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PACKAGE LEAFLET: INFORMATION FOR THE USER Read all of this leaflet carefully before you start
If you have had another act of unprotected using this medicine.
intercourse more than 72 hours ago, conception may have occurred. Treatment with NorLevo This medicine has been prescribed for you. following the second act of intercourse may Do not pass it on to others. It may harm them, therefore be ineffective in preventing pregnancy.
even if their symptoms are the same as yours.
- Keep this leaflet. You may need to read it again.
Repeated administration of NorLevo within a menstrual - If you have any further questions, ask your doctor, cycle is not advisable because it may upset your cycle.
pharmacist or family planning clinic.
NorLevo does not work as well as regular methods - If any of the side effects gets serious, or if you of contraception. Your doctor can tell you about notice any side effects not listed in this leaflet, long-term methods of contraception which are more please tell your doctor or pharmacist.
effective in preventing from getting pregnant.
In this leaflet:
1. What NorLevo 1.5 mg tablet is and what it is used for It is mandatory to exclude pregnancy by performing a - if your next menstrual period is delayed more - in case of abnormal bleeding even at the date If you did not use a condom (or if it has been torn 1. WHAT NORLEVO 1.5 MG TABLET IS AND WHAT
or has been slided down) during the intercourse, IT IS USED FOR
it might be possible that you have caught a sexual y NorLevo is an oral emergency contraceptive. transmitted disease or the HIV virus. The use of emergency contraception does not protect against What is emergency contraception?
sexual y transmitted diseases and cannot replace the Emergency contraception is a rescue method necessary precautions and measures to be taken in intended to prevent pregnancy after unprotected case of risk of transmission (see National Information).
intercourse or in case of failure of a contraceptive Taking other medicines
The medicines listed below, including medicines When should emergency contraception be used?
obtained without prescription, can reduce or This contraceptive method should be used as soon as possible, preferably within 12 hours and no later - certain medicines used to treat epilepsy than a period of 72 hours (3 days), after unprotected (phenobarbital, phenytoin, primidone, carbamazepin), sexual intercourse or failure of a contraceptive - certain medicines used to treat HIV infection method. It is more effective if you take it as soon as possible after unprotected sex. NorLevo can only - certain medicines to treat certain bacterial prevent you becoming pregnant if you take it within infections (rifabutin, rifampicin, griseofulvin), 72 hours of unprotected sex. It does not work if - herbal medicines containing St. John’s Wort you are already pregnant. If you have unprotected sex after taking NorLevo, it will not stop you from Please tell your doctor or pharmacist if you are taking or have recently taken any other - if you have had sexual intercourse without Pregnancy and breast-feeding
- if you have forgotten to take your contraceptive This medication does not end an ongoing pregnancy.
- if your partner’s condom has broken, slipped If you take this medication and you still become pregnant, studies to date have not shown any risk - if you fear that your intrauterine device has been of malformation for the developing foetus. However this medication should not be taken - 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 If you do become pregnant after taking NorLevo, interruptus or the rhythm method has failed; 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 - stopping your ovaries from releasing an egg if you develop severe pain in your abdomen after - stopping a fertilised egg from attaching to the womb taking NorLevo or if you ever had an ectopic This tablet is only for emergency contraception, not for pregnancy, surgery to your fallopian tubes or pelvic a regular method of contraception as it is less effective than the ‘normal’ contraceptive pil (“the pil ”).
Breast-feeding is possible. However, since 2. BEFORE YOU USE NORLEVO 1.5 MG TABLET
levonorgestrel is excreted into breast milk, it is Do not use NorLevo 1.5 mg tablet
suggested that you breastfeed immediately before - if you are allergic (hypersensitive) to levonorgestrel taking the NorLevo tablet and refrain from nursing or to any of the other ingredients of NorLevo for at least 8 hours following NorLevo administration Take special care with NorLevo 1.5 mg tablet
Ask your doctor or pharmacist for advice before The use of NorLevo is not recommended in the Driving and using machines
- if you have had a tubal (ectopic) pregnancy, - or an infection in your fallopian tubes (salpingitis), After NorLevo intake, some women experienced - if you have personal or family history of known risk fatigue and dizziness (see paragraph 4 “POSSIBLE SIDE EFFECTS”): do not drive or use machines - or if you have a severe digestive disease which impairs absorption of food and medications, No studies on the effect on the ability to drive - or if you have severe hepatic dysfunction or severe and use machines have been reported.
malabsorption syndrome, such as Crohn’s disease.
Important information about some of the
A previous ectopic pregnancy and a previous infection ingredients of NorLevo 1.5 mg tablet
of the fal opian tubes increase the risk of a new ectopic pregnancy. Therefore, if you have had an ectopic monohydrate. If you have been told by your doctor pregnancy or an infection of the fal opian tubes you that you have an intolerance to some sugars, contact should contact your doctor before taking NorLevo.
your doctor before taking this medicinal product.
