Levomine mini

Package leaflet: Information for the user

Levomine mini, 20 micrograms + 100 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 use 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, 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.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Levomine mini is and what it is 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 known as "combined" tablets. Due to the low hormone content, Levomine mini is a low-dose contraceptive.

2. Important information before using Levomine mini

General remarks
Before starting to take Levomine mini, 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 to use Levomine mini, your doctor will ask 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 using Levomine mini or when its effectiveness may be reduced. In such cases, 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 mini alters body temperature and cervical mucus characteristics throughout the month.
Levomine mini, like other hormonal contraceptives, does not protect against infection with the HIV virus (AIDS) or any other sexually transmitted diseases.

When not to use Levomine mini
Do not use Levomine mini 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 use Levomine mini:

• 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 have (or have ever had) blood clots in 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, presence of factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a long time (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 have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) severe liver disease and your liver still does not function properly;
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or if there is suspicion of breast cancer or genital organ cancer;
• 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 medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section "Levomine mini and other medicines").

Additional information for special patient groups
Use in children
Levomine mini is not intended for women who have not yet started menstruating.
Use in elderly women
Levomine mini is not indicated after menopause.
Women with liver function disorders
If you suffer from liver disease, you should not use Levomine mini. See also sections "When not to use Levomine mini" and "Warnings and precautions".
Women with kidney function disorders
You should contact your doctor. Available data do not suggest any change in the use of Levomine mini.

Warnings and precautions
Before starting to use Levomine mini, discuss this with your doctor or pharmacist.
When should you contact a doctor?
You should seek immediate medical advice:

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot 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 symptoms of these serious adverse effects, see section "How to recognize the occurrence of blood clots".
You should inform your doctor if you have any of the following conditions.
In certain situations, you need to exercise particular caution when using Levomine mini or any other combined hormonal contraceptive, and regular monitoring of your health by your doctor may be necessary. Inform your doctor if any of the following conditions occur or worsen while taking Levomine mini:

• 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 (HUS – a blood disorder causing kidney damage);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have 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 long time (see section 2 "Blood clots");
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Levomine mini;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see "Levomine mini and other medicines");
• if you have a condition that first appeared during pregnancy or during previous use of sex hormones (for example, hearing loss, porphyria (a blood disorder), pemphigoid gestationis (a blistering skin rash occurring during pregnancy), Sydenham's chorea (a nerve disorder involving sudden involuntary movements));
• if you have (or have ever had) brownish patches (chloasma) called "melasma", 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, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

Psychiatric disorders
Some women using hormonal contraceptives, including Levomine mini, have reported depression or low mood. Depression can be severe and may sometimes 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 mini is associated with an increased risk of blood clots compared to not using such medication. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

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

Complete recovery after a blood clot is not always possible. 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 caused by using Levomine mini is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you notice any of the following symptoms.

Are you experiencing any of these symptoms? Likely reason
for your symptoms

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

BLOOD CLOTS IN VEINS
What can happen if blood clots form in a vein?
The use of combined hormonal contraceptives is associated with an increased risk of blood clots in 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 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 blood clots in veins the 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 a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women not using combined hormonal contraceptives.
If a woman stops taking Levomine mini, the risk of blood clots returns to normal within a few weeks.

What is the risk of developing blood clots in veins?
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 mini is low.

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

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

• if the patient has significant overweight (body mass index BMI above 30 kg/m²);
• if someone in the patient's immediate family 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 inherited clotting disorders;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue the use of Levomine mini several weeks before surgery or during immobilization. If the patient must stop taking Levomine mini, consult the doctor about when it is safe to resume treatment.
• with increasing age (particularly above 35 years);
• if the patient has given birth within the last 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 the use of Levomine mini.
Inform the doctor if any of the above conditions change during treatment with Levomine mini, for example, if someone in the immediate family is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

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

• with age (above approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Levomine mini, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another form of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the immediate 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 heart attack or stroke;
• if the patient or someone in her immediate family has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, heart rhythm disorder known 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 mini, for example, if the patient starts smoking, if someone in the immediate family is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Levomine mini and tumors

• Cases of cervical cancer have been reported in women who have used oral contraceptives for a long time. However, this may be related to behavioral sexual factors or other factors such as 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 discontinuation of the pills. It is important to regularly examine the breasts and contact a doctor if any lump is detected.
• In rare cases, benign liver tumors have been observed in women using combined oral contraceptives, and even more rarely, malignant liver tumors. Contact the treating physician if the patient experiences severe abdominal pain.

Intermenstrual 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 starts after several months, the doctor must investigate the cause.

Management if withdrawal bleeding does not occur during the weekly break
If all tablets have been taken correctly, there have been no vomiting or severe diarrhea, and no other medications have been taken, it is unlikely that the patient is pregnant.
However, if two consecutive expected withdrawal bleeds do not occur, pregnancy is possible. Contact the doctor immediately, as pregnancy must be ruled out before continuing to take the tablets. The next blister pack may only be started if the patient is certain she is not pregnant.

Levomine mini and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Also inform any other doctor or dentist who prescribes a medicine (or the pharmacist dispensing it) that the patient is taking Levomine mini. They will advise whether additional contraceptive methods (e.g. condoms) are needed and for how long they should be used.
Some medicines may affect the blood levels of Levomine mini, which may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• medicines used to treat:
• gastrointestinal motility disorders (e.g. metoclopramide);
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or 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, antifungal azole drugs such as: 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);
• arthritis, degenerative joint disease (etoricoxib);
• herbal products containing St. John's wort ( Hypericum perforatum ).

The antibiotic troleandomycin, when used concomitantly with combined oral contraceptives, may increase the risk of cholestasis.

Levomine mini 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),
• melatonin,
• theophylline,
• tizanidine.

Do not use Levomine mini 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 AlAT activity).
The doctor will recommend another form of contraception before starting these medicines.
Levomine mini may be resumed approximately 2 weeks after stopping the treatment. See section "When not to use Levomine mini".
Before taking any medicine, consult a doctor or pharmacist.

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

Effect on 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
If pregnancy occurs while taking Levomine mini, stop taking the medicine immediately and contact the doctor.
If the patient plans a pregnancy, she may stop taking Levomine mini at any time (see also section 3 "Discontinuing Levomine mini").
Before taking any medicine, consult a doctor or pharmacist.

Breastfeeding
Levomine mini is generally not recommended during breastfeeding. If the patient wishes to take tablets while breastfeeding, she should contact her doctor.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
The effect of Levomine mini on the ability to drive or operate machinery is unknown.

Levomine mini contains lactose and sodium
If the patient has been informed that she has an 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 mini

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Each blister contains 21 tablets. On the packaging, each tablet is marked with the day of the week
on which it should be taken. For example, if treatment starts on Tuesday, take the tablet marked
"Tu". Then continue following the direction of the arrows on the blister.
Take one tablet daily for 21 days, with a small amount of water if necessary. Tablets may be taken
with or without food, but they should be taken at approximately the same time each day.
Then, do not take any tablets for 7 days. During these 7 days, when no tablets are taken,
withdrawal bleeding should begin. This so-called "withdrawal bleeding" usually starts on the 2nd or 3rd
day of the weekly break.
On the 8th day after taking the last Levomine mini tablet, start a new blister pack, even if bleeding
has not stopped. This means that you should start the next blister on the same day of the week,
and withdrawal bleeding should occur on the same days each month.

Starting the first pack of Levomine mini

• If no hormonal contraceptive has been used in the previous month Start taking Levomine mini on the first day of your cycle (i.e. the first day of menstruation). If Levomine mini is started on the first day of menstruation, contraceptive protection is immediate. You may also start between day 2 and day 5 of the cycle, but in this case, use additional contraceptive methods (e.g. condoms) for the first 7 days.
• Switching from another combined hormonal contraceptive, combined vaginal ring, or transdermal patch 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 transdermal patch), but no later than the day after the tablet-free interval of the previous pack ends (or after removal of the vaginal ring or transdermal patch), or after taking the last active tablet of the previous contraceptive pack.
• Switching from a progestogen-only method (progestogen-only pill, injection, progestogen-only implant, or intrauterine system releasing progestogen) 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 – when the next injection is due). However, in all these cases, additional barrier methods (e.g. condoms) must be used for the first 7 days of tablet intake.
• After miscarriage or first-trimester termination of pregnancy Follow your doctor’s advice.
• After childbirth or second-trimester termination of pregnancy Begin taking Levomine mini tablets between days 21 and 28 after childbirth or second-trimester termination of pregnancy. If starting later than day 28, use an additional barrier method (e.g. condoms) for the first 7 days of taking Levomine mini. If sexual intercourse has occurred after childbirth and before starting Levomine mini, first confirm that you are not pregnant or wait until the next menstrual period occurs.
• Breastfeeding and intention to start Levomine mini after childbirth See section “Breastfeeding”.

If you are unsure when to start taking the medicine, consult your doctor.
Taking more than the recommended dose of Levomine mini
There are no data on serious harmful effects from taking too many Levomine mini 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 overdose of Levomine mini is taken or if a child has accidentally ingested tablets, consult your
doctor or pharmacist immediately.
Missing a dose of Levomine mini
If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the
missed tablet as soon as possible, and continue taking the following tablets at the 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 guidelines:

• The tablet-free interval must never exceed 7 days.
• At least 7 consecutive 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.
Resume taking tablets at the usual time and use additional contraception (e.g. condoms) 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 greater the number of missed tablets and the closer to the usual tablet-free
interval, the higher the chance 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.
Resume taking tablets at the usual time. Contraceptive protection is not reduced, provided that
tablets have been taken correctly for the previous 7 days. There is no need to use additional
contraceptive methods. If tablets have not been taken correctly or more than one tablet has been
missed, use additional contraception 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 it is 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 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 the remaining tablets at the usual time. Instead of the usual 7-day tablet-free interval, proceed directly to the next 21-tablet blister pack. Withdrawal bleeding is unlikely to occur until the end of the second blister, but spotting or breakthrough bleeding may occur during tablet intake.
   or
2. Alternatively, stop taking tablets from the current blister and proceed directly to the 7-day tablet-free interval, counting the day the tablet was missed as day 1 of the break.

If any tablet from the blister has been missed and no bleeding occurs during the first tablet-free
interval, this may indicate pregnancy.

Missed tablet
(delay less than 12 hours)
Take the missed tablet as soon as possible.

Did the patient have sexual intercourse in the 7 days before missing the tablet?
Yes: Consult your doctor.
No

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

Missed tablet
(days 8–14, delay exceeding 12 hours)

• Take the missed tablet.
• If tablets were not taken correctly in the previous 7 days, use a barrier method for the next 7 days.
• Continue taking tablets from the blister.

Missed tablet
(days 15–21)
Option 1:

• Take the missed tablet.
• Continue taking tablets from the blister.
• Skip the 7-day tablet-free interval.
• Immediately start the next 21-tablet blister pack.

or
Option 2:

• Immediately stop taking tablets.
• Begin a 7-day tablet-free interval (not longer than 7 days, including the day the tablet was missed).
• Then start the next blister.

What to do if vomiting or severe diarrhoea occurs
If vomiting or severe diarrhoea occurs 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 the next blister 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 if more than
12 hours have passed, follow the instructions under “Missing a dose of Levomine mini”.
Delayed withdrawal bleeding: what you should know
Although not recommended, it is possible to delay withdrawal bleeding by immediately starting a
new blister of Levomine mini instead of observing the tablet-free interval, continuing until the pack
is finished. During the second blister, spotting (small drops or stains of blood) or breakthrough
bleeding may occur. After finishing the second blister, observe a 7-day tablet-free interval.
If you plan to delay the onset of withdrawal bleeding, consult your doctor for advice.
Changing the first day of withdrawal bleeding: what you should know
If you wish to change the day on which withdrawal bleeding occurs, shorten the tablet-free interval.
The shorter the tablet-free interval, the greater the risk that no bleeding will occur during the break.
Later, light spotting or breakthrough bleeding may occur. The tablet-free interval must never be
extended.
Stopping Levomine mini
You may stop taking Levomine mini at any time. If you do not wish to become pregnant, consult your
doctor for advice on other reliable contraceptive methods. If you wish to become pregnant, stop
taking Levomine mini and wait for a menstrual period before trying to conceive. This will help to
calculate the due date more accurately.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health which the patient considers to be related to the use of Levomine mini, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the 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 mini".

The most commonly reported adverse effects during treatment with medicines containing ethinylestradiol and levonorgestrel are headache, spotting or intermenstrual bleeding.

The following adverse effects are associated with the use of these tablets:

Common adverse effects (may affect up to 1 in 10 women):

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

Uncommon adverse effects (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

Rare adverse effects (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 lung (pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidney or eye

The risk of blood clots increases if the patient has other risk factors for 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 effects have been reported slightly more frequently in women using oral contraceptive tablets, but it is not known whether they are caused by their use (see section 2: "Important information before taking Levomine mini"):

• 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
• 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 gestationis in late pregnancy
• Sydenham's chorea (sudden involuntary jerks or seizures)
• haemolytic uraemic syndrome (a condition occurring after diarrhoea caused by E. coli infection)
• liver disorders manifesting as jaundice
• lipid metabolism disorders
• hearing loss (otosclerosis)

In women suffering from a hereditary disease causing sudden swelling of the skin, mucous membranes, internal organs or brain (hereditary angioedema), the oestrogen contained in the tablet may trigger or worsen angioedema symptoms (see section 2, "Important information before taking Levomine mini").

Serious adverse effects

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 breathing difficulties (see also section 2, "Warnings and precautions").

Inform your doctor or pharmacist if you experience a serious effect from any of the adverse effects listed above, or if you experience any adverse effects not listed in this package leaflet.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Levomine mini

Keep this 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 stated month. The batch number is indicated on the packaging following the abbreviation "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Levomine mini contains
The active substances in this medicinal product are ethinylestradiol and levonorgestrel.
Each coated tablet contains 20 micrograms of ethinylestradiol and 100 micrograms of levonorgestrel.

The other ingredients are:
Tablet core:
Monohydrate lactose, corn starch, maltodextrin, sodium carboxymethyl starch (type A), magnesium stearate.
Tablet coating:
Hypromellose 15 cP, titanium dioxide (E 171), monohydrate lactose, macrogol 4000, sodium citrate.

What Levomine mini looks like and contents of the pack
Levomine mini is a round, white coated tablet.
Each blister pack made of PVC/PE/PVDC/Aluminium contains 21 coated tablets, packed in a cardboard box.
Levomine mini is available in packs containing 1 x 21, 3 x 21, and 6 x 21 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Poland

Manufacturer
mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna
Germany