Marvelon

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. 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 point 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using 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 or pharmacist should be consulted.
• This medicine has been prescribed to a specific 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 mentioned in this leaflet, they should tell their doctor or pharmacist. See point 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 package 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 side effects
• 5. How to store Marvelon
• 6. Contents of the packaging and other information
• 6.1 What Marvelon contains
• 6.2 How Marvelon looks and what the packaging contains
• 6.3 Other information

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 group of monophasic, combined oral contraceptives, as all tablets in the package contain the same amount of hormones.
Marvelon is used to prevent pregnancy.
The oral contraceptive method 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 point 2. It is especially important to read about the symptoms of blood clots (see point 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 abstain 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. Marvelon should not be given to others.
Marvelon should not be used to delay the start of menstruation.
In exceptional cases, when there is a need to delay the start of menstruation, 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 point 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 - for example, 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 point "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, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• hyperhomocysteinemia
• if you have (or have had) 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 malignant tumor that is hormone-dependent (e.g., breast or genital 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 point "Marvelon and other medicines").

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

2.2 When to exercise special caution when using Marvelon

Before starting to take 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 symptoms that may indicate the formation of blood clots, such as deep vein thrombosis, pulmonary embolism, heart attack, or stroke (see below "Blood clots"). To find a description of the symptoms of these serious side effects, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking 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 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 high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see point 2 "Blood clots");
• if you are immediately after childbirth, 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 childbirth;
• 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 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, Sydenham's chorea;
• if you have chloasma (brown patches on the skin, 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 taking the tablets, you should contact your doctor immediately.

2.2.1 Hormonal contraception and blood clotting disorders

BLOOD CLOTS

Taking 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 form

• in veins (deep vein thrombosis or venous thromboembolism)
• in arteries (arterial thrombosis or arterial thromboembolism)

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

It is essential to remember that the overall risk of developing harmful blood clots due to 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 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;
• skin color changes in the affected 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. Pulmonary embolism

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to 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 highest?

The risk of forming blood clots in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.
If you stop taking 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 developing blood clots in the legs or lungs due to Marvelon is small.

• During a year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9-12 out of 10,000 women who take 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 due to 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 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 genetic blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time (see point 2 "Blood clots");
• 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 (more than 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 you have any of the above risk factors, even if you are not sure. Your doctor may decide to stop Marvelon.
If any of the above conditions change while taking Marvelon, such as starting to smoke, someone in your immediate family being diagnosed with a blood clot without a known cause, or significant weight gain, you should inform your doctor.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similar 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 due to Marvelon is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke. While taking 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 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 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 taking Marvelon, such as starting to smoke, someone in your immediate family being diagnosed with a blood clot without a known cause, or significant weight gain.

2.2.2 Hormonal contraception and cancer

Women taking contraceptive pills have a slightly higher risk of breast cancer than women of the same age who do not take them. This small increase in the risk of breast cancer disappears gradually within 10 years of stopping the contraceptive pills. It is not known whether this difference is caused by the contraceptive pills. It may be related to the fact that women taking contraceptive pills are more likely to have medical check-ups and breast cancer is diagnosed earlier in them.
In very rare cases, women taking contraceptive pills have been found to have 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 a 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 taken contraceptive pills for an extended period. This may not be caused by the contraceptive pills. It is likely related to sexual behavior or other factors.

Psychological disorders

Some women taking 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 a 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 taking. You should also inform your doctor or dentist prescribing other medicines (or pharmacist) about taking Marvelon. They may inform you about the need to use additional contraceptive methods (e.g., condoms) and for how long, as well as whether it is necessary to modify the use of other medicines.
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

• 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 take Marvelon, as it may cause an increase in liver function test results in the blood (increase in liver enzyme ALT activity).
Before starting these medicines, your doctor will prescribe a different type of contraceptive.
You can resume taking Marvelon about 2 weeks after finishing this treatment. See point "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 taking this medicine.
Marvelon is contraindicated in pregnancy.
If you suspect you are pregnant while taking Marvelon, you should see your doctor immediately.
Marvelon is not recommended during breastfeeding.
If you want to take Marvelon while breastfeeding, you should consult your doctor.

