Marvelon

Leaflet accompanying the packaging: user information

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").

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be re-read.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this person. 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Marvelon and what is it used for 1
• 2. Important information before using Marvelon 2
• 2.1 When not to use Marvelon 2
• 2.2 When to exercise special caution when using Marvelon 3
• 2.3 When to consult a doctor 10
• 3. How to use Marvelon 10
• 3.1 When and how to take the tablets 10
• 3.2 Starting the first package of Marvelon 11
• 3.3 Using a higher dose of Marvelon than recommended 12
• 3.4 What to do in case of… 12
• 3.5 Stopping the use of Marvelon 15
• 4. Possible side effects 15
• 5. How to store Marvelon 17
• 6. Package contents and other information 17
• 6.1 What Marvelon contains 17
• 6.2 How Marvelon looks and what the package contains 17
• 6.3 Responsible entity and manufacturer 17
• 6.4 Date of the last update of the leaflet 17

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 (progestogen) and ethinylestradiol (estrogen). Due to the small hormone content, Marvelon is called a low-dose contraceptive pill. Marvelon belongs to the monophasic, combined oral contraceptives, as all tablets in the package 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 a tablet should be discontinued or when the effectiveness of the tablet 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 (AIDS) or other sexually transmitted diseases.

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

• 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 have surgery or will be immobilized for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms);
• if you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a disease called hyperhomocysteinemia
• if you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) pancreatitis associated with severe hypertriglyceridemia;
• 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 unexplained vaginal bleeding;
• if you have an enlarged endometrium (abnormal growth of the uterine lining);
• if you are pregnant or breastfeeding;
• 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, the medicine should be discontinued and a doctor should be consulted, and a non-hormonal contraceptive method should be used 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 possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots (thrombosis)"). To find a description of the symptoms of these serious side effects, see "How to recognize the formation of blood clots".

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 inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a history of blood clots, heart attack, or stroke in your immediate family;
• if you have migraines;
• if you have epilepsy;
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Marvelon after giving birth;
• if you have a history of breast cancer in your immediate family;
• 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 hereditary disease of 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/or difficulty swallowing or hives with potential shortness of breath, you should see your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• if you currently have or have had chloasma (yellow-brown skin pigmentation, especially on the face); in these cases, you should avoid sun exposure or ultraviolet radiation.

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

2.2.1 Hormonal contraception and blood clotting 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 the therapy.
Blood clots can form

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

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

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

HOW TO RECOGNIZE THE FORMATION 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 be suffering from
this condition?

• 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 affected leg, such as pallor, redness, or cyanosis. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough without an obvious cause, 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 you are unsure, you should see your doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for less serious conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Most symptoms occur in one eye:

• 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, fullness, or pressure in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• discomfort in the lower 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 disturbances, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden walking disturbances, 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 a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). Although these side effects are rare, they can occur. Most often, they occur in the first year of using 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 breaks loose from the leg and travels to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

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

The risk of forming blood clots in a vein 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 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.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During 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", 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/m);
• if someone in your immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time 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, if someone in your immediate 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 an artery?

Similarly to blood clots in veins, blood clots in arteries can have 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 about 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 immediate 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 immediate family has been diagnosed with 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, if someone in your immediate 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 gradually disappears during the 10 years after 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, women using contraceptive pills have been diagnosed with benign liver tumors, and even more rarely, malignant tumors. 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 thought that cervical cancer may occur slightly more often 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.

Psychological 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 or 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, as well as 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 use additional mechanical contraception. 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
• the antiepileptic drug lamotrigine (this 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 (increased activity of the liver enzyme ALT).
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.
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

Using Marvelon does not affect the ability to drive or use machines.

2.2.6 Marvelon contains lactose.

If you have been diagnosed with an 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-ups
Women 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 possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see section above "Blood clots". To find a description of the symptoms of these serious side effects, see "How to recognize the formation of blood clots".
• if you experience 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 immediate family 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/or difficulty swallowing or hives with potential shortness of breath (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 need to have surgery or will be immobilized (you should consult your doctor at least 4 weeks in advance);
• if you experience irregular, heavy vaginal bleeding;
• if you forget to take a tablet 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 (you should not start the next package 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 package of Marvelon contains 21 tablets. Each tablet has a symbol of the day of the week on which it should be taken. 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, during which time menstrual bleeding (withdrawal bleeding) should occur. This usually occurs 2-3 days after taking the last tablet of Marvelon. You should take the first tablet of the next package on the 8th day, even if the bleeding is still present. This means that you will always start a new package on the same day of the week and that the withdrawal bleeding will occur at approximately 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 package 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 menstruation. There is no need to use additional contraceptive methods.
You can also start taking the tablets between the 2nd and 5th day of your menstrual 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 were previously using 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 planned break from your current contraceptive (or the day after the last placebo tablet of your current contraceptive).
In the case of a vaginal ring or patch, you should start taking Marvelon on the day the ring or patch is removed, but no later than the day a new ring or patch would be applied.
If you have been using a progestogen-only injection, implant, or intrauterine system, you should start taking Marvelon on the day the next injection would be due 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 are having 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

According to your doctor's instructions.

3.3 Using a higher dose of Marvelon than recommended

No serious harmful effects have been observed after an overdose of Marvelon. After taking several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.
If a child has taken 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 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 missed tablets, the higher the risk of reduced contraceptive effectiveness. A higher risk of pregnancy exists if a tablet is missed at the beginning or end of the cycle. Please refer to the information below (see also the scheme).

More than one missed tablet from the package

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 once), and continue taking 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 once), and continue taking 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 facilitate determining the expected date of delivery.
In case of any further doubts regarding the use of this drug, 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 blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis). To get detailed information about the various 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 urticaria potentially with dyspnea (see also section 2 "Important information before using Marvelon").
Common(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

Uncommon(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

Rare(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 risk of blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors 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

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 Monitoring of Adverse Reactions to Medicinal Products of the 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 specified 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 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: colloidal anhydrous silica, lactose monohydrate, potato starch, povidone, stearic acid, α-tocopherol.

6.2 What Marvelon looks like and what the package contains

The tablets are round, biconvex, 6 mm in diameter, marked with code 5 below TR on one side, and Organon* on the other.
21 tablets - 1 blister of 21 tablets.
63 tablets - 3 blisters of 21 tablets.
PVC/Al blister in a sachet, in a cardboard box.

6.3 Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
organonpolska@organon.com

Manufacturer

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands

6.4 Date of last revision of the leaflet: 09/2022