Microgynon 21

Package leaflet: Information for the user

Microgynon 21, 30 µg + 150 µg, coated tablets
Ethinylestradiolum + Levonorgestrelum
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 blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots")

Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Microgynon 21 is and what it is used for
2. What you need to know before taking Microgynon 21
3. How to take Microgynon 21
4. Possible side effects
5. How to store Microgynon 21
6. Contents of the pack and other information

1. What Microgynon 21 is and what it is used for

Microgynon 21 is a combined oral contraceptive. Each tablet contains a small amount of two different female hormones: levonorgestrel (a progestogen) and ethinylestradiol (an oestrogen). Due to its low hormone content, Microgynon 21 is a low-dose oral contraceptive.
Indications
Contraception.
Oral contraception is a highly effective method of preventing pregnancy. When oral hormonal contraceptives are used correctly, the likelihood of becoming pregnant is very small.

2. Important information before using Microgynon 21

Before starting to take Microgynon 21, you should read the information about blood clots in section 2. It is especially important to be aware of the symptoms of blood clots (see section 2 “Blood clots”).

When not to use Microgynon 21

Do not use Microgynon 21 if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative contraceptive method may be more suitable.

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if you have had a heart attack or stroke;
• if you have (or have 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 you have any of the following conditions, which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol or triglycerides);
  • a condition called hyperhomocysteinemia;
• if you currently have or have previously had a type of migraine called “migraine with aura”;
• if you have (or have previously had) severe liver disease (until liver function tests return to normal);
• if you have had or currently have benign or malignant liver tumours;
• if you currently have or have previously had a hormone-dependent cancer (e.g. breast cancer or cancer of the genital organs);
• if you have unexplained vaginal bleeding.

Do not use Microgynon 21 if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section “Microgynon 21 and other medicines”).

Special patient groups:

Children and adolescents
Microgynon 21 is not indicated for use before the onset of menstruation (first menstrual period). Data on efficacy and safety in children and adolescents after the onset of menstruation are limited.

Women of older age
There is no indication for use of Microgynon 21 after menopause.

Women with liver impairment
Microgynon 21 is contraindicated in women with severe liver disease (see section “When not to use Microgynon 21” and “Warnings and precautions”).

Women with kidney impairment
Talk to your doctor. Microgynon 21 has not been studied in women with kidney impairment.

Warnings and precautions

When to contact your doctor
Seek immediate medical advice if:

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

If you are taking oral contraceptives and have any of the conditions listed below, special and regular medical monitoring is required.

Tell your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Microgynon 21, 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 disorders;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if there have been cases of thrombosis, heart attack, or stroke in close family members;
• if you have migraines;
• if you have epilepsy;
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if breast cancer has occurred or currently occurs in your close family;
• if you have liver or gallbladder disease;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the natural immune system);
• if you have 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 require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Microgynon 21;
• if you have a condition that first appeared or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes gestationis, Sydenham’s chorea);
• if you currently have or have previously had skin pigmentation (yellow-brown discolouration, so-called chloasma); in such cases, avoid excessive exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives that may cause breathing difficulties, seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives such as Microgynon 21 is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious problems.

Blood clots may occur:

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

Full recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

It should be remembered that the overall risk of harmful blood clots caused by using Microgynon 21 is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

Seek immediate medical advice if you experience any of the following symptoms.

Do you experience any of these symptoms? What might be the likely cause?

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

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

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When the risk of venous blood clots is highest
The risk of venous blood clots is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives at all.
If a woman stops taking Microgynon 21, the risk of blood clots returns to normal within a few weeks.

What determines the risk of blood clots
The risk depends on a woman’s natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive being used.
The overall risk of developing blood clots in the legs or lungs associated with using Microgynon 21 is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• The risk of blood clots depends on the individual’s medical history (see “Factors increasing the risk of venous blood clots” below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Microgynon 21 is small, however,
some factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Microgynon 21 several weeks before surgery or during immobilization. If the patient must stop taking Microgynon 21, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has recently 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, especially if the patient has another risk factor. 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 the use of Microgynon 21.

