Mercilon

Leaflet accompanying the packaging: user information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Mercilon

0.15 mg + 0.02 mg, tablets

Desogestrel + Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "BLOOD CLOTS").

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Mercilon and what is it used for
• 2. Important information before taking Mercilon
• 2.1 When not to take Mercilon
• 2.2 When to exercise special caution 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 than the recommended dose of Mercilon
• 3.4 What to do in case of...
• 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 what the pack contains
• 6.3 Other information

1. What is Mercilon and what is it used for

Mercilon is a combined oral contraceptive. Each tablet contains a small dose of two different female hormones. These are desogestrel (progestagen) and ethinylestradiol (estrogen). Due to the small hormone content, Mercilon is called a low-dose contraceptive pill. Mercilon belongs to the group of monophasic, combined oral contraceptives, as all the tablets in the pack contain the same amount of hormones.

Mercilon is used to prevent pregnancy.

Oral contraception is a very effective method of birth control. The possibility of becoming pregnant while taking contraceptive pills (provided that the patient does not forget to take the pills) is very small.

2. Important information before taking Mercilon

General notes

Before starting to take Mercilon, the patient should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "BLOOD CLOTS").

This leaflet describes most situations where the pill should be stopped or where its effectiveness may be reduced. In these situations, the patient should refrain from sexual intercourse or use additional, non-hormonal contraceptive methods, such as a condom or another mechanical method. The calendar method or temperature measurement method should not be used. These methods may be ineffective because contraceptive pills cause changes in temperature and cervical mucus that occur during the menstrual cycle.

Mercilon, like other contraceptive pills, does not protect against HIV (AIDS) or other sexually transmitted diseases.

Mercilon is prescribed by a doctor individually for each patient. Mercilon should not be given to other people.

Mercilon should not be used to delay the start of menstrual bleeding.

In exceptional cases, when there is a need to delay the start of menstrual bleeding, the patient should consult a doctor.

2.1 When not to take Mercilon

Mercilon should not be taken if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is allergic to the active substances or 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), lungs (pulmonary embolism), or other organs;
• if the patient knows they have a blood coagulation disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section "BLOOD CLOTS");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• hyperhomocysteinemia;
• if the patient has (or has had) a type of migraine called "migraine with aura";
• if the patient has (or has had) pancreatitis associated with severe hypertriglyceridemia;
• if the patient has jaundice or severe liver disease;
• if the patient has (or has had) a hormone-dependent malignant tumor (e.g., breast or genital organ cancer);
• if the patient has (or has had) a benign or malignant liver tumor;
• if the patient has (or has had) unexplained vaginal bleeding;
• if the patient has an enlarged endometrium (abnormal growth of the uterine lining);
• if the patient is pregnant or breastfeeding;
• if the patient has a 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 occur for the first time while taking Mercilon, the medicine should be stopped and a doctor consulted. In this case, a non-hormonal contraceptive method should be used (see also section 2 "GENERAL NOTES").

2.2 When to exercise special caution when taking Mercilon

Before starting to take Mercilon, the patient should discuss this with their doctor or pharmacist.

When should the patient contact their doctor?

• if the patient notices any of the following symptoms, which may indicate that they have a blood clot in their leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see section "BLOOD CLOTS" below). To find out about the symptoms of these serious side effects, see "HOW TO RECOGNIZE A BLOOD CLOT".

The patient should tell their doctor if they have any of the following conditions.

If these symptoms occur or worsen while taking Mercilon, the patient should also tell their doctor:

• if the patient smokes;
• if the patient has diabetes;
• if the patient is overweight;
• if the patient has high blood pressure;
• if the patient has heart valve problems or heart rhythm disorders;
• if the patient has inflammation of the veins under the skin (superficial thrombophlebitis);
• if the patient has varicose veins;
• if the patient has a history of blood clots, heart attack, or stroke in their immediate family;
• if the patient has migraines;
• if the patient has epilepsy;
• if the patient has elevated 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 the patient needs to undergo surgery or will be immobilized for a long time (see section "BLOOD CLOTS");
• if the patient has recently given birth, as they are at increased risk of blood clots. The patient should consult their doctor about when to start taking Mercilon after giving birth;
• if the patient has a history of breast cancer in their immediate family;
• if the patient has liver or gallbladder disease;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a genetic disorder that affects red blood cells);
• if the patient has experienced any of the following conditions for the first time during pregnancy or previous use of hormonal contraception: hearing loss, porphyria, pregnancy-related herpes, or Sydenham's chorea;
• if the patient experiences symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives potentially with difficulty breathing, they should contact their doctor immediately. Estrogen-containing products may cause or worsen symptoms of hereditary and acquired angioedema.
• if the patient has chloasma (yellow-brown skin pigmentation, especially on the face); in these cases, the patient should avoid sun exposure or ultraviolet radiation.

