Marvelon

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Marvelon
0.15 mg + 0.03 mg, tablets
Desogestrelum + Ethinylestradiolum
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 use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

Read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms appear identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 exercise particular caution with 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 treatment
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 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 contraceptive tablet. Marvelon belongs to the group of monophasic combined oral contraceptives, as all tablets in the pack contain the same amount of hormones.
Marvelon is used to prevent pregnancy.
The method of oral contraception is a highly effective method of birth control. The chance of becoming pregnant while taking contraceptive tablets (provided the patient does not forget to take them) is very small.

2. Important information before using Marvelon

General notes
Before starting to take Marvelon, you should read the information about blood clots in section 2. It is 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. During such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or another mechanical method. Do not use the calendar method or temperature measurement 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 diseases.
Marvelon is prescribed individually by a doctor for each woman. Do not give Marvelon to other people.
Do not use Marvelon to delay the onset of menstrual bleeding.
In exceptional cases, when there is a need to delay the start of bleeding, consult your doctor.

2.1 When not to use Marvelon
Do not use Marvelon if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have 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 you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you currently have or have previously had pancreatitis associated with severe hypertriglyceridemia;
• if you have jaundice or severe liver disease;
• if you currently have or have previously had a hormone-dependent malignant tumour (e.g. of the breast or reproductive organs);
• if you currently have or have previously had a benign or malignant liver tumour;
• if you have vaginal bleeding of unknown cause;
• if you have endometrial hyperplasia (abnormal growth of the uterine lining);
• if you are or may be pregnant;
• if you have hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir or glecaprevir, pibrentasvir (see also section "Marvelon with other medicines").

If any of the above conditions occur for the first time while taking Marvelon, stop taking the medicine and consult your doctor immediately, using a non-hormonal method of contraception in the meantime (see also section 2 "General notes").

2.2 When to exercise special caution when using Marvelon
Before starting Marvelon, discuss this with your doctor or pharmacist.
When should you contact a doctor?
Seek immediate medical advice:

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack or stroke (see section below "Blood clots"). For a description of symptoms of these serious adverse effects, see "How to recognize blood clots".

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen while taking Marvelon, 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 problems;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if thromboembolic disease, myocardial infarction or stroke has occurred in close family members;
• if you have migraine;
• if you have epilepsy;
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have 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 long time (see section 2 "Blood clots");
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Marvelon;
• 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 defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have experienced for the first time or worsening during pregnancy or previous use of hormonal contraception conditions such as: hearing loss, porphyria, herpes gestationis, Sydenham's chorea;
• if you develop symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulties – seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you currently have or have previously had chloasma (yellowish-brown pigmentation spots on the skin, 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 while taking the tablets, 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 hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious health problems.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to 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.
Remember that the overall risk of harmful blood clots caused by using Marvelon is low.
HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

BLOOD CLOTS IN VEINS
What can happen if blood clots form 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 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 using 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, 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 developing 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 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 developing blood clots in veins" and "Factors increasing the risk of developing blood clots in arteries" 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 is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had 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 tendency to form blood clots;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Marvelon several weeks before surgery or during immobilization. If the patient must stop taking Marvelon, ask the doctor when it is safe to restart;
• with increasing age (especially 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.
Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor.
It is important to inform the doctor if any of these factors apply, even if uncertain. The doctor may decide to discontinue Marvelon.
Inform the doctor if any of the above conditions change during treatment with Marvelon, e.g. if a close family member develops unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if a blood clot forms in an artery?
As with venous blood clots, arterial clots can cause serious consequences, such as heart attack or stroke.

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

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Marvelon, it is recommended 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 a close family member 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 family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known 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 blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Marvelon, e.g. if the patient starts smoking, a close family member develops unexplained thrombosis, or if the patient gains significant weight.

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

Very rarely, benign liver tumours have been observed in women using contraceptive pills, and even more rarely, malignant ones. These tumours may lead to bleeding into the abdominal cavity. If severe abdominal pain occurs, contact a doctor immediately.

Chronic infection with human papillomavirus (HPV) is the most important risk factor for cervical cancer. Cervical cancer may occur slightly more often in women who use contraceptive pills for a long time. This may not be caused by the pills themselves, but rather by sexual behaviour 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 a 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. Also inform any other doctor or dentist prescribing medicines (or a pharmacist) that Marvelon is being used. They may advise using an additional method of contraception (e.g. condoms), and if so, for how long, and whether any adjustment of other medication is needed.

