Mercilon

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Mercilon
0.15 mg + 0.02 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 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 the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• 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 the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Mercilon is and what it is used for
2. Important information before taking Mercilon
       2.1 When not to take Mercilon
       2.2 When to be cautious when taking Mercilon
       2.3 When to consult a doctor
3. How to take Mercilon
       3.1 When and how to take the tablets
       3.2 Starting the first pack of Mercilon
       3.3 Taking more Mercilon than recommended
       3.4 What to do if...
       3.5 Stopping Mercilon
4. Possible side effects
5. How to store Mercilon
6. Contents of the pack and other information
       6.1 What Mercilon contains
       6.2 What Mercilon looks like and contents of the pack
       6.3 Other information

1. What Mercilon is and what it is used for

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

2. Important information before using Mercilon

General notes
Before starting to take Mercilon, 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 when you should stop taking the tablet or when its effectiveness
may be reduced. In such situations, you should avoid sexual intercourse or
use additional non-hormonal contraceptive methods, such as condoms or another
barrier method. Do not use the calendar method or temperature measurement for contraception. These methods
may be ineffective because contraceptive pills cause changes in body temperature and cervical mucus
throughout the menstrual cycle.
Mercilon, like other contraceptive pills, does not protect against HIV infection (AIDS) or
other sexually transmitted infections.
Mercilon is prescribed individually by a doctor for each patient. Do not give Mercilon
to other people.
Mercilon 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 Mercilon

Do not use Mercilon if any of the following conditions apply to the patient. If any of the conditions listed below are present, 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, or antiphospholipid antibodies;
• if the patient requires surgery or will be unable to walk for a prolonged period (see section “BLOOD CLOTS”);
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a 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 clot:
  • 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 has (or has had in the past) a type of migraine called “migraine with aura”;
• if the patient has (or has had in the past) pancreatitis associated with severe hypertriglyceridaemia;
• if the patient has jaundice or severe liver disease;
• if the patient has (or has had in the past) a hormone-dependent malignant tumour (e.g. of the breast or genital organs);
• if the patient has (or has had in the past) benign or malignant liver tumour;
• if the patient has vaginal bleeding of unknown cause;
• if the patient has endometrial hyperplasia (abnormal thickening of the uterine lining);
• 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 “Mercilon and other medicines”).

If any of the above conditions occurs for the first time during treatment with Mercilon, the medicine should be discontinued and the patient should consult a doctor. In the meantime, a non-hormonal method of contraception should be used (see also section 2 “General warnings”).

2.2 When to exercise special caution when using Mercilon

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

• if you notice symptoms suggesting blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the 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 conditions develop or worsen during treatment with Mercilon, 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 disturbances;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if thromboembolic disease, myocardial infarction, or stroke occurred in close family members;
• if you suffer from 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 are in the immediate postpartum period, as you are at increased risk of developing blood clots. You should consult your doctor about how soon after delivery you can start taking Mercilon;
• 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 natural immune 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 have 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 possibly with breathing difficulties, you must 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 (brownish 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 must contact your doctor immediately.
Hormonal contraception and thromboembolic disorders
BLOOD CLOTS
The use of combined hormonal contraceptives, such as Mercilon, 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 complications.
Blood clots may occur

• in veins (hereinafter referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (hereinafter referred to as "arterial thrombosis" or "arterial thromboembolic events").

Complete recovery after a blood clot is not always possible. 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 Mercilon is small.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
You should seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms and do you know why?

• swelling of the leg or swelling along a vein in the leg, particularly if accompanied by:
  Deep vein thrombosis

• pain or tenderness in the leg, which may be felt only while standing or walking;

• increased warmth in the affected leg;

• change in skin color of the leg, such as paleness, redness, or blueness.

• sudden onset of unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• sudden cough without apparent cause, which may be associated with coughing up blood;

• sharp chest pain, which may worsen with deep breathing;

• severe dizziness or lightheadedness;

• rapid or irregular heartbeat;

• severe stomach pain.

If you are unsure, you should consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g., cold).
Symptoms usually affect one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or

• painless visual disturbances, which may progress to vision loss.

• chest pain, discomfort, pressure, heaviness;
  Myocardial infarction

• squeezing, fullness, or pressure sensation 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, especially on one side of the body;
  Stroke

• sudden confusion, speech disturbances, or difficulty understanding.

VENOUS BLOOD CLOTS
What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (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 venous blood clots the highest?
The risk of developing venous blood clots 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 than in women not using combined hormonal contraceptives.
If a patient stops taking Mercilon, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
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 Mercilon is low.

