MARVELON

Patient Information Leaflet

Warning! Keep this leaflet – Important information is provided on the immediate packaging in a foreign language!
Marvelon
0.15 mg + 0.03 mg, tablets
Desogestrel + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Please read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Marvelon is and what it is used for
2. Important information before taking Marvelon
       2.1 When not to take Marvelon
       2.2 When to be cautious 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 Marvelon than recommended
       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 contents of the pack
       6.3 Marketing Authorisation Holder and Manufacturer

1. What Marvelon is and what it is used for

Marvelon is a combined oral contraceptive. Each tablet contains a small dose of two different female hormones: desogestrel (a progestogen) and ethinylestradiol (an oestrogen). Because of its low hormone content, Marvelon is known as a low-dose oral contraceptive. Marvelon is a monophasic combined oral contraceptive, as all tablets in the pack contain the same amount of hormones.
Marvelon is used to prevent pregnancy.
Oral contraception is a highly effective method of birth control. The chance of becoming pregnant while taking oral contraceptives (provided the patient does not miss any tablets) is very small.

2. Important information before taking Marvelon

General notes
Before starting Marvelon, you should read the information regarding blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
This leaflet describes most situations in which you should stop taking the tablet or when its effectiveness may be reduced. In such situations, you should abstain from sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or another mechanical method. Do not use the rhythm method or the temperature method. These methods may be ineffective because contraceptive pills cause changes in body temperature and cervical mucus that occur during the menstrual cycle.
Marvelon, like other contraceptive pills, does not protect against HIV infection (AIDS) or other sexually transmitted infections.
Marvelon is prescribed individually by a doctor for each woman. Do not give Marvelon to other people.
Marvelon should not be used to delay the onset of bleeding.
In exceptional circumstances, when there is a need to delay the start of bleeding, you should consult your doctor.

2.1 When not to use Marvelon

Do not use Marvelon if any of the following conditions apply to the patient. If any of the conditions listed below apply, inform the doctor. The doctor will discuss with the patient which alternative method of contraception may be more suitable.

• if the patient has an allergy to the active substances or to 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 veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows she has blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if the patient has had a heart attack or stroke;
• if the patient has (or has previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if the patient has any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• if the patient currently has (or has previously had) a type of migraine called “migraine with aura”;
• if the patient has (or has previously had) pancreatitis associated with severe hypertriglyceridemia;
• if the patient has jaundice or severe liver disease;
• if the patient has (or has previously had) a hormone-dependent malignant tumour (e.g. of the breast or genital organs);
• if the patient has (or has previously had) a benign or malignant liver tumour;
• if the patient has vaginal bleeding of unknown cause;
• if the patient has endometrial hyperplasia (abnormal thickening of the lining of the uterus);
• if the patient is or may be pregnant;
• if the patient has 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 conditions listed above occur for the first time while taking Marvelon, the medicine should be discontinued and the patient should consult a doctor and use a non-hormonal method of contraception in the meantime (see also section 2 “General precautions”).

2.2 When to exercise special caution when using Marvelon

Before starting to use Marvelon, you should discuss this with your doctor or pharmacist.
When should you contact your doctor?
You should seek medical advice immediately

• if you notice any symptoms suggesting a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below “BLOOD CLOTS”. For a description of the symptoms of these serious adverse effects, see “HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS”.

You should inform your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Marvelon, you should also
inform your doctor.

• if you smoke;
• if you have diabetes;
• if you are obese;
• if you have high blood pressure;
• if you have heart valve disorders or heart rhythm abnormalities;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if thromboembolic disease, heart attack, or stroke occurred in close family members;
• if you have migraine;
• if you have epilepsy;
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, as you are then at increased risk of developing blood clots. You should consult your doctor about when it is safe to start taking Marvelon after childbirth;
• if breast cancer is currently present or has occurred in close family members;
• 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 affecting the body’s natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anemia (an inherited disorder of red blood cells);
• if you experienced hearing loss, porphyria, herpes gestationis, or Sydenham's chorea for the first time or if these conditions worsened during pregnancy or previous use of hormonal contraception;
• if you develop symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives potentially accompanied by breathing difficulties, you should seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you currently have or have had chloasma (yellowish-brown skin patches, especially on the face); in such cases, avoid exposure to sunlight or ultraviolet radiation.

