Microginon 21

Leaflet accompanying the packaging: information for the user

Microgynon 21, 30 µg + 150 µg, coated tablets

Ethinylestradiol+ Levonorgestrel

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")

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Microgynon 21 and what is it used for
• 2. Important information before using Microgynon 21
• 3. How to use Microgynon 21
• 4. Possible side effects
• 5. How to store Microgynon 21
• 6. Contents of the packaging and other information

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

Microgynon 21 is a combined oral contraceptive. Each tablet contains a small amount of two different female hormones. These are: levonorgestrel (progestogen) and ethinylestradiol (estrogen). Due to the low hormone content, Microgynon 21 is a low-dose contraceptive.

Indications for use

Contraception. Oral contraception is a very effective method of preventing pregnancy. During correct use of oral hormonal contraceptives, the likelihood of becoming pregnant is very low.

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 read about the symptoms of blood clots (see section 2 "Blood clots").

When not to use Microgynon 21

You should not use Microgynon 21 if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. The doctor will discuss with you which other contraceptive method will 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), lungs (pulmonary embolism), or other organs;
• if you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "Blood clots").
• if you have had a heart attack or stroke;
• if you have 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 you have 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 you have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) severe liver disease (until liver function tests return to normal);
• if you have (or have ever had) benign or malignant liver tumors;
• if you have (or have ever had) a hormone-dependent tumor (breast or genital cancer);
• if you have bleeding from the genital tract of unknown cause.

You should not use Microgynon 21 if you have hepatitis C and are taking antiviral medicines containing ombitasvir, 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 first menstrual bleeding. Data on the efficacy and safety of use in children and adolescents after the first menstrual bleeding are limited.

Women of advanced age

There is no indication for the use of Microgynon 21 after menopause.

Women with liver failure

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 failure

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

Warnings and precautions

When to contact a doctor

You should contact a doctor immediately

• -if you notice possible symptoms of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots"). To get a description of these serious side effects, see "How to recognize the occurrence of blood clots".

If you are taking oral contraceptives in any of the following situations, medical supervision is necessary.

Tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Microgynon 21, you should also tell your doctor.

• if you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have heart valve problems or heart rhythm disorders;
• if you have inflammation of the veins under the skin (thrombophlebitis);
• if you have varicose veins;
• if there have been cases of blood clots, heart attack, or stroke in close relatives;
• if you have migraines;
• if you have epilepsy;
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if there have been cases of breast cancer in close relatives;
• 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 that affects the natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have recently given birth, you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Microgynon 21 after giving birth;
• if you have a disease that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea);
• if you have skin discoloration (yellow-brown pigment spots, so-called chloasma) currently or in the past; you should then avoid excessive exposure to the sun or ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial, tongue, and/or throat swelling and/or difficulty swallowing or breathing, you should contact your doctor immediately. Estrogen-containing medicines may cause or worsen the 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 them. In rare cases, a blood clot can block a blood vessel and cause serious complications.

Blood clots can occur

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease")
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

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

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

You should contact a doctor immediately if you notice any of the following symptoms.

Are you experiencing any of these symptoms?

Why is the patient likely to suffer?

Deep vein thrombosis

• 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 while standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, e.g., pallor, redness, or cyanosis;

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur most frequently in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles 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 a vein highest

The risk of blood clots in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the 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 you stop using Microgynon 21, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots

The risk of blood clots associated with Microgynon 21 is small, but some factors can increase this risk. The risk is higher:

• if you are significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in your immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop using Microgynon 21 for a few weeks before surgery or immobilization. If you need to stop using Microgynon 21, you should ask your doctor when you can resume taking the medicine;
• with age (especially over 35);
• if you smoke;

Tell your doctor if any of the above conditions change while you are taking Microgynon 21, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery

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 Microgynon 21 is very small, but it may increase:

• with age (over about 35);
• if you smoke.While taking a hormonal contraceptive like Microgynon 21, it is recommended to quit smoking. If you are unable to quit smoking and are over 35, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if you have diabetes. If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher.

Tell your doctor if any of the above conditions change while you are taking Microgynon 21, e.g., if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

If you experience symptoms suggesting a blood clot, you should stop taking the tablets and consult your doctor immediately (see also "When to contact a doctor").

Oral contraception and cancer

In women taking oral contraceptives, breast cancer is slightly more common than in women of the same age who do not take them. It is not known whether this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women taking hormonal contraceptives are more frequently examined and breast cancer is detected earlier in them. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after stopping oral contraceptives.

In women taking combined oral contraceptives, rare cases of benign or, even more rarely, malignant liver tumors have been reported, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, you should inform your doctor as soon as possible.

There are reports of a more frequent occurrence of cervical cancer in women taking oral contraceptives for a long time. However, this relationship may not be related to taking the tablets but to sexual behavior or other factors.

The mentioned tumors can be life-threatening or cause death.

Psychiatric disorders

Some women taking hormonal contraceptives, including Microgynon 21, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible to receive further medical advice.

Microgynon 21 and other medicines

Some medicines may affect the level of Microgynon 21 in the blood, may reduce its effect, and cause unexpected bleeding. This applies to medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (e.g., rifampicin, rifabutin), HIV or hepatitis C virus infections (so-called protease inhibitors or non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, azole antifungal medicines, 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 joint degeneration (etoricoxib), as well as medicines containing St. John's wort (Hypericum perforatum), used mainly to treat depressive moods. A similar effect is observed when consuming grapefruit juice.

Troleandomycin used simultaneously with combined oral contraceptives may increase the risk of intrahepatic cholestasis.

Oral contraceptives may affect the metabolism of other medicines, whose levels in the blood and tissues may increase (e.g., cyclosporin) or decrease (e.g., lamotrigine).

Microgynon 21 may also affect: a slight increase in midazolam or theophylline levels and a moderate increase in melatonin or tizanidine levels.

You should not use Microgynon 21 if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause abnormal liver function test results in the blood (increased liver enzyme activity). Your doctor will recommend a different type of contraception before starting these medicines. You can resume taking Microgynon 21 about 2 weeks after finishing the treatment. See section "When not to use Microgynon 21".

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Microgynon 21 with food and drink

Microgynon 21 can be taken with or without food, and the tablet can be washed down with a small amount of liquid if necessary. Microgynon 21 should not be taken with grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, you should consult your doctor or pharmacist before using this medicine.

You should not take Microgynon 21 if you are pregnant or think you may be pregnant. If you suspect you are pregnant, you should consult your doctor as soon as possible.

It is not recommended to use Microgynon 21 during breastfeeding.

Driving and using machines

No effect of Microgynon 21 on the ability to drive and use machines has been observed.

Regular check-ups

While taking Microgynon 21, your doctor will inform you about the need for regular medical check-ups.

When to contact a doctor

You should contact a doctor immediately if:

• you notice worrying changes in your health, especially any of the conditions listed in this leaflet (see also "Important information before using Microgynon 21" and "How to use Microgynon 21"; you should also remember the points about close relatives);

a lump is found in the breast;

• you plan to take other medicines (see also "Microgynon 21 and other medicines");
• you are going to have surgery or plan to be immobilized (you should inform your doctor at least 4 weeks in advance);
• you experience heavy vaginal bleeding;
• you missed tablets in the first week of taking Microgynon 21 and had sexual intercourse during the previous 7 days;
• you have severe diarrhea;
• you have not had bleeding during the first two months of using Microgynon 21 or suspect you are pregnant (you should not start the next pack without consulting your doctor).

The situations and symptoms listed above are described in more detail in other parts of this leaflet.

The medicine contains lactose monohydrate and sucrose.

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to use Microgynon 21

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

General notes

The leaflet describes many situations in which you should stop taking Microgynon 21 or in which the effectiveness of the medicine may be reduced. It also lists circumstances in which you should not have sexual intercourse or should use additional contraceptive methods, e.g., condoms or other mechanical methods. The calendar method and the temperature measurement method cannot be used because Microgynon 21 affects temperature changes and cervical mucus properties characteristic of the menstrual cycle.

Microgynon 21, like other oral contraceptives, does not protect against HIV (AIDS) or sexually transmitted diseases.

How to use Microgynon 21

• When and how to take the tablets?

The blister pack contains 21 coated tablets. On the packaging, each tablet is marked with the day of the week on which it should be taken. The tablets should be taken in the order indicated on the packaging, every day, at about the same time, washed down with a small amount of liquid if necessary. For 21 consecutive days, take 1 tablet per day. Each subsequent pack should be started after a 7-day break, during which no tablets are taken and bleeding usually occurs. Bleeding usually starts within 2-3 days after taking the last tablet and may still occur after starting the next pack.

• Using Microgynon 21 for the first time

If you have not used hormonal contraception in the last month

Take the first tablet on the first day of your natural menstrual cycle (i.e., the first day of menstrual bleeding). You can also start taking the tablets between the 2nd and 5th day of your menstrual cycle; in this case, during the first cycle, you should use additional mechanical contraception for the first 7 days of taking the tablets.

If you have previously used another combined oral contraceptive (tablet, 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 of the usual break in taking active tablets or placebo tablets of the previous combined oral contraceptive.

If you have previously used a progestogen-only tablet (mini-pill)

You can stop taking the mini-pill at any time and start taking Microgynon 21 at the same time. If you have sexual intercourse during the first 7 days of taking Microgynon 21, you should also use other contraceptive methods (mechanical methods).

If you have previously used a progestogen-only injection, implant, or intrauterine system

Start taking Microgynon 21 on the day the next injection was scheduled or on the day the implant or intrauterine system is removed. If you have sexual intercourse during the first 7 days of taking the tablets, you should also use other contraceptive methods (mechanical methods).

• After a miscarriage in the first trimester of pregnancy You can start taking Microgynon 21 immediately. In this case, you do not need to use additional contraceptive methods.
• After childbirth or miscarriage in the second trimester of pregnancy You should start taking the tablets 21-28 days after childbirth or miscarriage in the second trimester of pregnancy. If you start taking the tablets later, you should use additional mechanical contraception for the first 7 days of taking the tablets. If you have had sexual intercourse before starting the combined oral contraceptive, you should make sure you are not pregnant or wait for your first menstrual period.

Using more than the recommended dose of Microgynon 21

Nausea, vomiting, or vaginal bleeding may occur. This type of bleeding may occur even in girls who have not yet started menstruating but have taken the medicine by mistake. There are no reports of serious side effects after taking multiple tablets of Microgynon 21 at the same time. If you have taken more than the recommended dose of Microgynon 21, you should inform your doctor.

Stopping Microgynon 21

You can stop taking the medicine at any time. Your doctor will recommend other contraceptive methods.

If you stop taking Microgynon 21 because you want to become pregnant, you should wait until you have had a natural menstrual period. This will help determine the expected date of delivery.

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

Missing a dose of Microgynon 21

If it has been less than 12 hourssince you missed a tablet, the contraceptive effectiveness of Microgynon 21 is maintained. You should take the missed tablet as soon as possible and continue taking the next tablets at the usual time.

If it has been more than 12 hourssince you missed a tablet, the effectiveness of Microgynon 21 may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or end of the pack. In this case, you should follow the rules below (see also the scheme below).

Missing more than one tablet from the pack

You should consult your doctor.

Missing one tablet in the first week of taking Microgynon 21

Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the next tablets at the usual time. For the next 7 days, use additional mechanical contraceptive methods.

If you had sexual intercourse during the week before missing the tablet, it is possible that you may become pregnant. You should consult your doctor as soon as possible.

Missing one tablet in the second week of taking Microgynon 21

Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the next tablets at the usual time. The contraceptive effectiveness of Microgynon 21 is maintained, and you do not need to use additional contraceptive methods. However, if you made mistakes when taking the tablets earlier or missed more than one tablet, you should use additional mechanical contraceptive methods for 7 days.

Missing one tablet in the third week of taking Microgynon 21

You can choose one of the following options without the need for additional contraceptive methods, provided that you have taken the tablets correctly for the 7 days preceding the missed dose. If not, you should follow the first of the two options below and use additional mechanical contraceptive methods for 7 days.

• 1. Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the next tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, i.e., without a 7-day break. Bleeding will occur after finishing the second pack, but during tablet-taking, you may experience spotting or breakthrough bleeding.
• 2. You can also stop taking the tablets from the current pack, take a break (not more than 7 days, counting from the day you missed the tablet), and then continue taking the tablets from the next pack.

If you miss a tablet and do not have the expected bleeding during the first break from taking the tablets, it is possible that you are pregnant. Before starting the next pack of Microgynon 21, you should consult your doctor.

Scheme for missing a tablet

Consult your doctor

had sexual intercourse in the week before missing the tablet
Week 1
did not have sexual intercourse in the week before missing the tablet

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

Missed only 1 tablet (delay of more than 12 hours, but less than 24 hours)
Week 2

• take the missed tablet
• finish the pack

take the missed tablet
Week 3

• take the missed tablet
• finish the pack
• do not take a 7-day break
• continue with the next pack

or

• stop taking the tablets from the current pack
• take a break (not more than 7 days, counting from the day you missed the tablet)
• continue with the next pack

4. Possible side effects

Like any medicine, Microgynon 21 can cause side effects, although they may not occur in everyone. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of the Microgynon 21 drug, a doctor should be consulted.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using the Microgynon 21 drug".

Severe side effects

Severe side effects related to the use of the Microgynon 21 drug and their symptoms are described in the following sections of the leaflet: "Warnings and precautions", "BLOOD CLOTS". This part of the leaflet should be read to obtain additional information, and if necessary, consult a doctor immediately.
A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (see also the "Warnings and precautions" section).

Other possible side effects

Below are symptoms reported by patients taking the Microgynon 21 drug, although they may not have been caused by the drug. These symptoms may occur in the first few months of using the Microgynon 21 drug and usually disappear over time.
Frequently(more than 1 in 100 people):

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

Less frequently(more than 1 in 1000 people and less than 1 in 100 people):

• vomiting, diarrhea,
• fluid retention,
• migraine,
• decreased libido,
• breast enlargement,
• rash, hives.

Rarely(less than 1 in 1000 people):

• intolerance to contact lenses,
• hypersensitivity,
• weight loss,
• increased libido,
• discharge, breast secretion,
• erythema nodosum, erythema multiforme.
• 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 myocardial infarction
o stroke
o mini-stroke or transient stroke symptoms, known as a transient ischemic attack
o blood clots in the liver, stomach, and/or intestine, kidneys, or eye
The likelihood of blood clots may be higher if the patient has any other risk factors (refer to section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Description of selected side effects

Below are very rare side effects or side effects whose symptoms occur with a delay and are related to the use of combined oral contraception (refer to the "Contraindications" and "Warnings and precautions" sections):
Cancers

• The incidence of breast cancer is slightly higher in the group of patients using oral contraception. Since the incidence of breast cancer in women under 40 is rare, the risk is small in relation to the overall risk of breast cancer. The causal relationship with the use of combined oral contraceptives is unknown.
• Liver tumors (benign and malignant)

Other conditions

• Women with hypertriglyceridemia (increased risk of pancreatitis when using oral contraceptives).
• Hypertension.
• Occurrence or worsening of conditions for which a causal relationship with the use of oral contraception has not been confirmed: jaundice and/or itching associated with bile stasis, gallstones, metabolic disease called porphyria, systemic lupus erythematosus (a disease of the immune system), hemolytic-uremic syndrome, Sydenham's chorea (a neurological disease), herpes gestationis (a skin disease occurring during pregnancy), hearing loss associated with otosclerosis.
• Liver function disorders.
• Combined oral contraceptives may affect insulin resistance and glucose tolerance.
• Crohn's disease and ulcerative colitis.
• Chloasma,

Interactions
Intermenstrual bleeding or reduced contraceptive efficacy may be caused by the interaction of oral contraceptives with other medications (e.g., St. John's Wort Hipericum perforatum, medications used to treat epilepsy, tuberculosis, HIV infections, and others) (refer to the "Microgynon 21 drug and other medications" section).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the drug.

5. How to store the Microgynon 21 drug

Store in a place invisible and inaccessible to children.
Do not store at a temperature above 25°C.
Do not use this drug after the expiration date stated on the packaging after EXP:.
The expiration date means the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What the Microgynon 21 drug contains

The active substances of the Microgynon 21 drug are ethinylestradiol (30 micrograms) and levonorgestrel (150 micrograms).
Other ingredients of the drug are:
tablet core:

• lactose monohydrate,
• 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),
• montan glycol wax.

What the Microgynon 21 drug looks like and what the package contains

Beige-colored film-coated tablets.
PVC/Al foil blister in a cardboard box.
21 pieces – 1 blister of 21 pieces.
63 pieces – 3 blisters of 21 pieces.
126 pieces – 6 blisters of 21 pieces.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer:

Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
To obtain more detailed information, contact the representative of the marketing authorization holder:
Bayer Sp. z o. o.
Al. Jerozolimskie 158
02-326 Warsaw, Poland
phone (0-22) 572 35 00

Date of the last update of the leaflet: