Levonelle 1.5 mg Levonorgestrel Emergency Contraception 1 tablet

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Levonelle 1.5 mg Levonorgestrel Emergency Contraception 1 tablet on sale in our bio. Levonelle 1.5 mg generic is a drug that comes in the form of a tablet. It is used as a means of emergency contraception.

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Levonelle 1.5 mg Levonorgestrel Emergency Contraception 1 tablet

For warnings, precautions for use and against-indications, please refer to the user manual.

Levonelle 1.5 mg Levonorgestrel is a drug that is in the form of a tablet. It is used as a means of emergency contraception.


Description of Levonelle 1.5 mg Levonorgestrel Emergency Contraception

Levonelle 1.5 mg Levonorgestrel Emergency Contraception 1 pill is an emergency contraception. Emergency contraception is a remedial method that aims to prevent pregnancy after unprotected sex or failure of contraceptive method.

This emergency contraception must be used as soon as possible, preferably within 12 hours and no later than within 72 hours (3 days) after unprotected sex or in case of failure of the contraceptive method . It is more effective if you take it as soon as possible after unprotected sex. NORLEVO allows not prevent pregnancy if you take it within 72 hours after unprotected intercourse. It does not work if you are already pregnant. If you have unprotected sex after taking NORLEVO, NORLEVO will not prevent pregnancy.

It has been shown that Levonelle 1.5mg could prevent 52% to 85% of expected pregnancies.

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

· If you have had sex without contraception;

· If you have forgotten to take your birth control pill on time;

· If the condom on your partner broke, slipped or fell;

· If you fear that your IUD was expelled;

· If your contraceptive cap or diaphragm is moved or if you have removed too soon;

· If you fear a failure of the method of intercourse interrupted or the temperature method;

· In cases of rape.

Levonelle 1.5mg works by preventing your ovaries from releasing an egg. It can not prevent a fertilized egg from attaching to the uterus.

This tablet is only used for emergency contraception; it is not a regular method of contraception because it is less effective than the pill "normal" ( "the pill").

Directions for use of Levonelle 1.5 mg Levonorgestrel Emergency Contraception

Take one as soon as possible after sex tablet; if possible within 12 hours, and no later than 72 hours after the report.
If vomiting occurs within 3 hours of taking, get another medicine box and repeat the taking.
If successive intercourse during the same day, the dose is the same. If sex during successive days, the 72-hour period runs from the first report. This information is indicative to the extent that these situations should not arise: the emergency contraception should be exceptional.


Composition of Levonelle 1.5 mg Levonorgestrel Emergency Contraception  

The active substance is levonorgestrel.

The other ingredients are lactose monohydrate, corn starch, povidone, colloidal anhydrous silica, the magnesium stearate.

Levonorgestrel belongs to a group of called emergency contraception drugs.

Use caution Levonelle 1.5 mg Levonorgestrel Emergency Contraception

This emergency contraception is not completely effective: a pregnancy can occur despite treatment. It is intended for emergency use and can not be a regular method of contraception. It has no preventive effect for future reports, and a local contraception must be used until the end of the current cycle before the possible resumption of a contraceptive pill (the first day of menstruation).
Treatment is effective and possible within 3 days of the potentially fertilizing report. He did, of course, no effect on the transmission of venereal diseases.
This medicine does not usually change the date of occurrence of the rules, but they can be shifted a few days. If rules delay of more than 5 days, that does not necessarily mean that the treatment has failed, a pregnancy test will show whether this delay is due to an ongoing pregnancy or a hormonal imbalance.
The use of this drug is not recommended for women at risk of ectopic pregnancy (previous history of infection of the fallopian tubes (salpingitis) or ectopic pregnancy). If abdominal pain or abnormal bleeding around the expected date rules, practice a pregnancy test and see your doctor if emergency testing positive. The diagnosis of ectopic pregnancy is carried out by ultrasound.
Precautions are necessary in case of severe liver disease.
Repeated use of this treatment during the same cycle is to be avoided: increased risk of hormonal imbalance and side effects.

Levonelle Levonorgestrel 1.5mg Introducing Emergency Contraception

Transmission of 1 tablet

Our Pharmacy expert advice  

Emergency contraception aims to block ovulation or to prevent implantation following unprotected intercourse. It is inefficient since implantation began.

Every time a woman has sex without using contraception, the possibility of pregnancy can not be excluded. If you have used this medicine and you do not use a regular contraceptive method, it is you strongly recommended to consult your doctor or family planning clinic for advice on a contraceptive method suitable for you.


Warnings about medications

Attention, the drug is not a product like any other. Read the package leaflet before ordering. Do not let drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug


VIDAL OF THE FAMILY

NORLEVO

Emergency Contraceptive

levonorgestrel

. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Undesirable effects . Lexicon

PRESENTATIONS (summary)

NORLEVO 1.5 mg: tablet (white); box of 1.
Refunded at 65%. - price: 6,34 euro (s).

Laboratory

COMPOSITION (summary)
p cp
levonorgestrel 1.5 mg
Lactose +

INDICATIONS (summary)
This medication is an oral contraceptive (pill) that contains a progestin . It is active only during the period before ovulation: it is not a method of abortion.
It is used for emergency contraception, also called the "morning-after pill", in particular in the following cases:
  • forgetting or breaking a condom,
  • delay in taking the usual contraceptive tablet beyond the acceptable time limit (see this time limit in your contraceptive pill form),
  • loss of an IUD spontaneously expelled from the uterus,
  • displacement or early withdrawal of a vaginal diaphragm or a contraceptive cape,
  • doubt about the good practice of the method of interrupted coitus,
  • error of date when using periodic abstinence method (temperature method),
  • sexual relationship resulting from rape.
WARNING (Contents)
This emergency contraception is not totally effective: a pregnancy can occur despite the treatment. It is intended for exceptional use and can not constitute a regular method of contraception. It does not have a preventive effect on subsequent reports, and local contraception should be used until the end of the current cycle before a contraceptive pill is taken (the first day of menstruation).
Treatment is effective and possible only within 3 days of the potentially fertile relationship. It has, of course, no action on the transmission of venereal diseases.
This medication usually does not change the date of occurrence of the rules, but these may be delayed by a few days. In case of delayed periods of more than 5 days, which does not necessarily mean that the treatment has failed, a pregnancy test will show whether this delay is due to a progressive pregnancy or a hormonal disorder.
Use of this medication is not recommended in women at risk for ectopic pregnancy (previous tubal infection (salpingitis) or ectopic pregnancy). In case of abdominal pain or abnormal bleeding around the expected date of menstruation, take a pregnancy test and consult your doctor if your test is positive. The diagnosis of ectopic pregnancy is made by ultrasound.
Precautions are necessary in case of severe liver disease.
Repeated use of this treatment during the same cycle should be avoided: increased risk of hormonal dysregulation and adverse effects.
If you have to drive, make sure that taking the medication does not cause dizziness or excessive fatigue.
DRUG INTERACTIONS (summary)
The effectiveness of this emergency contraceptive may be reduced if you are taking an enzyme inducer medication such as certain drugs used to treat epilepsy (such as barbiturates, primidone, phenytoin or carbamazepine), certain medicines used for treating tuberculosis (such as rifampicin or rifabutin), certain drugs used to treat HIV (such as ritonavir or efavirenz), or certain medications used to treat fungal infections (such as griseofulvin) or a herbal product containing of St. John's wort. If you have been treated with any of these drugs in the past 4 weeks, it is recommended that you use non-hormonal emergency contraception, such as laying an intrauterine copper dose of levonorgestrel. Ask your doctor or pharmacist.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
The use of this medication during an evolving pregnancy is useless, but its accidental intake during an unknown pregnancy should not raise any particular concerns about the course of this pregnancy.

