Lesinelle

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

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

Lesinelle(Dorinelletheramex)

3 mg + 0.02 mg, coated tablets

Drospirenonum + Ethinylestradiolum
Lesinelle and Dorinelletheramex are different trade names for the same medicine.

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

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same. 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.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• You should be vigilant and consult a doctor if the patient suspects that symptoms of a blood clot have occurred (see section 2 "Blood clots").

Table of contents of the leaflet

• 1. What is Lesinelle and what is it used for
• 2. Important information before taking Lesinelle
• 3. How to take Lesinelle
• 4. Possible side effects
• 5. How to store Lesinelle
• 6. Contents of the package and other information

1. What is Lesinelle and what is it used for

Lesinelle is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, namely
drospirenone and ethinylestradiol.
Contraceptive pills that contain two hormones are called "combined" pills.

2. Important information before taking Lesinelle

General notes

Before starting to take Lesinelle, you should read the information about
blood clots (thrombosis) in section 2. It is especially important to read about the symptoms
of blood clots (see section 2 "Blood clots (thrombosis)").
Before starting to take Lesinelle, the doctor will ask a few questions about your health
and about the health of your close relatives. The doctor will also measure your blood pressure and, in individual
cases, may also perform some other tests.
This leaflet describes several situations in which you should stop taking Lesinelle,
or in which the effectiveness of Lesinelle 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, as Lesinelle modifies the monthly changes in body temperature and cervical mucus.

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

When not to take Lesinelle

You should not take Lesinelle if you have any of the following conditions. If you have any of the following conditions, you should inform your doctor. The doctor will discuss with you which other contraceptive method will 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 that you have blood clotting disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "Blood clots").
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary symptoms of a stroke);
• if you have any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• hyperhomocysteinemia
• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) liver disease, and liver function is still abnormal;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Lesinelle and other medicines");
• if you have kidney problems (kidney failure);
• if you have (or have had in the past) liver cancer;
• if you have (or have had in the past) or suspect breast or genital cancer;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of Lesinelle (listed in section 6). This allergy may be the cause of itching, rash, or swelling.

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

Warnings and precautions

When to be particularly careful when taking Lesinelle

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

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

To find a description of the symptoms of these serious side effects, see "How to recognize a blood clot".
In some situations, you should be particularly careful when taking Lesinelle or any other combined hormonal contraceptive, and you may also need to be regularly examined by your doctor.

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

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

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

BLOOD CLOTS (THROMBOSIS)

Taking combined hormonal contraceptives, such as Lesinelle, is associated with an increased risk of blood clots, compared to not taking the therapy.
Blood clots can form

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

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

Remember that the overall risk of harmful blood clots caused by taking Lesinelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should see your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
What disease is likely to occur in you?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color in the affected leg, such as pallor, redness, or cyanosis. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood; Pulmonary embolism

BLOOD CLOTS IN VEINS

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

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

When is the risk of blood clots in 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 Lesinelle, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

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 Lesinelle is small.

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

Factors that increase the risk of blood clots in veins

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

• if you are significantly overweight (body mass index (BMI) over 30 kg/m);
• 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 hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots"). You may need to stop taking Lesinelle for a few weeks before surgery or immobilization. If you need to stop taking Lesinelle, you should ask your doctor when you can resume taking it;

Lesinelle on several occasions. You should tell your doctor if any of these conditions occur in you, even if you are not sure. Your doctor may decide to stop taking Lesinelle.
You should inform your doctor if any of the above conditions change while taking Lesinelle, e.g. you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or you gain significant weight.

BLOOD CLOTS IN ARTERIES

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

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is important to note that the risk of a heart attack or stroke associated with taking Lesinelle is very small, but it may increase:

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

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while taking Lesinelle, e.g. you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or you gain significant weight.

Lesinelle and cancer

Women taking combined contraceptives, including Lesinelle, 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 contraceptives because they are examined by doctors more often. The frequency of breast tumors decreases gradually after stopping combined hormonal contraceptives.
It is important to examine your breasts regularly and contact your doctor if you feel any lump.
Women taking combined contraceptives have also been reported to have, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. If you experience severe abdominal pain, you should contact your doctor.

Irregular bleeding

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

What to do if bleeding does not occur during the weekly break

If you have taken all the tablets according to the schedule, have not vomited, or have not had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive weeks, it may mean that you are pregnant. You should contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

Psychological disorders

Some women taking hormonal contraceptives, including Lesinelle, 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.

Lesinelle and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should also tell any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Lesinelle. They may tell you whether you should use additional contraceptive methods (such as condoms) and for how long or whether you should modify the use of other medicines.
Some medicines may affect the level of Lesinelle in your blood and may cause it to be less effective in preventing pregnancyor may cause unexpected bleeding. These include:

• medicines used to treat: epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g. rifampicin), HIV and hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) fungal infections (griseofulvin, ketoconazole), arthritis, degenerative joint disease (etoricoxib), high blood pressure in the pulmonary blood vessels (bosentan)
• herbal medicines containing St. John's wort ( Hypericum perforatum).

