1.5 mg tablet
of levonorgestrel
WHAT NORLEVO 1.5 MG TABLET IS AND WHAT IT IS USED FOR
| NorLevo is an emergency contraceptive pill. |
What are emergency – birth control pills?
Acute – birth control pills are intended to prevent pregnancy after unprotected intercourse or if a contraceptive method has not worked.
When should emergency pills be used?
This method of contraception should be used as soon as possible, preferably within 12 hours and not later than 72 hours (3 days) after unprotected intercourse or if a method of contraception has not worked. NorLevo is most effective if you take it as soon as possible after unprotected intercourse. It can only prevent you from getting pregnant if you take it within 72 hours after unprotected intercourse. It does not work if you are already pregnant. If you have had unprotected intercourse after taking NorLevo, it does not prevent you from becoming pregnant.
NorLevo has been shown to prevent 52% to 85% of expected pregnancies.
If you suspect you may be pregnant due to any of the following:
- that you have had intercourse without contraception
- that you forgot to take your birth control pill on time
- that your partner’s condom has broken, slipped or fallen off
- that you think your IUD (intrauterine contraceptive) has been rejected
- that your diaphragm has come out of position or if you have taken it out too soon
- that you are afraid that interrupted intercourse or the calendar method has not worked
- in case of rape.
NorLevo works by preventing the ovaries from releasing an egg. The drug can not stop a fertilized egg from attaching to the uterus.
The tablet is only intended as an emergency contraceptive method, not as a standard contraceptive method as it is less effective than regular birth control pills.
NorLevo is not for use before the first menstrual period ( menarche ).
Levonorgestrel contained in NorLevo may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
WHAT YOU NEED TO KNOW BEFORE USING NORLEVO 1.5 MG TABLET
Do not use NorLevo 1.5 mg tablet
- if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
In the following cases, it is recommended that you do not use NorLevo:
- if you have had an ectopic pregnancy (ectopic pregnancy)
- if you have had ovarian inflammation (salpingitis)
- if you or someone in your family has a known risk factor for thrombosis (blood clot)
- if you have a severe digestive disease that impairs the absorption of food and medicine
- if you have a serious liver disease or any serious disease of the small intestine, e.g. Crohn’s disease .
Previous ectopic pregnancies and previous fallopian tube inflammation increase the risk of a new ectopic pregnancy. Therefore, you should consult a doctor before using NorLevo if you have had an ectopic pregnancy or fallopian tube inflammation.
| Acute – birth control pills may only be used occasionally and should not replace a standard method of contraception because: it does not always protect against pregnancy there is a risk of hormone excess, which can disrupt your menstrual cycle. Acute – birth control pills can not terminate a pregnancy. |
If you have had another unprotected intercourse more than 72 hours ago, you may have become pregnant. Treatment with NorLevo after the second intercourse may therefore be ineffective in preventing pregnancy.
Repeated administration of NorLevo during a menstrual cycle is not recommended as it may upset the cycle.
NorLevo does not work as well as standard contraceptive methods. Your doctor can tell you about long-term contraceptive methods that are more effective in preventing you from getting pregnant.
After taking this medicine:
It is mandatory to rule out pregnancy by taking a pregnancy test:
- if your next period is delayed more than five days
- in case of abnormal bleeding, even if it occurs at the time of expected menstruation.
Acute – birth control pills should be taken as soon as possible after unprotected intercourse. This applies to all women. There is some evidence that the effect of NorLevo may decrease with increasing body weight or body mass index ( BMI ), but these data are limited and incomplete. Therefore, NorLevo is still recommended for all women regardless of weight and BMI.
Talk to your healthcare provider if you have any thoughts about any problems related to the use of emergency contraceptive pills.
If you have not used a condom (or if it has broken or slipped off) during intercourse, you may have contracted a sexually transmitted disease or HIV. Acute – birth control pills do not protect against sexually transmitted diseases and can not replace the precautions necessary for the risk of transmission (see national information).
Children and young people
Do not use this medicine before the first menstrual period ( menarche ).
Other medicines and NorLevo
Tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and (traditional) herbal medicines.
Some medicines may prevent NorLevo from working effectively.
If you have been taking any of the medicines below for the past 4 weeks, NorLevo may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, ie copper coil. If this is not an option for you or if you do not have the opportunity to see a doctor immediately, you can take a double dose of NorLevo:
- barbiturates and other antiepileptic medicines (eg primidone, phenytoin )and carbamazepine)
- drugs against tuberculosis (eg rifampicin, rifabutin)
- treatment of HIV (ritonavir, efavirenz)
- medicines for fungal infections (griseofulvin)
- (traditional) herbal medicines containing St. John’s wort ( Hypericum perforatum ).
Talk to your pharmacist or doctor if you need further advice on the right dose for you.
Consult your doctor as soon as possible after taking the tablets for further advice on reliable common contraceptives and to rule out pregnancy. (See also section 3 “How to use NorLevo 1.5 mg tablet” for further advice).
NorLevo may also affect the effectiveness of other medicines
– a drug called cyclosporin (suppresses the immune system).
NorLevo should not be taken with other medicines containing ulipristal acetate.
