Marvelon

Leaflet accompanying the packaging: information for the user

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

Marvelon

0.15 mg + 0.03 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 "Blood clots").

You should carefully 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 necessary.
• In case of 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 their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Marvelon and what is it used for
• 2. Important information before using Marvelon
• 2.1 When not to use Marvelon
• 2.2 When to exercise special caution when using Marvelon
• 2.3 When to consult a doctor
• 3. How to use Marvelon
• 3.1 When and how to take the tablets
• 3.2 Starting the first pack of Marvelon
• 3.3 Using more than the recommended dose of Marvelon
• 3.4 What to do in case of…
• 3.5 Stopping the use of Marvelon
• 4. Possible undesirable effects
• 5. How to store Marvelon
• 6. Contents of the packaging and other information
• 6.1 What Marvelon contains
• 6.2 What Marvelon looks like and what the packaging contains
• 6.3 Marketing authorization holder and manufacturer
• 6.4 Date of last revision of the leaflet

1. What is Marvelon and what is it used for

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

2. Important information before using Marvelon

General notes

Before starting to take Marvelon, you 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 "Blood clots"). Most of the situations described in this leaflet indicate when you should stop taking the pill or when the effectiveness of the pill may be reduced. In these situations, you should refrain from sexual intercourse or use additional, non-hormonal contraceptive methods, such as a condom or another mechanical method. You should not use the calendar method or the temperature measurement method. These methods may be ineffective because contraceptive pills cause changes in temperature and cervical mucus that occur during the menstrual cycle.

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

Marvelon is prescribed by a doctor individually for each patient. Do not give Marvelon to others. Marvelon should not be used to delay the start of menstrual bleeding. In exceptional cases, when there is a need to delay the start of menstrual bleeding, you should consult a doctor.

2.1 When not to use Marvelon

Do not use Marvelon if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable for you.

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to undergo surgery or will be immobilized for a long time (see "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have 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 you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• hyperhomocysteinemia
• if you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) pancreatitis associated with high levels of triglycerides;
• if you have jaundice or severe liver disease;
• if you have (or have had) a hormone-dependent malignant tumor (e.g. breast or genital organ cancer);
• if you have (or have had) a benign or malignant liver tumor;
• if you have vaginal bleeding of unknown cause;
• if you have an enlarged endometrium (abnormal growth of the uterine lining);
• if you are pregnant or think you may be pregnant;
• if you have a hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir and pibrentasvir (see also section "Marvelon and other medicines").

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

2.2 When to exercise special caution when using Marvelon

Before starting to use Marvelon, 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 of the following symptoms that may indicate a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

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

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

If these symptoms occur or worsen while using Marvelon, you should also tell your doctor.

• if you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have heart valve problems or heart rhythm disorders;
• if you have superficial thrombophlebitis (inflammation of the veins under the skin);
• if you have varicose veins;
• if thromboembolic diseases, heart attacks, or strokes occur in your close relatives;
• if you have migraines;
• if you have epilepsy;
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. You should consult your doctor about how soon you can start taking Marvelon after giving birth;
• if breast cancer has occurred or occurs in your close relatives;
• if you have liver or gallbladder disease;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder that affects red blood cells);
• if you have experienced any of the following conditions for the first time during pregnancy or previous use of hormonal contraception: hearing loss, porphyria, herpes during pregnancy, or Sydenham's chorea;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and difficulty swallowing or hives potentially with difficulty breathing, you should see your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• if you have chloasma (yellow-brown skin discoloration, especially on the face) now or in the past; in these cases, you should avoid sun exposure or ultraviolet radiation.

If any of the above factors occur for the first time while using Marvelon, you should contact your doctor immediately.

