Mercilon

Patient Information Leaflet

Keep this leaflet! The packaging contains information in a foreign language.
Mercilon
0.15 mg + 0.02 mg, tablets
Desogestrel + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Mercilon is and what it is used for

Mercilon is a combined oral contraceptive. Each tablet contains a 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 contraceptive pill. 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 oral contraceptive method is a highly effective method of birth control. The chance of becoming pregnant while taking contraceptive pills (provided the patient does not miss any tablets) is very small.

2. Important information before using Mercilon

General remarks
Before starting to take Mercilon, you should read the information about
blood clots in section 2. It is particularly important to be aware of the symptoms of
blood clots (see section 2 "Blood clots").
This leaflet describes most situations in which you should stop taking the tablet or when the effectiveness
of the tablet may be reduced. In such situations, you should avoid sexual intercourse
or use additional non-hormonal contraceptive methods, such as a condom or another mechanical method.
Do not use the calendar method or the temperature 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 contraceptive pills, does not protect against HIV infection (AIDS)
or other sexually transmitted diseases.
Mercilon is prescribed individually by a doctor for each woman. Do not give Mercilon to other people.
Mercilon should not be used to delay the onset of bleeding.
In exceptional circumstances, when there is a need to delay the start date of bleeding, you should consult your doctor.

2.1 When not to use Mercilon

Do not use Mercilon if the patient has any of the conditions listed below. If any of these conditions are present, inform the doctor. The doctor will discuss with the patient which alternative method of contraception would be more suitable.

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows she has blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if the patient has had a heart attack or stroke;
• if the patient has (or has previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if the patient has any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a condition called hyperhomocysteinemia;
• 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 hypertriglyceridemia;
• 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 above conditions occurs for the first time during treatment with Mercilon, the medicine should be discontinued and the patient should consult her doctor. During this time, a non-hormonal method of contraception should be used (see also section 2 “General warnings”).

2.2 When to exercise special caution when using Mercilon

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

• if you notice symptoms suggesting blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or stroke (see section below "Blood clots"). For a description of the symptoms of these serious adverse reactions, see "How to recognize the occurrence of blood clots".

You must inform your doctor if you have any of the following conditions.
If any of these symptoms 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 problems;
• if you have inflammation of the superficial 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 elevated blood lipid levels (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you are in the immediate postpartum period, as you are then at increased risk of developing blood clots. You should consult your doctor for advice on 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 body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you experienced hearing loss, porphyria, herpes gestationis, or Sydenham's chorea for the first time or worsening during pregnancy or previous use of hormonal contraception;
• if you develop symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria potentially accompanied by breathing difficulties – seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• if you currently have or have previously had chloasma (yellowish-brown pigmented patches on the skin, particularly on the face); in such cases, exposure to sunlight or ultraviolet radiation should be avoided.

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

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

Recovery from a blood clot is not always complete. 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 OCCURRENCE OF BLOOD CLOTS
Seek medical advice immediately if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or Deep vein thrombosis in the foot, particularly if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased warmth in the affected leg;

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• Use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thromboembolism). Although these adverse events are rare, they occur most frequently 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 initial use of combined hormonal contraceptives. The risk may also be increased when restarting combined hormonal contraceptives (same or 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 factors influence the risk of blood clots?
The risk depends on the individual's baseline 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 9–12 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 increasing the risk of venous blood clots" below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Mercilon is small, however
some factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years of age). In such case the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, is immobilised 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 immobilisation. If the patient needs to stop taking Mercilon, ask the doctor when it is safe to restart taking the medicine;
• with increasing age (particularly over 35 years of age);
• if the patient has given birth within the last few weeks.

