Lesinelle

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Lesinelle (Dorinelletheramex)
3 mg + 0,02 mg, coated tablets
Drospirenone + Ethinylestradiol
Lesinelle and Dorinelletheramex are different brand names of the same medicine.
Please read the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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, particularly during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "BLOOD CLOTS (thrombosis)").

Table of contents of the leaflet

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

1. What Lesinelle is and what it is used for

Lesinelle is a contraceptive tablet used to prevent pregnancy.
Each 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 Lesinelle

General notes
Before starting to take Lesinelle, 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 taking Lesinelle, 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 perform additional 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 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 measurement method. These methods may be unreliable because Lesinelle alters 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 use Lesinelle
Do not take Lesinelle if you have any of the conditions listed below. If you have any of these conditions, 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 the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "BLOOD CLOTS (thrombosis)");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) 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 had in the past) a type of migraine called "migraine with aura";
• if you currently have (or have had in the past) liver disease and liver function remains abnormal;
• if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, or glecaprevir/pibrentasvir (see also section "Lesinelle with other medicines");
• if you have kidney function disorders (kidney failure);
• if you currently have (or have had in the past) liver tumour;
• if you currently have (or have had in the past) or suspect breast cancer or cancer of the genital organs;
• if you have any 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 cause 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 menstruating.

Women of advanced age
Lesinelle is not intended for use after menopause.

Women with liver function disorders
Do not take Lesinelle if you have liver disease. See also sections "When not to use Lesinelle" and "Warnings and precautions".

Women with kidney function disorders
Do not take Lesinelle if you have kidney failure or acute kidney failure. See also sections "When not to use Lesinelle" and "Warnings and precautions".

Warnings and precautions
When to exercise special caution when taking Lesinelle
Before starting to take Lesinelle, discuss this with your doctor or pharmacist.
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that 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 symptoms of these serious adverse effects, see "HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS".
In certain situations, special caution is required when taking Lesinelle or any other combined hormonal contraceptive, and regular medical check-ups may be necessary.
Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Lesinelle, inform your doctor:

• if breast cancer is currently present or has occurred in the past 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 diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence 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 been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have 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 Lesinelle;
• if you have phlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see section "Lesinelle with other medicines");
• if you have a condition that first appeared during pregnancy or previous use of sex hormones, such as hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a nervous system disorder with involuntary body movements (Sydenham's chorea);
• if you currently have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as melasma). If so, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, products containing estrogens may trigger or worsen symptoms. Seek immediate medical attention if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives accompanied by breathing difficulties.

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

• in veins (referred to below as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic events").

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

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What condition might you have?

• 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 cyanosis;

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

• 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 first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more. After the first year, the risk decreases, although it remains higher than when not using combined hormonal contraceptives. If a patient stops taking Lesinelle, the risk of developing blood clots returns to normal within a few weeks.

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

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

Risk of developing blood clots within one year
Women who do not use combined hormonal tablets, patches, or vaginal systems and are not pregnant: Approximately 2 out of 10,000 women
Women using combined oral contraceptives containing levonorgestrel, norethisterone, or norgestimate: Approximately 5–7 out of 10,000 women
Women using Lesinelle: Approximately 9–12 out of 10,000 women

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

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have inherited clotting disorders;
• if the patient needs to undergo 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 stop taking Lesinelle several weeks before surgery or during reduced mobility. If the patient must stop taking Lesinelle, 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 last few weeks).

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

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

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

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Lesinelle, 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 another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

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

Lesinelle 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 use of the product. For example, more tumours may be detected in women using combined contraceptives because these women are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to examine the breasts regularly and contact a doctor if any lump is detected.
Rarely, benign liver tumours and, even more rarely, malignant liver tumours have been reported in women using combined hormonal contraceptives. If the patient experiences an unusual, severe abdominal pain, they should contact a doctor.

Intermenstrual bleeding
During the first few months of taking Lesinelle, unexpected bleeding (bleeding outside the week of the break) may occur. If such bleeding lasts longer than a few months, or if it starts after several months, the doctor should investigate the cause.

What to do if no bleeding occurs during the week of the break
If all tablets have been taken according to the schedule, without vomiting or severe diarrhoea, and no other medicines have been taken, it is very unlikely that pregnancy has occurred.
If the expected bleeding does not occur for two consecutive cycles, this may indicate pregnancy. The patient should contact their doctor immediately. Do not start the next pack until pregnancy has been ruled out.