Some medicines:

• may affect the blood levels of Marvelon
• 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 infections (e.g. griseofulvin);
• high blood pressure in the pulmonary arteries (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, additional mechanical contraception is necessary during this time.

Marvelon may affect the action of other medicines, such as e.g.

• medicines containing cyclosporine
• the anticonvulsant 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 cause increased liver function test parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).
Before starting these medicines, the treating doctor will prescribe a different type of contraceptive.

Marvelon may be restarted approximately 2 weeks after completing this treatment. See section "When not to use Marvelon".

2.2.4 Pregnancy and breast-feeding
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or plans to have a baby, 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 a doctor immediately.
Marvelon is not recommended during breast-feeding.
If the patient wishes to use Marvelon while breast-feeding, 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 monohydrate 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
The patient using contraceptive pills should be informed by the doctor about the need for regular medical examinations. These are usually performed once a year.

Contact a doctor immediately in the following cases:

• if the patient notices symptoms suggesting blood clots, which may indicate deep vein thrombosis in the leg, pulmonary embolism, heart attack or stroke (see section above "BLOOD CLOTS"). For a description of symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".
• if any changes in health occur, especially conditions mentioned earlier in this leaflet (see sections "When not to use Marvelon" and "Important information before using Marvelon"), including information about the health of close family members that may affect the use of contraceptive pills;
• detection of a breast lump;
• if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with possible breathing difficulties (see also section 2.2 When to exercise special caution when using Marvelon);
• before using other medicines (see also section 2.2.3 "Marvelon and other medicines");
• immobilization or planned surgical procedure (consult the doctor at least 4 weeks in advance);
• if irregular, heavy vaginal bleeding occurs;
• if tablets are forgotten during the first week of use and sexual intercourse occurred in the preceding 7 days;
• if severe diarrhoea occurs;
• if menstruation does not occur twice in succession or if pregnancy is suspected (do not start the next pack without consulting a doctor).

3. How to take Marvelon

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

3.1 When and how to take the tablets

The Marvelon blister pack contains 21 tablets. Each tablet is marked on the blister with the symbol of the day of the week on which it should be taken (see "Translation of symbols for days of the week located next to each tablet on the immediate packaging" at the end of this leaflet). Tablets should be taken at the same time each day, with water if necessary. Continue taking one tablet daily for 21 days in the direction indicated by the arrows. Then, stop taking tablets for 7 days. A withdrawal bleed (menstrual-like bleeding) should occur during these 7 tablet-free days. This 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 has not stopped. This ensures that a 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 Marvelon 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 contraception
  Start taking the first Marvelon tablet 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.

Alternatively, tablets may be started between day 2 and day 5 of the cycle. However, in this case, an additional contraceptive method (e.g. a mechanical method such as a condom) must be used for the first 7 days of tablet-taking in the first cycle.

• If the patient was previously using another combined hormonal contraceptive (oral tablets, vaginal ring, transdermal patch)
  Start taking Marvelon the day after taking the last active tablet of the previous contraceptive (without a break for the tablet-free days). If the current contraceptive includes placebo tablets, start Marvelon the day after the last hormone-containing tablet (if in doubt about which tablet this is, consult your 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 current contraceptive (or the day after the last placebo tablet). For users of a vaginal ring or transdermal patch, start Marvelon preferably on the day of removal of the ring or patch, but no later than the day when the next ring or patch would normally be inserted or applied.

If the patient has been using oral contraceptive tablets, a vaginal ring, or a transdermal patch regularly and is certain she is not pregnant, she may discontinue the current method on any day and immediately start taking Marvelon.

When switching to Marvelon according to the above instructions, no additional contraceptive method is required.

• If the patient was previously using a progestogen-only pill (so-called "mini-pill")
  The mini-pill may be discontinued at any time, and Marvelon should be started the next day at the same time. An additional contraceptive method (mechanical method, e.g. condom) must be used for the first 7 days of tablet-taking if sexual intercourse occurs.

• If the patient was previously using a progestogen-only method (injection, implant, or intrauterine system releasing progestogen)
  Start taking Marvelon 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-taking if sexual intercourse occurs.

• After childbirth
  Your doctor may advise delaying the start of tablets until the first menstrual period. Your doctor may also recommend starting earlier. If breastfeeding, discuss the use of hormonal contraception with your doctor.

• After miscarriage
  As advised by your doctor.

3.3 Taking more Marvelon than prescribed

No serious harmful effects have been observed after overdose with Marvelon. If several tablets are taken at once, nausea, vomiting, or vaginal bleeding may occur. If a child accidentally takes Marvelon, consult a doctor immediately.

