Levomine

Leaflet attached to the packaging: information for the user

Levomine, 30 micrograms + 150 micrograms, film-coated tablets

Ethinylestradiol + Levonorgestrel

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

One should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• One should keep this leaflet to be able to read it again if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Levomine and what is it used for

Levomine is a contraceptive pill and is used to prevent pregnancy.
Each pill contains small amounts of two different female hormones: ethinylestradiol
and levonorgestrel.
Contraceptive pills that contain two hormones are called combined pills. Due to the low hormone content, Levomine is a low-dose contraceptive.

2. Important information before using Levomine

General notes

Before starting to take Levomine, one should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2. "Blood clots").
Before starting to use Levomine, the doctor will ask the patient some questions about her health and that of her close relatives. The doctor will also measure the patient's blood pressure and, depending on the patient's condition, may also perform some other tests.
This leaflet describes various situations in which one should stop using Levomine, or in which the effectiveness of Levomine may be reduced. In such situations, one should either not have sexual intercourse or use additional, non-hormonal contraceptive protection, e.g. a condom or another barrier method. One should not use the calendar or temperature method. These methods may be unreliable because Levomine changes the body temperature and the properties of the cervical mucus throughout the month.

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

When not to take Levomine

One should not use Levomine if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

Do not take Levomine

• if the patient is allergic to ethinylestradiol or levonorgestrel or any of the other ingredients of this medicine (listed in section 6). This may manifest as itching, rash or swelling;
• if the patient has (or has ever had) blood clots in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism) or other organs;
• if the patient knows that she has disorders that affect blood clotting - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, presence of factor V Leiden mutation or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section "Blood clots");
• if the patient has ever had a heart attack or stroke;
• if the patient has (or has ever had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (transient stroke symptoms);
• If the patient has any of the following diseases, which may increase the risk of arterial thrombosis.
• severe diabetes with vascular damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a disease called hyperhomocysteinemia;
• if the patient has (or has ever had) a type of migraine called migraine with aura;
• if the patient has (or has ever had) severe liver disease and the liver is not functioning properly;
• if the patient has (or has ever had) a liver tumor;
• if the patient has (or has ever had) or if breast cancer or genital organ cancer is suspected;
• if the patient has any unexplained vaginal bleeding;
• if the patient has unexplained absence of menstruation, probably caused by exercise or diet;
• if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir (see section "Levomine and other medicines").

Warnings and precautions

When to contact a doctor?
One should contact a doctor immediately

• if the patient notices any of the possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack or stroke (see below "Blood clots").

In order to get a description of the serious side effects listed, see "How to recognize a blood clot".

One should tell the doctor if the patient has any of the following conditions.

In some situations, the patient must be particularly careful when using Levomine or any other combined pill and may need regular health checks by a doctor. Also, if any of the following diseases occur or worsen while taking Levomine, one should tell the doctor:

• if any of the patient's close relatives have had breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression;
• if the patient has Crohn's disease or ulcerative colitis (a chronic inflammatory bowel disease);
• if the patient has systemic lupus erythematosus (an immune system disease);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, in which case she is at increased risk of blood clots. One should consult a doctor to find out how soon after childbirth it is possible to start taking Levomine;
• if the patient has inflammation of the veins under the skin (superficial thrombophlebitis);
• if the patient has varicose veins;
• if the patient has epilepsy (see "Levomine and other medicines");
• if the patient has a disease that first appeared during pregnancy or while taking sex hormones (e.g. hearing loss, a blood disease called porphyria, a skin rash with blisters that occurs during pregnancy [pregnancy rash], a nerve disease that causes sudden movements of the body [Sydenham's chorea]);
• if the patient has or has ever had brown spots (chloasma) on the skin, especially on the face. In this case, one should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives that may cause difficulty breathing, one should contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

Psychiatric disorders:

Some women taking hormonal contraceptives, including Levomine, have reported depression
or low mood. Depression may be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, one should contact a doctor as soon as possible to receive further medical advice.
BLOOD CLOTS
Taking combined hormonal contraceptives, such as Levomine, is
associated with an increased risk of blood clots compared to not taking them. In rare cases, a blood clot can block a blood vessel
and cause serious complications.
Blood clots can occur

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease")
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

Not all patients who have had a blood clot will fully recover. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

One should remember that the overall risk of harmful blood clots caused by taking Levomine is small.

