Lesine

PACKAGE LEAFLET: 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 brand names of the
same medicine.
Please read the entire leaflet before taking the medicine, as it contains important information
for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Important information regarding combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Table of contents of the leaflet

1. What Lesine is and what it is used for
2. What you need to know 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 Lesine is and what it is used for

Lesine is an oral contraceptive pill 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 known as "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 particularly important to be aware of the symptoms
of blood clots (see section 2 “Blood clots”).
Before you can start taking Lesine, your doctor will ask you several questions about your health
and that of your close relatives. Your doctor will also measure your blood pressure and, in individual
cases, may carry out 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 avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the calendar method or temperature monitoring. These methods may be unreliable because Lesine modifies monthly changes in body temperature and cervical mucus.
Lesine, like other hormonal contraceptives, does not protect against infection
with HIV (AIDS) or other sexually transmitted diseases.

When not to use Lesine
Do not take Lesine if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception would be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following diseases that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia.
• if you currently have (or have previously had) a type of migraine called “migraine with aura”;
• if you currently have (or have previously had) liver disease and liver function remains abnormal;
• if you have viral hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentaswir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Lesine and other medicines”);
• if you have kidney function disorders (kidney failure);
• if you currently have (or have previously had) liver tumour;
• if you currently have (or have previously had) or suspect breast cancer or genital organ cancer;
• if you have any 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 whose menstrual cycles have not yet started.
Older women
Lesine is not intended for use after menopause.
Women with liver function disorders
Do not take Lesine if you have liver disease. See also sections “When not to use Lesine” and “Warnings and precautions”.
Women with kidney function disorders
Do 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 exercise special caution when using Lesine
Before starting to take Lesine, discuss this with your doctor or pharmacist.
When should you contact your doctor?
You should contact your doctor immediately

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

For a description of symptoms of these serious adverse effects, see “How to recognize the occurrence of blood clots”.
In certain situations, special caution is required when using Lesine or any other combined hormonal contraceptive, and regular medical check-ups may be necessary.
You should inform your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Lesine, you should also inform your doctor:

• if there is currently or has ever been 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 (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease affecting the body’s natural immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”).
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Lesine.
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see section “Lesine and other medicines”);
• if you have a condition that first occurred during pregnancy or previous use of sex hormones, for example, hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), or a nervous system disorder with involuntary body movements (Sydenham’s chorea);
• if you currently have or have previously had chloasma (skin pigmentation, especially on the face and neck, also known as melasma). If so, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, products containing estrogens may trigger or worsen symptoms. Seek immediate medical attention if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with breathing difficulties.

BLOOD CLOTS (thrombosis)
Using combined hormonal contraceptives such as Lesine is associated with an increased risk of
blood clots compared to not using such treatment. In rare cases, a blood clot may block a blood vessel and
cause serious complications.
Blood clots may occur

• in veins (hereinafter referred to as “venous thrombosis” or “venous thromboembolic disease”)
• in arteries (hereinafter referred to as “arterial thrombosis” or “arterial thromboembolic events”).

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Lesine is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What condition is likely occurring in you?

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, such as pallor, redness, or blueness.
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden coughing without an obvious cause, which may be associated with coughing up blood;
• sharp chest pain, which may worsen with deep breathing;

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these adverse effects are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Lesine, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Lesine is low.

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

Factors increasing the risk of blood clots in veins
The risk of developing blood clots associated with the use of Lesine is small, but
certain factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue use of Lesine several weeks before surgery or immobilization. If the patient must stop taking Lesine, consult the doctor about when it is safe to resume treatment.
• with increasing age (particularly over 35 years);
• if the patient has given birth within the past few weeks.

