Mivi

Leaflet accompanying the packaging: user information

MYWY, 3 mg + 0.02 mg, film-coated tablets

Drospirenone + Ethinylestradiol

Important information about combined hormonal contraceptives

• If 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 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 carefully 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 necessary.
• In case of 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 another person.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is MYWY and what is it used for

MYWY is a contraceptive pill used to prevent pregnancy.
Each of the 24 pink tablets contains a small amount of two different female hormones,
drospirenone and ethinylestradiol.
4 white tablets do not contain active substances and are referred to as placebo tablets.
Contraceptive pills containing two hormones are called "combined" pills.

2. Important information before using MYWY

General notes

Before starting to take MYWY, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before starting to use MYWY, the doctor will ask the patient a few questions about her health and the health of her close relatives. The doctor will also measure blood pressure and, depending on the individual case, may perform other tests.
This leaflet describes various situations in which MYWY should not be used or in which its effectiveness may be reduced. In such cases, you should abstain from sexual intercourse or use additional, non-hormonal methods of contraception, such as a condom or another barrier method. You should not use the rhythm method (calendar method) or the method based on body temperature measurements. These methods may be unreliable because MYWY disrupts the monthly cycle of body temperature changes and cervical mucus secretion.

MYWY, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use MYWY

Do not use MYWY 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 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 blood clotting disorders - 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 "Blood clots").
• if you have had a heart attack or stroke;
• if you have (or have had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if 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).
• hyperhomocysteinemia
• if you have (or have had) a type of migraine called "migraine with aura";
• if you currently have (or have had) liver disease, and liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you have (or have had) liver cancer;
• if you have (or have had) breast cancer or cancer of the genital organs;
• if you have vaginal bleeding of unknown cause;
• if you are allergic to drospirenone or ethinylestradiol or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling. Do not use MYWY if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "MYWY and other medicines").

Additional information for special populations

Children and adolescents
MYWY is not intended for use in girls who have not yet started their menstrual cycle.
Elderly women
MYWY is not intended for use after menopause.
Women with liver function disorders
Do not take MYWY if you have liver disease. See also "When not to use MYWY" and "Warnings and precautions".
Women with kidney function disorders
Do not take MYWY if you have kidney failure or acute kidney failure. See also "When not to use MYWY" and "Warnings and precautions".

Warnings and precautions

When should you contact your doctor?
You should contact your doctor immediately

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

In certain situations, you should be particularly careful when using MYWY or any other combined contraceptive pill, and your doctor may recommend regular health checks.

You should tell your doctor if you have any of the following conditions.

If any of the following symptoms occur or worsen while using MYWY, you should also tell your doctor.

• 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 immune 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 have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you have recently given birth, you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start taking MYWY after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin).
• if you have varicose veins;
• if there is a history of breast cancer in your close family;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have epilepsy (see "Other medicines and MYWY");
• if you have a disease that first occurred during pregnancy or while using sex hormones, such as hearing loss, porphyria (a blood disease), or a skin rash with blisters (pregnancy herpes);
• if you have chloasma (brown spots, so-called pregnancy spots, especially on the face). In this case, you should avoid direct sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing products may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as MYWY, is associated with an increased risk of blood clots, compared to not using hormonal contraceptives. In rare cases, a blood clot can block blood vessels and cause serious complications.
Blood clots can occur

• in veins (also known as "venous thrombosis" or "venous thromboembolism")
• in arteries (also known as "arterial thrombosis" or "arterial thromboembolism"). Not everyone who has had a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to MYWY is small.

HOW TO RECOGNIZE A BLOOD CLOT
You should contact your doctor immediately if you notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from
these symptoms?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• skin color changes in the leg, such as pallor, redness, or cyanosis;

redness or swelling of the leg;

• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

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

• symptoms usually occur in one eye:
• sudden loss of vision or
• painless vision disturbances, which can lead to loss of vision.

chest pain, discomfort, pressure, or heaviness;

• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• discomfort in the lower part of the body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding;
• sudden vision disturbances in one or both eyes; Stroke

BLOOD CLOTS IN VEINS

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They most often occur 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 forming a blood clot 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 MYWY, the risk of blood clots returns to normal within a few weeks.

