NORLEVO - PACKAGE LEAFLET - LEAFLETS

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Norlevo - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life

Active ingredients: Levonorgestrel

Norlevo 750 micrograms tablets

Norlevo package inserts are available for pack sizes:

Norlevo 750 micrograms tablets
Norlevo 1.5 mg tablets

Why is Norlevo used? What is it for?

Norlevo is an emergency oral contraceptive.

What is emergency contraception?

Emergency contraception is an emergency method that aims to prevent pregnancy after unprotected sexual intercourse or if a contraceptive method is not working.

When should emergency contraception be used?

This method of birth control should be used as soon as possible, preferably within 12 hours and no later than 72 hours (3 days), after unprotected sexual intercourse or after failure of a contraceptive system. The effectiveness of the method is higher the sooner the treatment is started after unprotected intercourse. Norlevo can prevent pregnancy only if taken within 72 hours of unprotected intercourse. It is not effective if you are already pregnant. If you have unprotected sex after taking Norlevo, the drug will not be able to prevent pregnancy.

Norlevo has been shown to prevent 52% to 85% of expected pregnancies.

If you suspect that you may be pregnant for one of the following reasons:

if you have had sex without using a contraceptive;
if you forgot to take the birth control pill in time;
if your partner's condom broke, slipped or was removed;
if you are concerned that your intrauterine device has been expelled;
if your contraceptive diaphragm or cervical cap has shifted or been removed early;
if he fears that the coitus interruptus method or the rhythm method have not worked;
in case of rape.

Norlevo works by blocking the release of an egg from your ovaries. It cannot prevent implantation of a fertilized egg into the uterus.

This tablet is for emergency contraception only, not regular contraception, since it is less effective than the "regular" birth control pill ("the pill").

Contraindications When Norlevo should not be used

Do not use Norlevo 750 micrograms tablets

if you are allergic (hypersensitive) to levonorgestrel or any of the other ingredients of Norlevo

Take special care with Norlevo 750 microgram tablets

The use of Norlevo is not recommended in the following cases:

if you have had an ectopic (ectopic) pregnancy, - or if you have had an infection of the fallopian tubes (salpingitis),
if you have a personal or family history of known risk factors for thrombosis (blood clotting),
o if you suffer from severe digestive disease which impairs the absorption of food and medicines,
or if you have severe liver problems or severe small bowel disease, such as Crohn's disease

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 a 'fallopian tube infection, you should consult your doctor before taking Norlevo.

Emergency contraception should only be used in exceptional cases and should not replace a regular method of contraception because:

does not prevent pregnancy under all circumstances;
there is a risk of a hormonal overdose which can cause disturbances to your menstrual cycle.

Emergency contraception cannot interrupt an existing pregnancy.

If you have had another unprotected intercourse for more than 72 hours, conception may have occurred. Treatment with Norlevo following the second unprotected intercourse may therefore prove ineffective in preventing pregnancy.

Repeated administration of Norlevo within the same menstrual cycle is not recommended due to the possibility of cycle alterations.

Norlevo does not work in the same way as regular contraception methods. Your doctor can tell you about long-term contraception methods that are more effective in preventing pregnancy.

Precautions for use What you need to know before taking Norlevo

After taking this medicine:

It is mandatory to verify the absence of pregnancy by performing a pregnancy test:

if your period is more than five days late,
in case of abnormal bleeding even if on the expected date of the menstrual period.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. According to some data, Norlevo may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive. Therefore, Norlevo is recommended for all women regardless of weight or BMI.

If you are concerned that you have any problems with taking emergency contraception, talk to a healthcare professional

If a condom was not used during intercourse (or if it broke or slipped off), it may be possible that you have contracted a sexually transmitted disease or HIV virus. The use of emergency contraception does not protect against sexually transmitted diseases, nor can it replace the necessary precautions and measures to be taken in the event of a risk of transmission (see National Information).

Interactions Which drugs or foods may change the effect of Norlevo

The medicines listed below, including medicines that do not require a prescription, may reduce or negate the effectiveness of Norlevo:

Some medicines used to treat epilepsy (phenobarbital, phenytoin, primidone, carbamazepine),
Some medicines used to treat HIV infections (ritonavir),
Some medicines to treat some infections (rifabutin, rifampicin, griseofulvin),
Preparations based on medicinal plants containing St. John's wort (Hypericum perforatum).