3.4 What to do if…

A tablet is missed

• If the delay in taking the tablet is less than 12 hours, contraceptive protection remains intact. 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.
• If the delay in taking the tablet is more than 12 hours, contraceptive effectiveness may be reduced. The more tablets missed, the greater the risk of reduced contraceptive effectiveness. The risk of pregnancy is higher if a tablet is missed at the beginning or end of the cycle. Please read the information below (see also the flowchart).

More than one tablet missed in a pack
Consult your doctor.

One tablet missed in 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 as usual. Use an additional contraceptive method (e.g. condom) for the next 7 days. There is a risk of pregnancy if sexual intercourse occurred in the week before the missed tablet. Consult your doctor.

One tablet missed in 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 as usual. Contraceptive effectiveness is maintained, and no additional contraceptive method is required. However, if the above condition was not met (i.e. tablets were not taken correctly in the 7 days prior to the missed tablet) or if more than one tablet was missed, use an additional contraceptive method for the next 7 days.

One tablet missed in the third week of use
There are two options to maintain contraceptive protection without needing an additional method, provided that tablets were taken correctly in the 7 days before the missed tablet. Otherwise, the patient should follow the first option 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 current pack, start the next pack without a break. Withdrawal bleeding may not occur until after finishing the second pack. However, spotting or intermenstrual bleeding may occur during tablet-taking.

Or

2. Stop taking the remaining tablets in the current pack, take a 7-day or shorter break (including the day the tablet was missed), and then start the next pack. When using this method, you may start 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. Consult your doctor before starting the next pack.

Missed more than one tablet
Consult your doctor

Cycle
Yes
Sexual intercourse in the week
Week 1 Week 1
preceding the missed tablet
No

• Take the missed tablet
• Use an additional contraceptive method for 7 days
• Finish the pack

Only one tablet missed
Week 2 – Take the missed tablet – Take the missed tablet (break – finish the pack – finish the pack longer than 12 hours)

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

Week 3
or

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

In case of gastrointestinal disorders (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, so follow the instructions for a missed tablet. In case of severe diarrhoea, consult your doctor.

Changing the day of withdrawal bleeding
If tablets are taken as directed, withdrawal bleeding usually occurs on approximately the same day each month. To change the day of bleeding, shorten (but never extend) the next tablet-free interval. For 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 interval, but spotting or intermenstrual bleeding may occur during the next pack.

If unexpected bleeding occurs during tablet-taking
During the first few months of using any combined oral contraceptive, irregular vaginal bleeding (spotting or intermenstrual bleeding) may occur between withdrawal bleeds. In this case, do not stop taking the contraceptive tablets. This bleeding usually resolves during the 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, vomiting has not occurred, and no other medicines have been taken concurrently. You may continue taking Marvelon tablets as usual.

However, 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, consult your doctor about alternative contraceptive methods.

If you are planning pregnancy, it is usually recommended to wait until the first natural menstrual period after stopping the tablets, as this helps determine the expected date of delivery.

If you have any further questions about 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 using Marvelon".

Seek immediate medical attention if the patient develops symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria potentially accompanied by breathing difficulties (see also section 2, "Important information before using Marvelon").

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

• Depressed mood, mood changes
• Headache
• 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):

• 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 ischaemic attack (TIA)
• Blood clots in the liver, stomach/intestines, kidneys or eye. The likelihood of developing blood clots may be higher if the patient has any 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 (e.g. erythema nodosum, erythema multiforme)
• Breast discharge
• Vaginal discharge
• Weight loss

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can 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 enhance the safety monitoring of the medicine.

5. How to store Marvelon

Keep this medicine out of sight and reach of children.
Store below 30°C. Do not freeze. Keep in the original packaging to protect from light and moisture.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Do not use this medicine if you notice any changes in tablet colour, tablet crumbling, or other visible signs of tablet degradation.

6. Contents of the pack and other information
6.1 What Marvelon contains
The active substances are desogestrel 0.15 mg (150 micrograms) and ethinylestradiol 0.03 mg (30 micrograms).
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 pack containing 21 tablets
63 tablets – 3 blister packs containing 21 tablets each
PVC/Aluminium blisters, each in an aluminium foil 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 further detailed information, contact the Marketing Authorisation Holder or 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Marketing Authorisation number in the Netherlands, country of export: RVG 08859
Parallel Import Licence number: 254/19
Translation of the day-of-the-week symbols printed next to each tablet in the immediate packaging:
MA – Monday
DI – Tuesday
WO – Wednesday
DO – Thursday
VR – Friday
ZA – Saturday
ZO – Sunday