MARVELON 0.15 mg/0.03 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.
3. Marvelon (Marvelon 21)
4. 15 mg + 0.03 mg, tablets
   1. Important information about combined hormonal contraceptives
   2. The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet
5. What is Marvelon and what is it used for
6. Important information before taking Marvelon
   1. General notes
   2. Marvelon, like other contraceptive pills, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
7. 1 When not to take Marvelon
8. 2 When to exercise special caution when taking Marvelon
   1. The patient should tell their doctor if they have any of the following conditions.
9. 1 Hormonal contraception and blood clots
   1. BLOOD CLOTS
   2. It should be remembered that the overall risk of serious blood clots caused by taking Marvelon is small.
   3. HOW TO RECOGNIZE A BLOOD CLOT
   4. BLOOD CLOTS IN VEINS
   5. What can happen if a blood clot forms in a vein?
   6. When is the risk of blood clots in veins highest?
   7. What factors increase the risk of blood clots in veins?
   8. BLOOD CLOTS IN ARTERIES
   9. What can happen if a blood clot forms in an artery?
   10. Factors that increase the risk of blood clots in arteries
10. 2 Hormonal contraception and cancer
    1. Psychological disorders
11. 3 Marvelon and other medicines
12. 4 Pregnancy and breastfeeding
13. 5 Driving and using machines
14. 6 Marvelon contains lactose.
15. 7 Use in children and adolescents
16. 3 When to consult a doctor
17. How to take Marvelon
18. 1 When and how to take the tablets
    1. Use in children and adolescents
19. 2 Starting the first pack of Marvelon
20. 3 Taking more than the recommended dose of Marvelon
21. 4 What to do in case of…
    1. Missing a dose of Marvelon
    2. More than one missed tablet from the pack
    3. 1 missed tablet in the first week of taking
    4. 1 missed tablet in the second week of taking
22. 5 Discontinuation of Marvelon
23. Possible side effects
    1. Reporting side effects
24. How to store Marvelon
25. Package contents and other information
26. 1 What Marvelon contains
27. 2 What Marvelon looks like and what the package contains
28. 3 Other information
    1. To obtain more detailed information, please contact the marketing authorization holder or parallel importer.
    2. Marketing authorization holder in Romania, the country of export:
    3. Manufacturer:
    4. Parallel importer:
    5. Repackaged by:
    6. Parallel import authorization number: 52/07
    7. Translation of day-of-the-week symbols on the packaging:
    8. Date of leaflet approval: 06.07.2023

Leaflet accompanying the packaging: information for the user

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

Marvelon (Marvelon 21)

0.15 mg + 0.03 mg, tablets

Desogestrel + Ethinylestradiol
Marvelon and Marvelon 21 are different trade names for the same medicine.

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").

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Marvelon and what is it used for
• 2. Important information before taking Marvelon
• 2.1 When not to take Marvelon
• 2.2 When to exercise special caution when taking Marvelon
• 2.3 When to consult a doctor
• 3. How to take Marvelon
• 3.1 When and how to take the tablets
• 3.2 Starting the first pack of Marvelon
• 3.3 Taking more than the recommended dose of Marvelon
• 3.4 What to do in case of…
• 3.5 Stopping Marvelon
• 4. Possible side effects
• 5. How to store Marvelon
• 6. Contents of the pack and other information
• 6.1 What Marvelon contains
• 6.2 What Marvelon looks like and what the pack 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 group of monophasic, combined oral contraceptives, as all the tablets in the pack contain the same amount of hormones.
Marvelon is used to prevent pregnancy.
Oral contraception is a very effective method of birth control. The possibility of becoming pregnant while taking the contraceptive pills (provided that the patient does not forget to take the pills) is very small.

2. Important information before taking Marvelon

General notes

Before starting to take Marvelon, the patient should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
This leaflet describes most situations where the patient should stop taking the pill or where the effectiveness of the pill may be reduced. In these situations, the patient should refrain from sexual intercourse or use additional, non-hormonal contraceptive methods, such as a condom or another mechanical method. The patient should not use the calendar method or the temperature measurement method. These methods may be ineffective because the contraceptive pill causes 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 for each patient individually. The patient should not give Marvelon to others.
Marvelon should not be used to delay the start of menstrual bleeding.
In exceptional cases, where there is a need to delay the start of menstrual bleeding, the patient should consult a doctor.