Norlevo should not be used together with drugs containing ulipristal acetate.

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant:

This medicine does not interrupt an ongoing pregnancy.

If you take this contraceptive and still become pregnant, studies performed to date have shown no risk of malformation of the developing fetus.

In any case, this medicine must not be taken if you are pregnant.

If you become pregnant after taking Norlevo, you should contact your doctor. Your doctor may want to check if the pregnancy is not ectopic (development of the baby outside the womb). This is especially important if you have severe abdominal pain after taking Norlevo or if you have already had an ectopic pregnancy, fallopian tube surgery or inflammatory pelvic disease.

If you are breastfeeding:

It is possible to breastfeed. However, as levonorgestrel is excreted in breast milk, it is advised to breastfeed immediately before taking the Norlevo tablet and to avoid breastfeeding for at least 8 hours after taking Norlevo.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

After taking Norlevo, some women have experienced fatigue and dizziness (see section 4 "POSSIBLE SIDE EFFECTS"): do not drive or use machines if these symptoms occur.

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 750 microgram tablets

Norlevo 750 micrograms tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Dosage and method of use How to use Norlevo: Dosage

Always use Norlevo 750 micrograms tablets exactly as your doctor or pharmacist has told you.

If in doubt, you should consult your doctor or pharmacist. Norlevo is for oral use. The tablets should be taken with a glass of water and should not be chewed

The two tablets should be taken in a single administration as soon as possible, preferably within 12 hours, after unprotected intercourse and no later 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 tablets, you must immediately take two more tablets. Contact your pharmacist or doctor for more tablets.

After using an emergency contraceptive, you must use a local method of contraception (condom, spermicide, cervical cap) until the next menstruation resumes. If another unprotected intercourse occurs after taking Norlevo (even if it occurs during the same menstrual cycle), the tablets do not exert their contraceptive effect and there is a risk of pregnancy again. If you are using a regular method. contraception such as the oral birth control pill, you should continue to take it normally.

If you are taking oral contraceptives (birth control pills), you should continue taking the pill as usual after taking Norlevo. If your period does not appear during the pill withdrawal period, do a pregnancy test to rule out pregnancy.

Your doctor can also tell you which long-term birth control methods are most effective in preventing pregnancy. If you continue to use hormonal contraception regularly such as the birth control pill and do not leak during the pill withdrawal period, consult your doctor to make sure you are not pregnant.

Menstrual period after taking Norlevo

After taking Norlevo, menstrual periods are usually normal and occur on the expected date; but sometimes they can be anticipated or delayed by a few days.

If your period is more than 5 days late or is unusually short or unusually heavy, or if you think you may be pregnant for any other reason, you should check if you are pregnant by taking a pregnancy test. If you become pregnant even after taking this medicine, it is important that you consult your doctor.

Overdose What to do if you have taken too much Norlevo

If you take more Norlevo 750 microgram tablets than you should

No acute toxicity or serious adverse effects have been observed when taking multiple doses of this medicine. However, you may feel nauseous, vomit, or have vaginal bleeding. You need to contact your doctor or pharmacist.

If you forget to take Norlevo 750 microgram tablets

The efficacy of this medicine is not guaranteed if one tablet is omitted.

If you have any further questions on the use of Norlevo 750 microgram tablets, ask your doctor or pharmacist.

Side Effects What are the side effects of Norlevo

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 parameters:

very common (affecting more than 1 in 10 users)

common (affecting 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:

Very common side effects:

dizziness, headache
nausea, abdominal pain
breast tenderness, menstruation delay, heavy periods, uterine bleeding, pain in the uterus
fatigue

Common side effects:

Diarrhea, vomiting
Painful menstruation

Frequency not known:

Cases of thromboembolic events (blood clotting) have been reported during the postmarketing period
Allergic reactions such as swelling of the throat and face and skin rashes may occur after taking this medicine.

If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Expiry and Retention

Keep this medicine out of the reach and sight of children.

Keep the blister in the outer carton to protect the medicine from light.

Do not use Norlevo 750 microgram tablets after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not use Norlevo 750 microgram tablets if you notice visible signs of deterioration; in this case, return it to the pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

OTHER INFORMATION

What Norlevo 750 micrograms tablets contain

The active ingredient is levonorgestrel.
The other ingredients are: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate

Levonorgestrel belongs to the group of drugs called emergency contraceptives.

