NORLEVO 1.5 mg Tablet

Зміст інструкції

1. Norlevo 1,5 mg tablets
   1. WHAT IS NORLEVO 1.5 MG TABLETS AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING NORLEVO 1.5 MG TABLETS
   3. HOW TO USE NORLEVO 1,5 MG TABLETS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE NORLEVO 1,5 MG TABLETS
   6. CONTENUTO DELLA CONFEZIONE E ALTRE INFORMAZIONI
2. Norlevo 1,5 mg tablets
   1. WHAT NORLEVO 1,5 MG TABLETS ARE AND WHAT THEY ARE USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING NORLEVO 1.5 MG TABLETS
   3. HOW TO USE NORLEVO 1,5 MG TABLETS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE NORLEVO 1,5 MG TABLETS
   6. CONTENT OF THE PACK AND OTHER INFORMATION

Norlevo 1,5 mg tablets

Levonorgestrel

Read this leaflet carefully before using this medicinebecause it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist or family planning clinic has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor, pharmacist or family planning clinic. If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Norlevo 1,5 mg tablets is and what it is used for
• 2. What you need to know before using Norlevo 1,5 mg tablets
• 3. How to use Norlevo 1,5 mg tablets
• 4. Possible side effects
• 5. How to store Norlevo 1,5 mg tablets
• 6. Contents of the pack and other information

1. WHAT IS NORLEVO 1.5 MG TABLETS AND WHAT IS IT USED FOR

Norlevo is an emergency oral contraceptive.

What is emergency contraception?
Emergency contraception is an emergency method aimed at preventing pregnancy
after unprotected sexual 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 72 hours (3 days), after unprotected sexual intercourse or after the failure
of a contraceptive system. The effectiveness of the method is all the greater the sooner treatment is started
after unprotected sexual intercourse. Norlevo can only prevent pregnancy if
taken within 72 hours of unprotected sexual intercourse. It is not effective if you are already pregnant.
If you have unprotected sexual intercourse after taking Norlevo, the medicine will not be able to prevent
pregnancy.
It has been shown that Norlevo prevents 52% to 85% of expected pregnancies.
If you suspect you may become pregnant for any of the following reasons:

• if you have had sexual intercourse without using contraception;
• if you forgot to take your contraceptive pill on time;
• if your partner's condom broke, slipped off or was removed;
• if you fear that your intrauterine device has been expelled;
• if your cervical cap or diaphragm has moved or been removed prematurely;
• if you fear that the withdrawal method or the rhythm method have not worked;
• in case of sexual assault.

Norlevo works by blocking the release of an egg from your ovaries. It cannot prevent implantation in the uterus
of a fertilized egg.
This tablet is only for emergency contraception, not for regular contraception, since
it is less effective than the “regular” contraceptive pill (“the pill”).
Norlevo is not indicated for use before the first menstrual bleeding (menarche).

2. WHAT YOU NEED TO KNOW BEFORE USING NORLEVO 1.5 MG TABLETS

Do not use Norlevo 1.5 mg tablets

• if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

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

• if you have had an ectopic pregnancy,
• or if you have had an infection of the fallopian tubes (salpingitis),
• if you have a personal or family history of factors known to increase the risk of thrombosis (blood clots),
• or if you suffer from a severe digestive disease that impairs the absorption of food and medicines,
• or in case of severe liver problems or severe small intestine 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 an infection
of the fallopian tubes, you should consult your doctor before taking Norlevo.
Emergency contraception should only be used in exceptional cases and should not replace a
regular contraceptive method because:

• it does not prevent pregnancy in every circumstance;
• 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 more than 72 hours ago, conception may have occurred. The
treatment with Norlevo following the second unprotected intercourse may therefore be ineffective in
preventing pregnancy.
Repeated administration of Norlevo within the same menstrual cycle is not recommended due to the possibility
of menstrual cycle alterations.
Norlevo does not work in the same way as regular contraceptive methods. Your doctor can advise you on
long-term contraceptive methods that are more effective in preventing pregnancy.
After you have taken this medicine:
It is essential to check for pregnancy by performing a pregnancy test:

• if your period is delayed by more than five days,
• in case of abnormal bleeding even if it is on the expected date of your 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 an increase in body
weight or body mass index (BMI), but this data is limited and not conclusive. Therefore,
Norlevo is recommended for all women regardless of weight or BMI.
If you are concerned about problems related to taking emergency contraception, talk to a
healthcare professional.
If, during intercourse, a condom was not used (or it broke or slipped), it is 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, nor can it replace the necessary
precautions and measures to be taken in case of risk of transmission (see National Information).