2.1 When not to take Marvelon

Marvelon should not be taken if the patient has any of the conditions listed below. If the patient has any of these 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 (transient 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 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 taking Marvelon, the patient should stop taking the medicine and consult a doctor, and use a non-hormonal contraceptive method during this time (see also section 2 "General notes").

2.2 When to exercise special caution when taking Marvelon

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

• if they notice any of the symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), blood clot in their lungs (pulmonary embolism), heart attack, or stroke (see section below "Blood clots"). To find out about the symptoms of these serious side effects, see "How to recognize a blood clot".

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

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

• if the patient smokes;
• if the patient has diabetes;
• if the patient is overweight;
• if the patient has high blood pressure;
• if the patient has heart valve problems or heart rhythm disorders;
• if the patient has inflammation of the veins under the skin (superficial thrombophlebitis);
• if the patient has varicose veins;
• if the patient has a history of blood clots, heart attack, or stroke in their immediate family;
• if the patient has migraines;
• if the patient has epilepsy;
• if the patient has elevated 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 the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, as they are at increased risk of blood clots. The patient should consult their doctor to find out how soon they can start taking Marvelon after giving birth;
• if the patient has a history of breast cancer in their immediate family;
• if the patient has liver or gallbladder disease;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a genetic disorder that affects red blood cells);
• if the patient has experienced any of the following conditions for the first time during pregnancy or previous use of hormonal contraception: hearing loss, porphyria, herpes during pregnancy, or Sydenham's chorea;
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing, they should see their doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• if the patient has chloasma (yellow-brown pigmentation spots on the skin, especially on the face) currently or in the past; in these cases, the patient should avoid sun exposure or ultraviolet radiation.

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

2.2.1 Hormonal contraception and blood clots

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Marvelon, is associated with an increased risk of blood clots compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also known as "arterial thromboembolism").

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;

increased temperature in the affected leg;

• change in skin color of the leg, such as pallor, redness, or discoloration.

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms 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 frequently 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 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 forming a blood clot 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 the patient stops 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 of blood clots associated with taking 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/m2);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, the patient may have inherited blood clotting disorders;
• 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 stop taking Marvelon for a few weeks before surgery or immobilization. If the patient needs to stop taking Marvelon, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of the above factors apply to the patient, even if they are not sure. The doctor may decide to stop the patient from taking Marvelon.
The patient should inform their doctor if any of the above conditions change while taking Marvelon, e.g., if they start smoking, if someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

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 complications, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with taking Marvelon is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While taking a hormonal contraceptive like Marvelon, the patient is advised to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50). 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 immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should inform their doctor if any of the above conditions change while taking Marvelon, e.g., if they start smoking, if someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

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 the pill. This small increase in the risk of breast cancer disappears gradually within 10 years of stopping the pill. It is not known whether this difference is caused by the pill. It may be that women taking the pill are more likely to have their breasts examined and breast cancer is detected earlier.
In very rare cases, women taking the pill have been found to have benign liver tumors, and even more rarely, malignant liver tumors. These tumors can cause bleeding into the abdominal cavity. If the patient experiences severe abdominal pain, they should see their doctor immediately.
Chronic infection with 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 the pill for an extended period. This may not be caused by the pill. It is likely to be 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 and symptoms of depression occur, the patient should see their doctor as soon as possible for further medical advice.

2.2.3 Marvelon and other medicines

The patient should always tell their doctor about any medicines or herbal products they are currently taking. The patient should also inform their doctor or dentist prescribing other medicines (or pharmacist) that they are taking Marvelon. They may inform the patient 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.
Certain 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 the patient is taking medicines or herbal products that may reduce the effectiveness of Marvelon, they should use a mechanical contraceptive method as well. 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

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

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

2.2.4 Pregnancy and breastfeeding

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

If the patient has been diagnosed with intolerance to some sugars, they should consult their 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 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.
The patient should see their doctor immediately in the following cases:

• if they notice any of the symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), blood clot in their lungs (pulmonary embolism), heart attack, or 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 their health, especially the conditions mentioned earlier in this leaflet (see sections "When not to take Marvelon" and "Important information before taking Marvelon"), including information about the health of their immediate family that may affect the use of contraceptive pills;
• if they feel a breast lump;
• if they experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing (see also section "When to exercise special caution when taking Marvelon");
• if they plan to take other medicines (see also section "Marvelon and other medicines");
• if they will be immobilized or plan to undergo surgery (they should consult their doctor at least 4 weeks in advance);
• if they experience irregular, heavy vaginal bleeding;
• if they forget to take a pill in the first week of taking it and have had sexual intercourse in the previous 7 days;
• if they experience severe diarrhea;
• if they do not have their period for two consecutive months or if they suspect they are pregnant (they should not start the next pack before consulting their doctor).

