Lesiplus

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Lesiplus(Drospirenone/Ethinylestradiol 3/0.02 mg 24+4 Theramex)

3 mg + 0.02 mg, film-coated tablets

Drospirenonum + Ethinylestradiolum
Lesiplus and Drospirenone/Ethinylestradiol 3/0.02 mg 24+4 Theramex are different trade names for the same medicine.

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.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

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

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

Table of contents of the leaflet

1. What is Lesiplus and what is it used for

2. Important information before taking Lesiplus

3. How to take Lesiplus

4. Possible side effects

5. How to store Lesiplus

6. Contents of the pack and other information

1. What is Lesiplus and what is it used for

• Lesiplus is a contraceptive and is used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• The 4 white tablets that do not contain active substances are also called placebo tablets.
• Contraceptive tablets that contain two hormones are called "combined" tablets.

2. Important information before taking Lesiplus

General notes

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

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

When not to take Lesiplus:

You should not take Lesiplus 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 blood clotting disorders - 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 due to injury or illness or have a leg in a cast. It may be necessary to stop taking Lesiplus for a few weeks before surgery or immobilization. If you need to stop taking Lesiplus, you should ask your doctor when you can resume taking the medicine;
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases that may increase the risk of a blood clot in an artery: severe diabetes with blood vessel damage; very high blood pressure; very high levels of fats in the blood (cholesterol or triglycerides); a disease called hyperhomocysteinemia;
• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) liver disease, and liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you have (or have had in the past) liver cancer;
• if you have (or have had in the past) or suspect you have breast cancer or cancer of the genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of Lesiplus (listed in section 6). This allergy may cause itching, rash, or swelling;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, or glecaprevir/pibrentasvir (see also section "Lesiplus and other medicines").

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

Warnings and precautions

When should you contact your doctor?
You should contact your doctor immediately

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

To find out about the symptoms of these serious side effects, see "How to recognize a blood clot".
In certain situations, you should be extra careful when taking Lesiplus or any other combined hormonal contraceptive and may need to be regularly checked by your doctor.

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

If these symptoms occur or worsen while taking Lesiplus, you should also tell your doctor.

• if someone in your close family has had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder of the red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you are immediately after childbirth, you are at a higher risk of blood clots. You should consult your doctor to find out how soon you can start taking Lesiplus after childbirth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Lesiplus and other medicines");
• if you have a disease that first appeared during pregnancy or previous use of sex hormones, such as hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pemphigoid gestationis), a neurological disease characterized by involuntary movements of the body (Sydenham's chorea);
• if you have currently or have had in the past golden-brown skin discolorations (chloasma), mainly on the face. If so, you should avoid direct exposureto sunlight or ultraviolet radiation;
• if you have hereditary angioedema, estrogen-containing medications may cause or worsen its symptoms. You should contact your doctor immediatelyif you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with difficulty breathing.

Before starting to take Lesiplus, you should discuss it with your doctor or pharmacist.

Blood clots (thrombosis)

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

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

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

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

How to recognize a blood clot

You should contact your doctor immediately if you notice any of the following symptoms.

Blood clots in a vein

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

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

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

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

What factors increase the risk of blood clots in veins?

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

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

Factors that increase the risk of blood clots in veins

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

• if you are overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have a genetic blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. You may need to stop taking Lesiplus for a few weeks before surgery or immobilization. If you need to stop taking Lesiplus, you should ask your doctor when you can resume taking the medicine;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is 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 Lesiplus.
You should inform your doctor if any of these conditions change while taking Lesiplus, 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 an artery

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

Similar to blood clots in veins, blood clots in arteries can cause serious complications, 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 heart attack or stroke associated with taking Lesiplus is very small, but it may increase:

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

If you have more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of these conditions change while taking Lesiplus, 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.

Lesiplus and cancer

Women taking combined oral contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the medicine. For example, it may be that more tumors are detected in women taking combined oral contraceptives because they are examined by doctors more often.
The frequency of breast cancer tumors decreases gradually after stopping combined hormonal contraceptives.
It is essential to examine your breasts regularly and contact your doctor if you feel any lump.

Blood clots

During the first few months of taking Lesiplus, you may experience unexpected bleeding (bleeding outside of the placebo period). If such bleeding occurs for more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if bleeding does not occur during the placebo period

If you have taken all the active tablets correctly, 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 your expected bleeding does not occur twice 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.

Psychological disorders

Some women taking hormonal contraceptives, including Lesiplus, 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.

Lesiplus and other medicines

Always tell your doctor or pharmacist about all medicines or herbal products you are currently taking or have recently taken, as well as any medicines you plan to take. You should also tell any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Lesiplus. 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.
You should not take Lesiplus if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause increased liver function test results in the blood (increased liver enzyme activity).
Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
Lesiplus can be taken again about 2 weeks after finishing this treatment. See section "When not to take Lesiplus".
Some medicines may affect the levels of Lesiplus in the blood and may cause Lesiplus to be less effective in preventing pregnancyor may cause unexpected bleeding. This includes medicines used to treat

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g., rifampicin)
• HIV and hepatitis C infections (e.g., 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)
• and herbal products containing St. John's Wort (Hypericum perforatum)

Lesiplus may affect the action of other medicines, such as:

• medicines containing cyclosporin
• antiepileptic medicines
• theophylline (used for breathing problems)
• tizanidine (used to treat muscle pain and/or muscle spasms)
• medicines containing lamotrigine (may increase the frequency of seizures)

Before taking any medicine, you should consult your doctor or pharmacist.

