Mywy

Package leaflet: Information for the user

MYWY, 3 mg + 0,02 mg, film-coated tablets
Drospirenone + Ethinylestradiol
Important information about combined hormonal contraceptives

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

Please read this leaflet carefully before using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What MYWY is and what it is used for

MYWY is a contraceptive tablet used to prevent pregnancy.
Each of the 24 pink tablets contains a small amount of two different female hormones,
drospirenone and ethinylestradiol.
The 4 white tablets contain no active substances and are referred to as placebo tablets.
Contraceptive tablets containing two hormones are known as "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 particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Before starting to use MYWY, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual case, may perform other examinations.
This leaflet describes various situations in which you should stop using MYWY 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 condoms or other barrier methods. Do not use fertility awareness methods (calendar method) or methods 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, inform your doctor. Your doctor will discuss with you which alternative contraceptive method would be more suitable.

• 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 disorders affecting blood clotting – 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 had in the past) 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 diseases that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol or triglycerides);
  • a condition called hyperhomocysteinemia;
• if you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you currently have (or have had in the past) liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you currently have (or have had in the past) liver tumour;
• if you currently have (or have ever had) diagnosed or suspected breast cancer or cancer of the reproductive 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 section "MYWY and other medicines").

Additional information for special populations
Children and adolescents
MYWY is not intended for use in girls whose menstrual cycles have not yet begun.
Women of advanced age
MYWY is not intended for use after menopause.
Women with liver function disorders
Do not take MYWY if you have liver disease. See also sections "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 sections "When not to use MYWY" and "Warnings and precautions".

Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice 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 section below "Blood clots"). For a description of symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

In certain situations, special caution should be exercised when using MYWY or any other combined oral contraceptive. Your doctor may recommend regular health check-ups.
You should inform your doctor if you have any of the following conditions.
If any of the following symptoms appear or worsen during treatment with MYWY, you should also inform your doctor.

• 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 causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have elevated levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you are immediately postpartum, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking MYWY;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if there is a current or past 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 section "Other medicines and MYWY");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones, for example, hearing loss, porphyria (a blood disorder), pregnancy-related blistering skin rash (herpes gestationis), a nervous system disorder causing sudden body movements (Sydenham's chorea);
• if you have melasma (brownish pigmented patches, so-called pregnancy mask, especially on the face) or have ever had it. In such cases, avoid direct 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, which may cause breathing difficulties, seek immediate medical advice. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as MYWY is associated with an increased risk of blood clots compared to not using such treatment. In rare cases, a blood clot may block blood vessels and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events"). Complete 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 MYWY is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Is the patient experiencing any of these symptoms? What is the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:

  • pain or tenderness in the leg, which may occur only when standing or walking;
  • increased temperature in the affected leg;
  • change in skin colour of the leg, e.g., paleness, redness, or blueness;

• sudden onset of unexplained shortness of breath or rapid breathing; Pulmonary embolism

• sudden onset of cough without obvious cause, which may be associated with coughing up blood;

• sudden chest pain, which may worsen with deep breathing;

• severe dizziness or lightheadedness;

• rapid or irregular heartbeat;

• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g., cold).

• symptoms most commonly affecting one eye: Retinal vein thrombosis

  • sudden loss of vision or (blood clot in the eye)
  • painless visual disturbances, which may progress to vision loss.

• chest pain, discomfort, pressure, heaviness; Heart attack

• squeezing or fullness in the chest, arm, or below the breastbone;

• feeling of fullness, indigestion, or choking;

• discomfort in the lower part of the body radiating to the back, jaw, throat, arm, or stomach;

• sweating, nausea, vomiting, or dizziness;

• extreme weakness, anxiety, or shortness of breath;

• rapid or irregular heartbeat.

• sudden weakness or numbness of the face, arms, or legs, Stroke especially on one side of the body;

• sudden confusion, speech or comprehension difficulties;

• sudden visual disturbances in one or both eyes;

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 developing blood clots in veins (venous thrombosis). However, these adverse effects 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 is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be increased 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 MYWY, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of MYWY is low.

• In the course of 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 the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as MYWY, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors increasing the risk of developing blood clots in veins" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of MYWY is low, but certain factors may increase this risk. The risk is higher:

• if the patient has significant 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 an inherited clotting disorder;
• if the patient is due to undergo surgery, if she is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking MYWY several weeks before surgery or periods of immobility. If the patient must stop taking MYWY, she should consult her doctor about when to restart the medication.
• with increasing age (particularly over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing 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 present.
It is important to inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of MYWY.
The patient should inform her doctor if any of the above conditions change during treatment with MYWY, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can cause 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 MYWY is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as MYWY, smoking should be discontinued. 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 has overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a relatively 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, particularly 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 patient should inform her doctor if any of the above conditions change during treatment with MYWY, for example, if she starts smoking, if a close relative is diagnosed with unexplained thrombosis, or if she gains significant weight.

CONTRACEPTIVE TABLET AND CANCER
Women using combined hormonal contraceptives have a slightly increased incidence of breast cancer, but it is not known whether this is caused by taking these tablets. It is possible, for example, that more cancers are detected in women using combined hormonal contraceptives because they are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. Regular breast examinations are important, and the patient should contact her doctor if she detects any lump.

Rarely, benign liver tumors and even more rarely malignant liver tumors have been observed in women using contraceptive tablets. If unusual, severe abdominal pain occurs, the patient should contact her doctor.

INTERMENSTRUAL BLEEDING
During the first few months of using MYWY, unexpected bleeding (bleeding outside the placebo tablet phase) may occur. If such bleeding persists for longer than a few months or appears after several months, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the placebo tablet phase
If all pink tablets have been taken correctly, without vomiting or severe diarrhea, and no other medications have been taken, the likelihood of pregnancy is very low.

If the expected withdrawal bleeding does not occur twice in succession, this may indicate pregnancy. The patient should contact her doctor immediately. She should not start the next blister pack until pregnancy has been ruled out.

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

MYWY and other medicines
The patient should inform her doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines she plans to take. She should also inform any other doctor or dentist prescribing another medicine (or a pharmacist dispensing a medicine) that she is taking MYWY. They may advise whether additional contraceptive methods (e.g., condoms) are needed, for how long, and whether the use of another medicine she is taking needs to be changed.

Some medicines:

• may affect the blood concentration of MYWY,
• may cause it to be 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, osteoarthritis (etoricoxib),
• used to treat pulmonary hypertension (bosentan),
• herbal products containing St. John's wort (Hypericum perforatum).

MYWY may affect the action of other medicines, e.g.:

• those containing cyclosporine,
• antiepileptic lamotrigine (which may lead to increased frequency of epileptic seizures),
• theophylline (used for breathing problems),
• tizanidine (used to treat pain and/or muscle spasms).

MYWY should not be used if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may lead to increased blood test results assessing liver function (increased levels of the liver enzyme AlAT). The doctor will recommend another type of contraception before starting treatment with these medicines. Approximately 2 weeks after completing such treatment, MYWY may be restarted. See section "When not to use MYWY."

MYWY with food and drink
MYWY can be taken during meals or between meals; if needed, it can be taken with a small amount of water.

Laboratory tests
If a blood test is required, the patient should inform the doctor or laboratory staff that she is taking MYWY, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Women who are pregnant should not take MYWY. If the patient becomes pregnant while taking MYWY, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking MYWY at any time (see also section "Discontinuation of MYWY").

Before taking any medicine, consult a doctor or pharmacist.

Breastfeeding
MYWY is generally not recommended during breastfeeding. However, if a breastfeeding woman wishes to use MYWY during lactation, she should consult her doctor.

Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
There is no information on the effect of MYWY on the ability to drive and operate machinery.

MYWY contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking the medicine.
Each pink tablet of this medicine contains less than 1 mmol (23 mg) of sodium, meaning the medicine is considered "sodium-free."

3. How to take MYWY

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, 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 colours are arranged in a specific order. One blister
contains 28 tablets.
Take one MYWY tablet daily, with or without a small amount of water. The tablets may be taken
independently of meals, but should be taken every day at approximately the same time.
Do not confuse the tablets: take the pink tablets for the first 24 days, followed by the white
placebo tablets for the last 4 days. A new blister should be started immediately (24 pink, then
4 white tablets). Therefore, do not make a break between two blisters.
Due to differences in tablet composition, it is essential to start from the first tablet in the top
left corner of the blister and then take the tablets each day in the direction indicated by the
arrows on the blister.
Preparing the blister
To help remember which day of the week to take the tablet, each MYWY blister is supplied
with 7 self-adhesive strips printed with the days of the week. Select the strip that starts with the
day of the week on which you begin taking the tablets. For example, if you start taking tablets
on a Wednesday, use the strip starting with “Wed”.
Stick the label in the upper part of the MYWY blister, in the area marked “Place the day-of-the-week label here”. This way, the first day is indicated above the tablet marked with the number “1”. This ensures that each tablet is associated with the correct day of the week, allowing you to verify whether the appropriate tablet has been taken each day. Arrows indicate the order of tablet intake.
During the 4 days of taking the white placebo tablets (the placebo period), bleeding (so-called
withdrawal bleeding) should occur. This bleeding usually starts on the 2nd or 3rd day after taking
the last pink tablet containing the active substances of MYWY. After taking the last white
tablet, start the next blister immediately, regardless of whether bleeding has stopped or is still
ongoing. This means that new packs will always be started on the same day of the week, and
bleeding should occur on the same days each month.
Taking MYWY according to these instructions provides protection against pregnancy even
during the 4 days of taking placebo tablets.
When to start the first blister?

• If no hormonal contraceptives were used in the previous month Start taking MYWY on the first day of your cycle (i.e. the first day of menstruation). Starting MYWY on the first day of menstruation ensures immediate protection against pregnancy. You may also start on days 2–5 of the cycle, but in this case, additional contraceptive precautions (e.g. condoms) must be used for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined vaginal contraceptive system or transdermal system You may start taking MYWY the day after taking the last active tablet of the previous pack, but no later than the day after the end of the tablet-free interval of the previous contraceptive (or after the last inactive tablet of the previous contraceptive). If switching from a combined vaginal contraceptive system or transdermal system, follow your doctor’s advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device releasing progestogen) You may switch at any time from the progestogen-only pill (in the case of an implant or intrauterine device, on the day of removal; in the case of an injectable method, on the day of the next scheduled injection), but in all these cases, additional contraceptive precautions (e.g. condoms) must be used for the first 7 days of tablet intake.
• After miscarriage Follow your doctor’s advice.
• After childbirth You may start taking MYWY between the 21st and 28th day after childbirth. If starting later than the 28th day, use a mechanical method (e.g. condoms) for the first 7 days of taking MYWY. If you have had sexual intercourse after childbirth but before starting MYWY, you must first confirm that you are not pregnant or wait until bleeding occurs.
• If the patient is breastfeeding and wishes to start (or restart) taking MYWY after childbirth Read section “Breastfeeding”.

If you are unsure when to start taking the medicine, consult your doctor.
Taking more than the recommended dose of MYWY
There are no reports of serious harmful effects from taking too many MYWY tablets.
If several tablets are taken at once, nausea or vomiting may occur, or vaginal bleeding may appear.
Even young girls who have not yet started menstruating may experience such bleeding if they
accidentally take this medicine.
If too many MYWY tablets are taken or if a child swallows several tablets, consult your doctor or
pharmacist.
Missed dose of MYWY
The last 4 tablets in the 4th row of the blister are placebo tablets. If one of these is missed,
the contraceptive efficacy of MYWY is maintained. Discard the missed placebo tablet.
If a pink tablet containing active substances (tablets 1–24 in the blister) is missed, follow the
instructions below:

• If less than 24 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, then continue taking the following tablets at the usual time.
• If more than 24 hours have passed since the missed tablet, protection against pregnancy may be reduced. The more tablets missed, the higher the risk of pregnancy. The risk of inadequate protection is greatest if a pink tablet is missed at the beginning or end of the pack. Therefore, follow the rules below (see also the diagram below):
• More than one tablet missed in the blister Contact your doctor.
• One tablet missed on days 1–7 (first row) Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the following tablets at the usual time and use additional precautions, such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the missed tablet or if you forgot to start the next blister, there is a risk of pregnancy. In this case, contact your doctor.
• One tablet missed on days 8–14 (second row) Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the following tablets at the usual time. Protection against pregnancy is not reduced and no additional precautions are needed.
• One tablet missed on days 15–24 (third or fourth row) Two options are available:
  1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the following tablets at the usual time. Instead of taking the white placebo tablets, discard them and start the next blister immediately (the starting day of the cycle will be different). Withdrawal bleeding will most likely occur at the end of the second blister, but spotting or intermenstrual bleeding may occur during the second blister.
  2. Alternatively, stop taking the pink active tablets and go directly to the 4 white placebo tablets (before starting the placebo tablets, note the day on which the tablet was missed). If you wish to start the new blister on your usual starting day, the placebo period may be shortened to less than 4 days.

If you follow either of these recommendations, protection against pregnancy will be maintained.
If you missed any tablet from the blister and no bleeding occurs during the first placebo period,
this may indicate pregnancy. Before starting the next blister, consult your doctor.

What to do in case of vomiting or severe diarrhoea
If vomiting occurs within 3 to 4 hours after taking a pink tablet containing active substances, or
if severe diarrhoea occurs, there is a risk that the active substances have not been fully absorbed.
This situation is similar to missing a tablet. After vomiting or diarrhoea, take another pink tablet
from a spare blister as soon as possible. Ideally, take it within 24 hours of your usual tablet-taking time. If this is not possible or if 24 hours have passed, follow the advice given in the section “Missed dose of MYWY”.
Delaying the onset of menstrual bleeding: what you need to know
Although not recommended, it is possible to delay withdrawal bleeding by skipping the white
placebo tablets in the 4th row and immediately starting the second MYWY blister until its
completion. Spotting or intermenstrual bleeding may occur during the second blister. Complete
the second pack by taking the 4 white placebo tablets from the 4th row of the second pack. Then
start the next blister.
Before deciding to delay bleeding, consult your doctor.
Changing the first day of bleeding: what you need to know
When taking tablets as directed, withdrawal bleeding will begin during the placebo tablet period.
If you wish to change this day, shorten (but never extend – 4 days is the maximum!) the placebo
tablet period. For example, if the placebo period starts on Friday and you wish to change it to
Tuesday (3 days earlier), start the new blister 3 days earlier than usual. In this case, bleeding may
not occur and spotting or intermenstrual bleeding may occur instead.
If you are unsure how to proceed, contact your doctor.
Stopping treatment with MYWY
You may stop taking MYWY at any time. If you do not wish to become pregnant, consult your
doctor about other effective methods of contraception. If you plan to become pregnant, stop taking
MYWY and wait for menstruation to occur. This makes it easier to calculate the expected date of delivery.
If you have any further doubts regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of MYWY, medical advice should be sought from a physician.
Serious adverse reactions
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before using MYWY".
The following adverse reactions have been associated with the use of MYWY:
Common adverse reactions (may occur in 1 to 10 out of 100 people):

• mood swings,
• headache,
• nausea,
• breast tenderness, menstrual problems such as irregular bleeding, absence of bleeding.

Uncommon adverse reactions (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, flatulence, gastritis, diarrhoea,
• acne, itching, rash,
• pain-related complaints, e.g. back pain, limb pain, muscle cramps,
• fungal vaginal infection, pelvic pain, breast enlargement, benign breast tumour, uterine/vaginal bleeding (which usually resolves during continued use of the medicine), vaginal discharge, hot flushes, vaginal inflammation, menstrual bleeding disorders, painful bleeding, scanty bleeding, very heavy bleeding, vaginal dryness, abnormal cervical smear, decreased interest in sex.

Rare adverse reactions (may occur in 1 to 10 out of 10,000 people):

• candidiasis (fungal infection),
• anaemia, increased platelet count,
• allergic reaction,
• endocrine disorders,
• increased appetite, loss of appetite, significant increase in blood potassium levels, significant decrease in blood sodium levels,
• anorgasmia, insomnia,
• dizziness, chills,
• eye disorders, e.g. eyelid inflammation, dry eyes,
• significant tachycardia,
• phlebitis, nosebleed, fainting,
• abdominal distension, intestinal disorders, bloating sensation, gastric hernia, fungal infection of the mouth, constipation, dry mouth,
• pain in the biliary tract or gallbladder, cholecystitis,
• yellow-brown skin patches, rash, hair loss, acneiform dermatitis, dry skin, nodular skin inflammation, hirsutism, skin diseases, striae, dermatitis, photosensitivity, skin nodules,
• dyspareunia, vaginal inflammation, post-coital bleeding, withdrawal bleeding, breast cyst, increased number of cells (hyperplasia) in breast glands, malignant breast tumour, significant endometrial hyperplasia, endometrial atrophy or shrinkage, ovarian cysts, uterine enlargement,
• general malaise,
• weight loss,
• harmful blood clots in veins or arteries, 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 ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, 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 clot formation).

The following adverse reactions have been observed, but their frequency cannot be estimated reliably based on available data: hypersensitivity, erythema multiforme (rash with redness or target-shaped ulcers).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine MYWY

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP:". The expiry date refers to the last day of the stated month.
No special precautions regarding storage temperature of the medicinal product are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What MYWY contains
The active substances are drospirenone and ethinylestradiol.
Each pink coated tablet contains 3 mg of drospirenone and 0.02 mg of ethinylestradiol.
The white coated tablets do not contain any active substances.
Other ingredients are:

• Composition of pink tablets containing active substances:
  Tablet core: lactose monohydrate, maize starch gelatinised, povidone K30, sodium croscarmellose, 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.

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

Marketing Authorisation 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 medicinal product is authorised 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 about this medicinal product, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00