3. How to take Marvelon

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

3.1 When and how to take the tablets

The pack of 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. The patient should continue taking the tablets for 21 days, following the direction of the arrows. Then, they should wait for 7 days during which they do not take any 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 patient should take the first tablet of the next pack on the 8th day, even if they are still bleeding. This means that the patient will always start a new pack on the same day of the week, and their period 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 pack of Marvelon

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

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

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

The patient can start taking Marvelon the day after taking the last active tablet of their previous contraceptive. If their previous contraceptive had placebo tablets, they can start taking Marvelon the day after taking the last active tablet (if in doubt, they should ask their doctor or pharmacist). The patient can also start taking Marvelon later, but no later than the day after the tablet-free period of their previous contraceptive (or the day after taking the last placebo tablet of their previous contraceptive).
In the case of a vaginal ring or patch, the patient should start taking Marvelon on the day they would normally remove the ring or patch, or on the day they would normally apply a new ring or patch.

• If the patient previously used a progestogen-only pill (mini-pill)

The patient can stop taking the mini-pill and start taking Marvelon the next day, at the same time. The patient should also use an additional contraceptive method (e.g., a condom) for the first 7 days of taking the tablets in the first cycle, if they have sexual intercourse.

• If the patient previously used an injection, implant, or intrauterine system releasing progestogen

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

• After childbirth

The doctor may advise the patient to wait until their first period before starting to take Marvelon. The doctor may also advise the patient to start taking the tablets earlier. If the patient is breastfeeding, they should discuss taking hormonal contraception with their doctor.

• After a miscarriage

According to the doctor's advice.

3.3 Taking more than the recommended dose of Marvelon

No serious harmful effects have been reported after taking an overdose of Marvelon. If more than one tablet is taken at the same time, the patient may experience nausea, vomiting, or vaginal bleeding. If a child has taken Marvelon, the patient should consult their 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 pill is maintained. The patient should take the missed tablet as soon as possible and continue taking the rest of the tablets as usual.
• If the delay in taking a tablet is more than 12 hours, the effectiveness of the pill may be reduced. The more missed tablets, the higher the risk of reduced contraceptive effectiveness. There is a higher risk of pregnancy if the patient misses a tablet at the beginning or end of the cycle. Please see the information below (also see the diagram).

More than one missed tablet from the pack

The patient should consult their doctor.

1 missed tablet in the first week of taking

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

1 missed tablet in the second week of taking

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the rest of the tablets as usual. The effectiveness of the pill is maintained, and there is no need to use additional contraceptive methods. If the above conditions are not met, or if the patient has missed more than one tablet, they 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 they do not occur in everyone. If side effects occur, especially severe and persistent ones, or changes in health that you consider related to the use of Marvelon, you should consult a doctor.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). To obtain detailed information about the various risk factors associated with the use of combined hormonal contraceptives, you should refer to point 2 "Important information before taking Marvelon".
You should immediately consult a doctor if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with dyspnea (see also point 2 "Important information before taking Marvelon").
Frequently(occurring more often than in 1 woman in 100, but less often than in 1 in 10 women):

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

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

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

Rarely(occurring more often than in 1 woman in 10,000, 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 risk of blood clots may be higher if you have any other risk factors (see point 2 for more information about risk factors for blood clots and symptoms of blood clots)
• hypersensitivity
• increased libido
• intolerance to contact lenses
• skin diseases (erythema nodosum, erythema multiforme)
• breast discharge
• leucorrhea
• weight loss

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje 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 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 expiration date stated on the package. The expiration date indicates the last day of the given month.
Store at a temperature below 25°C, in the original package.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of unused medicines. 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 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 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 pack of 21 tablets.
63 tablets – 3 blister packs of 21 tablets.
PVC/Al blisters, each packaged separately in a cardboard box, with a paper sleeve.
A cardboard sleeve is attached to the package, in which you should place the blister pack after removing it from the protective foil.

6.3 Other information

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

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

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

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 1508/2009/01
1508/2009/02

Parallel import authorization number: 52/07

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

Lu

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

Date of leaflet approval: 06.07.2023

[Information about the trademark]