Children and adolescents
The effectiveness of Norlevo in adolescents (under 18 years of age) is comparable to that of the
adult population. The dose for adolescents is the same as for adults.
Do not administer this medicine before the first menstrual bleeding (menarche).

Other medicines and Norlevo 1.5 mg
Tell your pharmacist or doctor if you are taking or have recently taken any other medicines,
including those obtained without a prescription or herbal medicines.
Some medicines may prevent Norlevo from working effectively. If you have used any of the
medicines listed below during the last 4 weeks, Norlevo may be less suitable for
you. Your doctor may prescribe you another type (non-hormonal) of emergency contraception, namely a
copper intrauterine device (Cu-IUD). If this is not an acceptable option for you or if
you cannot go to the doctor promptly, take a double dose of Norlevo:

• barbiturates and other medicines (used for the treatment of epilepsy (e.g. primidone, phenytoin and carbamazepine)
• medicines used in the treatment of tuberculosis (e.g. rifampicin, rifabutin)
• a treatment for HIV (ritonavir, efavirenz)
• a medicine used to treat fungal infections (griseofulvin)
• herbal preparations containing St. John's Wort (Hypericum perforatum)

Ask your doctor or pharmacist if you need further advice on the correct dose of medicine
for you.
After taking the tablets, consult your doctor as soon as possible for further advice on how to use
regular and reliable contraception and to rule out a
pregnancy. (See also section 3 “HOW TO USE NORLEVO 1.5 MG TABLETS” for further
information).
Norlevo may also affect the functioning of other medicines

• a medicine called cyclosporine (which suppresses the immune system).

Norlevo must not be used together with medicines containing ulipristal acetate.

Pregnancy and breastfeeding

If you are pregnant:
This medicine does not interrupt an existing pregnancy.
If you take this contraceptive and still become pregnant, studies conducted to date have not
shown any risk of malformation of the developing fetus.
In any case, this medicine should not be taken during pregnancy.
If you become pregnant after taking Norlevo, you should contact your doctor. The doctor may want to check
if the pregnancy is not ectopic (development of the baby outside the uterus). This is particularly
important if you have severe abdominal pain after taking Norlevo or if
you have already had an ectopic pregnancy, surgery on the fallopian tubes or a pelvic inflammatory disease.

If you are breastfeeding:
Breastfeeding is possible. However, since levonorgestrel is excreted in breast milk, it is recommended to breastfeed
immediately before taking the Norlevo tablet and to avoid breastfeeding for at least 8 hours
after taking Norlevo. During this period, if you express milk, you should throw it away.
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 vehicles or use machines if you experience such
symptoms.
No studies have been reported on the effect on the ability to drive vehicles and operate machinery.

Important information about some ingredients of Norlevo 1.5 mg tablets
Norlevo 1.5 mg tablets contain lactose monohydrate. If your doctor has diagnosed you with a
lactose intolerance, consult him before taking this medicine.

3. HOW TO USE NORLEVO 1,5 MG TABLETS

Take Norlevo 1,5 mg tablets following exactly what is stated in this leaflet or by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Norlevo can be taken at any time during the menstrual cycle provided you are not pregnant or suspect you may be pregnant. Do not chew the tablet but swallow it whole with some water.
Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3
days) after unprotected sexual intercourse. Do not delay taking the tablet. The effectiveness
of the tablet is the higher the sooner it is taken after unprotected sexual intercourse. The
tablet can only prevent pregnancy if taken within 72 hours of unprotected sexual intercourse.

• If you are using any of the medicines that may prevent Norlevo from working properly (see the section above “Other medicines and Norlevo 1,5 mg”) or if you have used any of these medicines in the last 4 weeks, Norlevo may be less effective for you. Your doctor may prescribe you another type of emergency contraception (non-hormonal), namely a copper intrauterine device (Cu-IUD). If this is not an acceptable option for you or if you cannot promptly see a doctor, take a double dose of Norlevo 1,5 mg tablets (i.e. 2 tablets taken together at the same time).
• If you are already using a regular contraceptive method, such as the pill, you can continue taking it at the usual times. If your period does not occur during the pill-free interval, perform a pregnancy test to rule out pregnancy.

