Lesine

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Lesine (Ethinylestradiol/Drospirenone 0.03 mg/3 mg Theramex)

3 mg + 0.03 mg, coated tablets

Drospirenonum + Ethinylestradiolum
Lesine Ethinylestradiol/Drospirenone 0.03 mg/3 mg Theramexare different trade names for the same drug.

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 necessary.
• 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 tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
Contraceptive pills containing 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 (thrombosis)").
Before you can start taking Lesine, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, in individual cases, may also perform certain 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 infection (AIDS) or other sexually transmitted diseases.

When not to take Lesine

You should not take Lesine if you have any of the following conditions. If you have any of the following conditions, 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 you have a blood clotting disorder - for example, 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 2 "Blood clots (thrombosis)");
• 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 sign of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases, which 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/pibrentaswir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Lesine and other medicines");
• if you have kidney problems (renal 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 or genital cancer;
• 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 cycle.
Elderly 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

When to be particularly careful when taking Lesine

Before starting to take Lesine, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?
You should see your doctor immediately

• if you notice any of the following symptoms, which could be signs of a blood clot: swelling of the leg or 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 warmth of the affected leg; change in the color of the leg, such as whitening, reddening, or blue discoloration.

In order to describe the symptoms of the serious side effects mentioned, see "How to recognize a blood clot".
In certain situations, you should be particularly careful when taking Lesine or any other combined hormonal contraceptive, and you may also need to be regularly examined by your doctor.

Tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Lesine, you should also tell your doctor:

• if there is a history of breast cancer in your close family;
• 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 hereditary disease of red blood cells);
• if you have been told you have an increased level of fats in your blood (hypertriglyceridemia) or if you 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 (thrombosis)");
• if you are immediately after childbirth, as you are at increased risk of blood clots. You should ask your doctor how soon you can start taking Lesine after childbirth;
• 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 appeared during pregnancy or previous use of sex hormones, such as hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pemphigoid gestationis), a neurological disease characterized by involuntary movements of the body (Sydenham's chorea);
• if you have (or have had) chloasma (skin discoloration, especially on the face and neck, so-called pregnancy spots). If so, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, estrogen-containing products may cause or worsen its symptoms. You should see your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with difficulty breathing.

BLOOD CLOTS (THROMBOSIS)

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

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

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-term 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 see your doctor immediately if you notice any of the following symptoms.
What disease is the patient likely to have?

• swelling of the leg or 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 warmth of the affected leg; change in the color of the leg, such as whitening, reddening, or blue discoloration.
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased warmth of the affected leg;
• change in the color of the leg, such as whitening, reddening, or blue discoloration.
• 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; Pulmonary embolism

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 thromboembolism). 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 deep vein thrombosis;
• If a blood clot breaks loose from the leg and lodges in 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 product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.
If you stop taking Lesine, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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 out of 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 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots;
• During a year, about 9 to 12 out of 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/m2);
• if someone in your close family has had a blood clot in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots (thrombosis)");
• with age (especially over 35 years old);
• if you have recently given birth.

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 important 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 taking Lesine.
You should inform your doctor if any of the above 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 weight significantly.

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 important 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, it is recommended to quit smoking. If you are unable to quit 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 increased 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, irregular heartbeat);
• if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, the risk of a blood clot may be even higher.
You should inform your doctor if any of the above 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 weight significantly.

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 contraceptive. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by doctors more often.
The frequency of breast tumors decreases gradually after stopping combined hormonal contraceptives.
It is important to examine your breasts regularly and contact your doctor if you feel any lump.
Women taking combined contraceptives have also been reported to have, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. 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 longer 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 have not 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 low mood. Depression can be severe and sometimes 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 (such as condoms) and for how long or if you need to adjust your other medicines.
Certain medicines may affect the levels of Lesine in your blood and may make it less effective in preventing pregnancy or 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 infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin, ketoconazole),
• arthritis, degenerative joint disease (etoricoxib),
• high blood pressure in the blood vessels of 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 frequency 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/pibrentaswir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increased liver enzyme levels in the blood (increased ALT activity).
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, if necessary with a small amount of water.

Lab tests

If a blood test is necessary, 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 use a contraceptive method while breastfeeding, you should contact your doctor.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

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

Lesine contains lactose monohydrate.

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

Lesine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially "sodium-free".