Lesiplus with food and drinks

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

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking contraceptives, as the hormones in contraceptives may affect the results of some tests.

Pregnancy

Pregnant women should not take Lesiplus. If you become pregnant while taking Lesiplus, you should stop taking it immediately and contact your doctor.
If you plan to become pregnant, you can stop taking Lesiplus at any time (see also "Stopping Lesiplus").
Before taking any medicine, you should consult your doctor or pharmacist.

Breastfeeding

Lesiplus is not usually recommended for use during breastfeeding. If you want to use a contraceptive during breastfeeding, you should consult your doctor.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

There is no information suggesting that taking Lesiplus affects the ability to drive or use machines.

Lesiplus contains lactose monohydrate

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

Lesiplus contains sodium

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

3. How to take Lesiplus

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Each blister pack contains 24 pink tablets and 4 white placebo tablets.
The Lesiplus tablets in two different colors are arranged in the blister pack in a specific order.
One blister pack contains 28 tablets.
You should take one Lesiplus 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.
Do not confuse the tablets:the pink tablets are taken for the first 24 days, followed by the white tablets for the last 4 days. A new blister pack should be started immediately (24 pink, followed by 4 white tablets). There is no break between the two blister packs.
Due to the differences in tablet composition, it is essential to start taking the tablets from the first tablet in the top left corner of the blister pack and continue taking them every day. To maintain the correct order, you should move in the direction of the arrows on the blister pack.

Preparing the blister pack

To help you remember to take your contraceptive, each Lesiplus blister pack comes with 7 self-adhesive strips with the days of the week printed on them. According to the day of the week you start taking the tablets, you should choose the corresponding self-adhesive strip. For example, if the first day of taking the tablets was Wednesday, you should choose the strip with "Wed" as the first day of the week.
You should stick the strip along the top of the blister pack, where it says "Plaats het etiket hier" (which means "Place the label here"), so that the first day is above the tablet marked "1". This way, each tablet has the corresponding day of the week, and you can check if you have taken the tablet. The arrows indicate the order in which the tablets should be taken.
During the 4 days when the white placebo tablets are taken (placebo days), you should experience bleeding (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last pink active tablet. After taking the last white tablet, you should start a new blister pack, regardless of whether the bleeding has stopped. This means that you will start a new blister pack on the same day of the week, and the bleeding should occur at about the same time every month.
If you take Lesiplus in this way, you are also protected against pregnancy during the 4 days when you take the placebo tablets.

When to start the first blister pack

• If you have not taken a hormonal contraceptive in the previous monthYou should start taking Lesiplus on the first day of your cycle (i.e., the first day of your period). If you start taking Lesiplus on the first day of your period, you are immediately protected against pregnancy. You can also start taking Lesiplus on days 2-5 of your cycle, but you will need to 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 patchYou can start taking Lesiplus the day after taking the last active tablet (the last tablet containing active ingredients) from the previous pack, but no later than the day after the end of the previous contraceptive's tablet-free period (or after the last inactive tablet of the previous contraceptive). When switching from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Switching from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen)You can switch at any time from a progestogen-only mini-pill (from an implant or intrauterine system on the day of its removal, or from an injection when the next injection would be due), but in all these cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Lesiplus.
• After a miscarriageFollow your doctor's advice.
• After childbirthYou can start taking Lesiplus between 21 and 28 days after giving birth. If you start taking Lesiplus later than 28 days after giving birth, you should use a mechanical method (e.g., condoms) for the first 7 days of taking Lesiplus.
  If you have had sexual intercourse after giving birth, you should make sure you are not pregnant before (re)starting Lesiplus or wait until your next menstrual period.

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

Taking more than the recommended dose of Lesiplus

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

Missing a dose of Lesiplus

The last four tablets in the fourthrow of the blister pack are placebo tablets. If you miss one of them, the contraceptive effectiveness of Lesiplus is maintained. You should discard the missed placebo tablet.
If you miss a pink active tablet (tablets 1-24 of the blister pack), you should follow these instructions:

• If it has been less than 24 hourssince you missed the tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as possible and continue taking the tablets at the usual time.
• If it has been more than 24 hourssince you missed the 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 pink tablet at the beginning or end of the blister pack. Therefore, you should follow these rules (see also the diagram below):

Missing more than one tablet in a blister pack

You should contact your doctor.

Missing one tablet between days 1-7 (first row)

You should take the missed tablet as soon as possible, even if it means taking two tablets at once. You should then continue taking the tablets at the usual time and use additional protectionfor the next 7 days, such as condoms. 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.

Missing one tablet between days 8-14 (second row)

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

Missing one tablet between days 15-24 (third and fourth rows)

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. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this blister pack, you should discard them and start taking the tablets from the next blister pack (the starting day will be different).