Breastfeeding:
The punctual use of this medication does not contraindicate the continuation of the breast-feeding. It is recommended to breastfeed just before taking the medication and to avoid breastfeeding for the next 6 hours.
DIRECTIONS FOR USE AND DOSAGE (summary)
Take 1 tablet as soon as possible after intercourse; if possible within 12 hours, and no later than 72 hours after the report.
If vomiting occurs within 3 hours of taking, get another can of medicine and renew the intake.
In case of successive sexual intercourse during the same day, the dosage is the same. In case of sexual intercourse during successive days, the 72-hour period runs from the first report. This information is given as an indication to the extent that these situations should not occur: this method of emergency contraception should remain exceptional.
POSSIBLE ADVERSE EFFECTS (summary)
Nausea, abdominal pain, vomiting.
Dizziness , headache, tiredness.
Transient hormonal dysregulation: early or delayed menstruation, intermittent bleeding outside menstruation, breast tension.
Allergic reaction .
Cases of thromboembolic events have been reported since commercialization.


GLOSSARY (summary)


thromboembolic events
Accident resulting from obstruction (embolism) of a blood vessel by a clot (thrombus).
The vessel can be an artery: it is an arterial embolism, which causes ischemia (deprivation of oxygenated blood) in the region that this artery irrigated. Severe ischaemia leads to the death of tissues deprived of oxygen: infarction. Fortunately, in many cases, a neighboring artery helps to prevent infarction by supplying oxygenated blood to the area affected by ischemia.
The heart is irrigated by the coronary arteries which have the property of being unrelated to one another, which explains the seriousness of a coronary thromboembolic accident: part of the cardiac muscle, the myocardium, is destroyed (myocardial infarction).
The obstruction of a vein is less serious, as the veins ensure the return of blood loaded with carbon dioxide to the heart. The obstruction of a vein is usually called thrombophlebitis. The severity of a thrombophlebitis, or phlebitis, is due to the possibility of a clot detaching itself from the vein and being carried away by the venous blood to the heart. After passing through the right atrium and right ventricle, this clot penetrates a pulmonary artery and clogs a blood vessel, causing pulmonary embolism and pulmonary infarction.


contraceptive
Who opposes conception: oral contraceptive (pill), local (IUD, spermicide, diaphragm and condom).


ectopic pregnancy
Pregnancy developing outside the uterus: during a normal pregnancy, the egg is fertilized in the fallopian tube by a spermatozoon; it should normally progress to the uterus where it is attached to the endometrium. In some cases, this progression is stopped and the egg develops in the proboscis, which is likely to rupture. This is an ectopic pregnancy diagnosed by ultrasound and requires surgery. The signs suggestive of ectopic pregnancy are lower abdominal pain and intermittent bleeding in a woman who has a positive pregnancy test.


enzymatic inducer
The liver, a true chemical plant in the body, ensures the elimination or destruction of many drugs.
Some substances stimulate the hepatic enzymes that provide this elimination function. These substances are enzymatic inducers, and their consumption can reduce the blood concentration of drugs sensitive to their action, diminishing or even canceling their effect. An increase in the dosage of the drug often makes it possible to compensate for the effect of the joint use of an enzyme inducer, but the risk of inefficiency sometimes leads to discouragement of their association. This is the case for oral contraceptives ("pills"), which may lose their effectiveness if they are combined with the regular intake of an enzyme inducer.
The risk is mentioned in the section Drug Interactions when a drug is likely to be significantly modified by the use of an enzyme inducer.
The main enzymatic inducers are usually themselves medicines:
  • anti-epileptic drugs (anticonvulsants): carbamazepine, phenobarbital, phenytoin, primidone;
  • antituberculosis drug: rifabutin, rifampicin;
  • antifungal: griseofulvin.
Other substances may have an enzymatic inducing effect:
  • St. John's wort, a plant contained in certain preparations;
  • tobacco and alcohol.


liver disease
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


progestin
Substance whose action is similar to that of progesterone.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


Dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 26/06/2017

Name of the medicinal product

NORLEVO ® 1.5 mg tablet

levonorgestrel

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or family planning center.