2.2.1 Hormonal contraception and thromboembolic disorders

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Marvelon, is associated with an increased risk of blood clots compared to not using 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 recovers fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It is essential to remember that the overall risk of developing harmful blood clots while using Marvelon is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

You should see your doctor immediately if you notice any of the following symptoms. Are you experiencing any of these symptoms? Why is the patient likely to suffer 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 while standing or walking;
• increased temperature in the affected leg;
• skin color changes in the leg, such as pallor, redness, or discoloration. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• severe chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, you should see your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g. a cold). Pulmonary embolism

• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, or heaviness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a 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 fainting;
• 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 disorders, 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

BLOOD CLOTS IN VEINS

What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these adverse effects are rare, they can occur most frequently in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose 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 forming blood clots in veins is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of 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 using combined hormonal contraceptives. If you stop using Marvelon, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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

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

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Marvelon 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/m2);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, you may have a hereditary blood clotting disorder;
• if you need to undergo surgery, are immobilized for a long time due to injury or illness, or have a leg in a cast. It may be necessary to stop using Marvelon for a few weeks before surgery or immobilization. If you need to stop using Marvelon, you should ask your doctor when you can resume using the medicine;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor. It is essential to tell your doctor if any of the above factors apply to you, even if you are unsure. Your doctor may decide to stop using Marvelon. You should inform your doctor if any of the above conditions change while using Marvelon, e.g. if you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or if you gain 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 consequences, 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 Marvelon is very small, but it may increase:

• with age (over 35 years old);
• if you smoke. While using a hormonal contraceptive like Marvelon, 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 increased 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, heart rhythm disorder 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 using Marvelon, e.g. if you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

2.2.2 Hormonal contraception and cancer

Women using contraceptive pills have a slightly higher incidence of breast cancer than women of the same age who do not use them. This small increase in breast cancer incidence disappears gradually within 10 years of stopping the use of contraceptive pills. It is not known whether this difference is caused by the use of contraceptive pills. It may be related to the fact that women using contraceptive pills are more frequently examined by doctors and breast cancer is diagnosed earlier in them. In very rare cases, benign liver tumors, and even more rarely, malignant liver tumors, have been observed in women using contraceptive pills. These tumors can cause bleeding into the abdominal cavity. If you experience severe abdominal pain, you should see your doctor immediately. Chronic infection with the human papillomavirus (HPV) is the most significant risk factor for cervical cancer. It is believed that cervical cancer may occur slightly more frequently in women who have used contraceptive pills for an extended period. This may not be caused by contraceptive pills. It is likely related to sexual behavior or other factors.

Psychiatric disorders

Some women using hormonal contraceptives, including Marvelon, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should see your doctor as soon as possible for further medical advice.

2.2.3 Marvelon and other medicines

You should always tell your doctor about the medicines or herbal products you are currently using. You should also inform your doctor or another doctor prescribing other medicines (or pharmacist) about the use of Marvelon. They may inform you about the need to use an additional contraceptive method (e.g. condoms), and if so, for how long, and whether it is necessary to modify the use of another medicine. Some medicines

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

• cyclosporine
• antiepileptic drugs
• lamotrigine (may lead to an increased frequency of seizures)

If you have a hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir and pibrentasvir, you should not use Marvelon, as it may cause an increase in liver function test results in the blood (increase in alanine aminotransferase activity). Before starting these medicines, your doctor will prescribe a different type of contraceptive. You can resume using Marvelon about 2 weeks after completing this treatment. See section "When not to use Marvelon".

2.2.4 Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. Marvelon is contraindicated in pregnancy. If you suspect you are pregnant while using Marvelon, you should see your doctor immediately. The use of Marvelon is not recommended during breastfeeding. If you want to use Marvelon during breastfeeding, you should consult your doctor.

2.2.5 Driving and using machines

The use of Marvelon does not affect the ability to drive and use machines.