What Norlevo 750 microgram tablets look like and contents of the pack

Norlevo 750 micrograms tablets are white, biconvex, round unbranded tablets.

Each pack of Norlevo contains two 750 microgram tablets of levonorgestrel.

NATIONAL INFORMATION

a) Some information on the menstrual cycle and contraception

Period

The menstrual cycle is the time between two menstrual periods. Normally the cycle lasts 28 days, although its duration can vary greatly from one woman to another. Menstrual periods occur when a woman is not pregnant.

Fertilization

In the middle of the cycle, an egg (ovum) is expelled from one of the 2 ovaries (this time is called "ovulation"). Ovulation usually occurs in the middle of the cycle, but it can occur at any time in the cycle. If the spermatozoa are in the vicinity of the egg when it is released, fertilization (ie the fusion of a sperm with the egg to form an embryo). After a few days, the fertilized egg implants itself in the uterus and pregnancy begins.

Contraception

The methods of contraception are aimed at preventing:

l "ovulation: this is the case with the contraceptive pill,
fertilization (fusion of a spermatozoon with the egg): this is the case with condoms or
the implantation of a fertilized egg: this is the case with intrauterine devices.
Emergency contraception pills

Emergency contraception pills work by blocking or delaying ovulation after intercourse. They are not effective if ovulation has already occurred.

Whenever a woman has intercourse without using a contraceptive method, the possibility of pregnancy cannot be ruled out.

If you have taken this medicine but do not use a regular method of birth control, it is strongly recommended that you contact your doctor or family clinic for advice on an appropriate method of birth control for you.

b) Recommendations in case of risk of transmission of sexually transmitted diseases

If you have unprotected sex, you may be at risk of contracting sexually transmitted diseases, especially if you don't know your partner's sexual history or have multiple partners. If you have any further questions, ask your pharmacist, doctor or family clinic.

GLOSSARY

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

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Norlevo can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

NORLEVO

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains: Active ingredient: levonorgestrel 750 mcg.

For excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Tablets.

White, round, unbranded tablets.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Emergency contraceptive to be used within 72 hours of unprotected sexual intercourse or if a contraceptive system is not working.

04.2 Posology and method of administration

The treatment requires the intake of two tablets in a single administration. The effectiveness of the method is higher the sooner the treatment is started after unprotected intercourse.

Therefore, the two tablets should be taken as soon as possible, preferably within 12 hours, after unprotected intercourse and no later than 72 hours (3 days) after intercourse.

Norlevo can be taken at any time during the menstrual cycle.

If vomiting occurs within three hours of taking the tablets, two more tablets should be taken immediately.

After using the emergency contraceptive, it is recommended to use a local contraceptive (condom, spermicide, diaphragm) until the next menstrual cycle. The use of Norlevo does not contraindicate the continuation of regular hormonal contraception.

04.3 Contraindications

Hypersensitivity to levonorgestrel or to any of the excipients.

04.4 Special warnings and appropriate precautions for use

Emergency contraception is an occasional method.

In no case should it replace the use of a regular contraceptive method.

Emergency contraception is not always effective in preventing pregnancy, especially if there is uncertainty about when unprotected intercourse occurred.

In case of doubt (menstruation delayed by more than 5 days or abnormal bleeding at the expected date of menstruation, pregnancy symptoms) it is mandatory to verify the absence of pregnancy by carrying out a pregnancy test.

If a woman has had unprotected intercourse for more than 72 hours during the same menstrual cycle, conception may have occurred. Treatment with Norlevo following the second unprotected intercourse may therefore prove ineffective in preventing pregnancy.

If pregnancy occurs after treatment with Norlevo, the possibility of an ectopic pregnancy should be considered. The absolute risk of an ectopic pregnancy is probably low as Norlevo prevents ovulation and fertilization. The ectopic pregnancy can continue despite the occurrence of uterine bleeding. Norlevo should therefore not be given to patients at risk of ectopic pregnancy (clinical history of salpingitis or ectopic pregnancy).

Norlevo must not be used in patients with severe hepatic dysfunction. Severe malabsorption syndromes, such as Crohn's disease, can impair the effectiveness of Norlevo.

After taking Norlevo, menstrual periods are of normal duration, occur on the expected date and are of normal abundance. Sometimes they can be anticipated or delayed by a few days.

