LESTRONETTE - PACKAGE LEAFLET - LEAFLETS

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Lestronette - Package Leaflet

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

Active ingredients: Levonorgestrel, Ethinylestradiol

Lestronette 0.10 mg + 0.02 mg film-coated tablets

Why is Lestronette used? What is it for?

Lestronette is a contraceptive pill used to prevent pregnancy.

Each tablet contains a small amount of two different female hormones called levonorgestrel and ethinyl estradiol.

Contraceptive pills containing two hormones are called "combination pills".

Contraindications When Lestronette should not be used

Do not take Lestronette

if you have, or have ever had, a blood clot (thrombosis) in a blood vessel of the leg, lung (embolus) or other organs;
if you have, or have had in the past, a heart attack or stroke;
if you have, or have had in the past, diseases that may be predictive of a heart attack (for example angina pectoris, which can cause severe chest pain) or stroke (for example, a mild transient stroke with no residual consequences);
if you have a disease which could increase the risk of thrombosis in the arteries. This refers to the following situations:
- diabetes that has damaged blood vessels;
- very high blood pressure;
- very high levels of fat in the blood (cholesterol and triglycerides);
if you suffer from bleeding disorders (e.g. lack of protein C);
if you have or have suffered from certain types of migraines (associated with so-called focal neurological symptoms);
if you have or have suffered in the past from inflammation of the pancreas (pancreatitis);
if you have or have suffered in the past from liver disease and your liver function values are not yet normal;
if you have or have suffered in the past from liver cancer;
if you have, have had, or are suspected of having breast or genital organ cancer;
if you have vaginal bleeding of unknown origin;
if you are allergic to levonorgestrel, ethinyl estradiol or any of the other ingredients of this medicine (listed in section 6). This condition is recognizable by the presence of itching, rash or swelling.

Precautions for use What you need to know before you take Lestronette

General notes

Before you start taking Lestronette, your doctor will ask you a few questions about your health and the health of your closest relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may also order further tests.

In this leaflet, some situations are described in which you must stop taking Lestronette or in which a reduction in the effectiveness of Lestronette may occur. In these situations you should not have sexual intercourse or you should take additional non-hormonal contraceptive precautions, such as the use of condoms or other barrier methods. Do not use rhythm or basal temperature methods. These methods may be unreliable as Lestronette alters the normal changes in temperature and cervical mucus that occur during the menstrual cycle.

Lestronette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

In some situations you need to be especially careful when using Lestronette or other combined hormonal contraceptives. Your doctor may need to check you regularly.

If you have any of the following conditions, you must tell your doctor before you start taking Lestronette. You should also consult your doctor if any of these conditions develop or worsen while using Lestronette:

If a first degree family member has or has ever had breast cancer.
If you have liver disease or if you have gallstones.
If you have diabetes.
If you suffer from depression.
If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease).
If you suffer from SUE (haemolytic uremic syndrome, a blood disorder that causes kidney damage).
If you have sickle cell anemia (an inherited disease affecting the red blood cells).
If you suffer from epilepsy.
If you suffer from SLE (systemic lupus erythematosus, a disorder of the immune system).
If you have disorders that first appeared during pregnancy or during sex hormone treatment (for example, hair loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash that occurs during pregnancy], Sydenham's chorea [nerve disease with sudden body movements]).
If you have or have suffered from chloasma (yellowish-brown pigmentation of the skin, called pregnancy spots, especially on the face). In this case, avoid direct exposure to sunlight or ultraviolet rays.
If you have hereditary angioedema; Medicines containing estrogen can cause or worsen the symptoms of angioedema. If you have symptoms of angioedema such as swelling of the face, tongue and / or pharynx, and / or difficulty in swallowing or hives together with difficulty in breathing, contact your doctor immediately.

Interactions Which drugs or foods may change the effect of Lestronette

Always tell your doctor who prescribes Lestronette if you are taking any other medicines or herbal preparations. Also tell any other doctors or dentists who may prescribe other medicines (or your pharmacist) that you are using Lestronette. This way they can tell you if and for how long to use additional methods of contraception (for example a condom).

Some medicines can make Lestronette less effective in preventing pregnancy or can cause unexpected bleeding.

Among these are medicines

used to treat epilepsy (eg primidone, phenytoin, barbiturates, carbamazepine, oxicarbamazepine, topiramate, felbamate) or migraine (topiramate)
used to treat tuberculosis (eg rifampicin), HIV infection (ritonavir) or other infections (griseofulvin),
for the increase of intestinal motility (eg. metoclopramide)
remedies based on St. John's wort.

If you intend to use St John's Wort products while you are taking Lestronette you should first consult your doctor.

Lestronette may reduce the effectiveness of other medicines, for example:

medicines containing cyclosporine
lamotrigine anti-epileptics (this may lead to an increase in the frequency of seizures).

Diagnostic tests

If you need a blood test, tell your doctor or laboratory that you are using the pill as oral contraceptives can alter the results of some tests.

