Package leaflet: Information for the patient

Myviolet 0,02mg/3mg film-coated tablets

ethinylestradiol/drospirenone
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See Section 4.

Important things to know 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 alert and contact your doctor if you think you have symptoms of a blood clot (see Section 2 “Blood clots”).

Contents of this leaflet
1. What Myviolet is and what it is used for
2. What you need to know before taking Myviolet

Do not take Myviolet
Warnings and precautions
Myviolet and venous and arterial thrombosis
Myviolet and cancer
Bleeding between periods
What to do if you do not have a bleed during the interval week
Other medicines and Myviolet
Laboratory tests
Pregnancy and breastfeeding
Driving and using machines
Myviolet contains lactose

3. How to take Myviolet

When you can start with the first blister pack
If you take more Myviolet than you should
If you forget to take Myviolet
What to do in case of vomiting or severe diarrhoea
Delayed menstrual period: what you should know
Change in the first day of your menstrual cycle: what you should know
If you stop treatment with Myviolet

4. Possible side effects
5. How to store Myviolet
6. Contents of the pack and other information
1. What Myviolet is and what it is used for
Myviolet is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, specifically
ethinylestradiol and drospirenone.
Contraceptive pills containing two hormones are called "combined" pills.

2. What you should know before taking Myviolet

General information
Before starting to use Myviolet, 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 taking Myviolet, your doctor will ask you some questions about your personal and family medical
history. In addition, your doctor will measure your blood pressure and, depending on your individual
circumstances, may carry out other examinations.
This patient leaflet describes several situations in which you must stop taking Myviolet, or in which the
safety of Myviolet may be reduced. In such situations, you must not have sexual intercourse or you must use
additional non-hormonal contraceptive measures, for example, use a condom or other barrier methods. Do
not use rhythm or temperature-based methods. These methods may not be reliable because Myviolet
alters the monthly variations in body temperature and cervical mucus.
Myviolet, like other hormonal contraceptives, does not protect against HIV (AIDS) or other
sexually transmitted infections.
Do not take Myviolet
Do not use Myviolet 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 may 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 about to undergo surgery or will be bedridden for a prolonged period (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 conditions, which could increase the risk of developing 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) a liver disease and liver function has not yet returned to 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 if it is suspected that you have 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). This condition may manifest as itching, rash, or swelling.

Do not use Myviolet if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir /
ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (also see section
“Other medicines and Myviolet”).
Children and adolescents
Myviolet is not intended for use in women whose menstrual cycle has not yet started.
Elderly women
Myviolet is not intended for use after menopause.
Women with hepatic impairment
Do not take Myviolet if you suffer from liver disease (see sections “Do not take Myviolet” and
“Warnings and precautions”).
Women with renal impairment
Do not take Myviolet if you suffer from poorly functioning kidneys or acute renal failure (see sections “Do
not take Myviolet” 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 stroke (see the following section “Blood clot”).

For a description of the symptoms of these serious side effects, go to the section “How to recognize a
blood clot”.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Myviolet, you must inform your doctor.
In some situations, you must exercise particular caution when using Myviolet or any other combined pill,
and it may be necessary for you to be regularly monitored by your doctor.
Contact your doctor, pharmacist, or nurse before taking Myviolet

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 about to undergo surgery or will be bedridden for a prolonged period (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 delivery you can start taking Myviolet
if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
if you have varicose veins
if a close relative has or has ever had breast cancer
if you have cancer
if you have liver disease (e.g. bile duct obstruction which may cause jaundice or symptoms such as itching) or gallbladder disease (e.g. gallstones)
if you have other kidney problems and are taking medicines that increase potassium levels in the blood
if you have diabetes
if you suffer from depression
if you suffer from epilepsy (see section “Other medicines and Myviolet”)
if you have a condition that first appeared during pregnancy or during previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disorder with sudden involuntary movements of the body (Sydenham's chorea))
if during treatment you have uncontrolled high blood pressure despite medication
if you have or have ever had chloasma (a skin pigmentation disorder, particularly on the face or neck, known as “pregnancy mask”). In this case, avoid direct exposure to sunlight or ultraviolet light while taking this medicine
if you notice symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible breathing difficulties, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Myviolet 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 or, very
rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Myviolet is
low.
HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have one of these signs? What might you be suffering from?

swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
pain or tenderness in the leg, which may only be felt when standing or walking
increased warmth in the affected leg
change in skin colour of the leg, such as paleness, redness or bluish discoloration
sudden and unexplained shortness of breath or rapid breathing;
sudden cough without an obvious cause, possibly with coughing up of blood;
sharp chest pain that may worsen when breathing deeply;
severe dizziness or lightheadedness;

rapid or irregular heartbeat; •severe stomach pain If you are unsure, inform your doctor as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g. a "common cold").
Symptoms occurring more frequently in one eye: •sudden loss of vision or •painless blurring of vision which may progress to loss of vision	Retinal vein thrombosis (blood clot in the eye)
pain, discomfort, pressure or heaviness in the chest •crushing sensation or fullness in the chest, one arm or under the breastbone; •feeling of fullness, indigestion or suffocation; •discomfort in the upper body spreading to back, jaw, throat, arms and stomach; •sweating, nausea, vomiting or dizziness; •extreme weakness, anxiety or shortness of breath; •rapid or irregular heartbeats	Heart attack
sudden numbness or weakness of the face, arm or leg, especially on one side of the body; •sudden confusion, difficulty speaking or understanding; •sudden trouble seeing with one or both eyes; •sudden trouble walking, dizziness, loss of balance or coordination; •sudden, severe or prolonged headache with no known cause; •loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue discoloration of a limb; •severe abdominal pain (acute abdomen)	Blood clots blocking other blood vessels

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 travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
Very rarely, a 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 taking 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 Myviolet, 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 venous thromboembolism (VTE) and on 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 Myviolet is low.
The likelihood of developing a blood clot increases with the use of the pill.

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 Myviolet, about 9–12 will develop a blood clot in one year.
The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

	Risk of developing a blood clot in one year
Women who are not using a combined hormonal pill/patch/ring and who are not pregnant	About 2 women out of 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women out of 10,000
Women who use Myviolet	About 9-12 women out of 10,000

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

if you are very 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 are due to have surgery or need to remain bedridden for a long time due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking Myviolet several weeks before surgery or during periods of reduced mobility. If you need to stop taking Myviolet, ask your doctor when you can start taking it again;
as you get older (especially over 35 years);
if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
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 Myviolet.
If any of the above conditions change while you are using Myviolet—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 can 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 Myviolet is very low, but it may increase:

with increasing age (over 35 years);
if you smoke. When using a combined hormonal contraceptive such as Myviolet, it is advisable to stop smoking. If you are unable to stop smoking and 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 Myviolet—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.

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

Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using the pill. Contact your doctor if you experience unusual and severe abdominal pain, abdominal swelling (which may be due to liver enlargement), or stomach bleeding.

Bleeding between periods
During the first two months of taking Myviolet, unexpected bleeding (bleeding outside the interval week between two cycles) may occur. If this bleeding continues for several months or starts after a few months, your doctor should investigate the cause.

What to do if bleeding does not occur during the interval week
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Psychiatric disorders
Some women using hormonal contraceptives, including Myviolet, have reported depression or depressed mood. Depression can be severe and sometimes may 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 Myviolet
Inform your doctor about any medicines or herbal remedies you are taking, have recently taken, or might take. Also inform any other doctor, dentist, or pharmacist prescribing other medicines that you are taking Myviolet. They will advise you whether you need to use additional contraceptive precautions (e.g., condom), for how long, or whether the use of another medicine you require needs to be adjusted.

Do not use Myviolet if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir,
as these may cause an increase in certain liver test results (elevated liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Myviolet can be resumed approximately 2 weeks after completing this treatment. See the section "Do not take Myviolet."

Some medicines may affect the blood levels of Myviolet and may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate) or tuberculosis (e.g., rifampicin) or HIV and hepatitis C infections (medicines known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or fungal infections (griseofulvin, ketoconazole) or arthritis, osteoarthritis (etoricoxib)
pulmonary hypertension (bosentan)
the herbal preparation St. John's wort.

If you are taking any of the above medicines together with Myviolet, you must use additional contraceptive precautions (e.g., use of a condom) during treatment and for 28 days after stopping treatment.
Myviolet may affect the action of other medicines, for example:

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

Your doctor may monitor your blood potassium levels if you are taking certain medicines for heart conditions (e.g., diuretics).

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

Pregnancy and breastfeeding
Pregnancy
Do not take Myviolet if you are pregnant. If you become pregnant while taking Myviolet, stop taking it immediately and inform your doctor. If you wish to become pregnant, you may stop taking Myviolet at any time (see "If you stop treatment with Myviolet").

Breastfeeding
The use of Myviolet is generally not recommended for women who are breastfeeding. If you wish to take the pill while breastfeeding, contact your doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

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

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

3. How to take Myviolet

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Take one Myviolet tablet daily, with a small amount of water if necessary. You may take the tablets with or without food, but you should take them at approximately the same time each day.

The blister pack contains 21 tablets. Next to each tablet, the day of the week on which it should be taken is printed. For example, if you start on Wednesday, use the tablet marked “WED” next to it, and follow the direction of the arrow on the blister pack until you take the 21st tablet.

Then do not take any tablets for 7 days. During these 7 tablet-free days (also called the "interval week"), your menstrual period should begin. This so-called "withdrawal bleeding" usually starts on the 2nd or 3rd day of the interval week.