If any of the above factors occur for the first time, recur, or worsen during treatment with the tablets, you should contact your doctor immediately.
2.2.1 Hormonal contraception and thromboembolic disorders
BLOOD CLOTS
Using combined hormonal contraceptives such as Marvelon is associated with an increased risk of blood clots compared to not using any hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots may occur

• in veins (referred to below as “venous thrombosis” or “venous thromboembolic disease”)
• in arteries (referred to below as “arterial thrombosis” or “arterial thromboembolic events”).

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
It should be remembered that the overall risk of harmful blood clots associated with the use of Marvelon is low.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely reason?

• swelling of the leg or swelling along a vein in the leg or foot, particularly if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased warmth in the affected leg;
• change in skin color of the leg, such as pallor, redness, or blueness.
• sudden onset of unexplained shortness of breath or rapid breathing;
• sudden coughing without an obvious cause, which may be associated with coughing up blood;
• sudden sharp chest pain, which may worsen on deep breathing;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, consult your doctor,
as some of these symptoms, such as coughing or
shortness of breath, may be mistaken for milder
conditions such as a respiratory tract infection (e.g.
common cold).
Symptoms most commonly affecting one eye: Retinal vein thrombosis

• sudden loss of vision, or (blood clot in the eye)
• painless visual disturbances, which may progress to vision loss
• chest pain, discomfort, pressure, or heaviness;
• tightness or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, or stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.
• sudden weakness or numbness of the face, arms, or legs, Stroke particularly on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding;
• sudden visual disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden, severe, or prolonged headache without known cause;
• loss of consciousness or fainting with or without seizures

BLOOD CLOTS IN VEINS
What can happen if blood clots develop in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest 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 product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Marvelon, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Marvelon is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and who are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing desogestrel, such as Marvelon, will develop blood clots.
• The risk of developing blood clots depends on the individual medical history of the woman (see "Factors increasing the risk of venous blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Marvelon is small, but certain factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Marvelon several weeks before surgery or immobilization. If the patient must stop taking Marvelon, consult the doctor about when it is safe to resume treatment;
• with increasing age (particularly over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots, especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Marvelon.
Inform the doctor if any of the above conditions change during treatment with Marvelon, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Marvelon is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Marvelon, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac rhythm disorder such as atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of arterial blood clots may be further increased.

Inform the doctor if any of the above conditions change during treatment with Marvelon, for example, if the patient starts smoking, if a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

2.2.2 Hormonal contraception and cancer
Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. This slight increase in breast cancer diagnosis gradually disappears within 10 years after stopping oral contraceptives. It is not known whether this difference is caused by the use of oral contraceptives. It may be related to the fact that women using oral contraceptives undergo medical examinations more frequently, leading to earlier detection of breast cancer.

Very rarely, benign liver tumors have been observed in women using oral contraceptives, and even more rarely, malignant ones. These tumors may lead to intra-abdominal bleeding. If severe abdominal pain occurs, seek immediate medical attention.

Chronic infection with human papillomavirus (HPV) is the most important risk factor for cervical cancer. Cervical cancer may occur slightly more frequently in women who have used oral contraceptives for a long time. This may not be caused by oral contraceptives and is probably related to sexual behavior or other factors.

Psychiatric disorders
Some women using hormonal contraceptives, including Marvelon, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

2.2.3 Interaction of Marvelon with other medicines
Always inform the doctor about any medicines or herbal products currently being used by the patient. Also inform any other specialist doctor or dentist, or pharmacist prescribing other medicines, about the use of Marvelon. They may advise using additional contraceptive methods (e.g. condoms), how long this should be continued, and whether any adjustment of other medication is needed.

Some medicines:

• may affect the blood concentration of Marvelon
• may reduce its contraceptive effectiveness
• may cause unexpected bleeding

This applies to medicines used in the treatment of:

• 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);
• pulmonary arterial hypertension (bosentan);
• depression (St. John's wort (Hypericum perforatum)).