Pregnancy and breastfeeding
If you are pregnant
This medicine does not terminate a pregnancy:
If you are taking this medicine and you still become pregnant, studies to date have not shown any risk of malformation of the growing fetus. However, you should not take this medicine if you are pregnant.
If you become pregnant after using NorLevo, consult your doctor. Your doctor may want to check that you have not had an ectopic pregnancy (that the fetus is developing outside the womb). This is especially important if you have severe abdominal pain after taking NorLevo or if you have had an ectopic pregnancy, operated on your fallopian tubes, or had inflammation in the pelvic region.
If you are breast-feeding
You can breastfeed. However, levonorgestrel passes into breast milk. You should therefore breastfeed immediately before taking NorLevo and then wait to breastfeed for at least eight hours after taking NorLevo.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
After using NorLevo, some women may feel tired and dizzy (see section 4 “Possible side effects”): do not drive or use machines if they experience these symptoms.
No studies on the effects on the ability to drive and use machines have been reported.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
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 an intolerance to some sugars, contact your doctor before taking this medicine.
HOW TO TAKE NORLEVO 1.5 MG TABLET
Always use this medicine exactly as described in this leaflet or as instructed by a midwife or pharmacist. If you are not sure, talk to your doctor, midwife, or pharmacist.
NorLevo can be taken at any time during the menstrual cycle if you are not already pregnant or think you may be pregnant.
Do not chew the tablet but swallow it whole with water.
| Take the tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected intercourse. Do not delay ingestion of the tablet. The tablet works better the faster you take it after unprotected intercourse. It can only prevent a pregnancy if you take it within 72 hours after unprotected intercourse. |
- If you are taking any medicine that may prevent NorLevo from working effectively (see section “Other medicines and NorLevo above”) or if you have used any of these medicines in the last 4 weeks, NorLevo may be less effective Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, ie copper IUD If this is not an option for you or if you do not have the opportunity to see a doctor immediately, you can take a double dose of NorLevo (ie 2 tablets at the same time).
- If you are already using a regular contraceptive such as birth control pills , you can continue to take this at the usual times.If you do not get any menstrual bleeding during your next tabletop break, you should do a pregnancy test to rule out pregnancy.
If you vomit within three hours of taking the tablet, take a new tablet immediately.
After you have used emergency contraceptive pills, you should use another method of contraception (condoms, spermicides, diarrhea ) until your next period. If you have further unprotected intercourse after taking NorLevo (even during the same menstrual cycle), the tablets will not have a preventive effect and there is a risk that you will become pregnant. If you use a regular method of contraception, such as birth control pills, you should continue to use it as usual.
Your doctor or midwife can also tell you about long-term contraceptives that are more effective in preventing you from getting pregnant.
If you continue to use regular hormonal contraceptives such as birth control pills and you have not experienced any bleeding during your tablet-free period, you should contact your doctor to check that you are not pregnant.
Your next period after taking NorLevo
After using NorLevo, your period is usually normal and starts on a normal day, but sometimes it can be a few days late or early.
If your period is more than 5 days late or is unusually mild or unusually extensive, or if you think you may be pregnant for some other reason, check if you are pregnant with a pregnancy test. If you become pregnant even after taking this medicine, you must consult a doctor.
If you use more NorLevo 1.5 mg tablet than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
No acute poisoning or serious adverse effects have been demonstrated with multiple doses. However, you may feel nauseous, become nauseous (vomit) or have vaginal bleeding. Contact a doctor or pharmacist for advice.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed:
Very common side effects (may affect more than 1 user in 10):
- dizziness, headache
- nausea, abdominal pain
- tenderness in the breasts, delayed menstruation, heavy menstruation, bleeding, pain in the uterus
- fatigue
Common side effects (may affect up to 1 in 10 people):
- diarrhea, vomiting
- painful menstruation
Has been reported (occurs in an unknown number of users):
- Cases of thromboembolic events (blood clots) have been reported after marketing authorization
- Allergic reactions such as swelling of the throat and face as well as rash may 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 1.5 MG TABLET
Keep this medicine out of the sight and reach of children.
Store the blister pack in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. respectively EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice signs of visible deterioration. Return the medicine to the pharmacy.
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.
CONTENTS OF THE PACKAGING AND OTHER INFORMATION
Content declaration
- The active substance is levonorgestrel.
- The other ingredients are lactose monohydrate , corn starch, povidone, colloidal anhydrous silica, magnesium stearate.
Levonorgestrel belongs to a group of medicines called emergency contraceptives.
What the medicine looks like and contents of the pack
NorLevo 1.5 mg tablet is a white, round, biconvex tablet debossed with NL 1.5 on one side.
Each pack of NorLevo contains one 1.5 mg levonorgestrel tablet.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
LABORATOIRE HRA PHARMA
200 avenue de Paris
92320 CHATILLON
France
Manufacturer
CENEX
17, Rue de Pontoise
95520 Osny
France
or
DELPHARM LILLE SAS
Roubaix-Est Activity Park
22 rue de Toufflers
CS 50070
59452 Lys Lez Lannoy
France
Local representative
Midsona Sverige AB
Box 505 77
202 15 Malmö
Email: lakemedel@midsona.se
This medicinal product is authorized under the European Economic Area under the names:
NorLevo 1.5 mg tablet
Vikela 1.5 mg tablet (Austria)