3. How to take Lesine

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should contact your doctor or pharmacist.
You should take one Lesine tablet every day, if necessary with a small amount of water.
The blister pack contains 21 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 (see "Translation of day symbols on the packaging" at the end of the leaflet).
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 called the "tablet-free week"), you should experience bleeding. This is called "withdrawal bleeding", which usually starts on the 2nd or 3rd day of the tablet-free week.
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 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 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 you will need to use additional contraceptive methods (such as condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal system or transdermal system.You should start taking Lesine the next day after taking the last active tablet (the last tablet containing active substances) from the previous pack, but no later than the day after the end of the previous contraceptive product's tablet-free period (or the last inactive tablet from the previous product). When switching from a combined hormonal contraceptive vaginal system or transdermal system, 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 you must use additional contraceptive methods (such as 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 between 21 and 28 days after childbirth. If you start taking Lesine later than 28 days, you should use additional contraceptive methods (such as condoms) for the first 7 days of taking Lesine.

If you have had sexual intercourse after childbirth, before (re)starting Lesine, you should first make sure you are not pregnant or wait for your first menstrual period.

• If you are breastfeeding and want to (re)start taking Lesine after childbirth.You should read the section "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.
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 cycle, but have taken the medicine by mistake.
If you take too many Lesine tablets or if a child has taken 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 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 forget, the higher the risk of becoming pregnant.

The risk of reduced protection from pregnancy is highest if you forget tablets at the beginning or end of the blister pack. Therefore, you should follow the rules 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 take the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If you had sexual intercourse in 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 take the next tablets at the usual time. Your protection from pregnancy is not reduced, and you do not need to use additional protection.
• •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 take the next tablets at the usual time. Instead of the tablet-free period, you should start taking tablets from the next blister pack immediately.

You will probably experience bleeding at the end of the second blister pack, but you may also experience spotting or irregular bleeding while taking tablets from the second blister pack.

• 2. You can also stop taking tablets from the blister pack and go directly 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 recommendations, 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, you may be pregnant. In this case, you should contact your doctor before starting the next blister pack.

What to do if you vomit or have severe diarrhea

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

Delaying your period: what you need to know

Although it is not recommended, you can delay your period by going directly to a new Lesine blister pack, skipping the tablet-free period, until the end of the pack. You may experience spotting or irregular bleeding while taking tablets from the second blister pack.
After the usual 7-day tablet-free period, you should start taking tablets from the next blister pack.
You can ask your doctor for advice before deciding to delay your period.

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

If you take the tablets as directed, you will experience bleeding 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 it to a Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If the tablet-free period is significantly shortened (e.g., to 3 days or less), you may experience bleeding during those days. As a result, you may experience spotting or irregular bleeding.
If you are unsure what to do, you should contact your doctor.

Stopping Lesine

You can stop taking Lesine at any time. If you do not want to become pregnant, you should consult your doctor about other effective methods of birth control. If you want to become pregnant, you should stop taking Lesine and wait for your menstrual period before trying to become pregnant. This way, it is easier to calculate the expected date of delivery.
If you have any further doubts about taking this medicine, you should contact your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially severe or persistent ones, or changes in your health that you think may be related to the use of Lesine, you should consult your doctor.
In all women using combined hormonal contraceptives, there is an increased risk of 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, please refer to section 2 "Important information before taking Lesine".
The following side effects have been associated with the use of Lesine.
Common side effects(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect 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 affect up to 1 in 1000 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 borders);
• 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 likelihood of blood clots may be higher if you have any other risk factors that increase this risk (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting Side Effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to Store Lesine

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.

Expiry Date

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 the medicine are ethinylestradiol and drospirenone.
Each coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone.
The other ingredients are:
Tablet core: lactose monohydrate, corn starch, pregelatinized starch, cornstarch, crospovidone, povidone K 30, polysorbate 80, magnesium stearate.
Tablet coating: Opadry II Yellow (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172)).

What Lesine Looks Like and What the Package Contains

Yellow, round, coated tablets.
Lesine is available in boxes of 1 or 3 blisters, each containing 21 tablets. The packaging includes a cardboard sachet in which the blister should be placed.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in the Netherlands, the Country of Export:

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

Manufacturer:

Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
C/La Vallina s/n

• 24008 – Villaquilambre, León Spain

Parallel Importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands export license number: RVG 107290

Parallel Import License Number: 577/15

Translation of Day Symbols on the Packaging:

maa

• Monday din
• Tuesday woe
• Wednesday don
• Thursday vrij
• Friday zat
• Saturday zon
• Sunday

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Approval Date of the Leaflet: 22.11.2023

[Information about the trademark]