The risk of blood clots increases with the number of risk factors present in the
patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue Mercilon.
Inform the doctor if any of the above conditions change during treatment with Mercilon,
e.g. if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.
BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots may cause serious
consequences, such as heart attack or stroke.
Factors increasing the risk of blood clots in arteries
It is important to note that the risk of heart attack or stroke associated with the use of Mercilon
is very low, 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 another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under
  50 years of age). 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 blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve damage, 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,
e.g. if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.
2.2.2 Hormonal contraception and cancer
Breast cancer occurs slightly more frequently in women using contraceptive pills than in women
of the same age who do not use them. This slight increase in the frequency of breast cancer diagnosis
gradually disappears over a 10-year period after stopping the use of contraceptive pills.
It is not known whether this difference is caused by the use of contraceptive pills. It may
be related to the fact that women using contraceptive pills undergo medical examinations more frequently and breast cancer is diagnosed earlier in them.
In very rare cases, benign
liver tumours have been observed in women using contraceptive pills, and even more rarely malignant ones. Such tumours may lead to bleeding into the abdominal cavity. In case of severe abdominal pain, contact a doctor immediately.
Chronic infection with human papillomavirus (HPV) is the most significant risk factor for cervical cancer. It is believed that cervical cancer may occur slightly more frequently in women who have used contraceptive pills for a long time. This may not be caused by contraceptive pills. It is probably related to sexual behaviour or other factors.
Psychiatric disorders
Some women using hormonal contraceptives, including Mercilon, have reported
depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible to obtain 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 a doctor of another specialty or a dentist, or a pharmacist prescribing other medicines, about the use of Mercilon. They may advise on the need for additional contraceptive methods (e.g. condoms), how long they should be used, and whether any modification of the other medicine is necessary.
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);
• high blood pressure in the pulmonary blood vessels (bosentan);
• depressive mood disorders (St. John's wort (Hypericum perforatum)).

If the patient is taking medicines or herbal remedies that may reduce the effectiveness of Mercilon,
a mechanical contraceptive method should also be used. Due to the fact that the effect of another medicine on Mercilon may persist for up to 28 days after discontinuation of the medicine, additional mechanical contraception must be used during this time.
Mercilon may affect the action of other medicines such as, e.g.

• medicines containing cyclosporine
• the anticonvulsant lamotrigine (this may lead to increased frequency of seizures)

If the patient has hepatitis C virus infection and is taking medicines
containing ombitasvir, paritaprevir, ritonavir and dasabuvir or glecaprevir, pibrentasvir, Mercilon should not be used, as this may lead to increased liver function parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).
Before starting these medicines, the treating doctor will prescribe another type of contraceptive.
Mercilon may be restarted approximately 2 weeks after completion of this treatment.
See section "When not to use Mercilon".
2.2.4 Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to have a
child, 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.
The use of Mercilon is not recommended during breastfeeding.
If the patient wishes to use Mercilon during breastfeeding, consult a doctor.
2.2.5 Driving and operating machinery
The use of Mercilon has no effect on the ability to drive vehicles and operate machinery.
2.2.6 Mercilon contains lactose
If it has been previously diagnosed that the patient has intolerance to certain sugars, the patient should
consult a doctor before taking the 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
The patient using contraceptive pills should be informed by the doctor about
the need for regular medical examinations. Such examinations are usually performed
once a year.
Contact a doctor immediately in the following cases:

• if the patient notices symptoms suggesting blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack or stroke (see section above "BLOOD CLOTS". For a description of symptoms of these serious adverse reactions, see "How to recognise the formation of blood clots");
• if any changes in health status occur, especially the disorders mentioned earlier in the leaflet (see sections: "When not to use Mercilon" and "Important information before using Mercilon"), without forgetting information relating to the health status of close family members that may affect the use of contraceptive pills;
• if a breast lump is detected;
• if the patient develops symptoms of angioedema, e.g. swelling of the face, tongue and/or throat, and/or difficulty swallowing or urticaria potentially with breathing difficulties (see also section 2.2 When to exercise particular caution when using Mercilon);
• when planning to use other medicines (see also section 2.2.3 Mercilon and other medicines);
• immobilisation or planned surgical procedure (consult a doctor at least 4 weeks in advance);if irregular, heavy vaginal bleeding occurs;
• if the patient missed tablets in the first week of use and had sexual intercourse within the preceding 7 days;
• if severe diarrhoea occurs;
• if menstruation does not occur for two consecutive cycles or if pregnancy is suspected (do not start the next pack before consulting a doctor).

3. How to use Mercilon
This medicine should always be used according to the doctor's instructions. In case of doubt, consult
the doctor or pharmacist.
3.1 When and how to take tablets
The Mercilon pack contains 21 tablets. Each tablet has a symbol indicating the day of the
week on which it should be taken (translation of the day-of-the-week symbols next to each tablet on the immediate packaging is at the end of the leaflet). Tablets should be taken at the same time each day, with water if necessary. Continue taking tablets for 21 days in the direction of the arrows. Then wait 7 days without taking any tablets. Withdrawal bleeding (menstrual-like bleeding)
should occur within these 7 days. It usually occurs 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 ongoing. This means that a new pack is always started on the same day of the week, and withdrawal bleeding occurs more or less on 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 in the previous month the patient did not use any hormonal contraceptive method

Start taking the first tablet of Mercilon 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 the 2nd and 5th day of the cycle, but in this
case an additional contraceptive method (mechanical method, e.g.
condom) must be used for the first 7 days of tablet intake in the first cycle.