Warnings It is important to know that:

Lestronette and venous and arterial blood clots

The use of any combination pill, including Lestronette, increases a woman's risk of developing a blood clot in the vein (venous thrombosis) compared to women who do not take any contraceptive pill.

The risk of venous thrombosis in users of combination pills increases:

With increasing age.
If you are overweight.
If one of your first degree relatives has had a blood clot in the leg, lung (pulmonary embolism) or other organs at a young age.

If you have surgery, have had a serious accident or are immobilized for a long time. It is important that you tell your doctor in advance that you are taking Lestronette, as treatment may need to be stopped. Your doctor will tell you when to resume taking Lestronette. Generally, taking Lestronette should not be resumed until 2 weeks have elapsed after returning to normal walking.

If you take the pill, your chances of having a blood clot are increased.

Out of 100,000 women who do not take the pill and who are not pregnant, about 5-10 can develop a blood clot in a year.
Out of 100,000 women who take a pill, such as Lestronette, about 20 could develop a blood clot in a year, the exact number is not known.
Out of 100,000 pregnant women, about 60 could develop a blood clot in a year.

A blood clot in the veins can travel to the lungs and can block blood vessels (called a pulmonary embolus).

The formation of blood clots in the veins can be fatal in 1-2% of cases.

The level of risk can vary depending on the type of pill you take. Discuss possible options with your doctor.

The use of combination pills has been associated with an increased risk of a blood clot forming in the arteries (arterial thrombosis), for example in vessels of the heart (heart attack) or brain (stroke).

The risk of blood clots forming in the arteries (arterial thrombosis) in users of combination pills increases:

With increasing age.
If you smoke. It is therefore strongly advised to stop smoking when using Lestronette, especially if you are over 35 years of age.
If you have high levels of cholesterol or triglycerides in your blood.
If you are overweight If one of your first degree relatives has had a heart attack or stroke at a young age.
If you have high blood pressure.
If you suffer from migraines.
If you have heart problems (valve disorder, or a heart rhythm disorder).

Stop taking Lestronette and contact your doctor immediately if you notice possible signs of a thrombosis such as:

Severe pain and / or swelling in one leg
Sudden severe pain in the chest, which may radiate to the left arm
Sudden shortness of breath
Sudden cough with no obvious cause
Any unusual, severe or prolonged headache, or a worsening of migraine
Partial or total loss of vision or double vision
Difficulty or inability to speak
Feeling dizzy or faint
Weakness, strange sensation or numbness of any part of the body
Difficulty in controlling his movements
Sudden severe pain in the stomach

Lestronette and cancer

Breast cancer is diagnosed slightly more often in women using combination pills, but it is not known if this is due to the treatment. For example, this may be due to the fact that women who use combination pills are seen by their doctor more often. The risk of developing breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and contact your doctor if you feel any lumps.

Benign liver tumors have been observed in rare cases in women using the pill, and even more rarely malignant liver tumors. Contact your doctor immediately if you experience any severe abdominal pain.

Bleeding between menstruation

Unexpected bleeding (bleeding outside the interval period) may occur during the first few months of taking Lestronette. If this bleeding persists for more than a few months or if it starts again after a few months, your doctor should investigate the cause.

What should be done if no bleeding occurs in the gap week

If you have taken all the tablets correctly, have not had vomiting or severe diarrhea and have not taken any other medicines, it is very unlikely that you are pregnant. If the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure you are not pregnant.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant you should not use Lestronette. If you become pregnant while taking Lestronette, stop immediately and contact your doctor.

If you want to get pregnant you can stop Lestronette at any time (see also "If you want to stop using Lestronette").

The use of Lestronette is generally not recommended while breastfeeding. If you want to take the pill while breastfeeding, you will need to contact your doctor.

Driving and using machines

There is no information showing that the use of Lestronette can affect the ability to drive and use machines.

Lestronette contains lactose.

If your doctor has diagnosed you with "intolerance to some sugars, contact your doctor before you start using Lestronette.

Lestronette contains red aluminum lake (E 129)

It can cause allergic reactions.

Dose, Method and Time of Administration How to use Lestronette: Posology

Take one Lestronette tablet each day with a small amount of water as needed. You must take the tablets at about the same time every day.

The blister contains 21 tablets. It is marked with the days of the week on which the pill should be taken. You must take the pill every day for 21 days, following the direction of the arrow printed on the blister, until all 21 tablets are used up. Stop taking the tablets for 7 days.

Your period should appear during these 7 days off the pill (also called a gap week). The so-called withdrawal bleeding usually begins between the 2nd and 3rd day of the withdrawal week.

Start the new pack on the eighth day after taking the last Lestronette tablet (the day after the 7-day rest period), even if your period has not yet finished.

By doing so, the new blister will always be started on the same day of the week and the withdrawal bleeding will always occur on approximately the same days of the week, every month.

If you use Lestronette according to these instructions, you are protected against pregnancy even during the 7 days of stopping the pill.

When can you start with the first blister

If you have not used any hormonal contraceptive in the previous month.