On the 8th day after the last Myviolet tablet (i.e., after the 7 days of the interval week), start the next blister pack, even if bleeding has not yet stopped. This means you will start the next pack on the same day of the week, and withdrawal bleeding should occur during this period.

If you use Myviolet in this way, you will be protected from pregnancy during the 7 days when you do not take the tablet.

When to start the first blister pack

If you have not used a hormonal contraceptive in the previous month: Start taking Myviolet on the first day of your cycle (i.e., the first day of menstruation). If you start taking Myviolet on the first day of your period, you will be immediately protected against pregnancy. You may also start between day 2 and day 5 of your cycle, but you must use additional contraceptive precautions (e.g., a condom) for the first 7 days.
Switching from another combined hormonal contraceptive or from a combined vaginal ring or patch: You should start taking Myviolet preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the tablet-free interval (or after the last inactive tablet of your previous pill). When switching from a combined hormonal vaginal ring or patch, follow your doctor’s advice.
Switching from a progestogen-only method (progestogen-only pills, injection, implant, or progestogen-releasing intrauterine device - IUD): You may switch on any day from a progestogen-only pill (from an implant or IUD on the day of its removal, from an injectable when the next injection is due), but in all these cases you must use additional contraceptive precautions (e.g., a condom) for the first 7 days of tablet intake.
After an abortion or termination of pregnancy: Follow your doctor’s advice.
After childbirth: You may start using Myviolet between 21 and 28 days after delivery. If you start more than 28 days after childbirth, you must use a so-called barrier contraceptive method (e.g., a condom) for the first 7 days of taking Myviolet. If you have had sexual intercourse after childbirth and before starting Myviolet, you must first ensure you are not pregnant, otherwise wait until your next menstruation.
If you are breastfeeding and wish to start (or restart) using Myviolet after childbirth: Read the section “Breast-feeding”.

If you are unsure, ask your doctor when to start.

If you take more Myviolet than you should

There are no reports of serious or life-threatening consequences from taking too many Myviolet tablets.

If you have taken several tablets at once, you may experience symptoms such as nausea, vomiting, or vaginal bleeding. Even girls who have not yet had their first menstrual period but have accidentally taken this medicine may experience such bleeding.

If you have taken too many Myviolet tablets or if you discover that a child has ingested them, contact your doctor or pharmacist for advice.

If you forget to take Myviolet

If you are less than 12 hours late in taking a tablet, your protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, then take the next tablet at your usual time.
If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The greater the number of missed tablets, the higher the risk of becoming pregnant.

The risk of incomplete protection is higher if you missed a tablet at the beginning or end of the pack. Therefore, follow these rules (see the diagram below):

More than one tablet missed in the pack: Contact your doctor.
One tablet missed in the first week: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time and use additional precautions for the next 7 days (e.g., a condom). If you had sexual intercourse during the week before missing the tablet, consider that pregnancy may have occurred. In this case, contact your doctor.
One tablet missed in the second week: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. Protection against pregnancy is not reduced, and additional precautions are not needed.
One tablet missed in the third week: 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 following tablets as scheduled. Instead of the tablet-free interval, start the next pack immediately. Your period will most likely occur at the end of the second pack, but you may experience spotting or breakthrough bleeding during the second pack.
2. You may also stop taking tablets and go directly into the 7-day tablet-free interval (including the days when you missed the tablet; note the day on which you forgot to take the tablet). If you wish to start a new pack on your usual starting day, shorten the tablet-free interval to less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

If you have missed any tablets in a pack and do not have a period during the first tablet-free interval, this may indicate that you are pregnant. Contact your doctor before starting the next pack.

The following diagram describes what to do if you forget to take tablets.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, there is a risk that the active ingredients of the tablet are not fully absorbed by your body. In this case, you may need to use additional protection (such as a condom) to avoid pregnancy. The situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible: if possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the advice given in the section “If you forget to take Myviolet”.

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period by starting a new blister pack of Myviolet immediately instead of having the tablet-free interval, and continuing until the end of the second pack. Light spotting or breakthrough bleeding may occur during the use of the second pack. After finishing the second pack, take the usual 7-day tablet-free interval and then continue with the next pack.

Ask your doctor for advice before deciding to delay your menstrual period.

Changing the first day of your menstrual period: what you should know

If you take the tablets as instructed, your menstrual period will start during the tablet-free interval. If you wish to change the starting day, you may shorten the tablet-free interval (never lengthen it – 7 days is the maximum!). For example, if your tablet-free interval starts on Friday and you want to shift it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If you have a very short tablet-free interval (e.g., 3 days or less), you may not have any bleeding during the tablet-free period. Light spotting or breakthrough bleeding may occur.

If you are unsure about what to do, contact your doctor for advice.

If you stop taking Myviolet

You may stop taking Myviolet 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 Myviolet and wait for one menstrual cycle before trying to conceive. This will make it easier to calculate your due date accurately.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Myviolet, 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 Myviolet”.

Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

If you experience any of the following side effects, you may need urgent medical attention. Stop taking Myviolet and contact a doctor or go immediately to the nearest hospital.

Uncommon (may affect up to 1 in 100 women):

dangerous blood clots in the lung (pulmonary embolism)

Rare (may affect up to 1 in 1,000 women):

dangerous blood clots in a vein or an artery, for example: in a leg or foot (i.e. deep vein thrombosis (DVT)), heart attack, stroke, mini-stroke or temporary stroke-like symptoms known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestines, kidneys or eyes.

Conditions that may occur or worsen during pregnancy or with previous use of the pill include:

systemic lupus erythematosus (SLE, a disease affecting the immune system)
inflammation of the colon or other parts of the intestine (with signs such as bloody diarrhoea, pain on defecation, abdominal pain) (Crohn’s disease and ulcerative colitis)
epilepsy
uterine fibroids (non-cancerous tumours that may develop within the muscular tissue of the uterus)
blood pigment disorder (porphyria)
blistering rash (herpes gestationis) during pregnancy
Sydenham’s chorea (a nerve disorder causing sudden, involuntary movements of the body)
blood disorders causing kidney damage (haemolytic uraemic syndrome with signs such as reduced urine output, blood in urine, reduced red blood cells, nausea, vomiting, confusion and diarrhoea)
yellowing of the skin or whites of the eyes due to bile duct obstruction (cholestatic jaundice).

Additionally, breast cancer has been observed (see section 2 “Myviolet and cancer”), as well as benign and malignant liver tumours (with signs such as abdominal swelling, weight loss, liver function abnormalities detectable in blood tests), and chloasma (brownish-yellow patches on the skin, particularly on the face, also known as “melasma” or “mask of pregnancy”), which may be permanent, especially in women who previously experienced chloasma during pregnancy.

Other possible side effects

Common (may affect up to 1 in 10 women):

mood changes
headache
abdominal pain (stomach ache)
acne
breast pain, breast enlargement, breast tenderness, painful or irregular menstruation
weight gain.

Uncommon (may affect up to 1 in 100 women):

candidiasis (fungal infection)
cold sores (herpes simplex)
allergic reactions
increased appetite
depression, nervousness, sleep disorders
tingling, dizziness
vision problems
irregular or abnormally fast heartbeat
high blood pressure, low blood pressure, migraine, varicose veins
sore throat
nausea, vomiting, inflammation of the stomach and/or intestine, diarrhoea, constipation
hair loss (alopecia), eczema, itching, skin rashes, dry skin, disorders of sebum production (seborrhoeic dermatitis)
neck pain, limb pain, muscle cramps
bladder infection
breast lumps (benign), milk production without pregnancy (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, very heavy menstruation, vaginal discharge, vaginal infection or inflammation, vaginal dryness, lower abdominal (pelvic) pain, abnormal cervical smear (Papanicolaou or Pap test), decreased interest in sex
fluid retention, lack of energy, excessive thirst, increased sweating
weight loss
widespread pain.

Rare (may affect up to 1 in 1,000 women):

asthma
hearing impairment
erythema nodosum (characterized by painful, red skin nodules)
erythema multiforme (characterized by circular red skin rash or lesions)

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 Myviolet

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date which is stated on the blister and on the packaging after "Do not use after" or "EXP". The expiry date refers to the last day of that month.
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 Myviolet contains

The active substances are ethinylestradiol and drospirenone. Each tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
The other components are monohydrate lactose, pregelatinized corn starch, povidone (E1201), sodium croscarmellose, polysorbate 80 (E433), magnesium stearate (E470b), partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) (see section 2, "Myviolet contains lactose and sodium").

Description of the appearance of Myviolet and contents of the pack
The tablets are pink, round, film-coated.
Myviolet is available in boxes containing 1, 2, 3, 6 and 13 blisters of 21 tablets each.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturer(s)
Laboratorios León Farma, S.A.,
C/ La Vallina s/n, Pol. Ind. Navatejera,
24193 - Villaquilambre, León,
Spain.
McDermott Laboratories Ltd,
35 Baldoyle Industrial Estate, Grange Road,
Dublin 13,
Ireland.
Mylan Hungary Kft,
2900 Komárom,
Mylan Utca 1,
Hungary.