HOW TO RECOGNIZE A BLOOD CLOT

One should contact a doctor immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
Why is the patient
probably suffering
from?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in the color of the leg skin, e.g. pallor, redness, cyanosis
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain;

If the patient is unsure, they should contact a doctor,
because some of these symptoms, such as cough or
shortness of breath, may be mistaken
for milder conditions, such as a respiratory infection (e.g. a cold).
Symptoms usually occur in one eye:
Retinal vein thrombosis
(blood clot in the eye)

• sudden loss of vision or

BLOOD CLOTS IN VEINS

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

Taking combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). These side effects are rare. They most often occur in the first year of taking combined hormonal contraceptives. If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis. If a blood clot moves from the leg and settles in the lungs, it can cause pulmonary embolism. In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest?

The risk of blood clots in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.
If the patient stops taking Levomine, the risk of blood clots returns to normal within a few weeks.

What is the risk of developing blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with taking Levomine is small.

• Within a year, about 2 in 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• Within a year, about 5-7 in 10,000 women taking combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimate will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots in veins", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with taking Levomine is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had blood clots in the legs, lungs or other organs at a young age (e.g. under 50). In this case, the patient may have hereditary blood clotting disorders;
• if the patient needs to have surgery, is immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Levomine for a few weeks before surgery or immobilization. If the patient needs to stop taking Levomine, they should ask their doctor when they can resume taking it.
• with age (especially over 35);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (> 4 hours) may temporarily increase the risk of blood clots, especially
if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop taking Levomine.
One should inform the doctor if any of the above conditions change while taking Levomine, e.g. if someone in the patient's close family is diagnosed with thrombosis without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?
Like blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.
Factors that increase the risk of blood clots in arteries
It is essential to emphasize that the risk of heart attack or stroke associated with taking Levomine is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes.While taking a hormonal contraceptive, such as Levomine, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their close family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of developing blood clots may be even higher.
One should inform the doctor if any of the above conditions change while taking Levomine, e.g. if the patient starts smoking, someone in the patient's close family is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

Levomine and cancer

• There have been reports of cervical cancer in women taking oral contraceptives for a long time. However, this may be due to the effects of sexual behavior or other factors, such as the human papillomavirus (HPV).
• Breast cancer has been reported slightly more often in women taking combined oral contraceptives, but it is not known if this is due to their use. The frequency of breast tumors decreases after stopping the pills. It is essential to regularly examine one's breasts and contact a doctor if a lump is found.
• In women taking combined oral contraceptives, benign liver tumors have been diagnosed in rare cases, and malignant liver tumors have been diagnosed in even rarer cases. One should contact the treating doctor if severe abdominal pain occurs.

Irregular bleeding

During the first few months of taking Levomine, unexpected bleeding (bleeding outside the weekly break) may occur. If this bleeding occurs after three
months or if it starts after several months, the doctor must investigate the cause.

What to do if bleeding does not occur during the weekly break

If all the pills have been taken correctly, there has been no vomiting or severe diarrhea, and no other medicines have been taken, it is unlikely that the patient is pregnant.
If two consecutive expected bleedings have not occurred, it is possible that the patient is pregnant. One should contact a doctor immediately. One should not start the next blister pack until it has been confirmed that the patient is not pregnant.

Levomine and other medicines

One should tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Also, one should tell any other doctor or dentist who prescribes another medicine (or pharmacist who dispenses it) about taking Levomine. They will inform whether it is necessary to use additional contraceptive methods (e.g. a condom) and how long to use them.
Some medicines:

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

This applies to:

• medicines used to treat:
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV or hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g. griseofulvin);
• arthritis, degenerative joint disease (etoricoxib);
• high blood pressure in the blood vessels of the lungs (bosentan);
• herbal products containing St. John's wort (Hypericum perforatum).

