Lesine

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, 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 and Ethinylestradiol/Drospirenone 0.03 mg/3 mg Theramex are different trade names for the same medicine.

You should read the contents of the leaflet before using 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 using Lesine
• 3. How to use 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 used to prevent pregnancy.
Each 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 USING 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 a blood clot (see section 2 "Blood clots").
Before you can start using 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 some other examinations.
This leaflet describes several situations in which you should stop using 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 can 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 USE 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 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 "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 (transient symptoms of a stroke);
• 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/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 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 be the cause of 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.
Women of childbearing age
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 use 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 use Lesine" and "Warnings and precautions".

WARNINGS AND PRECAUTIONS

WHEN TO BE PARTICULARLY CAREFUL WHEN USING LESINE

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

• if you notice any possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see section below "Blood clots (thrombosis)").

In order to get a description of the serious side effects mentioned, see "How to recognize a blood clot".
In certain situations, you should be particularly careful when using Lesine or any other combined hormonal contraceptive and regular medical check-ups may also be necessary.

YOU SHOULD TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS.

If these symptoms occur or worsen while using 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 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 have just given birth, you are at a higher risk of blood clots. You should consult your doctor to find out how soon you can 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 using sex hormones, such as hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pemphigoid gestationis), a nervous system disease characterized by involuntary movements of the body (Sydenham's chorea);
• if you have 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 products may cause or worsen its symptoms. You should contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing with wheezing.

BLOOD CLOTS (THROMBOSIS)

The use of combined hormonal contraceptives, such as Lesine, is associated with an increased risk of blood clots, compared to a situation where no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also called "venous thromboembolism" or "venous thrombotic event")
• in arteries (also called "arterial thromboembolism" or "arterial thrombotic event").

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

REMEMBER THAT THE OVERALL RISK OF DEVELOPING A BLOOD CLOT WHILE USING 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 the patient likely to have?
Is the patient experiencing any of these symptoms?

• 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 skin, such as pallor, redness, or cyanosis. Deep vein thrombosis
• 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?

• The use of 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 using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and settles 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 VEINS THE HIGHEST?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of 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 compared to a situation where combined hormonal contraceptives are not used.
If you stop using 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 developing venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of developing a blood clot in the legs or lungs while using Lesine is small.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop a blood clot.
• During a year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop a blood clot.
• During a year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Lesine, will develop a blood clot.
• The risk of developing a blood clot 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 developing a blood clot while using Lesine is small, but some factors can increase this risk. The risk is higher:

• if you are severely overweight (body mass index (BMI) over 30 kg/m);
• if someone in your close family has had a blood clot in their 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 due to injury or illness or have a leg in a cast. It may be necessary to stop using Lesine for a few weeks before surgery or immobilization. If you need to stop using Lesine, you should ask your doctor when you can resume using the medicine.
• with age (especially over 35 years old);
• if you have given birth in the last few weeks.

The risk of developing a blood clot increases with the number of risk factors present in the patient.
Long-distance air travel (>4 hours) may temporarily increase the risk of developing a blood clot, 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 using Lesine.
You should inform your doctor if any of the above conditions change while using 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 essential to note that the risk of a heart attack or stroke associated with Lesine is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke.While using a hormonal contraceptive, such as Lesine, it is recommended to quit smoking. If you cannot quit smoking and are over 35 years old, your doctor may recommend using 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 a higher risk of having a heart attack or stroke;
• if you or someone in your close family has been diagnosed with 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, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of developing a blood clot may be even higher.
You should inform your doctor if any of the above conditions change while using 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 using 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 using combined contraceptives because they are examined by doctors more often. The incidence of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives.
It is essential to examine your breasts regularly and contact your doctor if you feel any lump.

BLOOD SPOTTING

During the first few months of taking Lesine, you may experience unexpected bleeding (bleeding outside of the withdrawal bleeding week). If such bleeding lasts longer than a few months or starts after a few months, your doctor should investigate the cause.

