Levomine midi

Leaflet accompanying the packaging: information for the user

Levomine midi, 30 micrograms + 125 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
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots")

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given 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 side effects 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 midi and what is it used for
• 2. Important information before taking Levomine midi
• 3. How to take Levomine midi
• 4. Possible side effects
• 5. How to store Levomine midi
• 6. Contents of the pack and other information

1. What is Levomine midi and what is it used for

• Levomine midi is a contraceptive pill and is used to prevent pregnancy.
• Each tablet 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 midi is called a low-dose contraceptive.

2. Important information before taking Levomine midi

General notes

Before starting to take Levomine midi, you 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 take Levomine midi, the doctor will ask questions about the patient's health and that of their close relatives. The doctor will also measure blood pressure and, depending on the patient's condition, may perform some other tests.
This leaflet describes different situations in which Levomine midi should not be taken or in which the effectiveness of Levomine midi may be reduced. In such situations, either no sexual intercourse should take place or additional non-hormonal contraceptive precautions should be used, e.g. a condom or another barrier method. The calendar or temperature method should not be used. These methods may be unreliable because Levomine midi changes body temperature and cervical mucus properties throughout the month.

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

When not to take Levomine midi

Levomine midi should not be taken 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 midi

• if the patient is allergic to levonorgestrel, ethinylestradiol or any of the other ingredients of this medicine (listed in section 6). This may cause 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 they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, the presence of factor V Leiden mutation or antiphospholipid antibodies;
• if the patient needs to undergo 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 a transient ischaemic attack (transient stroke symptoms);
• if the patient has any of the following diseases that may increase the risk of a blood clot in the arteries:
• severe diabetes with blood vessel 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) liver disease and the liver is not yet functioning properly;
• if the patient has (or has ever had) a liver tumour;
• if the patient has (or is suspected to have) breast cancer or cancer of the genital organs;
• 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 midi and other medicines").

Warnings and precautions

When should a doctor be contacted?
A doctor should be contacted 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 describe the symptoms of these serious side effects, see "How to recognize a blood clot".

The doctor should be told if the patient has any of the following conditions.

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

• if any close relative has 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 haemolytic uraemic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle-cell anaemia (a hereditary disease of red blood cells);
• if the patient has had elevated levels of fats in the blood (hypertriglyceridaemia) or a positive family history for this disease. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, as they are at increased risk of blood clots. The doctor should be consulted to find out how soon after delivery they can start taking Levomine midi;
• 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 midi and other medicines");
• if the patient has a disease that first appeared during pregnancy or previous use of 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 patches on the skin, especially on the face (chloasma). In this case, they should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient experiences symptoms of angio-oedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, they should contact their doctor immediately. Products containing oestrogens may cause or worsen symptoms of both hereditary and acquired angio-oedema.

Psychiatric disorders

Some women taking hormonal contraceptives, including Levomine midi, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the doctor should be contacted as soon as possible for further medical advice.
BLOOD CLOTS
Taking combined hormonal contraceptives, such as Levomine midi, 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 (also known as "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also known as "arterial thromboembolism" or "arterial thrombosis")

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

It should be remembered that the overall risk of harmful blood clots caused by taking Levomine midi is small.

HOW TO RECOGNIZE A BLOOD CLOT

A doctor should be contacted immediately if any of the following symptoms are noticed.

Is the patient experiencing any of these symptoms? Why is the patient likely to be suffering?

• 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 colour of the leg skin, such as paleness, redness or bruising.
• 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 stomach pain.

If the patient is unsure, they should contact their doctor,
as some of these symptoms, such as coughing 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
• painless vision disturbances, which may lead to loss of vision.
• chest pain, feeling of discomfort, feeling of Heart attack

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 in 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 a 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 veins highest?

The risk of blood clots in veins 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 midi, 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 midi 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 who take 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 midi 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/m2);
• 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 years). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to undergo 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 midi for a few weeks before surgery or immobilization. If the patient needs to stop taking Levomine midi, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years);
• 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 midi.
The doctor should be informed if any of the above conditions change while taking Levomine midi, e.g. if someone in the patient's close family is diagnosed with a blood clot 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?

