Lesine

Leaflet accompanying the packaging: information for the user

Lesine, 3 mg + 0.03 mg, coated tablets

Drospirenone + Ethinylestradiol

You should read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same. If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more
• You should be vigilant and consult a doctor if you suspect that you have symptoms of a blood clot (see section 2 "Blood clots")

Table of contents of the leaflet

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

1. What is Lesine and what is it used for

Lesine is a contraceptive pill and is used to prevent pregnancy.
Each coated tablet contains a small amount of two different female hormones, namely
drospirenone and ethinylestradiol.
Contraceptive pills that contain two hormones are called "combined" pills.

2. Important information before taking Lesine

General notes

Before starting to take Lesine, you should read the information about
blood clots (thrombosis) in section 2. It is especially important to read about the symptoms
of blood clots (see section 2 "Blood clots").
Before you can start taking Lesine, your doctor will ask you a few questions about your health and about
the health of your close relatives. Your doctor will also measure your blood pressure and, in individual
cases, may also perform some other tests.
This leaflet describes several situations in which you should stop taking Lesine, or in which the effectiveness of Lesine may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as
condoms or other mechanical methods. You should not use the calendar method or the temperature measurement method. These methods may be unreliable because Lesine modifies the monthly
changes in body temperature and cervical mucus.

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

When not to take Lesine

You should not take Lesine if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know that you have blood clotting disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia.
• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) liver disease, and liver function is still abnormal;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Lesine and other medicines");
• if you have kidney problems (kidney failure);
• if you have (or have had in the past) liver cancer;
• if you have (or have had in the past) or suspect you have breast cancer or cancer of the genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of Lesine (listed in section 6). This allergy may cause itching, rash, or swelling.

Additional information for special populations
Children and adolescents
Lesine is not intended for use in girls who have not yet started their menstrual cycles.
Older women
Lesine is not intended for use after menopause.
Women with liver disease
You should not take Lesine if you have liver disease. See also sections "When not to take Lesine" and "Warnings and precautions".
Women with kidney disease
You should not take Lesine if you have kidney failure or acute kidney failure. See also sections "When not to take Lesine" and "Warnings and precautions".

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting to take Lesine.

When to be extra careful when taking Lesine

When should you contact your doctor?

• if you notice any of the following symptoms of a blood clot, which could indicate that you have a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below under "Blood clots").

To find out more about the symptoms of these serious side effects, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

Before taking Lesine, you should consult your doctor. In some situations, you should be extra careful when taking Lesine or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor. If these symptoms occur or worsen while taking Lesine, you should also tell your doctor:

• if you have a family history of breast cancer
• if you have liver or gallbladder disease
• if you have diabetes
• if you have depression
• if you have Crohn's disease or ulcerative colitis (a chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system)
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure)
• if you have sickle cell anemia (a genetic disorder that affects red blood cells)
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots")
• if you are breastfeeding, as you are at a higher risk of blood clots. You should consult your doctor for advice on when to start taking Lesine after giving birth
• if you have superficial thrombophlebitis (blood clots in the veins under the skin)
• if you have varicose veins
• if you have epilepsy (see section "Lesine and other medicines")
• if you have a disease that first occurred during pregnancy or while taking sex hormones, such as hearing loss, porphyria (a blood disorder), or herpes gestationis (a skin disorder that occurs during pregnancy)

if you have (or have had) chloasma (skin discoloration, especially on the face and neck, also known as melasma). If so, you should avoid direct exposure to sunlight or ultraviolet radiation

• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medicines may cause or worsen the symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS (THROMBOSIS)

Taking combined hormonal contraceptives, such as Lesine, is associated with an increased risk of blood clotscompared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in the veins (also known as "venous thrombosis" or "venous thromboembolism")
• in the arteries (also known as "arterial thrombosis" or "arterial thromboembolism").

Not everyone who has a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to taking Lesine is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
What disease is likely to occur in the patient

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking,
• increased temperature in the affected leg
• change in the color of the leg, such as pallor, redness, or cyanosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat.
• severe abdominal pain;

If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, can be mistaken for less serious conditions, such as a respiratory infection (e.g., a cold).