Bleeding will most likely occur at the end of the second blister pack, during the placebo period, but it may also occur as spotting or breakthrough bleeding during the second blister pack.

• 2.You can also stop taking the pink active tablets and go directly to the 4 white placebo tablets (before starting the placebo tablets, you should note the day you missed the tablet). If you want to start the next blister pack on your usual start day, take the placebo tablets for less than 4 days.

If you follow one of these two instructions, your protection against pregnancy will be maintained.

• If you miss any of the tablets in the blister pack and do not experience bleeding during the placebo period, you may be pregnant. In this case, you should contact your doctor before starting the next blister pack.

Yes
Day

• 1. – 7. 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 the tablets in the blister pack Day
• 8. – 14. Missed only 1 pink tablet (taken more than 24 hours late)
• Take the missed tablet
• Finish the tablets in the blister pack
• Take the missed tablet and
• Finish the pink active tablets
• Discard the 4 white placebo tablets
• Start the next blister pack Day
• 15. – 24. or
• Stop taking the pink active tablets immediately
• Go directly to the 4 white placebo tablets
• Start the next blister pack

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 Lesiplus, a doctor should be consulted.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important information before taking Lesiplus".
The following side effects have been associated with the use of Lesiplus.

• Common side effects (may occur in up to 1 in 10 people): mood swings, headaches, nausea, breast pain, menstrual disorders, such as irregular periods, absence of periods
• Uncommon side effects (may occur in up to 1 in 100 people): depression, nervousness, drowsiness, dizziness, "tingling and numbness", migraine, varicose veins, high blood pressure, abdominal pain, vomiting, indigestion, intestinal gas, gastritis, diarrhea

acne, itching, rash, pain, such as back pain, limb pain, painful muscle spasms, vaginal thrush, pelvic pain, breast enlargement, benign breast tumors, intermenstrual bleeding and (or) vaginal bleeding (which usually subsides during treatment), vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual disorders, painful menstruation, scanty menstruation, very heavy menstruation, vaginal dryness, abnormal Pap smear result, decreased libido, lack of energy, increased sweating, fluid retention, weight gain

• Rare side effects (may occur in up to 1 in 1000 people): candidiasis (fungal infection), anemia, increased platelet count in the blood, allergic reactions, endocrine disorders, increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood, inability to achieve orgasm, insomnia, dizziness, tremors, eye disorders, such as conjunctivitis, dry eye syndrome, abnormally fast heart rhythm, vein inflammation, nosebleeds, fainting, abdominal enlargement, intestinal disease, feeling of fullness, abdominal hernia, oral thrush, constipation, dry mouth, biliary colic or cholecystitis, cholecystitis, yellow-brown spots on the skin, eczema, abnormal hair growth (hirsutism), acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair loss (alopecia), skin disorders, skin stretch marks, skin inflammation, photosensitive skin inflammation, skin tumors, difficult and painful intercourse, vaginal inflammation (vulvovaginitis), intermenstrual bleeding, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast tumors, abnormal growth of the cervical mucosa, contraction or thinning of the uterine mucosa, ovarian cysts, uterine enlargement, general malaise, weight loss, harmful blood clots in a vein or artery, such as:
• in the leg or foot (e.g., deep vein thrombosis)
• in the lungs (e.g., pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach, and 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 more information on risk factors for blood clots and symptoms of blood clots).
The following side effects have been reported, but their frequency cannot be determined from the available data: hypersensitivity, erythema multiforme (rash with red, painful borders).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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, more information can be gathered on the safety of the use of the medicine.

5. How to store Lesiplus

The medicine should be stored out of sight and reach of children.
Lesiplus should not be used after the expiry date stated on the carton and blister pack after the words "Expiry date" or "EXP:". The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Lesiplus contains

• The active substances of Lesiplus are ethinylestradiol and drospirenone.
• Each pink film-coated tablet contains the active substances: 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
• The white film-coated tablets do not contain active substances.
• Other ingredients are:
• Pink film-coated tablets containing active substances:
• Tablet core: lactose monohydrate, maize starch, povidone K30, sodium croscarmellose, polysorbate 80, magnesium stearate.
• Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
• White film-coated placebo tablets:
• Tablet core: lactose, povidone K30, magnesium stearate.
• Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Lesiplus looks like and what the pack contains

• Each Lesiplus blister pack contains 24 pink film-coated tablets containing active substances in rows 1, 2, 3, and 4 of the blister pack and 4 white film-coated placebo tablets in row 4 of the blister pack.
• Lesiplus tablets, both pink and white, are film-coated tablets; the tablet core is coated.
• Lesiplus is available in cartons containing 1 blister pack of 28 tablets (24 + 4).

For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization 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.
C/ La Vallina s/n, Pol Ind
Navatejera
24008-León
Spain
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80
31-546 Kraków
Poland
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial
Malpica
50016 Zaragoza
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Netherlands marketing authorization number: RVG 109940
Parallel import authorization number: 293/22
Date of approval of the leaflet: 28.07.2022
[Information about the trademark]