• if previously the patient used another combined oral contraceptive (tablets, vaginal ring, transdermal system)

You may start taking Mercilon tablets the day after taking the last tablet of the
previous medicine (without taking a break for the tablet-free days). If the currently used medicine also contains placebo tablets, you may start taking Mercilon the day after taking the last hormone-containing tablet (in case of doubt about which tablet this is, ask the doctor or pharmacist). You may also start taking the first Mercilon tablet later, but not later than the day following the tablet-free days of the currently used medicine (or the day after the last placebo tablet of the currently used medicine). For a vaginal ring or transdermal system, start taking Mercilon on the day of removal of the vaginal ring or transdermal system, but no later than the date when the vaginal ring or transdermal system should be re-applied.
If the patient has regularly used contraceptive tablets, a transdermal system or a vaginal ring and is sure she is not pregnant, she may discontinue the tablets, vaginal ring or transdermal system on any day and immediately start taking Mercilon.
When using Mercilon according to the above instructions, an additional contraceptive method is not required.

• if previously the patient used a progestogen-only pill (so-called mini-pill)

The mini-pill may be discontinued at any time and the next day Mercilon should be started at the same time. An additional contraceptive method (mechanical method) must be used
simultaneously for the first 7 days of tablet intake if sexual intercourse is maintained.

• if previously the patient used contraception by injection, implant or intrauterine system releasing progestogen

Start taking Mercilon tablets on the day when the next injection should be given 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
simultaneously for the first 7 days of tablet intake if sexual intercourse is maintained.

• after childbirth

After childbirth, the doctor may recommend waiting until the first menstruation before starting tablets. The doctor may also recommend starting tablets earlier. In case of breastfeeding, discuss the use of hormonal contraception with the doctor.

• after miscarriage

According to the doctor's recommendations.
3.3 Use of a higher than recommended dose of Mercilon
No serious harmful effects have been observed after overdose of Mercilon. After taking several tablets at once, nausea, vomiting or vaginal bleeding may occur.
In case of accidental ingestion of Mercilon by a child, consult a doctor.
3.4 What to do in case of...
Missing a dose of Mercilon:

• If the delay in taking tablets is less than 12 hours, the effectiveness of the tablets is maintained. Take the missed tablet as soon as possible and continue taking the remaining tablets as usual.
• If the delay in taking tablets is more than 12 hours, the effectiveness of the tablets may be reduced. The more tablets missed, the greater the risk of reduced contraceptive effectiveness. The risk of pregnancy is higher if a tablet is missed at the beginning or end of the cycle. Please refer to the information provided below (see also the scheme).

More than one tablet missed from the pack
Consult a doctor.
One tablet missed in the first week of use
Take the missed tablet as soon as possible (even if this means taking two tablets
at the same time), and continue with the remaining tablets as usual. For the next 7 days, use an additional contraceptive method (mechanical method, e.g. condom). There is a possibility of pregnancy if sexual intercourse occurred in the week preceding the missed tablet. Consult a doctor.
One tablet missed in the second week of use
Take the missed tablet as soon as possible (even if this means taking two tablets
at the same time), and continue with the remaining tablets as usual. The effectiveness of the tablet is maintained and additional contraceptive methods are not required. If the above condition was not met or the patient missed more than one tablet, an additional contraceptive method should be used for the next 7 days.
One tablet missed in the third week of use
There are two options without the need to use an additional contraceptive method, provided that in the 7 days preceding the missed tablet the patient took tablets correctly. Otherwise, the patient should apply the first of the two options below and simultaneously use an additional contraceptive method for 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue with the remaining tablets as usual. After taking the last tablet of the pack, start the next pack the next day without taking a break. Withdrawal bleeding may occur only after completing the tablets from the second pack. However, spotting or intermenstrual bleeding may occur during tablet intake.

