Vikela_gi_engl_dez2013

PACKAGE LEAFLET: INFORMATION FOR THE USER
NorLevo 1.5 mg tablet
Read all of this leaflet carefully before you start using this medicine.

(Statement to be used when product is delivered without a medical prescription)
This medicine is available without prescription. However, you still need to use NorLevo 1.5 mg tablet
carefully to get the best results from it.
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Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or family planning clinic. 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. (Statement to be used when product is delivered with a medical prescription) This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or family planning clinic. 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.
In this leaflet:
1.
What NorLevo 1.5 mg tablet is and what it is used for WHAT NORLEVO 1.5 MG TABLET IS AND WHAT IT IS USED FOR
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 may 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;
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”).
2.
BEFORE YOU USE NORLEVO 1.5 MG TABLET

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 (see “What Norlevo 1.5 mg tablet is and what it is used for” for further details)
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.

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 (see paragraph 4 “POSSIBLE SIDE
EFFECTS”): 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.
Important information about some of the ingredients of NorLevo 1.5 mg tablet
NorLevo 1.5 mg tablet contains lactose monohydrate. If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before taking this medicinal product.
3
HOW TO USE NORLEVO 1.5 MG TABLET

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 other 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.
4.
POSSIBLE SIDE EFFECTS

Like all medicines, NorLevo can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).
The following side effects have been observed:


breast tenderness, delay of menses, heavy menses, bleeding, uterine pain Cases of thromboembolic events (bood 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.
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 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.
Do not use NorLevo 1.5 mg tablet if you notice visible signs of deterioration; it should be returned to your
pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION

What NorLevo 1.5 mg tablet contains

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The active substance is levonorgestrel. The other ingredients are lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate. Levonorgestrel belongs to a group of medicines called emergency contraceptives.

What NorLevo 1.5 mg tablet looks like and contents of the pack

NorLevo 1.5 mg tablet is a white, round biconvex tablet engraved with code NL 1.5 on one face.
Each pack of NorLevo contains one tablet of 1.5 mg of levonorgestrel.
Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder
<[To be completed nationally]>
{Name and Address}
Manufacturer
CENEXI
17, Rue de Pontoise
95520 OSNY - FRANCE
or
DELPHARM LILLE SAS.
Z.I. de Roubaix Est
Rue des Toufflers
59390 LYS LEZ LANNOY - FRANCE

This medicinal product is authorised in the Member States of the EEA under the following names:
Norlevo 1.5 mg tablet
Vikela 1.5 mg tablet (Austria)

This leaflet was last approved in {MM/YYYY}.
<[To be completed nationally]>
NATIONAL INFORMATION

a) Some information about the menstrual cycle and contraception

- The menstrual cycle
The menstrual cycle is the time elapsed between two menstrual periods. Normally, the cycle lasts for 28 days
although its length can vary noticeably from one woman to another. Menstrual periods occur when a woman
is not pregnant.
- Fertilisation
At the middle of the cycle, an egg (ovum) is expelled by one of the 2 ovaries (this moment is called
“ovulation”).Usually ovulation takes place at the middle of the cycle, but it can occur at any moment during
the cycle.
If sperm cells are near the ovum when it is released, fertilisation (i.e. fusion of a sperm cell with the ovum to
form an embryo) can take place.
After a few days, the fertilised ovum implants in the womb and the pregnancy starts.

- Contraception
Contraceptive methods are aimed to prevent:
- ovulation : this is the case for the contraceptive pill, - fertilisation (fusion of a sperm cell with the ovum): this is the case for condoms, or - implantation of a fertilised ovum: this is the case for intrauterine devices.
- Emergency contraception pills
Emergency contraception pills act by blocking or delaying ovulation following sexual intercourse. They are
not effective if ovulation has already occurred.
Whenever a woman has sexual intercourse occurs without use of a contraceptive method, the possibility of a
pregnancy cannot be excluded.
If you have taken this medicine but you do not use a regular contraceptive method, it is strongly
recommended you visit your doctor or family planning clinic to obtain advice on a contraceptive method
suitable for you.
b) Advice in case of risk of transmission of sexually transmitted disease

If you have unprotected sexual intercourse 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
questions, please ask your pharmacist, doctor or family planning clinic.

GLOSSARY
• Ectopic pregnancy: a pregnancy that develops outside of the uterus, usually in one of the fallopian tubes. Warning signs include persistent abdominal pain, missed menstrual periods, vaginal bleeding, signs of pregnancy (nausea, breast tenderness). If you experience such symptoms, consult your doctor immediately. • Salpingitis: infection of the fallopian tubes. Symptoms include abdominal pain, fever and heavy vaginal

Source: http://www.vikela.info/sites/default/files/pdfs/Vikela_information_for_user_Dec2013.pdf