2.2.5 Driving and using machines

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

2.2.6 Marvelon contains lactose monohydrate

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

2.2.7 Use in children and adolescents

There are no available clinical data on the efficacy and safety of Marvelon 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.
You should see your doctor immediately in the following cases:

• if you notice any symptoms that may indicate the formation of blood clots, such as deep vein thrombosis, pulmonary embolism, heart attack, or stroke (see point above "Blood clots"). To find a description of the symptoms of these serious side 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 points "When not to use Marvelon" and "Important information before using Marvelon"), not forgetting the information about 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 swelling of the face, tongue, and/or throat, and/or difficulty swallowing;
• if you plan to take other medicines (see also "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 forgot to take a tablet in the first week of taking it and had sexual intercourse in the previous 7 days;
• if you experience severe diarrhea;
• if you miss two consecutive periods 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 taken 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 (see point 6.2 "Explanation of the day of the week symbols on the packaging"). The tablets should be taken at the same time every day, if necessary, with a glass of water. The tablets should be taken 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 tablet-free days. It usually starts 2-3 days after taking the last tablet of Marvelon. The first tablet of the next package should be taken on the 8th day, even if bleeding is still present. This means that you will always start a new package 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 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.
Taking the tablets can also be started between the 2nd and 5th day of the menstrual cycle, but in this case, you should use an additional contraceptive method (mechanical method, e.g., a condom) for the first 7 days of taking the tablets in the first cycle.

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

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 tablet-free period of 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 taking contraceptive pills regularly and are sure you are not pregnant, you can stop taking the pills and start taking Marvelon immediately.
When taking Marvelon according to the above instructions, additional contraceptive methods are not necessary.

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

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

• If you used injectable contraception, an implant, or an intrauterine system releasing progestogen previously

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 (mechanical method, e.g., a condom) for the first 7 days of taking the tablets if you have sexual intercourse.

• After childbirth

Immediately after childbirth, 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 taking hormonal contraception with your doctor.

• After a miscarriage

According to your doctor's instructions.

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, 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. There is a higher risk of pregnancy if you miss a tablet at the beginning or end of the cycle. Please see the information below (also see the diagram).

More than one missed tablet from the package

You should consult your doctor.

1 missed tablet in the first week of taking

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 tablets as usual. For the next 7 days, you should use an additional contraceptive method (e.g., a condom). There is a possibility 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 taking

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 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 about the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like any medicine, Marvelon can cause side effects, although not everybody gets them. If you experience any side effects, especially severe and persistent ones, or changes in your health that you think are 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 the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using Marvelon".
Common(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

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

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

Rare(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:
• 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 blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots)
• 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 not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the drug.

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.
Store at a temperature below 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 in a dose of 0.15 mg and ethinylestradiol in a dose of 0.03 mg.
The other ingredients are: colloidal anhydrous silica, lactose monohydrate, potato starch, povidone, stearic acid, all-rac-α-tocopherol.

6.2 What Marvelon looks like and package contents

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, each packaged separately in a laminated aluminum foil sachet, in a cardboard box.
A cardboard sachet is attached to the package, in which you should put the blister after removing it from the protective foil.

Translation of day of the week symbols on the packaging:

MA

• Monday DI
• Tuesday WO
• Wednesday DO
• Thursday VR
• Friday ZA
• Saturday ZO
• Sunday

6.3 Other information

To obtain more detailed information, please contact the marketing authorization holder or 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:

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
Netherlands marketing authorization number, in the country of export: RVG 08859

Parallel import authorization number: 196/17 Date of leaflet approval: 06.06.2022

[Information about the trademark]