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue use of Lesine.
Inform the doctor if any of the above conditions change during treatment with Lesine, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with use of Lesine is very small, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Lesine, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Lesine, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Lesine and cancer
Women using combined hormonal contraceptives have a slightly increased incidence of breast cancer, but it is not known whether this is caused by the use of the contraceptive. For example, more cancers may be detected in women using combined hormonal contraceptives because these women are examined more frequently by doctors. The incidence of breast cancer gradually decreases after discontinuation of combined hormonal contraceptives.
It is important to examine the breasts regularly and to contact the doctor if any lump is detected.
Rare cases of benign liver tumors and even rarer cases of malignant liver tumors have been reported in women using combined hormonal contraceptives. If the patient experiences unusual, severe abdominal pain, she should contact the doctor.

Intermenstrual bleeding
During the first few months of taking Lesine, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for more than a few months, or if it starts after several months, the doctor should investigate the cause.

What to do if no bleeding occurs during the pill-free week
If all tablets have been taken according to schedule, without vomiting, severe diarrhea, or concomitant use of other medications, the likelihood of pregnancy is very low.
If the expected withdrawal bleeding does not occur twice in succession, pregnancy may be present. The patient should contact her doctor immediately. Do not start the next blister pack until pregnancy has been ruled out.

Psychiatric disorders
Some women using hormonal contraceptives, including Lesine, have reported depression or mood changes. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Lesine and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Also inform any other doctor or dentist prescribing another medicine (or pharmacist) that Lesine is being used. They may advise whether additional contraceptive methods (e.g., condoms) are needed, for how long, or whether other medicines need to be adjusted.
Some medicines may affect the blood concentration of Lesine and may make it less effective in preventing pregnancy or 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 infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz), fungal infections (griseofulvin, ketoconazole), arthritis, osteoarthritis (etoricoxib), high blood pressure in the pulmonary arteries (bosentan),
• herbal products containing St John's wort ( Hypericum perforatum )

Lesine may affect the action of other medicines, for example:

• medicines containing cyclosporine
• antiepileptic medicines containing lamotrigine (may lead to increased frequency of seizures)
• theophylline (used for breathing problems)
• tizanidine (used to treat muscle pain and/or muscle spasms).
  Before taking any medicine, consult your doctor or pharmacist.
  Do not administer Lesine to patients with hepatitis C virus infection who are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may lead to increased liver function test results in blood (increased activity of liver enzyme AlAT). The doctor will prescribe another type of contraception before starting treatment with these medicines. Lesine may be restarted approximately 2 weeks after completion of this treatment. See section "When not to use Lesine".

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

Laboratory tests
If blood tests are required, inform the doctor or laboratory staff that you are using a contraceptive, as oral contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Lesine must not be used during pregnancy. If the patient becomes pregnant while taking Lesine, she should stop taking it immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking Lesine at any time (see also "Discontinuation of Lesine").

Before taking any medicine, consult your doctor or pharmacist.

Breastfeeding
Lesine is generally not recommended during breastfeeding. If the patient wishes to use a contraceptive during breastfeeding, she should contact her doctor.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
There is no information indicating that use of Lesine affects the ability to drive or operate machinery.

Lesine contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. the medicine is considered "sodium-free".

Lesine contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Lesine

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Take one Lesine tablet daily, with or without water.
The tablets may be taken with or without food, but should be taken every day at approximately the
same time.
The blister pack contains 21 tablets. Next to each tablet is printed the day of the week on which
the tablet should be taken. For example, if tablet-taking starts on Wednesday, take the tablet next
to which the symbol "woe" is printed (indicating Wednesday – see "Translation of symbols for days
of the week printed next to each tablet on the immediate packaging" at the end of this leaflet and
on the sachet). Move in the direction of the arrow on the blister until all 21 tablets have been taken.
Afterwards, no tablets should be taken for 7 days. During these 7 days, when no tablets are taken
(also called the tablet-free week), withdrawal bleeding should occur. This so-called "withdrawal
bleeding" usually begins on the 2nd or 3rd day of the tablet-free week.
On the 8th day after taking the last tablet of Lesine (i.e. after the 7-day break), start a new blister
pack regardless of whether bleeding has stopped or not. This means that each subsequent blister
pack should be started on the same day of the week, and withdrawal bleeding should occur on the
same days each month.
If the patient uses Lesine in this way, she is protected against pregnancy during the 7 days when
no tablets are taken.

When to start the first blister pack?

• If no hormonal contraceptive has been used in the previous month: Start taking Lesine on the first day of the cycle (i.e. the first day of menstruation). If the patient starts taking Lesine on the first day of menstruation, she is protected immediately against pregnancy. It is also possible to start on days 2–5 of the cycle, but in this case additional contraceptive methods (e.g. condoms) must be used for the first 7 days.
• Switching from a combined hormonal contraceptive product, a combined contraceptive vaginal system, or a transdermal contraceptive system: It is best to start taking Lesine the 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 tablet-free period of the previous contraceptive product ends (or after the last inactive tablet of the previous contraceptive product). If switching from a combined contraceptive vaginal system or transdermal system, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only minipill, injections, implants, or intrauterine system releasing progestogen): You may switch at any time from progestogen-only minipills (from an implant or intrauterine system on the day of removal, or from an injectable form on the day the next injection is due), but in all cases additional contraceptive methods (e.g. condoms) must be used for the first 7 days of tablet-taking.
• After miscarriage: Follow your doctor's advice.
• After childbirth: After childbirth, you may start taking Lesine between day 21 and day 28. If you start taking the medicine later than day 28, you should additionally use a mechanical method (e.g. condoms) for the first seven days of taking Lesine.

If sexual intercourse has occurred after childbirth, before (re)starting Lesine, the patient should
first ensure she is not pregnant or should wait until the next menstrual bleeding.

• If the patient is breastfeeding and wishes to (re)start taking Lesine after childbirth: Please read section "Breastfeeding".

If the patient is unsure when to start taking the medicine, she should consult her doctor.

Taking more Lesine than you should

There have been no reports of serious harmful effects from taking too many Lesine tablets.
If several tablets are taken at once, nausea and vomiting may occur. In young girls, vaginal bleeding may occur.
If too many Lesine tablets are taken or accidentally swallowed by a child, consult a doctor or pharmacist immediately.

Missed dose of Lesine

• If less than 12 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, and continue taking the next tablets at the usual time.
• If more than 12 hours have passed since the missed tablet, protection against pregnancy may be reduced. The more tablets missed, the greater the risk of becoming pregnant.

The risk of inadequate protection against pregnancy is greatest if a tablet is forgotten at the beginning or end of the blister pack. Therefore, follow the rules below (see also the chart below):

• Missing more than one tablet in the same blister pack: Contact your doctor.
• Missing one tablet in week 1: Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time and use additional contraception, such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, there is a risk of pregnancy. In this case, contact your doctor.
• Missing one tablet in week 2: Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Protection against pregnancy is not reduced, and additional contraception is not needed.
• Missing one tablet in week 3: There are two options:
  1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Instead of the tablet-free week, start the next blister pack immediately. Withdrawal bleeding will most likely occur at the end of the second blister pack, but spotting or breakthrough bleeding may occur during the second pack.
  2. Alternatively, stop taking tablets from the current blister and proceed directly to the 7-day tablet-free interval (note the day on which the tablet was missed). If the patient wishes to start the new blister on her usual starting day, the tablet-free interval may be shortened to less than 7 days. If either of these two options is followed, protection against pregnancy will be maintained.
• If any tablet in the blister pack has been missed and no bleeding occurs during the first tablet-free interval, this may indicate that the patient is pregnant. In this case, contact a doctor before starting the next blister pack.

yes
in the week Did sexual intercourse take place in the week

1. preceding the missed tablet?

no

• Take the missed tablet
• Use a mechanical method (condom) for the next 7 days and
• Continue taking tablets from the blister pack Only 1 tablet missed in the week
• Take the missed tablet (taken more than 12 hours 2.
• Continue taking tablets from too late) blister pack
• Take the missed tablet and
• Continue taking tablets from the blister pack
• Instead of the 7-day break, start taking tablets from the next blister pack in week 3. or
• Immediately stop taking tablets from the blister pack
• Begin the 7-day break (no longer than 7 days, including the missed tablet)
• Start taking tablets from the next blister pack

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking the tablet or if severe diarrhoea occurs,
there is a risk that the active substances from the tablet have not been completely absorbed by the body.
This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible, take it within 12
hours of the usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the instructions given in the section "Missed dose of Lesine".

Delayed onset of bleeding: what you should know
Although not recommended, delaying the onset of bleeding is possible by moving directly to a new blister pack of Lesine without taking the tablet-free interval, continuing until the end of the next pack.
Breakthrough bleeding or intermenstrual spotting may occur during the intake of tablets from the second blister pack. After the usual 7-day tablet-free interval, start taking tablets from the next blister pack.
You may consult your doctor for advice before deciding to delay bleeding.

Changing the first day of bleeding: what you should know
If the patient takes the tablets as instructed, bleeding will begin during the tablet-free week. If it is necessary to change this day, this can be done by shortening (but never extending – maximum 7 days!) the tablet-free interval. For example, if the tablet-free period starts on Friday, and the patient wishes to change the day to Tuesday (3 days earlier), she should start the new blister pack 3 days earlier than usual. If the break in treatment is very short (e.g. 3 days or less), bleeding may occur during these days. This may result in spotting or intermenstrual bleeding.
If the patient is unsure how to proceed, she should contact her doctor.

Discontinuing use of Lesine
Lesine may be discontinued at any time. If the patient does not wish to become pregnant, she should consult her doctor regarding other effective methods of birth control. If the patient wishes to become pregnant, she should discontinue Lesine and wait for a menstrual period before attempting to conceive. This makes it easier to calculate the expected date of delivery.
In case of any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers to be related to the use of Lesine, medical advice should be sought from a physician.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Lesine".

The following adverse effects have been associated with the use of Lesine:

Common adverse effects (may occur in up to 1 in 10 people)

• Menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• Headache, depression,
• Migraine,
• Nausea,
• Thick, whitish vaginal discharge and fungal vaginal infections.

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

• Changes in libido (interest in sex),
• High blood pressure, low blood pressure,
• Vomiting, diarrhoea,
• Acne, skin rash, severe itching, hair loss (alopecia),
• Breast enlargement,
• Vaginal infections,
• Fluid retention and changes in body weight.

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

• Allergic reactions (hypersensitivity), asthma,
• Breast discharge,
• Hearing disorders,
• Nodular erythema (manifesting as painful red nodules on the skin) or erythema multiforme (manifesting as a rash with red, painful rings),
• 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 ischaemic attack (TIA)
  • 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 that increase this risk (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lesine

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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: monohydrate lactose, maize starch, pregelatinized maize starch,
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 cardboard boxes with a blister pack containing 21 tablets.

A cardboard sachet is included in the package, into which the blister should be placed after removal from its protective foil.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in the Netherlands, 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
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorization number in the Netherlands, country of export: RVG 107290
Parallel Import License number: 81/20

Translation of the weekday symbols printed next to each tablet on the immediate packaging:
maa – Monday
din – Tuesday
woe – Wednesday
don – Thursday
vrij – Friday
zat – Saturday
zon – Sunday

This medicinal product is authorized for marketing in the European Economic Area countries under the following names:

| Country of the Member State | Name of the medicinal product | |-----------------------------|-------------------------------| | Norway | Dretine 0.03 mg/3 mg tablets, film-coated | | Austria | Dretine 0.03 mg/3 mg 21 Film 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 tablet, film-coated | | Hungary | Corenelle 0.03 mg/3 mg film-coated tablet | | Ireland | Dretine 0.03 mg/3 mg Film-coated Tablets | | Poland | Lesine | | Slovakia | Softine 0.03 mg/3 mg film-coated tablets |