In case of vomiting within three hours of taking the tablet, you should immediately take another
tablet. Contact your pharmacist or doctor to obtain another tablet.
After using emergency contraception, you should use a local (barrier, spermicidal, cervical cap) contraceptive
method until the next period. If another unprotected intercourse occurs after taking Norlevo (even if it occurs during the same
menstrual cycle), the tablet will not have its contraceptive effect and there is again a risk
of pregnancy. If you are using a regular method of contraception such as the oral contraceptive
pill, you should continue to take it normally.
Your doctor can also inform you about long-term contraceptive methods that are more effective in
preventing pregnancy.
If you continue to use hormonal contraception regularly, such as the contraceptive pill,
and do not have any bleeding during the pill-free interval, consult your doctor to make sure you are not
pregnant.

Menstrual period following the use of Norlevo
After taking Norlevo, periods are usually normal and occur on the expected date;
but sometimes they may be anticipated or delayed by a few days.
If your period is delayed by more than 5 days or is unusually light 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.

If you take more Norlevo 1,5 mg tablets than you should
No acute toxicity or serious adverse effects have been observed in case of taking more doses of this
medicine. However, you may experience nausea, vomiting or vaginal bleeding. It is necessary
to see your doctor or pharmacist.

4. 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 in 10 people):

• dizziness, headache
• nausea, abdominal pain
• breast tenderness, delayed menstruation, heavy menstrual bleeding, uterine bleeding, uterine pain
• fatigue

Common side effects (may affect up to 1 in 100 people):

• Diarrhea, vomiting
• Painful menstruation

Not known (frequency cannot be estimated from the available data):

• Cases of thromboembolic events (blood clotting) have been reported during the post-marketing 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 worse, or if you notice any side effect

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE NORLEVO 1,5 MG TABLETS

Keep this medicine out of the reach and sight of children.
Keep the blister in the outer packaging to protect the medicine from light.
Do not use this medicine 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 this medicine if you notice visible signs of deterioration; in that case return it to the pharmacist.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. CONTENUTO DELLA CONFEZIONE E ALTRE INFORMAZIONI

Cosa contiene Norlevo 1,5 mg compresse

• Il principio attivo è levonorgestrel.
• Gli altri componenti sono: lactose monohydrate, corn starch, povidone, anhydrous colloidal silica, magnesium stearate. Levonorgestrel belongs to the group of medicines called emergency contraceptives

Descrizione dell’aspetto di Norlevo 1,5 mg compresse e contenuto della confezione
Norlevo 1,5 mg is a white, biconvex and round tablet with the code NL1.5 engraved on one side.
Each pack of Norlevo contains one 1.5 mg tablet of levonorgestrel.

Titolare dell’Autorizzazione all’Immissione in Commercio e Produttore

Titolare dell’autorizzazione all’immissione in commercio

LABORATOIRE HRA PHARMA
200, avenue de Paris
92320 CHATILLON - FRANCIA

Legale rappresentante in Italia:

Perrigo Italia S.r.l
Viale dell’Arte, 25 – 00144 Roma (RM)

Produttore

CENEXI
17, Rue de Pontoise
95520 OSNY - FRANCIA
o

DELPHARM LILLE S.A.S.
Parc d’Activités Roubaix-Est
22 rue de Toufflers
CS 50070
59452 LYS LEZ LANNOY - FRANCIA

Questo medicinale è autorizzato negli Stati Membri dello Spazio Economico Europeo con le
seguenti denominazioni
Norlevo 1,5 mg compresse
Vikela 1,5 mg compresse (Austria)

INFORMAZIONI NAZIONALI
a) Alcune informazioni sul ciclo mestruale e la contraccezione

• Ciclo mestruale The menstrual cycle is the time between two menstrual periods. Normally the cycle lasts 28 days, although its duration can vary considerably from woman to woman. Menstrual periods occur when a woman is not pregnant.
• Fecondazione Mid-cycle, an egg (ovum) is released from one of the 2 ovaries (this moment is called "ovulation"). Ovulation normally occurs mid-cycle, but can occur at any time during the cycle. If sperm are present near the egg when it is released, fertilization (i.e. the fusion of a sperm with the egg to form an embryo) can occur.

After a few days, the fertilized egg implants in the uterus and pregnancy begins.

• Contraccezione Contraceptive methods aim to prevent:
• ovulation: this is the case with the contraceptive pill,
• fertilization (fusion of a sperm 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 sexual intercourse. They are not effective if ovulation has already occurred.

Whenever a woman has sexual intercourse without using a contraceptive method, the possibility of pregnancy cannot be
excluded.
If she has taken this medicine but does not use a regular contraceptive method, it is strongly
recommended to contact her doctor or a family planning clinic for advice on a
contraceptive method appropriate for her case.

b) Raccomandazioni in caso di rischio di trasmissione di malattie trasmesse sessualmente
If you have unprotected sexual intercourse, you may be at risk of contracting sexually
transmissible diseases, especially if you do not know your partner's sexual history or have multiple partners. If you have any
doubts, consult your pharmacist, doctor or family planning clinic.

GLOSSARIO

• Gravidanza ectopica: ectopic pregnancy: a pregnancy that develops outside the uterus, usually in one of the fallopian tubes. Warning signs include persistent abdominal pain, missed menstrual period, vaginal bleeding, pregnancy symptoms (nausea, breast tenderness). If such symptoms occur, consult a doctor immediately.
• Salpingite: salpingitis: infection of the fallopian tubes. Symptoms include abdominal pain, fever, and heavy vaginal discharge.

Norlevo 1,5 mg tablets

Levonorgestrel

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or family planning clinic.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Norlevo 1,5 mg tablets is and what it is used for
• 2. What you need to know before using Norlevo 1,5 mg tablets
• 3. How to use Norlevo 1,5 mg tablets
• 4. Possible side effects
• 5. How to store Norlevo 1,5 mg tablets
• 6. Contents of the pack and other information

1. WHAT NORLEVO 1,5 MG TABLETS ARE AND WHAT THEY ARE USED FOR

Norlevo is an emergency oral contraceptive.

What is emergency contraception?
Emergency contraception is an emergency method intended to prevent pregnancy
after unprotected sexual 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 72 hours (3 days), after unprotected sexual intercourse or after the failure
of a contraceptive system. The effectiveness of the method is all the greater the sooner treatment is started
after unprotected sexual intercourse. Norlevo can prevent pregnancy only if
taken within 72 hours of unprotected sexual intercourse. It is not effective if you are already pregnant.
If you have unprotected sexual intercourse after taking Norlevo, the medicine will not be able to prevent
pregnancy.
It has been shown that Norlevo prevents 52% to 85% of expected pregnancies.
If you suspect you may be pregnant for any of the following reasons:

• if you have had sexual intercourse without using contraception;
• if you forgot to take your contraceptive pill on time;
• if your partner's condom broke, slipped off, or was removed;
• if you fear that your intrauterine device has been expelled;
• if your cervical diaphragm or cap has shifted or been removed prematurely;
• if you fear that the withdrawal method or the rhythm method have not worked;
• in case of sexual assault.

Norlevo works by blocking the release of an egg from your ovaries. It cannot prevent the implantation in the uterus
of a fertilised egg.
This tablet is only for emergency contraception, not for regular contraception, since
it is less effective than the “regular” contraceptive pill (“the pill”).
Norlevo is not indicated for use before the first menstrual bleeding (menarche).

2. WHAT YOU NEED TO KNOW BEFORE USING NORLEVO 1.5 MG TABLETS

Do not use Norlevo 1.5 mg tablets

• if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

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

• if you have had an ectopic pregnancy,
• or if you have had an infection of the fallopian tubes (salpingitis),
• if you have a personal or family history of factors known to increase the risk of thrombosis (blood clots),
• or if you suffer from a severe digestive disease that compromises the absorption of food and medicines,
• or in case of severe liver problems or severe small intestine 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 an infection
of the fallopian tubes, you should consult your doctor before taking Norlevo.
Emergency contraception should only be used in exceptional cases and should not replace a
regular contraceptive method because:

• it does not prevent pregnancy in every circumstance;
• there is a risk of a hormonal overdose which may cause disturbances to your menstrual cycle. Emergency contraception cannot interrupt an existing pregnancy.

If you have had another unprotected intercourse more than 72 hours ago, conception may have occurred. The
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 menstrual cycle alterations.
Norlevo does not work in the same way as regular contraceptive methods. Your doctor can advise you on
long-term contraceptive methods that are more effective in preventing pregnancy.
After you have taken this medicine:
It is essential to check for the absence of pregnancy by performing a pregnancy test:

• if your period is delayed by more than five days,
• in case of abnormal bleeding even if it occurs on the expected date of your 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 an increase in body
weight or body mass index (BMI), but this data is limited and inconclusive. Therefore,
Norlevo is recommended for all women regardless of weight or BMI.
If you are concerned about problems related to taking emergency contraception, talk to a
healthcare professional.
If, during intercourse, a condom was not used (or it broke or slipped), it may be possible that
you have contracted a sexually transmitted disease or HIV. 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 case of risk of transmission (see National Information).