· Keep this leaflet. You might need to read it again.

· Contact your doctor, pharmacist or family planning center for advice or information.

· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

What is in this leaflet?

1. What is NORLEVO 1.5 mg tablet and when it is used?

2. What information should I take before taking NORLEVO 1.5 mg tablet?

3. How to take NORLEVO 1.5 mg tablet?

4. What are the possible side effects?

5. How to store NORLEVO 1.5 mg tablet?

6. Package contents and other information.

1. WHAT NORLEVO 1.5 mg tablet is AND WHAT IT IS USED FOR?

NORLEVO is an oral emergency contraception.

What is emergency contraception?

Emergency contraception is a catch-up method that aims to prevent pregnancy after unprotected intercourse or failure of the contraceptive method.

When to use this emergency contraception?

This emergency contraception should be used as soon as possible, preferably within 12 hours and at the latest within 72 hours (3 days), after unprotected intercourse, or in case of contraceptive failure . It is more effective if you take it as soon as possible after unprotected intercourse. NORLEVO can prevent a pregnancy only if you take it within 72 hours after unprotected intercourse. It does not work if you are already pregnant. If you have unprotected sex after taking NORLEVO, NORLEVO will not prevent pregnancy.

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

If you suspect you are pregnant for any of the following reasons:

· if you have had sex without a contraceptive method;

· if you forgot to take your birth control pill in time;

· if your partner's condom has broken, slipped or fallen;

· if you are concerned that your IUD has been expelled;

· if your contraceptive cape or diaphragm has moved or you removed it too soon;

· if you fear a failure of the method of interrupted sex or the method of temperatures;

· in case of rape.

NORLEVO works by preventing your ovaries from releasing an egg. It can not prevent a fertilized egg from attaching itself to the uterus.

This tablet is used only as an emergency contraception method; it is not a regular method of contraception because it is less effective than the "normal" contraceptive pill ("the pill").

NORLEVO is not indicated before the first menstrual bleeding (puberty).

2. BEFORE YOU TAKE NORLEVO 1.5 mg tablet?

Do not take NORLEVO 1.5 mg tablets in the following cases:

· if you are allergic (hypersensitive) to levonorgestrel or any of the other ingredients of this medication mentioned in section 6.

Warnings and Precautions

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

· if you have had an ectopic (ectopic) pregnancy,

· or a fallopian tube infection (salpingitis),

· if you have a personal or family history of a known risk factor for thrombosis (blood clotting),

· or if you have a serious illness of the digestive system that hinders the absorption of food and medications,

· or if you have severe hepatic dysfunction or severe malabsorption syndrome, such as Crohn's disease.

Anterior ectopic pregnancy and anterior tubal uterine infection increase the risk of a new ectopic pregnancy. Therefore, if you have had an ectopic pregnancy or a fallopian tube infection, you should contact your doctor before taking NORLEVO.

Emergency contraception should be used only occasionally and should not be used as a substitute for a regular method of contraception as:

· it does not prevent pregnancy in all cases;

· the risk of hormonal overdosage or menstrual cycle disorders is undesirable in case of regular use;

Emergency contraception can not interrupt pregnancy.

If you have had another unprotected sex that dates more than 72 hours, the design may have occurred. Treatment with NORLEVO taken after second intercourse may then be ineffective in preventing pregnancy.

Repeated administration of NORLEVO during the same menstrual cycle is discouraged because your cycle may be affected.

NORLEVO does not work as well as regular methods of contraception. Your doctor can tell you more about long-term contraceptive methods, which are more effective in preventing pregnancy.

After taking this medication :

It is essential to exclude any pregnancy by doing a pregnancy test:

· if your periods are more than five days late;

· in case of abnormal bleeding, even on the scheduled date of your period.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. Some data suggest that NORLEVO is less effective with an increase in body weight or body mass index (BMI), but these data are limited and inconclusive. NORLEVO is therefore always recommended for all women regardless of weight or BMI.