If the patient is taking medicines or herbal remedies that may reduce the effectiveness of Marvelon, additional mechanical contraception should also be used. Because the effect of another medicine on Marvelon may persist for up to 28 days after stopping the medicine, additional mechanical contraception is necessary during this period.

Marvelon may affect the action of other medicines, such as:

• medicines containing cyclosporine
• anticonvulsant medicines
• lamotrigine (this may lead to increased frequency of seizures)

If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir, pibrentasvir, Marvelon should not be used, as this may lead to increased liver function parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).
Before starting these medicines, the treating doctor will prescribe another type of contraceptive.
Marvelon may be restarted approximately 2 weeks after completion of this treatment. See section "When not to use Marvelon".

2.2.4 Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Marvelon is contraindicated during pregnancy.
If pregnancy is suspected during treatment with Marvelon, contact the doctor immediately.
Marvelon is not recommended during breastfeeding.
If the patient wishes to use Marvelon while breastfeeding, she should consult a doctor.

2.2.5 Driving and operating machinery
The use of Marvelon has no influence on the ability to drive or operate machinery.

2.2.6 Marvelon contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult a doctor before taking this medicine.

2.2.7 Use in children and adolescents
There are no clinical data available on the efficacy and safety of use in children and adolescents under 18 years of age.

2.3 When to consult a doctor

Regular check-ups
A woman using oral contraceptive pills should be informed by her doctor about the need for regular medical examinations. Such examinations are usually carried out once a year.

You should contact your doctor immediately in the following cases:

• if you notice symptoms that may indicate a blood clot, which could mean you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section above "BLOOD CLOTS". For a description of symptoms related to these serious adverse effects, see "How to recognize the development of blood clots").
• if any changes in your health occur, especially the conditions mentioned earlier in this leaflet (see sections "When not to use Marvelon" and "Important information before taking Marvelon"), including information relating to the health of your immediate family that may affect the use of oral contraceptive pills;
• detecting a breast lump;
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives potentially accompanied by breathing difficulties (see also section 2.2 "Take special care with Marvelon");
• planning to take other medicines (see also section 2.2.3 "Marvelon and other medicines");
• immobilization or planned surgical procedure (consult your doctor at least 4 weeks in advance);
• if irregular, heavy vaginal bleeding occurs;
• if you forget to take the tablets during the first week of use and had sexual intercourse within the previous 7 days;
• if you experience severe diarrhoea;
• if your period does not occur twice in a row, or if you suspect you may be pregnant (do not start the next pack before consulting your doctor).

3. How to use Marvelon

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

3.1 When and how to take the tablets

The Marvelon pack contains 21 tablets. Each tablet is marked with the symbol of the day of the week on which it should be taken (see "Translation of the day-of-the-week symbols on the immediate packaging" at the end of this leaflet). The tablets should be taken at the same time each day, with water if necessary. Take one tablet daily for 21 consecutive days, following the direction of the arrows. Then wait for 7 days without taking any tablets. A withdrawal bleed should occur during these 7 tablet-free days. It usually starts 2–3 days after taking the last Marvelon tablet. The first tablet of the next pack should be taken on the 8th day, even if bleeding is still occurring. This ensures that each new pack is always started on the same day of the week and that withdrawal bleeding occurs approximately on the same days each month.

Use in children and adolescents
There are no available clinical data on the efficacy and safety of use in children and adolescents under 18 years of age.

3.2 Starting the first pack of Marvelon

• if the patient has not previously used any hormonal contraceptive method

The first tablet of Marvelon should be taken on the first day of the menstrual cycle, i.e.
the first day of menstruation. There is no need to use an additional contraceptive method.
Tablets may also be started between day 2 and day 5 of the cycle; however, in this
case, an additional contraceptive method (a mechanical method, e.g.
condom) must be used for the first 7 days of tablet intake during the first cycle.

• if the patient has previously used another combined hormonal contraceptive (oral tablets, vaginal contraceptive systems, transdermal systems)

Marvelon tablets may be started the day after taking the last active tablet of the previous contraceptive (without a break or tablet-free interval). If the currently used product also contains placebo tablets, Marvelon may be started the day after the last hormone-containing tablet is taken (in case of doubt about which tablet this is, consult a doctor or pharmacist). Alternatively, the first Marvelon tablet may be taken later, but not later than the day following the tablet-free interval of the currently used contraceptive (or the day after the last placebo tablet of the current product). For a vaginal contraceptive system or transdermal system, Marvelon should preferably be started on the day of removal of the vaginal ring or transdermal patch, but no later than the date when the next application would have been due.
If the patient has been taking oral contraceptive tablets, a transdermal system, or a vaginal contraceptive system regularly and is certain she is not pregnant, she may discontinue the tablets, vaginal system, or transdermal system on any day and immediately start taking Marvelon.
When Marvelon is started according to the above instructions, no additional contraceptive method is required.

• if the patient has previously used a progestogen-only pill (so-called “minipill”)

The patient may stop taking the minipill at any time and start taking Marvelon the next day at the same time. In addition, an additional contraceptive method (mechanical method, e.g. condom) must be used for the first 7 days of tablet intake if sexual intercourse occurs.

• if the patient has previously used contraception in the form of an injection, implant, or intrauterine system releasing progestogen

Marvelon tablets should be started on the day the next injection would have been due, or on the day of removal of the implant or intrauterine system releasing progestogen. An additional contraceptive method (mechanical method, e.g. condom) must be used for the first 7 days of tablet intake if sexual intercourse occurs.

• after childbirth

The doctor may advise waiting until the first menstrual period before starting Marvelon. The doctor may also recommend starting tablets earlier. If breastfeeding, the use of hormonal contraception should be discussed with a doctor.

• after miscarriage

As directed by the physician.

3.3 Use of a higher than recommended dose of Marvelon

No serious harmful effects have been observed after overdose of Marvelon.
If several tablets are taken at the same time, nausea, vomiting, or vaginal bleeding may occur. In
the case of accidental ingestion of Marvelon by a child, medical advice should be sought.

3.4 What to do in case of…

Missing a dose of Marvelon

• If the delay in taking the tablet is less than 12 hours, contraceptive protection remains. Take the missed tablet as soon as possible and continue taking the remaining tablets at your usual time.
• If the delay in taking the tablet is more than 12 hours, contraceptive effectiveness may be reduced. The greater the number of missed tablets, the higher the risk of reduced contraceptive efficacy. The risk of pregnancy is higher if a tablet is missed at the beginning or end of the cycle. Please refer to the information below (see also the chart).

More than one tablet missed from the pack
Seek medical advice.
One tablet missed during the first week of use
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time) and continue taking the remaining tablets at your usual time. Use an additional contraceptive method (e.g. a condom) for the next 7 days. There is a risk of pregnancy if intercourse occurred in the week before the missed tablet. Consult your doctor.
One tablet missed during the second week of use
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time) and continue taking the remaining tablets at your usual time. Contraceptive protection remains effective, and no additional contraceptive methods are needed. However, if the above condition was not met or more than one tablet was missed, use an additional contraceptive method for the next 7 days.
One tablet missed during the third week of use
There are two options to maintain contraceptive protection without using additional methods, provided that the tablets were taken correctly in the 7 days before the missed tablet. Otherwise, the patient should follow the first of the two options below and also use an additional contraceptive method for 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time) and continue taking the remaining tablets as usual. After finishing the last tablet in the pack, start a new pack the next day without a break. Withdrawal bleeding may not occur until the end of the second pack. However, breakthrough bleeding or spotting may occur during tablet intake.

or

2. Stop taking the remaining tablets in the pack, take a 7-day break (including the day the tablet was missed), and then start a new pack. Using this method, you may begin the next pack on the same day of the week as usual.

• If a tablet is missed and no withdrawal bleeding occurs during the first tablet-free interval, pregnancy should be considered. In this case, consult your doctor before starting the next pack.