Emergency contraception must be used only occasional y and should not replace a regular 3. HOW TO USE NORLEVO 1.5 MG TABLET
Always use NorLevo 1.5 mg tablet exactly as your - it does not prevent pregnancy in every instance; doctor has told you. You should check with your - the risk of hormonal overload and cycle disturbance doctor or pharmacist if you are not sure. is not advisable in case of regular intake.
Emergency contraception cannot interrupt a pregnancy.
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,
6. FURTHER INFORMATION
preferably within 12 hours, after unprotected
What NorLevo 1.5 mg tablet contains
intercourse and no longer than 72 hours (3 days)
- The active substance is levonorgestrel.
- The other ingredients are lactose monohydrate, NorLevo can be taken at any time during the maize starch, povidone, colloidal anhydrous Levonorgestrel belongs to a group of medicines If you vomit within three hours of taking the tablet, you should take another tablet immediately.
What NorLevo 1.5 mg tablet looks like and
After using emergency contraception, you should contents of the pack
use a local contraceptive method (condom, NorLevo 1.5 mg tablet is a white, round biconvex spermicide, cervical cap) until your next menstrual tablet engraved with code NL 1.5 on one face.
period. If another unprotected intercourse takes Each pack of NorLevo contains one tablet 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 Marketing Authorisation Holder
of pregnancy. Using NorLevo does not contraindicate LABORATOIRE HRA PHARMA
continuing with regular hormonal contraception.
If you take oral contraception (birth control pills), you should carry on taking your birth control pills Manufacturer
as usual after using NorLevo. In case you do not OSNY PHARMA SAS
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 This medicinal product is authorised
in preventing you from getting pregnant. in the Member States of the EEA under
If you continue to use regular hormonal contraception the following names:
such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to Your next period after you use NorLevo
This leaflet was last approved in 04/2010
After the use of NorLevo, your period is usually normal and will start at the usual day; however NATIONAL INFORMATION
sometimes, this will be a few days later or earlier. a) Some information about the menstrual cycle
If your period is more than 5 days late or is and contraception
unusual y light or unusual y heavy, or if you think - The menstrual cycle
that you might be pregnant caused by another The menstrual cycle is the time elapsed between reason, you should check whether you are pregnant two menstrual periods. Normally, the cycle lasts by a pregnancy test. If you do become pregnant for 28 days although its length can vary noticeably even after taking this medicine, it is important that from one woman to another. Menstrual periods If you use more NorLevo 1.5 mg tablet
- Fertilisation
than you should
At the middle of the cycle, an egg (ovum) is expelled No acute toxicity or serious harmful effects by one of the 2 ovaries (this moment is called has been demonstrated with this medicine in case “ovulation”). Usually ovulation takes place at of intake of several doses. However, you may the middle of the cycle, but it can occur at any feel sick, actual y be sick (vomit) or have vaginal bleeding. You should contact your doctor If sperm cells are near the ovum when it is released, fertilisation (i.e. fusion of a sperm cell with the ovum 4. POSSIBLE SIDE EFFECTS
After a few days, the fertilised ovum implants Like all medicines, NorLevo can cause side effects, in the womb and the pregnancy starts.
- Contraception
The frequency of possible side effects listed below Contraceptive methods are aimed to prevent: is defined using the following convention: - ovulation: this is the case for the contraceptive pill, very common (affects more than 1 user in 10) - fertilisation (fusion of a sperm cell with the ovum): very rare (affects less than 1 user in 10,000) - implantation of a fertilised ovum: this is the case not known (frequency cannot be estimated from The fol owing side effects have been observed: - Emergency contraception
Emergency contraception acts by blocking ovulation or preventing implantation following sexual intercourse. It is not effective if implantation - breast tenderness, delay of menses, heavy Whenever a woman has sexual intercourse without use of a contraceptive method, the possibility If you have taken this medicine but you do not use a regular contraceptive method, it is strongly - Cases of thromboembolic events (bood clotting) recommended you visit your doctor or family have been reported during the postmarketing planning clinic to obtain advice on a contraceptive - Cutaneous hypersensitivity reactions can occur b) Advice in case of risk of transmission
of sexually transmitted disease
If any of the side effects gets serious, or if you notice If you have unprotected sexual intercourse any side effects not listed in this leaflet, please tell you may be at risk of contracting a sexually transmitted disease, particularly if you are unaware of your partner’s sexual history or have multiple partners. If you have any 5. HOW TO STORE NORLEVO 1.5 MG TABLET
Keep out of the reach and sight of children.
Keep the blister in the outer carton in order GLOSSARY
Do not use NorLevo 1.5 mg tablet after the expiry date which is stated on the carton and on the develops outside of the uterus, usually in one blister after EXP. The expiry date refers to the last of the fallopian tubes. Warning signs include persistent abdominal pain, missed menstrual Do not use NorLevo 1.5 mg tablet if you notice visible signs of deterioration; it should be returned of pregnancy (nausea, breast tenderness). If you experience such symptoms, consult Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how - Salpingitis: infection of the fallopian tubes. to dispose of medicines no longer required. These measures will help to protect the environment.

Source: http://www.norlevo.com/medias/notices/Norlevo_Ireland.pdf