As with blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with taking Levomine midi is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes. While taking a hormonal contraceptive like Levomine midi, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, 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 years). 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 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, irregular heartbeat 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 particularly severe, the risk of developing blood clots may be even higher.
The doctor should be informed if any of the above conditions change while taking Levomine midi, e.g. if the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

Levomine midi and cancer

• In some studies, cases of cervical cancer were slightly more common in women who had taken oral contraceptives for a long time. However, it is not clear how much the effects of sexual behaviour or other factors, such as the human papillomavirus (HPV), increase this risk.
• Breast cancer has been slightly more common in women taking combined oral contraceptives, but it is not known if this is caused by the treatment. The higher frequency of breast cancer in women taking combined oral contraceptives may be due to the fact that they are more likely to have regular medical check-ups. The frequency of breast tumours decreases gradually after stopping combined hormonal contraceptives. It is essential to regularly check the breasts and contact a doctor if the patient finds any lump.
• In rare cases, women taking oral contraceptives have been found to have benign liver tumours, and in even rarer cases, malignant liver tumours. The patient should contact their doctor if they experience severe stomach pain.

Irregular bleeding

During the first few months of taking Levomine midi, unexpected bleeding (bleeding outside the weekly break) may occur. If this bleeding continues for longer than a few months or starts after a few months, the doctor should investigate the cause.

What to do if there is no bleeding during the weekly break

If all the tablets have been taken correctly, there has been no vomiting or severe diarrhoea, and no other medicines have been taken, it is unlikely that the patient is pregnant.
If two consecutive expected bleedings have not occurred, the patient may be pregnant. Before continuing to take the tablets, pregnancy should be ruled out, and the doctor should be contacted immediately. The next blister should not be started until it has been confirmed that the patient is not pregnant.

Levomine midi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. They should also tell any other doctor or dentist who prescribes another medicine (or pharmacist) that they are taking Levomine midi. They will inform the patient if additional contraceptive precautions are necessary (e.g. a condom) and for how long.
Some medicines may affect the level of Levomine midi in the blood and make it less effective in preventing pregnancy or cause unexpected bleeding.
This applies to:

• medicines used to treat:
• gastrointestinal motility disorders (e.g. metoclopramide);
• 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);
• fungal infections (e.g. griseofulvin, itraconazole, voriconazole, fluconazole);
• bacterial infections (macrolide antibiotics, e.g. erythromycin, clarithromycin);
• certain heart conditions, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem);
• arthritis, degenerative joint disease (etoricoxib);
• herbal products containing St. John's Wort (Hypericum perforatum).

The antibiotic troleandomycin taken with Levomine midi tablets may increase the risk of jaundice.
Levomine midi 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);
• melatonin;
• midazolam;
• theophylline (used to treat respiratory disorders);
• tizanidine (used to treat muscle pain and/or muscle spasms).

Levomine midi should not be taken 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 elevated liver enzyme test results (increased ALT enzyme activity).
The doctor will recommend a different contraceptive method before starting these medicines.
Levomine midi can be resumed about 2 weeks after the end of treatment. See section "When not to take Levomine midi".
Before taking any medicine, a doctor or pharmacist should be consulted.

Taking Levomine midi with food and drink

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

Lab tests

If lab tests are necessary, the doctor or lab staff should be informed about taking the tablets, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

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

Driving and using machines

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

Levomine midi contains lactose and sodium

If the patient has been told 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 it is essentially "sodium-free".

3. How to take Levomine midi

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Each blister pack contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken. For example, if tablet-taking starts on a Tuesday, the tablet marked "Tue" should be taken from the blister pack.
One Levomine midi tablet should be taken every day for 21 days, with a small amount of water if necessary. The tablets can be taken with or without food, but they should be taken at about the same time every day.
After taking 21 tablets, no tablets should be taken for the next 7 days. During these 7 days, a new menstrual cycle will begin (withdrawal bleeding), which usually starts 2-3 days after taking the last tablet of Levomine midi.
The next blister pack should be started on the 8th day, even if the withdrawal bleeding has not yet stopped. This way, a new pack always starts on the same day of the week, and withdrawal bleeding occurs at about the same time every month.