It is recommended that you contact a health professional if you are concerned about problems associated with taking an emergency contraceptive.

If you have not used a condom (or torn or slipped) during sex, you may have contracted a sexually transmitted disease or HIV. The use of emergency contraception does not protect against sexually transmitted diseases and can not replace the precautions and necessary measures to be taken in case of risk of transmission (see Advice / Health Education).

Children and Youth

Do not use this medication before the first menstrual bleeding (puberty).

Other drugs and NORLEVO

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

Some medicines may prevent NORLEVO from working properly.

If you have used any of the medicines mentioned below in the past 4 weeks, NORLEVO may be less suitable for you. Your doctor may prescribe another type of emergency (non-hormonal) contraceptive, an intrauterine device (IUD-Cu). If this is not possible for you or if you can not see your doctor quickly, you can take a double dose of NORLEVO:

- barbiturates and other medicines used to treat epilepsy (eg primidone, phenytoin and carbamazepine)

- medicines used to treat tuberculosis (rifampicin, rifabutin, for example)

- treatment for HIV infection (ritonavir, efavirenz)

- a drug used to treat fungal infections (griseofulvin)

- medicinal herbal preparations containing St. John's wort ( Hypericum perforatum )

Talk to your doctor or pharmacist if you need further advice on the appropriate dose for you.

Consult your doctor as soon as possible after taking the tablets to get advice on a reliable means of regular contraception and to exclude a pregnancy. (See also section 3 for more tips "How to take NORLEVO 1.5 MG, TABLET?") .

If you have any further questions, ask your pharmacist or doctor.

NORLEVO may also affect the way other drugs work, including:

· a drug called ciclosporin (it depresses the immune system).

NORLEVO should not be used at the same time as medicines containing ulipristal acetate.

NORLEVO with food and beverages

Not applicable.

Pregnancy

This medication does not interrupt an ongoing pregnancy.

If, despite taking this medication, a pregnancy occurs, studies available to date have shown no risk of malformation in the developing fetus. However, this medication should not be taken if you are pregnant.

If a pregnancy occurs after taking NORLEVO, consult your doctor. The baby may want to check if the pregnancy is not ectopic (the baby develops outside your uterus). This is especially important if you have severe abdominal pain after taking NORLEVO or if you have ever had an ectopic pregnancy, tubal surgery or pelvic inflammatory disease.

feeding

Breastfeeding is possible. However, since levonorgestrel is excreted in breast milk, you are advised to breastfeed immediately before taking the NORLEVO tablet and avoid breast-feeding for at least 8 hours after taking NORLEVO.

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

Sport

Not applicable.

Driving and using machines

After taking NORLEVO, some women experience fatigue and dizziness (see section 4 "POSSIBLE SIDE EFFECTS"): Do not drive or use machinery if you experience these symptoms.

There are no data on the effects of this medication on individual ability to drive or use a machine.

NORLEVO tablet contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, contact him or her before taking this product.

3. HOW TO TAKE NORLEVO 1.5 mg tablet?

Always take this medication as described in the package leaflet or exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

· Take the tablet as soon as possible , preferably within 12 hours, and no later than 72 hours (3 days) after unprotected intercourse . NORLEVO can be taken at any time in your menstrual cycle to the extent that you are not already pregnant or you do not think to be pregnant. Do not chew, but swallow the whole tablet with water. Do not delay taking the tablet. The tablet is all the more effective as you take it as soon as possible after having had unprotected sex.

· If you are using any of the medicines that may prevent NORLEVO from functioning properly (see section "Other medicines and NORLEVO 1.5 MG TABLET" above) or if you have used any of these medicines in the past 4 weeks, NORLEVO can act less efficiently for you. Your doctor may prescribe another type of emergency (non-hormonal) contraceptive, an intrauterine copper (Cu-IUD) device. If this is not possible for you or if you can not see your doctor quickly, you can take a double dose of NORLEVO 1.5 MG COMPRESSED (2 tablets taken simultaneously).

· If you are already using a regular contraceptive method such as birth control pills, you can continue taking it at your regular time. If you do not have your period at the end of the plate, do a pregnancy test to make sure you are not pregnant.

If vomiting occurs within three hours of taking the tablet, immediately take another tablet.

After using this emergency contraception, it is strongly recommended to use a local contraceptive method (condom, spermicide, cervical cap) until your next period. If other unprotected intercourse occurs after use of NORLEVO (and if this occurs during the same menstrual cycle), the tablets will not have their contraceptive effect and there is a risk of pregnancy again. The use of NORLEVO does not contraindicate the continuation of regular hormonal contraception.

Your doctor may also tell you about long-term contraceptive methods, which are more effective in preventing you from getting pregnant.

If you continue to use a regular hormonal contraceptive method, such as birth control pills, and you do not have your period during the period without pills, consult your doctor to make sure you are not pregnant.

Your first period after taking NORLEVO 1.5 mg tablet

After using NORLEVO, your periods are usually normal and will begin on the scheduled day; however, it happens a few days later or earlier than usual.

If your periods are more than 5 days late or are abnormally mild or abundant, or if you think you may be pregnant for any other reason, you should check if you are pregnant. If a pregnancy occurs even after taking this medication, it is important that you consult your doctor.

Use in children and adolescents

Not applicable.

If you take more NORLEVO 1.5 mg tablet than you should:

No acute toxicity or adverse effects have been demonstrated for this drug if several doses are ingested. However, you may feel bad, feel sick (vomiting) or have vaginal bleeding. Immediately consult your doctor or pharmacist.

If you forget to take NORLEVO 1.5 mg tablet:

Not applicable.

If you stop taking NORLEVO 1.5 mg tablet:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

The following adverse reactions were observed:

Very common side effects (affect more than 1 in 10 users):

· dizziness, headache

· nausea, abdominal pain

· sensation of tension of the breasts, delay of menstruation, abundant menstruation, bleeding, pain of the uterus

· tired

Common side effects (affect 1 to 10 users in 100):

· diarrhea, vomiting

· painful periods

Frequency not known (frequency can not be estimated from available data):

· Cases of thromboembolic events (blood clotting) have been reported post-marketing.

· Allergic reactions such as edema of the throat and face and a rash may occur after taking this medication.

Additional Adverse Events in Children and Adolescents

Not applicable.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE NORLEVO 1.5 mg tablet?

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

Keep the platelets in the outer packaging, protected from light.

Do not use this medicine after the expiry date which is stated on the carton and on the plate after the EXP letters. The expiry date refers to the last day of that month.

Do not use this medication if you notice any signs of deterioration. NORLEVO should be taken to your pharmacist.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What NORLEVO 1.5 mg contains: tablet

· The active substance is: levonorgestrel.

· The other components are: lactose monohydrate, corn starch, povidone, anhydrous colloidal silica, magnesium stearate.

Levonorgestrel belongs to a group of medicines called emergency contraception.

What is NORLEVO 1.5 mg tablet and contents of the pack

Each box of NORLEVO 1.5 mg contains a 1.5 mg tablet of levonorgestrel.

The tablet of NORLEVO 1.5 mg is a white, round, biconvex tablet with the code NL 1.5 written on one of the sides.

Marketing Authorization Holder

HRA PHARMA LABORATORY

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75003 PARIS

Marketing Authorization Operator

HRA PHARMA FRANCE

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75010 PARIS

Maker

Cenexi

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95520 OSNY

Or

DELPHARM LILLE SAS

ROUBAIX-EAST ACTIVITY PARK

22 RUE DE TOUFFLERS

CS 50070

59452 LYS LEZ LANNOY

Names of the medicinal product in the Member States of the European Economic Area

[To be completed at a later date by the holder]

The last date on which this leaflet was revised is:

[to be completed later by the holder]

<{MM / YYYY}> <{YYYY month}.>

Other

ADVICE / HEALTH EDUCATION

a) Some information on the menstrual cycle and contraception

Periods

The menstrual cycle is the time elapsed between two episodes of menstruation. Normally, the cycle lasts 28 days, although the duration may vary considerably from one woman to another. The rules arise when a woman is not pregnant.

Fertilization

In the middle of the cycle, an ovule is expelled by one of the 2 ovaries (this time is called "ovulation"). In general, ovulation occurs in the middle of the cycle but can occur at any point in the cycle.

If spermatozoa are found in the vicinity of the egg when released, "fertilization" (ie the encounter of the ovum and a spermatozoon to create an embryo) may take place.

After a few days, the fertilized egg will settle (or "implant") in the uterus, and the pregnancy begins.

Contraception

Contraceptive methods are designed to prevent:

· ovulation: this is the case of the birth control pill,

· fertilization (encounter of spermatozoa and ovum): this is the case of condoms,

· or implantation if the egg is fertilized: this is the case of the IUD.

Pills for Emergency Contraception

Emergency contraception pills are intended to block or delay ovulation following unprotected intercourse. They are ineffective if ovulation has already occurred.

Whenever a woman has sex without using a contraceptive method, the possibility of pregnancy can not be ruled out.

If you have used this medication and are not using regular contraception, it is strongly recommended that you consult with your doctor or family planning center for advice on contraception that is appropriate for you.

(b) Advice on the risk of transmission of a sexually transmitted disease

If you have unprotected sex, you are at risk of contracting a sexually transmitted disease, especially if you do not know your partner's sexual history or if you have multiple partners. If you have any questions, please contact your pharmacist, doctor or family planning center or call one of the following numbers:

· young people: 32.24 or from a mobile 01.44.93.30.74 (cost of ordinary communication), anonymous and free, daily from 8 am to midnight, www.filsantejeunes.com

· AIDS info service: 0 800 840 800

GLOSSARY

· Ectopic pregnancy: pregnancy that develops outside the uterus, usually in one of the fallopian tubes. Warning signs are persistent abdominal pain, delayed menstruation, vaginal bleeding, signs of pregnancy (nausea, tightness of the breasts). These symptoms should prompt you to consult your doctor immediately.

· Salpingitis: infection of the fallopian tubes. Symptoms include abdominal pain, fever and significant vaginal discharge.

IN SUMMARY

The important points

To behave

The use of NORLEVO 1.5 mg tablet should remain exceptional.

NORLEVO 1.5 mg tablet can be used at any time of the cycle.

The use of NORLEVO 1.5 mg tablets is not recommended if you have had an extra-uterine pregnancy or if you have had salpingitis in the past.

In case of doubt, or if your period seems abnormal, or if your periods do not arrive, or if you have abdominal pain, consult your doctor.

The tablet should be taken as soon as possible after unprotected intercourse.

Treatment requires a single tablet.

If you have vomited within 3 hours of taking the tablet, another tablet should be taken immediately.

NORLEVO 1.5 mg tablet is effective only 7 to 9 times out of 10.

If you have a delay of more than 5 days from the expected date, do a pregnancy test to make sure you are not pregnant.

After taking NORLEVO 1.5 mg tablets, local contraceptives should be used until the following rules.

If you have used this medication due to a forgetful birth control pill, you should continue taking the current pamphlet until the end.

If you do not have your period at the end of the next blister, make sure that you are not pregnant.

The intake of NORLEVO 1.5 mg tablet does not prevent the risk of sexually transmitted disease (especially AIDS).

If in doubt, consult your doctor or call one of the following:

Youth health net: 3224 or from a mobile phone 01.44.93.30.74 (cost of ordinary communication), anonymous and free, daily from 8 am to midnight, www.filsantejeunes.com

Sida info service : 0800 840 800

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