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and travels to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher than when not taking combined hormonal contraceptives.
If you stop taking Lesine, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with taking Lesine is small.

• During a year, about 2 in 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5 to 7 in 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9 to 12 in 10,000 women who take combined hormonal contraceptives containing drospirenone, such as Lesine, will develop blood clots.
• The risk of blood clots depends on the individual medical history of the patient (see "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with taking Lesine is small, but some factors can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have a genetic blood clotting disorder;
• if you need to have surgery, if you are immobilized for a long time due to injury or illness, or if you have a leg in a cast. It may be necessary to stop taking Lesine for a few weeks before surgery or immobilization. If you need to stop taking Lesine, you should ask your doctor when you can resume taking it;
• with age (especially over 35 years old);
• if you have given birth in the last few weeks.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop you from taking Lesine.
You should inform your doctor if any of these conditions change while taking Lesine, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with taking Lesine is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke.While taking a hormonal contraceptive like Lesine, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at higher risk of having a heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage or irregular heartbeat);
• if you have diabetes.

If you have more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of these conditions change while taking Lesine, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

Lesine and cancer

Women taking combined contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the medicine. For example, it may be that more breast cancers are detected in women taking combined contraceptives because they are more likely to have regular medical check-ups.
The risk of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Women taking combined contraceptives have also been reported to have an increased risk of benign liver tumors and, in rare cases, liver cancer. If you experience severe abdominal pain, you should contact your doctor.

Irregular bleeding

During the first few months of taking Lesine, you may experience irregular bleeding (bleeding outside of the weekly break). If such bleeding continues for more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not experience bleeding during the weekly break

If you have taken all the tablets as directed, have not vomited, or had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive weeks, it may mean that you are pregnant.
You should contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

Psychological disorders

Some women taking hormonal contraceptives, including Lesine, have reported depression or mood swings. Depression can be severe and, in some cases, lead to suicidal thoughts.
If you experience mood changes or symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

Lesine and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should also tell any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Lesine. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and for how long or if you need to adjust the dosage of other medicines.
Some medicines may affect the levels of Lesine in your blood and may cause it to be lesseffective in preventing pregnancyor may cause irregular bleeding. These include:

• medicines used to treat: epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g., rifampicin), HIV and hepatitis C virus (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz), fungal infections (griseofulvin, ketoconazole), arthritis (etoricoxib), high blood pressure in the lungs (bosentan)
• herbal medicines containing St. John's Wort ( Hypericum perforatum)

Lesine may affect the action of other medicines, such as:
medicines containing cyclosporin
antiepileptic medicines containing lamotrigine (may increase the risk of seizures)
theophylline (used for breathing problems),
tizanidine (used to treat muscle pain and/or muscle spasms).
Before taking any medicine, you should consult your doctor or pharmacist.
You should not take Lesine if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may increase liver function test results in the blood (increase in liver enzyme ALT).
Your doctor will prescribe a different contraceptive method before starting treatment with these medicines.
Lesine can be taken again about 2 weeks after finishing this treatment. See section "When not to take Lesine".

Lesine with food and drink

Lesine can be taken with or without food, as needed, with a small amount of water.

Lab tests

If you need to have a blood test, you should tell your doctor or laboratory staff that you are taking a contraceptive, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy
Lesine should not be taken during pregnancy. If you become pregnant while taking Lesine, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop taking Lesine at any time (see also "Stopping Lesine").
Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
Lesine is not usually recommended during breastfeeding. If you want to take a contraceptive while breastfeeding, you should consult your doctor.
Before taking any medicine, you should consult your doctor or pharmacist.
Lesine contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially "sodium-free".

Driving and using machines

There is no information to suggest that taking Lesine affects the ability to drive or use machines.

Lesine contains lactose.

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Lesine

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
You should take one Lesine tablet every day, as needed, with a small amount of water.
You can take the tablets with or without food, but you should take them at the same time every day.
The blister pack contains 21 coated tablets. The day of the week is printed next to each tablet. If, for example, you start taking the tablets on a Wednesday, you should take the tablet with "Wed" printed next to it. You should move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then, you should not take any tablets for 7 days. During these 7 days (also known as the "week off"), you should experience bleeding. This is called "withdrawal bleeding", which usually starts on the 2nd or 3rd day of the week off.
On the 8th day after taking the last Lesine tablet (i.e., after the 7-day break), you should start a new blister pack, regardless of whether the bleeding has stopped or not. This means that you should start each new blister pack on the same day of the week, and the withdrawal bleeding should occur on the same days every month.
If you take Lesine in this way, you are protected from pregnancy during the 7 days when you are not taking tablets.