When to start the first blister pack?

• If a hormonal contraceptive has not been taken in the last monthLevomine midi should be started on the first day of the menstrual cycle (i.e. the first day of menstruation). If Levomine midi is started on the first day of the menstrual cycle, contraceptive protection is immediate. The start can also be between days 2-5 of the menstrual cycle, but in this case, additional barrier methods (e.g. a condom) should be used for the first 7 days.
• Switching from another combined hormonal contraceptive or a vaginal ring or patchLevomine midi should be started on the day after taking the last active tablet from the previous pack (or after removing the vaginal ring or patch), but no later than the day after the usual tablet-free interval or the day after the last inactive tablet from the previous pack.
• Switching from a progestogen-only method (pill, injection, implant or intrauterine system)The switch from a progestogen-only pill to Levomine midi can be made at any time (from an implant or intrauterine system on the day of its removal, from an injection when the next injection is scheduled), but in all these cases, additional contraceptive precautions (e.g. a condom) should be used for the first 7 days of tablet-taking.
• After a miscarriage or abortion in the first trimesterThe doctor's advice should be followed.
• After childbirth or abortion in the second trimesterLevomine midi should be started between 21-28 days after childbirth or abortion in the second trimester. If Levomine midi is started later than 28 days, a barrier method (e.g. a condom) should be used for the first 7 days of tablet-taking. If the patient has had sexual intercourse after childbirth before starting Levomine midi, they should first ensure they are not pregnant or wait for their next menstrual period before starting Levomine midi.
• Breastfeeding and intention to restart Levomine midi after childbirthThe patient should read section 2 "Breastfeeding".

If there is any doubt about when to start taking Levomine midi, the doctor should be consulted.

What to do if too much Levomine midi is taken

There is no data on serious, harmful effects of taking too many Levomine midi tablets.
If several tablets 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 midi tablets are taken or if it is discovered that a child has taken some, a doctor or pharmacist should be contacted.

What to do if a dose of Levomine midi is missed

• If the delay in taking a tablet does not exceed 12 hours, contraceptive protection is not reduced. The tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.
• If the delay in taking a tablet exceeds 12 hours, contraceptive protection may be reduced. The more tablets that are missed, the higher the risk of pregnancy. Therefore, the following rules should be followed:
• A break in taking tablets must never be longer than 7 days.
• At least 7 days of regular tablet-taking are required to achieve adequate contraceptive protection.
• If the delay in taking a tablet exceeds 12 hours during the first 7 days of taking(see also the diagram): The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The tablets should be continued at the usual time, and additional barrier methods (e.g. a condom) should be used for the next 7 days. If the patient had sexual intercourse during the 7 days before missing a tablet, they should be aware of the risk of pregnancy. The more missed tablets and the closer they are to the usual tablet-free interval, the higher the risk of pregnancy. In this case, the doctor should be contacted.
• If the delay in taking a tablet exceeds 12 hours during days 8-14 of taking(see also the diagram): The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The tablets should be continued at the usual time. If the tablets have been taken correctly during the previous 7 days, there is no need for additional contraceptive precautions. If the tablets have not been taken correctly or if more than one tablet has been missed, additional precautions (e.g. a condom) should be used for the next 7 days.
• If the delay in taking a tablet exceeds 12 hours during days 15-21 of taking(see also the diagram): The risk of pregnancy increases the closer it is to the usual 7-day tablet-free interval. However, pregnancy can be prevented by adjusting the dosing schedule. If the following dosing schedule is used, there is no need for additional contraceptive precautions, provided that all tablets have been taken correctly during the 7 days before the first missed tablet. If this is not the case or if more than one tablet has been missed, the patient should follow the first of the two options below and use additional contraceptive precautions for the next 7 days.
• 1. The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The remaining tablets should be taken at the usual time. Instead of the 7-day tablet-free interval, the patient should move directly to the next 21-tablet blister pack. It is likely that there will be no withdrawal bleeding until the end of the second blister pack, but there may also be spotting or breakthrough bleeding during tablet-taking.
• 2. The patient can also stop taking the tablets from the current blister pack and move directly to the 7-day tablet-free interval, taking into account the days when the tablets were missed, and then continue taking the tablets from the next blister pack.