What factors can increase the risk of blood clots in veins?

The risk of blood clots associated with MYWY 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 close 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 (see "Blood clots");
• with age (especially over 35 years);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these factors apply to you, even if you are not sure. Your doctor may decide to stop using MYWY.
You should inform your doctor if any of the above conditions change while using MYWY, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

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

Like blood clots in veins, blood clots in arteries can have 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 MYWY is very small, but it may increase:

• with age (over approximately 35 years);
• if you smoke.While using a hormonal contraceptive like MYWY, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a relatively 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 close 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, arrhythmia called atrial fibrillation)
• if you have diabetes. If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher. You should inform your doctor if any of the above conditions change while using MYWY, e.g., if you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

CONTRACEPTIVE PILL AND CANCER

Women using combined contraceptives, including MYWY, have been found to have a slightly increased risk of breast cancer, but it is not known whether this is caused by the use of these pills. For example, there is a possibility that more breast cancers are detected in women using combined contraceptives because they are examined by doctors more frequently. The incidence of breast cancer gradually decreases after stopping the use of combined hormonal contraceptives. It is essential to regularly examine your breasts and contact your doctor if you feel any lump.
Women using the pill have also been found to have a rare increased risk of benign liver tumors and, even more rarely, malignant liver tumors. If you experience severe abdominal pain, you should contact your doctor.

IRREGULAR VAGINAL BLEEDING

During the first few months of using MYWY, you may experience unexpected bleeding (bleeding outside of the placebo period). If such bleeding persists for more than a few months or appears after a few months, your doctor should investigate its cause.

What to do if menstrual bleeding does not occur during the placebo period

If all the pink tablets were taken correctly, there was no vomiting, or severe diarrhea, and no other medicines were taken, it is very unlikely that you are pregnant.
If the expected menstrual bleeding does not occur twice in a row, it may indicate pregnancy. You should contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

PSYCHIATRIC DISORDERS

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

MYWY AND OTHER MEDICINES

You should 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. You should also inform any other doctor or dentist prescribing another medicine (or pharmacist dispensing a medicine) that you are taking MYWY. They may tell you if you should use additional contraceptive methods (e.g., condoms) and for how long, and whether you should change the use of another medicine you are taking.

• may affect the level of MYWY in your blood,
• may make MYWY less effective in preventing pregnancy,
• may cause unexpected bleeding.

This applies to medicines:

• used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• used to treat tuberculosis (e.g., rifampicin),
• used to treat HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• used to treat fungal infections (e.g., griseofulvin, ketoconazole),
• used to treat arthritis, degenerative joint disease (etoricoxib)
• used to treat pulmonary hypertension (bosentan),
• herbal products containing St. John's Wort.

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

• containing cyclosporin,
• antiepileptic - lamotrigine (which may lead to an increased frequency of seizures),
• theophylline (used for breathing problems),
• tizanidine (used to treat pain and/or muscle spasms). Do not use MYWY if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may lead to increased liver enzyme levels in the blood (increased ALT level). Your doctor will recommend a different type of contraception before starting treatment with these medicines. About 2 weeks after finishing such treatment, you can resume taking MYWY. See "When not to use MYWY".

MYWY WITH FOOD AND DRINK

MYWY can be taken with or without food; if necessary, it can be washed down with a small amount of water.

Laboratory tests

If laboratory tests are necessary, you should inform your doctor or laboratory staff that you are taking MYWY, as hormonal contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant should not take MYWY. If you become pregnant while using MYWY, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking MYWY at any time (see also "Stopping MYWY").
Before taking any medicine, consult your doctor or pharmacist.
Breastfeeding
It is not recommended to use MYWY during breastfeeding. If you are breastfeeding and want to use MYWY, you should consult your doctor.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

There is no information on the effect of MYWY on the ability to drive and use machines.

MYWY contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking MYWY.
Each pink tablet of this medicine contains less than 1 mmol (23 mg) of sodium, which means the medicine is considered "sodium-free".

3. How to use MYWY

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Each pack contains 24 pink tablets containing active substances and 4 white placebo tablets.
The two types of MYWY tablets of different colors are arranged in sequence. One blister pack contains 28 tablets.
You should take one MYWY tablet per day, with a small amount of water if necessary. You can take the tablets with or without food, but you should take them at approximately the same time every day.
Do not confuse the tablets:you should take the pink tablets for the first 24 days, followed by the white tablets for the last 4 days. You should start a new blister pack immediately (24 pink, followed by 4 white tablets). Do not take a break between the two blister packs.
Due to the differences in tablet composition, it is essential to start taking the tablets from the first tablet at the top left of the blister pack and then take the tablets every day in the direction of the arrows on the blister pack.

Preparing the blister pack

To help you remember the day you take the tablet, each MYWY blister pack comes with 7 self-adhesive strips with the days of the week printed on them. You should choose the strip that starts with the day of the week you want to start taking the tablets. For example, if you start taking the tablets on a Wednesday, you should use the strip that starts with "Wed".
You should stick the strip onto the top of the MYWY blister pack, where it says "Place the day of the week sticker here". This way, the first day is indicated above the tablet marked "1". You can check if you have taken the tablet for the day by looking at the day of the week above each tablet. The arrows show the order in which the tablets should be taken.
During the 4 days of taking the white placebo tablets (placebo period), you should experience bleeding (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last pink tablet containing the active substance of MYWY. After taking the last white tablet, you should start a new blister pack, regardless of whether the bleeding has stopped or is still ongoing. This means that new packs will be started on the same day of the week, and bleeding should also occur on the same days every month.
Taking MYWY according to these instructions ensures that you are also protected against pregnancy during the 4 days of taking the placebo tablets.

When to start using the first blister pack?

• If you did not use any hormonal contraceptives in the previous monthYou should start taking MYWY on the first day of your menstrual cycle (i.e., the first day of menstruation). Starting MYWY on the first day of menstruation provides immediate protection against pregnancy. You can also start taking MYWY on days 2-5 of your cycle, but in this case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined contraceptive vaginal ring or patchYou can start taking MYWY the day after taking the last tablet containing the active substance from the previous pack, but no later than the day after the end of the previous contraceptive-free period (or the last tablet without active substances from the previous contraceptive). In the case of switching from a combined contraceptive vaginal ring or patch, you should follow your doctor's instructions.
• Switching from a progestogen-only method (mini-pill, injection, implant, or intrauterine device releasing progestogen)You can switch from a mini-pill on any day, from an implant or intrauterine device on the day of its removal, and from an injectable contraceptive on the day the next injection is scheduled. However, in all these cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking MYWY tablets.
• After a miscarriageYou should follow your doctor's instructions.
• After childbirthYou can start taking MYWY between 21 and 28 days after giving birth. If you start later than 28 days, you should use a barrier method (e.g., condoms) for the first 7 days of taking MYWY. If you have had sexual intercourse after giving birth before starting MYWY, you should first ensure that you are not pregnant or wait for your first menstrual period.
• If you are breastfeeding and want to start taking MYWY again after childbirthYou should read the section "Breastfeeding".

If you are unsure when to start taking MYWY, you should consult your doctor.

What to do if you have taken more than the recommended dose of MYWY

There are no reports of serious, harmful effects from taking too many MYWY tablets at once.
If you have taken several tablets at once, you may experience nausea or vomiting, or you may have vaginal bleeding. Even young girls who have not yet started their menstrual cycle but have accidentally taken this medicine may experience such bleeding.
If you have taken too many MYWY tablets or if a child has swallowed some, you should consult your doctor or pharmacist.

What to do if you miss a dose of MYWY

The last 4 tablets in the 4th rowof the blister pack are placebo tablets. If you miss one of them, the contraceptive effectiveness of MYWY is maintained. You should discard the missed placebo tablet.
If you miss a pink tablet containing the active substance (tablets 1-24 in the blister pack), you should follow these instructions:

• if it has been less than 24 hourssince you missed the tablet, your contraceptive protection is not reduced. You should take the tablet as soon as possible and then take the next tablets at the usual time.
• if it has been more than 24 hourssince you missed the tablet, your contraceptive protection may be reduced. The more tablets you miss, the higher the risk of becoming pregnant. The risk of reduced contraceptive protection is highest if you miss a pink tablet at the beginning or end of the pack. Therefore, you should follow these rules (see also the scheme below):
• You missed more than one tablet in the blister packYou should contact your doctor.
• You missed one tablet in days 1-7 (first row)You should take the missed tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time and use additional contraceptive methods, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet or if you missed the start of the next blister pack, there is a risk of pregnancy. In this case, you should contact your doctor.
• You missed one tablet in days 8-14 (second row)You should take the missed tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time. Your contraceptive protection is not reduced, and you do not need to use additional contraceptive methods.
• You missed one tablet in days 15-24 (third or fourth row)There are two options to choose from:
• 1. You should take the missed tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time. Instead of the placebo period, you should discard the white placebo tablets and start a new blister pack immediately (the first day of taking the tablets will be different from before). You may experience bleeding or spotting during the second blister pack.
• 2. You can also stop taking the pink tablets containing the active substance and go directly to the 4 white placebo tablets (before starting the placebo tablets, make a note of the day you missed the tablet). If you want to start the next blister pack on your usual start day, you can shorten the placebo period to less than 4 days.

If you follow one of these instructions, your contraceptive protection will be maintained.
If you have missed any of the tablets in the blister pack and have not experienced menstrual bleeding during the first placebo period, you may be pregnant. Before starting the next blister pack, you should contact your doctor.

What to do in case of vomiting or severe diarrhea

If vomiting occurs within 3-4 hours after taking a pink tablet containing the active substance or if you experience severe diarrhea, there is a risk that the active substances from the tablet have not been fully absorbed into your body. The situation is similar to missing a tablet. After vomiting or diarrhea, you should take another pink tablet from a reserve blister pack as soon as possible. If possible, you should take it within 24 hours of the usual tablet-taking time. If this is not possible or more than 24 hours have passed, you should follow the instructions for missing a tablet (see "What to do if you miss a dose of MYWY").

Delaying menstrual bleeding: what you need to know

Although it is not recommended, you can delay menstrual bleeding by skipping the white placebo tablets from the 4th row and starting a new blister pack of MYWY immediately (24 pink, followed by 4 white tablets). During the second blister pack, you may experience spotting or breakthrough bleeding. You should finish the second blister pack, taking the 4 white placebo tablets from the 4th row of the second blister pack. Then, you should start a new blister pack.

You can consult your doctor before deciding to delay your menstrual bleeding.

Changing the first day of your menstrual cycle: what you need to know

When taking the tablets according to the instructions, menstrual bleeding will occur during the placebo period. If you want to change this day, you should shorten the placebo period (but never extend it - the maximum is 4 days!). For example, if your placebo period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. As a result, you may not experience menstrual bleeding. You may experience spotting or breakthrough bleeding instead.

If you are unsure what to do, you should consult your doctor.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If you experience any side effects, especially severe or persistent ones, or changes in your health that you think may be related to the use of MYWY, you should consult your doctor.

Severe side effects

You should contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing (see also "Warnings and precautions"). All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using MYWY". The following side effects have been associated with the use of MYWY: Common side effects(may occur in 1 to 10 out of 100 people):

• mood swings,
• headaches,
• nausea,
• breast pain, menstrual irregularities, such as irregular bleeding, absence of bleeding.

Uncommon side effects(may occur in 1 to 10 out of 1,000 people):

• depression, decreased libido, nervousness, drowsiness,
• dizziness, tingling sensation,
• migraine, varicose veins, increased blood pressure,
• abdominal pain, vomiting, indigestion, intestinal gas, gastritis, diarrhea,
• acne, itching, rash,
• painful conditions, e.g., back pain, limb pain, muscle cramps,
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast tumor, uterine/vaginal bleeding (which usually subsides during continued use of the medication), discharge, hot flashes, vaginal inflammation, menstrual bleeding problems, painful bleeding, scanty bleeding, very heavy bleeding, vaginal dryness, abnormal cervical smear, decreased interest in sex,
• lack of energy, increased sweating, fluid retention,
• weight gain.

Rare side effects(may occur in 1 to 10 out of 10,000 people):

• candidiasis (fungal infection),
• anemia, increased platelet count,
• allergic reaction,
• hormonal disorders (endocrine),
• increased appetite, loss of appetite, significant increase in potassium levels in the blood, significant decrease in sodium levels in the blood,
• orgasmic dysfunction, insomnia,
• dizziness, chills,
• eye disorders, e.g., blepharitis, dry eyes,
• significant acceleration of heart rate,
• phlebitis, nosebleeds, fainting,
• abdominal circumference increase, intestinal disorders, feeling of bloating, gastric hernia, oral thrush, constipation, dry mouth,
• bile duct or gallbladder pain, cholecystitis,
• yellow-brown spots on the skin, rash, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair growth, skin diseases, skin stretch marks, skin inflammation, skin hypersensitivity to light, skin nodules,
• difficult or painful intercourse, vaginal inflammation, post-coital bleeding, withdrawal bleeding, breast cyst, increased number of cells (hyperplasia) in the breast glands, malignant breast tumor, significant hyperplasia of the cervical mucosa, shrinkage or atrophy of the endometrium, ovarian cysts, uterine enlargement,
• general malaise,
• weight loss,
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis)
• in the lungs (e.g., pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach/intestine, kidneys, or eye The likelihood of developing blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

The following side effects have been observed, but their frequency cannot be determined from the available data: hypersensitivity, erythema multiforme (rash with redness or ulcers in a target shape).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. 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, tel.: +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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of the medication.

5. How to store MYWY medication

The medication should be stored out of sight and out of reach of children. Do not use this medication after the expiration date stated on the packaging and blister after: "EXP:". The expiration date refers to the last day of the specified month. There are no special precautions for storing the medicinal product at a certain temperature. Medications should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What MYWY medication contains

The active substances of the medication are drospirenone and ethinylestradiol. Each pink film-coated tablet contains 3 mg of drospirenone and 0.02 mg of ethinylestradiol. The white film-coated tablets do not contain active substances. The other ingredients are:

• Composition of pink tablets containing active substances: Tablet core: lactose monohydrate, corn starch, povidone K30, croscarmellose sodium, polysorbate 80, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• Composition of white tablets not containing active substances: Tablet core: anhydrous lactose, povidone K30, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance and package contents of MYWY medication

Each blister pack of MYWY medication contains 24 pink film-coated tablets containing active substances in rows 1, 2, 3, and 4, and 4 white film-coated placebo tablets in row 4. MYWY tablets, both pink and white, are film-coated; the tablet core is covered with a coating. MYWY medication is available in packs containing 1, 3, 6, or 13 blisters, each with 28 (24+4) tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s. U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Laboratorios León Farma, S.A. C/La Vallina s/n Pol.Ind. Navatejera 24193-León Spain

This medication is authorized for marketing in the Member States of the European Economic Area under the following names:

Germany, Poland, Czech Republic, Italy: MYWY Lithuania, Latvia: LETHE 3 mg / 0.02 mg

For further information on the medication, please contact:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 Date of last revision of the leaflet:November 2024