WHAT TO DO IF WITHDRAWAL BLEEDING DOES NOT OCCUR

If you have taken all the tablets according to the schedule, 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 withdrawal bleeding does not occur for the second time in a row, 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.

PSYCHIATRIC DISORDERS

Some women using 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 and 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 the 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 using 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 modify the use of other medicines.
Some medicines may affect the level of Lesine in your blood and may cause it to be lesseffective in preventing pregnancyor may cause unexpected 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 (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 cyclosporine
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/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause an increase in liver function test results in the blood (increase in liver enzyme ALT). Your doctor will prescribe a different type of contraception before starting treatment with these medicines. Lesine may be resumed about 2 weeks after the end of this treatment. See section "When not to use Lesine".

LESINE WITH FOOD AND DRINK

Lesine can be taken with or without food, if necessary with a small amount of water.

LABORATORY TESTS

If a blood test is necessary, you should tell your doctor or laboratory staff that you are using 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 using Lesine, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop using 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 for use during breastfeeding. If you want to use a contraceptive during 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 using Lesine affects the ability to drive or operate machines.

LESINE CONTAINS SODIUM

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

LESINE CONTAINS LACTOSE MONOHYDRATE

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

3. HOW TO USE LESINE

This medicine should always be used 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, if necessary with a small amount of water.
You can take the tablets with or without food, but you should take them every day at about the same time.
The blister pack contains 21 tablets. Next to each tablet, the day of the week is printed on which you should take the tablet. If, for example, you start taking the tablets on a Wednesday, you should take the tablet with the symbol "Wednesday" (see " Translation of the day of the week symbolson the packaging" at the end of the leaflet and on the sachet). 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 withdrawal bleeding week), you should experience bleeding. This is called "withdrawal bleeding", which usually starts on the 2nd or 3rd day of the withdrawal bleeding 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 use Lesine in this way, you are protected against pregnancy during the 7 days when you are not taking tablets.

WHEN CAN YOU START THE FIRST BLISTER PACK?

• If you have not used a hormonal contraceptive in the previous month.You should start taking Lesine on the first day of your menstrual cycle (i.e., on the first day of your period). If you start taking Lesine on the first day of your period, you are immediately protected against 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.It is best to 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 tablet-free period of the previous contraceptive. In the case of switching from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's instructions.
• 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.Follow your doctor's instructions.
• After childbirth.You can start taking Lesine from the 21st to the 28th day after giving birth. If you start taking Lesine later than on the 28th day, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Lesine.

If you have had sexual intercourse after giving birth, 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 "Breastfeeding".

If you are unsure when to start using 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.
In the event of taking several tablets at once, nausea and vomiting may occur. In young girls, vaginal bleeding may occur.
In the event of taking too many Lesine tablets or if a child has swallowed them, you should consult your doctor or pharmacist.

WHAT TO DO IF YOU MISS A DOSE OF LESINE

• If it has been less than 12 hourssince you missed a tablet, your protection against 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 missed a tablet, your protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of reduced protection against pregnancy is highest if you miss a tablet at the beginning or end of the blister pack. Therefore, you should follow the rules below (see also the diagram below):

WHAT TO DO IF YOU MISS MORE THAN ONE TABLET IN THE BLISTER PACK

You should contact your doctor.

WHAT TO DO IF YOU MISS ONE TABLET IN WEEK 1.

You should take the missed tablet as soon as possible, even if it means taking two tablets at once. 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 missing the tablet, there is a risk of pregnancy. In this case, you should contact your doctor.

WHAT TO DO IF YOU MISS ONE TABLET IN WEEK 2.

You should take the missed tablet as soon as possible, even if it means taking two tablets at once. Then, take the next tablets at the usual time.
Your protection against pregnancy is not reduced, and you do not need to use additional protection.

WHAT TO DO IF YOU MISS ONE TABLET IN WEEK 3.