• In one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who are using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who are using combined hormonal contraceptives containing desogestrel, such as Mercilon, will develop blood clots.
• The risk of developing venous blood clots depends on the individual’s medical history (see “Factors that increase 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 Mercilon is small, however
some 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 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). 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 plaster. It may be necessary to stop taking Mercilon several weeks before surgery or immobilization. If the patient needs to stop taking Mercilon, ask the doctor when it is safe to restart;
• 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 blood clots,
especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of these risk factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Mercilon.
Inform the doctor if any of the above conditions change during treatment with Mercilon, 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 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 Mercilon is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Mercilon, 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 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, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions, or if any of them is particularly severe, the risk of blood clots may be further increased.

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

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 the frequency of 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 more frequent medical examinations, leading to earlier diagnosis.

In very rare cases, benign liver tumors have been observed in women using oral contraceptives, and even more rarely, malignant ones. These tumors 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 is believed to occur slightly more frequently in women who use oral contraceptives for a long time. This may not be caused by the oral contraceptives themselves. It is probably related to sexual behavior or other factors.

Psychiatric disorders
Some women using hormonal contraceptives, including Mercilon, 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.

Mercilon and other medicines
Always inform the doctor about any medicines or herbal products currently used by the patient. Also inform any other doctor or dentist prescribing other medicines (or a pharmacist) about the use of Mercilon. 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 Mercilon;
• 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);
• high blood pressure in the pulmonary blood vessels (bosentan);
• depressive mood disorders (St John's wort (Hypericum perforatum)).

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

Mercilon may affect the action of other medicines, such as, for example:

• 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, Mercilon 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.

Mercilon may be restarted approximately 2 weeks after completion of this treatment.
See section "When not to use Mercilon".

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult a doctor or pharmacist before using this medicine.

Mercilon is contraindicated during pregnancy.
If pregnancy is suspected while taking Mercilon, contact a doctor immediately.

Use of Mercilon is not recommended during breastfeeding.
If the patient wishes to use Mercilon while breastfeeding, she should consult a doctor.

Driving and operating machinery
The use of Mercilon has no effect on the ability to drive or operate machinery.

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

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
Women using oral contraceptive tablets should be informed by their doctor about the need for regular medical examinations. Such examinations are usually performed once a year.

You should contact your doctor immediately in the following cases:

• if you notice symptoms that may indicate blood clots, which could mean you have blood clots 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 side 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 Mercilon” and “Important information before taking Mercilon”), including information concerning your immediate family’s medical history that may affect the use of oral contraceptives;
• if you detect 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 possibly accompanied by breathing difficulties (see also section 2.2 “When to take special care with Mercilon”);
• if you plan to take other medications (see also “Mercilon with other medicines”);
• in case of immobilization or planned surgical procedure (you should consult your doctor at least 4 weeks in advance);
• if you experience irregular, heavy vaginal bleeding;
• if you missed tablets during the first week of intake and had sexual intercourse within the preceding 7 days;
• if you develop severe diarrhoea;
• if you miss your period twice in succession, or if pregnancy is suspected (do not start the next pack without consulting your doctor).

3. How to use Mercilon

This medicine should always be used as directed by a doctor. If in doubt, consult a doctor or pharmacist.

3.1 When and how to take the tablets

The Mercilon 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 symbols for days of the week located next to each tablet on the immediate packaging" – section 6 at the end of the leaflet). 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. Then, a 7-day interval should follow, during which no tablets are taken. Withdrawal bleeding (menstrual-like bleeding) should occur during these 7 tablet-free days. It usually starts 2–3 days after taking the last Mercilon tablet. The first tablet of the next pack should be taken on the 8th day, even if bleeding has not stopped. 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 clinical data available on the efficacy and safety of use in children and adolescents under 18 years of age.

3.2 Starting the first pack of Mercilon

• if the patient has not previously used any hormonal contraceptive method
  The first tablet of Mercilon 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. a condom) must be used
during the first 7 days of tablet intake in the first cycle.

• if the patient has previously used another combined hormonal contraceptive (oral tablets, vaginal ring, transdermal patch)
  Mercilon tablets may be started the day after taking the last active tablet of the previous contraceptive (without a break or placebo tablet interval). If the currently used contraceptive also contains placebo tablets, Mercilon 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 Mercilon 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 contraceptive). In the case of a vaginal ring or transdermal patch, Mercilon 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 ring or patch would have been applied.

If the patient has been taking oral contraceptive tablets, a transdermal patch, or a vaginal ring regularly and is certain she is not pregnant, she may discontinue the tablets, vaginal ring, or transdermal system on any day and immediately start taking Mercilon.
When Mercilon is started according to the above instructions, an additional contraceptive method is not required.

