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 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.

• 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 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
• 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 a higher dose of Marvelon than recommended
• 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 (progestagen) 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 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 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) 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 bleeding.
In exceptional cases, when there is a need to delay the start of bleeding, you should consult a doctor.

2.1 When not to use Marvelon

Marvelon should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has (or has ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows that they have blood coagulation disorders, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• hyperhomocysteinemia
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) pancreatitis associated with severe hypertriglyceridemia;
• if the patient has jaundice or severe liver disease;
• if the patient has (or has had in the past) a hormone-dependent malignant tumor (e.g., breast or genital organ cancer);
• if the patient has (or has had in the past) a benign or malignant liver tumor;
• if the patient has vaginal bleeding of unknown cause;
• if the patient has an enlarged endometrium (abnormal growth of the uterine lining);
• if the patient is pregnant or may be pregnant;
• if the patient has a hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir (see also section "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 any possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots"). To find out about the symptoms of these serious side effects, see "How to recognize a blood clot".

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 inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if blood clots, heart attacks, or strokes occur in your close 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 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 to find out how soon you can start taking Marvelon after giving birth;
• if any of your close family members have had breast cancer;
• 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 pharyngeal swelling, and/or difficulty swallowing or hives potentially with dyspnea. Estrogen-containing products may cause or worsen the symptoms of hereditary and acquired angioedema;
• if you have chloasma (yellow-brown pigmentation spots on the skin, especially on the face) currently 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 the tablets, you should contact your doctor immediately.

2.2.1 Hormonal contraception and blood clots

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 long-term or, very rarely, fatal.

It should be remembered that the overall risk of serious blood clots caused by Marvelon is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should see your doctor immediately if you notice any of the following symptoms.
Do you experience any of these symptoms?
Why is the patient likely to suffer

• 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 cyanosis.

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• The use of 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 frequently in the first year of use.
• If blood clots form in the veins in the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot moves from the leg 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 veins highest?

The risk of 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 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" 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 the patient is significantly overweight (body mass index (BMI) over 30 kg/m^2);
• if someone in the patient's 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, the patient may have a hereditary blood clotting disorder;
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to discontinue Marvelon for a few weeks before surgery or immobilization. If the patient needs to discontinue Marvelon, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of the above factors apply, even if the patient is not sure. The doctor may decide to discontinue Marvelon.
If any of the above conditions change while using Marvelon, such as the patient starting to smoke, someone in their close family being diagnosed with a blood clot without a known cause, or the patient gaining significant weight, the doctor should be informed.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

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 a heart attack or stroke associated with Marvelon is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes.While using a hormonal contraceptive like Marvelon, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their close family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
If any of the above conditions change while using Marvelon, such as the patient starting to smoke, someone in their close family being diagnosed with a blood clot without a known cause, or the patient gaining significant weight, the doctor should be informed.

2.2.2 Hormonal contraception and cancer

Women using contraceptive pills have a slightly higher risk of breast cancer than women of the same age who do not use them. This small increase in the risk of breast cancer 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 likely to have medical check-ups and breast cancer is diagnosed earlier in them.
In very rare cases, women using 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 severe abdominal pain occurs, you should contact 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 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.

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 and symptoms of depression occur, you should contact 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 who prescribes other medicines (or pharmacist) that you are using 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

• 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, 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 finishing 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 baby, you should ask your doctor or pharmacist for advice before using this medicine.
Marvelon is contraindicated in pregnancy.
If you suspect you are pregnant while using Marvelon, you should contact your doctor immediately.
Marvelon should not be used 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 your 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 contact 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 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 contact your doctor immediately in the following cases:

• if you notice any possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack, or a stroke (see section above "Blood clots"). To find out about the symptoms of these serious side effects, see "How to recognize a blood clot".
• 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 that relates to the health of your close family and 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 pharyngeal swelling, and/or difficulty swallowing or hives potentially with dyspnea (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 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 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 section 6.2 "Explanation of the day of the week symbols on the immediate packaging"). 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 you should experience menstrual bleeding (withdrawal bleeding). This usually occurs 2-3 days after taking the last tablet of Marvelon. You should start the next pack on the 8th day, even if you are still bleeding. This means that you will always start a new pack on the same day of the week, and your menstrual 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 used another combined contraceptive method (pills, vaginal rings, patches)

You can start taking Marvelon the day after you take the last tablet of your previous contraceptive method (without taking a break). If your current contraceptive method also contains placebo tablets, you can start taking Marvelon the day after you take 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 you finish the inactive tablets of your current contraceptive method (or the day after you remove the vaginal ring or patch). In the case of a vaginal ring or patch, you should start taking Marvelon on the day you would normally put a new ring or patch in place.

• If you used a progestogen-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 used an injectable, implant, or intrauterine system that releases progestogen

You should start taking Marvelon on the day you would normally 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

According to your doctor's advice.

3.3 Using a higher dose of Marvelon than recommended

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 your 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 tablets you miss, the higher the risk of reduced contraceptive effectiveness. There is a higher risk of becoming pregnant if you miss a tablet at the beginning or end of a 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 tablets as usual. For the next 7 days, you should use an additional contraceptive method (e.g., a condom). There is a risk of becoming pregnant 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 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

Missed only 1
tablet (break
longer than 12
hours)

• take the missed tablet
• finish the package week 2
• take the missed tablet
• finish the package
• do not take a 7-day break
• continue taking tablets from the next package

week 3
or

• stop taking the remaining tablets from the package
• take a break (no more than 7 days, including the day the tablet was missed)
• continue taking tablets from the next package

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

4. Possible side effects

Like any medicine, Marvelon can cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Marvelon, the patient 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 detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before taking Marvelon".
The patient should immediately consult a doctor if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with dyspnea (see also section 2 "Important information before taking Marvelon").
Frequently(occurring more frequently than in 1 in 100 women, but less frequently than in 1 in 10 women):

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

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

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

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

• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis)
• in the lungs (e.g., pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach/intestine, kidneys, or eye

The risk of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for 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 any side effects occur, including any side effects not listed in the leaflet, the patient should tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
By reporting side effects, more information can be collected 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 containers. The patient should ask the pharmacist how to dispose of unused medicines. This will help protect the environment.
Do not use this medicine if changes in tablet color, tablet fragmentation, or other visible signs of tablet degradation are observed.

6. Package contents and other information

6.1 What Marvelon contains

The active substances of the drug are desogestrel at a dose of 0.15 mg and ethinyl estradiol at a dose of 0.03 mg.
The other ingredients are: anhydrous colloidal silica, lactose monohydrate, potato starch, povidone, stearic acid, RRR-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/Al blister in a cardboard box with a paper sleeve.
A paper sleeve has been added to the package, in which the blister should be placed after removal from the protective foil.
Translation of the day of the week symbols on the immediate packaging:
2 F

• Monday 3 F
• Tuesday 4 F
• Wednesday 5 F
• Thursday 6 F
• Friday SAB
• Saturday DOM - Sunday

6.3 Other information

To obtain more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Organon Portugal, Sociedade Unipessoal Lda.
Rua Alexandre Herculano, 50 - Piso 9
1250-011 Lisbon
Portugal

Manufacturer:

NV 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
Portuguese marketing authorization number, country of export:
8589804
8589812

Parallel import authorization number: 20/15

Date of approval of the leaflet: 08.01.2025

[Information about the trademark]