Marvelon

Patient Information Leaflet

Warning! Please 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 following a break of 4 weeks or more.
• Be vigilant and consult your 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It 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 your 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 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 pill. 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.
Oral contraception is a highly effective method of birth control. The chance of becoming pregnant while taking contraceptive pills (provided the tablets are taken as directed without missing any) 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 become familiar with 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 the effectiveness of the tablet 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 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 infection with HIV (AIDS) or other sexually transmitted diseases.
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 is allergic 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, 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 a 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 hyperhomocysteinaemia
• if the patient 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 hypertriglyceridaemia;
• if the patient has jaundice or severe liver disease;
• if the patient has or has previously had a malignant hormone-dependent 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 growth 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 above conditions occurs for the first time during treatment with Marvelon, the medicine should be discontinued immediately and the patient should consult a doctor. During this time, a non-hormonal method of contraception should be used (see also section 2 “General warnings”).

2.2 When to be cautious using Marvelon

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

• if you notice symptoms suggesting 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 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 symptoms 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 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 have occurred in close family members;
• if you suffer from migraine;
• if you have epilepsy;
• if you have high blood fat levels (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 long time (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 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 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 for the first time or worsening during pregnancy or previous use of hormonal contraception conditions such as: hearing loss, porphyria, herpes gestationis, or 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 potentially with breathing difficulties – you should immediately contact your doctor. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you currently have or have had chloasma (yellowish-brown pigmentation patches on the skin, especially on the face); in such cases, exposure to sunlight or ultraviolet radiation should be avoided.

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

Complete recovery after a blood clot does not always occur. 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
You should immediately contact your doctor if you notice any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt while standing or walking;
• increased warmth in the affected leg;
• change in skin color of the leg, e.g., pallor,

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 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 first-time use of combined hormonal contraceptives. 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 compared to not using combined hormonal contraceptives at all.
If a woman stops taking Marvelon, the risk of developing blood clots returns to normal within a few weeks.

What does the risk of developing blood clots in veins depend on?
The risk depends on the individual's 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 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 woman's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors increasing the risk of venous blood clots
The risk of developing blood clots associated with the use of Marvelon is small, however
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 of the patient 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 immobilised 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 immobilisation. If the patient must stop taking Marvelon, ask the doctor when it is safe to restart;
• with increasing age (particularly over 35 years);
• if the patient has recently 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 blood clots,
particularly 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 the use of Marvelon.
Inform the doctor if any of the above conditions change during treatment with Marvelon, e.g. if a close family member develops thrombosis of unknown cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
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 emphasize that the risk of heart attack or stroke associated with the use of Marvelon is very small, 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 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 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 fats in the blood (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 developing 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 thrombosis of unknown cause, or if the patient gains significant weight.

2.2.2 Hormonal contraception and cancer
Breast cancer occurs slightly more often in women using contraceptive pills than in women of the same age who do not use them. This slight increase in the diagnosis of breast cancer gradually disappears within 10 years after stopping the 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 more frequent medical examinations, 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, seek medical advice 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 have used contraceptive pills for a long time. This may not be caused by the contraceptive pills themselves. It is probably related to 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 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 taken by the patient. Also inform any other specialist doctor, dentist or pharmacist prescribing other medicines that Marvelon is being used. They may advise using an additional method of contraception (e.g. condoms), and if so, for how long, as well as whether adjustment of the other medicine is necessary.

Some medicines:

• may affect the blood levels 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, 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, e.g.

• medicines containing cyclosporine
• the antiepileptic drug 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 become pregnant, 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.
The use of 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 available clinical data 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 contraceptives 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 suggesting the occurrence of blood clots, which may indicate that you have blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see section above "BLOOD CLOTS"). For a description of symptoms related to these serious adverse effects, see "How to recognize the occurrence 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 contraceptives;
• detection of 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 "When to be cautious when using Marvelon");
• before taking any other medicines (see also section 2.2.3 "Marvelon and other medicines");
• immobilization or planned surgical procedure (you should consult your doctor at least 4 weeks in advance);
• if irregular, heavy vaginal bleeding occurs;
• if you forget to take tablets during the first week of use and have had sexual intercourse within the preceding 7 days;
• if you experience severe diarrhoea;
• if menstruation fails to occur twice in succession or if pregnancy is suspected (do not start the next pack without consulting your doctor).

3. How to use Marvelon

This medicine should always be used exactly as directed by your doctor. If you have any doubts, 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 section 6.2 "Translation of the day-of-the-week symbols on the immediate packaging"). The tablets should be taken at the same time each day, with water if necessary. Tablets should be taken continuously for 21 days, following the direction of the arrows. After this, a 7-day interval should be observed during which no tablets are taken. Withdrawal bleeding (menstrual-like bleeding) is expected to 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 ongoing. This means that a new pack is always started on the same day of the week and withdrawal bleeding will generally occur around 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 was previously using another combined hormonal contraceptive (oral tablets, vaginal systems, transdermal systems)

Marvelon tablets may be started the day after taking the last active tablet of the previous contraceptive (without taking a break for hormone-free days). If the current contraceptive also includes placebo tablets, Marvelon may be started the day after the last active tablet containing hormones (in case of doubt about which tablet is the last active one, consult a doctor or pharmacist). Alternatively, the first Marvelon tablet may be taken later, but no later than the day following the hormone-free interval (or the day after the last placebo tablet) of the current contraceptive.
For users of a vaginal contraceptive system or transdermal contraceptive system, Marvelon should preferably be started on the day of removal of the vaginal system or transdermal system, but no later than the day when the next application of the vaginal system or transdermal system would have been due.
If the patient has been using oral contraceptive tablets, a transdermal system or a vaginal contraceptive system regularly and is sure 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, an additional contraceptive method is not required.