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

• medicines containing cyclosporin,
• lamotrigine used to treat epilepsy (which may lead to an increased frequency of seizures),
• theophylline (used to treat respiratory disorders),
• tizanidine (used to treat muscle pain and/or muscle spasms).

One should not take Levomine if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause abnormal liver function test results in the blood (increased liver enzyme activity).
The doctor will suggest a different type of contraception before starting these medicines.
One can resume taking Levomine about 2 weeks after finishing the treatment. See section "When not to take Levomine".
Before taking any medicine, one should consult a doctor or pharmacist.

Using Levomine with food and drink

Levomine can be taken with or without food, with a small amount of water if necessary. Levomine should not be taken with grapefruit juice.

Lab tests

If lab tests are needed, one should tell the doctor or lab staff about taking the pills, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy
One should not take Levomine if the patient is pregnant. If the patient becomes pregnant while taking Levomine, one should stop taking it immediately and contact a doctor.
If the patient plans to become pregnant, they can stop taking Levomine at any time (see also section 3 "Stopping Levomine").
Before taking any medicine, one should consult a doctor or pharmacist.
Breastfeeding.
Levomine is not usually recommended during breastfeeding. If the patient wants to take the pills while breastfeeding, they should contact a doctor.
Before taking any medicine, one should consult a doctor or pharmacist.

Driving and using machines

There is no information to suggest that taking Levomine affects the ability to drive or use machines.

Levomine contains lactose and sodium.

If the patient has been informed that they do not tolerate some sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to use Levomine

This medicine should always be used as directed by a doctor or pharmacist. In case of doubts, one should consult a doctor or pharmacist.
One should take one Levomine pill every day, with a small amount of water if necessary.
The pills should be taken at about the same time every day.
The blister pack contains 21 pills. On the packaging, each pill is marked with the day of the week on which it should be taken. One should take one pill daily for 21 days, following the direction of the arrows on the blister pack, until all 21 pills have been taken.
Then, one should not take pills for 7 days. During these 7 days when pills are not taken (also called a break or weekly break), bleeding should start. This so-called "withdrawal bleeding" usually starts on the 2nd or 3rd day of the weekly break.
On the 8th day after taking the last Levomine pill (i.e. after a 7-day break), one should start the next blister pack, even if the bleeding has not stopped. This means that one should start the next blister pack on the same day of the week and that the withdrawal bleeding should occur on the same days every month.
If one uses Levomine in this way, they are also protected against pregnancy during the 7 days when pills are not taken.

When to start the first blister pack

• If a hormonal contraceptive has not been used in the last monthOne should start taking Levomine on the first day of the menstrual cycle (i.e. the first day of menstruation). If one starts taking Levomine on the first day of menstruation, contraceptive protection is immediate. One can also start taking it from the 2nd to the 5th day of the cycle, but in this case, additional barrier methods (e.g. a condom) should be used during the first 7 days.
• Switching from another combined hormonal contraceptive or a combined hormonal contraceptive, vaginal ring system or transdermal systemOne should start taking Levomine pills on the day after taking the last active pill from the previous pack (or after removing the vaginal ring or transdermal system), but no later than the day after the end of the break in taking pills from the previous pack (or the break in using the vaginal ring or transdermal system) or after taking the last inactive pill from the previous pack of pills.
• Switching from a progestogen-only method (pill, injection, implant containing only progestogen or intrauterine device releasing progestogen)The switch from a progestogen-only pill can be made at any time (from an implant or intrauterine device - on the day of their removal, from an injectable - when the next injection is scheduled), but in all these cases, additional barrier methods (e.g. a condom) should be used during the first 7 days of taking Levomine pills.
• After a miscarriage or abortion in the first trimesterOne should follow the doctor's instructions.
• After childbirth or abortion in the second trimesterOne should start taking Levomine pills between the 21st and 28th day after childbirth or abortion in the second trimester. If one starts taking it later than on the 28th day, one should use an additional barrier method (e.g. a condom) during the first 7 days of taking Levomine. If the patient has had sexual intercourse after childbirth before starting to take Levomine again, they should first make sure they are not pregnant or wait for the next menstrual period before taking Levomine.