Lesinelle may affect the action of other medicines, such as:
medicines containing cyclosporin
antiepileptic medicines containing lamotrigine (may increase the frequency of seizures)
theophylline (used for breathing problems),
tizanidine (used to treat muscle pain and/or muscle spasms).
Before taking any medicine, you should consult your doctor or pharmacist.
You should not take Lesinelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause an increase in liver function test results in the blood (increase in liver enzyme ALT). Your doctor will prescribe a different type of contraception before starting treatment with these medicines. Lesinelle may be resumed about 2 weeks after the end of this treatment. See section "When not to take Lesinelle".

Lesinelle with food and drink

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

Lab tests

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

Pregnancy and breastfeeding

Pregnancy
Lesinelle should not be taken during pregnancy. If you become pregnant while taking Lesinelle, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Lesinelle at any time (see also "Stopping Lesinelle").
Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
Lesinelle is not usually recommended for use during breastfeeding. If you want to use a contraceptive during breastfeeding, you should contact your doctor.

Driving and using machines

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

Lesinelle contains lactose.

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

Lesinelle contains sodium

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

3. How to take Lesinelle

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
You should take one Lesinelle tablet every day, if necessary with a small amount of water. You can take the tablets with or without food, but you should take them every day at about the same time.
The blister pack contains 21 tablets. Next to each tablet, the day of the week is printed when you should take it. If, for example, you start taking the tablets on Wednesday, you should take the tablet with the inscription "WO/MER/MI" (meaning Wednesday; see "Translation of day of the week symbols on the packaging" at the end of the leaflet). You should move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then you should not take any tablets for 7 days. During these 7 days, when you are not taking tablets (also called the weekly break), you should experience bleeding. This is called "withdrawal bleeding", which usually starts on the 2nd or 3rd day of the weekly break.
On the 8th day after taking the last Lesinelle tablet (i.e. after the 7-day break), you should start a new blister pack, regardless of whether the bleeding has stopped or not. This means that you should start each new blister pack on the same day of the week, and the withdrawal bleeding should occur on the same days every month.
If you take Lesinelle in this way, you are also protected against pregnancy during the 7 days when you are not taking tablets.

When can you start the first blister pack?

• If you have not taken a hormonal contraceptive in the previous month.You should start taking Lesinelle on the first day of your cycle (i.e. on the first day of your period). If you start taking Lesinelle on the first day of your period, you are immediately protected against pregnancy. You can also start taking Lesinelle on days 2-5 of your cycle, but then you should use additional contraceptive methods (such as condoms) for the first 7 days.
• Changing from a combined hormonal contraceptive product or a combined hormonal contraceptive vaginal system or transdermal system.You can start taking Lesinelle the next day after taking the last active tablet (the last tablet containing active substances) from the previous pack, but no later than the day after the end of the period without tablets from the previous product. In the case of changing from a combined hormonal contraceptive vaginal system or transdermal system, you should follow your doctor's instructions.
• Changing from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen).You can switch on any day from a mini-pill, from an implant or intrauterine system on the day of its removal, or from injections on the day of the planned next injection, but in all these cases, you should use additional contraceptive methods (such as condoms) for the first 7 days of taking Lesinelle.
• After a miscarriage.Follow your doctor's instructions.
• After childbirth.You can start taking Lesinelle from 21 to 28 days after giving birth. If you start taking Lesinelle later than 28 days after giving birth, you should use additional contraceptive methods (such as condoms) for the first 7 days of taking Lesinelle. If you have had sexual intercourse after giving birth, before (re)starting Lesinelle, you should first make sure that you are not pregnant or wait for your next menstrual period.
• If you are breastfeeding and want to (re)start taking Lesinelle after giving birth.

You should read the section "Breastfeeding".
If you are unsure when to start taking Lesinelle, you should consult your doctor.

What to do if you take more Lesinelle than you should

There are no reports of serious, harmful effects from taking too many Lesinelle tablets at once.
If you have taken 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 cycle, but have taken the medicine by mistake.
If you have taken too many Lesinelle tablets or if a child has swallowed them, you should consult your doctor or pharmacist.

What to do if you forget to take Lesinelle

• If it has been less than 12 hourssince you forgot to take a tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as possible, and then take the next tablets at the usual time.
• If it has been more than 12 hourssince you forgot to take a tablet, your protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

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

What to do if you forget to take more than one tablet in this blister pack

You should contact your doctor.

What to do if you forget to take one tablet in week 1.

You should take the forgotten tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, there is a risk of pregnancy. In this case, you should contact your doctor.

What to do if you forget to take one tablet in week 2.

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

What to do if you forget to take one tablet in week 3.

There are two options to choose from:

• 1. Take the forgotten tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time. Instead of the weekly break, you should start taking tablets from the next blister pack immediately.

It is likely that your period will occur at the end of the second blister pack, but you may experience spotting or irregular bleeding while taking tablets from the second blister pack.

• 2. You can also stop taking tablets from the blister pack and go directly to the 7-day break ( note the day you forgot to take the tablet). If you want to start a new blister pack on your usual start day, you can shorten the break to less than 7 days.

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

• If you have forgotten to take any of the tablets in the blister pack and do not experience bleeding during the first break, it may mean that you are pregnant. In this case, you should contact your doctor before starting the next blister pack.

Forgot to take more than 1 tablet from one blister pack

You should consult your doctor

yes
in week

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

no

• Take the forgotten tablet
• Use a mechanical method (condoms) for the next 7 days and
• Finish taking the tablets from the blister pack in the week
• 2. Only 1 tablet forgotten (taken more than 12 hours late)
• Take the forgotten tablet
• Finish taking the tablets from the blister pack
• Take the forgotten tablet and
• Finish taking the tablets from the blister pack
• Instead of the weekly break, start taking tablets from the next blister pack in the week
• 3. or
• Stop taking tablets from the blister pack immediately
• Start the weekly break (no longer than 7 days, including the forgotten tablet)
• Start taking tablets from the next blister pack

What to do if you vomit or have severe diarrhea

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

Delaying the start of bleeding: what you need to know

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


4. Possible side effects

Like all medicines, Lesinelle can cause side effects, although they do not occur in everyone. If any side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Lesinelle, you should consult a doctor.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Lesinelle".
The following side effects have been associated with the use of Lesinelle:
Common side effects (may occur in up to 1 in 10 people)

• mood swings,
• headache,
• abdominal pain (stomach),
• acne,
• breast pain, breast enlargement, breast tenderness, painful or irregular periods,
• weight gain.

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

• candidiasis (fungal infection),
• herpes simplex (cold sore),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• tingling and numbness, vertigo (dizziness),
• vision problems,
• heart rhythm disorders or extremely fast heart rate,
• blood clots (thrombosis) in the lung (pulmonary embolism).
• high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation,
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat), and/or difficulty swallowing or hives with difficulty breathing (angioedema), hair loss (alopecia), eczema, itching, rashes, dry skin, seborrheic dermatitis,
• neck pain, limb pain, muscle cramps,
• urinary tract infection,
• breast lump (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, sudden flushing of the face, absence of menstruation, very heavy menstruation, white discharge, vaginal dryness, pain in the lower abdomen (pelvis), abnormal Pap smear, decreased libido,
• fluid retention, lack of energy, strong desire, increased sweating,
• weight loss.

Rare side effects (may occur in up to 1 in 1000 people)

• asthma,
• hearing problems,
• erythema nodosum (painful red lumps on the skin),
• erythema multiforme (rash with red, painful edges),
• harmful blood clots in a vein or artery, for example: in the leg or foot (e.g., deep vein thrombosis) in the lungs (e.g., pulmonary embolism) heart attack stroke or mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of 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).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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, you can help provide more information on the safety of this medicine.

5. How to store Lesinelle

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lesinelle contains

The active substances of Lesinelle are ethinylestradiol and drospirenone.
Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
The other ingredients of Lesinelle are:
Tablet core: lactose monohydrate, cornstarch, povidone K 30, croscarmellose sodium, polysorbate 80, magnesium stearate.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Lesinelle looks like and what the pack contains

Pink, round, film-coated tablets.

• Lesinelle is available in boxes containing 1 blister pack of 21 tablets. The packaging includes a cardboard wallet in which the blister should be placed.

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

Marketing authorization holder in Belgium, the country of export:

Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01YE64, Ireland

Manufacturer

Laboratorios León Farma, S.A., Pol. Ind. Navatejera, C/ La Vallina s/n, 24008 - Villaquilambre, León, Spain

• 24008 - Villaquilambre, León, Spain

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, Marketing authorization number in Belgium, the country of export: BE399716, Parallel import authorization number: 284/19, Translation of the day of the week symbols on the packaging:
MA/LUN/MO –Monday

DI/MAR/DI

• –Tuesday WO/MER/MI –Wednesday DO/JEU/DO –Thursday VR/VEN/FR –Friday ZA/SAM/SA –Saturday ZO/DIM/SO –Sunday

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of approval of the leaflet: 12.07.2024

[Information about the trademark]

Member State	Medicinal product name
Norway:	Dretinelle 0,02 mg/3 mg tabletter, filmdrasjerte
Austria:	Dretinelle 0,02 mg/3 mg 21 Filmtabletten
Czech Republic:	Softinelle 0,02 mg/3 mg potahované tablety
Spain:	Dretinelle 0.02 mg/3 mg comprimidos recubiertos con película
Hungary:	Corenelle 0.02 mg/3 mg filmtabletta
Ireland:	Dretinelle 0.02 mg/3 mg Film-coated Tablets
Poland:	Lesinelle
Slovakia:	Softinelle 0,02mg/3mg filmom obalené tablety