The doctor should be informed if any of the above conditions change during treatment
with Microgynon 21, for example, if a close relative is diagnosed with unexplained thrombosis
or if the patient gains significant weight.
ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.
Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of
Microgynon 21 is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Microgynon 21, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.

The doctor should be informed if any of the above conditions change during treatment
with Microgynon 21, for example, if the patient starts smoking, a close relative is diagnosed
with unexplained thrombosis, or if the patient gains significant weight.
If symptoms suggesting thrombosis occur, the patient should stop taking the tablets
and consult a doctor immediately (see also “When to contact the doctor”).
Oral contraception and cancer
Breast cancer occurs slightly more frequently in women who take oral contraceptives
than in women of the same age who do not. It is not known whether this difference
is solely due to the use of hormonal contraceptives. It may also be due to the fact that women
using hormonal contraception are examined more frequently, leading to earlier detection
of breast cancer. The difference in breast cancer incidence gradually decreases
and disappears within 10 years after stopping oral contraceptives.
Rare cases of benign and, even more rarely, malignant liver tumours have been reported
in women using combined oral contraceptives, which have led to life-threatening
intra-abdominal bleeding. If severe upper abdominal pain occurs, the doctor should be
informed as soon as possible.
There have been reports of increased incidence of cervical cancer in women who have used
oral contraceptives for a long time. However, this association may not be related to the use
of the pills, but rather to sexual behaviour or other factors.
The mentioned tumours may be life-threatening or lead to death.
Psychiatric disorders
Some women using hormonal contraceptives, including Microgynon 21, 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 the doctor as soon as possible
for further medical advice.
Microgynon 21 and other medicines
Some medicines may affect the blood levels of Microgynon 21, may reduce its effectiveness,
and cause unexpected bleeding. These include medicines used to treat epilepsy
(e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
tuberculosis (e.g. rifampicin, rifabutin), HIV or hepatitis C virus infection (protease inhibitors
or non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole), bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin), heart disease, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem), inflammation and degenerative joint diseases (etoricoxib), as well as herbal products containing St John's wort (Hypericum perforatum), mainly used for treating depressive mood. This effect may also occur when consuming grapefruit juice.
Concomitant use of troleandomycin with combined oral contraceptives may increase the risk of intrahepatic cholestasis.
Oral contraceptives may affect the metabolism of other drugs, increasing (e.g. cyclosporine) or decreasing (e.g. lamotrigine) their plasma and tissue concentrations.
Microgynon may also affect: slight increase in midazolam or theophylline levels, and moderate increase in melatonin or tizanidine levels.
Microgynon 21 should not be used if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause abnormal liver function test results (increased liver enzyme AlAT activity). The doctor will recommend another form of contraception before starting these medicines. Microgynon 21 may be resumed approximately 2 weeks after stopping treatment. See section “When not to use Microgynon 21”.
The doctor or pharmacist should be informed about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Microgynon 21 with food and drink
Microgynon 21 may be taken with or without food. Water may be used to help swallowing if needed.
Microgynon 21 should not be taken simultaneously with grapefruit juice.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, the patient should consult a doctor or pharmacist before using this medicine.
Microgynon 21 should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected, medical advice should be sought immediately.
Use of Microgynon 21 is not recommended during breastfeeding.
Driving and using machines
No influence of Microgynon 21 on the ability to drive and operate machinery has been observed.
Regular check-ups
While using Microgynon 21, the doctor will advise on the need for regular medical examinations.
When to contact the doctor
Contact the doctor immediately if:

• worrying changes in health occur, especially any of the conditions listed in this leaflet (see also: “Important information before taking Microgynon 21” and “How to take Microgynon 21”; also remember the points concerning
  close relatives);

• a breast lump is detected;

• other medicines are to be taken (see also “Microgynon 21 and other medicines”);

• immobilization or planned surgical procedure is expected (inform the doctor at least 4 weeks in advance);

• heavy vaginal bleeding occurs;

• tablets are missed in the first week of the cycle (each first week of subsequent months of taking Microgynon 21), and intercourse occurred in the previous 7 days;

• acute diarrhoea occurs;

• no withdrawal bleeding occurs in two consecutive months or pregnancy is suspected (do not start the next pack without the doctor’s advice).

The situations and symptoms listed above are described in more detail in other sections of this leaflet.
This medicine contains monohydrate lactose and sucrose.
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should
consult the doctor before taking this medicine.

3. How to use Microgynon 21

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
General notes
This leaflet describes many situations in which you should stop taking Microgynon 21 or in which
its effectiveness may be reduced. It also indicates circumstances under which sexual intercourse
should be avoided or additional contraceptive methods (e.g. condoms or other mechanical methods)
should be used. The calendar method and temperature measurement method are not suitable, as
Microgynon 21 affects body temperature changes and cervical mucus characteristics associated with
the menstrual cycle.
Microgynon 21, like other oral contraceptives, does not protect against infection with HIV (AIDS)
or sexually transmitted diseases.
How to take Microgynon 21

• When and how should the tablets be taken?

Each blister pack contains 21 coated tablets. Each tablet is marked on the packaging with the day of
the week on which it should be taken. Tablets should be taken in the order indicated on the pack,
every day at approximately the same time, with a small amount of liquid if needed. One tablet should
be taken daily for 21 consecutive days. A new pack should be started after a 7-day break, during
which no tablets are taken and withdrawal bleeding usually occurs. Bleeding typically begins 2–3
days after taking the last tablet and may continue into the first days of the next pack.

• Starting Microgynon 21 for the first time

If no hormonal contraception has been used in the previous month
Tablet taking should begin on Day 1 of the natural menstrual cycle (i.e. the first day of menstrual
bleeding). Tablets may also be started between Day 2 and Day 5 of the cycle; in this case, additional
mechanical contraception is recommended during the first 7 days of tablet intake.
If previously using another combined oral contraceptive (pill, vaginal ring, or transdermal patch)
It is recommended to start taking Microgynon 21 on the first day after taking the last active tablet
of the previous combined oral contraceptive, but no later than the first day after the usual tablet-free
or placebo interval of the previous combined oral contraceptive.
If using a vaginal ring or transdermal patch, Microgynon 21 should be started on the day of removal,
but no later than the day the next ring or patch would have been applied. If these recommendations
are followed, additional contraceptive methods are not required.
If previously using a progestogen-only pill (mini-pill)
You may stop taking the mini-pill at any time and start taking Microgynon 21 at the same time of day.
If sexual intercourse occurs during the first 7 days of taking Microgynon 21, additional contraceptive
methods (mechanical methods) should be used.
If previously using a progestogen-only injectable, implant, or intrauterine system releasing
progestogen
Microgynon 21 should be started on the day the next injection was due, or on the day of implant or
system removal. If sexual intercourse occurs during the first 7 days of taking Microgynon 21,
additional contraceptive methods (mechanical methods) should be used.

• After a first-trimester abortion
  Microgynon 21 may be started immediately. In this case, additional contraceptive methods are not
  required.
• After childbirth or second-trimester abortion
  Tablet intake should begin between 21 and 28 days after childbirth or second-trimester abortion.
  If starting later, additional mechanical contraception should be used for the first 7 days of tablet
  intake. If intercourse has occurred before starting the combined oral contraceptive, pregnancy
  should be ruled out or you should wait until the first natural menstrual period occurs.

Taking more Microgynon 21 than prescribed
Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have
not yet started menstruating but accidentally took the medicine. There are no reports of severe
adverse effects after taking multiple tablets of Microgynon 21 at once. If you or someone else has
taken more than the prescribed dose, inform your doctor immediately.
Stopping Microgynon 21
The medicine may be discontinued at any time. Your doctor will then suggest alternative
contraceptive methods.
If you stop taking the medicine because you wish to become pregnant, wait until you have a natural
menstrual period. This will help determine the expected date of delivery.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Missed dose of Microgynon 21
If less than 12 hours have passed since the missed tablet, the contraceptive effectiveness of
Microgynon 21 is maintained. Take the missed tablet as soon as possible and continue taking the
next tablets at the usual time.
If more than 12 hours have passed since the missed tablet, the effectiveness of Microgynon 21
may be reduced. The more consecutive tablets missed, the higher the risk of reduced contraceptive
effectiveness. The risk of pregnancy is particularly high if tablets at the beginning or end of the pack
are missed. In such cases, follow the rules below (see also the chart below).
Missing more than one tablet from a pack
Consult your doctor.
Missing one tablet during the first week of taking the medicine
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and take
the following tablets at the usual time. Use additional contraceptive methods (mechanical methods)
for the next 7 days.
If sexual intercourse occurred in the week before the missed tablet, pregnancy may have occurred.
Contact your doctor immediately.
Missing one tablet during the second week of taking the medicine
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and take
the following tablets at the usual time. The contraceptive effectiveness of Microgynon 21 is maintained,
and additional contraceptive methods are not required. However, if there were previous dosing
errors or if more than one tablet was missed, use an additional (mechanical) contraceptive method
for 7 days.
Missing one tablet during the third week of taking the medicine
One of the following options may be chosen without the need for additional contraceptive methods,
provided that the tablets were taken correctly during the 7 days prior to the missed dose. Otherwise,
the first of the two options below should be used, and an additional contraceptive method should be
used for the next 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at once), and take the following tablets at the usual time. Start the next pack immediately after finishing the current pack, i.e. without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but breakthrough bleeding or spotting may occur during tablet intake.
2. Alternatively, stop taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), and then continue with the next pack.

If you forget to take tablets and do not have the expected bleeding during the first tablet-free interval,
pregnancy may have occurred. Contact your doctor before starting the next pack.
Missed tablet management chart

Consult a doctor
a sexual intercourse took place during the week
preceding the missed tablet
no sexual intercourse took place

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

Only 1 tablet missed - take the missed tablet
Week 2 - finish taking the tablets
(delay longer than 12 hours
but less than 24 hours)
from the pack

• take the missed tablet
• finish the pack
• do not take the 7-day break
• continue taking tablets from the next pack immediately

or
Week 3

• discard the remaining tablets in the pack
• take a break (no longer than 7 days, counting from the day of the missed tablet)
• continue taking tablets from the next pack

Instructions in the following situations:

• occurrence of gastrointestinal disturbances

If vomiting or severe diarrhoea occurs, the active substances in Microgynon 21 may not be completely absorbed. If vomiting occurs within 3 to 4 hours after taking the tablet, follow the instructions for a missed tablet.
In case of severe gastrointestinal disturbances, additional contraceptive methods should be used.

• intention to delay the withdrawal bleed

To delay the withdrawal bleed, start the next pack immediately after finishing the current pack, without taking the 7-day break. Tablets may be taken until the pack is finished. If the patient wishes to have a bleed, she should stop taking the tablets. During intake of tablets from the next pack, slight breakthrough bleeding or spotting may occur. The next pack should be started after a 7-day break.

• intention to change the day of the week on which withdrawal bleeding occurs

When taking the tablets as directed, bleeding usually occurs approximately on the same day every 4 weeks. To change the day of the week on which withdrawal bleeding occurs, shorten the next tablet-free interval by as many days as the desired shift in the timing of bleeding. For example, if bleeding usually starts on Fridays and the patient wants it to start on Tuesdays (3 days earlier), she should start the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not occur during this period. Slight bleeding or spotting may occur during intake of tablets from the next pack.

• occurrence of unexpected bleeding

During treatment with Microgynon 21, irregular vaginal bleeding (spotting or breakthrough bleeding) may occur during the first few months. Despite this, continue taking the tablets as prescribed. Irregular vaginal bleeding usually resolves after 3 cycles of Microgynon 21 treatment. If bleeding persists, becomes heavy, or recurs, consult a doctor.

• absence of withdrawal bleeding

If all tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medications have been taken concurrently, the likelihood of pregnancy is very low. Continue taking Microgynon 21 as scheduled.
If withdrawal bleeding does not occur in two consecutive months, pregnancy is possible. Immediately inform your doctor. Do not start the next pack of Microgynon 21 until pregnancy has been ruled out by a doctor.

4. Possible adverse effects

Like all medicines, Microgynon 21 may cause adverse effects, although not everyone experiences them. If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Microgynon 21, medical advice should be sought from a doctor.

All women using combined hormonal contraceptives have an increased risk of developing 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, please refer to section 2, "Important information before taking Microgynon 21".

Serious adverse effects
Serious adverse effects associated with taking Microgynon 21 and their accompanying symptoms are described in the following sections of this leaflet: "Warnings and precautions" and "BLOOD CLOTS". Please read these sections carefully for additional information and seek immediate medical advice if necessary.

Seek immediate medical attention if any of the following symptoms of angioedema occur: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, possibly causing breathing difficulties (see also section "Warnings and precautions").

Other possible adverse effects
The symptoms listed below have been reported by women taking Microgynon 21, although they may not necessarily have been caused by the medicine. These symptoms may occur during the first few months of using Microgynon 21 and usually resolve with time.

Common (more than 1 in 100 people):

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

Uncommon (more than 1 in 1,000 people and less than 1 in 100 people):

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

Rare (less than 1 in 1,000 people):

• intolerance to contact lenses,
• hypersensitivity,
• weight loss,
• increased libido,
• vaginal discharge, galactorrhoea,
• nodular erythema, erythema multiforme.
• 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
  • transient ischaemic attack (mini-stroke) or temporary stroke-like symptoms known as transient ischaemic attack
  • blood clots in the liver, stomach and/or intestines, kidneys or eye

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

Description of selected adverse effects
Below are very rare adverse effects or those with delayed onset associated with the use of combined oral contraceptives (see section "When not to take Microgynon 21" and "Warnings and precautions"):

Neoplasms

• The incidence of breast cancer is slightly higher among women using oral contraceptives. However, since breast cancer is rare in women under 40 years of age, the overall risk remains small. A causal relationship with the use of combined oral contraceptives has not been established.

• Liver tumours (benign and malignant)

Other conditions

• Women with hypertriglyceridaemia (increased risk of pancreatitis when using oral contraceptives).
• Hypertension.
• Occurrence or worsening of conditions for which a causal relationship with oral contraceptive use has not been confirmed: jaundice and/or pruritus associated with cholestasis, gallstones, a metabolic disorder called porphyria, systemic lupus erythematosus (an autoimmune disease), haemolytic uraemic syndrome, Sydenham's chorea (a neurological disorder), herpes gestationis (a skin condition occurring during pregnancy), hearing loss associated with otosclerosis.
• Disorders of liver function.
• Combined oral contraceptives may affect insulin resistance and glucose tolerance.
• Crohn's disease and ulcerative colitis.
• Common cold.

Interactions
Intermenstrual bleeding or reduced contraceptive effectiveness may result from interactions between oral contraceptives and other medicines (e.g. St John's wort Hypericum perforatum, drugs used in the treatment of epilepsy, tuberculosis, HIV infection, and others) (see section "Microgynon 21 and other medicines").

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Microgynon 21

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP:.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Microgynon 21 contains
The active substances are ethinylestradiol (30 micrograms) and levonorgestrel (150 micrograms).
Other components of the medicine are:
tablet core:

• monohydrate lactose,
• corn starch,
• povidone K25,
• talc,
• magnesium stearate.

coating:

• sucrose,
• povidone K90,
• macrogol 6000,
• calcium carbonate,
• talc,
• glycerol 85%,
• titanium dioxide (E 171),
• yellow iron oxide (E 172),
• montanoglycol wax.

What Microgynon 21 looks like and contents of the pack
Beige film-coated tablets.
PVC/Aluminum foil blister in a cardboard box.
21 tablets – 1 blister containing 21 tablets
63 tablets – 3 blisters containing 21 tablets each
126 tablets – 6 blisters containing 21 tablets each
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany
Manufacturer:
Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
Bayer Weimar GmbH und Co. KG, Weimar
Doebereinerstrasse 20
99427 Weimar
Germany
For further information, please contact the Marketing Authorisation Holder's representative:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw, Poland
tel. (0-22) 572 35 00