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Margotviatris 20 0.02 mg/3 mg film-coated tablets
Italy: Myviolet 0.02 mg/3 mg film-coated tablets
Netherlands: Ethinylestradiol/Drospirenon Viatris 0.02 mg/3 mg, filmomhulde tabletten
Portugal: Drospirenona + Etnilestradiol Mylan

Package leaflet: Information for the patient

Myviolet 0.03 mg/3 mg film-coated tablets

ethinylestradiol/drospirenone
Equivalent medicine
Please 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

They are among the most reliable reversible methods of contraception 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 alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

What Myviolet is and what it is used for
What you need to know before taking Myviolet
Do not take Myviolet
Myviolet and cancer
Bleeding between periods
What to do if no bleeding occurs during the tablet-free interval
Other medicines and Myviolet
Laboratory tests
Pregnancy and breastfeeding
Driving and use of machines
Myviolet contains lactose and sodium
How to take Myviolet
When to start the first blister pack
If you take more Myviolet than you should
If you forget to take Myviolet
What to do if you vomit or have severe diarrhoea
Delayed menstrual period: what you should know
Change in the first day of your menstrual period: what you should know
If you stop treatment with Myviolet
Possible side effects
How to store Myviolet
Contents of the pack and other information
What Myviolet is and what it is used for
What you need to know before taking Myviolet
Do not take Myviolet
Warnings and precautions
Myviolet and cancer
Bleeding between periods
What to do if no bleeding occurs during the tablet-free interval
Other medicines and Myviolet
Laboratory tests
Pregnancy and breastfeeding
Driving and use of machines
Myviolet contains lactose
How to take Myviolet
When to start the first blister pack
If you take more Myviolet than you should
If you forget to take Myviolet
What to do if you vomit or have severe diarrhoea
Delayed menstrual period: what you should know
Change in the first day of your menstrual period: what you should know
If you stop treatment with Myviolet
Possible side effects
How to store Myviolet
Contents of the pack and other information

7. What Myviolet is and what it is used for

Myviolet is a contraceptive pill used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, specifically
ethinylestradiol and drospirenone.
Contraceptive pills that contain two hormones are called "combined" pills.

8. What you should know before taking Myviolet

General notes
Before starting to use Myviolet, 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 taking Myviolet, your doctor will ask you some questions about your personal and family medical history. In addition, your doctor will measure your blood pressure and, depending on your individual condition, may carry out other examinations.
This patient leaflet describes several situations in which you must stop taking Myviolet or in which the safety of Myviolet may be reduced. In such situations, you must not have sexual intercourse or must use additional non-hormonal contraceptive measures, for example, use a condom or other barrier methods. Do not use rhythm or temperature-based methods. These methods may not be reliable because Myviolet alters the monthly variations in body temperature and cervical mucus.

Myviolet, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

Do not take Myviolet
Do not use Myviolet 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 may be more suitable for your case.

if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in 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 about to undergo surgery or will be bedridden for a prolonged period (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 that 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 may increase the risk of developing 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 liver function has not returned to 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 if it is suspected that you have cancer of the breast or genital organs;
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). This condition may manifest as itching, rash, or swelling.

Children and adolescents
Myviolet is not intended for use in women who have not yet started menstruating.

Elderly women
Myviolet is not intended for use after menopause.

Women with hepatic impairment
Do not take Myviolet if you suffer from liver disease (see sections “Do not take Myviolet” and “Warnings and precautions”).

Women with renal impairment
Do not take Myviolet if you suffer from poorly functioning kidneys or acute renal failure (see sections “Do not take Myviolet” 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 your leg (deep vein thrombosis), in your lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clot (thrombosis)”).

For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Myviolet, you must inform your doctor.
In certain situations, you must use special caution when using Myviolet or any other combined oral contraceptive, and regular monitoring by your doctor may be necessary.
Talk to your doctor, pharmacist, or nurse before taking Myviolet:

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 about to undergo surgery or will be bedridden for a prolonged period (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 delivery you can start taking Myviolet;
if you have inflammation of veins 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 disease (e.g. bile duct obstruction which may cause jaundice or symptoms such as itching) or gallbladder disease (e.g. gallstones);
if you have other kidney problems and are taking medicines that increase potassium levels in the blood;
if you have diabetes;
if you suffer from depression;
if you suffer from epilepsy (see section “Other medicines and Myviolet”);
if you have a disease that first appeared during pregnancy or during a previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disorder with sudden involuntary movements (Sydenham’s chorea));
if during treatment you have high blood pressure that is not controlled by medication;
if you have had or have chloasma (a skin pigmentation disorder, particularly on the face or neck, known as “melasma” or “pregnancy mask”). In this case, avoid direct exposure to sunlight or ultraviolet rays while taking this medicine;
if you notice symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Myviolet 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, these may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Myviolet is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

Do you have any of these signs? What might you be suffering from?

| Signs | Likely condition | |------|------------------| | Swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• Pain or tenderness in the leg, which may only be felt when standing or walking
• Increased warmth in the affected leg
• Change in skin colour of the leg, such as paleness, redness, or bluish discoloration | Deep vein thrombosis | | Sudden and unexplained shortness of breath or rapid breathing;
• Sudden cough without an obvious cause, possibly with coughing up blood;
• Sharp chest pain that may worsen when breathing deeply;
• Severe dizziness or lightheadedness;
• Rapid or irregular heartbeat;
• Severe stomach pain | Pulmonary embolism |

If you are unsure, inform your doctor, as some

These symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g., a "common cold").
Symptoms occurring more frequently in one eye: • sudden loss of vision or • painless blurring of vision that may progress to vision loss	Retinal vein thrombosis (blood clot in the eye)
• pain, discomfort, pressure, or heaviness in the chest • sensation of squeezing or fullness in the chest, in one arm, or under the sternum; • feeling of fullness, indigestion, or choking; • discomfort in the upper body, radiating to back, jaw, throat, arms, or stomach; • sweating, nausea, vomiting, or dizziness; • extreme weakness, anxiety, or shortness of breath; • rapid or irregular heartbeat	Heart attack
• sudden numbness or weakness of the face, arm, or leg, especially on one side of the body; • sudden confusion, difficulty speaking or understanding; • sudden difficulty seeing in one or both eyes; • sudden difficulty walking, dizziness, loss of balance or coordination; • sudden severe or prolonged headache with no known cause; • loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue discoloration of a limb; • severe abdominal pain (acute abdomen)	Blood clots blocking other blood vessels

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 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 may cause deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
Very rarely, a 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 taking a combined hormonal contraceptive (the same or a different product) 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 Myviolet, 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 venous thromboembolism (VTE) 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 Myviolet is low.
The likelihood of having a blood clot increases with the use of oral contraceptives.

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

	Chance of developing a blood clot in one year
Women who are not using a combined hormonal pill/patch/ring and who are not pregnant	About 2 women in 10,000
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women in 10,000
Women using Myviolet	About 9-12 women in 10,000

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

if you are very overweight (body mass index or BMI over 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 may have an inherited blood clotting disorder;
if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Myviolet several weeks before surgery or during periods of reduced mobility. If you need to stop taking Myviolet, 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 when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
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 to stop your use of Myviolet.
If any of the above conditions change while you are using Myviolet, 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.

with increasing age (over 35 years);
if you smoke. When using a combined hormonal contraceptive such as Myviolet, it is advisable to stop smoking. If you are unable to stop smoking and 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 Myviolet—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.

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

Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using oral contraceptives. Contact your doctor if you experience unusual and severe abdominal pain or abdominal swelling (which may be due to liver enlargement) or stomach bleeding.

Breakthrough bleeding
During the first two months of taking Myviolet, unexpected bleeding (bleeding outside the interval week between two cycles) may occur. If this bleeding continues for several months or starts after several months, your doctor should investigate the cause.

What to do if no bleeding occurs during the interval week
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Psychiatric disorders
Some women using hormonal contraceptives, including Myviolet, have reported depression or low mood. Depression can be severe and sometimes may 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 Myviolet
Inform your doctor about any medicines or herbal remedies you are currently taking, have recently taken, or might take. Also inform any other doctor or dentist who prescribes you medicines (or your pharmacist) that you are taking Myviolet. They will advise you whether you need to use additional contraceptive precautions (e.g., condom) and for how long, or whether the use of another medicine you need should be adjusted.

Do not use Myviolet if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these may cause an increase in certain liver test results (elevated liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Myviolet can be resumed approximately 2 weeks after completing this treatment. See the section "Do not take Myviolet."

Some medicines may affect blood levels of Myviolet and may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine, felbamate, topiramate), tuberculosis (e.g., rifampicin), HIV and hepatitis C infections (medicines called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz), fungal infections (griseofulvin, ketoconazole), arthritis, osteoarthritis (etoricoxib), or pulmonary hypertension (bosentan);
the herbal remedy St. John's wort (Hypericum perforatum).

If you are taking any of the above medicines together with Myviolet, you must use additional contraceptive precautions (for example, use of a condom) during treatment and for 28 days after stopping the treatment.

Myviolet may affect the action of other medicines, for example:

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

Your doctor may monitor your blood potassium levels if you are taking certain medicines for heart conditions (e.g., diuretics).

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

Pregnancy and breastfeeding
Pregnancy
Do not take Myviolet if you are pregnant. If you become pregnant while taking Myviolet, you must stop taking it immediately and inform your doctor. If you wish to become pregnant, you can stop taking Myviolet at any time (see "If you stop taking Myviolet").

