Lestronette

Package leaflet: Information for the user

Lestronette 0.10 mg + 0.02 mg film-coated tablets

levonorgestrel/ethinylestradiol
Generic medicine
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

1. What Lestronette is and what it is used for
2. What you need to know before taking Lestronette
3. How to take Lestronette
4. Possible side effects
5. How to store Lestronette
6. Contents of the pack and other information

1. What Lestronette is and what it is used for

• Lestronette is a contraceptive pill used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.
• Contraceptive pills containing two hormones are known as "combined pills". Lestronette is referred to as a "low-dose" contraceptive pill because it contains only a small amount of hormones.

2. What you should know before taking Lestronette

General information
Before starting to use Lestronette, you must read the information about blood clots in section 2.
It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before you start taking Lestronette, your doctor will ask you questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may prescribe additional tests.
This leaflet describes certain situations in which you must stop taking Lestronette or in which its effectiveness may be reduced. In these situations, you must either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or other barrier methods. Do not use rhythm or basal body temperature methods.
These methods may be unreliable because Lestronette alters the normal changes in body 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.

When not to use Lestronette
Do not use Lestronette if you have any of the conditions listed below. If you suffer from any of the conditions listed below, you must inform your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your case.

Do not take Lestronette

• if you are allergic to levonorgestrel, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6). This condition may cause itching, rash, or swelling;
• if you have or have ever had a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, for example: protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have or have ever had a heart attack or stroke;
• if you have or have ever had angina pectoris (a condition that may cause severe chest pain and can be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions that could increase the risk of arterial clots:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol and triglycerides);
  • a condition known as hyperhomocysteinaemia;
• if you suffer or have ever suffered from a type of migraine called “migraine with aura”;
• if you suffer or have ever suffered from severe liver disease and your liver function values are not yet normal;
• if you suffer or have ever suffered from liver tumours;
• if you have, have ever had, or are suspected of having breast cancer or genital organ cancer;
• if you have vaginal bleeding of unknown origin;
• if you have stopped menstruating, possibly due to physical exercise or diet;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Lestronette”).

Additional information for special populations
Use in children
Lestronette is not intended for use in women whose menstrual cycle has not yet started.
Use in elderly women
Lestronette is not intended for use after menopause.
Women with hepatic impairment
Do not take Lestronette if you suffer from liver disease. See also sections "When not to use Lestronette" and "Warnings and precautions".
Women with renal impairment
Consult your doctor. Available data do not suggest the need to modify the use of Lestronette.

Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently

• if you notice signs of a possible blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clot").

For a description of the symptoms of these serious adverse effects, see section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
Consult your doctor before taking Lestronette. In some situations, you need to be particularly careful when using Lestronette or other combined pills. Your doctor may need to perform regular check-ups.
If any of these conditions develop or worsen while you are taking Lestronette, you must inform your doctor:

• If a first-degree relative has had breast cancer.

• If you suffer from liver or gallbladder disease.

• If you suffer from diabetes.

• If you suffer from depression.

• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).

• If you suffer from systemic lupus erythematosus (SLE, a disease affecting your natural immune system).

• If you suffer from haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).

• If you suffer from sickle cell anaemia (an inherited disease affecting red blood cells).

• If you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).

• If you are due to undergo surgery or need to remain bedridden for a prolonged period (see section 2 “Blood clots”).

• If you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Lestronette.

• If you have inflammation of veins under the skin (superficial thrombophlebitis). If you have varicose veins.

• If you suffer from epilepsy (see “Other medicines and Lestronette”).

• If you have conditions that first appeared during pregnancy or during treatment with sex hormones (e.g. hair loss, a blood disorder called porphyria, a blistering skin rash occurring during pregnancy (herpes gestationis), or a nerve disorder causing sudden body movements (Sydenham’s chorea)).

• If you have suffered from patchy brown-yellow skin pigmentation (chloasma), also known as pregnancy spots, especially on the face. In such cases, avoid direct exposure to sunlight or ultraviolet rays.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Lestronette increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop:

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Lestronette is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

Do you have one of these signs? What are you probably suffering from?

• swelling in one leg or along a vein in the leg or Deep vein thrombosis of the foot, especially if accompanied by:
  • pain or tenderness in the leg, which may only be felt when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, such as paleness, redness, or bluish discoloration
• sudden and unexplained shortness of breath Pulmonary embolism
• sudden cough without an obvious cause, possibly with coughing up blood
• sharp chest pain that may worsen when breathing deeply
• severe dizziness or lightheadedness
• rapid or irregular heartbeat
• severe stomach pain

If you are unsure, inform your doctor, as some of these
symptoms such as cough or shortness of breath may be mistaken
for a milder condition such as a respiratory tract infection (e.g. a “common cold”).

Retinal vein thrombosis
Symptoms occurring more frequently in one eye:

• sudden loss of vision or (blood clot in the eye)
• painless blurring of vision that may progress to loss of vision
• pain, discomfort, pressure, or heaviness in the chest Heart attack
• squeezing or fullness in the chest, arm, or under the sternum
• feeling of fullness, indigestion, or suffocation
• discomfort in the upper body, radiating to the back, jaw, throat, arms, and stomach
• sweating, nausea, vomiting, or dizziness
• extreme weakness, anxiety, or shortness of breath
• rapid or irregular heartbeat
• sudden numbness or weakness of the face, arm, or leg, especially on one side of the body Stroke
• sudden confusion, difficulty speaking or understanding
• sudden difficulty seeing with one or both eyes
• sudden difficulty walking, dizziness, loss of balance or coordination
• sudden severe or prolonged headache without known cause
• loss of consciousness or fainting, with or without seizures

Sometimes stroke symptoms may be brief, with almost immediate
and complete recovery, but you should still contact a doctor
urgently as you may be at risk of another stroke.

• swelling and pale blue discoloration of a limb; Blood clots blocking
• severe stomach (acute abdomen) pain other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?
The risk of developing a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases but remains slightly higher than when not using a combined hormonal contraceptive.
When you stop taking Lestronette, the risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Lestronette is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel such as Lestronette, about 5–7 will develop a blood clot in a year.
• Your risk of having a blood clot will vary depending on your personal medical history (see "Factors that increase the risk of a blood clot" below).

Factors that increase the risk of a blood clot in a vein
The risk of a blood clot with Lestronette is low, but certain conditions can increase it.
The risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²)
• if a close family member has had a blood clot in the leg, lung, or another organ at a young age (e.g. before approximately 50 years). In this case, you might have an inherited blood clotting disorder
• if you are due to have surgery, or if you are immobile for a long period due to injury or illness, or if you have a plaster cast on your leg. Use of Lestronette may need to be stopped several weeks before surgery or during periods of immobility. If you need to stop taking Lestronette, ask your doctor when you can start again
• as you get older (particularly after about 35 years of age)
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases the more of these conditions you have.
Air travel (>4 hours) may temporarily increase the risk of a blood clot, especially if some of the other listed factors are present.
It is important to inform your doctor if any of these conditions apply to you, even if you are unsure.
Your doctor may decide that Lestronette should be discontinued.
If any of the above conditions change while you are using Lestronette, for example if a close family member develops thrombosis without a known cause, or if you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems.
For example, it can cause a heart attack or stroke.

Factors that increase the risk of a blood clot in an artery
It is important to note that the risk of heart attack or stroke due to use of Lestronette is very low, but it may increase:

• with increasing age (over about 35 years)
• if you smoke. When using a combined hormonal contraceptive such as Lestronette, you are advised to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive
• if you are overweight
• if you have high blood pressure
• if a close family member has had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also have an increased risk of heart attack or stroke
• if you or a close family member have high levels of fats in the blood (cholesterol or triglycerides)
• if you suffer from migraine, particularly migraine with aura
• if you have a heart condition (valvular disorder, rhythm disorder called atrial fibrillation)
• if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, your risk of developing a blood clot may increase even further.
If any of the above conditions change while you are using Lestronette—for example, if you start smoking, if a close family member has a thrombosis without a known cause, or if you gain a lot of weight—inform your doctor.

Lestronette and cancer

• Cervical cancer has been reported in women taking long-term contraceptives, but it is unclear whether this is due to sexual behaviour or other factors such as human papillomavirus (HPV).
• Breast cancer is diagnosed slightly more frequently in women using combined pills, but it is not known whether this is due to the treatment. The risk of developing breast cancer decreases after stopping the pills. It is important that you regularly check your breasts and contact your doctor if you notice any lumps.
• Benign (non-cancerous) liver tumours are rare, and malignant (cancerous) liver tumours are even more rarely reported in users of combined pills. Contact your doctor if you have unusually severe stomach pain.

Psychiatric disorders
Some women using hormonal contraceptives, including Lestronette, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Bleeding between periods
During the first few months of taking Lestronette, unexpected bleeding (bleeding outside the pill-free days) may occur. If this bleeding occurs for more than three months, or if it restarts after a few months, your doctor should investigate the cause.

What to do if no bleeding occurs during the pill-free days
If you have taken all tablets correctly, have not vomited or had severe diarrhoea, and have not taken other medicines, it is very unlikely that you are pregnant. However, if the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately, as pregnancy must be ruled out before continuing the pill. Start the next pack only if you are certain you are not pregnant.

Other medicines and Lestronette
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines. Also inform any other doctors, dentists, or pharmacists who may prescribe medicines that you are using Lestronette. This way, they can advise you whether and for how long you need to use additional contraceptive methods (e.g. condoms).

• Some medicines may:
  • affect blood levels of Lestronette
  • reduce its effectiveness in preventing pregnancy, or
  • cause unexpected bleeding.

These include medicines used to treat:

• intestinal motility (e.g. metoclopramide)
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate or felbamate)
• tuberculosis (e.g. rifampicin)
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
• fungal infections (griseofulvin)
• arthritis, osteoarthritis (etoricoxib)
• high blood pressure in the blood vessels of the lungs (bosentan)
• St. John’s wort (Hypericum perforatum).

The antibiotic troleandomycin may increase the risk of cholestatic jaundice when taken with the pill.

• Lestronette may affect the action of other medicines, for example:
  • drugs containing cyclosporine
  • the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures)
  • theophylline (used to treat respiratory problems)
  • tizanidine (used to treat muscle pain and/or muscle cramps).

Do not use Lestronette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood test results (increase in liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Lestronette may be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Lestronette”.

Lestronette with food and drink
Lestronette may be taken with or without food, if necessary with a small amount of water.
Lestronette should not be taken with grapefruit juice.

Diagnostic tests
If you need a blood test, inform your doctor or laboratory that you are taking the pill, as oral hormonal contraceptives may alter the results of certain tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Lestronette if you are pregnant. If you become pregnant while taking Lestronette, stop taking Lestronette immediately and contact your doctor. If you wish to become pregnant, you may stop taking Lestronette at any time (see also “If you stop taking Lestronette”).

Using Lestronette is not recommended during breastfeeding unless advised by your doctor. If you wish to take the pill while breastfeeding, you should consult your doctor.

Driving and using machines
There is no evidence that use of Lestronette affects the ability to drive or use machinery.

Lestronette contains lactose.
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

Lestronette contains aluminium lake red (E 129)
May cause allergic reactions.

3. How to take Lestronette

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Each blister pack contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken. For example, if you start taking the tablets on Tuesday, press the tablet through the aluminium foil at the blister marked "TUE". Take the tablets every day in the order indicated by the arrows.

Take one Lestronette tablet daily for 21 days, with or without water. You may take the tablets with or without food, but you should take them at approximately the same time each day.

After taking the 21 tablets, you will not take any tablets for the following 7 days. Your menstrual period (withdrawal bleeding) will usually begin during these 7 days, typically 2–3 days after taking the last Lestronette tablet.

Start the next blister pack on the 8th day, even if bleeding has not stopped. This way, you will always start a new pack on the same day of the week, and withdrawal bleeding will occur approximately at the same time each month.

