Mercilon

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Mercilon

0.15 mg + 0.02 mg, tablets

Desogestrel + Ethinylestradiol

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.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2.2.1 "BLOOD CLOTS").

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed specifically for the person it is intended for. It should not be given 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 this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Mercilon and what is it used for
• 2. Important information before taking Mercilon
• 2.1 When not to take Mercilon
• 2.2 When to exercise special caution when taking Mercilon
• 2.3 When to consult a doctor
• 3. How to take Mercilon
• 3.1 When and how to take the tablets
• 3.2 Starting the first pack of Mercilon
• 3.3 Taking more than the recommended dose of Mercilon
• 3.4 What to do in case of…
• 3.5 Stopping Mercilon
• 4. Possible side effects
• 5. How to store Mercilon
• 6. Contents of the pack and other information
• 6.1 What Mercilon contains
• 6.2 What Mercilon looks like and what the pack contains
• 6.3 Other information

1. What is Mercilon and what is it used for

Mercilon is a combined oral contraceptive. Each tablet contains a small dose of two different female hormones. These are desogestrel (progestogen) and ethinylestradiol (estrogen). Due to the small hormone content, Mercilon is called a low-dose contraceptive pill. Mercilon belongs to the group of monophasic, combined oral contraceptives, as all tablets in the pack contain the same amount of hormones.
Mercilon is used to prevent pregnancy.
Oral contraception is a very effective method of birth control. The likelihood of becoming pregnant while taking contraceptive pills (provided the patient does not forget to take the pills) is very low.

2. Important information before taking Mercilon

General notes

Before starting to take Mercilon, the patient should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2.2.1 "BLOOD CLOTS").
This leaflet describes most situations that require stopping the pill or when the pill's effectiveness may be reduced. In these situations, the patient should refrain from sexual intercourse or use additional, non-hormonal contraceptive methods, such as a condom or another mechanical method. The calendar method or temperature measurement method should not be used. These methods may be ineffective because contraceptive pills cause changes in temperature and cervical mucus that occur during the menstrual cycle.

Mercilon, like other contraceptive pills, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Mercilon is prescribed by a doctor specifically for each patient. Mercilon should not be given to others.
Mercilon should not be used to delay the start of bleeding.
In exceptional cases, when there is a need to delay the start of bleeding, the patient should consult a doctor.

2.1 When not to take Mercilon

Mercilon should not be taken if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2.2.1 "BLOOD CLOTS");
• if the patient has had a heart attack or stroke;

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• if the patient has (or has ever had) 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 the patient has 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)
• a disease called hyperhomocysteinemia;
• if the patient has (or has ever had) a type of migraine called "migraine with aura";
• if the patient has (or has ever had) pancreatitis associated with severe hypertriglyceridemia;
• if the patient has jaundice or severe liver disease;
• if the patient has (or has ever had) a malignant tumor that is hormone-dependent (e.g., breast or genital cancer);
• if the patient has (or has ever had) a benign or malignant liver tumor;
• if the patient has vaginal bleeding of unknown cause;
• if the patient has an enlarged endometrium (abnormal growth of the uterine lining);
• if the patient is pregnant or breastfeeding;
• if the patient has a hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir (see also section 2.2.3 "Mercilon and other medicines").

If any of the above conditions occur for the first time while taking Mercilon, the patient should stop taking the medicine and consult a doctor, and use a non-hormonal contraceptive method (see also section 2 "General notes").

2.2 When to exercise special caution when taking Mercilon

Before starting to take Mercilon, the patient should discuss it with their doctor or pharmacist.
When should the patient contact their doctor?
The patient should see their doctor immediately

• if they notice any of the symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see section 2.2.1 "BLOOD CLOTS"). To find out about the symptoms of these serious side effects, see section 2.2.1 "HOW TO RECOGNIZE A BLOOD CLOT".

The patient should tell their doctor if they have any of the following conditions.

If these symptoms occur or worsen while taking Mercilon, the patient should also tell their doctor:

• if the patient smokes;
• if the patient has diabetes;
• if the patient is overweight;
• if the patient has high blood pressure;
• if the patient has heart valve problems or heart rhythm disorders;
• if the patient has inflammation of the veins under the skin (superficial thrombophlebitis);
• if the patient has varicose veins;

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• if a close relative has had a blood clot, heart attack, or stroke;
• if the patient has migraines;
• if the patient has epilepsy;
• if the patient has a high level of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2.2.1 "BLOOD CLOTS");
• if the patient has recently given birth, as they are at increased risk of blood clots. The patient should consult their doctor about when to start taking Mercilon after giving birth;
• if the patient has a family history of breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that can cause kidney failure);
• if the patient has sickle cell anemia (a genetic disorder that affects red blood cells);
• if the patient has experienced any of the following conditions for the first time during pregnancy or previous use of hormonal contraception: hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea;
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with potential respiratory distress, they should see their doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema;
• if the patient has chloasma (yellow-brown skin discoloration, especially on the face); in these cases, the patient should avoid exposure to the sun or ultraviolet radiation.