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

Lesinelle and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect the blood levels of Lesinelle and may make it less effective in preventing pregnancy or 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 virus infection (so-called 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).

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

• medicines containing cyclosporine,
• antiepileptic medicines containing lamotrigine (may lead to increased frequency of seizures),
• theophylline (used for breathing problems),
• tizanidine (used to treat muscle pain and/or muscle spasms).

Before taking any medicine, consult your doctor or pharmacist.
Do not give Lesinelle to patients with hepatitis C virus infection who are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may lead to increased liver function test results in blood (increased liver enzyme AlAT activity).
The doctor will prescribe another type of contraception before starting treatment with these medicines.
Lesinelle may be restarted approximately 2 weeks after completion of this treatment.
See section “When not to use Lesinelle”.

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

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

Pregnancy and breastfeeding
Pregnancy
Lesinelle must not be taken during pregnancy. If the patient becomes pregnant while taking Lesinelle, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking Lesinelle at any time (see also “Discontinuing use of Lesinelle”).

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

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

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

Lesinelle 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 take Lesinelle

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Take one Lesinelle tablet daily, with or without a small amount of water. The tablets may be taken
with or without food, but they should be taken every day at approximately the same time.
The blister pack contains 21 tablets. Next to each tablet, the day of the week on which it should be
taken is printed. For example, if tablet-taking begins on Wednesday, take the tablet marked "WO/MER/MI"
(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 until all 21 tablets have been taken.
After this, no tablets should be taken for 7 days. During these 7 days, when no tablets are taken
(also called the "tablet-free week"), withdrawal bleeding should occur. This so-called "withdrawal
bleeding" usually begins on the 2nd or 3rd day of the tablet-free week.
On the 8th day after taking the last tablet of Lesinelle (i.e., after the 7-day break), start a new
blister pack regardless of whether bleeding has stopped or not. This means that each subsequent
blister pack should be started on the same day of the week, and withdrawal bleeding should occur
on the same days each month.
If the patient takes Lesinelle as described above, she is protected against pregnancy during the 7
days when no tablets are taken.
When to start the first blister pack?

• If no hormonal contraceptive has been used in the previous month. Start taking Lesinelle on the first day of the cycle (i.e., the first day of menstruation). If the patient starts taking Lesinelle on the first day of her period, she is immediately protected against pregnancy. 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 from a combined vaginal contraceptive system or transdermal system. Start taking Lesinelle the day after the last active tablet (the last tablet containing active ingredients) from the previous pack is taken, but no later than the day after the tablet-free period of the previous contraceptive product ends (or after the last inactive tablet of the previous contraceptive product). When switching from a combined vaginal contraceptive system or transdermal system, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen). Switching can occur on any day from progestogen-only pills (on the day of removal of an implant or intrauterine system, or on the day of the next scheduled injection for injectable forms), but in all these cases, additional contraceptive methods (e.g., condoms) must be used for the first 7 days of tablet-taking.
• After miscarriage. Follow your doctor's advice.
• After childbirth. After delivery, Lesinelle may be started between days 21 and 28. If the patient starts taking the medicine later than day 28, an additional barrier method (e.g., condoms) should be used for the first 7 days of taking Lesinelle. If sexual intercourse has occurred after childbirth, before (re)starting Lesinelle, the patient should first confirm she is not pregnant or wait until the next menstrual bleeding.
• If the patient is breastfeeding and wishes to (re)start taking Lesinelle after childbirth. Read section "Breast-feeding".

If the patient is unsure when to start taking the medicine, she should consult her doctor.
Taking more Lesinelle than recommended
There have been no reports of serious harmful effects from taking too many Lesinelle tablets.
If several tablets are taken at once, nausea and 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 Lesinelle tablets have been taken or if a child has swallowed any tablets, consult a doctor
or pharmacist immediately.
Missed dose of Lesinelle

• 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, then continue taking the following 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 higher the risk of becoming pregnant.

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

• Missing more than one tablet in the same blister pack Contact your doctor.
• Missing one tablet in week 1 Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, there is a risk of pregnancy. In this case, contact your doctor.
• Missing one tablet in week 2 Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. Protection against pregnancy is not reduced, and no additional protection 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 the same time. Continue taking the following tablets at the usual time. Instead of the tablet-free week, immediately start taking tablets from the next blister pack.

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

2. Alternatively, stop taking tablets from the current blister pack and proceed directly to the 7-day tablet-free interval ( note the day on which the tablet was missed ). If you wish to start the next blister pack on your 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 has missed any tablet from the blister pack and no bleeding occurs during the first tablet-free interval, this may indicate that the patient is pregnant. In this case, contact your doctor before starting the next blister pack.