A medical examination is recommended to initiate or adopt a regular method of contraception. If the drug has been taken during regular hormonal contraception and no menstruation occurs during the pill withdrawal period following the use of Norlevo, it must be ensured that there is no pregnancy in progress.

Repeated administration within the same menstrual cycle is not recommended, in order to avoid the patient an undesirably high hormonal load and the possibility of severe cycle disturbances.

Women who come repeatedly for emergency contraception should be advised to consider a long-term method of contraception.

The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases.

The medicine contains lactose; therefore patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take the medicine.

04.5 Interactions with other medicinal products and other forms of interaction

Associations to be considered:

The metabolism of levonorgestrel increases with the concomitant use of drugs inducing liver enzymes: anticonvulsants (phenobarbital, phenytoin, primidone, carbamazepine); rifabutin; rifampicin; griseofulvin; ritonavir; preparations based on Hypericum perforatum (St. John's wort). "Norlevo's effectiveness may be decreased by concomitant use of these drugs.

04.6 Pregnancy and lactation

Pregnancy:

The drug is not indicated in case of pregnancy already in progress (see section 5.3) and cannot terminate the pregnancy itself. In case of failure of this method of contraception, with continuation of pregnancy, epidemiological studies have indicated that progestins have no adverse effects of a malformative type on the fetus. The consequences for the newborn are not known if doses higher than 1.5 mg of levonorgestrel are taken.

Feeding time:

Levonorgestrel is excreted in breast milk. Therefore it is recommended to breastfeed immediately before taking Norlevo tablets and to omit breastfeeding after taking Norlevo for at least 6 hours.

04.7 Effects on ability to drive and use machines

No studies on the ability to drive and use machines have been reported.

04.8 Undesirable effects

The table below shows the frequency of undesirable effects reported in clinical studies.

Table 1 - Undesirable effects in women after taking 2 tablets in a single administration

Side effects Percentage of women with side effect in two studies * Nausea 14-24.3 Lower abdominal pain 14-15.6 Fatigue 141 Headache 10-21.3 Dizziness 10-12.6 Breast tenderness 8-12.9 He retched 1-7.8 Abundant menstruation 15.5 2 Diarrhea 41 Uterine bleeding 311 Delay of menstruation 5-19.93

* Study 1 (n = 544): Contraception, 2002,66,269-273

* Study 2 (n = 1359): Lancet, 2002,360: 1803-10

1 Not reported in Study 1

2 Not reported in Study 2

3 Delay understood as greater than 7 days

These effects generally disappear within 48 hours of taking Norlevo. Breast tenderness, spotting and irregular uterine bleeding are reported in more than 30% of patients and may last until the next menstruation which may be delayed.

Hypersensitivity skin reactions have been reported after taking Norlevo.

04.9 Overdose

No serious effects have been reported after acute ingestion of high doses of oral contraceptives. An overdose can cause nausea and withdrawal bleeding. There are no specific antidotes and treatment should be symptomatic.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Progestogens - G03AC03:

Norlevo's mechanism of action is not precisely known.

At the dose regimen used, levonorgestrel is believed to suppress ovulation thereby inhibiting fertilization if intercourse occurred in the preovulatory phase, when the likelihood of fertilization is greatest. The drug may also prevent implantation; it is no longer effective when the implantation process has already begun.

In clinical studies, Norlevo has been shown to prevent 85% of expected pregnancies.

The effectiveness appears to decrease with the time elapsed after intercourse (95% within 24 hours, 85% between 24 and 48 hours, 58% when used between 48 and 72 hours). The effectiveness after 72 hours is not known.

At the dose regimen used, levonorgestrel is not expected to induce significant changes in coagulation factors, lipid and carbohydrate metabolism.

05.2 Pharmacokinetic properties

Bioavailability after oral administration of levonorgestrel is approximately 100%.

In plasma it binds strongly to sex hormone binding globulins (SHBG).

Levonorgestrel is metabolically eliminated by the kidney (60-80%) and the liver (40-50%). After oral administration of 1.5 mg of levonorgestrel, the plasma half-life of the product is estimated to be 43 hours. Maximum plasma levels of levonorgestrel (approximately 40 nmol / L) are reached within three hours of administration.

Levonorgestrel is hydroxylated in the liver and the metabolites are eliminated as glucurono-conjugates.

05.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans beyond the information already reported in other sections of this Summary of Product Characteristics. Animal experiments with levonorgestrel have shown virilization of female fetuses at high doses.