• if the patient has previously used a progestogen-only pill (so-called "minipill")
  The progestogen-only pill may be discontinued at any time, and Mercilon may be started the following day at the same time. An additional contraceptive method (mechanical method, e.g. condom) must be used during the first 7 days of tablet intake if sexual intercourse occurs.

• if the patient has previously used a progestogen-releasing injectable, implant, or intrauterine system
  Mercilon tablets should be started on the day the next injection would have been administered, or on the day of removal of the implant or progestogen-releasing intrauterine system. An additional contraceptive method (mechanical method, e.g. condom) must be used during 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 tablets. The doctor may also recommend starting tablets earlier. If breastfeeding, the use of hormonal contraception should be discussed with a doctor.

• after miscarriage
  As advised by the doctor.

3.3 Use of a higher than recommended dose of Mercilon

No severe harmful effects have been observed following overdose of Mercilon. After taking several tablets at once, nausea, vomiting, or vaginal bleeding may occur. If Mercilon has been ingested by a child, consult a doctor.

3.4 What to do in case of...

Missing a dose of Mercilon:

• 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 as usual.
• 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 greater if a tablet is missed at the beginning or end of the cycle. Please refer to the information below (see also the scheme).

More than one tablet missed from the 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 (a barrier method, e.g. a condom) 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 has been missed, an additional contraceptive method should be used 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 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. Withdrawal bleeding may not occur until after finishing the second pack. However, breakthrough bleeding or spotting may occur during tablet intake.

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. When using this method, subsequent packs may be started on the same day of the week as usual.

• If a tablet is missed and the expected withdrawal bleeding does not occur during the first tablet-free interval, pregnancy should be considered. In such a case, consult your doctor before starting the next pack.

missed more than consult your doctor
1 tablet in the cycle
yes
sexual intercourse in the week
week 1
preceding the missed tablet
no

• take the missed tablet
• use an additional contraceptive method for 7 days
• finish the pack

missed only 1 - take the missed tablet
tablet (break - finish the pack
week 2
greater 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

• stop taking the remaining tablets in the pack
• take a break (no longer than 7 days, including the day the tablet was missed)
• continue with tablets from 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 Mercilon 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.
In case of wishing to change the day on which withdrawal bleeding starts
If tablets are taken as directed, withdrawal bleeding usually occurs approximately on the same day every 4 weeks. To change this day, 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, 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 adjustment period (typically after 3 cycles). If prolonged, heavy, or recurrent bleeding occurs, consult your doctor.
In case withdrawal bleeding does not occur
Pregnancy is unlikely if tablets have been taken correctly, no vomiting occurred, and no other medications were taken concurrently. You may continue taking Mercilon 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 Mercilon to rule out pregnancy.

3.5 Stopping Mercilon

You may stop taking Mercilon at any time. If you do not intend to become pregnant, you should consult your doctor about using another method of contraception.
If you plan to become pregnant, it is usually recommended to wait until the first natural menstrual period after stopping the tablets, which will facilitate determining 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, Mercilon can cause adverse reactions, although they do not occur in everyone.
If any adverse reactions occur, especially severe and persistent ones, or any changes in health which the patient considers to be related to the use of Mercilon, medical advice should be sought.
All women using combined hormonal contraceptives have an increased risk of developing venous blood clots (venous thromboembolic disease) or arterial blood clots (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 Mercilon".
Immediate medical attention should be sought if the patient experiences symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria possibly accompanied by breathing difficulties (see also section 2, "Important information before taking Mercilon").

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,
• 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 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 blood clots)
• hypersensitivity,
• increased libido,
• intolerance to contact lenses,
• skin disorders (nodular erythema, erythema multiforme),
• nipple discharge,
• vaginal discharge,
• weight loss.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. 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 Mercilon

Keep this 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 colour changes in the tablets, tablet crumbling, or other visible signs of tablet degradation.

6. Contents of the pack and other information
6.1 What Mercilon contains
The active substances are desogestrel 0.15 mg and ethinylestradiol 0.02 mg.
The other ingredients are: potato starch, colloidal anhydrous silica, all-rac-α-Tocopherol, stearic acid, povidone, lactose monohydrate.

6.2 What Mercilon looks like and contents of the pack

The tablets are round, biconvex, 6 mm in diameter, marked with the code 4 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 blisters, each in an aluminum laminated foil sachet, all in a cardboard box.
A cardboard sachet is included in the pack, 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, the 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:
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
Marketing authorisation number in the Netherlands, the country of export: RVG 11508
Parallel import licence number: 109/14
Translation of the weekday symbols found next to each tablet on the immediate packaging:
MA – Monday
DI – Tuesday
WO – Wednesday
DO – Thursday
VR – Friday
ZA – Saturday
ZO – Sunday