Children and adolescents
The effectiveness of Norlevo in adolescents (under 18 years of age) is comparable to that of the
adult population. The dose for adolescents is the same as for adults.
Do not administer this medicine before the first menstrual bleeding (menarche).

Other medicines and Norlevo 1.5 mg
Tell your pharmacist or doctor if you are taking or have recently taken any other medicines,
including those obtained without a prescription or herbal medicines.
Some medicines may prevent Norlevo from working effectively. If you have used any of the
medicines listed below during the last 4 weeks, Norlevo may be less suitable for
you. Your doctor may prescribe you another type (non-hormonal) of emergency contraception, namely a
copper intrauterine device (Cu-IUD). If this is not an acceptable option for you or if
you cannot go to the doctor promptly, take a double dose of Norlevo:

• barbiturates and other medicines (used for the treatment of epilepsy (e.g. primidone, phenytoin and carbamazepine)
• medicines used in the treatment of tuberculosis (e.g. rifampicin, rifabutin)
• a treatment for HIV (ritonavir, efavirenz)
• a medicine used to treat fungal infections (griseofulvin)
• herbal preparations containing St. John's Wort (Hypericum perforatum)

Ask your doctor or pharmacist if you need further advice on the correct dose of medicine
for you.
After taking the tablets, see your doctor as soon as possible for further advice on how to
use regular and reliable contraception and to rule out a
pregnancy. (See also section 3 “HOW TO USE NORLEVO 1.5 MG TABLETS” for further
information).
Norlevo may also affect the functioning of other medicines

• a medicine called cyclosporine (which suppresses the immune system).

Norlevo must not be used together with medicines containing ulipristal acetate.

Pregnancy and breastfeeding

If you are pregnant:
This medicine does not interrupt an existing pregnancy.
If you take this contraceptive and still become pregnant, studies conducted to date have not
shown any risk of malformation of the developing fetus.
However, this medicine should not be taken during pregnancy.
If you become pregnant after taking Norlevo, you should contact your doctor. The doctor may want to check
whether the pregnancy is not ectopic (development of the baby outside the uterus). This is of particular
importance if you have severe abdominal pain after taking Norlevo or if
you have already had an ectopic pregnancy, surgery on the fallopian tubes or a pelvic inflammatory disease.

If you are breastfeeding:
Breastfeeding is possible. However, since levonorgestrel is excreted in breast milk, it is recommended to breastfeed
immediately before taking the Norlevo tablet and to avoid breastfeeding for at least 8 hours
after taking Norlevo. During this period, if you express milk, it should be discarded.
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 vehicles or use machines if you experience these
symptoms.
No studies have been reported on the effect on the ability to drive vehicles and operate machinery.

Important information about some ingredients of Norlevo 1.5 mg tablets
Norlevo 1.5 mg tablets contain lactose monohydrate. If your doctor has diagnosed you with
lactose intolerance, contact him/her before taking this medicine.

3. HOW TO USE NORLEVO 1,5 MG TABLETS

Take Norlevo 1,5 mg tablets following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Norlevo can be taken at any time during your menstrual cycle provided you are not pregnant or suspect 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 sexual intercourse. Do not delay taking the tablet. The effectiveness
of the tablet is higher the sooner it is taken after unprotected sexual intercourse. The
tablet can only prevent pregnancy if taken within 72 hours of unprotected sexual intercourse.

• If you are using any medicines that may prevent Norlevo from working properly (see the section above “Other medicines and Norlevo 1,5 mg”) or if you have used any of these medicines in the last 4 weeks, Norlevo may be less effective for you. Your doctor may prescribe you another type of emergency contraception (non-hormonal), namely a copper intrauterine device (Cu-IUD). If this is not an acceptable option for you or if you cannot get to your doctor promptly, take a double dose of Norlevo 1,5 mg tablets (i.e. 2 tablets taken together at the same time).
• If you are already using a regular method of contraception, such as the pill, you can continue taking it at your usual times. If your period does not occur during the pill-free break, take a pregnancy test to rule out pregnancy.