Start taking Lestronette on the first day of your period (the first day of your period). If you start taking Lestronette on the first day of your period, you are immediately protected against pregnancy. It can also start between the 2nd and 5th day of the cycle, but in this case you must resort to additional contraceptive methods (for example condoms) for the first 7 days.

Changing from another combined hormonal contraceptive, combined vaginal contraceptive ring or patch

You can start taking Lestronette the day after the end of your previous pill withdrawal period (or after the last inactive tablet of your previous pill).

Changing from progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing IUD)

You can switch from the progestogen-only pill on any day (from an implant or IUD on the day of removal, and from an injection on the day the next injection should be given) but in all these cases you must use an additional method of contraception (e.g. condom) in the first 7 days of tablet-taking.

After a miscarriage or miscarriage

Follow your doctor's advice.

After having a baby

After having a baby, you can start taking Lestronette between the 21st and 28th day after having a baby. If you start after day 28, you must use a so-called barrier method (for example a condom) during the first 7 days of taking Lestronette. If after having a baby you have had sex before taking Lestronette you must first make sure that you are not pregnant or wait until your next period.

Ask your doctor for advice if you are not sure when to start.

If you are breastfeeding and want to start taking Lestronette after having a baby Read section 2 'Breastfeeding'.

If you forget to take Lestronette

If you are less than 12 hours late in taking the tablet, the protection against pregnancy is not reduced. Take the pill as soon as you remember and then follow the usual rhythm.
If you are more than 12 hours late in taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets forgotten, the greater the risk that the protection against pregnancy is reduced. The risk of non-protection from pregnancy it is higher if you forget to take your tablet at the beginning or at the end of the strip. In this case, you will have to follow the rules below (see also the diagram below):
If you have forgotten more than one tablet in a strip

Contact your doctor.

One tablet forgotten in week 1

Take the tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets as usual and use additional contraceptive methods for the next 7 days, for example a condom. If you have had sexual intercourse in the week before you forget or if you forgot to start a new strip after the pill-free period, there is a possibility that you are pregnant. If so, contact your doctor.

One tablet forgotten in week 2

Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets as usual. The protection against pregnancy is not reduced and it is not necessary to use additional contraceptive methods.

One tablet forgotten in week 3

You can choose one of the following 2 possibilities:

Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets as usual. Start the new pack without the pill withdrawal interval. You may have your period (withdrawal bleeding) at the end of the second strip but you may also have spotting or breakthrough bleeding during the second strip.

Take the tablets off and observe a 7-day pill-free period (include the day you forgot the pill). If you want to start a new strip on a fixed day, follow a withdrawal period of less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

If you have forgotten to take tablets from a strip and you do not have a period in the first pill-free interval, this means that you may be pregnant. You should contact your doctor before starting the new strip.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours of taking the tablet or have severe diarrhea there is a risk that the active substances in the tablet will not be completely absorbed. The situation is similar to that of a forgotten tablet. In case of vomiting or diarrhea you should take another tablet from the reserve blister as soon as possible. If possible, take it within 12 hours or when you usually take the tablet.If this is not possible or if 12 hours have already passed, you should follow the instructions given in the section "If you forget to take Lestronette".

Postponing your period: what you need to know

Although it is not recommended, you can postpone your period by switching directly to the new Lestronette strip instead of observing the pill withdrawal period, until the second pack is finished. You may experience mild or menstrual-like bleeding while using the second strip. After the usual 7-day pill-free period, start with the next strip.

Ask your doctor for advice before deciding to postpone your period.

Change the first day of your period: what you need to know

If you take the tablets correctly, your period will start in the pill-free week on the same day. If you want to change this day, you must shorten (never extend!) The next suspension period. For example, if your pill withdrawal period starts on a Friday and you want your period to start on a Tuesday (3 days earlier) in the future, you should start the next pack 3 days earlier than usual. If you shorten your pill-free interval a lot (for example 3 days or less) you may not have any vaginal bleeding in that interval.

You may have mild or menstrual-like bleeding.

If you are unsure how to do this, contact your doctor for advice.

If you want to stop using Lestronette

You can stop taking Lestronette at any time. If you still want to avoid becoming pregnant, ask your doctor for advice on other methods of birth control. If you want to get pregnant, stop taking Lestronette and wait for a while. period before trying to get pregnant. He will be able to calculate the estimated due date more easily.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose What to do if you have taken too much Lestronette

No serious harmful effects have been reported after taking many Lestronette tablets. If you have taken several tablets at the same time, you may feel sick or vomit. Young girls may have vaginal bleeding.

If you have taken too many Lestronette tablets or find that a child has taken some, ask your doctor or pharmacist for advice.

Side Effects What are the side effects of Lestronette

Like all medicines, this medicine can have side effects, although not everybody gets them.

The following is a list of side effects that have been associated with the use of Lestronette.