Or

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

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

• take the missed tablet
• use an additional contraceptive method for 7 days missed - complete the pack only 1 tablet
• take the missed tablet - take the missed tablet (break week 2 week 2
• complete the pack - complete the pack more than 12 hours)
• take the missed tablet
• complete the pack
• do not take a 7-day break
• continue taking tablets from the next pack

or
week 3

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

In case of gastrointestinal disorders (e.g. vomiting, severe diarrhoea)
If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a Mercilon tablet,
the absorption of the active substances of the medicine may be incomplete. This is a situation similar to missing a tablet, therefore the same steps should be taken as in case of a missed tablet. In case of severe diarrhoea, consult a doctor.
In case of a desire to change the day of onset of withdrawal bleeding
If tablets are taken as directed, withdrawal bleeding occurs more or less on the same day every 4 weeks. To change it, shorten (never extend) the next break in tablet intake. Example: if bleeding usually occurs on Friday and in the future you want it to occur on Tuesday (3 days earlier), start taking tablets from the next pack 3 days earlier than usual. If the break in tablet intake is very short (e.g. 3 days or less), withdrawal bleeding may not occur at all during this break, but instead, slight intermenstrual bleeding or spotting may occur during the intake of tablets from the next pack.
In case of unexpected bleeding during tablet intake
During the first few months of taking all combined oral contraceptives, irregular vaginal bleeding (spotting or intermenstrual bleeding) may occur between withdrawal bleeds. In this case, do not stop taking contraceptive tablets. These bleedings usually disappear after an adaptation period (usually after 3 cycles). If bleeding persists, is heavy or recurrent, seek medical advice.
If withdrawal bleeding does not occur
Pregnancy is unlikely if tablets were taken as directed, vomiting did not occur, and no other medicines were taken simultaneously. You may continue taking Mercilon tablets.
If menstruation does not occur for two consecutive cycles, pregnancy is possible. In this case, contact a doctor immediately before starting the next pack of Mercilon to confirm pregnancy.
3.5 Discontinuation of Mercilon
You may stop taking Mercilon at any time. If pregnancy is not planned, ask the doctor for another contraceptive method.
When planning pregnancy, it is usually advised to wait for the first natural menstruation after stopping tablet intake, which helps determine the expected date of delivery.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Mercilon may cause adverse effects, although not everyone will experience them. If any adverse effects occur, particularly severe and persistent ones, or changes in health status that the patient considers related to the use of Mercilon, consult a doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using Mercilon".
Contact a doctor immediately if the patient develops symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or urticaria potentially with breathing difficulties (see also section 2 "Important information before using Mercilon").
Common (occurring in more than 1 woman in 100, but less than 1 in 10 women):

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

Uncommon (occurring in more than 1 woman in 1,000, but less than 1 in 100 women):

• fluid retention,
• decreased libido,
• migraine,
• vomiting,
• diarrhoea,
• rash,
• urticaria,
• breast enlargement.

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

• harmful blood clots in a vein or artery, for example:
  o in the leg or foot (e.g. deep vein thrombosis),
  o in the lungs (e.g. pulmonary embolism),
  o heart attack,
  o stroke,
  o mini-stroke or transient ischaemic attack,
  o blood clots in the liver, stomach/intestine, kidneys or eye.
  The likelihood of blood clots may be higher if the patient has any other factors increasing 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 (lupus erythematosus, erythema multiforme),
• nipple discharge,
• hot flushes,
• weight loss.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps gather more information on the safety of the medicine.
5. How to store Mercilon
Keep the medicine out of 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.
Do not use this medicine if you notice any change in tablet colour, tablet crumbling or other visible signs of tablet degradation.
Do not dispose of medicines via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer used. This will help protect the environment.
6. Contents of the pack and other information
6.1 What Mercilon contains
The active substances are desogestrel 0.15 mg and ethinylestradiol 0.02 mg.
Other ingredients are: potato starch, colloidal anhydrous silica,
all-rac-α-tocopherol, stearic acid, povidone, monohydrate lactose.

6.2 What Mercilon looks like and contents of the pack

The tablets are round, biconvex, 6 mm in diameter, marked with the code 4 below TR on one side and the word Organon* on the other.
21 tablets – 1 blister pack containing 21 tablets
63 tablets – 3 blister packs containing 21 tablets each
PVC/Aluminium blisters, each in an aluminium foil sachet, packed in a cardboard box.
A cardboard sachet is included in the package, in which the blister should be placed after removal from the protective foil.

6.3 Other information

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, 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:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in the Netherlands, country of export: RVG 11508
Parallel import authorisation number: 182/19
Translation of the weekday symbols printed on each tablet in the immediate packaging:
MA - Monday
DI - Tuesday
WO - Wednesday
DO - Thursday
VR - Friday
ZA - Saturday
ZO - Sunday