• if the patient was previously using a progestogen-only pill (the so-called "minipill")

The patient may stop taking the minipill on any day and start taking Marvelon the following day at the same time. 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 was previously using a progestagen-releasing injectable, implant, or intrauterine system

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 progestagen-releasing intrauterine system. 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

Immediately after delivery, the doctor may advise delaying the start of tablets until the first menstrual period. The doctor may also recommend starting tablets earlier. If breastfeeding, the use of hormonal contraception should be discussed with the doctor.

• after miscarriage

As advised by the doctor.

3.3 Use of a higher than recommended dose of Marvelon

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

3.4 What to do in case of…

Missed intake of Marvelon tablets

• If the delay in taking the tablet is less than 12 hours, contraceptive protection remains intact. Take the missed tablet as soon as possible and continue taking the remaining tablets at the 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 particularly increased if tablets are missed at the beginning or end of the cycle. Please refer to the information below (see also the scheme).

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. condoms) for the next 7 days. There is a risk of pregnancy if sexual intercourse occurred in the week preceding 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 protection remains effective, and no additional contraceptive methods are required. However, if this condition was not met, 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 the patient has taken the tablets correctly during the 7 days preceding 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 the next pack without a break the next day. Withdrawal bleeding may not occur until after completing the second pack. However, breakthrough bleeding or spotting may occur during the intake of tablets from the second pack.

Or

2. Stop taking the remaining tablets in the current pack, take a 7-day break or shorter (including the day the tablet was missed), and then start the next pack. Using this method, you may begin the new pack on the same day of the week as usual.
   • Missing a tablet and the absence of expected withdrawal bleeding during the first tablet-free interval may indicate pregnancy. In such a case, consult your doctor before starting the next pack.

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

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

Only 1 tablet missed (gap – take the missed tablet
Week 2
greater than 12 hours)
– Finish the 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, act as in the case of a missed tablet. In case of severe diarrhoea, consult your doctor.
If intending to change the day of withdrawal bleeding
When tablets are taken as directed, withdrawal bleeding usually occurs approximately on the same day every 4 weeks. To change this, shorten (but never extend) the next tablet-free interval. Example: if bleeding usually occurs on Friday and you wish to shift it to Tuesday (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 breakthrough bleeding or spotting may occur during intake of the next pack.
In case of unexpected bleeding during tablet intake
During the first few months of taking any oral contraceptive tablets, irregular vaginal bleeding (spotting or intermenstrual bleeding) between withdrawal bleeds may occur. In such cases, do not stop taking the contraceptive tablets. These bleedings usually resolve after an adaptation period (typically after 3 cycles). If bleeding is prolonged, heavy, or recurrent, 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 taken concomitantly. 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 treatment

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

week 3 or

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

You may stop taking Marvelon at any time. If you do not plan to become pregnant, please ask your doctor for another 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 will help 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 any medicine, this Marvelon medicine can cause adverse reactions, although not everyone will experience them. If any adverse reactions occur, especially severe and persistent ones, or changes in health status which the patient considers to be related to the use of Marvelon, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of venous thromboembolism (blood clots in veins) or arterial thromboembolism (blood clots in arteries). 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 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 taking 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
• Diarrhoea
• 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 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 any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of thrombosis).

• Hypersensitivity
• Increased libido
• Intolerance to contact lenses
• Skin disorders (erythema nodosum, erythema multiforme)
• Galactorrhoea (discharge from the breast)
• Vaginal discharge
• Weight loss

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your 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 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.
Store below 30°C. Do not freeze.
Keep 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. Such measures 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 in Marvelon are desogestrel at a dose of 0.15 mg and ethinylestradiol at a dose of 0.03 mg.
The other ingredients are: colloidal anhydrous silica, lactose monohydrate, potato starch, povidone, stearic acid, RRR-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/Al blister in a pouch inside a cardboard box.
A cardboard pouch is included in the package, into which the blister should be placed after removal from the protective foil.
Translation of the day-of-the-week symbols on the immediate packaging:
2 F - Monday
3 F - Tuesday
4 F - Wednesday
5 F - Thursday
6 F - Friday
SAB - Saturday
DOM - Sunday

6.3 Other information

For further information, contact the responsible party or the parallel importer.
Responsible party in Portugal, the country of export:
Organon Portugal, Sociedade Unipessoal Lda.
Rua Alexandre Herculano, 50 - Piso 9
1250-011 Lisbon
Portugal
Manufacturer:
NV Organon
Kloosterstraat 6, 5349 AB Oss, Netherlands
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in Portugal, the country of export: 8589804
Parallel import authorization number: 20/15