MYVIOLET 0.02 mg/3 mg Film-coated tablets

Зміст інструкції

1. Myviolet 0.02mg/3mg film-coated tablets
   1. How to take Myviolet
   2. Cosa deve sapere prima di prendere Myviolet
   3. How to take Myviolet
   4. Possible side effects
   5. How to store Myviolet
   6. Package contents and other information
2. Myviolet 0.03 mg/3mg film-coated tablets
   1. What is Myviolet and what is it used for?
   2. What you need to know before taking Myviolet
   3. How to take Myviolet
   4. Possible side effects
   5. How to store Myviolet
   6. Package contents and other information

Myviolet 0.02mg/3mg film-coated tablets

etinilestradiolo/drospirenone
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 methods of contraception, when used correctly
• They slightly increase the risk of blood clots forming 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
• Pay attention and see your doctor if you think you may 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 you take 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 withdrawal bleed
• 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
• If you take more Myviolet than you should
• If you forget to take Myviolet
• What to do in case of vomiting or severe diarrhea
• Delayed menstrual period: what you need to know
• Change of the first day of your menstrual cycle: what you need to know
• If you stop taking 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 that contain two hormones are called “combined” pills.

2. Cosa deve sapere prima di prendere Myviolet

Note generali
Before starting to use Myviolet, read the information on blood clots in paragraph 2. It is
particularly important that you read the symptoms of a blood clot (see paragraph 2 “Blood
clots”)
Before taking Myviolet, your doctor will ask you some questions about your personal medical history and that
of your family. In addition, the doctor will measure your blood pressure and, depending on your
personal conditions, may also perform other tests.
or in which the safety of Myviolet may be reduced. In such situations, you should not have sexual
intercourse or you should take additional non-hormonal contraceptive measures, e.g. use a condom or other
barrier methods. Do not use rhythm-based 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 diseases.
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. The doctor will discuss with you other methods of birth control
that may be more suitable for your case.

• if you have (or have ever had) a blood clot in a leg vessel (deep vein thrombosis, DVT) of the lung (pulmonary embolism, PE) or other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden, or antiphospholipid antibodies;
• if you are going to have surgery or if you will be bedridden for a long period (see paragraph “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and which may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which could increase the risk of clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a disease known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have had) liver disease and liver function has not yet returned to normal
• if your kidneys are not functioning properly (renal insufficiency)
• if you have (or have ever had) a liver tumor
• if you have (or have ever had) or suspect you have breast or genital 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 paragraph 6). This condition can manifest with 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 (see also paragraph “Other
medicines and Myviolet”).

Children and adolescents
Myviolet is not intended for use in women whose cycle has not yet begun.

Elderly women
Myviolet is not intended for use after menopause.

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

Women with renal insufficiency
Do not take Myviolet if you suffer from poorly functioning kidneys or acute renal failure (see paragraphs “Do not
take Myviolet” and “Warnings and precautions”).

Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently

• if you observe possible signs of a blood clot that may indicate that you are suffering from a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack or a stroke (see the following paragraph "Blood clot").

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

Tell your doctor if any of the following conditions apply to you.
If this condition appears or worsens while you are using Myviolet, you should tell your doctor.
In some situations, you must use particular care when using Myviolet or any other combined pill
and you may need to be regularly checked by your doctor.
Consult 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 that affects the body's defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have surgery or if you will be bedridden for a long period (see paragraph 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start taking Myviolet
• if you have inflammation of the 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 cancer
• if you have a liver disease (e.g. obstruction of the bile duct that can 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 paragraph “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 disease called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disease in which sudden movements of the body appear (Sydenham's chorea))
• if during therapy you have high blood pressure that is not controlled by treatment with medicines
• if you have or have ever had chloasma (a change in skin color, especially on the face or neck known as “pregnancy spots”). 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 difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS
The use of a combined hormonal contraceptive like Myviolet causes an increased risk of developing
a blood clot compared to not using it.
In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, 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 any of these signs? What are you likely 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 that may only be felt when standing or walking
• increased warmth in the affected leg
• change in skin color of the leg, such as paleness, redness or bluish discoloration Deep vein thrombosis
• sudden shortness of breath or rapid breathing;
• sudden cough without a clear cause, with possible blood production;
• sharp chest pain that may increase when breathing deeply;
• severe dizziness or lightheadedness; Pulmonary embolism

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 blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can 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 you take
a combined hormonal contraceptive for the first time. The risk may also be higher if you
restart a combined hormonal contraceptive (the same medicine or a different medicine)
after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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 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 the pill.

• Out of 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing drospirenone, like Myviolet, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see below “Factors that increase the risk of a blood clot forming”).

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 some conditions cause an
increase. Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m2);
• if a close relative of yours has had a blood clot in a leg, in the lung or in another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you need to undergo surgery or if you need to stay in bed for a long period due to an injury or illness or if you have a leg in plaster. You may need to stop taking Myviolet a few weeks before the operation or during the time when you are less mobile. 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) can temporarily increase the risk of a blood clot
forming, especially if you have some of the other risk factors listed.
It is important that you inform your doctor if any of these conditions apply to you, even if
you are not sure.
The doctor may decide to stop you from taking Myviolet.
If any of the conditions above change while you are using Myviolet, for example if a close relative
develops thrombosis for no known reason or if you gain a lot of 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 cause 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 can increase:

• with increasing age (over 35 years);
• if you smoke.When using a combined hormonal contraceptive like Myviolet it is advisable that you stop smoking. If you cannot stop smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high 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 any heart problems (valve 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 conditions above change
while you are using Myviolet, for example if you start smoking, if a close relative develops thrombosis without
any known reason or if you gain a lot of weight, contact your doctor.

Myviolet and cancer
Breast cancer has been observed slightly more frequently in women who use “combined pills” but it is not known whether this is caused by the treatment. For example, it is possible that a greater number of tumors are diagnosed in women who use “combined pills” because they undergo
more frequent medical check-ups. The occurrence of breast cancer becomes less frequent
gradually after stopping combined hormonal contraceptives. It is important to check your breasts regularly and
contact your doctor if you feel any lumps.
In rare cases, benign and in even rarer cases, malignant tumors of the liver have been reported in women
who use the pill. Contact your doctor if you experience unusual and severe abdominal pain or abdominal bloating (which may be due to enlargement of the liver) or stomach bleeding.

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

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

Psychiatric disorders
Some women who use hormonal contraceptives including Myviolet have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
mood changes and depressive symptoms, see your doctor as soon as possible for further medical advice.

Other medicines and Myviolet
Tell your doctor about any medicines or herbal remedies you are taking, have recently taken or may
take. Also tell any other doctor or dentist who prescribes other medicines to you (or the pharmacist) that
you are taking Myviolet. They may tell you whether you need to use additional contraceptive precautions (e.g.
the condom) and for how long or whether the use of another medicine you need must be
modified.
Do not use Myviolet if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir
because these can cause an increase in the results of some liver tests (increased liver enzyme
ALT).
Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines.
Myviolet can be resumed about 2 weeks after completion of this treatment. See the
paragraph "Do not take Myviolet”.
Some medicines can have an influence on the blood levels of Myviolet and can make it less
effective in preventing pregnancyor can cause unexpected bleeding. These include:

• medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate) or tuberculosis (e.g. rifampicin) or HIV and hepatitis C infections (medicines called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or fungal infections (griseofulvin, ketoconazole) or arthritis, osteoarthritis (etoricoxib)

or pulmonary hypertension (bosentan)

• herbal preparation St John's Wort.

If you are taking any of the medicines listed above together with Myviolet you must use additional
contraceptive precautions (e.g. the condom) during and for 28 days after the therapy.
Myviolet can affect the effect of other medicines, e.g.

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this can lead to a higher frequency of seizures).
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain and/or muscle cramps).

Your doctor may check your blood potassium levels if you are taking some medicines to treat
heart problems (e.g. diuretics).

Laboratory tests
If you need a blood test, tell your doctor or laboratory staff that you are taking the
pill, because oral contraceptives can alter the results of some tests.

Pregnancy and breastfeeding
Pregnancy
Do not take Myviolet if you are pregnant. If you become pregnant while taking Myviolet, you should stop it
immediately and inform your doctor. If you want 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 want to take the pill
while breastfeeding you should contact your doctor.
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice 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 told you that you have an intolerance to some sugars, contact your doctor 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 always exactly as your doctor or pharmacist has told you. If you have
any doubts ask your doctor or pharmacist.
Take one tablet of Myviolet each day, if necessary with a small amount of water. You can take
the tablets with a full or empty stomach, but you must take them every day at approximately the same time.
The blister contains 21 tablets. Next to each tablet is printed the day of the week on which it must
be taken. If, for example, you start on Wednesday, use the tablet with “WED” written on it,
follow the direction of the arrow on the blister until you have taken the 21st tablet.
Then do not take tablets for 7 days. During these 7 days without tablets (also called the interval week)
your period should start. This so-called “withdrawal bleeding” usually begins on the
2nd or 3rd day of the interval week.
On the eighth day after the last tablet of Myviolet (i.e. after the 7 days of the interval week),
start the next blister, even if the bleeding has not yet ended. This means that you must start the
next blister on the same day of the week and that the withdrawal bleeding should occur during
this period.
If you use Myviolet in this way, you will be protected from pregnancy even during the 7 days when you do not take the
pill.