Missed more than 1 tablet from one blister pack?
Yes
Did sexual intercourse occur in the week
preceding the missed tablet?

No

• Take the missed tablet
• Use a barrier method (condoms) for the next 7 days, and
• Finish taking all tablets from the blister pack
  Only 1 tablet missed in a week - Take the missed tablet
  2. - Finish taking tablets from the blister pack (taken more than 12 hours late)
• Take the missed tablet and
• Finish taking tablets from the blister pack
• Instead of the tablet-free week, immediately start taking tablets from the next blister pack 3. or
• Immediately stop taking tablets from the blister pack
• Start the tablet-free week (no longer than 7 days, including the day the tablet was missed)
• Start taking tablets from the next blister pack

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking 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 your usual tablet-taking time. If this is not
possible or more than 12 hours have passed, follow the instructions under "Missed dose of Lesinelle".
Delayed onset of bleeding: what you need to know
Although not recommended, it is possible to delay the onset of bleeding by moving directly to a new
Lesinelle blister pack, skipping the tablet-free interval, until the end of the new pack. Spotting or
intermenstrual bleeding may occur during the intake of tablets from the second blister pack. After
the usual 7-day tablet-free interval, start taking tablets from the next blister pack.
You may wish to consult your doctor for advice before deciding to delay the onset of bleeding.
Changing the first day of bleeding: what you need to know
If the patient takes the tablets as instructed, bleeding will begin during the tablet-free week. If it is
necessary to change this day, this can be done by shortening (but never extending – maximum 7 days!)
the tablet-free interval. For example, if the tablet-free interval usually 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 lead to spotting or intermenstrual bleeding.
If the patient is unsure how to proceed, she should contact her doctor.
Stopping treatment with Lesinelle
Lesinelle 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 Lesinelle 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Lesinelle may cause adverse effects, although not everyone will experience them. If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Lesinelle, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Lesinelle".

The following adverse effects have been associated with the use of Lesinelle.

Common adverse 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 menstruation,
• Weight gain.

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

• Candidiasis (fungal infection),
• Cold sores (Herpes simplex),
• Allergic reactions,
• Increased appetite,
• Depression, nervousness, sleep disturbances,
• Tingling and numbness sensations, vertigo (dizziness of labyrinthine origin),
• Vision problems,
• Heart rhythm disorders or abnormally rapid heartbeat,
• Blood clot (thrombosis) in the lung (pulmonary embolism),
• High blood pressure, low blood pressure, migraine, varicose veins,
• Sore throat,
• Nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation,
• Sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing, or urticaria with breathing difficulties (angioedema), hair loss (alopecia), eczema, itching, rashes, dry skin, seborrheic skin disorders (seborrheic dermatitis),
• Neck pain, limb pain, muscle cramps,
• Urinary tract infection,
• Breast lump (benign and malignant), milk discharge in non-pregnant women (galactorrhea), ovarian cysts, sudden facial flushing, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic), abnormal cervical smear (Papanicolaou test or Pap smear), decreased sexual desire,
• Fluid retention, lack of energy, excessive thirst, increased sweating,
• Weight loss.

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

• Asthma,
• Hearing problems,
• Nodular erythema (characterized by painful red skin nodules),
• Erythema multiforme (characterized by a rash with red, painful rings),
• Harmful blood clots in a vein or artery, for example:
  • In the leg or foot (e.g. deep vein thrombosis),
  • In the lungs (e.g. pulmonary embolism),
  • Heart attack,
  • Stroke,
  • Mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack (TIA),
  • Blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lesinelle

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

6. Contents of the pack and other information

What Lesinelle contains
The active substances in this medicine are ethinylestradiol and drospirenone.
Each tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone.
Other ingredients are:
Tablet core: monohydrate lactose, pregelatinized corn starch, povidone K 30, sodium croscarmellose,
polysorbate 80, magnesium stearate.
Tablet coating: partially hydrolysed 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 contents of the pack
Pink, round, film-coated tablets.
Lesinelle is available in cartons containing 1 or 3 blisters, each blister containing 21 tablets. A cardboard wallet is included with the pack, in which the blister should be placed.
For more detailed information, contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Belgium, 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
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Belgium, country of export: BE399716
Parallel Import Licence Number: 295/17
Translation of the weekday symbols printed next to each tablet on the immediate 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 authorised for marketing in the European Economic Area countries under the following names: