Levomine

Package leaflet: Information for the user

Levomine, 30 micrograms + 150 micrograms, coated tablets
Ethinylestradiolum + Levonorgestrelum
Important information about combined hormonal contraceptives

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

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms of illness are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Levomine is and what it is used for

Levomine is a contraceptive tablet used to prevent pregnancy.
Each tablet contains small amounts of two different female hormones: ethinylestradiol and levonorgestrel.
Contraceptive tablets containing two hormones are known as combined oral contraceptives. Due to its low hormone content, Levomine is a low-dose contraceptive.

2. Important information before using Levomine

General information
Before starting to take Levomine, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2. "Blood clots").
Before starting treatment with Levomine, your doctor will ask you several questions about your health and that of your close family members. Your doctor will also measure your blood pressure and, depending on your condition, may carry out several other tests.
This leaflet describes various situations in which you should stop taking Levomine or in which the effectiveness of Levomine may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive protection, such as a condom or another barrier method. Do not use the calendar or temperature method. These methods may be unreliable because Levomine alters body temperature and cervical mucus characteristics throughout the month.
Levomine, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or any other sexually transmitted diseases.

When not to take Levomine
Do not take Levomine if you have any of the conditions listed below. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

Do not take Levomine

• if you are 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 you currently have (or have ever had) blood clots in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol or triglycerides);
  • a condition called hyperhomocysteinemia;
• if you currently have (or have ever had) a type of migraine called migraine with aura;
• if you currently have (or have ever had) severe liver disease and your liver still does not function properly;
• if you currently have or have ever had a liver tumour;
• if you currently have (or have ever had) or are suspected of having breast cancer or cancer of the genital organs;
• if you have any unexplained vaginal bleeding;
• if you have unexplained absence of menstruation, probably caused by exercise or diet;
• if you have hepatitis C and are 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 should you contact your doctor?
You should contact your doctor immediately

• if you notice possible symptoms of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack or a stroke (see section below "Blood clots").

For a description of the symptoms of these serious adverse events, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
In certain situations, you need to be particularly careful when using Levomine or any other combined oral contraceptive, and regular monitoring of your health by your doctor may be necessary. If any of the following conditions occur or worsen while taking Levomine, inform your doctor:

• if breast cancer has occurred in your close family members;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (an autoimmune disease);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are then at increased risk of developing blood clots. Consult your doctor for advice on how soon after delivery you can start taking Levomine;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see "Levomine and other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy [prurigo of pregnancy], a nerve disorder causing sudden body movements [Sydenham's chorea]);
• if you have or have ever had brownish patches (chloasma) on the skin, particularly on the face. In such cases, avoid direct exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives that may cause breathing difficulties, contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

Psychiatric disorders:
Some women using hormonal contraceptives, including Levomine, have reported depression or low mood. Depression can be severe and, in some cases, may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.

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

• in veins (referred to below as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic disorders").

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with the use of Levomine is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.

Do you experience any of these symptoms?
What is the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may occur only when standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as pallor, redness or blueness
• sudden unexplained shortness of breath or
  rapid breathing
• sudden coughing without obvious cause, which may be associated with coughing up blood
• sharp chest pain, which may worsen with deep breathing
• severe dizziness or vertigo
• rapid or irregular heartbeat
• severe stomach pain

If you are unsure, contact your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).
Symptoms 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 blood clots form in the veins?
The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). However, these adverse effects are rare. They most commonly occur during the first year of using combined hormonal contraceptives. If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis. If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism. In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots highest?
The risk of venous blood clots is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or another product) after a break of 4 weeks or more.

After the first year, the risk decreases, although it always remains higher compared to not using combined hormonal contraceptives.
If a 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 thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Levomine is low.

• In one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who are using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• The risk of blood clots depends on the individual medical history of the patient (see "Factors increasing the risk of venous blood clots" below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Levomine is small, however,
some factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Levomine several weeks before surgery or reduced mobility. If the patient must stop taking Levomine, consult the doctor about when it is safe to resume.
• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially
if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed risk factors apply to the patient,
even if uncertain. The doctor may decide to discontinue Levomine.
Inform the doctor if any of the above conditions change during treatment with Levomine, e.g., if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with Levomine use is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Levomine, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has experienced a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Levomine, e.g., if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Levomine and cancer

• Cases of cervical cancer have been reported in women using oral contraceptives for a long time. However, this may be due to behavioral factors such as sexual activity or other factors like human papillomavirus (HPV).
• Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by their use. The incidence of breast tumors decreases after stopping the pills. It is important to regularly examine the breasts and contact a doctor if any lump is detected.
• Benign liver tumors have rarely been observed in women using combined oral contraceptives, and malignant liver tumors have been reported even more rarely. Contact the treating doctor if the patient experiences severe abdominal pain.

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

What to do if withdrawal bleeding does not occur during the weekly break
If all tablets have been taken correctly, there have been no episodes of vomiting or severe diarrhea, and no other medications have been taken, it is unlikely that the patient is pregnant.
If two consecutive expected withdrawal bleeds do not occur, pregnancy is possible. Contact the doctor immediately. Do not start the next blister pack until pregnancy has been ruled out.

Levomine and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take. Also inform any other doctor or dentist prescribing another medicine (or a pharmacist dispensing it) that Levomine is being used. They will advise whether additional contraceptive methods (e.g., condoms) are needed and for how long.
Some medicines:

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

These include:

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

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

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

Levomine must not be used 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 (increased activity of liver enzymes AlAT).
The doctor will recommend another form of contraception before starting treatment with these medicines.
Levomine may be resumed approximately 2 weeks after completing treatment. See section “When not to use Levomine”.
Before taking any medicine, consult a doctor or pharmacist.

Taking Levomine with food and drink
Levomine may be taken with or without food, swallowing the tablet with a small amount of water if needed. Do not take Levomine with grapefruit juice.

Laboratory tests
If blood tests are required, inform the doctor or laboratory staff about taking the tablets, as oral contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Do not take Levomine if the patient is pregnant. If pregnancy occurs while taking Levomine, stop taking the medicine immediately and contact the doctor.
If the patient plans to become pregnant, she may stop taking Levomine at any time (see also section 3 “Stopping Levomine”).

Before taking any medicine, consult a doctor or pharmacist.

Breastfeeding
Levomine is generally not recommended during breastfeeding. If the patient wishes to take the tablets while breastfeeding, she should contact her doctor.

Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
There is no information indicating that Levomine affects the ability to drive or operate machinery.

Levomine contains lactose and sodium.
If the patient has been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered “sodium-free”.

3. How to take Levomine

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
Take one Levomine tablet daily, with a small amount of water if necessary.
Tablets should be taken at approximately the same time each day.
The blister pack contains 21 tablets. Each tablet on the pack is marked with the day of the week on
which it should be taken. Take one tablet daily for 21 days, following the direction of the arrows on
the blister, until all 21 tablets have been taken.
Afterwards, do not take any tablets for 7 days. During these 7 days, when tablets are not taken (also
called the break or weekly break), withdrawal bleeding usually occurs. This so-called "withdrawal
bleeding" typically begins on the 2nd or 3rd day of the weekly break.
On the 8th day after taking the last Levomine tablet (i.e., after the 7-day break), start a new blister
pack, even if bleeding has not yet stopped. This means that you should start the next pack on the
same day of the week, and withdrawal bleeding should occur on the same days each month.
If you take Levomine in this way, you are protected against pregnancy also during the 7 days when
you do not take tablets.

When to start the first blister pack

• If you have not used any hormonal contraceptive in the previous month Start taking Levomine on the first day of your cycle (i.e., the first day of your period). If you start Levomine on the first day of your period, contraceptive protection is immediate. You may also start between day 2 and day 5 of your cycle, but in this case, you must use additional contraceptive methods (e.g., a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive or from a combined hormonal contraceptive vaginal ring or transdermal patch Begin taking Levomine tablets the day after taking the last active tablet of your previous pack (or after removing the vaginal ring or transdermal patch), but no later than the day after the tablet-free interval of your previous pack ends (or the interval of the vaginal ring or transdermal patch), or after taking the last inactive tablet of your previous contraceptive pack.
• Switching from a progestogen-only method (progestogen-only pill, injection, progestogen-releasing implant or intrauterine system) Switching from a progestogen-only pill can occur on any day (from an implant or intrauterine system – on the day of removal, from an injectable contraceptive – when the next injection is due), but in all these cases, you must use additional barrier methods (e.g., a condom) for the first 7 days of tablet intake.
• After miscarriage or termination of pregnancy in the first trimester Follow your doctor's advice.
• After childbirth or termination of pregnancy in the second trimester Begin taking Levomine tablets between day 21 and day 28 after childbirth or termination of pregnancy in the second trimester. If you start taking the medicine later than day 28, use an additional barrier method (e.g., a condom) for the first 7 days of taking Levomine. If you have had sexual intercourse after childbirth and before starting Levomine, you should first ensure you are not pregnant or wait until your next period before starting Levomine.

If you are uncertain about when to start taking the medicine, consult your doctor.

• Breastfeeding and intention to restart Levomine after childbirth See section 2, part "Breastfeeding".

Taking more Levomine than recommended
There are no data on severe harmful effects from taking too many Levomine tablets.
If several tablets are taken at once, symptoms such as nausea or vomiting may occur. In young girls,
vaginal bleeding may occur.
If an excessive amount of Levomine tablets has been taken or if a child has accidentally ingested
tablets, consult your doctor or pharmacist immediately.

Missed dose of Levomine
If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the
tablet as soon as possible, and continue taking the following tablets at your usual time.
If the delay in taking a tablet exceeds 12 hours, contraceptive protection may be reduced. The more
tablets missed, the higher the risk of pregnancy. Therefore, follow these rules:

• The tablet-free interval must never exceed 7 days.
• At least 7 days of regular tablet intake are required to achieve adequate contraceptive protection.

If the delay in taking a tablet exceeds 12 hours during days 1–7 of the cycle (see also diagram):
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time.
Continue taking tablets at your usual time and use additional protection (e.g., a condom) for the next
7 days. If you had sexual intercourse within the 7 days before missing the tablet, be aware of the
risk of pregnancy. The more tablets missed and the closer to the usual tablet-free interval, the higher
the risk of pregnancy. In such a case, consult your doctor.

If the delay in taking a tablet exceeds 12 hours during days 8–14 of the cycle (see also diagram):
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time.
Continue taking tablets at your usual time. Contraceptive protection is not reduced, provided that
tablets were taken correctly during the previous 7 days, and there is no need for additional
contraceptive methods. However, if tablets were not taken correctly or if more than one tablet was
missed, use additional protection for the next 7 days.

If the delay in taking a tablet exceeds 12 hours during days 15–21 of the cycle (see also diagram):
The risk of pregnancy increases the closer you are to the usual 7-day tablet-free interval. However,
pregnancy can be prevented by adjusting the dosing regimen.
If the following dosing regimen is followed, there is no need for additional contraceptive methods,
provided that the seven tablets preceding the missed tablet were taken correctly. If this is not the
case, follow the instructions under the first of the two options below and use additional contraceptive
methods for the next 7 days.

1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking tablets at your usual time. Instead of the 7-day tablet-free interval, proceed directly to the next 21-tablet pack. Withdrawal bleeding may not occur until the end of the second pack, but spotting or breakthrough bleeding may occur during tablet intake.
   or
2. You may also stop taking tablets from the current pack, proceed directly to a 7-day tablet-free interval (including the days when tablets were missed), and then continue with the next pack.

If you missed any tablet from the pack and no bleeding occurred during the first tablet-free interval,
this may indicate pregnancy.

Missed tablet
(Delay less than 12 hours)
Take the tablet as soon as possible.
Did you have sexual intercourse
in the week before missing the tablet?
Days 1–7
Yes: consult your doctor.
No
­ Take the missed tablet.
­ Use a barrier method (condom) for the next 7 days.
­ Continue taking tablets from the pack.
­ Take the missed tablet.
­ Use a barrier method for the next 7 days if
Missed tablet
Days 8–14 you did not take tablets correctly
(Delay exceeds 12 hours)
during the first 7 days.
­ Continue taking tablets from the pack.
­ Take the missed tablet.
­ Finish taking tablets from the current pack.
­ Do not take a 7-day break.
­ Proceed directly to the next 21-tablet blister pack.
or
Days 15–21
­ Immediately stop taking tablets.
­ Start a 7-day break (no longer than 7 days,
including the day the tablet was missed).
­ Then start the next blister pack.

What to do if you vomit or have severe diarrhoea
If you vomit or have severe diarrhoea within 3–4 hours after taking a tablet, there is a risk that the
active substances in the tablet may not be fully absorbed. This situation is similar to missing a tablet.
After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If
possible, take the tablet within 12 hours of the time it was normally due. If this is not possible or more
than 12 hours have passed, follow the advice given under "Missed dose of Levomine".

Delaying withdrawal bleeding: what you should know
Although not recommended, it is possible to delay withdrawal bleeding by starting a new Levomine
blister pack immediately, without taking the tablet-free interval, and continuing until the second pack
is finished. During intake of the second pack, spotting (small drops or spots of blood) or breakthrough
bleeding may occur. After the usual 7-day break, continue taking tablets from the next pack.
If you plan to delay withdrawal bleeding, consult your doctor for advice.

Changing the day of withdrawal bleeding: what you should know
If you take the tablets as directed, withdrawal bleeding will occur during the tablet-free week on the
same day each month. If you wish to change the day of bleeding, you can do so by shortening the
tablet-free interval (but never by extending it). For example, if your tablet-free interval starts on a
Friday and you wish to change it to Tuesday (three days earlier), you should start the new pack three
days earlier than usual. If the tablet-free interval is very short (e.g., 3 days or fewer), no bleeding may
occur during the break. Later, spotting or breakthrough bleeding may occur.
If you have any doubts about how to proceed, consult your doctor.

Stopping Levomine
You may stop taking Levomine at any time. If you do not wish to become pregnant, consult your
doctor about other reliable contraceptive methods.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health that the patient considers to be related to the use of Levomine, medical advice should be sought from a doctor.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Levomine".
The most common adverse reactions during use of tablets containing ethinylestradiol or levonorgestrel are headache and spotting or intermenstrual bleeding.
The following are possible adverse reactions associated with the use of these tablets:
Common adverse reactions (may affect up to 1 in 10 women):

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

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

• decreased libido
• migraine
• vomiting, diarrhoea
• skin rash
• itching or raised lumps on the skin
• swollen breasts
• fluid retention
• hair loss.

Rare adverse reactions (may affect up to 1 in 1000 women):

• intolerance to contact lenses
• allergic reactions
• increased libido
• breast discharge, vaginal discharge
• redness of the skin or skin spots
• weight loss
• harmful blood clots in veins or arteries, for example:
• in the leg or foot (deep vein thrombosis)
• in the lungs (pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack
• blood clots in the liver, stomach and intestines, kidneys or eye.

The risk of blood clots increases if the patient has other factors that increase the risk of blood clots (for information on conditions increasing the risk of blood clots and symptoms of a blood clot, see section 2).
The following serious adverse reactions have been reported slightly more frequently in women using contraceptive tablets, 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 function disorders, liver tumours.

The following conditions have also been associated with the use of combined oral hormonal contraception:
Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, benign uterine tumours, porphyria (a metabolic disorder causing abdominal pain and psychiatric disturbances), systemic lupus erythematosus (a condition in which the body attacks and damages its own organs and tissues), herpes in late pregnancy, Sydenham's chorea (sudden involuntary jerking or twitching), haemolytic-uraemic syndrome (a condition occurring after diarrhoea caused by E. coli infection), liver disorders manifesting as jaundice, elevated blood lipid levels, hearing loss.
In women with hereditary angioedema, estrogens in contraceptive tablets may trigger or worsen symptoms of angioedema (see section 2 "Important information before taking Levomine").
Serious adverse reactions
Seek immediate medical advice if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria, which may cause difficulty breathing (see also section 2 "Warnings and precautions").
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Levomine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Levomine contains
The active substances in Levomine are: ethinylestradiol and levonorgestrel.
Each coated tablet contains 30 micrograms of ethinylestradiol and 150 micrograms of levonorgestrel.
The medicine also contains:
Tablet core:
Monohydrate lactose, corn starch, maltodextrin, magnesium stearate,
sodium carboxymethyl starch (type A).
Tablet coating:
Hypromellose 6 cP, titanium dioxide (E 171), polyethylene glycol 400, iron oxide yellow (E 172).
What Levomine looks like and contents of the pack
Levomine is available as round, yellow coated tablets.
Levomine is available in packs containing:
1 blister containing 21 coated tablets
3 blisters, each containing 21 coated tablets
6 blisters, each containing 21 coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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