If any of the above factors occur for the first time while taking Mercilon, the patient should contact their doctor immediately.

Hormonal contraception and blood clots

BLOOD CLOTS

Taking combined hormonal contraceptives like Mercilon is associated with an increased risk of blood clots compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.

Blood clots can occur:

• in veins (also known as "venous thrombosis" or "venous thromboembolism");
• in arteries (also known as "arterial thrombosis" or "arterial thromboembolism").

Not everyone who gets a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It should be remembered that the overall risk of a blood clot caused by taking Mercilon is small.

HOW TO RECOGNIZE A BLOOD CLOT

The patient should contact their doctor immediately if they notice any of the following symptoms.

Is the patient experiencing any of these symptoms?

Why is the patient likely to be suffering from this condition?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may be felt only when standing or walking;

This can be felt when standing or walking;

• increased temperature in the affected leg;
• change in the color of the leg skin, such as pallor, redness, or cyanosis.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough without an obvious cause, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If the patient is unsure, they should contact their doctor, as some of these symptoms, such as coughing or shortness of breath, can be mistaken for less serious conditions, such as a respiratory infection (e.g., a cold).

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). Although these side effects are rare, they can occur, especially in the first year of taking combined hormonal contraceptives.
• If a blood clot forms in the veins of the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot moves from the leg to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.

If the patient stops taking Mercilon, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots caused by taking Mercilon is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's immediate family has had a blood clot in their leg, lung, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop taking Mercilon for a few weeks before surgery or immobilization. If the patient needs to stop taking Mercilon, they should ask their doctor when they can resume taking it;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of a blood clot increases with the number of risk factors present in the patient.

Air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.

It is essential to tell the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop Mercilon.

The patient should inform their doctor if any of the above conditions change while taking Mercilon, such as starting to smoke, a family member being diagnosed with a blood clot without a known cause, or significant weight gain.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similar to blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

What factors increase the risk of blood clots in arteries?

It is essential to note that the risk of a heart attack or stroke associated with taking Mercilon is very small, but it may increase:

• with age (over 35 years old);
• if the patient smokes. While taking a hormonal contraceptive like Mercilon, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, their doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of these conditions or if any of them are severe, the risk of a blood clot may be even higher.

The patient should inform their doctor if any of the above conditions change while taking Mercilon, such as starting to smoke, a family member being diagnosed with a blood clot without a known cause, or significant weight gain.

Hormonal contraception and cancer

Women taking contraceptive pills have a slightly higher risk of breast cancer than women of the same age who do not take contraceptive pills. This small increase in the risk of breast cancer disappears gradually within 10 years of stopping contraceptive pills.

It is not known whether this difference is caused by the contraceptive pills. It may be that women taking contraceptive pills are more likely to have medical check-ups and breast cancer is detected earlier.

In very rare cases, women taking contraceptive pills have been found to have benign liver tumors, and even more rarely, malignant liver tumors. These tumors can cause bleeding into the abdominal cavity.

If the patient experiences severe abdominal pain, they should contact their doctor immediately.

Chronic infection with the human papillomavirus (HPV) is the most significant risk factor for cervical cancer. It is thought that cervical cancer may occur slightly more often in women who have taken contraceptive pills for a long time.

This may not be caused by the contraceptive pills. It is likely that it is related to sexual behavior or other factors.

Psychological disorders

Some women taking hormonal contraceptives, including Mercilon, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts.

If the patient experiences mood changes or symptoms of depression, they should contact their doctor as soon as possible for further medical advice.

Mercilon and other medicines

The patient should always tell their doctor about any medicines or herbal products they are currently taking.

The patient should also inform their doctor or another doctor who prescribes other medicines (or pharmacist) that they are taking Mercilon.

Some medicines:

• may affect the levels of Mercilon in the blood;
• may reduce its contraceptive effectiveness;
• may cause unexpected bleeding.

This applies to medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g., boceprevir, telaprevir);
• other infectious diseases (e.g., griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depression (St. John's Wort (Hypericum perforatum)).

If the patient is taking medicines or herbal products that may reduce the effectiveness of Mercilon, they should also use a mechanical contraceptive method.

Because the effect of another medicine on Mercilon may last up to 28 days after stopping the medicine, it is necessary to use additional mechanical contraception during this time.

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

• cyclosporine;
• the antiepileptic medicine lamotrigine (this may lead to an increased frequency of seizures).

If the patient has a hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, they should not take Mercilon, as this may cause an increase in liver function test results in the blood (increase in liver enzyme ALT activity).

Before starting these medicines, the patient's doctor will prescribe a different type of contraceptive.

Mercilon can be started again about 2 weeks after finishing this treatment.

See section "WHEN NOT TO TAKE MERCILON".

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Mercilon is contraindicated in pregnancy.

If the patient becomes pregnant while taking Mercilon, they should contact their doctor immediately.

Mercilon is not recommended during breastfeeding.

If the patient wants to take Mercilon while breastfeeding, they should consult their doctor.

Driving and using machines

Taking Mercilon does not affect the ability to drive or use machines.

Mercilon contains lactose monohydrate

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking Mercilon.

Use in children and adolescents

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

2.3 When to consult a doctor

Regular check-ups

A woman taking contraceptive pills should be informed by her doctor about the need for regular medical check-ups.

These check-ups are usually done once a year.

The patient should contact their doctor immediately in the following cases:

• if the patient notices any of the following symptoms, which may indicate that they have a blood clot in their leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see section "BLOOD CLOTS" above). To find out about the symptoms of these serious side effects, see "HOW TO RECOGNIZE A BLOOD CLOT";
• if there are any changes in their health, especially the conditions mentioned earlier in this leaflet (see sections "WHEN NOT TO TAKE MERCILON" and "IMPORTANT INFORMATION BEFORE TAKING MERCILON"), not forgetting the information about their family medical history that may affect the use of contraceptive pills;
• if they feel a breast lump;
• if the patient experiences symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives potentially with difficulty breathing (see also section 2.2 "WHEN TO EXERCISE SPECIAL CAUTION WHEN TAKING MERCILON");
• if they plan to take other medicines (see also section "MERCILON AND OTHER MEDICINES");
• if they are immobilized or plan to undergo surgery (they should consult their doctor at least 4 weeks in advance);
• if they experience irregular, heavy vaginal bleeding;
• if they missed a period and are experiencing symptoms of pregnancy;
• if they have severe diarrhea;
• if they missed a period and are experiencing symptoms of pregnancy (they should not start the next pack of Mercilon until they have consulted their doctor).

3. How to take Mercilon

This medicine should always be taken exactly as prescribed by the doctor.

In case of doubt, the patient should consult their doctor or pharmacist.

3.1 When and how to take the tablets

The pack of Mercilon contains 21 tablets. Each tablet has a symbol of the day of the week on which it should be taken (see "TRANSLATION OF DAY SYMBOLS ON THE BLISTER PACK" - section 6 at the end of the leaflet).

The tablets should be taken at the same time every day, if necessary with a glass of water.

Taking the tablets should be continued for 21 days, following the direction of the arrows.

Then, the patient should wait for 7 days during which they do not take tablets.

Menstrual bleeding (withdrawal bleeding) should occur during these 7 tablet-free days.

It 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 the patient is still bleeding.

This means that the patient will always start a new pack on the same day of the week and that the withdrawal bleeding will occur at about the same time every month.

Use in children and adolescents

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

3.2 Starting the first pack of Mercilon

• If the patient did not use any hormonal contraceptive method in the previous monthThe patient should start taking the first tablet of Mercilon on the first day of their period.

  No additional contraceptive method is needed.

Taking the tablets can also be started between the 2nd and 5th day of the menstrual cycle, but in this case, an additional contraceptive method (mechanical method, e.g., condom) should be used during the first 7 days of tablet intake in the first cycle.

• If the patient previously used another combined hormonal contraceptive (pills, vaginal rings, patches)The patient can start taking Mercilon the next day after taking the last active tablet of their previous contraceptive.

  If the previous contraceptive had placebo tablets, the patient can start taking Mercilon the next day after taking the last active tablet (if in doubt, the patient should ask their doctor or pharmacist which tablet is the last active one).

  The patient can also start taking Mercilon later, but no later than the day after the tablet-free period of their previous contraceptive (or the day after taking the last placebo tablet of their previous contraceptive).

If the patient has been taking contraceptive pills regularly, they can stop taking them and start taking Mercilon at any time.

When taking Mercilon according to the above instructions, no additional contraceptive method is needed.

• If the patient previously used a progestogen-only pill (minipill)The patient can stop taking the minipill at any time and start taking Mercilon the next day, at the same time.

  An additional contraceptive method (mechanical method, e.g., condom) should be used during the first 7 days of tablet intake if the patient has sexual intercourse.

• If the patient previously used an injectable, implant, or intrauterine system releasing a progestogenThe patient should start taking Mercilon on the day they would have had their next injection or on the day the implant or intrauterine system is removed.

  An additional contraceptive method (mechanical method, e.g., condom) should be used during the first 7 days of tablet intake if the patient has sexual intercourse.