When can you start the first blister pack?

• If you have not taken a hormonal contraceptive in the previous month.You should start taking Lesine on the first day of your menstrual cycle (i.e., the first day of your period). If you start taking Lesine on the first day of your period, you are immediately protected from pregnancy. You can also start taking Lesine on days 2-5 of your cycle, but in this case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.You should start taking Lesine the next day after taking the last active tablet (the last tablet containing active ingredients) from the previous pack, but no later than the day after the end of the previous contraceptive's tablet-free period (or after the last inactive tablet). When switching from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Switching from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen).You can switch at any time, but in all cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Lesine.
• After a miscarriage.You should follow your doctor's advice.
• After childbirth.You can start taking Lesine from 21 to 28 days after giving birth. If you start taking Lesine later than 28 days after giving birth, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Lesine.

If you have had sex after giving birth and before (re)starting Lesine, you should first make sure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and want to (re)start taking Lesine after giving birth. You should read the section on "Breastfeeding".

If you are unsure when to start taking Lesine, you should consult your doctor.

What to do if you take more Lesine than you should

There are no reports of serious, harmful effects from taking too many Lesine tablets at once.
If you take several tablets at once, you may experience nausea and vomiting or vaginal bleeding. This type of bleeding can occur even in girls who have not yet started their menstrual cycles, but have taken the medicine by mistake.
If you take too many Lesine tablets or if a child swallows them, you should consult your doctor or pharmacist.

What to do if you forget to take Lesine

• if it has been less than 12 hourssince you forgot to take a tablet, your protection from pregnancy is not reduced. You should take the tablet as soon as possible, and then take the next tablets at the usual time.
• if it has been more than 12 hourssince you forgot to take a tablet, your protection from pregnancy may be reduced. The more tablets you have missed, the higher the risk of becoming pregnant.

The risk of reduced protection from pregnancy is highest if you forget to take a tablet at the beginning or end of the blister pack. Therefore, you should follow the instructions below (see also the diagram below):

• Forgetting to take more than one tablet in this blister packYou should contact your doctor.
• Forgetting to take one tablet in week 1.You should take the forgotten tablet as soon as possible, even if it means taking two tablets at the same time. You should then continue taking the tablets at the usual time and use additional contraceptive methods, such as condoms, for the next 7 days. If you had sex during the week before forgetting the tablet, there is a risk of pregnancy. In this case, you should contact your doctor.
• Forgetting to take one tablet in week 2.You should take the forgotten tablet as soon as possible, even if it means taking two tablets at the same time. You should then continue taking the tablets at the usual time. Your protection from pregnancy is not reduced, and you do not need to use additional contraceptive methods.
• Forgetting to take one tablet in week 3.There are two options to choose from:
• 1. Take the forgotten tablet as soon as possible, even if it means taking two tablets at the same time. You should then continue taking the tablets at the usual time.

Instead of the tablet-free week, you can start taking tablets from the next blister pack immediately.
It is likely that you will experience bleeding at the end of the second blister pack, but you may also experience spotting or breakthrough bleeding while taking tablets from the second blister pack.

• 2. You can also stop taking tablets from the blister pack and go straight to the 7-day tablet-free period ( make a note of the day you forgot to take the tablet). If you want to start the next blister pack on your usual start day, you can shorten the tablet-free period to less than 7 days. If you follow one of these two instructions, your protection from pregnancy will be maintained.
• If you forget to take any of the tablets in the blister pack and do not experience bleeding during the first tablet-free period, it may mean that you are pregnant. In this case, you should contact your doctor before starting the next blister pack.

Forgot to take more
than 1 tablet from this
blister pack
Should consult a doctor
yes
in week 1.
Did you have sex during the week
before forgetting the tablet?

