Mercilon

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Mercilon
0.15 mg + 0.02 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 a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please 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 give it to others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 Marketing authorisation holder and manufacturer

1. What Mercilon is and what it is used for

Mercilon is a combined oral contraceptive. Each tablet contains a low 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 oral contraceptive. Mercilon belongs to the group of monophasic combined oral contraceptives, because all tablets in the pack contain the same amount of hormones.
Mercilon is used to prevent pregnancy.
The method of oral contraception is a highly effective method of birth control. The possibility of becoming pregnant while taking oral contraceptive tablets (provided the patient does not forget to take the 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 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 its effectiveness may be reduced. In such situations, you should abstain from sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or another mechanical method. Do not use the 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.
Mercilon, like other oral contraceptives, does not protect against infection with the HIV virus (AIDS) or other sexually transmitted diseases.
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 situations, when there is a need to delay the start of bleeding, you should consult your doctor.

2.1 When not to use Mercilon

Mercilon should not be used if any of the following conditions apply to the patient. If any of the conditions listed below apply to the patient, inform the doctor. The doctor will discuss with the patient which alternative method of contraception would be more suitable.

• if the patient has hypersensitivity 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 2 "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 diseases, which 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 currently has (or has previously had) a type of migraine called "migraine with aura";
• if the patient currently has or has previously had pancreatitis associated with severe hypertriglyceridaemia;
• if the patient has jaundice or severe liver disease;
• if the patient currently has or has previously had a hormone-dependent malignant tumour (e.g. of the breast or genital organs);
• if the patient currently 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 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 with other medicines").

If any of the conditions listed above occur 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 be especially careful using Mercilon

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

• 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 a stroke (see section below "Blood clots (thrombosis)").

For a description of the symptoms of these serious adverse effects, see "How to recognize the development of blood clots".
You should inform your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with 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 have recently given birth, as you are then at increased risk of developing blood clots. You should consult your doctor to find out 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 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 have experienced for the first time or worsening during pregnancy or previous use of hormonal contraceptives 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 breathing difficulties, you should seek immediate medical attention. Estrogen-containing products may cause or worsen symptoms of hereditary or acquired angioedema.
• if you currently have or have had chloasma (yellow-brown pigmented patches on the skin, especially on the face); in such cases, you should avoid exposure to sunlight or ultraviolet radiation.

If any of the above factors occur for the first time, recur, or worsen during treatment with the tablets, you should contact your doctor immediately.
2.2.1 Hormonal contraception and thromboembolic disorders
BLOOD CLOTS
The use of combined hormonal contraceptives such as Mercilon 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 complications.
Blood clots may occur

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

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 low.
HOW TO RECOGNIZE THE DEVELOPMENT OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Are you experiencing any of these symptoms? What might be the reason?

Deep vein thrombosis

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may occur only while standing or walking;
• increased warmth in the affected leg;
• change in skin color of the leg, such as pallor, redness, or blueness.

Pulmonary embolism

• sudden unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious 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 a respiratory tract infection (e.g. a cold).
Symptoms most commonly occur in one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or
• painless visual disturbances, which may progress to vision loss

Heart attack

• chest pain, discomfort, pressure, heaviness;
• squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the lower part of the body radiating to the back, jaw, throat, arm, or stomach;
• sweating, nausea, vomiting, or

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 venous blood clots (venous thromboembolism). 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 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 product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Mercilon, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots 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 using Mercilon is low.

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

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Mercilon 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 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 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 discontinue Mercilon several weeks before surgery or immobilization. If the patient must stop taking Mercilon, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the past 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 present.
It is important to inform the doctor if any of the above 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 family member develops 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 lead to serious consequences such as heart attack or stroke.

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

• with age (over approximately 35 years);
• if the patient smokes. When 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 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 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 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 Mercilon, for example, if the patient starts smoking, if 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 oral contraceptives than in women of the same age who do not use them. This small increase in breast cancer incidence gradually disappears within 10 years after stopping oral contraceptives. It is not known whether this difference is caused by the use of oral contraceptives. It may be related to the fact that women using oral contraceptives undergo medical examinations more frequently, leading to earlier detection of breast cancer.