Missed more than
Consult your doctor
One tablet in a cycle
Yes
sexual intercourse in the week
Week 1 preceding
missed tablet
No

• Take the missed tablet – use additional contraception for 7 days
• Finish the pack

Missed only one
tablet (delay longer
than 12 hours) – take the missed tablet
Week 2

• Finish the pack
• Take the missed tablet
• Finish the pack
• Do not take a 7-day break
• Continue taking tablets

or
Week 3

• Discard the remaining tablets in the pack
• Take a break (no longer than 7 days, including the day of the missed tablet)
• Continue with the next pack

In case of gastrointestinal disturbances (e.g. vomiting, severe diarrhoea)
If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a Marvelon tablet, absorption of the active ingredients may be incomplete. This situation is similar to missing a tablet; therefore, follow the instructions for a missed tablet. In case of severe diarrhoea, consult your doctor.
If you wish to change the day on which withdrawal bleeding starts
If tablets are taken as directed, withdrawal bleeding usually occurs approximately every 4 weeks on the same day. To change this, shorten (but never extend) the next tablet-free interval. Example: if bleeding usually occurs on Fridays and you wish to shift it to Tuesdays (3 days earlier), start the next pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not occur during this break, but breakthrough bleeding or spotting may occur during the next pack.
In case of unexpected bleeding during tablet intake
During the first few months of using any oral contraceptive, irregular vaginal bleeding (spotting or breakthrough bleeding) may occur between withdrawal bleeds. In such cases, do not stop taking the contraceptive tablets. These bleedings usually resolve after an adaptation period (typically after 3 cycles). If bleeding persists, is heavy, or recurs, consult your doctor.
If withdrawal bleeding does not occur
Pregnancy is unlikely if tablets have been taken correctly, no vomiting occurred, and no other medications were used. You may continue taking Marvelon tablets.
If withdrawal bleeding does not occur in two consecutive cycles, pregnancy is possible. In this case, contact your doctor immediately before starting the next pack of Marvelon to rule out pregnancy.

3.5 Stopping Marvelon

You may stop taking Marvelon at any time. If you do not plan to become pregnant, you should ask your doctor for an alternative method of contraception.
If you are planning a pregnancy, it is usually recommended to wait until the first natural menstrual period after stopping the tablets, which helps determine the expected date of delivery.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Marvelon may cause adverse reactions, although not everyone experiences them. If any adverse reactions occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Marvelon, medical advice should be sought immediately.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Marvelon".

Immediate medical attention must be sought if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria with possible breathing difficulties (see also section 2, "Important information before taking Marvelon").

Common (occurring in more than 1 in 100 women but less than 1 in 10 women):

• Depressed mood, mood changes
• Headaches
• Nausea, abdominal pain
• Breast pain and tenderness
• Weight gain

Uncommon (occurring in more than 1 in 1,000 women but less than 1 in 100 women):

• Fluid retention
• Decreased libido
• Migraine
• Vomiting
• Diarrhea
• Rash
• Urticaria
• Breast enlargement

Rare (occurring in more than 1 in 10,000 women but less than 1 in 1,000 women):

• Blood clots in veins or arteries, 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 ischaemic attack (TIA)
  • Blood clots in the liver, stomach/intestines, kidneys or eyes

The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of thrombosis).

• Hypersensitivity
• Increased libido
• Intolerance to contact lenses
• Skin disorders (nodular erythema, erythema multiforme)
• Galactorrhea
• Vaginal discharge
• Weight loss

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Marvelon

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not freeze.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Do not use this medicine if you notice any colour changes in the tablets, tablet crumbling, or other visible signs of tablet degradation.

6. Contents of the packaging and other information
6.1 What Marvelon contains
The active substances are desogestrel 0.15 mg and ethinylestradiol 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 contents of the pack

The tablets are round, biconvex, 6 mm in diameter, marked with the code 5 below TR on one side and the word Organon* on the other.
21 tablets – 1 blister strip containing 21 tablets
63 tablets – 3 blister strips containing 21 tablets each
PVC/Aluminium blisters, each in a laminated aluminium sachet, packed in a cardboard box.
A cardboard sachet is included in the package, in which the blister should be placed after removal from the protective foil.

6.3 Other information
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Netherlands, country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Number of Marketing Authorisation in the Netherlands, country of export: RVG 08859
Number of Parallel Import Licence: 313/23

Translation of the weekday symbols printed next to each tablet in the immediate packaging:
MA – Monday
DI – Tuesday
WO – Wednesday
DO – Thursday
VR – Friday
ZA – Saturday
ZO – Sunday