There are two options to choose from:

• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at once. Then, take the next tablets at the usual time. Instead of the tablet-free week, start taking tablets from the next blister pack immediately. You will probably have your period at the end of the second blister pack, but you may also experience spotting or breakthrough bleeding during 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 ( note the day you missed the tablet). If you want to start the new 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 against pregnancy will be maintained.
• If you miss any tablets in the blister pack and do not have withdrawal 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.

yes
in week

• 1. Did you have sexual intercourse in the week before missing the tablet?

no

• Take the missed tablet
• Use a mechanical method (condoms) for the next 7 days and
• Finish taking the tablets from the blister pack in the week
• 2. Only 1 tablet missed (taken more than 12 hours late)
• Take the missed tablet
• Finish taking the tablets from the blister pack
• Take the missed tablet and
• Finish taking the tablets from the blister pack
• Instead of the tablet-free week, start taking tablets from the next blister pack in the week
• 3. or
• Stop taking tablets from the blister pack immediately
• Start the tablet-free week (no longer than 7 days, including the missed 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 after taking a tablet or have severe diarrhea, there is a risk that the active substances from the tablet have not been fully absorbed into your body.
The situation is similar to missing a tablet. After vomiting or diarrhea, you should take another tablet from the reserve blister pack as soon as possible. If possible, you should take it within 12hoursafter the normal time of taking the tablet. If this is not possible or more than 12 hours have passed, you should follow the instructions given in the section "Missing a dose of Lesine".

DELAYING WITHDRAWAL BLEEDING: WHAT YOU NEED TO KNOW

Although it is not recommended, delaying withdrawal bleeding is possible by going directly to a new Lesine blister pack, skipping the tablet-free period, and continuing until the end of the second pack. You may experience spotting or breakthrough bleeding during the second 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 deciding to delay withdrawal bleeding.

CHANGING THE FIRST DAY OF WITHDRAWAL BLEEDING: WHAT YOU NEED TO KNOW

If you take the tablets according to the instructions, withdrawal bleeding will start during the tablet-free week. If you need to change this day, you do so by shortening (but never lengthening - up to a maximum of 7 days!) the tablet-free period. For example, if the tablet-free period starts on a Friday and you want to change the day to a Tuesday (3 days earlier), you should start the new blister pack 3 days earlier than usual. If the break in taking Lesine is very short (e.g., to 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 contact your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Lesine, consult a doctor. All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thromboembolism). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, see 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 fungal infections.

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

• changes in libido (sexual interest),
• 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 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 a transient ischemic attack blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood 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 those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lesine

Store in a place out of sight and reach of children. There are no special storage precautions. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lesine contains

The active substances 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, 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 contents of the pack

Yellow, round, film-coated tablets.

• Lesine is available in boxes containing 21 tablets in a blister pack.

A cardboard wallet is included in the packaging, in which the blister should be placed after removal from the protective foil. For further information, consult the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Netherlands, the country of export:

Theramex Ireland Limited 3rd 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:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź Marketing Authorisation Number in the Netherlands, the country of export: RVG 107290 Parallel Import Authorisation Number: 81/20

Translation of the days of the week 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:

Member State

Medicinal product name

Norway: Dretine 0.03 mg/3 mg tablets, film-coated Austria: Dretine 0.03 mg/3 mg 21 film-coated tablets Czech Republic: Softine 0.03 mg/3 mg coated tablets Denmark: Dretine film-coated tablets Spain: Dretine 0.03 mg/3 mg film-coated tablets Finland: Dretine 0.03 mg/3 mg tablets, film-coated Hungary: Corenelle 0.03 mg/3 mg film-coated tablets Ireland: Dretine 0.03 mg/3 mg film-coated tablets Poland: Lesine Slovakia: Softine 0.03 mg/3 mg film-coated tablets

Date of revision of the leaflet: 17.01.2025

[Information on trademark]