Very rarely, benign liver tumors have been observed in women using oral contraceptives, and even more rarely, malignant liver tumors. These tumors may lead to intra-abdominal bleeding. 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 frequently in women who have used oral contraceptives for a long time. This may not be caused by oral contraceptives but may be 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 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 Mercilon and other medicines
Always inform the doctor about any medicines or herbal products currently used by the patient. Also inform any other doctor, dentist, or pharmacist prescribing other medicines about the use of Mercilon. They may advise whether additional contraceptive methods (e.g. condoms) are needed, for how long, and whether adjustment of the other medicine is required.

Some medicines:

• may affect the blood concentration 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);
• 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 Mercilon, a mechanical contraceptive method 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 time.

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

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

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.
Mercilon is contraindicated during pregnancy.
If pregnancy is suspected during treatment with 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.

2.2.5 Driving and using machines
Mercilon has no influence on the ability to drive or use machines.

2.2.6 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.

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

You should contact your doctor immediately in the following cases:

• if you notice symptoms that could indicate blood clots, which may mean 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 the symptoms of these serious side effects, see “How to recognize the occurrence of blood clots”;
• if any changes occur in your health status, especially the conditions mentioned earlier in this leaflet (see sections: “When not to use Mercilon” and “Important information before using Mercilon”), including information relating to the health of your immediate family that may affect the use of contraceptive tablets;
• if you feel a lump in your breast;
• if you develop symptoms of angioedema, such as swelling of the face, tongue and (or) throat, and (or) difficulty swallowing, or hives accompanied by breathing difficulties (see also section 2.2 “Take special care with Mercilon”);
• if you plan to take other medicines (see also section 2.2.3 “Mercilon and other medicines”);
• 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 taking them and had sexual intercourse within the previous 7 days;
• if you develop severe diarrhoea;
• if your period is missed twice in a row, or if you suspect you may be pregnant (do not start the next pack before consulting your doctor).

3. How to use Mercilon

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your 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 day-of-the-week symbols located next to each tablet on the immediate packaging" at the end of this leaflet). The tablets should be taken at the same time each day, taken 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. A withdrawal bleed (menstrual-like bleeding) should occur during these 7 tablet-free days. This usually starts 2–3 days after taking the last tablet of Mercilon. The first tablet of the next pack should be taken on the 8th day, even if bleeding is still occurring. This means that a new pack is always started on the same day of the week as before, and withdrawal bleeding will typically 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 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 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 ring, transdermal patch)

Mercilon tablets may be started the day after taking the last active tablet of the previous contraceptive (without a break or tablet-free interval). If the current contraceptive also includes placebo tablets, Mercilon may be started the day after taking the last hormone-containing tablet (if there is any doubt about which tablet this is, consult a doctor or pharmacist). Alternatively, the first Mercilon tablet may be taken later, but no later than the day following the tablet-free interval of the current 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 day when the next ring or patch would have been inserted or applied.
If the patient has been taking oral contraceptive tablets, a vaginal ring, or a transdermal patch regularly and is certain she is not pregnant, she may discontinue the tablets, vaginal ring, or transdermal patch at any time and immediately start taking Mercilon.
When Mercilon is started according to the above instructions, an additional contraceptive method is not 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 Mercilon may be started the next day at the same time. An additional contraceptive method (mechanical method) must be used during the first 7 days of tablet intake if sexual intercourse occurs.

• if the patient was previously using a progestogen-only contraceptive method such as an injection, implant, or intrauterine system releasing progestogen

Mercilon tablets should be started on the day when the next injection would have been administered, 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 during the first 7 days of tablet intake if sexual intercourse occurs.

• after childbirth

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 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 after overdose of Mercilon. After ingestion of several tablets at once, nausea, vomiting, or vaginal bleeding may occur. In case of accidental ingestion of Mercilon by a child, consult a physician.

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 effective. 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 more tablets missed, the greater the risk of reduced contraceptive efficacy. The risk of pregnancy is higher when 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 during the first week of use:
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time) and continue taking the remaining tablets at the usual time. Use an additional method of contraception (e.g. a barrier method such as a condom) for the next 7 days. There is a possibility of becoming pregnant if sexual intercourse occurred in the week before the missed tablet. Consult your doctor.

One tablet missed during the second week of use:
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time) and continue taking the remaining tablets at the usual time. Contraceptive protection remains effective and no additional contraceptive method is required, provided the above condition has been met. However, if this condition has not been met, or if more than one tablet has been missed, an additional method of contraception should be used for the next 7 days.

