Lesine

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is 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 using the medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are the same. If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Important information about 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 treatment 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 (thrombosis)”).

Table of contents

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 a contraceptive tablet used to prevent pregnancy.
Each coated tablet contains a small amount of two different female hormones, namely
drospirenone and ethinylestradiol.
Contraceptive tablets 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 (thrombosis)").
Before you can start using 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 additional 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 cases, 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 method. These methods may be unreliable because Lesine alters the monthly changes in body temperature and cervical mucus.
Lesine, like other hormonal contraceptives, does not protect against infection with the
HIV virus (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 your legs (deep vein thrombosis), in your 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 (thrombosis)");
• 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 conditions 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 hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Lesine with other medicines");
• if you have kidney function disorders (kidney failure);
• if you currently have (or have previously had) a liver tumour;
• if you currently have (or have previously had) or suspect you have 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 who have not yet started menstruating.
Elderly 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
Before starting to use Lesine, discuss this with your doctor or pharmacist.
When to exercise particular caution when using Lesine
When should you contact your doctor?
Seek immediate medical advice if:

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

For a description of the symptoms of these serious adverse effects, see "How to recognize blood clots".
Tell your doctor if you have any of the following conditions.
Before starting to take Lesine, consult your doctor. In certain situations, particular caution is required when using Lesine or any other combined hormonal contraceptive, and regular medical check-ups may be necessary. If any of these conditions appear or worsen during treatment with Lesine, inform your doctor:

• if breast cancer is currently present (or has previously occurred) 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 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 hypertriglyceridaemia (elevated blood fat levels) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2, "Blood clots (thrombosis)");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Lesine;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see section "Lesine with 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 (herpes 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 experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria that may cause breathing difficulties, seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

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

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic disorders").
  Full recovery from a blood clot is not always possible. 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 associated with the use of Lesine is low.

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

• 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 onset of 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 the 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 using combined hormonal contraceptives for the first time. 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 compared to not using 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 developing 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 the course of 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 the course of 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 the course of 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 individual patient's medical history (see "Factors increasing the risk of blood clots", below).

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

• if the patient is very overweight (body mass index (BMI) above 30 kg/m²);
• if a blood clot in the legs, lungs, or other organs occurred at a young age (e.g., under 50 years) in someone from the patient's immediate family. In such cases, the patient may have an inherited clotting disorder;
• if the patient requires surgery, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Lesine several weeks before surgery or reduced mobility. If the patient must stop taking Lesine, ask the doctor when it is safe to restart;
• with increasing age (especially over 35 years);
• if the patient has recently 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, particularly 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 Lesine.
Inform the doctor if any of the above conditions change during treatment with Lesine, for example, if someone in the immediate family 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 may cause serious complications, 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 using Lesine is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While 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 heart attack or stroke occurred at a young age (under 50 years) in someone from the patient's immediate family. In such cases, 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 fats (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorder called 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, if someone in the immediate family is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Lesine and cancer
In women using combined hormonal contraceptives, breast cancer is observed slightly more frequently, but it is not known whether this is caused by the contraceptive. For example, the higher number of detected cancers may simply reflect more frequent medical examinations among women using combined hormonal contraceptives. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to examine breasts regularly and contact a doctor if any lump is detected.
Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using combined hormonal contraceptives. If the patient experiences an unusual, severe abdominal pain, she should contact her doctor.

Breakthrough bleeding
During the first few months of taking Lesine, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding lasts longer than a few months, or starts after several months of use, the doctor should investigate the cause.

What to do if no bleeding occurs during the pill-free week
If all tablets were taken correctly, without vomiting or severe diarrhoea, and no other medications were taken, the likelihood of pregnancy is very low.
If expected bleeding does not occur in two consecutive cycles, pregnancy may be possible. 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 depressed mood. Depression can be severe and, in some cases, may 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 the patient is taking Lesine. They will 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 levels 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
  • fungal infections (griseofulvin, ketoconazole),
  • arthritis, osteoarthritis (etoricoxib),
  • pulmonary hypertension (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 a doctor or pharmacist.
Do not give 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 the 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 completing 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 the patient is using a hormonal contraceptive, as oral contraceptives may affect the results of certain tests.

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

Before taking any medicine, consult your doctor or pharmacist.
Breast-feeding
Lesine is generally not recommended during breast-feeding. If the patient wishes to use a contraceptive during breast-feeding, she should contact her doctor.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
There is no information indicating that Lesine affects the ability to drive or operate machinery.

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

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

3. How to use Lesine

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Take one Lesine tablet daily, with or without a small amount of 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 coated tablets. Next to each tablet is printed the day of the week on
which the tablet should be taken. For example: if tablet-taking begins on Wednesday, take the tablet
next to which the word “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).
Proceed in the direction of the arrow on the blister pack until all 21 coated tablets have been taken.
Then, do not take any tablets for 7 days. During these 7 days, when no tablets are taken (also called
the "tablet-free week"), withdrawal bleeding should occur. This is known as "withdrawal bleeding"
and 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), start a new blister
pack, regardless of whether bleeding has stopped or not. This means that each new blister pack
should be started on the same day of the week, and withdrawal bleeding should occur during the
same days every month.
If the patient uses Lesine in this way, she is protected against pregnancy during the 7 days when
tablets are not 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 against pregnancy immediately. Alternatively, treatment may be started 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 or a combined hormonal vaginal contraceptive system or transdermal system: It is best to start taking Lesine the day after the last active tablet (the last tablet containing active substances) from the previous pack. This should be no later than the day after the tablet-free interval of the previous contraceptive product ends (or the day after the last inactive tablet of the previous product). When switching from a combined hormonal vaginal contraceptive system or transdermal system, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only mini-pill, injections, implants, or intrauterine system releasing progestogen): You may switch at any time from progestogen-only pills (from an implant or intrauterine system on the day of removal, or from injectable form on the day of the next scheduled injection), but in all cases, additional contraceptive methods (e.g. condoms) must be used for the first 7 days of taking the tablets.
• After miscarriage: Follow your doctor’s advice.
• After childbirth: After childbirth, Lesine may be started between day 21 and 28. If the patient starts taking the medicine later than on day 28, an additional barrier method (e.g. condoms) must be used 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 occurs.

• If the patient is breastfeeding and wishes to (re)start taking Lesine after childbirth: Read section “Breast-feeding”.

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

Taking more Lesine than recommended

There have been no reports of serious harmful effects following the ingestion of too many Lesine
tablets.
If several tablets are taken at once, nausea, vomiting, or vaginal bleeding may occur. Such bleeding
may even occur in girls who have not yet started menstruating but have accidentally taken this
medicine.
If too many Lesine tablets are taken or if a child swallows any tablets, consult a doctor or pharmacist.

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 missed at the beginning
or end of the pack. Therefore, follow the rules below (see also the chart below):

• Missing more than one tablet in the same pack: Consult your doctor.
• Missing one tablet in week 1: Take the missed tablet as soon as possible, even if this means taking two tablets at once. 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, consult your doctor.
• Missing one tablet in week 2: Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Protection against pregnancy is not reduced and no additional contraception is 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 once. Continue taking the remaining tablets at the usual time. Instead of the tablet-free interval, immediately start taking tablets from the next blister pack.

Menstruation will most likely occur at the end of the second blister pack, but spotting or
intermenstrual bleeding may also occur during the intake of tablets from the second pack.

2. Alternatively, you may stop taking tablets from the current pack 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 pack 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 the patient missed any tablet in the pack and no bleeding occurred during the first tablet-free interval, this may indicate that the patient is pregnant. In this case, consult your doctor before starting the next pack.

What to do if vomiting or severe diarrhoea occurs

If vomiting occurs within 3 to 4 hours after taking a tablet or if severe diarrhoea occurs, there is a risk
that the active substances in the tablet have not been completely absorbed. 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 under “Missed dose of Lesine”.

Delayed onset of bleeding: what you should know

Although not recommended, it is possible to delay the onset of bleeding by starting a new Lesine
blister pack immediately, without taking the tablet-free interval, continuing until the end of the
second pack. Spotting or intermenstrual bleeding may occur during the intake of tablets from the
second pack. After the usual 7-day tablet-free interval, start taking tablets from the next blister
pack.
Consult your doctor for advice before deciding to delay the onset of bleeding.

Changing the day on which bleeding starts: what you should know

If the patient takes the tablets as directed, bleeding will start 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 interval normally starts on Friday, and
the patient wishes to change it to Tuesday (3 days earlier), start the new blister pack 3 days earlier
than usual. If the break in taking the medicine 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 consult her doctor.

Stopping treatment with Lesine

Lesine may be stopped at any time. If the patient does not wish to become pregnant, she should
consult her doctor about other effective methods of birth control. If the patient wishes to become
pregnant, she should stop taking Lesine and wait for a menstrual period before trying to conceive.
This makes it easier to calculate the expected date of delivery.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status which the patient considers to be related to the use of Lesine, medical advice should be sought.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in 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".

Serious adverse reactions
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria, which may cause difficulty breathing (see also section "Warnings and precautions").

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

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

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

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

• changes in libido (sexual interest);
• 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 reactions (may occur in up to 1 in 1000 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 veins or arteries, 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/intestines, 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 factors increasing the risk of blood clots and symptoms of blood clot formation).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of this 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Lesine contains
The active substances are drospirenone and ethinylestradiol.
Each coated tablet contains 3 mg drospirenone and 0.03 mg ethinylestradiol.
The other ingredients are:
Monohydrate lactose, corn starch, pregelatinized corn 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 containing 1 or 3 blisters, each blister containing 21 tablets. A cardboard pouch is included with the package, in which the blister should be placed.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Netherlands, 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
Poland

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

Dutch Marketing Authorisation Number (country of export): RVG 107290
Parallel Import Licence Number: 577/15

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 authorised in the European Economic Area countries under the following names: