Mercilon

Leaflet accompanying the packaging: 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

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 or pharmacist should be consulted.
• This medicine has been prescribed specifically for one 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 packaging and other information
• 6.1 What Mercilon contains
• 6.2 How Mercilon looks and what the packaging 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 tablets in the packaging contain the same amount of hormones. Mercilon is used to prevent pregnancy. The method of 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, you 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"). Most of the situations described in this leaflet indicate when you should stop taking the pill or when the effectiveness of the pill may be reduced. In these situations, you should refrain from sexual intercourse or use additional, non-hormonal contraceptive methods, such as a condom or another mechanical method. You should not use the calendar method or the temperature measurement method. 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 others. Mercilon should not be used to delay the start of menstruation. In exceptional cases, when there is a need to delay the start of menstruation, you 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 clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have 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 in the past) 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)
• a disease 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 hypertriglyceridemia;
• if the patient has jaundice or severe liver disease;
• if the patient has (or has had in the past) a malignant tumor that is hormone-dependent (e.g., breast or genital organ cancer);
• if the patient has (or has had in the past) a benign or malignant liver tumor;
• if the patient has 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 and pibrentasvir (see also section "Mercilon and other medicines").

If any of the above conditions occur for the first time during Mercilon treatment, the medicine should be stopped and a doctor consulted, and during this time, 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.

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

If these symptoms occur or worsen during Mercilon treatment, 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 (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 been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, in which case they are at increased risk of blood clots. The patient should consult their doctor to find out how soon they can start taking Mercilon after giving birth;
• if the patient has breast cancer, either currently or in the past, or if it has occurred in their immediate family; When to consult a doctor? The patient should consult their doctor immediately
• if the patient notices any possible symptoms of blood clots, which may indicate that they have blood clots in their leg (deep vein thrombosis), blood clots in their lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots"). To find out about the symptoms of these serious side effects, see "How to recognize blood clots".
• 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, herpes gestationis, or Sydenham's chorea;
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing, they should consult their doctor immediately (see also section 2.2 "When to exercise special caution when taking Mercilon");
• if the patient has chloasma (yellow-brown pigmentation spots on the skin, 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 during Mercilon treatment, the patient should consult their doctor immediately.

2.2.1 Hormonal contraception and blood clotting 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 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 thromboembolism" or "deep vein thrombosis")
• in arteries (also known as "arterial thromboembolism").

Not everyone recovers fully from a blood clot. 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 serious blood clots caused by Mercilon is small.

HOW TO RECOGNIZE BLOOD CLOTS

The patient should consult 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?

• 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 only be felt when standing or walking;
• increased temperature in the affected leg;

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 blood clots in veins (venous thromboembolism). Although these side effects are rare, they occur most often in the first year of use.
• If blood clots form in the veins of the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges in 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 veins highest?

The risk of blood clots in veins is highest during the first year of use of combined hormonal contraceptives for the first time. The risk may also be higher when resuming use of 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 using 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 depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used. The overall risk of blood clots in the legs or lungs associated with Mercilon is small.

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

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Mercilon is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m^2);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50); in this case, the patient may have a genetic blood clotting disorder;
• if the patient needs to have 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);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient. Air travel (more than 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 not sure. The doctor may decide to stop Mercilon. The patient should inform their doctor if any of the above conditions change during Mercilon treatment, e.g., if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?

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

Factors that increase the risk of blood clots in arteries

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

• with age (over about 35);
• 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, the 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). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or someone in their immediate family has been diagnosed with 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 blood clots may be even higher.

The patient should inform their doctor if any of the above conditions change during Mercilon treatment, e.g., if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

2.2.2 Hormonal contraception and cancer

Women taking contraceptive pills may have a slightly higher risk of breast cancer than women who do not take contraceptive pills. This small increase in risk is likely to disappear within 10 years of stopping treatment. It is not known whether this difference is caused by the contraceptive pills. It may be that women taking contraceptive pills are examined by doctors more often and breast cancer is detected earlier. In very rare cases, women taking contraceptive pills have been reported 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 see a doctor immediately.

Psychological disorders

Some women taking 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, the patient should see their doctor as soon as possible for further medical advice.

2.2.3 Mercilon and other medicines

The patient should always tell their doctor about any medicines or herbal products they are currently taking. They should also inform their doctor or dentist prescribing other medicines (or pharmacist) that they are taking Mercilon. These healthcare professionals may inform them about the need to use an additional contraceptive method (e.g., a condom) and for how long, as well as whether the patient needs to adjust the dose of the other medicine. Some medicines

• may affect the level 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);
• depressive moods (St. John's Wort (Hypericum perforatum)).

If the patient is taking medicines or herbal products that may reduce the effectiveness of Mercilon, they should use an additional mechanical contraceptive method. Since the effect of another medicine on Mercilon may persist for 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 and pibrentasvir, they should not take Mercilon, as this may cause an increase in liver enzyme levels in blood tests (increase in alanine aminotransferase activity). Before starting these medicines, the doctor will prescribe a different type of contraceptive. The patient can resume taking Mercilon about 2 weeks after finishing this treatment. See section "When not to take Mercilon".

2.2.4 Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Mercilon is contraindicated in pregnancy. If the patient suspects they are pregnant during Mercilon treatment, they should see their doctor immediately. Mercilon is not recommended during breastfeeding. If the patient wants to take Mercilon during breastfeeding, they should consult their doctor.

2.2.5 Driving and using machines

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

2.2.6 Mercilon contains lactose

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

2.2.7 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 The patient taking contraceptive pills should be informed by their doctor about the need for regular medical check-ups. These check-ups are usually performed once a year. The patient should see their doctor immediately in the following cases:

• if the patient notices any possible symptoms of blood clots, which may indicate that they have blood clots in their leg (deep vein thrombosis), blood clots in their lungs (pulmonary embolism), a heart attack, or a stroke (see section above "Blood clots"). To find out about the symptoms of these serious side effects, see "How to recognize blood clots";
• if there are any changes in their health, especially any of the conditions mentioned earlier in this leaflet (see sections "When not to take Mercilon" and "Important information before taking Mercilon"), including 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 swelling of the face, tongue, and/or throat, 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 2.2.3 "Mercilon and other medicines");
• if they are immobilized or plan to have surgery (they should consult their doctor at least 4 weeks in advance); if they experience irregular, heavy vaginal bleeding;
• if they missed a pill in the first week of taking it and had sexual intercourse in the previous 7 days;
• if they experience severe diarrhea;
• if they do not have their period for two consecutive months or if they suspect they are pregnant (they should not start the next pack without consulting 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. The tablets should be taken at the same time every day, if necessary with a little water. The patient should continue taking the tablets for 21 days, following the direction of the arrows. Then, they should take a 7-day break during which they will not take any tablets. Withdrawal bleeding (breakthrough bleeding) should occur during these 7 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 bleeding has not stopped yet. This means that the patient will always start a new pack of Mercilon on the same day of the week, and the withdrawal bleeding will occur on the same days of each 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 month

The patient should start taking the first tablet of Mercilon on the first day of their menstrual cycle (i.e., the first day of bleeding). There is no need to use an additional contraceptive method. The patient can also start taking the first tablet between the 2nd and 5th day of their menstrual cycle, but in this case, they should use an additional mechanical contraceptive method (e.g., a condom) for the first 7 days of tablet-taking.

• If the patient previously used another combined hormonal contraceptive (pills, transdermal patches, vaginal rings)

The patient can start taking Mercilon on the day after taking the last active tablet of their previous contraceptive. If their previous contraceptive contained placebo tablets, the patient can start taking Mercilon on the day after taking the last placebo tablet (if they are not sure which tablet it is, they should ask their doctor or pharmacist). The patient can also start taking Mercilon later, but no later than the day they would have started their next contraceptive. In the case of a transdermal patch or vaginal ring, the patient should start taking Mercilon on the day they would have applied a new patch or inserted a new ring.

• If the patient previously used a progestogen-only contraceptive (mini-pill, implant, or intrauterine system)

The patient can stop taking the mini-pill and start taking Mercilon on the following day. If they used an implant or intrauterine system, they should start taking Mercilon on the day the implant is removed or the intrauterine system is taken out. The patient should use an additional mechanical contraceptive method (e.g., a condom) for the first 7 days of tablet-taking if they have sexual intercourse.

• After childbirth

The doctor may advise the patient to start taking Mercilon from the first day of their menstrual cycle. The doctor may also advise the patient to start taking Mercilon earlier. In the case of breastfeeding, the patient should consult their doctor before taking Mercilon.

• After miscarriage or abortion

The patient should follow their doctor's advice.

3.3 Taking more than the recommended dose of Mercilon

No serious harmful effects have been observed after taking 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 has taken 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 contraceptive effectiveness is maintained. The patient should take the missed tablet as soon as possible and continue taking the tablets as usual.
• If the delay in taking a tablet is more than 12 hours, the contraceptive effectiveness may be reduced. The more tablets the patient misses, the higher the risk of reduced effectiveness. There is a higher risk of pregnancy if the patient misses a tablet at the beginning or end of the pack. Please see the information below (also see the diagram).

More than one missed tablet from the pack

The patient should consult their doctor.

One missed tablet in the first week of taking Mercilon

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 tablets as usual. For the next 7 days, the patient should use an additional mechanical contraceptive method (e.g., a condom). There is a risk of pregnancy if the patient had sexual intercourse in the week before missing the tablet. The patient should consult their doctor.

4. Possible adverse reactions

Like all medicines, Mercilon can cause adverse reactions, although they do not occur in every patient. If any adverse reactions occur, especially severe and persistent ones, or changes in health that the patient considers to be related to the use of Mercilon, the patient should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, the patient should read section 2 "Important information before taking Mercilon".
The patient should immediately consult a doctor if they experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with dyspnea (see also section 2 "Important information before taking Mercilon").
Frequently(occurring in less than 1 in 100 patients, but more frequently than in 1 in 1,000 patients):

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

Less frequently(occurring in less than 1 in 1,000 patients, but more frequently than in 1 in 10,000 patients):

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

Rarely(occurring in less than 1 in 10,000 patients, but more frequently than in 1 in 100,000 patients):

• 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 likelihood of blood clots may be higher if the patient has 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 nodosum, erythema multiforme),
• breast discharge,
• leucorrhea,
• weight loss.

Reporting adverse reactions

If any adverse reactions occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Drug Safety Monitoring of 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, https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to gather more information on the safety of the drug.

5. How to store Mercilon

The drug should be stored in a place inaccessible to children.
Do not use the drug after the expiration date stated on the packaging. The expiration date is the last day of the given month.
Store at a temperature below 30°C. Do not freeze. Store in the original packaging to protect from light and moisture.
Do not use this drug if a change in the color of the tablets, crumbling of the tablets, or other visible signs of tablet degradation are observed.
Drugs should not be disposed of in sewage or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

6.1 What Mercilon contains

The active substances of the drug 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 what the package contains

The tablets are round, biconvex, 6 mm in diameter, and marked with the code 4 below TR on one side and the inscription Organon* on the other.
21 tablets – 1 blister pack of 21 tablets.
63 tablets – 3 blister packs of 21 tablets each.
PVC/Aluminum blisters, each in a foil pouch, in a cardboard box.
A cardboard pouch is attached to the packaging, in which the blister should be placed after removal from the protective foil.

6.3 Other information

For more detailed information, the patient should contact the marketing authorization holder or 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Netherlands marketing authorization number, country of export:RVG 11508
Parallel import authorization number:182/19
Translation of the day of the week symbols on the packaging:
MA -Monday
DI -Tuesday
WO -Wednesday
DO -Thursday
VR -Friday
ZA -Saturday
ZO -Sunday

Date of leaflet approval: 25.04.2024

[Information about the trademark]