Mywy

Package leaflet: Information for the user

MYWY

3 mg/0.02 mg/film-coated tablets
Ethinylestradiol/Drospirenone
Equivalent medicine

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be vigilant and consult your doctor if you think you are experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 pill and is used to prevent pregnancy.
Each of the 24 pink tablets contains a small amount of two different female hormones,
called drospirenone and ethinylestradiol.
The 4 white tablets do not contain any active ingredients and are also known as placebo tablets.
Contraceptive pills that contain two hormones are called "combined" pills.

2. What you should know before taking MYWY

General information
Before starting to use MYWY, you must read the information about blood clots in section 2.
It is particularly important that you read about the symptoms of a blood clot (see section 2
“Blood clots”).
Before you can start taking MYWY, your doctor will ask you some questions about your
personal medical history and that of your close relatives. Your doctor will also measure your
blood pressure and, depending on your individual situation, may carry out further tests.
This patient leaflet describes various situations in which you will need to stop using
MYWY or in which the effectiveness of MYWY may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive measures, such as using a condom or another barrier method. Do not use fertility awareness-based methods or temperature-based methods. These methods may be unreliable because MYWY alters the monthly changes in body temperature and cervical mucus.
MYWY, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or
any other sexually transmitted disease.
Do not take MYWY
Do not use MYWY if you have any of the conditions listed below. If you have any of the
conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your case.

• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be bedridden for a long time (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which could increase the risk of forming clots in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”
• if you have (or have ever had) liver disease and your liver function is not yet normal;
• if your kidneys do not work properly (renal failure);
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or are suspected of having breast or genital organ cancer;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). In this case, you may experience itching, rash, or swelling.
• Do not use MYWY if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir and dasabuvir (see also section “Other medicines and MYWY”).

Additional information on special populations
Children and adolescents
MYWY is not intended for use in women whose menstrual cycles have not yet started.
Elderly women
MYWY is not intended for use after menopause.
Women with hepatic impairment
Do not take MYWY if you suffer from liver disease. See also sections “Do not use
MYWY” and “Warnings and precautions”.
Women with renal impairment
Do not take MYWY if you suffer from kidney malfunction or acute renal failure.
See also sections "Do not take MYWY" and "Warnings and precautions".
Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clots").

For a description of the symptoms of these serious adverse effects, go to the section “How
to recognize a blood clot”.
In certain situations, you must exercise particular caution when using MYWY or any other
combined oral contraceptive pill, and your doctor may need to examine you regularly.
If any of the following conditions apply to you, inform your doctor before starting to take MYWY. If any of the following conditions develop or worsen while you are using MYWY, you must inform your doctor:

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or will be bedridden for a long time (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start taking MYWY;
• if you have inflammation of the veins just under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if a close relative has, or has ever had, breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you suffer from depression;
• if you suffer from epilepsy (see “Other medicines and MYWY”);
• if you have a disease that first appeared during pregnancy or during previous use of sex hormones [e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden jerky movements of the body (Sydenham’s chorea)];
• if you have, or have ever had, brownish-yellow pigmented patches (chloasma), known as “pregnancy mask”, especially on the face. In this case, avoid direct exposure to sunlight or ultraviolet light; If you have hereditary angioedema, medicines containing oestrogens may cause or worsen its symptoms. You should contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with breathing difficulties.

BLOOD CLOTS
Using a combined hormonal contraceptive such as MYWY increases the risk of developing
a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, and very rarely, such effects may be fatal. It is important to remember that the overall risk of a harmful blood clot associated with MYWY is low. HOW TO RECOGNIZE A BLOOD CLOT Seek immediate medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot breaks away from the leg and travels to the lung, it can cause a pulmonary embolism.
• Very rarely, the clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking MYWY, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with MYWY is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as MYWY, about 9–12 will develop a blood clot in one year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with MYWY is low, but certain conditions can increase this risk. Your risk is higher:

• if you are significantly overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you need to undergo surgery or must remain bedridden for a prolonged period due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking MYWY several weeks before surgery or during periods of reduced mobility. If you need to stop taking MYWY, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases if you have several of these conditions simultaneously. Air travel (lasting > 4 hours) may temporarily increase the risk of blood clots, particularly if you have other listed risk factors.