When to start the first blister pack

• If you have not used any hormonal contraceptive in the previous month: Start taking Lestronette on the first day of your cycle (the first day of menstruation). If you start taking Lestronette on this day, you are immediately protected against pregnancy. Alternatively, you may start between the 2nd and 5th day of your cycle, but in this case you must use additional contraceptive methods (e.g. condoms) for the first 7 days.
• Switching from another combined hormonal contraceptive, vaginal contraceptive ring, or contraceptive patch: Start taking Lestronette the day after taking the last active tablet of the previous pill (or after removing the ring or patch), or at the latest, the day after the usual pill-free interval (without ring or patch) or after the last placebo tablet of the previous hormonal contraceptive.
• Switching from a progestogen-only method (oral pill, injection, implant, or intrauterine system/device IUS/IUD): You may switch to Lestronette on any day from the progestogen-only pill (on the same day of removal from an implant or IUS/IUD, or on the day the next injection would have been due). However, in all these cases, you must use an additional contraceptive method (e.g. condom) during the first 7 days of tablet intake.
• After a first-trimester abortion: Follow your doctor’s advice.
• After childbirth or a second-trimester abortion: Start taking Lestronette between the 21st and 28th day after childbirth or second-trimester abortion. If you start later than the 28th day, you must use an additional barrier method (e.g. condom) during the first 7 days of taking Lestronette. If you have had sexual intercourse after childbirth, before starting (or restarting) Lestronette, you must first ensure you are not pregnant or wait until your next menstrual period before starting Lestronette.
• If you are breastfeeding and wish to restart taking Lestronette after childbirth: Read section 2 “Pregnancy and breastfeeding”.

Consult your doctor if you are unsure about when to start.

If you take more Lestronette than you should

No serious harmful effects have been reported after taking many Lestronette tablets at once. If you have taken several tablets at the same time, you may feel sick, vomit, or have vaginal bleeding. Even girls who have not yet had their periods but have accidentally taken this medicine may experience such bleeding.

If you have taken too many Lestronette tablets or discover that a child has taken some, consult your doctor or pharmacist.

If you forget to take Lestronette

• If you are less than 12 hours late in taking the tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember, then continue at your usual time.
• If you are more than 12 hours late in taking the tablet, protection against pregnancy may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy.

In such cases, follow these rules:

• The intake of tablets should never be interrupted for more than 7 days.
• The effectiveness of Lestronette depends on 7 consecutive days of uninterrupted tablet intake.
• If you are more than 12 hours late during days 1 to 7 (see also the diagram): Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the following tablets as usual. In addition, use a barrier contraceptive method (e.g. condom) for the next 7 days. If you had sexual intercourse during the 7 days before the missed tablet, consider the possibility of pregnancy. The greater the number of missed tablets and the closer to the regular tablet-free interval, the higher the risk of pregnancy. Consult your doctor if this happens.
• If you are more than 12 hours late during days 8 to 14 (see also the diagram): Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the following tablets as usual. Provided you have taken the tablets correctly during the 7 days before the first missed tablet, no additional contraceptive precautions are needed. If you have not taken the tablets correctly or have missed more than one tablet, you must use additional contraceptive precautions for the next 7 days.
• If you are more than 12 hours late during days 15 to 21 (see also the diagram): The risk of pregnancy increases the closer you are to the 7-day tablet-free interval. However, pregnancy may still be prevented by adjusting the dosing. If you follow the advice below, additional contraceptive precautions are not necessary, provided all tablets were taken correctly during the 7 days before the first missed tablet. Otherwise, follow the first of the two options below and use additional contraceptive precautions for the next 7 days. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time.
  1. Then continue taking the remaining tablets as usual. Instead of taking a 7-day break without tablets, start immediately with the next 21-tablet blister pack. Withdrawal bleeding may not occur until the end of the second pack, but spotting or breakthrough bleeding may occur during tablet intake. Alternatively, you may stop taking tablets from the current pack and take a 7-day tablet-free break (including the days on which you missed tablets), then continue with the next blister pack.
• If you miss several tablets and no withdrawal bleeding occurs during the first normal tablet-free interval, consider the possibility of pregnancy.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours of taking a tablet or have severe diarrhoea, there is a risk that the active ingredients will not be fully absorbed by your body. This situation is similar to that of a missed tablet. In case of vomiting or diarrhoea, take another tablet from a different blister pack as soon as possible. If possible, take it within 12 hours, or at your usual time of tablet intake. If this is not possible, or if more than 12 hours have passed, follow the instructions under “If you forget to take Lestronette”.