If one is unsure when to start taking Levomine, they should consult a doctor.

• Breastfeeding and intention to resume taking Levomine after childbirthRead section 2, "Breastfeeding".

What to do if too much Levomine is taken

There are no data on the serious, harmful effects of taking too many Levomine pills.
If several pills are taken at the same time, symptoms such as nausea or vomiting may occur. In young girls, vaginal bleeding may occur.
If too many Levomine pills are taken or if it is discovered that several pills have been taken by a child, one should contact a doctor or pharmacist.

What to do if a Levomine pill is missed

If the delay in taking a pill does not exceed 12 hours, the contraceptive protection is not reduced. One should take the pill as soon as possible, and subsequent pills at the usual time.
If the delay in taking a pill exceeds 12 hours, the contraceptive protection may be reduced. The more pills that are missed, the higher the risk of pregnancy.
Therefore, one should follow these rules:

• The break in taking pills should never be longer than 7 days.
• At least 7 days of regular pill-taking are required to achieve adequate contraceptive protection.

If the delay in taking a pill exceeds 12 hours during days 1-7(see also the diagram):
One should take the missed pill as soon as possible, even if it means taking two pills at the same time. Pills should be taken again at the usual time, and an additional barrier method (e.g. a condom) should be used for the next 7 days. If the patient had sexual intercourse during the 7 days before missing the pill, they should be aware of the risk of pregnancy. The more pills that are missed and the closer it is to the usual break in taking pills, the higher the risk of pregnancy. In this case, one should contact a doctor.
If the delay in taking a pill exceeds 12 hours during days 8-14(see also the diagram):
One should take the missed pill as soon as possible, even if it means taking two pills at the same time. Pills should be taken again at the usual time.
Contraceptive protection is not reduced, provided that the pills were taken correctly during the last 7 days and there is no need to use additional contraceptive methods.
If the pills were not taken correctly or if more than one pill was missed, one should use an additional barrier method for the next 7 days.
If the delay in taking a pill exceeds 12 hours during days 15-21(see also the diagram):
The risk of pregnancy increases, the closer it is to the usual 7-day break in taking pills. However, one can prevent pregnancy by adjusting the dosing.
If the following dosing is used, there is no need to use additional contraceptive methods, provided that the 7 pills preceding the missed pill were taken correctly. If this is not the case, one should follow the first of these two options and use additional contraceptive methods for the next 7 days.

• 1. One should take the missed pill as soon as possible, even if it means taking two pills at the same time. Pills should be taken again at the usual time. Instead of the 7-day break in taking pills, one should proceed directly to the next 21-pill pack. or
• 2. One can also stop taking pills from the current pack and proceed directly to the 7-day break, taking into account the days when pills were missed, and then continue taking pills from the next pack.

If a pill is missed from the pack and bleeding does not occur during the first break, it may mean that the patient is pregnant.
Missed pill
(delay did not exceed
12 hours)
One should take the pill as soon as possible.
Was the patient sexually active
in the week preceding the missed pill?
Yes: one should consult a doctor.
Days 1-7
No
­
Take the missed pill.
­
Use a barrier method (condom) for the next 7 days.
­
Continue taking pills from the pack.
­
Take the missed pill.
­
Use a barrier method for the next 7 days if the patient did not take the pills correctly in the first 7 days.
­
Continue taking pills from the pack.
Missed pill
(delay exceeded 12 hours)
­
Take the missed pill.
­
Finish taking the pills.
­
Do not take a 7-day break
­
Proceed directly to the next 21-pill pack.
or
Days 8-14
­
Take the missed pill.
­
Continue taking pills at the usual time.
Days 15-21
­
Stop taking pills immediately.
­
Start the weekly break (no longer than 7 days, taking into account the day the pill was missed).
­
Start the next pack.

What to do if vomiting or severe diarrhea occurs

If vomiting or severe diarrhea occurs within 3-4 hours after taking a pill, there is a risk that the active substances contained in the pill may not be fully absorbed into the body. This situation is similar to missing a pill. After vomiting or diarrhea, one should take another pill from a spare pack as soon as possible. If possible, one should take the pill within 12 hours of the time when the pill should have been taken normally. If this is not possible or more than 12 hours have passed, one should follow the instructions described in the section "What to do if a Levomine pill is missed".

Delaying the start of withdrawal bleeding: what to know

Although it is not recommended, delaying the start of withdrawal bleeding is possible by starting a new Levomine pack immediately instead of taking a break, until the second pack is finished. While taking pills from the second pack, spotting (small spots or drops of blood) or irregular bleeding may occur.
After the usual 7-day break, one should continue taking pills from the next pack.
If the patient wants to delay the start of withdrawal bleeding, they can consult a doctor for advice.

Changing the day of withdrawal bleeding: what to know

If the patient takes the pills as directed, withdrawal bleeding will occur during the break in taking pills on the same day of the week. If the patient needs to change the day of bleeding, they will do so by shortening the break in taking pills (but never by lengthening it!). For example, if the break starts on a Friday and the patient wants to change this day to Tuesday (three days earlier), they should start the new pack three days earlier than usual.
If the break in taking pills is very short (e.g. 3 days or less), there may not be any withdrawal bleeding during the break. Later, spotting or irregular bleeding may occur.
If the patient is unsure how to proceed, they should consult a doctor for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Levomine, they should consult a doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disease). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Levomine".
The most common side effects when taking the medicine in the form of tablets containing ethinylestradiol or levonorgestrel are headaches and spotting or intermenstrual bleeding.
The following possible side effects related to the use of these tablets are:

• mood changes, depression
• headache
• nausea, abdominal pain
• breast pain, breast tenderness
• weight gain
• rash.

Uncommon side effects (may affect up to 1 in 100 patients):

• decreased libido
• migraine
• vomiting, diarrhea,
• skin rash
• itching or raised bumps on the skin
• swollen breasts
• fluid retention in the body
• hair loss.

Rare side effects (may affect up to 1 in 1000 patients):

• intolerance to contact lenses
• allergic reactions
• increased libido
• breast discharge, vaginal discharge
• redness of the skin or spots on the skin
• weight loss
• harmful blood clots in a vein or artery, e.g.,
• in the leg or foot (deep vein thrombosis)
• in the lung (pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach, and intestines, kidneys, or eye.

The risk of blood clots increases if the patient has other risk factors for blood clots (for information on conditions that increase the risk of blood clots and symptoms of blood clots, see section 2).
The following serious side effects have been reported slightly more frequently in women taking oral contraceptives, but it is not known whether they are caused by their use (see section 2: "Important information before taking Levomine"):

• cervical cancer, breast cancer
• high blood pressure
• liver dysfunction, liver tumors.

The following conditions are also associated with the use of combined hormonal oral contraception:
Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, benign uterine tumors, porphyria (a metabolic disorder that causes abdominal pain and mental disorders), systemic lupus erythematosus (the body attacks and damages its own organs and tissues), herpes in late pregnancy, Sydenham's chorea (sudden, involuntary jerks or convulsions), hemolytic-uremic syndrome (a condition that occurs after diarrhea caused by E. coli infection), liver disease with jaundice, elevated blood fat levels, hearing loss.
In women with hereditary angioedema, estrogens in oral contraceptives may cause or worsen symptoms of angioedema (see section 2 "Important information before taking Levomine").
Severe side effects
Seek medical attention immediately if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing (see also section 2 "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Levomine

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Levomine contains

The active substances of the medicine are: ethinylestradiol and levonorgestrel.
Each coated tablet contains 30 micrograms of ethinylestradiol and 150 micrograms of levonorgestrel.
The medicine also contains:
Tablet core:
Lactose monohydrate, corn starch, maltodextrin, magnesium stearate, sodium carboxymethyl cellulose (type A).
Tablet coating:
Hypromellose 6cP, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172).

What Levomine looks like and what the pack contains

Levomine is available in the form of round, yellow, coated tablets.
Levomine is available in packs containing:
1 blister pack of 21 coated tablets
3 blister packs, each containing 21 coated tablets
6 blister packs, each containing 21 coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Date of last update of the leaflet:04.2023