Asubtela

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Asubtela (Etindros)

3 mg + 0.03 mg, coated tablets

Drospirenonum + Ethinylestradiolum
Asubtela and Etindros are different trade names for the same drug.

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 a blood clot have occurred (see section 2 "Blood clots")

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this 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 Asubtela and what is it used for

2. Important information before using Asubtela

3. How to use Asubtela

4. Possible side effects

5. How to store Asubtela

6. Contents of the packaging and other information

1. What is Asubtela and what is it used for

Asubtela is a contraceptive pill used to prevent pregnancy.
Each pill contains a small amount of two different female hormones: drospirenone and ethinylestradiol.
Contraceptive pills containing two hormones are called "combined" pills.

2. Important information before using Asubtela

General notes

Before starting to take Asubtela, 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 Asubtela, the doctor will ask a few questions about your health and the health of your close relatives. The doctor will also measure your blood pressure and, depending on the individual case, may also perform some other tests.
This leaflet describes several situations in which you should stop using Asubtela or in which the effectiveness of Asubtela may be reduced.
In such situations, you should not have sexual intercourse or use additional non-hormonal contraceptive products, such as condoms or other mechanical methods.
During this time, you should also not use the calendar method or the temperature method. These methods may be unreliable because Asubtela modifies the monthly changes in body temperature and cervical mucus.

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

When not to use Asubtela:

Asubtela should not be used 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.

• if the patient is allergic to ethinylestradiol or drospirenone 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) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows that they have a blood clotting disorder - for example, deficiency of protein C, protein S, antithrombin III, presence of factor V Leiden or antiphospholipid antibodies;
• if the patient needs to have 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 Asubtela for several weeks before surgery or immobilization. If the patient must stop using Asubtela, they should ask their doctor when they can resume using the medicine.
• if the patient has (or has ever had) a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• 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) migraine (with so-called focal neurological symptoms);
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) pancreatitis;
• if the patient has (or has had in the past) liver disease and

liver function has not yet returned to normal;

• if the patient's kidneys do not work properly (renal failure);
• if the patient has (or has had in the past) liver cancer;
• if the patient has currently (or has ever had) breast cancer or genital cancer;
• if the patient has any vaginal bleeding of unknown cause;
• if the patient has liver disease type C and is taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir (see "Asubtela and other medicines").

Additional information for special patient groups

Children and adolescents
Asubtela is not indicated for use in patients who have not yet had their first menstrual period.

Warnings and precautions

When to exercise special caution when using Asubtela

When should you contact your doctor?
You should contact your doctor immediately

• if you notice any of the following symptoms, which could indicate that you have a blood clot in your leg (deep vein thrombosis), lung (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".

You should tell your doctor if you have any of the following conditions.

If symptoms occur or worsen while using Asubtela, you should also tell your doctor. If you are using Asubtela or other oral contraceptives in any of the following situations, regular medical check-ups are necessary.
Before starting to use Asubtela, you should discuss this with your doctor:

• if a close relative has had breast cancer or has had it in the past
• if you have cancer
• if you have liver disease (such as bile duct obstruction, which can cause jaundice or itching) or gallstones (such as gallstones)
• if you have other kidney problems and are taking medicines that increase potassium levels in the blood
• if you have diabetes
• if you have depression
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases)
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system)
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure)
• if you have a blood disease called sickle cell anemia (a hereditary disease of red blood cells)
• if you have a family history of high levels of fats in the blood (hypertriglyceridemia) or have had it yourself. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis.
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots")

and

• if you have just given birth, you are at increased risk of blood clots. You should contact your doctor to find out how soon you can start taking Asubtela after giving birth
• if you have superficial thrombophlebitis (blood clots in the veins under the skin)
• if you have varicose veins
• if you have epilepsy (see "Asubtela and other medicines")
• if you have a disease that first occurred during pregnancy or while using hormonal contraceptives (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters that occurs during pregnancy (pregnancy pemphigoid), a neurological disease that causes uncontrolled body movements (Sydenham's chorea))
• if you have high blood pressure that is not well controlled by medicines
• if you have or have had chloasma (skin discoloration, especially on the face and neck, also known as "pregnancy spots"). In this case, you should avoid direct exposure to sunlight and ultraviolet radiation.
• if you have hereditary angioedema, estrogen-containing products may cause or worsen the symptoms of angioedema. If symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, you should see a doctor immediately.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Asubtela, is associated with an increased risk of blood clots, compared to not using these products. 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 occlusion").

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It is essential to remember that the overall risk of a blood clot caused by Asubtela is small.

HOW TO RECOGNIZE A BLOOD CLOT
You should contact your doctor immediately if you notice any of the following symptoms.
Are you 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;

which may be felt when standing or walking;

• increased temperature in the affected leg;
• change in the color of the leg skin, such as pallor, redness, or cyanosis.
• sudden unexplained shortness of breath or rapid breathing; 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). Although these side effects are rare, they can occur, especially 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 breaks loose from the leg and lodges 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 highest?

The risk of forming a blood clot 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 not using combined hormonal contraceptives.
If the patient stops using Asubtela, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Asubtela, 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" and "Factors that increase the risk of blood clots in arteries", below).

Factors that increase the risk of blood clots in veins

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

• if the patient is overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have 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 Asubtela for several weeks before surgery or immobilization. If the patient must stop using Asubtela, they should ask their doctor when they can resume using the medicine.
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (>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 Asubtela.
The patient should inform the doctor if any of the above conditions change while using Asubtela, e.g., if someone in their immediate family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Like blood clots in veins, blood clots in arteries can cause serious complications, 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 a heart attack or stroke associated with Asubtela is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. While using a hormonal contraceptive like Asubtela, it is recommended to quit smoking. If the patient is unable to quit 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 immediate family has had a heart attack or stroke at a young age (under 50 years old). 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 immediate 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 severe, the risk of blood clots may be even higher.
The patient should inform the doctor if any of the above conditions change while using Asubtela, e.g., if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain weight significantly.

Asubtela and cancer

Women using combined hormonal contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by these medicines. It is possible that more tumors are detected in women using hormonal contraceptives because they are examined by a doctor more often.
The incidence of breast cancer decreases gradually after stopping the use of combined hormonal contraceptives.
It is essential to regularly examine your breasts and contact your doctor if you find any lumps.
Women using combined hormonal contraceptives have, in rare cases, been diagnosed with benign liver tumors, and in even rarer cases, malignant liver tumors.
The patient should contact their doctor if they experience severe abdominal pain or notice swelling of the abdomen (which may be caused by liver enlargement), vomiting blood, or black tarry stools (which may be symptoms of stomach bleeding).

Psychiatric disorders:

Some women using hormonal contraceptives, including Asubtela, 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.

Irregular bleeding

During the first few months of using Asubtela, unexpected bleeding (outside of the weekly break) may occur. If bleeding occurs for longer than the first few months or if it occurs after several months, the patient should contact their doctor, who must determine the cause.

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

If all the pills were taken correctly, there was no vomiting or severe diarrhea, and the patient did not take any other medicines, it is unlikely that they are pregnant.
If two consecutive withdrawal bleedings do not occur, the patient may be pregnant. In this case, they should contact their doctor immediately. Before starting the next pack of Asubtela, they should rule out pregnancy.

Asubtela and other medicines

The patient should always tell their doctor about all medicines or herbal products they are currently taking or have recently taken, as well as any medicines they plan to take. They should also inform any other doctor or dentist prescribing another medicine (or pharmacist) that they are using Asubtela. They may say whether the patient should use additional contraceptive products (e.g., condoms) and for how long.
Asubtela should not be used in patients with liver disease type C who are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir, as this may cause liver function test abnormalities (elevated liver enzyme alanine aminotransferase (ALT)).
The doctor will recommend using a different contraceptive method before starting these medicines.
Asubtela can be used again after about 2 weeks after stopping these medicines.
See section "When not to use Asubtela".

• Certain medicines may make Asubtela less effective in preventing pregnancy or may cause unexpected bleeding or spotting. These include:
• medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate)
• medicines used to treat tuberculosis (e.g., rifampicin)
• medicines used to treat HIV or hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• medicines used to treat fungal infections (e.g., griseofulvin, ketoconazole)
• medicines used to treat arthritis, degenerative joint disease (etoricoxib)
• medicines used to treat high blood pressure in the lungs (bosentan)
• herbal products containing St. John's Wort (Hypericum perforatum)

If the patient is taking any of the above medicines with Asubtela, they should use additional contraceptive methods (e.g., condoms) during and for 28 days after stopping the above medicines.
Asubtela may affect the action of other medicines, such as:

• medicines containing cyclosporin
• antiepileptic medicines, lamotrigine (this may lead to an increased frequency of seizures)
• theophylline (used for breathing problems)
• tizanidine (used to treat muscle pain and/or muscle spasms)

The doctor may recommend monitoring potassium levels in the blood if the patient has heart disease and is taking certain medicines (e.g., diuretics).

Lab tests

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

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant should not use Asubtela. If the patient becomes pregnant while using Asubtela, they should stop using the medicine immediately and contact their doctor.
If the patient plans to become pregnant, they can stop using Asubtela at any time (see also "Stopping Asubtela").
Breastfeeding
It is generally not recommended to use Asubtela during breastfeeding. If the patient wants to use a contraceptive during breastfeeding, they should consult their doctor.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

There is no information to suggest that using Asubtela affects the ability to drive or use machines.

Asubtela contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to use Asubtela

This medicine should always be used as directed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
One Asubtela tablet should be taken every day, if necessary with a small amount of water. The tablets can be taken with or without food, but they should be taken at the same time every day.
One blister pack contains 21 tablets. The day of the week is printed next to each tablet. If, for example, the patient starts taking the medicine on a Wednesday, they should take the tablet with "Trečiadienis/Trešdiena" (Wednesday) printed next to it (see "Translation of day names on the packaging" at the end of the leaflet). The tablets should be taken in the direction indicated by the arrows on the blister pack until all 21 tablets have been taken.
Then, the patient should not take any tablets for 7 days. During this 7-day break (also called the withdrawal bleed), bleeding should occur. The bleeding, also known as "withdrawal bleeding", usually starts on the 2nd or 3rd day of the break.
On the 8th day after taking the last Asubtela tablet (i.e., after the 7-day break), 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 the bleeding should occur on the same day every month.
If the patient is taking Asubtela as directed, they will also be protected from pregnancy during the 7-day break.

When can the first pack be started?

• If no hormonal contraceptive has been used in the previous monthThe patient can start taking Asubtela on the first day of their menstrual cycle (i.e., on the first day of their period). If the patient starts using Asubtela on the first day of their period, they will be immediately protected from pregnancy. The patient can also start taking the medicine from the 2nd to the 5th day of their cycle, but they will need to use additional contraceptive methods (e.g., condoms) for the first 7 days.
• They can start taking the medicine from the 2nd to the 5th day of their cycle, but they will need to use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Changing from a combined hormonal contraceptive or a vaginal ring or transdermal patchThe patient should start taking Asubtela the next day after taking the last active tablet (the last tablet containing the active substances) of their previous contraceptive, but no later than the day after the break in taking the previous tablets (or after taking the last inactive tablet of the previous medicine). When changing from a vaginal ring or transdermal patch, the patient should start taking Asubtela on the day the previous ring or patch is removed, but no later than the day the next ring or patch would have been applied.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS))The change from a progestogen-only pill can be made at any time (from an implant or IUS on the day of its removal; from injections when the next injection would have been due) but in all cases, additional contraceptive methods (e.g., condoms) should be used for the first 7 days of tablet-taking.
• After a miscarriageThe patient should follow their doctor's advice.
• After childbirthThe patient can start taking Asubtela between the 21st and 28th day after giving birth. If the patient starts taking the medicine more than 28 days after giving birth, they should use a barrier method (e.g., condoms) for the first 7 days of taking Asubtela. If the patient has had sexual intercourse after giving birth before starting to use Asubtela again, they should first make sure they are not pregnant or wait for their next menstrual period.
• If the patient is breastfeeding and wants to start taking Asubtela again after giving birthSee section "Breastfeeding".

If the patient is unsure when to start taking Asubtela, they should consult their doctor.

What to do if too much Asubtela is taken

There are no reports of serious harmful effects from taking too many Asubtela tablets at once.
If the patient has taken too many tablets, they may experience nausea or vomiting. In young girls, vaginal bleeding may occur.
If the patient has taken too much Asubtela or thinks a child has swallowed some tablets, they should contact their doctor or pharmacist.

Missing a dose of Asubtela

• If it has been less than 12 hourssince the missed tablet, the protection from pregnancy is not reduced. The patient should take the missed tablet as soon as they remember and take the next tablets at the usual time.
• If it has been more than 12 hourssince the missed tablet, the protection from pregnancy may be reduced. The more tablets that are missed, the higher the risk of pregnancy.

The risk of reduced protection from pregnancy is highest if a tablet is missed at the beginning or end of the pack. Therefore, the patient should follow the instructions below (see also the diagram below):

More than one tablet is missed from the blister pack

The patient should contact their doctor.

A tablet is missed in week 1.

The patient should take the missed tablet as soon as they remember and take the next tablets at the usual time, even if it means taking two tablets at the same time. The patient should also use additional protection(e.g., condoms) for the next 7 days. If the patient had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, the patient should contact their doctor.

A tablet is missed in week 2.

The patient should take the missed tablet as soon as they remember and take the next tablets at the usual time, even if it means taking two tablets at the same time. The patient should also use additional protection(e.g., condoms) for the next 7 days.

A tablet is missed in week 3.

There are two options to choose from:

• 1. The patient should take the missed tablet as soon as they remember and take the next tablets at the usual time, even if it means taking two tablets at the same time. Instead of the weekly break, the patient should start the next blister pack immediately.

Most likely, bleeding will occur at the end of the second pack, but the patient may also experience spotting or bleeding while taking the tablets from the second pack.

• 2. The patient can also stop taking the tablets from the current pack and start the 7-day break ( the patient should note the day they missed the tablet). If the patient wants to start the new pack on the day they usually start, the break should be less than 7 days.

If the patient follows one of the above instructions, the protection from pregnancy will be maintained.

• If the patient misses any tablets from the current pack and does not experience withdrawal bleeding during the break, they may be pregnant. In this case, the patient should consult their doctor before starting the next pack.

A diagram shows how to proceed in case of a missed tablet (tablets):
Missed more than
Contact your doctor for advice
1 tablet from
1 pack
Yes
Did you have sex in the week before missing the tablet?
In week 1.
No

• Take the missed tablet
• Use a barrier method (condoms) for the next 7 days and
• Finish the current pack

Missed only
one tablet
(taken after
12 hours)

• Take the missed tablet
• Finish the current pack In week 2.
• Take the missed tablet and
• Finish the pack
• Instead of the weekly break, start the next pack immediately

or
In week 3

• Stop taking the tablets from the current pack immediately
• Start the 7-day break (not more than 7 days, including the day the tablet was missed)
• Start the next pack

What to do if vomiting or severe diarrhea occurs

If vomiting or severe diarrhea occurs within 3-4 hours after taking a tablet, there is a risk that the active substances in the tablet may not have been fully absorbed into the body, which may require the use of additional protection (e.g., condoms) to prevent pregnancy. The situation is almost the same as if a tablet is missed. After vomiting or diarrhea, the patient should take another tablet from the spare pack as soon as possible. If possible, the patient should take the tablet within 12 hoursof the usual time of taking the tablet. If this is not possible or if more than 12 hours have passed, the patient should follow the instructions in the section "Missing a dose of Asubtela".

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 to be related to the use of Asubtela, you should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before taking Asubtela".

In case of the following side effects, immediate medical attention is necessary. You should stop taking Asubtela and immediately contact a doctor or go to the nearest hospital.

Rare side effects(may occur in up to 1 in 1000 people):

• allergic reactions (with symptoms such as: swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives with accompanying breathing difficulties)
• harmful blood clots in a vein or artery, for example: o in the leg or foot (e.g., deep vein thrombosis) o in the lungs (e.g., pulmonary embolism) o heart attack o stroke o mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack o blood clots in the liver, stomach, and/or intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).
Diseases that may occur or worsen during pregnancy or previous tablet use:

• systemic lupus erythematosus (SLE, a disease affecting the immune system)
• inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) with symptoms such as bloody diarrhea, pain during bowel movements, abdominal pain
• epilepsy
• uterine fibroids (a non-cancerous tumor that grows in the muscle tissue of the uterus)
• porphyria (a blood disorder)
• herpes gestationis (a skin rash that occurs during pregnancy)
• Sydenham's chorea (a nerve disorder characterized by sudden movements of the body)
• certain blood diseases that cause kidney damage (hemolytic-uremic syndrome with symptoms such as decreased urine output, blood in the urine, decreased red blood cell count, nausea, vomiting, disorientation, and diarrhea)
• jaundice or discoloration of the skin and whites of the eyes due to bile duct obstruction (cholestatic jaundice).

Additionally, breast cancer (see section 2 "Asubtela and tumors") and non-cancerous (benign) and cancerous (malignant) liver tumors (with symptoms such as abdominal swelling, weight loss, liver function disorders, which may be visible in blood tests) and chloasma (yellow-brown spots on the skin, especially the face, so-called "pregnancy spots") have been observed, which may be a permanent change, especially in women who have had chloasma during pregnancy.

Other possible side effects

Common side effects(may occur in up to 1 in 10 people):

• depressive mood
• headache
• migraine
• nausea
• menstrual disorders, intermenstrual bleeding, breast tenderness, breast pain
• thick, white vaginal discharge and vaginal yeast infection.

Uncommon side effects(may occur in up to 1 in 100 people):

• breast enlargement, decreased libido
• high blood pressure, low blood pressure
• vomiting, diarrhea
• acne, skin rash, severe itching, hair loss (alopecia)
• vaginal infection
• fluid retention, weight loss or weight gain.

Rare side effects(may occur in up to 1 in 1000 people):

• allergic reactions (hypersensitivity), asthma
• hearing loss
• skin disorders: erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (a rash with redness resembling targets or gunshot wounds)
• breast discharge
• harmful blood clots in a vein or artery, for example: o in the leg or foot (e.g., deep vein thrombosis) o in the lungs (e.g., pulmonary embolism) o heart attack o stroke o mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack o blood clots in the liver, stomach, and/or intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If any side effects occur, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Asubtela

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use Asubtela after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Asubtela contains

• The active substances are ethinylestradiol 0.03 mg and drospirenone 3 mg.
• The other ingredients are: Core of the tablet: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K 30, crospovidone, polysorbate 80, magnesium stearate.

Coating of the tablet: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), ,
macrogol 3350 ,talc ,yellow iron oxide (E 172).

What Asubtela looks like and what the pack contains

Yellow, round, film-coated tablets with a diameter of about 5.7 mm.
Asubtela is available in packs containing 1 or 3 blister packs, each containing 21 tablets.
A cardboard wallet is included with the packaging, in which the blister pack should be placed.
For more detailed information, you should contact your doctor, the marketing authorization holder, or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

UAB "Exeltis Baltics"
Islandijos pl. 209A
Kaunas, LT-49163
Lithuania

Manufacturer:

Laboratorios León Farma, S.A.
C/ La Vallina s/n
Pol. Ind. Navatejera
24008 Villaquilambre – Leon
Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Lithuania, the country of export:LT/1/10/1891/006
Parallel import authorization number:338/21

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Jangee 0.03 mg/3 mg Filmtabletten
Bulgaria
Jangee 0.03 mg/3 mg филмирани таблетки
Denmark
Movinella filmovertrukne tablet
Estonia
Jangee 0.03 mg/3 mg ohukese polümeerikilega kaetud tablett
Greece
Estrofix 0.03 mg/3 mg δισκίο επικαλυμμένο με λεπτή μεμβράνη
Spain
Drosurelle 0,03 mg/3 mg comprimidos recubiertos con película EFG
Ireland
Ethinylestradiol/Drospirenone Leon Farma 0.03 mg/3 mg film coated tablets
Lithuania
Etindros 0.03 mg/3 mg plėvele dengtos tabletės
Latvia
Etindros 0.03 mg/3 mg apvalkotās tabletes
Poland
Asubtela
Portugal
Drospirenona + Etinilestradiol Generis 3 mg + 0.03 mg Comprimidos revestidos por película
Romania
Jolina 0.03 mg/3 mg comprimate filmate
Slovakia
KarHla
Slovenia
Etindros 0.03 mg/3 mg filmsko obložene tablete
Hungary
Jangee 3 mg/0.03 mg filmtabletta

Translation of the day of the week designations on each tablet on the immediate packaging:

Pirmadienis/Pirmdiena

• Monday Antradienis/Otrdiena
• Tuesday Trečiadienis/Trešdiena
• Wednesday Ketvirtadienis/Ceturtdiena
• Thursday Penktadienis/Piektdiena
• Friday Šeštadienis/Sestdiena
• Saturday Sekmadienis/Svētdiena
• Sunday

Date of approval of the leaflet: 16.02.2022
[Information about the trademark]