• Take the forgotten tablet
• Use a mechanical method (condoms) for the next 7 days and
• Finish the tablets in the blister pack without

Only 1 tablet forgotten
(taken more than 12 hours
late)

• Take the forgotten tablet
• Finish the tablets in the blister pack in week 2.
• Take the forgotten tablet and
• Finish the tablets in the blister pack
• Instead of the tablet-free week, start taking tablets from the next blister pack in week 3.
• or
• Stop taking tablets from the blister pack immediately
• Start the tablet-free week (no longer than 7 days, including the forgotten tablet)
• Start taking tablets from the next blister pack

What to do if you vomit or have severe diarrhea

If you vomit within 3 to 4 hours of taking a tablet or have severe diarrhea, there is a risk that the active ingredients from the tablet may not have been fully absorbed into your bloodstream.
The situation is similar to forgetting a tablet. After vomiting or diarrhea, you should take another tablet from the spare blister pack as soon as possible. If possible, you should take it within
12 hoursof the normal time for taking the tablet. If this is not possible or more than 12 hours have passed, you should follow the instructions given in the section "If you forget to take Lesine".

Delaying your period: what you need to know

Although it is not recommended, you can delay your period by going straight to the next Lesine blister pack, skipping the tablet-free week, and finishing it. You may experience spotting or breakthrough bleeding while taking tablets from the second blister pack.
After the usual 7-day tablet-free period, you should starttaking tablets from the next blister pack.
You can ask your doctor for advice before making a decision to delay your period.

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

If you take the tablets as directed, your period will start during the tablet-free week. If you want to change this day, you can do so by shortening (but never lengthening - maximum 7 days!) the tablet-free period. For example, if your tablet-free period starts on a Friday and you want to change the day to a Tuesday (3 days earlier), you should start the next blister pack 3 days earlier than usual. If the tablet-free period is very short (e.g., 3 days or less), you may experience bleeding during those days. As a result, you may experience spotting or breakthrough bleeding.
If you are unsure what to do, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers to be related to the use of Lesine, the patient should consult her doctor. All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before taking Lesine". Severe side effects The patient should immediately contact her doctor if she experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives that may cause difficulty breathing (see also the section "Warnings and precautions"). The following side effects have been associated with the use of Lesine. Common side effects (may occur in up to 1 in 10 people)

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• headaches, depression,
• migraine,
• nausea,
• thick, white vaginal discharge and vaginal fungal infections.

Uncommon side effects (may occur in up to 1 in 100 people)

• changes in libido (interest in sex),
• high blood pressure, low blood pressure,
• vomiting, diarrhea,
• acne, skin rash, severe itching, hair loss (alopecia),
• breast enlargement,
• vaginal infections,
• fluid retention and changes in body weight.

Rare side effects (may occur in up to 1 in 1,000 people)

• allergic reactions (hypersensitivity), asthma,
• breast discharge,
• hearing disorders,
• erythema nodosum (characterized by painful, red nodules on the skin) or erythema multiforme (characterized by a rash with red, painful edges).
• harmful blood clots in a vein or artery, for example: in the leg or foot (e.g., deep vein thrombosis) in the lungs (e.g., pulmonary embolism) heart attack stroke so-called "mini-stroke" or transient stroke symptoms, known as transient ischemic attack blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell her doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Lesine

The medicine should be stored out of sight and reach of children. This medicine does not require any special precautions for storage.

Expiry date

Do not use this medicine after the expiry date stated on the blister and packaging after the words "Expiry date" or "EXP". The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. The patient should ask her pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Lesine contains

The active substances of Lesine are ethinylestradiol and drospirenone. Each tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone. The other ingredients are: Tablet core: lactose monohydrate, corn starch, pregelatinized starch, maize starch, crospovidone, povidone K30, polysorbate 80, magnesium stearate. Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Lesine looks like and what the pack contains

Yellow, round, film-coated tablets.

• Lesine is available in packs of 1 or 3 blisters, each containing 21 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

Manufacturer

Laboratorios León Farma S.A., C/ La Vallina s/n, Pol. Ind. Navatejera, 24193 Villaquilambre – Leon, Spain, Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country names:

Date of revision of the leaflet:May 2025