In case of vomiting within three hours of taking the tablet, you should immediately take another
tablet. Contact your pharmacist or doctor to obtain another tablet.
After using emergency contraception, you should use a local (barrier, spermicidal, cervical cap) method of contraception
until your next period. If another unprotected intercourse occurs after taking Norlevo (even if it occurs during the same
menstrual cycle), the tablet will not have its contraceptive effect and there is a renewed risk
of pregnancy. If you are using a regular method of contraception such as the oral contraceptive
pill, you should continue to take it normally.
Your doctor can also inform you about long-term contraceptive methods that are more effective in
preventing pregnancy.
If you continue to use hormonal contraception regularly, such as the oral contraceptive
pill, and do not have breakthrough bleeding during the pill-free break, consult your doctor to make sure you are not
pregnant.

Next menstrual period after taking Norlevo
After taking Norlevo, periods are usually normal and occur on the expected date;
but sometimes they may be earlier or delayed by a few days.
If your period is more than 5 days late, or is unusually light 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.

If you take more Norlevo 1,5 mg tablets than you should
No acute toxicity or serious adverse effects have been reported in case of taking more doses of this
medicine. However, you may experience nausea, vomiting or vaginal bleeding. It is necessary
to consult your doctor or pharmacist.

4. 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 in 10 people):

• dizziness, headache
• nausea, abdominal pain
• breast tenderness, delayed menstruation, heavy menstrual bleeding, uterine bleeding, uterine pain
• fatigue

Common side effects (may affect up to 1 in 10 people):

• Diarrhea, vomiting
• Painful menstruation

Not known (frequency cannot be estimated from available data):

• Cases of thromboembolic events (blood clotting) have been reported during the post-marketing 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 gets serious, or if you notice any side effect

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. HOW TO STORE NORLEVO 1,5 MG TABLETS

Keep this medicine out of the reach and sight of children.
Keep the blister in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is reported on the carton and blister after SCAD.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration; in this case return it to the pharmacist.
Do not dispose of any medicine in wastewater or household waste. Ask the pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What Norlevo 1,5 mg tablets contains

• The active ingredient is levonorgestrel.
• The other ingredients are: lactose monohydrate, corn starch, povidone, anhydrous colloidal silica, magnesium stearate. Levonorgestrel belongsto the group of medicines called emergency contraceptives

Description of the appearance of Norlevo 1,5 mg tablets and contents of the pack
Norlevo 1,5 mg is a white, biconvex and round tablet with the code NL1.5 engraved on one side.
Each pack of Norlevo contains one 1.5 mg tablet of levonorgestrel.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

LABORATOIRE HRA PHARMA
200, avenue de Paris
92320 CHATILLON - FRANCE

Legal representative in Italy:
Perrigo Italia S.r.l
Viale dell’Arte, 25 – 00144 Roma (RM)

Manufacturer

CENEXI
17, Rue de Pontoise
95520 OSNY - FRANCE
or

DELPHARM LILLE S.A.S.
Parc d’Activités Roubaix-Est
22 rue de Toufflers
CS 50070
59452 LYS LEZ LANNOY - FRANCE

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations
Norlevo 1,5 mg tablets
Vikela 1,5 mg tablets (Austria)

NATIONAL INFORMATION
a) Some information about the menstrual cycle and contraception

• Menstrual cycle The menstrual cycle is the time that elapses between two menstrual periods. Normally the cycle lasts 28 days, although its duration can vary considerably from woman to woman. Menstrual periods occur when a woman is not pregnant.
• Fertilization Mid-cycle, an egg (ovum) is released from one of the 2 ovaries (this moment is called "ovulation"). Normally ovulation occurs mid-cycle, but can occur at any time during the cycle. If sperm are present near the egg when it is released, fertilization (i.e. the fusion of a sperm with the egg to form an embryo) can occur.

After a few days, the fertilized egg implants in the uterus and pregnancy begins.

• Contraception Contraceptive methods aim to prevent:
• ovulation: this is the case with the birth control pill,
• fertilization (fusion of a sperm with an 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 sexual intercourse. They are not effective if ovulation has already occurred.

Whenever a woman has sexual intercourse without using a contraceptive method, the possibility of pregnancy cannot be
excluded.
If she has taken this medicine but does not use a regular contraceptive method, it is strongly
recommended that she contact her doctor or family planning clinic for advice on a
contraceptive method appropriate for her case.

b) Recommendations in case of risk of sexually transmitted disease transmission
If you have unprotected sex, you may be at risk of contracting sexually
transmitted diseases, especially if you do not know your partner's sexual history or have multiple partners. If you have any
doubts, consult your pharmacist, doctor or family planning clinic.

GLOSSARY

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