When you can start with the first blister

• If you have not used a hormonal contraceptive in the previous monthStart taking Myviolet on the first day of your cycle (i.e. the first day of your period). If you start taking Myviolet on the first day of your period you will be immediately protected from pregnancy. You can also start between the 2nd and 5th day of your cycle, but you must use additional protective measures (e.g. a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive or from a combined contraceptive in the form of avaginal ring or patchYou should start taking Myviolet preferably the day after the last active tablet (the last tablet containing the active ingredients) of the previous pill, or at the latest the day after the end of the pill-free interval (or after the last inactive tablet of the previous pill). When switching from a combined contraceptive in the form of a vaginal ring or patch, follow your doctor's advice.
• Switching from a progestin-only method (progestin-only pills, injection, implant orprogestin-releasing intrauterine system - IUD)You can switch from the progestin-only pill at any time (from an implant or IUD on the day of its removal, from an injectable when you are due to have the next injection), but in all these cases you must use additional protective measures (e.g. a condom) for the first 7 days of taking the tablets.
• After an abortion termination of pregnancy.Follow your doctor's advice.
• After childbirth.After childbirth you can start using Myviolet between 21 and 28 days after delivery. If you start after more than 28 days, 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 delivery before starting to use Myviolet, you must first make sure you are not pregnant, otherwise you must wait until your next period.
• If you are breastfeeding and want to start (or restart) using Myviolet after childbirth.Read the paragraph “Breast-feeding”.

If you are not sure, ask your doctor for advice on when to start.

If you take more Myviolet than you should
There are no reports of serious and dangerous consequences of taking too many tablets of
Myviolet.
If you have taken several tablets at once, you may have symptoms of nausea or vomiting or bleeding
from the vagina. Also girls who have not yet had their first menstrual period but who have accidentally taken
this medicine may have such bleeding.
If you have taken too many tablets of Myviolet or if a child has swallowed them, contact your doctor or
pharmacist for advice.

If you forget to take Myviolet

• If you are less than 12 hours latein taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the next tablet as usual.
• If you are more than 12 hours latein taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of becoming pregnant.

The risk of incomplete protection from pregnancy is greater if you have forgotten a tablet
at the beginning or end of the blister. Therefore, you must follow these rules (see the diagram below):

• More than one tablet forgotten in the blisterContact your doctor.
• One tablet forgotten in the first weekTake the forgotten tablet as soon as you remember, even if this means taking 2 tablets at once. Take the next tablets as usual and use additional precautionsfor the next 7 days, for example a condom. If you had sexual intercourse in the week before forgetting the tablet, you should consider that there is a risk of pregnancy... In this case contact your doctor.
• One tablet forgotten in the second weekTake the forgotten tablet as soon as you remember, even if this means taking 2 tablets at once. Take the next tablets as usual. The protection against pregnancy is not reduced and you do not need to take additional precautions.
• One tablet forgotten in the third weekYou can choose between 2 options
• 1. Take the forgotten tablet as soon as you remember, even if this means taking 2 tablets at once. Take the next tablets as usual. Instead of the pill-free period, start the next blister directly. You will most likely have your period at the end of the second blister, but spotting or bleeding may occur during the second blister
• 2. You can also stop taking the tablets and go directly to the 7-day pill-free period (including the days in which you did not take the tablet, note the day you forgot totake the tablet).If you want to start a new blister on your usual day of start, shorten the pill-free period to less than 7 days.

If you follow one of these two recommendations, you will remain protected from pregnancy.

• If you have forgotten any of the tablets in a blister and do not have a period during the first pill-free period, this may mean that you are pregnant. Contact your doctor before starting

the next blister.
The following diagram describes how to proceed if you have forgotten to take tablets.

What to do in case of vomiting or severe diarrhea
If you vomit within 3-4 hours of taking a tablet or if you have severe diarrhea, there is a risk that the
active ingredients of the tablet are not completely absorbed by the body, in which case you may
need to use additional protection (such as a condom) to avoid pregnancy. The
situation is similar to that in case of forgetting a tablet. After vomiting or diarrhea, you must
take as soon as possible, another tablet from a reserve blister: if possible take it within 12 hours
of the usual time of taking the pill. If this is not possible or if more than 12 hours have passed, you must
follow the advice provided in the paragraph “If you forget to take Myviolet”.

Delay of the menstrual period: what you should know
Although not recommended, it is possible to delay your menstrual period by starting a new
blister of Myviolet directly instead of the pill-free period and finishing it. Light spotting
or menstrual-like bleeding may occur during the use of the second blister. After the second blister is
finished, have your usual 7-day pill-free period and continue with the next blister.