• After childbirthThe doctor may advise the patient to wait until their first menstrual period before starting to take Mercilon.

  The doctor may also advise the patient to start taking Mercilon earlier.

  If the patient is breastfeeding, they should discuss taking hormonal contraception with their doctor.

• After a miscarriageAccording to the doctor's instructions.

3.3 Taking more than the recommended dose of Mercilon

No serious harmful effects have been observed after an overdose of Mercilon.

If several tablets are taken at the same time, the patient may experience nausea, vomiting, or vaginal bleeding.

If a child accidentally takes Mercilon, the patient should consult their doctor.

3.4 What to do in case of...

Missing a dose of Mercilon:

• If the delay in taking a tablet is less than 12 hours, the effectiveness of the tablet is maintained.

  The patient should take the missed tablet as soon as possible and continue taking the rest of the tablets as usual.

• If the delay in taking a tablet is more than 12 hours, the effectiveness of the tablet may be reduced.

  The more tablets the patient misses, the higher the risk of reduced contraceptive effectiveness.

  A higher risk of pregnancy exists if the patient misses a tablet at the beginning or end of the cycle.

  The patient should read the information below (see also the scheme).

More than one missed tablet in a pack

The patient should consult their doctor.

1 missed tablet in the first week of taking

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time) and continue taking the rest of the tablets as usual.

For the next 7 days, the patient should use an additional contraceptive method (mechanical method, e.g., condom).

There is a risk of pregnancy if the patient has had sexual intercourse during the week before missing the tablet.

The patient should consult their doctor.

1 missed tablet in the second week of taking

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time) and continue taking the rest of the tablets as usual.

The effectiveness of the tablet is maintained, and no additional contraceptive method is needed.

If the above condition is not met or the patient has missed more than one tablet, the patient should be advised to use an additional contraceptive method for the next 7 days.

3.5 Stopping Mercilon

You can stop taking Mercilon at any time. If you do not plan to become pregnant, you should ask your doctor for another contraceptive method.
In case of planning a pregnancy, it is usually recommended to wait until the first natural menstruation after stopping the tablets, which will make it easier to determine the expected date of delivery.
In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Mercilon can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that you consider related to the use of Mercilon, you should consult a doctor.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before taking Mercilon".
You should immediately consult a doctor if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria potentially with dyspnea (see also section 2 "Important information before taking Mercilon").
Common(occurring more frequently than in 1 in 100 women, but less frequently than in 1 in 10 women):

• depressive mood, mood changes,
• headaches,
• nausea, abdominal pain,
• breast pain and tenderness,
• weight gain.

Uncommon(occurring more frequently than in 1 in 1000 women, but less frequently than in 1 in 100 women):

• fluid retention in the body,
• decreased sexual desire,
• migraine,
• vomiting,
• diarrhea,
• rash,
• urticaria,
• breast enlargement.

Rare(occurring more frequently than in 1 in 10,000 women, but less frequently than in 1 in 1000 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 stroke-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach/intestine, kidneys, or eye. The risk of blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors and symptoms of blood clots)
• hypersensitivity,
• increased sexual desire,
• intolerance to contact lenses,
• skin diseases (erythema multiforme, erythema nodosum),
• breast discharge,
• leucorrhea,
• weight loss.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Mercilon

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiration date stated on the package. The expiration date refers to the last day of the given month.
Store at a temperature below 30°C. Do not freeze.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of unused medicines. This will help protect the environment.
Do not use this medicine if you notice changes in the color of the tablets, crushing of the tablets, or other visible signs of tablet degradation.

6. Package contents and other information

6.1 What Mercilon contains

The active substances of the medicine are desogestrel at a dose of 0.15 mg and ethinylestradiol at a dose of 0.02 mg.
Other ingredients are: potato starch, colloidal anhydrous silica, all-rac-α-tocopherol, stearic acid, povidone, lactose monohydrate.

6.2 What Mercilon looks like and what the package contains

The tablets are round, biconvex, 6 mm in diameter, marked with code 4 below TR on one side and Organon* on the other.
21 tablets – 1 blister of 21 tablets.
63 tablets – 3 blisters of 21 tablets each.
PVC/Al blisters, each in a laminated aluminum foil sachet, in a cardboard box.
A cardboard sachet is attached to the package, in which you should put the blister after removing it from the protective foil.

6.3 Other information

For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Manufacturer:

N.V. 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands export license number: RVG 11508

Parallel import license number: 109/14

Translation of day-of-the-week symbols on the packaging:

MA – Monday
DI

• Tuesday WO - Wednesday DO
• Thursday VR
• Friday ZA
• Saturday ZO
• Sunday

Leaflet approval date: 12.02.2024

[Information about the trademark]