, you may feel sick, actually be sick (vomit) or have vaginal bleeding. You should contact your doctor or pharmacist for advice.
Possible side effects
Like all medicines, NorLevo can cause side effects, although not everybody gets them.
The following side effects have been observed:
Very common side effects:
- dizziness, headache
- nausea, abdominal pain
- breast tenderness, delay of menses, heavy menses, bleeding,
- uterine pain - fatigue
Common side effects:
- diarrhoea, vomiting - painful menses
- Cases of thromboembolic events (blood clotting) have been reported during the postmarketing period.
- Allergic reactions such as swelling of throat and face and skin rash can occur after taking this medicine
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Norlevo Tablets
- Keep out of the reach and sight of children.
- Keep the blister in the outer carton in order to protect from light.
- Do not use NorLevo 1.5 mg tablet after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.