Postponing menstruation: what you should know

Although not recommended, you may postpone your period by starting a new blister pack of Lestronette immediately, continuing until it is finished. Spotting (small drops or stains of blood) or breakthrough bleeding may occur during the use of the second blister pack. After finishing the second blister pack, a 7-day break without tablets is required.

Consult your doctor before deciding to postpone your period.

Changing the first day of your menstrual cycle: what you should know

If you wish to change the starting day or have your period on a different day of the week, you may shorten the next tablet-free interval by as many days as desired. The shorter the interval, the higher the risk that withdrawal bleeding will not occur and that breakthrough bleeding or spotting may occur during the second pack. Never extend the tablet-free interval.

If you stop taking Lestronette

You may stop taking Lestronette at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other birth control methods. If you wish to become pregnant, stop taking Lestronette and wait for a menstrual period before trying to conceive. This will make it easier to estimate your due date.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Lestronette, inform your doctor.
Serious side effects
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined oral contraceptives, see section 2 “What you need to know before taking Lestronette”.
Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also “Warnings and precautions”).
The following is a list of side effects associated with the use of Lestronette.

• Common: may affect up to 1 in 10 women:
• mood changes, depression
• headache
• nausea, abdominal pain
• breast tenderness or breast pain
• weight gain
• Uncommon: may affect up to 1 in 100 women:
• reduced sexual desire,
• migraine
• vomiting, diarrhoea
• skin rash
• itching or skin lumps
• breast enlargement
• fluid retention
• Rare: may affect up to 1 in 1,000 women:
• intolerance to contact lenses
• allergic reactions
• increased sexual desire
• breast or vaginal discharge
• redness or skin patches
• weight loss
• harmful blood clots in a vein or artery, for example:
  • in a leg or foot (DVT),
  • in a lung (PE),
  • heart attack,
  • stroke,
  • mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA),
  • blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
• Not known: frequency cannot be estimated from the available data: increased liver enzymes (elevated transaminases).

The following serious adverse events have been reported slightly more frequently in women using oral contraceptive pills, but it is not known whether they are caused by the treatment (see section 2 “What you need to know before taking Lestronette”):

• increased blood pressure
• liver tumours or breast cancer.

The following conditions have been associated with combined oral contraception:
Crohn’s disease, ulcerative colitis, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (when the body attacks and damages its own organs and tissues), herpes during late pregnancy, Sydenham's chorea (jerky movements or rapid involuntary contractions), haemolytic uraemic syndrome (a condition occurring after diarrhoea caused by E. coli), liver problems manifested by jaundice.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Lestronette

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 on the blister after "Exp.". The
expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lestronette contains
The active substances are levonorgestrel and ethinylestradiol.
Each tablet contains 0.10 mg of levonorgestrel and 0.02 mg of ethinylestradiol.
The other components are: 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, aluminium lake red (E 129), lecithin (E 322), iron oxide red (E 172) and aluminium lake blue (E 132)].

Description of the appearance of Lestronette and pack contents

• Each film-coated tablet is pink and round.
• Lestronette is available in 21-tablet strips (blister packs).
• Packs contain 1, 3 or 6 blisters, each blister containing 21 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer
Merckle GmbH - Ludwig-Merckle Strasse 3, 89143 Blaubeuren (Germany)
Laboratorios Leon Farma S.A., C/La Vallina s/n, Poligono Industrial Navatejera, 24008 Navatejera, Leon (Spain)

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Liana-ratiopharm
Italy: Lestronette 0.10 mg+0.02 mg film-coated tablets
Netherlands: Ethinylestradiol/levonorgestrel Teva 0.02/0.1 mg film-coated tablets