Common (may affect up to 1 in 10 women): headache, mood changes (including depression), nausea, abdominal pain, breast pain, breast tightness, weight gain.
Uncommon (may affect up to 1 in 100 women): vomiting, diarrhea, fluid retention or edema, migraine, decreased sexual desire, breast enlargement, rash, hives.
Rare (may affect up to 1 in 1000 women): eye irritation with contact lens wear, hypersensitivity, weight loss, breast discharge, vaginal discharge, increased libido, erythema nodosum (lumps in the legs), erythema multiforme (skin lesions).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

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

Do not store above 30 ° C.

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 the month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What Lastronette contains

The active ingredients are levonorgestrel and ethinyl estradiol.

Each tablet contains 0.10 mg of levonorgestrel and 0.02 mg of ethinylestradiol.

The other ingredients are: anhydrous lactose, povidone K-30 (E 1201), magnesium stearate (E 572) and opadry II pink [polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), polyethylene glycol 3350, aluminum lake red (E 129), lecithin (E 322), red iron oxide (E 172) and blue aluminum lake (E 132)].

What Lestronette looks like and contents of the pack

Each film-coated tablet is pink and round.
Lestronette is available in strips (blisters) of 21 tablets.
The packs are of 1, 3 and 6 blisters, each containing 21 tablets.

Not all pack sizes may be marketed.

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 Lestronette is available 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 interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 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 RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

LESTRONETTE 0,10 MG + 0,02 MG TABLETS COATED WITH FILM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

Each film-coated tablet contains 0.10 mg of levonorgestrel and 0.02 mg of ethinylestradiol.

Excipients with known effect:

Lactose (89 mg / tablet), red aluminum lake (E 129)

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Film-coated tablet.

Round tablets of pink color.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Oral contraception.

04.2 Posology and method of administration -

Method of administration: oral use.

How to use Lestronette

The tablets should be taken orally in the order indicated on the blister, every day at approximately the same time, if necessary with some liquid. The tablets should be taken every day for 21 consecutive days. Subsequent packs should be taken every day for 21 consecutive days. start after a 7-day interval, during which withdrawal bleeding usually occurs. Such bleeding usually occurs 2-3 days after taking the last tablet and may still be present when the next pack is started.

How to start treatment with Lestronette

• No hormonal contraceptive treatment (in the previous month)

Taking the tablets should begin on the first day of the natural menstrual cycle (ie the first day of menstruation). It is also possible to start between the second and fifth day of the cycle but, in this case, during the first seven days of the first cycle an additional contraceptive method is also recommended.

• Changing from another combined hormonal contraceptive (CHC, vaginal ring, or transdermal patch)

The use of Lestronette should preferably start the day after the last active tablet of the previous COC (or after removal of the ring or patch) or at the latest the day after the usual pill withdrawal period (from ring, from patch) or the day after the last placebo tablet of the previous hormonal contraceptive.

• Changing from a progestogen-only contraceptive (minipill, injection, implant) or intrauterine system (IUS)

The woman can switch to Lestronette at any time if it comes from the minipill (or from an implant or IUS on the day of its removal, from an injectable on the day the next injection should be given), but in any case she should be warned. to also use a contraceptive method for the first 7 days of taking the tablets.

• After a first trimester abortion

You can start taking the tablets immediately. No additional contraceptive measures are necessary.

• After childbirth or a second trimester abortion

For breastfeeding women see section 4.6.

Tablet-taking should begin on the 21st to 28th day following delivery or a second trimester abortion. If taking the tablet is postponed, contraception should also be used in the first 7 days of tablet-taking, however, if in the meantime the woman has had sexual intercourse, pregnancy must be ruled out or her first menstruation must be waited for before starting the COC.

Forgotten tablets

The following recommendations are applicable in case of missing active tablets:

Lestronette contains a very low dose of both hormones and therefore the margin of contraceptive efficacy is small if a tablet is forgotten.

If you are less than 12 hours late in taking any tablet, contraceptive protection is not reduced. You should take the forgotten tablet as soon as you remember and the following tablets at the usual pace.

If you are more than 12 hours late in taking any of the tablets, contraceptive protection may be reduced. In cases where you have forgotten the tablets, the following two basic rules apply:

1. taking the tablets cannot be suspended for more than 7 consecutive days;

2. to obtain an "adequate suppression of the hypothalamic-pituitary-ovarian axis, it is necessary to take the tablets continuously for 7 days.

As a result, the following tips can be given in daily practice:

Week 1

You should take the last forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Then she should continue taking the other tablets at the usual pace. In addition, a contraceptive method, such as a condom, should be used for the next 7 days. consider the possibility of pregnancy The greater the number of missed tablets and the shorter the withdrawal period, the greater the risk of pregnancy.

Week 2

You should take the last forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Then she should continue taking the other tablets at the usual rhythm. No additional contraceptive methods are needed, provided that in the 7 days preceding the first missed tablet, the woman has taken the tablets correctly. In case the tablets are not. have been taken correctly or if more than one missed tablets, the use of additional precautions for 7 days should be recommended.

Week 3

Given the imminent 7-day tablet-free interval, the risk of reduced contraceptive reliability is greater.

