Levomine mini

Leaflet attached to the packaging: information for the user

Levomine mini, 20 micrograms + 100 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.
• To a small extent, they 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").

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be passed on to others. The medicine may harm another person.
• 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 mini and what is it used for
• 2. Important information before using Levomine mini
• 3. How to use Levomine mini
• 4. Possible side effects
• 5. How to store Levomine mini
• 6. Contents of the pack and other information

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

• Levomine mini is a combined oral contraceptive and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones: ethinylestradiol and levonorgestrel.
• Contraceptive tablets containing two hormones are called "combined" tablets. Due to the small hormone content, Levomine mini is a low-dose contraceptive.

2. Important information before using Levomine mini

General notes

Before starting to take Levomine mini, 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 use Levomine mini, the doctor will ask the patient a few 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 a few other tests.
This leaflet describes various situations in which Levomine mini should not be used, or in which the effectiveness of Levomine mini may be reduced. In such situations, the patient should either not have sexual intercourse or use additional, non-hormonal contraceptive protection, such as a condom or another barrier method. The calendar or temperature method should not be used. These methods may be unreliable because Levomine mini changes the body temperature and cervical mucus properties during the month.

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

When not to use Levomine mini

Levomine mini should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.
Levomine mini should not be used:

• 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 blood clotting disorders - 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 due to injury or illness or has a leg in a cast. It may be necessary to stop using Levomine mini for a few weeks before surgery or immobilization. If the patient needs to stop using Levomine mini, they should ask their doctor when they can resume using the medicine.
• 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 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) severe liver disease and the liver is still not functioning properly;
• if the patient has (or has ever had) a liver tumor;
• 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 amenorrhea, probably caused by exercise or diet;.
• if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir (see "Levomine mini and other medicines").

Additional information for special patient groups

Use in children
The medicinal product Levomine mini is not intended for women who have not yet menstruated.
Use in elderly women
The medicinal product Levomine mini is not indicated after menopause.
Women with liver function disorders
If the patient suffers from liver disease, she should not use Levomine mini. See also "When not to use Levomine mini" and "Warnings and precautions".
Women with kidney function disorders
The patient should consult a doctor. Available data do not suggest a change in the use of Levomine mini.

Warnings and precautions

Before starting to use Levomine mini, the patient should discuss this with their doctor or pharmacist.
When should the patient contact their doctor?
The patient should contact their doctor immediately

• if the patient notices any 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 the section "How to recognize a blood clot".

The patient should tell their doctor if they have any of the following conditions.

In some situations, the patient must be particularly careful when using Levomine mini or any other combined hormonal tablet, and regular health checks by the doctor may be necessary. If any of the following diseases occur or worsen while taking Levomine mini, the patient should tell their doctor:

• if any of the patient's close relatives have (or 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 (HUS - a blood disease that can cause kidney damage);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has been found to have a high level of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia 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 just given birth, she is at increased risk of blood clots. The patient should consult their doctor for information on how soon they can start taking Levomine mini after giving birth;
• if the patient has superficial thrombophlebitis (inflammation of the veins under the skin);
• if the patient has varicose veins;
• if the patient has epilepsy (see "Levomine mini and other medicines");
• if the patient has a disease that first appeared during pregnancy or while taking sex hormones (e.g. hearing loss, porphyria (a blood disease), pemphigoid gestationis (a skin rash with blisters that occurs during pregnancy), Sydenham's chorea (a nerve disease that causes sudden body movements);

and

• if the patient has or has ever had brown spots (chloasma) on the skin, especially on the face. In this case, the patient 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, the patient should contact their 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 mini, 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 patient should contact their doctor as soon as possible for further medical advice.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Levomine mini, is associated with an increased risk of blood clots, compared to a situation where no therapy is used. 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.

It should be remembered that the total risk of harmful blood clots caused by Levomine mini is small.

HOW TO RECOGNIZE A BLOOD CLOT

The patient should contact their doctor immediately if they notice any of the following symptoms.

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:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or cyanosis Venous thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting; Pulmonary embolism

BLOOD CLOTS IN VEINS

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

The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). These side effects are rare. They most often occur in the first year of using 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 a vein the highest?

The risk of blood clots in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of 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 a situation where combined hormonal contraceptives are not used.
If the patient stops using Levomine mini, 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 total risk of developing blood clots in the legs or lungs associated with Levomine mini is small.

• Within a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• Within a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimate, such as Levomine mini, 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 Levomine mini 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). In this case, the patient may have hereditary blood clotting disorders;
• 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 using Levomine mini for a few weeks before surgery or immobilization. If the patient needs to stop using Levomine mini, they should ask their doctor when they can resume using the medicine.
• 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.
Air travel (>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 using Levomine mini.
The patient should inform their doctor if any of the above conditions change while using Levomine mini, e.g. if someone in their close family is found to have 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?

Similarly to 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 emphasize that the risk of a heart attack or stroke associated with Levomine mini is very small, but some factors can increase this risk. The risk may increase:

• with age (over about 35 years);
• if the patient smokes. While using a hormonal contraceptive like Levomine mini, 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 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 particularly severe, the risk of developing blood clots may be even higher.
The patient should inform their doctor if any of the above conditions change while using Levomine mini, e.g. if the patient starts smoking, someone in their close family is found to have a blood clot without a known cause, or if the patient gains significant weight.