2.2.6 Marvelon contains lactose.

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

2.2.7 Use in children and adolescents

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

2.3 When to consult a doctor

Regular check-upsWomen using 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. You should see your doctor immediately in the following cases:

• -if you notice any symptoms that may indicate a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see above "Blood clots"). To learn about the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".
• -if there are any changes in your health, especially the conditions mentioned earlier in this leaflet (see sections "When not to use Marvelon" and "Important information before using Marvelon"), not forgetting the information related to the health of your close relatives that may affect the use of contraceptive pills;
• -if you feel a breast lump;
• -if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and difficulty swallowing or hives potentially with difficulty breathing (see also section 2.2 "When to exercise special caution when using Marvelon");
• -if you plan to use other medicines (see also section 2.2.3 "Marvelon and other medicines");
• -if you are immobilized or plan to undergo surgery (you should consult your doctor at least 4 weeks in advance);
• -if you experience irregular, heavy vaginal bleeding;
• -if you forget to take a pill in the first week of use and have had sexual intercourse in the previous 7 days;
• -if you experience severe diarrhea;
• -if your menstrual period does not occur twice in a row or if you suspect you are pregnant (do not start the next pack before consulting your doctor).

3. How to use Marvelon

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

3.1 When and how to take the tablets

The packaging of Marvelon 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" at the end of the leaflet). The tablets should be taken at the same time every day, if necessary, with a glass of water. You should continue taking the tablets for 21 days, following the direction of the arrows. Then, you should wait 7 days without taking tablets. Menstrual bleeding (withdrawal bleeding) should occur during these 7 days without tablets. It usually starts 2-3 days after taking the last tablet of Marvelon. You should start the next pack on the 8th day, even if bleeding is still present. This means that you will always start a new pack on the same day of the week, and your 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 using Marvelon in children and adolescents under 18 years of age.

3.2 Starting the first pack of Marvelon

• If you did not use any hormonal contraceptive method in the previous month

You should start taking the first tablet of Marvelon on the first day of your menstrual cycle (i.e. the first day of your period). There is no need to use an additional contraceptive method. You can also start taking the tablets between the 2nd and 5th day of your cycle, but in this case, you should use an additional contraceptive method (e.g. a condom) for the first 7 days of taking the tablets in the first cycle.

• If you previously used another combined hormonal contraceptive (pills, vaginal rings, patches)

You can start taking Marvelon the day after taking the last active tablet of your previous contraceptive (without a break). If your current contraceptive has placebo tablets, you can start taking Marvelon the day after taking the last active tablet (if you are unsure which tablet is the last active one, you should ask your doctor or pharmacist). You can also start taking Marvelon later, but no later than the day after the last inactive tablet of your current contraceptive (or the day after the last placebo tablet). In the case of a vaginal ring or patch, you should start taking Marvelon on the day the ring or patch is removed, or no later than the day a new ring or patch would be applied.

• If you previously used a progestin-only pill (minipill)

You can stop taking the minipill and start taking Marvelon the next day at the same time. You should also use an additional contraceptive method (e.g. a condom) for the first 7 days of taking the tablets, if you have sexual intercourse.

• If you previously used an injection, implant, or intrauterine system releasing progestin

You should start taking Marvelon on the day you would have your next injection or on the day the implant or intrauterine system is removed. You should also use an additional contraceptive method (e.g. a condom) for the first 7 days of taking the tablets, if you have sexual intercourse.

• After childbirth

After giving birth, your doctor may advise you to wait until your first menstrual period before starting to take the tablets. Your doctor may also advise you to start taking the tablets earlier. If you are breastfeeding, you should discuss the use of hormonal contraception with your doctor.

• After a miscarriage

As advised by your doctor.

3.3 Using more than the recommended dose of Marvelon

No serious harmful effects have been observed after an overdose of Marvelon. If several tablets are taken at the same time, nausea, vomiting, or vaginal bleeding may occur. If a child has ingested Marvelon, you should consult a doctor.

3.4 What to do in case of…

Missing a dose of Marvelon

• If the delay in taking a tablet is less than 12 hours, the effectiveness of the tablet is maintained. You should take the missed tablet as soon as possible and continue taking the rest of the tablets as usual.
• If the delay in taking a tablet is more than 12 hours, the effectiveness of the tablet may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness. There is a higher risk of pregnancy if you miss a tablet at the beginning or end of the cycle. Please refer to the information below (see also the diagram).

More than one missed tablet from the pack

You should consult your doctor.

1 missed tablet in the first week of use

You 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 tablets as usual. For the next 7 days, you should use an additional contraceptive method (e.g. a condom). There is a risk of pregnancy if you have had sexual intercourse in the week before missing the tablet. You should consult your doctor.

1 missed tablet in the second week of use

You 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 tablets as usual. The effectiveness of the tablet is maintained, and there is no need to use additional contraceptive methods. If the above condition is not met or if you have missed more than one tablet, you should use an additional contraceptive method for the next 7 days.

3.5 Discontinuation of Marvelon

You can stop taking Marvelon at any time. If you do not plan to become pregnant, you should ask your doctor for another contraceptive method.
In case of planning a pregnancy, it is usually recommended to wait until the first natural menstruation after stopping the tablets, which will make it easier to determine the expected date of delivery.
In case of any further doubts regarding the use of this medication, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Marvelon can cause side effects, although not everybody gets them. If you experience any side effects, especially serious or persistent ones, or changes in your health that you think may be related to the use of Marvelon, you should consult a doctor.
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 thromboembolism). To get detailed information about the different risk factors associated with the use of combined hormonal contraceptives, you should read section 2 "Important information before using Marvelon".
You should immediately consult a doctor if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with dyspnea (see also section 2 "Important information before using Marvelon").
Frequently(occurring more often than in 1 in 100 women, but less often than in 1 in 10 women):

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

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

• fluid retention
• decreased libido
• migraine
• vomiting
• diarrhea
• rash
• hives
• breast enlargement

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

• harmful blood clots in a vein or artery, for example: o in the leg or foot (e.g., deep vein thrombosis) o in the lungs (e.g., pulmonary embolism) o heart attack o stroke o mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack o blood clots in the liver, stomach/intestine, kidneys, or eye The risk of developing blood clots may be higher if you have any other risk factors (see section 2 for more information about risk factors for developing blood clots and symptoms of blood clots)
• hypersensitivity
• increased libido
• intolerance to contact lenses
• skin diseases (erythema multiforme, erythema nodosum)
• breast discharge
• leucorrhea
• weight loss

Reporting side effects

If you experience any side effects, 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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
By reporting side effects, you can help gather more information on the safety of the medication.

5. How to store Marvelon

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the package. The expiry date refers to the last day of the given month.
Do not store above 30°C. Do not freeze.
Store in the original package to protect from light and moisture.
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.
Do not use this medicine if you notice any changes in the color of the tablets, crumbling of the tablets, or other visible signs of tablet degradation.

6. Package contents and other information

6.1 What Marvelon contains

The active substances of the medicine are desogestrel at a dose of 0.15 mg and ethinylestradiol at a dose of 0.03 mg.
The other ingredients are: anhydrous colloidal silica, lactose monohydrate, potato starch, povidone, stearic acid, all-rac-α-tocopherol.

6.2 What Marvelon looks like and what the package contains

The tablets are round, biconvex, 6 mm in diameter, and marked with the code 5 below TR on one side and the inscription Organon* on the other.
21 tablets – 1 blister pack of 21 tablets.
63 tablets – 3 blister packs of 21 tablets.
PVC/Aluminum blisters, each in a laminated aluminum sachet, in a cardboard box.
A cardboard sachet is attached to the package, in which you should place the blister after removing it from the protective foil

6.3 Other information

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

Marketing authorization holder in the Netherlands, the country of export:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands
Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in the Netherlands, the country of export: RVG 08859

Parallel import authorization number: 313/23

Translation of day-of-the-week symbols on the packaging:

MA - Monday
DI - Tuesday
WO - Wednesday
DO - Thursday
VR - Friday
ZA - Saturday
ZO – Sunday

Date of leaflet approval: 29.12.2023

[Information about the trademark]