However, by changing the pattern of taking the pill, the reduction in contraceptive protection can still be prevented. By adopting one of the following options there is therefore no need to use additional contraceptive methods as long as in the 7 days preceding the first missed tablet, all tablets have been taken correctly. Otherwise it should be recommended to follow the first of the two options and also to use additional precautions for the next 7 days:

1. You should take the last forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Then you should continue taking the other tablets at the usual pace. The next pack should be started immediately after finishing the tablets from the previous pack, ie without observing the withdrawal period. In this case it is likely that no bleeding will occur. suspension before the interval of the second pack; however, the woman may experience breakthrough bleeding or spotting while taking the tablets.

2. You can also stop taking the tablets from the current pack. The woman should then observe a pill-free interval of up to 7 days, including those in which the tablets have been forgotten, and then continue with a new pack. .

If the tablets have not been taken and, in the first regular withdrawal period, there is no withdrawal bleeding, the possibility of pregnancy should be considered.

Recommendations in case of gastrointestinal disorders

In case of severe vomiting or diarrhea, the absorption of the active substances may not be complete and additional contraceptive measures must be taken.

If vomiting or severe diarrhea occurs within 3-4 hours of taking the tablet, a new tablet should be taken as soon as possible. If more than 12 hours have passed, the recommendations regarding missed tablets should be applied. change the usual dosing schedule, extra tablets should be taken from a new pack.

How to change the start day or how to postpone a period

To postpone a period, a new pack should be started immediately after finishing the current pack, without observing the withdrawal period. Menstruation can be postponed as long as desired, but not beyond the end of the second pack. During this time the woman may experience breakthrough bleeding or spotting.

Regular intake of Lestronette resumes after the normal seven day withdrawal period.

If you want to move the start day of your period so that it starts on a different day of the week, you can shorten the duration of the next suspension period by as many days as you like. The shorter the interval, the greater the risk of no withdrawal bleeding, but the woman may experience breakthrough bleeding or spotting while taking the second pack (such as when postponing a period).

04.3 Contraindications -

Combined oral contraceptives (COCs) should not be used in the presence of any of the conditions listed below. If any of these conditions appear for the first time while using the COC, the drug should be stopped immediately.

• Current or previous venous thrombosis (deep vein thrombosis, pulmonary embolism).

• Current or previous arterial thrombosis (eg myocardial infarction) or prodromal conditions (eg angina pectoris and transient ischemic attack).

• Present or previous cerebrovascular event.

• The presence of one or more risk factors for arterial thrombosis:

• Diabetes mellitus with vascular involvement

• Severe hypertension

• Severe dyslipoproteinemia

• Hereditary or acquired predisposition for venous or arterial thrombosis, such as resistance to activated protein C (APC), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anti-cardiolipin antibodies, lupus anticoagulant).

• History of migraine with focal neurological symptoms.

• Pancreatitis or a history of this condition, if associated with severe hypertriglyceridaemia.

• Previous or current severe liver disease until liver function values have returned to normal.

• Presence or history of liver tumors (benign or malignant).

• Known or suspected hormone-dependent malignancies (eg of the genital organs or the breast).

• Vaginal bleeding of an unknown nature

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

04.4 Special warnings and appropriate precautions for use -

Warnings

If any of the conditions / risk factors listed below is present, the benefits of using COCs should be weighed against the possible risks of each individual case and discussed with the patient before deciding to initiate treatment.In the event of worsening, exacerbation or first appearance of any of these conditions or risk factors, the patient should contact her physician. The physician should decide whether COC-taking should be discontinued.

• Circulatory disorders

Epidemiological studies have shown that the incidence of venous thromboembolism (VTE) in women using low estrogen oral contraceptives (

The excessive risk of VTE is greatest during the first year a woman starts using COCs or when she starts using COCs again after a pill-free interval of at least one month. This increased risk is less than the risk of VTE associated with pregnancy. , which is estimated to be 60 cases per 100,000 pregnancies, and VTE is fatal in 1-2% of cases.

The overall absolute risk (incidence) of VTE for combined oral contraceptives containing levonorgestrel with 30 mcg ethinyl estradiol is approximately 20 cases per 100,000 women for years of use.

Epidemiological studies have also associated the use of combined COCs with an increased risk of myocardial infarction, transient ischemic attack and stroke.

Very rarely, thrombosis affecting other vascular districts, eg. hepatic, mesenteric, renal and retinal arteries and veins. There is no consensus that the occurrence of these events is associated with the use of hormonal contraceptives.

Symptoms of venous or arterial thrombosis, thromboembolic events or cerebrovascular accidents may include:

• unusual unilateral pain and / or swelling in one leg

• sudden severe pain in the chest, whether or not it radiates to the left arm

• sudden shortness of breath

• cough that starts suddenly

• unusual, severe and prolonged headache

• first appearance or worsening of migraine

• sudden partial or complete loss of vision

• diplopia

• slurred speech or aphasia

• dizziness

• collapse with or without focal seizure

• weakness or marked numbness suddenly affecting one side or part of the body

• motor disturbances

• "acute" abdomen

The appearance of one or more of these symptoms may constitute grounds for immediate discontinuation of the use of Lestronette.