Levomine mini and cancer

• -Cases of cervical cancer have been reported in women who have been taking oral contraceptives for a long time. However, this may be due to the effects of sexual behavior or other factors such as human papillomavirus (HPV).
• -The occurrence of breast cancer has been slightly more frequent in women taking combined oral contraceptives, but it is not known whether this is due to their use. The frequency of breast tumors decreases after stopping the tablets. It is essential to regularly examine your breasts and contact your doctor if you find any lump.
• -In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been found in women taking combined oral contraceptives. The patient should contact their doctor if they experience severe abdominal pain.

Irregular bleeding

During the first few months of taking Levomine mini, unexpected bleeding (bleeding outside the weekly break) may occur.
If this bleeding occurs after 3 months or if it starts after several months, the doctor must investigate the cause.

Procedure in case of no bleeding during the weekly break

If all the tablets 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.
However, if two consecutive expected bleedings have not occurred, the patient may be pregnant. The patient should contact their doctor immediately, as it is necessary to rule out pregnancy before continuing to take the tablets. The next blister can only be started if the patient is sure they are not pregnant.

Levomine mini 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.
The patient should also tell any other doctor or dentist who prescribes another medicine (or pharmacist who dispenses it) that they are taking Levomine mini. They will inform the patient whether it is necessary to use additional contraceptive methods (e.g. condoms) and for how long.
Some medicines may affect the level of Levomine mini in the blood, which may make it less effective in preventing pregnancy or may cause unexpected bleeding. This applies to:

• medicines used to treat:
• gastrointestinal motility (e.g. metoclopramide);
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate or 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, azole antifungal medicines, e.g. itraconazole, voriconazole, fluconazole);
• bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin);
• certain heart conditions, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem);
• high blood pressure in the pulmonary blood vessels (bosentan);
• rheumatoid arthritis or osteoarthritis (etoricoxib);
• herbal products containing St. John's wort (Hypericum perforatum).

The antibiotic troleandomycin used simultaneously with combined oral contraceptives may increase the risk of cholestasis.

Levomine mini 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,
• theophylline,
• tizanidine.

Levomine mini should 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 liver enzyme activity).
The doctor will suggest another type of contraception before starting these medicines.
Levomine mini can be resumed about 2 weeks after the end of treatment. See "When not to use Levomine mini".
Before using any medicine, the patient should consult their doctor or pharmacist.

Using Levomine mini with food and drink

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

Effect on laboratory tests

If laboratory tests are necessary, the patient should tell their doctor or laboratory staff that they are taking the tablets, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

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

Driving and using machines

The effect of Levomine mini on the ability to drive and use machines is not known.

Levomine mini 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 mini

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Each blister pack contains 21 tablets. On the packaging, each tablet is marked with the day of the week on which it should be taken. If, for example, the patient starts taking the medicine on a Tuesday, they should take the tablet marked "Tue". Then, the patient should continue taking the tablets in the direction of the arrows on the blister pack.
The patient should take one tablet daily 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.
Then, the patient should not take any tablets for 7 days. During these 7 days when the tablets are not taken, 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 tablet of Levomine mini, the patient should start the next blister pack, even if the bleeding has not stopped. This means that the patient 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.

Starting the first pack of Levomine mini

• If a hormonal contraceptive has not been used in the last monthThe patient should start taking Levomine mini on the first day of their cycle (i.e. the first day of menstruation). If the patient starts taking Levomine mini on the first day of menstruation, contraceptive protection is immediate. The start can also be between the 2nd and 5th day of the cycle, but in this case, the patient should use additional barrier methods (e.g. condoms) for the first 7 days.
• Changing from another combined hormonal contraceptive or a combined contraceptive patch or vaginal ringThe patient should start taking Levomine mini tablets 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 end of the break in tablet-taking or the break in using the patch or ring.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant or intrauterine device)The change from a progestogen-only pill can be made on any day (from an implant or intrauterine device - on the day of their removal, from an injection - when the next injection is scheduled), but in all these cases, the patient should use additional barrier methods (e.g. condoms) for the first 7 days of tablet-taking.
• After a miscarriage or abortion in the first trimesterThe patient should follow the doctor's instructions.
• After childbirth or abortion in the second trimesterThe patient should start taking Levomine mini tablets between the 21st and 28th day after childbirth or abortion in the second trimester. If the patient starts taking the tablets later than on the 28th day, they should use an additional barrier method (e.g. condoms) for the first 7 days of tablet-taking. If the patient has had sexual intercourse after childbirth before starting to take Levomine mini (again), they should first make sure they are not pregnant or wait for their next menstrual period.
• Breastfeeding and intention to start taking Levomine mini after childbirthSee "Breastfeeding" section.

If the patient has doubts about when to start using Levomine mini, they should contact their doctor.

Taking more than the recommended dose of Levomine mini

There are no data on the serious, harmful effects of taking too many Levomine mini 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 the patient has taken too many Levomine mini tablets or if it is suspected that a child has taken several tablets, the patient should contact their doctor or pharmacist.

Missing a dose of Levomine mini

If the delay in taking a tablet does not exceed 12 hours, contraceptive protection is not reduced. The patient should take the tablet as soon as possible and then take the next tablets 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 patient should follow these rules:

• The break in taking tablets should 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 days 1-7 of taking the medicine(see also the diagram):
The patient should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The patient should then take the tablets at the usual time and use additional barrier methods (e.g. condoms) for the next 7 days.
If the delay in taking a tablet exceeds 12 hours during days 8-14 of taking the medicine(see also the diagram):
The patient should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The patient should then take the tablets at the usual time. Contraceptive protection is not reduced, provided that the tablets have been taken correctly for the last 7 days and there is no need to use additional contraceptive methods. If the tablets have not been taken correctly, or if more than one tablet has been missed, the patient should use additional barrier methods for the next 7 days.
If the delay in taking a tablet exceeds 12 hours during days 15-21 of taking the medicine(see also the diagram):
The risk of pregnancy increases the closer it is to the usual 7-day break in taking the tablets. However, pregnancy can be prevented by adjusting the dosing.

• 1. The patient should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The rest of the tablets should be taken at the usual time. Instead of the 7-day break in taking the tablets, the patient should immediately start taking the tablets from the next 21-tablet pack. It is most likely that withdrawal bleeding will not occur until the end of the second pack, but spotting or breakthrough bleeding may occur while taking the tablets. or
• 2. The patient can also stop taking the tablets from the pack and go directly to the 7-day break, taking into account the day the tablet was missed.

If the patient misses any tablet from the pack and does not experience withdrawal bleeding during the first break, the patient may be pregnant.
Missed
tablet
(delay not
exceeding 12
hours)
The patient should take the tablet as soon as possible.
1-7 days of
taking the medicine
Did the patient have sexual intercourse in the week preceding the missed tablet?
Yes: The patient should contact their doctor.
No

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

Missed
tablet
(delay exceeding
12 hours)

• Take the missed tablet on days 8-14 (if the tablets have not been taken correctly during the first 7 days, the patient should use a barrier method of contraception for the next 7 days).
• Continue taking the tablets from the pack.
• Take the missed tablet.
• Continue taking the tablets from the pack.
• Miss the 7-day break in taking the tablets.
• Immediately start taking the tablets from the next 21-tablet pack.

15-21 days of
taking the medicine
or

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

Procedure in case of vomiting or severe diarrhea

If vomiting occurs within 3-4 hours after taking a tablet, or if the patient experiences severe diarrhea, there is a risk that the active substances contained in the tablet may not be fully absorbed into the body. This situation is almost the same as when a tablet is missed. After vomiting or diarrhea, the patient should take another tablet from the next pack as soon as possible. If possible, the patient should take the tablet within12 hours of the time when the tablet should have been taken normally.
If this is not possible or more than 12 hours have passed, the patient should follow the instructions described in the section "Missing a dose of Levomine mini".

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 mini, a doctor should be consulted.
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 mini".
The most common side effects that occur when using drugs containing ethinylestradiol and levonorgestrel are headache and spotting or intermenstrual bleeding.
Below are the side effects associated with the use of these tablets.
Common side effects (may affect up to 1 in 10 patients):

• mood changes, depression
• headache
• nausea, abdominal pain
• breast pain or 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

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/intestine, kidney, 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 a blood clot, see section 2).
Below are serious side effects that 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 mini"):

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

Below are conditions that are also associated with the use of combined hormonal contraception:
Crohn's disease, ulcerative colitis, 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 during 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, lipid metabolism disorders, a form of deafness (otosclerosis).
In women who suffer from a hereditary disease that causes sudden swelling of the skin, mucous membranes, internal organs, or brain (hereditary angioedema), the estrogen contained in the tablet may cause or worsen the symptoms of angioedema (see section 2 "Important information before taking Levomine mini").
Serious side effects
A doctor should be consulted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which may cause difficulty breathing (see also section 2 "Warnings and precautions").
A doctor or pharmacist should be informed about the serious impact of one of the listed side effects or if side effects not listed in this leaflet occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be told. 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 to gather more information on the safety of the medicine.

5. How to store Levomine mini

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. The batch number is stated on the packaging after the abbreviation "Lot".
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Levomine mini contains

The active substances of the medicine are ethinylestradiol and levonorgestrel.
Each coated tablet contains 20 micrograms of ethinylestradiol and 100 micrograms of levonorgestrel.
The medicine also contains:
Core:
Lactose monohydrate, corn starch, maltodextrin, sodium carboxymethyl cellulose (type A), magnesium stearate.
Coating:
Hypromellose 15 cP, titanium dioxide (E 171), lactose monohydrate, macrogol 4000, sodium citrate.

What Levomine mini looks like and contents of the pack

Levomine mini is available in the form of round, white, coated tablets.
Each PVC/PE/PVDC/Aluminum blister pack contains 21 coated tablets, in a carton box.
Levomine mini is available in packs containing 1 x 21, 3 x 21, and 6 x 21 tablets.

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:04.2023