Breastfeeding
The use of Myviolet is generally not recommended for women who are breastfeeding. If you wish to take the pill while breastfeeding, you should contact your doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

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

Myviolet contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

9. How to take Myviolet

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take one Myviolet tablet every day, if necessary with a small amount of water. You may take the
tablets with or without food, but you must take them at approximately the same time each day.
The blister pack contains 21 tablets. Next to each tablet, the day of the week on which it should be
taken is printed. For example, if you start on Wednesday, use the tablet marked “WED” next to it, and
follow the direction of the arrow on the blister pack until you take the 21st tablet.
Then do not take any tablets for 7 days. During these 7 tablet-free days (also called the interval week), your menstrual period should begin. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the interval week.
On the 8th day after taking the last Myviolet tablet (i.e., after the 7-day interval week), start the next blister pack, even if the bleeding has not yet stopped. This means you should start the next pack on the same day of the week, and the withdrawal bleeding should occur during this time.
If you use Myviolet in this way, you will be protected against pregnancy during the 7 days when you do not take tablets.

When to start the first blister pack

If you have not used a hormonal contraceptive in the previous month: Start taking Myviolet on the first day of your cycle (i.e., the first day of menstruation). If you start taking Myviolet on the first day of your period, you will be immediately protected against pregnancy. You may also start between the 2nd and 5th day of your cycle, but you must use additional contraceptive precautions (e.g., a condom) for the first 7 days.
Switching from another combined hormonal contraceptive or from a combined vaginal ring or contraceptive patch: You should preferably start taking Myviolet the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the tablet-free interval (or after the last inactive tablet of your previous pill). When switching from a combined hormonal vaginal ring or contraceptive patch, follow your doctor’s advice.
Switching from a progestogen-only method (progestogen-only pills, injection, implant, or progestogen-releasing intrauterine device - IUD): You may switch on any day from a progestogen-only pill (from an implant or IUD on the day of its removal, from an injectable when the next injection is due), but in all these cases you must use additional contraceptive precautions (e.g., a condom) for the first 7 days of tablet intake.
After an abortion or termination of pregnancy: Follow your doctor’s advice.
After childbirth: You may start using Myviolet between 21 and 28 days after delivery. If you start more than 28 days after childbirth, you must use a so-called barrier method of contraception (e.g., a condom) for the first 7 days of taking Myviolet. If you have had sexual intercourse after childbirth before starting Myviolet, you must first ensure that you are not pregnant; otherwise, wait until your next menstrual period.
If you are breastfeeding and wish to start (or restart) using Myviolet after childbirth: See the section “Breastfeeding”.

If you are unsure, ask your doctor when to start.

If you take more Myviolet than you should
There are no reports of serious or life-threatening consequences from taking too many Myviolet tablets.
If you have taken several tablets at once, you may experience symptoms such as nausea, vomiting, or vaginal bleeding. Even girls who have not yet had their first menstrual period but have accidentally taken this medicine may experience such bleeding.
If you have taken too many Myviolet tablets or if you discover that a child has ingested them, contact your doctor or pharmacist for advice.

If you forget to take Myviolet

If you are less than 12 hours late in taking a tablet, the protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, then take the next tablet at your usual time.
If you are more than 12 hours late in taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets missed, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greater if you missed a tablet at the beginning or end of the pack. Therefore, follow these rules (see the diagram below):

More than one tablet missed in the pack: Contact your doctor.
One tablet missed in the first week: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets at your usual time and use additional precautions for the next 7 days (e.g., a condom). If you had sexual intercourse in the week before missing the tablet, consider that pregnancy may have occurred. In this case, contact your doctor.
One tablet missed in the second week: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets at your usual time. Protection against pregnancy is not reduced, and no additional precautions are needed.
One tablet missed in the third week: 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. Take the following tablets at your usual time. Instead of the tablet-free interval, start the next blister pack immediately. You will most likely experience menstruation at the end of the second pack, but during the second pack you may experience spotting or light bleeding, or even menstrual-like bleeding.
2. You may also stop taking tablets and go directly to the 7-day tablet-free interval (including the days when you missed taking the tablet; note the day you forgot to take the tablet). If you wish to start a new pack on your usual starting day, shorten the tablet-free interval to less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

If you missed any tablet in a pack and do not have a period during the first tablet-free interval, this may mean you are pregnant. Contact your doctor before starting the next pack.

The following diagram describes what to do if you forget to take tablets:
What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or if you have severe diarrhoea, there is a risk that the active ingredients of the tablet are not fully absorbed by your body. In this case, you may need to use additional protection (such as a condom) to avoid pregnancy. The situation is similar to that of missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible: if possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the advice given in the section “If you forget to take Myviolet”.

Delaying your menstrual period: what you should know
Although not recommended, it is possible to delay your menstrual period by starting a new blister pack of Myviolet immediately instead of having the tablet-free interval, and continuing until the end of the second pack. Light spotting or menstrual-like bleeding may occur during the use of the second pack. After finishing the second pack, take the usual 7-day tablet-free interval, then continue with the next blister pack.
Ask your doctor for advice before deciding to delay your menstrual period.

Changing the first day of your menstrual period: what you should know
If you take the tablets as instructed, your menstrual period will start during the tablet-free interval. If you wish to change the starting day, you may shorten the tablet-free interval (never extend it – 7 days is the maximum!). For example, if your tablet-free interval starts on Friday and you wish to move it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If you have a very short tablet-free interval (e.g., 3 days or less), you may not have any bleeding during the tablet-free interval. Light spotting or menstrual-like bleeding may occur.
If you are unsure what to do, contact your doctor for advice.

If you stop treatment with Myviolet
You may stop taking Myviolet 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 Myviolet and wait for one menstrual cycle before trying to conceive. This will make it easier to calculate your due date.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Myviolet, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using Myviolet”.
Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).
If any of the following side effects occur, you may need urgent medical attention. Stop taking Myviolet and contact a doctor or go immediately to the nearest hospital.
Rare (may affect up to 1 in 1,000 women):

hypersensitivity (allergic reactions with signs such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives together with breathing difficulties)
dangerous blood clots in a vein or artery, for example: in a leg or foot (i.e. deep vein thrombosis (DVT)), or in a lung (e.g. pulmonary embolism), or heart attack, or stroke, or mini-stroke, or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eyes.

The likelihood of developing a blood clot may be higher if you have any other condition that increases the risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of blood clots).
Conditions that may occur or worsen during pregnancy or with previous use of the pill include:

systemic lupus erythematosus (SLE, a disease affecting the immune system)
inflammation of the colon or other parts of the intestine (with signs such as bloody diarrhoea, pain during defecation, abdominal pain) (Crohn’s disease and ulcerative colitis)
epilepsy
uterine fibroids (non-cancerous tumours that may develop within the muscular tissue of the uterus)
blood pigment disorder (porphyria)
blistering rash (herpes gestationis) during pregnancy
Sydenham's chorea (a nerve disorder causing sudden, involuntary body movements)
blood disorders causing kidney damage (haemolytic uraemic syndrome with signs such as reduced urine production, blood in urine, reduced red blood cells, nausea, vomiting, confusion and diarrhoea)
yellowing of the skin or whites of the eyes due to obstruction of the bile duct (cholestatic jaundice).

In addition, breast cancer has been observed (see section 2 “Myviolet and cancer”), as well as benign and malignant liver tumours (with signs such as abdominal swelling, weight loss, abnormal liver function tests detectable in blood tests), and chloasma (brownish patches on the skin, particularly on the face, so-called “melasma” or “pregnancy mask”), which may be permanent, especially in women who previously developed chloasma during pregnancy.
Other possible side effects
Common (may affect up to 1 in 10 women):

menstrual disorders, bleeding between periods, breast pain, breast tenderness
headache, depressed mood
migraine
nausea
thick, whitish vaginal discharge, vaginal fungal infection.

Uncommon (may affect up to 1 in 100 women):

breast enlargement
high blood pressure, low blood pressure
vomiting, diarrhoea
acne, skin rash, intense itching, hair loss (alopecia)
vaginal infection
fluid retention and weight gain or weight loss.

Rare (may affect up to 1 in 1,000 women):

asthma
breast discharge
impaired hearing
skin conditions: nodular erythema (characterised by painful, red skin nodules) or erythema multiforme (characterised by circular red skin eruptions or lesions).

11. How to store Myviolet

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date which is stated on the blister and outer packaging after "Do not use after" or "EXP". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

12. Contents of the pack and other information

What Myviolet contains

The active substances are ethinylestradiol and drospirenone. Each tablet contains 0.03 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
The other components are monohydrate lactose, maize starch, pregelatinized starch (maize), crospovidone type A and B, povidone (E1201), polysorbate 80 (E433), magnesium stearate (E470b), partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), and yellow iron oxide (E172) (see section 2 “Myviolet contains lactose and sodium”).

Description of the appearance of Myviolet and contents of the pack
The tablets are yellow, round, film-coated tablets.
Myviolet is available in boxes containing 1, 2, 3, 6 and 13 blisters of 21 tablets each.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturers
Laboratorios León Farma, S.A.,
C/ La Vallina s/n, Pol. Ind. Navatejera,
24193 - Villaquilambre, León,
Spain.
McDermott Laboratories Ltd
35 Baldoyle Industrial Estate, Grange Road,
Dublin 13,
Ireland.
Mylan Hungary Kft,
2900 Komárom,
Mylan Utca 1,
Hungary.

This medicinal product is authorized in other European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Belgium: Margotviatris 30 0.03 mg/3 mg film-coated tablets
Italy: Myviolet 0.03 mg/3 mg film-coated tablets
Netherlands: Ethinylestradiol/Drospirenon Viatris 0.03 mg/3 mg, film-coated tablets
Portugal: Drospirenona + Etinilestradiol Mylan
United Kingdom (Northern Ireland): Acondro 3 mg/0.03 mg Film-coated Tablets