The risk of venous thromboembolic complications in CHC users increases with:

• increasing age;

• positive family history (venous thromboembolism even in a sibling or parent at a relatively young age). If there is a suspicion of a hereditary predisposition, it is suggested to consult the specialist for advice before deciding to use any COC;

• prolonged immobilization, major surgery, any leg surgery or severe trauma. In these circumstances it is advisable to stop taking the COC (in the case of elective surgery at least four weeks before the operation) and resume it no earlier than two weeks after complete remobilization. Antithrombotic treatments may be considered if the pill has not been stopped early;

• obesity (body mass index greater than 30 kg / m²);

• there is no consensus on the possible role of varicose veins and superficial thrombophlebitis in the development or progression of venous thrombosis.

The risk of thromboembolic arterial complications or cerebrovascular accidents in COC users increases with:

• increasing age;

• smoking habits (women over the age of 35 who wish to use a COC are strongly advised not to smoke);

• dyslipoproteinemia;

• obesity (body mass index greater than 30 kg / m²)

• positive family history (arterial thromboembolism even in a brother / sister or parent at a relatively young age). If hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding to use any CHC.

• hypertension;

• migraine, particularly migraine associated with focal neurological disorders;

• valvular heart disease;

• atrial fibrillation.

The presence of a serious risk factor or multiple risk factors for venous or arterial disease may also constitute a contraindication. The possibility of anticoagulant therapy may also be considered. Women using a CHC should be instructed to contact their physician in case of possible symptoms of thrombosis. In case of suspected or confirmed thrombosis, COC use should be discontinued. Adequate alternative contraceptive methods should be used due to the teratogenicity associated with anticoagulant (coumarin) therapy.

The increased risk of thromboembolism during the puerperium should be considered (see section 4.6).

Other medical conditions that have been associated with circulatory adverse events include diabetes mellitus, systemic lupus erythematosus, haemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle.

An increase in the frequency or severity of migraines while using a COC (which may be prodromal of a cerebrovascular event) may be reason to stop taking the COC immediately.

Tumors

Some epidemiological studies have reported an increased risk of developing cervical cancer in women on long-term treatment with a CHC, but it is still controversial how much this finding is influenced by confounding effects related to sexual behavior or other factors such as human papilloma virus. (HPV).

A meta-analysis of 54 epidemiological studies found that women who currently use a COC have a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed and that the excess risk gradually disappears over the course of 10 years after the interruption of treatment. Since breast cancer is rare in women under the age of 40, the extra number of breast cancers diagnosed in women taking or recently taking a CHC is low compared to the overall risk of breast cancer.

These studies do not provide evidence of a causal relationship

The observed pattern of increased risk could be due to an earlier diagnosis of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both. Breast cancers diagnosed in users tend to be less clinically advanced than cancers diagnosed in non-users.

Benign liver tumors and, even more rarely, malignant liver tumors have been reported rarely in women taking CHCs. In isolated cases, these tumors have resulted in life-threatening intra-abdominal haemorrhage. If a woman taking a CHC experiences severe upper abdominal pain, liver enlargement, or signs suggestive of intra-abdominal haemorrhage, the possibility of liver cancer should be considered in the differential diagnosis.

Other conditions

Women with hypertriglyceridaemia or a family history of this condition may have an increased risk of pancreatitis if they take a CHC.

Although small increases in blood pressure have been reported in many women taking CHCs, a clinically relevant increase is rare. Only in these rare cases is immediate discontinuation of the COC justified. Systematic correlation between the use of a COC and clinically significant hypertension has not been established. If during the use of a COC, in the presence of pre-existing hypertension, constantly elevated blood pressure values or a significant increase in blood pressure do not respond adequately to antihypertensive treatment, the use of a COC should be discontinued. If appropriate, COC use may be resumed if normal blood pressure values have been achieved with antihypertensive therapy.

The onset or worsening of the conditions listed below has been reported both during pregnancy and while taking a COC; however, there is no conclusive evidence of the correlation between these conditions and the use of a COC: jaundice and / or cholestatic pruritus; gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis hearing loss, depression.

Acute or chronic disturbances of liver function may require discontinuation of COC treatment until markers of liver function have returned to normal. Return of cholestatic jaundice and / or pruritus first occurring in pregnancy or during previous treatment with sex steroids it forces the interruption of the COC.

Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no evidence for the need for regimen adjustment in diabetic patients using low-dose COCs. However, diabetic patients should be followed closely, especially at the start of treatment with a COC.

Worsening of endogenous depression, Crohn's disease and ulcerative colitis have been reported during COC use.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. While taking a COC, patients with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation.

In women with exogenous hereditary angioedema, estrogen can cause or aggravate the symptoms of angioedema.

Medical examination / consultation

A complete medical history (including family history) should be taken before initiating or restarting administration of Lestronette and any existing pregnancy should be ruled out. Blood pressure should be measured and physical examination performed as indicated in Contraindications (see section 4.3) and Warnings (see section 4.4). The woman should also be instructed to read the package leaflet carefully and follow the recommendations given. The frequency and type of further periodic check-ups should be based on pre-established guidelines and individually adapted to the woman.

Women should be warned that oral contraceptives do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Reduction of effectiveness

The effectiveness of COCs may decrease if you miss tablets, vomit or diarrhea, or take other medicines at the same time.

Decreased cycle control

Irregular vaginal bleeding (spotting or breakthrough bleeding) may occur while taking any COC, especially in the first months of treatment. Therefore, the evaluation of any irregular vaginal bleeding is meaningful only after a settling phase lasting about three Treatment cycles In Lestronette users, any bleeding (spotting and / or breakthrough bleeding) was reported by more than 50% during the first 6 months of use.

If irregular bleeding persists or occurs after previously regular cycles, a non-hormonal cause should be considered and appropriate diagnostic measures should be implemented to rule out malignancy or pregnancy. These may include a scraping.

In some women, withdrawal bleeding may not occur during the withdrawal interval. If the COC has been taken as described in section 4.2, it is unlikely that she is pregnant. taken according to these directions or if two withdrawal bleeds have not occurred, pregnancy must be ruled out before continuing to take the COC.

Contains lactose

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take Lestronette.

Contains red aluminum lake (E129)

It can cause allergic reactions.

04.5 Interactions with other medicinal products and other forms of interaction -

Interactions with other medicines

Interaction between combined oral contraceptives and other medicinal products may lead to contraceptive failure and / or breakthrough bleeding.

Reduced absorption: medicines that increase gastrointestinal motility, such as eg. Metoclopramide, can reduce hormone absorption.

Hepatic metabolism: interactions may occur with medicinal products that induce liver microsomal enzymes which may lead to increased clearance of sex hormones. These medicines include hydantoin derivatives (e.g. phenytoin), barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin. Products containing St. John's wort should not be taken concomitantly with Lestronette as they could potentially lead to a loss of contraceptive efficacy. Breakthrough bleeding and unwanted pregnancies have been reported. Enzyme induction can be maintained for at least 2 weeks after stopping treatment with St John's wort.

Enterohepatic circulation: some clinical studies suggest that the enterohepatic circulation of estrogens may decrease with the concomitant administration of certain antibiotics (eg penicillins, tetracyclines) which may reduce the serum concentration of ethinylestradiol.

Women undergoing treatment with one or more of these medicines, in addition to taking the COC, must temporarily use a barrier method or another method of contraception. In the case of treatment with microsomal enzyme-inducing medicinal products, the barrier contraceptive method should be used for as long as the concomitant medicinal products are taken and for 28 days following their discontinuation. Women on antibiotic therapy (with the exception of rifampicin and griseofulvin) must use the barrier method of contraception during antibiotic therapy and up to 7 days after the end of the therapy. If the drug therapy continues even after the end of the tablets of the COC pack, the next COC pack should be started without observing the usual tablet-free interval.

Oral contraceptives can interfere with the metabolism of other medicines. Increases in the plasma concentration of cyclosporine have been reported with concomitant administration of a COC. COCs have been shown to affect lamotrigine metabolism resulting in sub-therapeutic plasma concentrations of lamotrigine.

Note: The prescribing information of the medicinal products to be taken in combination should be consulted in order to identify potential interactions.

Laboratory tests

The use of contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (transport) proteins (eg. Of corticosteroid-binding globulin and lipid / lipoprotein fractions), parameters of glucose metabolism, coagulation and fibrinolysis.The variations are generally within the range of normal laboratory values.

04.6 Pregnancy and breastfeeding -

Lestronette is not indicated during pregnancy.

If pregnancy occurs during treatment with Lestronette, its administration should be stopped immediately.

However, most epidemiological studies have not found an increased risk of birth defects in babies born to women who had used birth control pills before pregnancy, nor any teratogenic effects if contraceptive pills were inadvertently taken early in the pregnancy.

Breastfeeding can be influenced by birth control pills, as these can reduce the quantity and change the composition of breast milk. The use of COCs should therefore be discouraged until the end of breastfeeding. Small amounts of contraceptive steroids and / or their metabolites may be excreted in the milk.These amounts may affect the baby.

04.7 Effects on ability to drive and use machines -

Lestronette has no or moderate influence on the ability to drive or use machines.

04.8 Undesirable effects -

The most common side effect seen in women using Lestronette is headache (17-24% of women).

Other side effects reported among COC users, including Lestronette, are:

Organic system Frequency of adverse reactions common Uncommon Rare (> 1/100 and> 1/10) (> 1/1000 e (> 1 / 10,000 e Disorders of the immune system Hypersensitivity Metabolism and nutrition disorders Fluid retention Psychiatric disorders Depression, mood changes Decreased libido Increased libido Nervous system disorders Headache Migraine Eye disorders Contact lens intolerance Gastrointestinal disorders Nausea, abdominal pain Vomiting, diarrhea Skin and subcutaneous tissue disorders Rash, Urticaria Erythema nodosum, erythema multiforme Diseases of the reproductive system and breast Breast tenderness, breast pain Breast hypertrophy Breast secretions, vaginal secretions Diagnostic tests Weight gain Weight loss

Red aluminum lake (E 129) can cause allergic reactions.

The following serious side effects, discussed in section 4.4, have been reported in women using a CHC:

• venous thromboembolic disorders;

• arterial thromboembolic disorders;

• hypertension;

• liver tumors;

• Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine myoma, porphyria, systemic lupus erythematosus, gestational herpes, Sydenham's chorea, haemolytic-uremic syndrome, cholestatic jaundice.

The number of cases of breast cancer diagnosed has increased slightly among women taking COCs. Because breast cancer is rare in women under 40, the extra number of breast cancer cases is low compared to the overall risk of breast cancer. For more information see sections 4.3 and 4.4.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili

04.9 Overdose -

No serious adverse effects from overdose have been reported. Symptoms that can be caused by overdose are nausea, vomiting and, in girls, mild vaginal bleeding. There are no antidotes and any treatment should be symptomatic.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group (ATC): Fixed combination progestogens and estrogens

ATC code: G03AA07

The contraceptive effect of COCs is based on the interaction of various factors. The most important of these factors are the inhibition of ovulation and changes in cervical secretion.

Clinical studies were conducted on 2498 women between the ages of 18 and 40. The overall Pearl Index obtained from these studies was 0.69 (95% confidence interval 0.30-1.36) based on 15026 treatment cycles.

05.2 "Pharmacokinetic properties -

Ethinylestradiol

Absorption

Orally administered ethinylestradiol is rapidly and completely absorbed. Peak plasma levels of approximately 50 pg / ml are reached within 1-2 hours after taking Lestronette. During absorption and first pass hepatic metabolism, ethinylestradiol is intensively metabolised, with a mean oral bioavailability of approximately 45% (interindividual variations of approximately 20-65%).

Distribution

Ethinylestradiol is highly (approximately 98%), but not specifically, bound to serum albumin and induces an increase in plasma SHBG concentrations. An apparent volume of distribution of approximately 2.8-8.6 has been determined. l / Kg.

Metabolism

Ethinylestradiol is subject to presystemic conjugation at the level of both the mucosa of the small intestine and the liver. The main metabolic pathway of ethinylestradiol is aromatic hydroxylation and a wide range of hydroxylated and methylated metabolites are also formed, present in serum as free metabolites and conjugated with glucuronides and sulphates. The extent of metabolic clearance is 2.3-7 ml / min / kg.

Elimination

Plasma levels of ethinylestradiol show a reduction in two phases, characterized by a half-life of approximately 1 hour and 10-20 hours respectively. Ethinylestradiol is not excreted unchanged. Its metabolites are excreted via the urinary and biliary routes at a ratio of 4: 6 and the half-life is approximately 1 day.

Steady state

Serum concentrations of ethinylestradiol increase by approximately double after continuous intake of Lestronette. Due to the variable half-life in terminal serum clearance and daily dosing, steady state is achieved within approximately one week.

Levonorgestrel

Absorption

Orally administered levonorgestrel is rapidly and completely absorbed. Peak plasma levels, approximately 2.3 ng / mL, are reached approximately 1.3 hours after ingestion of Lestronette. Bioavailability is nearly 100%.

Distribution

Levonorgestrel binds to serum albumin and sex hormone binding globulin (SHBG). Only 1.1% of total serum drug concentrations are present as a free steroid, approximately 65% binds specifically to SHBG and 35% is not specifically bound to albumin. The increase in SHBG induced by ethinylestradiol influences the relative distribution of levonorgestrel in different protein fractions. Induction of the binding protein determines an increase in the SHBG-bound fraction and a reduction in the fraction bound to the "albumin. The apparent volume of distribution of levonorgestrel is 129 l after single administration.

Metabolism

Levonorgestrel is completely metabolised by the known metabolic pathways of steroids. The metabolic clearance in serum is approximately 1.0 ml / min / kg.

Elimination

Serum levels of levonorgestrel show a two-stage reduction. The final phase of elimination is characterized by a half-life of approximately 25 hours. Levonorgestrel is not excreted unchanged. Its metabolites are excreted via the urine and biliary (faeces) at a ratio of approximately 1: 1. The half-life of metabolite excretion is approximately 1 day.

Steady state

During continuous use of Lestronette, serum levels of levonorgestrel increase approximately 3-fold, reaching steady state in the second half of the course of treatment. The pharmacokinetics of levonorgestrel are affected by serum SHBG levels which increase by 1.5-1. , 6 times during estradiol use. Therefore, serum clearance and volume of distribution are slightly reduced at steady state (0.7 ml / min / kg and approximately 100 l)

05.3 Preclinical safety data -

Preclinical studies (general toxicity, genotoxicity, carcinogenic potential and reproductive toxicity) have shown no effects other than those that can be explained by the known profile of the hormones ethinyl estradiol and levonorgestrel.

However, it should be remembered that sex steroids can promote the growth of some hormone-dependent tissues and tumors.