One tablet missed during the third week of use:
There are two options to maintain contraceptive protection without needing an additional method, provided the patient has taken tablets correctly in the 7 days prior to the missed dose. 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), then continue taking the remaining tablets at the usual time. After finishing the last tablet in the pack, start the next pack without a break the following day. Withdrawal bleeding may not occur until the end of the second pack. However, spotting or intermenstrual bleeding may occur during tablet intake.

Or

2. Stop taking the remaining tablets in the pack, take a 7-day or shorter break (including the day the tablet was missed), and then start a new pack. When using this method, the next pack may be started on the same day of the week as usual.
   • If a tablet is missed and withdrawal bleeding does not occur during the first tablet-free interval, pregnancy should be considered. In this case, consult your doctor before starting tablets from the next pack.

yes
week 1 sexual intercourse during the week
preceding the missed tablet
no

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

Missed only 1 tablet – week 2

• take the missed tablet (gap longer than 12
• finish the pack hours)
• take the missed tablet
• finish the pack
• do not take the 7-day break
• continue taking tablets from the next pack week 3 or
• discard the remaining tablets in the pack
• take a break (no longer than 7 days in total, including the day of the missed tablet)
• continue taking 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 substances may be compromised. This situation is similar to
missing a tablet; therefore, act as if a tablet has been missed. In case of severe diarrhoea,
consult a physician.
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, shorten (never extend) the next break
from taking tablets. Example: if bleeding usually occurs on Friday and you wish to shift it to Tuesday (3 days earlier), start taking tablets from the next pack 3 days earlier than usual. If the break from taking tablets is very short (e.g. 3 days or less), withdrawal bleeding may not occur during this break; however, light intermenstrual bleeding or spotting may occur during intake of tablets from the next pack.
In case of unexpected bleeding during tablet intake
During the first few months of using any oral contraceptive tablets, irregular vaginal bleeding (spotting or intermenstrual bleeding) may occur between withdrawal bleeds. In such cases, do not stop taking the contraceptive tablets. This bleeding usually ceases after an adjustment period (typically after 3 cycles). If prolonged, heavy, or recurrent bleeding occurs, consult a physician.
In case withdrawal bleeding does not occur
Pregnancy is unlikely if tablets have been taken as directed, no vomiting occurred, and no other medications have been used concomitantly. You may continue taking Mercilon tablets.
If withdrawal bleeding does not occur consecutively for two cycles, pregnancy is possible. In this case, contact your physician immediately before starting the next pack of Mercilon to confirm whether pregnancy has occurred.

3.5 Stopping Mercilon

You may stop taking Mercilon at any time. If you do not plan 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 the estimation of 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 may cause adverse reactions, although not everyone experiences them. If any adverse reactions occur, especially if they are severe and persistent, or if the patient notices changes in health which she considers to be related to the use of Mercilon, medical advice should be sought from a doctor.

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

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 in 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
• Diarrhea
• Rash
• Urticaria
• Breast enlargement

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

• Blood clots in veins or arteries, for example:
  • in the leg or foot (e.g. deep vein thrombosis)
  • in the lungs (e.g. pulmonary embolism)
  • heart attack
  • stroke
  • transient ischaemic attack or temporary stroke-like symptoms, known as 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 that increase this risk (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

• Hypersensitivity
• Increased libido
• Intolerance to contact lenses
• Skin disorders (nodular erythema, erythema multiforme)
• Galactorrhea (milky discharge from breasts)
• 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 of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +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 the medicine out of the sight and reach of children.
Do not use the 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 in use. 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 packaging and other information
6.1 What Mercilon contains
The active substances are desogestrel 0.15 mg and ethinylestradiol 0.02 mg.
Other ingredients: colloidal anhydrous silica, monohydrate lactose, potato starch, povidone, stearic acid, all -rac-α -tokoferol.

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 of 21 tablets
63 tablets – 3 blisters of 21 tablets each
PVC/Al blister in a laminated aluminium sachet, packed in a cardboard box.
A cardboard pouch is included in the pack, into which the blister should be placed.
Translation of the symbols for days of the week printed next to each tablet on the immediate packaging:
MA – Monday
DI – Tuesday
WO – Wednesday
DO – Thursday
VR – Friday
ZA – Saturday
ZO – Sunday
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

6.3 Marketing Authorisation Holder and Manufacturer

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

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Number of the marketing authorisation in the Netherlands, the country of export: RVG 11508
Number of the parallel import authorisation: 221/19