If any of the above factors occur for the first time while taking Mercilon, the patient should contact their doctor immediately.

2.2.1 Hormonal contraception and blood clotting disorders

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Mercilon, 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 gets a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.
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It should be remembered that the overall risk of serious blood clots caused by taking Mercilon is small.

HOW TO RECOGNIZE A BLOOD CLOT

The patient should see their doctor immediately if they notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from

• 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 the color of the leg skin, such as pallor, redness, or discoloration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If the patient is unsure, they should see their doctor, as some of these symptoms, such as coughing or shortness of breath, can be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• instantaneous loss of vision or
• painless vision disturbances, which can lead to loss of vision Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, or heaviness;
• feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the lower part of the body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden, severe, or prolonged headaches without a known cause;
• loss of consciousness or fainting with or without seizures. Stroke

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BLOOD CLOTS IN VEINS

What can happen if blood clots form in veins?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they can occur most often 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 veins highest?

The risk of blood clots in veins 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 the patient stops taking Mercilon, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots caused by taking Mercilon is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had a blood clot in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have a genetic blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2.2.1 "BLOOD CLOTS");
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of the above risk factors are present, even if the patient is unsure. The doctor may decide to stop Mercilon.
The patient should inform their doctor if any of the above conditions change while taking Mercilon, e.g., if someone in their close family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?

Similarly 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 Mercilon is very small, but it may increase:

• with age (over approximately 35 years old);

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• if the patient smokes.While taking a hormonal contraceptive like Mercilon, the patient is advised to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their close family 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 called atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.

The patient should inform their doctor if any of the above conditions change while taking Mercilon, e.g., if they start smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

2.2.2 Hormonal contraception and cancer

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Women taking contraceptive pills have a slightly higher risk of breast cancer than women of the same age who do not take contraceptive pills. This small increase in the risk of breast cancer disappears gradually within 10 years of stopping contraceptive pills.
It is not known whether this difference is caused by the contraceptive pills. It may be that women taking contraceptive pills are more likely to have medical check-ups and breast cancer is diagnosed earlier.
In very rare cases, women taking contraceptive pills have been found to have benign liver tumors, and even more rarely, malignant liver tumors. These tumors can cause bleeding into the abdominal cavity. If the patient experiences severe abdominal pain, they should see their doctor immediately.
Chronic infection with human papillomavirus (HPV) is the most significant risk factor for cervical cancer. It is thought that cervical cancer may occur slightly more often in women who have taken contraceptive pills for a long time. This may not be caused by the contraceptive pills. It is likely that it is related to sexual behavior or other factors.

Psychological disorders

Some women taking hormonal contraceptives, including Mercilon, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If the patient experiences mood changes or symptoms of depression, they should see their doctor as soon as possible for further medical advice.

2.2.3 Mercilon and other medicines

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The patient should always tell their doctor about any medicines or herbal products they are currently taking. The patient should also inform their doctor or another doctor prescribing other medicines (or pharmacist) about taking Mercilon. They may inform the patient about the need to use an additional contraceptive method (e.g., condoms) and for how long, as well as whether it is necessary to modify the use of another medicine.
Certain medicines

• may affect the level of Mercilon in the blood;
• may reduce its contraceptive effectiveness;
• may cause unexpected bleeding.

This applies to medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g., boceprevir, telaprevir);
• other infectious diseases (e.g., griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (St. John's Wort (Hypericum perforatum)).

If the patient is taking medicines or herbal products that may reduce the effectiveness of Mercilon, they should also use a mechanical contraceptive method. Due to the fact that the effect of another medicine on Mercilon may persist for up to 28 days after stopping the medicine, it is necessary to use additional mechanical contraception during this time.
Mercilon may affect the actionof other medicines, such as for example

• cyclosporine;
• the antiepileptic drug lamotrigine (this may lead to an increased frequency of seizures).

If the patient has a hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, they should not take Mercilon, as this may cause an increase in liver function test results in the blood (increase in liver enzyme ALT activity).
Before starting these medicines, the doctor will prescribe a different type of contraceptive.
Mercilon can be taken again about 2 weeks after finishing this treatment.
See section 2 "When not to take Mercilon".

2.2.4 Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Mercilon is contraindicated in pregnancy.
If the patient becomes pregnant while taking Mercilon, they should see their doctor immediately.
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Mercilon is not recommended during breastfeeding.
If the patient wants to take Mercilon during breastfeeding, they should consult their doctor.

2.2.5 Driving and using machines

Taking Mercilon does not affect the ability to drive or use machines.

2.2.6 Mercilon contains lactose monohydrate

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Mercilon.

2.2.7 Use in children and adolescents

There are no available clinical data on the efficacy and safety of Mercilon in children and adolescents under 18 years of age.

2.3 When to consult a doctor

Regular check-ups
Women taking contraceptive pills should be informed by their doctor about the need for regular medical check-ups. These check-ups are usually performed once a year.
The patient should see their doctor immediately in the following cases:

• if they notice any of the symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see section 2.2.1 "BLOOD CLOTS"). To find out about the symptoms of these serious side effects, see section 2.2.1 "HOW TO RECOGNIZE A BLOOD CLOT";
• if there are any changes in their health, especially the conditions mentioned earlier in this leaflet (see sections "When not to take Mercilon" and "Important information before taking Mercilon"), not forgetting the information about their family's medical history that may affect the use of contraceptive pills;
• in case of a breast lump;
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with potential respiratory distress (see also section 2.2 "When to exercise special caution when taking Mercilon");
• in case of planned surgery or immobilization;
• if the patient experiences irregular, heavy vaginal bleeding;
• if the patient missed a pill in the first week of taking it and had sexual intercourse in the previous 7 days;
• if the patient experiences severe diarrhea;
• if the patient misses two consecutive periods or suspects they may be pregnant (they should not start the next pack without consulting their doctor).

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3. How to take Mercilon

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

3.1 When and how to take the tablets

The pack of Mercilon contains 21 tablets. Each tablet has a symbol of the day of the week on which it should be taken (see "Translation of the day of the week symbols on the packaging" - section 6 at the end of the leaflet). The tablets should be taken at the same time every day, if necessary with a glass of water. The patient should continue taking the tablets for 21 days, following the direction of the arrows. Then, they should wait 7 days during which they do not take tablets. Menstrual bleeding (withdrawal bleeding) should occur during these 7 tablet-free days. It usually starts 2-3 days after taking the last tablet of Mercilon. The first tablet of the next pack should be taken on the 8th day, even if bleeding is still present. This means that the patient will always start a new pack on the same day of the week and that withdrawal bleeding will occur at about the same time every month.

Use in children and adolescents

There are no available clinical data on the efficacy and safety of Mercilon in children and adolescents under 18 years of age.

3.2 Starting the first pack of Mercilon

• If the patient did not use any hormonal contraceptive method in the previous monthThe patient should start taking the first tablet of Mercilon on the first day of their menstrual cycle (i.e., the first day of their period). There is no need to use an additional contraceptive method.

The patient can also start taking the tablets between the 2nd and 5th day of their menstrual cycle, but in this case, they should use an additional contraceptive method (e.g., a condom) for the first 7 days of taking the tablets in the first cycle.

• If the patient previously used another combined contraceptive (pills, vaginal rings, patches)The patient can start taking Mercilon the day after taking the last active pill of their previous contraceptive (without taking a break). If the previous contraceptive contains placebo pills, the patient can start taking Mercilon the day after taking the last active pill (if in doubt, the patient should ask their doctor or pharmacist). The patient can also start taking Mercilon later, but no later than the day after the placebo pills or the day they would have started a new pack of their previous contraceptive.

If the patient has been taking another contraceptive, they can stop taking it and start taking Mercilon immediately.
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• If the patient previously used a progestogen-only pill (mini-pill)The patient can stop taking the mini-pill and start taking Mercilon the next day at the same time. The patient should also use an additional contraceptive method (e.g., a condom) for the first 7 days of taking the tablets in the first cycle.
• If the patient previously used an injectable, implant, or intrauterine system that releases progestogenThe patient should start taking Mercilon on the day they would have had their next injection or on the day the implant or intrauterine system is removed. The patient should also use an additional contraceptive method (e.g., a condom) for the first 7 days of taking the tablets, if they have sexual intercourse.
• after childbirthThe doctor may advise the patient to wait until their first menstrual period before starting to take Mercilon. The doctor may also advise the patient to start taking Mercilon earlier. If the patient is breastfeeding, they should discuss taking hormonal contraception with their doctor.
• after a miscarriageAccording to the doctor's advice.