If a tablet is missed from the blister pack and there is no withdrawal bleeding during the first tablet-free interval, the patient may be pregnant.
Missed
tablet
(delay not
exceeding 12
hours)
Take the tablet
Days 1-7
Did the patient have sexual intercourse in the week before missing the tablet?
Yes: consult a doctor
No

• Take the missed tablet.
• Use a barrier method (condom) for the next 7 days
• Continue taking the tablets from the blister pack

Missed
tablet
(delay exceeding
12 hours)
Days 8-14

• Take the missed tablet. (Use a barrier method for the next 7 days if the patient did not take the tablets correctly during the first 7 days)
• Continue taking

the tablets from the blister pack

• Take the missed tablet.
• Finish taking the tablets.
• Do not take the 7-day break
• Move directly to the next 21-tablet blister pack

Days 15-21
or

• Stop taking the tablets immediately
• Start the 7-day break (no longer than 7 days, taking into account the day the tablet was missed)
• Start the next blister pack

What to do if the patient vomits or has severe diarrhoea

If the patient vomits or has severe diarrhoea within 3-4 hours of taking a tablet, there is a risk that the active substances in the tablet will not be fully absorbed into the body. This situation is almost the same as missing a tablet. After vomiting or diarrhoea, the patient should take another tablet from a spare blister pack as soon as possible.
If possible, the tablet should be taken within 12 hoursof when it was normally taken. If this is not possible or more than 12 hours have passed, the patient should follow the advice given in the section "What to do if a dose of Levomine midi is missed".

Delaying the start of withdrawal bleeding: what to know

Although it is not recommended, the start of withdrawal bleeding can be delayed by starting a new blister pack of Levomine midi immediately, using the entire contents of the blister pack. During the use of tablets from the new blister pack, spotting or breakthrough bleeding may occur. After the usual 7-day tablet-free interval, the patient should continue taking the tablets from the next blister pack.
If the patient plans to delay the start of withdrawal bleeding, they should consult their 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 status that the patient considers related to the use of Levomine midi, consult a doctor. In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before taking Levomine midi". The most common side effects when using the medicine in the form of tablets containing ethinylestradiol or levonorgestrel are headaches and spotting or intermenstrual bleeding. The following possible side effects are related to the use of these tablets:

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

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.

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

• eye irritation when wearing contact lenses
• hypertension
• 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 using oral contraceptives, but it is not known if they are caused by their use (see section 2 "Important information before taking Levomine midi"):

• 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 (with very painful menstruation), 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 (involuntary, sudden jerks or convulsions), hemolytic-uremic syndrome (a condition that occurs after diarrhea caused by E. coli infection), liver disease with jaundice, abnormal blood lipid levels (dyslipidemia), hearing loss (otosclerosis). Serious side effects: If any of the following symptoms of angioedema occur, contact a doctor immediately: 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"). The estrogens in the tablet can cause or worsen symptoms of angioedema in women with hereditary, sudden skin, mucous membrane, internal organ, or brain edema (hereditary angioedema), see section 2 "Important information before taking Levomine midi".

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your 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, Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levomine midi

Store the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. The active substances in this medicine may pose a risk to aquatic environments. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levomine midi contains

• The active substances are ethinylestradiol and levonorgestrel. Each coated tablet contains 30 micrograms of ethinylestradiol and 125 micrograms of levonorgestrel.
• The other ingredients are: Tablet core: Lactose monohydrate, corn starch, maltodextrin, magnesium stearate, sodium carboxymethylcellulose (type A).

Tablet coating: Hypromellose 2910, 6 mPas, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172).

What Levomine midi looks like and what the pack contains

Levomine midi is a round, yellow, film-coated tablet with an imprint. The blister pack contains 21 film-coated tablets. Levomine midi is available in packs containing: 1 blister pack of 21 film-coated tablets, 3 blister packs, each containing 21 film-coated tablets, 6 blister packs, each containing 21 film-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 Date of last revision of the leaflet:12.2021