It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide that you should stop taking MYWY.
If any of the above conditions change while you are using MYWY—for example, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems; for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of MYWY is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as MYWY, it is advisable to stop smoking. If you cannot stop smoking and you are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using MYWY—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

THE PILL AND CANCER
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, it is possible that more breast tumors are diagnosed in users of combined pills because they undergo more frequent medical check-ups. The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.

In rare cases, benign liver tumors have been observed in users of the pill, and in an even smaller number of cases, malignant liver tumors. Contact your doctor if you experience unusual and severe abdominal pain.

INTERMENSTRUAL BLEEDING
During the first few months of taking MYWY, you may notice unexpected bleeding (bleeding outside the placebo days). If this bleeding occurs for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the placebo days
If you have taken all the active pink tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.

If menstruation does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Start the next blister pack only if you are certain you are not pregnant.

PSYCHIATRIC DISORDERS
Some women using hormonal contraceptives, including Mywy, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Other medicines and MYWY
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Also inform any other doctor or dentist who prescribes you another medicine (or the pharmacist) that you are using MYWY. They will advise you whether you need to take additional contraceptive measures (e.g., condom), and if so, for how long, or whether you need to adjust the use of another medicine.

Some medicines:

• can affect blood levels of MYWY;
• can make it less effective in preventing pregnancy;
• may cause unexpected bleeding.

These include 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 (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 high blood pressure in the blood vessels of the lungs (bosentan);
• containing the herbal preparation St. John’s wort (Hypericum perforatum).

MYWY may affect the effect of other medicines, for example:

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain and/or muscle cramps).

Do not use MYWY if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as they may cause increases in blood liver function tests (elevation of liver enzyme ALT). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
MYWY can be restarted approximately 2 weeks after completion of this treatment. See the section "Do not take MYWY".

MYWY with food and drinks
MYWY can be taken with or without food, if necessary with a little water.

Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may alter the results of certain laboratory tests.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, you must not take MYWY. If you become pregnant while taking MYWY, stop taking the pill immediately and contact your doctor. You may discontinue MYWY at any time if pregnancy occurs (see also “If you stop taking MYWY”).

Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding
Generally, the use of MYWY is not recommended while breastfeeding. If you wish to take the pill while breastfeeding, you must contact your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and use of machines
There is no evidence to suggest that the use of MYWY affects the ability to drive vehicles or operate machinery.

MYWY contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Each pink tablet of this medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take MYWY

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Each blister contains 24 pink active tablets and 4 white placebo tablets.
The two types of tablets of different colours in MYWY are arranged in sequence. One blister contains 28 tablets.
Take one tablet of MYWY every day, if necessary with a little water. You may take the tablets with or without food, but you must take them at approximately the same time each day.
Do not confuse the tablets: take one pink tablet for the first 24 days, followed by one white tablet for the last 4 days. Then immediately start a new blister of tablets (24 pink tablets and 4 white tablets). Therefore, there is no break between the two blisters.
Since the composition of the tablets is different, you must start with the first tablet located in the top left corner of the blister and take the tablets every day in order. Follow the direction of the arrows on the blister to ensure correct sequence.

Preparing the blister
To help you keep track of the tablets, each MYWY blister is supplied with 7 adhesive labels indicating the 7 days of the week. Choose the weekly adhesive label starting with the day on which you begin taking the tablets. For example, if you start on Wednesday, use the weekly adhesive label beginning with “WED”.
Apply the weekly adhesive label along the top edge of the blister where it says “Place weekly label here”, so that the first day appears above the tablet marked with the number “1”. Now each tablet has a day marked above it, allowing you to see whether you have taken a particular tablet. The arrows indicate the order in which to take the tablets.

During the 4 days when you take the white placebo tablets (the placebo days), you should experience menstruation (the so-called withdrawal bleeding). This usually starts on day 2 or 3 after the last pink active tablet of MYWY. After taking the last white tablet, you must immediately start the next blister, regardless of whether your period is still ongoing. This means that you must start each new blister on the same day of the week, and the withdrawal bleeding should occur on the same days each month.
If you use MYWY in this way, you are protected against pregnancy even during the 4 days when you take the placebo tablet.

When can you start the first blister?

• If you have not used a hormonal contraceptive in the previous month Start taking MYWY on the first day of your cycle (i.e. the first day of menstruation). If you start taking MYWY on the first day of your period, you will be immediately protected against pregnancy. You may also start taking the tablets between day 2 and day 5 of your cycle, but in this case you must use additional contraceptive measures (e.g. a condom) for the first 7 days.

• Switching from a combined hormonal contraceptive, a combined vaginal ring, or a transdermal contraceptive patch You may start taking MYWY preferably the day after the last active tablet (the last tablet containing active ingredients) of the previous pill, or at the latest the day after the end of the tablet-free interval of the previous pill (or after the last inactive tablet of the previous pill). When switching from a combined vaginal ring or a transdermal patch, follow your doctor’s advice.

• Switching from a progestogen-only method [progestogen-only pill, injection, implant, or a progestogen-releasing IUD] You may switch on any day from the progestogen-only pill (on the day of removal in case of an implant or IUD, or when the next injection is due in case of an injectable). However, in all these cases, you must use additional contraceptive measures (e.g. a condom) for the first 7 days of tablet intake.

• After an abortion Follow your doctor’s advice.

• After childbirth
  You may start taking MYWY between day 21 and day 28 after childbirth. If you start after day 28, you must use a so-called barrier method (e.g. a condom) during the first seven days of taking MYWY.
  If, after childbirth, you have had sexual intercourse before starting (or restarting) MYWY, you must first ensure that you are not pregnant or wait until your next menstruation.

• If you are breastfeeding and wish to start (or restart) taking MYWY after childbirth Please read the section "Breastfeeding".

Ask your doctor for advice if you are unsure about when to start.

If you take more MYWY than you should
There have been no reports of serious harmful effects following an overdose of MYWY tablets.
If you have taken several tablets at once, you may experience symptoms such as nausea, vomiting, or vaginal bleeding. Even young girls who have not yet started menstruating may experience similar bleeding if they accidentally take this medicine.
If you have taken too many MYWY tablets, or if you discover that a child has taken some, consult your doctor or pharmacist.

If you forget to take MYWY
The last 4 tablets in the 4th row of the blister are placebo tablets. If you forget to take one of these tablets, this will not affect the reliability of MYWY. Discard the forgotten placebo tablet.
If you forget to take an active pink tablet (tablets 1 to 24 of the blister), follow the instructions below:

• If you are less than 24 hours late in taking a tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and then take the following tablets at your usual time.
• If you are more than 24 hours late in taking a tablet, contraceptive protection may be reduced. The greater the number of tablets missed, the higher the risk of becoming pregnant.

The risk of incomplete contraceptive protection is greater if you missed a pink tablet at the beginning or end of the blister. Therefore, follow the instructions below (see also the diagram following):

• More than 1 tablet missed in this blister Contact your doctor.
• One tablet missed between days 1–7 (first row) Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional contraceptive measures (e.g. a condom) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a possibility that pregnancy has occurred. In this case, contact your doctor.
• One tablet missed between days 8–14 (second row) Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Contraceptive protection is not reduced, and no additional precautions are needed.
• One tablet missed between days 15–24 (third or fourth row) You have two options:
  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of taking the white placebo tablets from the current blister, discard them and immediately start the next blister (your starting day will be different).

You will most likely have a period at the end of the second blister—during the intake of the white placebo tablets—but you may experience light bleeding or spotting during the second blister.

2. Alternatively, you may stop taking the pink active tablets and immediately switch to the 4 white placebo tablets (before taking the placebo tablets, note down the day on which you missed the tablet). If you wish to start a new blister on your usual day, take the placebo tablets for less than 4 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.
If you have missed any tablet from the blister and do not have a withdrawal bleed during the placebo days, you may be pregnant. Contact your doctor before starting the next blister.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3-4 hours after taking an active pink tablet or have severe diarrhoea, there is a
risk that the active ingredients in the tablet may not be completely absorbed by your body. This
situation is comparable to missing a tablet. After vomiting or severe diarrhoea, you must take another
pink tablet from a spare blister pack as soon as possible. If possible, take it within 24 hours of your
usual pill-taking time. If this is not possible, or if more than 24 hours have passed, follow the
instructions given in the section “If you forget to take MYWY”.
Delayed menstruation: what you need to know
Although not recommended, it is possible to delay menstruation by not taking the white placebo
tablets in row 4 and immediately starting a new blister of MYWY, completing it. During use of this
second blister, you may experience light bleeding or menstrual-like bleeding. Finish this second
blister by taking the 4 white placebo tablets in row 4. Then start the next blister.
You may wish to consult your doctor before deciding to delay your menstrual cycle.
Changing the day your period starts: what you need to know
If you take the tablets as directed, your period will start during the placebo days. If you wish to
change this day, reduce the number of placebo days – while taking the white placebo tablets – (but
never increase them – 4 days is the maximum!). For example, if you usually start taking the placebo
tablets on Friday and wish to move it to Tuesday (3 days earlier), you should start a new blister 3
days earlier than usual. During this time, you may not have any bleeding at all. Afterwards, you may
experience light or menstrual-like bleeding.
If you are unsure what to do, consult your doctor.
If you stop taking MYWY
You may stop taking MYWY at any time. If you do not wish to become pregnant, consult your doctor
about other reliable methods of birth control. If you wish to become pregnant, stop taking MYWY
and wait for a menstrual period before trying to conceive. This will allow you to calculate your
expected date of delivery more easily.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effect, especially if it is severe and persistent, or if you notice any change in your health that you think could be due to MYWY, inform your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking MYWY”.

The following list includes side effects that have been associated with the use of MYWY:

• Common side effects (may affect up to 1 in 10 people):
• Mood swings.
• Headache.
• Nausea.
• Breast pain, menstrual cycle disturbances such as irregular menstruation, absence of menstruation.
• Uncommon side effects (may affect up to 1 in 100 people):
• Depression, nervousness, drowsiness.
• Dizziness, tingling sensations.
• Migraine, varicose veins, increased blood pressure.
• Stomach ache, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea.
• Acne, itching, rash.
• Discomfort and pain, for example back pain, limb pain, muscle cramps.
• Vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which generally decreases during continued treatment), genital discharge, hot flushes, vaginal inflammation (vaginitis), menstrual cycle disturbances, painful menstruation, scanty menstruation, very heavy menstruation, vaginal dryness, abnormal cervical smear, decreased interest in sex.
• Lack of energy, increased sweating, fluid retention.
• Weight gain.
• Rare side effects (may affect up to 1 in 1,000 people):
• Candidiasis (a fungal infection).
• Anaemia, increased number of platelets in the blood.
• Allergic reaction.
• Hormonal disorders (endocrine disorders).
• Increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood.
• Inability to achieve orgasm, insomnia.
• Dizziness, tremor.
• Eye disorders, for example eyelid inflammation, dry eyes.
• Rapid heartbeat.
• Inflammation of a vein, epistaxis (nosebleed), fainting.
• Abdominal swelling, intestinal disorders, bloating sensation, gastric hernia, fungal infection of the mouth, constipation, dry mouth.
• Bile duct or gallbladder pain, gallbladder inflammation.
• Yellow-brown skin patches, eczema, hair loss, acne-like skin inflammation, dry skin, granulomatous skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitivity-related skin inflammation, skin nodules.
• Painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the mucous surface of the cervix, reduction or narrowing of the uterine lining, ovarian cysts, uterine enlargement.
• General feeling of malaise.
• Weight loss.
• Harmful blood clots in a vein or an artery, for example:
• in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

The following side effects have also been reported, but their frequency cannot be determined from the available data: hypersensitivity, erythema multiforme (skin rash with target-like red lesions or ulcers).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MYWY contains
The active substances are drospirenone and ethinylestradiol.
Each pink film-coated active tablet contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol.
The white film-coated tablets do not contain any active substances.
The other components are:

• Pink film-coated active tablets: Tablet core: monohydrate lactose, pregelatinized starch (maize), povidone (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E572). Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• White film-coated inactive tablets: Tablet core: anhydrous lactose, povidone (E1201), magnesium stearate (E572). Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of MYWY and package contents

• Each MYWY blister pack contains 24 pink film-coated active tablets placed in rows 1, 2, 3 and 4 of the blister, and 4 white film-coated placebo tablets placed in row 4.
• The MYWY tablets, both pink and white, are film-coated tablets with a coated tablet core.
• MYWY is available in boxes containing 1, 3, 6 and 13 blisters, each blister containing 28 (24+4) tablets.

It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale Bodio, 37/B
20158 Milan, Italy
Manufacturer
Laboratorios León Farma, S.A.
Polígono Industrial Navatejera
La Vallina s/n
24008-Villaquilambre, León
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Czech Republic: MYWY
Germany, Poland, Italy: MYWY
Lithuania, Latvia: LETHE 0.02 mg/3mg