3.3 Taking more than the recommended dose of Mercilon

No serious harmful effects have been observed after taking an overdose of Mercilon. If several tablets are taken at the same time, the patient may experience nausea, vomiting, or vaginal bleeding. If a child has taken Mercilon, the patient should consult their doctor.

3.4 What to do in case of…

Missing a dose of Mercilon:

• If the delay in taking a tablet is less than 12 hours, the effectiveness of the pill is maintained. The patient should take the missed tablet as soon as possible and continue taking the rest of the pack as usual.
• If the delay in taking a tablet is more than 12 hours, the effectiveness of the pill may be reduced. The more missed tablets, the higher the risk of reduced contraceptive effectiveness. There is a higher risk of pregnancy if the patient misses a tablet at the beginning or end of the pack. The patient should

More than one missed tablet from the pack

The patient should consult their doctor.

1 missed tablet in the first week of taking

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the rest of the pack as usual. For the next 7 days, the patient should use an additional contraceptive method (e.g., a condom). There is a risk of pregnancy if the patient has had sexual intercourse in the week before missing the tablet. The patient should consult their doctor.

1 missed tablet in the second week of taking

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the rest of the pack as usual. The effectiveness of the pill is maintained, and there is no need to use additional contraceptive methods. If the above condition is not met or the patient has missed more than one tablet, the patient should use an additional contraceptive method for the next 7 days.

3.5 Discontinuation of Mercilon

Mercilon can be discontinued at any time. In case of not planning to become pregnant, the patient should ask a doctor for another contraceptive method.
In case of planning pregnancy, it is usually recommended to wait until the first natural menstruation after stopping the tablets, which will facilitate determining the expected date of delivery.
In case of any further doubts related to the use of this medication, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like any medication, Mercilon 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 Mercilon, the patient should consult a doctor.
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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 detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before using Mercilon".
The patient should immediately consult a doctor if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria potentially with dyspnea (see also section 2 "Important information before using Mercilon").
Frequently(occurring more frequently than in 1 in 100 women, but less frequently than in 1 in 10 women):

• depressive mood, mood changes
• headaches
• nausea, abdominal pain
• breast pain and tenderness
• weight gain.

Less frequently(occurring more frequently than in 1 in 1000 women, but less frequently than in 1 in 100 women):

• fluid retention
• decreased sexual desire
• migraine
• vomiting
• diarrhea
• rash
• urticaria
• breast enlargement.

Rarely(occurring more frequently than in 1 in 10,000 women, but less frequently than in 1 in 1000 women):

• 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 a transient ischemic attack
• blood clots in the liver, stomach/intestine, kidneys, or eye. The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots)
• hypersensitivity
• increased sexual desire
• intolerance to contact lenses
• skin diseases (erythema multiforme, Stevens-Johnson syndrome)
• breast discharge
• leucorrhea
• weight loss.

Reporting side effects

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If any side effects occur, including any side effects not listed in the leaflet, the patient should inform the doctor, pharmacist, or nurse. 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Mercilon

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the package. The expiration date refers to the last day of the given month.
Store in a temperature below 30°C, in the original package.
Medications should not be disposed of in the sewage system or household waste containers. The patient should ask the pharmacist how to dispose of unused medications. This will help protect the environment.
The medication should not be used if changes in tablet color, tablet fragmentation, or other visible signs of tablet degradation are observed.

6. Package contents and other information

6.1 What Mercilon contains

The active substances of Mercilon are desogestrel in a dose of 0.15 mg and ethinylestradiol in a dose of 0.02 mg.
Other ingredients are: potato starch, colloidal anhydrous silica, all-rac-α-tocopherol, stearic acid, povidone, lactose monohydrate.

6.2 What Mercilon looks like and what the package contains

The tablets are round, biconvex, 6 mm in diameter, marked with the code 4 below TR on one side and the inscription Organon* on the other.
21 tablets – 1 blister of 21 tablets.
63 tablets – 3 blisters of 21 tablets each.
PVC/Al blisters, each in a sachet, the whole in a cardboard box.
A cardboard sachet is attached to the package, in which the blister should be placed after being removed from the protective foil.

6.3 Other information

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

Marketing authorization holder in Romania, the country of export:

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Organon BioSciences S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania

Manufacturer:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 11029/2018/01
11029/2018/02
11029/2018/03

Parallel import authorization number: 818/12

Translation of day of the week symbols on the packaging:

Lu

• Monday Ma
• Tuesday Mi
• Wednesday Jo
• Thursday Vi
• Friday Sb
• Saturday Du
• Sunday

Date of leaflet approval: 30.11.2022
[Information about the trademark]
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