Marvelon

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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").

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 specifically for the person it is intended for. 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 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 if…
• 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 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 likelihood of becoming pregnant while taking contraceptive pills (provided the patient does not forget to take the pills) is very low.

2. Important information before taking Marvelon

General notes

Before starting to take Marvelon, the information about blood clots in section 2 should be read. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
This leaflet describes most situations that require stopping the pill or when the pill's effectiveness may be reduced. In these situations, sexual intercourse should be avoided or additional, non-hormonal contraceptive methods should be used, such as a condom or another mechanical method. The calendar method or temperature measurement method should not be used. These methods may be ineffective because contraceptive pills cause changes in temperature and cervical mucus that occur during the menstrual cycle.

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

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

2.1 When not to take Marvelon

Marvelon should not be taken 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 they have a blood clotting disorder - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have 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) angina pectoris (a condition that causes severe chest pain and may be a sign of a heart attack) or a transient ischemic attack (a temporary stroke-like condition);
• 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) a type of migraine called "migraine with aura";
• if the patient has (or has had) pancreatitis associated with high levels of triglycerides;
• if the patient has jaundice or severe liver disease;
• if the patient has (or has had) a hormone-dependent malignant tumor (e.g., breast or genital organ cancer);
• if the patient has (or has had) a benign or malignant liver tumor;
• if the patient has unexplained vaginal bleeding;
• if the patient has endometrial hyperplasia (abnormal thickening of the uterine lining);
• if the patient is pregnant or breastfeeding;
• if the patient has a hepatitis C 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 medicine should be stopped and a doctor 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 taking Marvelon

Before starting to take Marvelon, the patient should discuss it with their doctor or pharmacist.
When should the doctor be contacted?
The doctor should be contacted immediately

• if the patient notices any possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots"). To get a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

The doctor should be told if the patient has any of the following conditions.

If these symptoms occur or worsen while taking Marvelon, the doctor should also be told.

• 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 superficial thrombophlebitis (inflammation of the veins just under the skin);
• if the patient has varicose veins;
• if the patient has a family history of blood clots, heart attack, or stroke;
• if the patient has migraines;
• if the patient has epilepsy;
• if the patient has 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 the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, in which case they are at increased risk of blood clots. The doctor should be consulted to determine how soon Marvelon can be started after giving birth;
• if the patient has a family history of breast cancer;
• 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 can cause 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 contact their doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema;
• if the patient has chloasma (yellow-brown pigmentation spots on the skin, especially on the face); in these cases, sun exposure or ultraviolet radiation should be avoided.

If any of the above factors occur for the first time while taking the tablets, the doctor should be contacted 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 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 who gets a blood clot will recover fully. 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 having a harmful blood clot due to taking Marvelon is small.

HOW TO RECOGNIZE A BLOOD CLOT

The doctor should be contacted immediately if any of the following symptoms are noticed.
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: Deep vein thrombosis

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.

The risk of blood clots in the veins is highest during the first year of taking combined hormonal contraceptives. In rare cases, blood clots can form in the veins of the leg or foot, which can lead to deep vein thrombosis. If a blood clot breaks loose 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).

• If blood clots form in the veins of the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose 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 veins highest?

The risk of blood clots in veins is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting 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 than when 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 due to taking Marvelon is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had a blood clot in the leg, lung, or other organ at a young age (e.g., under 50 years old). In this case, the patient may have a genetic blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots"). The patient may need 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 start taking it again;

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.
Taking a long-haul flight (over 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 risk factors are present, even if the patient is unsure. The doctor may decide to stop Marvelon.
If any of the above conditions change while taking Marvelon, such as the patient starting to smoke, a family member 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?

Similar to blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

What factors increase the risk of blood clots in arteries?

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

• with age (over approximately 35 years old);
• if the patient smokes.While taking 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 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 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 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 doctor should be informed if any of the above conditions change while taking Marvelon, such as the patient starting to smoke, a family member being diagnosed with a blood clot without a known cause, or the patient gaining 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 medical check-ups 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 contact their doctor immediately.
Chronic infection with 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 a long time. This may not be caused by the pill. It is likely that it is 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, the doctor should be contacted as soon as possible for further medical advice.

2.2.3 Marvelon and other medicines

The doctor should always be told about any medicines or herbal products the patient is currently taking. The doctor or dentist prescribing other medicines (or pharmacist) should also be informed about the use of Marvelon. They may inform the patient about the need to use an additional contraceptive method (e.g., a condom) and for how long, as well as whether the patient needs to adjust the dose of the other medicine.
Some medicines

• may affect the levels 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 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 also use a mechanical contraceptive method. Since the effect of another medicine on Marvelon may persist for up to 28 days after stopping the medicine, it is necessary to use an additional mechanical contraceptive method during this time.
Marvelon may affect the actionof other medicines, such as for example

• cyclosporine
• the antiepileptic drug lamotrigine (which may lead to an increased frequency of seizures)

If the patient has a hepatitis C infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, Marvelon should not be taken, as it may cause an increase in liver function test results (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 baby, 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 contact their doctor immediately.
Marvelon is not recommended during breastfeeding.
If the patient wants 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 contact their 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 done once a year.
The doctor should be contacted immediately in the following cases:

• if the patient notices any possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see section above "Blood clots"). To get a description of the symptoms of these serious side effects, see "How to recognize a blood clot".
• if there are any changes in the patient's 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 the patient's immediate family that may affect the use of contraceptive pills;

a lump in the breast;

• 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 (see also section 2.2 "When to exercise special caution when taking Marvelon");
• if the patient plans to take other medicines (see also section 2.2.3 "Marvelon and other medicines");
• if the patient will be immobilized or plans to have surgery (the doctor should be consulted at least 4 weeks in advance);
• if the patient experiences irregular, heavy vaginal bleeding;
• if the patient forgets to take a tablet in the first week of taking Marvelon and has had sexual intercourse in the previous 7 days;
• if the patient experiences severe diarrhea;
• if the patient misses two consecutive periods or suspects they may be pregnant (the patient should not start the next pack of Marvelon 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 doctor or pharmacist should be consulted.

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 (see section 6.3 "Translation of the day of the week symbols on the packaging" at the end of this leaflet). 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, 7 days should be allowed to pass 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 pack should be taken on the 8th day, even if bleeding is still present. This means that a new pack is always started on the same day of the week, and withdrawal bleeding occurs 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 period. There is no need to use an additional contraceptive method.
Taking the tablets can also be started between the 2nd and 5th day of the menstrual cycle, but in this case, an additional contraceptive method (such as a condom) should be used for the first 7 days of taking the tablets in the first cycle.

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

The patient can start taking Marvelon the next day after taking the last active tablet of the previous contraceptive (without taking a break). If the currently used contraceptive has placebo tablets, the patient can start taking Marvelon the day after taking the last active tablet (if in doubt, the patient should ask their doctor or pharmacist). The patient can also start taking Marvelon later, but no later than the day after the free tablet period of the currently used contraceptive (or the day after the last placebo tablet of the currently used contraceptive). In the case of a vaginal ring or transdermal patch, the patient should start taking Marvelon on the day the ring or patch is removed, but no later than the day the next ring or patch would be applied.
If the patient has been taking contraceptive pills regularly and is sure they are not pregnant, they can stop taking the pills or vaginal ring/patch at any time and start taking Marvelon immediately.
If the patient follows the above instructions, there is no need for an additional contraceptive method.

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

The patient can stop taking the minipill at any time and start taking Marvelon the next day at the same time. The patient should also use an additional contraceptive method (such as a condom) for the first 7 days of taking the tablets, if they have sexual intercourse.

• If the patient previously used an injectable, implant, or intrauterine system that releases a progestogen

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

• After childbirth

After giving birth, 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 contraceptives with their doctor.

• After a miscarriage

According to the doctor's instructions.

3.3 Taking more than the recommended dose of Marvelon

No serious harmful effects have been observed after taking an overdose of Marvelon. If several tablets are 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 if…

Missing a dose of Marvelon

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

More than one missed tablet from the pack

The doctor should be consulted.

1 missed tablet in the first week of taking

The missed tablet should be taken as soon as possible (even if it means taking two tablets at the same time), and the remaining tablets should be taken as usual. For the next 7 days, an additional contraceptive method should be used (such as a condom). There is a risk of pregnancy if the patient has had sexual intercourse in the week before missing the tablet. The doctor should be consulted.

1 missed tablet in the second week of taking

The missed tablet should be taken as soon as possible (even if it means taking two tablets at the same time), and the remaining tablets should be taken as usual. The effectiveness of the tablet is maintained, and there is no need for an additional contraceptive method. If the above condition is not met or the patient has missed more than one tablet, an additional contraceptive method should be recommended for the next 7 days.

3.5 Stopping the use of Marvelon

The patient can stop taking Marvelon at any time. If pregnancy is not planned, the patient should ask the doctor for another contraceptive method.
In case of planned 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 about the use of this medication, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like any medication, Marvelon may cause side effects, although not everyone will experience 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 developing 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 using 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 using Marvelon").
Frequently(occurring more often than in 1 in 100 women, but less often than in 1 in 10 women):

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

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

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

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

• harmful blood clots in a vein or artery, for example: o in the leg or foot (e.g., deep vein thrombosis) o in the lungs (e.g., pulmonary embolism) o heart attack o stroke o mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack o blood clots in the liver, stomach/intestine, kidneys, or eye The risk of developing blood clots may be higher if 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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Marvelon

The medication should be stored out of sight and reach of children.
Do not use the medication after the expiration date stated on the package. The expiration date refers to the last day of the given month.
Store in a temperature below 30°C. Do not freeze.
Store in the original package to protect from light and moisture.
Medications should not be disposed of in the sewage system or household waste containers. The patient should ask the pharmacist how to dispose of unused medications. This will help protect the environment.
Do not use this medication if changes in tablet color, tablet crushing, 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 medication are desogestrel in a dose of 0.15 mg and ethinylestradiol in a dose of 0.03 mg.
Other ingredients are: colloidal anhydrous 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, 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 is attached to the package, in which the blister should be placed.

6.3 Other information

For more detailed information, the patient should 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
1250-048 Lisbon
Portugal

Manufacturer:

NV Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Portugal, the country of export:
8589804
8589812
Parallel import authorization number: 14/20
Translation of the day of the week symbols on the blister package:

2 F

• –Monday

3 F

• –Tuesday

4 F

• –Wednesday

5 F

• –Thursday

6 F

• –Friday SAB –Saturday DOM –Sunday

Date of leaflet approval: 16.01.2025

[Information about the trademark]