Ask your doctor for advice before deciding to delay your menstrual period.
Change of the first day of your menstrual period: what you should know
If you take the tablets according to the instructions your period will start during the pill-free period. If
you want to change the day of start, you can shorten the pill-free period ( never lengthening it – 7 days is the

maximum!). For example, if your pill-free period starts on Friday and you want to move it to Tuesday (3 days
earlier), you must start the new blister 3 days earlier. If you have a very short pill-free period (for
example 3 days or less) it may happen that you do not have any bleeding during the pill-free period.
Light spotting or menstrual-like bleeding may occur.

If you are not sure how to proceed, contact your doctor for advice.
If you stop taking Myviolet
You can stop taking Myviolet whenever you want. If you do not want to become pregnant, ask your doctor for advice on other reliable methods of contraception. If you want to become pregnant, stop taking
Myviolet and wait for a cycle before trying to become pregnant. You will be able to calculate more easily
the date of delivery.
If you have any further questions on 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.
A greater risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who take
combined hormonal contraceptives. For more detailed information on the different risks associated with
taking combined hormonal contraceptives, see paragraph 2 “What you need to 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 pharynx and/or difficulty swallowing or hives with possible difficulty breathing
(see also the paragraph “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.
Not Common(may affect up to 1 in 100 women)

• dangerous blood clots in a lung (pulmonary embolism)

Rare(may affect up to 1 in 1000 women)

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

The likelihood of having a blood clot may be greater if you have any other condition that
increases the risk (see paragraph 2 for more information on conditions that increase the risk of
clots and the symptoms of clots).

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

• systemic lupus erythematosus (SLE, a disease that affects the immune system)
• inflammation of the colon or other parts of the intestine (with signs such as bloody diarrhoea, pain when defecating, abdominal pain) (Crohn's disease and ulcerative colitis)
• epilepsy
• uterine fibroids (non-cancerous tumor that can develop within the muscle tissue of the uterus)
• disorder of blood pigment (porphyria)
• blistering rash (herpes gestationis) during pregnancy
• Sydenham's chorea (a nerve disease in which sudden body movements appear)
• blood disorders that cause kidney damage (haemolytic uraemic syndrome with signs such as decreased urine production, blood in the urine, decreased red blood cells, nausea, vomiting, confusion and diarrhoea)
• yellowing of the skin or whites of the eyes due to blockage of the bile duct (cholestatic jaundice).

In addition, breast cancer (see paragraph 2 “Myviolet and cancer”) and non-cancerous (benign) and cancerous (malignant) liver tumors (with signs such as abdominal swelling, weight loss, abnormalities
in liver function that can be observed with blood tests) and chloasma (brown-golden pigment spots on the skin, especially on the face, so-called “mask of pregnancy”), which may be
permanent, especially in women who have previously had chloasma during pregnancy, have been observed.

Other possible side effects
Common(may affect up to 1 in 10 women):

• mood swings
• headache
• abdominal pain (stomach pain)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular periods
• weight gain.

Not common(may affect up to 1 in 100 women):

• candidiasis (fungal infection)
• herpes labialis (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling, dizziness
• vision problems
• irregular or unusually fast heartbeat
• high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestines, diarrhoea, constipation
• hair loss (alopecia), eczema, itching, skin rashes, dry skin, disorders of sebum production (seborrheic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• benign breast nodules, milk production without pregnancy (galactorrhea), ovarian cysts, hot flushes, absence of menstruation, very heavy periods, vaginal discharge, vaginal infection or inflammation, vaginal dryness, pain in the lower abdomen (pelvic), 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(affect up to 1 in 1,000 women):

• asthma
• hearing impairment
• erythema nodosum (characterized by painful and reddened skin nodules)
• erythema multiforme (characterized by a rash with circular or lesion-like redness)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children .
Store at a temperature below 30° C.
Do not use this medicine after the expiry date which is stated on the blister and the 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 in 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 ingredients are ethinylestradiol and drospirenone. Each tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
• The other ingredients are lactose monohydrate, 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 package contents
The tablets are pink, round, film-coated.
Myviolet is available in packs containing 1, 2, 3, 6 and 13 blisters each containing 21 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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.

McDermottLaboratories Ltd,
35Baldoyle Industrial Estate, Grange Road,
Dubin 13,
Ireland.
Mylan Hungary Kft,
2900 Komárom,
Mylan Utca 1,
Hungary.

This medicinal product is authorised in the Member States of the European Economic Area 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, film-coated
tablets
Portugal: Drospirenona + Etnilestradiol Mylan

Myviolet 0.03 mg/3mg film-coated tablets

ethinylestradiol/drospirenone
Generic medicine

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 methods of contraception, if used correctly
• They slightly increase the risk of blood clots forming 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
• Pay attention and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)

Contents of this leaflet

• 1. What is Myviolet and what it is used for
• 2. What you need to know before you take Myviolet Do not take Myviolet Myviolet and cancer Bleeding between periods What to do if you do not have a withdrawal bleed Other medicines and Myviolet Laboratory tests Pregnancy and breastfeeding Driving and using machines Myviolet contains lactose and sodium
• 3. How to take Myviolet When you can start the first blister

If you take more Myviolet than you should
If you forget to take Myviolet
What to do if you vomit or have severe diarrhoea
Late period: what you need to know
Changing the first day of your period: what you need to know
If you stop taking Myviolet

• 4. Possible side effects
• 5. How to store Myviolet
• 6. Contents of the pack and other information
• 7. What is Myviolet and what it is used for
• 8. What you need to know before you take Myviolet Do not take Myviolet Warnings and precautions Myviolet and cancer Bleeding between periods What to do if you do not have a withdrawal bleed Other medicines and Myviolet Laboratory tests Pregnancy and breastfeeding Driving and using machines Myviolet contains lactose
• 9. How to take Myviolet When you can start the first blister If you take more Myviolet than you should If you forget to take Myviolet What to do if you vomit or have severe diarrhoea Late period: what you need to know Changing the first day of your period: what you need to know If you stop taking Myviolet
• 10. Possible side effects
• 11. How to store Myviolet
• 12. Contents of the pack and other information

7. What is Myviolet and what is it 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 that contain two hormones are called “combined” pills.

8. What you need to know before taking Myviolet

General notes
Before starting to use Myviolet, read the information on blood clots in section 2. It is
particularly important that you read the symptoms of a blood clot (see section 2 “Blood
clots”)
Before taking Myviolet, your doctor will ask you some questions about your personal medical history and that
of your family. In addition, the doctor will measure your blood pressure and, depending on your
personal conditions, may also perform other tests.
or in which the safety of Myviolet may be reduced. In such situations, you should not have sexual
intercourse or you should take additional non-hormonal contraceptive measures, e.g. use a condom or other
barrier methods. Do not use methods based on rhythm or temperature. 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 diseases.
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. The doctor will discuss with you other methods of control

• if you have (or have ever had) a blood clot in a blood vessel in the leg (deep vein thrombosis, DVT) of the lung (pulmonary embolism, PE) or other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have surgery or if you will be bedridden for a long 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 that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a disease known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have had) a liver disease and liver function has not yet returned to normal
• if your kidneys are not functioning properly (renal insufficiency)
• if you have (or have ever had) a liver tumor
• if you have (or have ever had) or suspect you have breast or genital 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 can 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 (see also section “Other
medicines and Myviolet”)

Children and adolescents
Myviolet is not intended for use in women whose cycle has not yet begun.

Elderly women
Myviolet is not intended for use after menopause.

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

Women with renal insufficiency
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 to consult a doctor?
Contact your doctor urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), a blood clot in the 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, see the section “How to recognize a
blood clot”.

Tell your doctor if any of the following conditions apply to you.
If this condition appears or worsens while you are using Myviolet, you should tell your doctor.
In some situations, you must use particular caution when using Myviolet or any other combined pill
and you may need to be regularly checked by your doctor.
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 that affects the natural defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have surgery or if you will be bedridden for a long period (see section 2 “Blood clots”);
• if you have just 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 the 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 cancer
• if you have a liver disease (e.g. obstruction of the bile duct that can 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 disease called porphyria, blistering rash during pregnancy (herpes gestationalis), a nervous disease in which sudden movements of the body appear (Sydenham’s chorea))
• if you have high blood pressure during therapy that is not controlled by treatment with medicines
• if you have or have ever had melasma (a change in skin color, especially on the face or neck known as “pregnancy spots”). 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 pharynx and/or difficulty swallowing or hives with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS
The use of a combined hormonal contraceptive like Myviolet causes an increased risk of developing
a blood clot compared to not using it.
In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term effects can occur or, very rarely, such effects can 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 your doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely to have?
or swelling in a leg or along a vein in the leg or foot, especially if
accompanied by:
or pain or sensitivity in the leg that can
only be felt when standing or walking
or increased warmth in the affected leg
or a change in skin color of the
leg, such as pallor, reddish or
bluish discoloration
or shortness of breath or rapid breathing Pulmonary embolism
suddenly and inexplicably;
or sudden cough without an obvious cause, with
possible blood emission;
or acute chest pain that may increase
when breathing deeply;
or severe dizziness or lightheadedness;
or rapid or irregular heartbeat;
or severe stomach pain
If you are unsure, inform your doctor as someorof these symptoms such as cough or shortness of breath can be mistaken for a milder condition such as a respiratory infection (e.g. a “common cold”).c Retinal vein thrombosis (blood clot in the eye) aSymptoms that occur more frequently in one eye: o sudden loss of vision or o painless blurred vision that may progress to vision lossm Stroke r a F l eo numbness or weakness suddenly on the face, on an arm or on a leg, especially on one side of the body; o sudden confusion, difficulty speaking or understanding; o sudden difficulty seeing with one or both eyes; a o sudden difficulty walking, dizziness, loss of balance or coordination; o sudden severe headache, prolonged, without known cause; o loss of consciousness or fainting with or without convulsions. Sometimes the symptoms of stroke can be brief, with almost immediate and complete recovery, but you should still contact a doctor urgently as you may be at risk of another stroke.d I a na

• swelling and bluish pale discoloration of i an extremity;
• severe stomach pain (acute abdomen)

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

• The use of combined hormonal contraceptives has been linked to an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can 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 you take
a combined hormonal contraceptive for the first time. The risk may also be higher if you
restart a combined hormonal contraceptive (the same medicine or a different medicine)
after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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 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 the pill.

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

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 some conditions cause an
increase. Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m2);
• if a close relative has had a blood clot in a leg, in the lung or in another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you are going to have surgery or if you have to lie down for a long period due to an injury or illness or if you have a leg in a cast. It may be necessary to stop taking Myviolet a few weeks before the operation or during the time when you are less mobile. 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) can temporarily increase the risk of a blood clot forming,
especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even if you
are not sure. The doctor may decide to stop you from taking Myviolet.
If any of the above conditions change while you are using Myviolet, for example if a close
relative develops thrombosis for no known reason or if you gain a lot of 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 cause 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 can increase:

• as you get older (over 35 years);
• if you smoke.When you use a combined hormonal contraceptive like Myviolet it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use 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 about 50 years). In this case you may also be at high 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 (valve 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 serious, 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 to
smoke, if a close relative develops thrombosis for no known reason or if you gain a lot of weight,
contact your doctor.

Myviolet and cancer
Breast cancer has been observed slightly more frequently in women who use “combined pills” but it is not known whether this is caused by the treatment. For example, it is possible that a greater number of tumors are diagnosed in women who use “combined pills” because they undergo more frequent medical check-ups. The occurrence of breast cancer becomes gradually less frequent after stopping combined hormonal contraceptives. It is important to check your breasts regularly and
contact your doctor if you feel any lumps.
In rare cases, benign and in even rarer cases, malignant tumors of the liver have been reported in women
who use the pill. Contact your doctor if you experience unusual and severe abdominal pain or abdominal swelling (which may be due to enlargement of the liver) or bleeding from the stomach.

Bleeding between periods
During the first two months of taking Myviolet, unexpected bleeding may occur
(bleeding outside the interval week between two cycles). If this bleeding continues for
more than a few months or if it starts after a few months, the doctor must find the cause.

What to do if you do not have bleeding in the interval week
If you have taken all the tablets correctly and you have not had severe vomiting or diarrhea and you have not taken any other
medicines, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive times, you may be pregnant. Contact
your doctor immediately. Do not start the next blister until you are sure you are not pregnant.

Psychiatric disorders
Some women who use hormonal contraceptives including Myviolet have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
changes in mood and depressive symptoms, see your doctor as soon as possible for further medical advice.

Other medicines and Myviolet
Tell your doctor about any medicines or herbal remedies you are taking, have recently taken or may
take. Also tell any other doctor or dentist who prescribes you other medicines (or the pharmacist) that
you are taking Myviolet. They may tell you whether you need to use additional contraceptive precautions (e.g.
the condom) and for how long or whether the use of another medicine you need must be
modified.
Do not use Myviolet if you suffer from hepatitis C and are taking medicines containing ombitasvir / paritaprevir /
ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir as these may
cause an increase in the results of some liver tests (increased liver enzyme ALT).
Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines.
Myviolet can be resumed about 2 weeks after completion of this treatment. See the
paragraph "Do not take Myviolet”
Some medicines can have an influence on the blood levels of Myviolet and can make it less
effective in preventing pregnancyor can cause unexpected bleeding. These include:

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

If you are taking any of the medicines listed above together with Myviolet you must use additional
contraceptive precautions (for example the condom) during and for 28 days after therapy.
Myviolet can affect the effect of other medicines, e.g.

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this may lead to a higher frequency of seizures).
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain and/or muscle cramps).

The doctor may check your blood potassium levels if you are taking some medicines to treat
heart problems (e.g. diuretics).

.

Laboratory tests
If you need a blood test, tell your doctor or laboratory staff that you are taking the
pill, because oral contraceptives can alter the results of some tests.

Pregnancy and breastfeeding
Pregnancy
Do not take Myviolet if you are pregnant. If you become pregnant while taking Myviolet, you should stop it
immediately and tell your doctor. If you want to become pregnant you can stop taking Myviolet in
any time (see “If you stop taking Myviolet”).

Breastfeeding
The use of Myviolet is generally not recommended for women who are breastfeeding. If you want to take the pill
while breastfeeding you should contact your doctor.
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice 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 use
machinery.

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

9. How to take Myviolet

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Take one tablet of Myviolet each day, if necessary with a small amount of water. You can take
the tablets with a full or empty stomach but you must take them every day at about the same time.
The blister contains 21 tablets. Next to each tablet, the day of the week is printed on which it must
be taken. If, for example, you start on Wednesday, use the tablet with “WED” written on it,
follow the direction of the arrow on the blister until you have taken the 21st tablet.
Then do not take tablets for 7 days. During these 7 days without tablets (also called the interval
week) you should start your period. This so-called “withdrawal bleeding” usually starts on the
2nd or 3rd day of the interval week.
On the eighth day after the last tablet of Myviolet (i.e. after the 7 days of the interval week),
start the next blister, even if the bleeding has not yet finished. This means that you must start the
next blister on the same day of the week and that the withdrawal bleeding should occur during
this period.
If you use Myviolet in this way, you will be protected from pregnancy even during the 7 days when you do not take the
pill.

When you can start with the first blister

• If you have not used a hormonal contraceptive in the previous monthStart taking Myviolet on the first day of your cycle (i.e. the first day of your period). If you start taking Myviolet on the first day of your period you will be immediately protected from pregnancy. You can also start between the 2nd and 5th day of your cycle, but you must use additional protective measures (e.g. a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive or from a combined contraceptive in the form of avaginal ring or patchStart taking Myviolet preferably the day after the last active tablet (the last tablet containing the active ingredients) of the previous pill, or at the latest the day after the end of the pill-free interval (or after the last inactive tablet of the previous pill). When switching from a combined contraceptive in the form of a vaginal ring or patch, follow your doctor’s advice.
• Switching from a progestin-only method (progestin-only pills, injection, implant orprogestin-releasing intrauterine system -IUD)You can switch from the progestin-only pill at any time (from an implant or IUD on the day of its removal, from an injectable when you are due to have the next injection), but in all these cases you must use additional protective measures (e.g. a condom) for the first 7 days of taking the tablets.
• After an abortion or termination of pregnancy.Follow your doctor’s advice.
• After childbirth.After childbirth you can start using Myviolet between 21 and 28 days after delivery. If you start after more than 28 days, 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 delivery before starting to use Myviolet, you must first make sure that you are not pregnant, otherwise you must wait until your next period.
• If you are breastfeeding and want to start (or restart) using Myviolet after childbirth.Read the paragraph “Breastfeeding”.

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

If you take more Myviolet than you should
There are no reports of serious and dangerous consequences of taking too many tablets of
Myviolet.
If you have taken several tablets at once, you may have symptoms of nausea or vomiting or bleeding
from the vagina. Also girls who have not yet had their first menstrual period but who have accidentally taken
this medicine may have such bleeding.
If you have taken too many tablets of Myviolet or if a child has swallowed them, contact your doctor or
pharmacist for advice.

If you forget to take Myviolet

• If you are less than 12 hours latein taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the next tablet as usual.
• If you are more than 12 hours latein taking a tablet, protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of becoming pregnant.

The risk of incomplete protection from pregnancy is greater if you have forgotten a tablet
at the beginning or end of the blister. Therefore, you must follow these rules (see the diagram below):

• More than one tablet forgotten in the blisterContact your doctor.
• One tablet forgotten in the first weekTake the forgotten tablet as soon as you remember, even if this means taking 2 tablets at once. Take the next tablets as usual and use additionalprecautionsfor the next 7 days, for example a condom. If you have had sexual intercourse in the week before forgetting the tablet, you should consider that there is a risk of pregnancy. In this case contact your doctor.
• One tablet forgotten in the second weekTake the forgotten tablet as soon as you remember, even if this means taking 2 tablets at once. Take the next tablets as usual. Protection against pregnancy is not reduced and you do not need to take additional precautions.
• One tablet forgotten in the third weekYou can choose between 2 options
• 1. Take the forgotten tablet as soon as you remember, even if this means taking 2 tablets at once. Take the next tablets as usual. Instead of the tablet-free period, start the next blister directly. You will most likely have your period at the end of the second blister, but during the second blister you may experience spotting or have some light bleeding or a withdrawal-like bleed during the second blister.
• 2. You can also stop taking the tablets and go straight to the 7-day pill-free period (includingthe days in which you did not take the tablet, note the day you forgot to takethe tablet).If you want to start a new blister on your usual day, shorten the pill-free period to less than 7 days.

If you follow one of these two recommendations, you will remain protected from pregnancy.

• If you have forgotten any of the tablets in a blister and you do not have a period during the first pill-free period, this may mean that you are pregnant. Contact your doctor before starting the next blister.

The following diagram describes how to proceed if you have forgotten to take tablets:

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

Delay of the menstrual period: what you should know
Although not recommended, it is possible to delay your menstrual period by starting a new
blister of Myviolet directly instead of the pill-free period and finishing it. Light bleeding
or a withdrawal-like bleed may occur during the use of the second blister. After the second blister is
finished, take your usual 7-day pill-free period and continue with the next blister.

Ask your doctor for advice before deciding to delay your menstrual period.
Change of the first day of your menstrual period: what you should know
If you take the tablets according to the instructions, your menstrual period will start during the pill-free period. If
you want to change the day of the start, you can shorten the pill-free period (never lengthening it – 7 days is the

maximum!). For example, if your pill-free period starts on Friday and you want to move it to Tuesday (3 days
earlier), you must start the new blister 3 days earlier. If you have a very short pill-free period (for
example 3 days or less) it may happen that you do not have any bleeding during the pill-free period.
Light bleeding or a withdrawal-like bleed may occur.

If you are unsure how to proceed, contact your doctor for advice.
If you stop taking Myviolet
You can stop taking Myviolet whenever you want. If you do not want to become pregnant, ask your doctor for advice on other reliable methods of contraception. If you want to become pregnant, stop taking
Myviolet and wait for a period before trying to become pregnant. You will be able to calculate more easily
the date of delivery.

If you have any further questions on 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 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.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who take
combined hormonal contraceptives. For more detailed information on the different risks associated with
taking combined hormonal contraceptives, see paragraph 2 “What you need to 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 pharynx and/or difficulty swallowing or hives with possible difficulty breathing
(see also the paragraph “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 1000 women)

• hypersensitivity (allergic reactions with signs such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing)
• dangerous blood clots in a vein or an 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 transient ischaemic attack (TIA) symptoms similar to a stroke, or clots in the liver, stomach/intestine, kidneys or eyes.

The likelihood of having a blood clot may be greater if you have any other condition that
increases the risk (see paragraph 2 for more information on conditions that increase the risk of
blood clots and the 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 that affects the immune system)
• inflammation of the colon or other parts of the intestine (with signs such as bloody diarrhoea, pain when defecating, abdominal pain) (Crohn's disease and ulcerative colitis)
• epilepsy
• uterine fibroids (non-cancerous tumour that can develop within the muscle tissue of the uterus)
• blood pigment disorder (porphyria)
• blistering rash (herpes gestationis) during pregnancy
• Sydenham's chorea (a nerve disease in which sudden movements of the body appear)
• blood disorders that cause kidney damage (haemolytic uraemic syndrome with signs such as decreased urine production, blood in the urine, decreased red blood cells, nausea, vomiting, confusion and diarrhoea)
• yellowing of the skin or whites of the eyes due to blockage of the bile duct (cholestatic jaundice).

In addition, breast cancer (see paragraph 2 “Myviolet and cancer”) and non-cancerous (benign) and cancerous (malignant) liver tumors (with signs such as abdominal swelling, weight loss, abnormalities
in liver function that can be observed with blood tests) and chloasma (brown-golden pigment spots on the skin, especially on the face, so-called “pregnancy mask”), which may be
permanent, especially in women who have previously had chloasma during pregnancy, have been observed.

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, fungal vaginal 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 loss.

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

• asthma
• nipple discharge
• impaired hearing
• skin condition: erythema nodosum (characterized by painful and reddened skin nodules) or erythema multiforme (characterized by a rash with circular or lesion-like redness).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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.

11. How to store Myviolet

Keep this medicine out of the sight and reach of children .
Store at a temperature below 30° C.
Do not use this medicine after the expiry date which is stated on the blister and the 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What Myviolet contains

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

Description of the appearance of Myviolet and package contents
The tablets are yellow, round, film-coated.
Myviolet is available in packs of 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,
Dubin 13,
Ireland,
Mylan Hungary Kft,
2900 Komárom,
Mylan Utca 1,
Hungary.

This medicinal product is authorised in the other Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
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