Asubtela

Leaflet accompanying the packaging: patient information

Asubtela 3 mg + 0.03 mg film-coated tablets

Drospirenone + Ethinylestradiol

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

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific 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

1/19

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 contraceptives, 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, as 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:

You should not use Asubtela if you have any of the conditions listed below.
If you have any of the conditions listed below, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable.

• if you are 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 you have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know that you have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop using Asubtela for a few weeks before surgery or immobilization. If you need to stop using Asubtela, you should ask your doctor when you can resume using the medicine.
• if you have (or have ever had) a heart attack or stroke;
• if you have (or have 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 (transient stroke symptoms);
• if you have 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

2/19

• if you have (or have ever had) migraine (with so-called focal neurological symptoms);
• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have ever had) pancreatitis;
• if you have (or have had in the past) liver disease and liver function has not yet returned to normal;
• if your kidneys do not work properly (renal failure);
• if you have (or have ever had) liver cancer;
• if you currently have or have had a diagnosis or suspicion of breast cancer or genital cancer;
• if you have any vaginal bleeding of unknown cause. You should not use Asubtela if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir (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 symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)"). To get a description of the serious side effects listed, 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
• 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

3/19

• 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 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 you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots")
• if you are immediately after childbirth, you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start taking Asubtela after childbirth
• 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 sex hormones (e.g. hearing loss, a blood disease called porphyria, a skin rash with blisters that occurs during pregnancy (pregnancy pemphigoid), a nervous system 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 ever 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 experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives with difficulty breathing, you should contact your doctor immediately. Estrogen-containing medicines may cause or worsen symptoms of hereditary or acquired angioedema.

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 thrombosis").

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 overall risk of serious blood clots 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.
4/19
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;

increased temperature in the affected leg;

• change in skin color of the leg, such as pallor, redness, or cyanosis.
• sudden onset of unexplained shortness of breath or rapid breathing;
• sudden onset of coughing without an obvious cause, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, you should contact your doctor,
because some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g. a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, tightness;
• feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack

Stroke

• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body; 5/19

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

• sudden confusion, speech or understanding disturbances;
• sudden vision disturbances in one or both eyes;
• sudden walking, dizziness, loss of balance, or coordination disturbances;
• sudden, severe, or prolonged headaches without a known cause;
• loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be transient with almost immediate and complete recovery, however, you should contact your doctor immediately, as you may be at risk of having another stroke.

• swelling and slight bluish discoloration of the skin of the legs or arms;
• severe abdominal pain. Blood clots blocking other blood vessels

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 of 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 you stop 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", 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 you are overweight (body mass index (BMI) over 30 kg/m);
• if someone in your 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, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop using Asubtela for a few weeks before surgery or immobilization. If you need to stop using Asubtela, you should ask your doctor when you can resume using the medicine.
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul 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 your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop using Asubtela.
7/19
You should inform your doctor if any of the above conditions change while using Asubtela, e.g. if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

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 heart attack or stroke associated with Asubtela is very small, but some factors can increase this risk. The risk is higher:

• with age (over about 35 years old);
• if you smoke.While using a hormonal contraceptive like Asubtela, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while using Asubtela, e.g. if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you 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, for example, that more breast cancers are detected in women using hormonal contraceptives because they are examined by a doctor more often. The frequency 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.
You should contact your doctor if you experience severe abdominal pain or notice swelling of the abdomen (which may be caused by liver enlargement), vomiting blood, blood in the stool, 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, you should contact your 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, you should contact your doctor, who will 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 you did not take any other medicines, it is unlikely that you are pregnant.
If two consecutive withdrawal bleedings do not occur, you may be pregnant. In this case, you should contact your doctor immediately. Before starting the next pack of Asubtela, you should rule out pregnancy.

Asubtela and other medicines

You should always tell your doctor about all medicines or herbal products you are currently taking or have recently taken, as well as any medicines you plan to take. You should also inform any other doctor or dentist prescribing another medicine (or pharmacist) that you are using Asubtela. They may tell you whether you should use additional contraceptives (e.g. condoms) and for how long.
Asubtela should not be used in patients with hepatitis C who are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased liver enzyme activity). Before starting these medicines, your doctor will prescribe a different contraceptive method.
You can start taking Asubtela again about 2 weeks after finishing the above treatment. See the 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)
• tuberculosis (e.g. rifampicin)

9/19

• HIV or hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g. griseofulvin, ketoconazole)
• arthritis, degenerative joint disease (etoricoxib)
• high blood pressure in the blood vessels of the lungs (bosentan)
• herbal products containing St. John's Wort (Hypericum perforatum)

If you are taking any of the above medicines at the same time as Asubtela, you should use additional contraceptive methods (e.g. condoms) during and for 28 days after stopping these 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).

Your doctor may order a potassium level test if you have heart disease and are taking certain medicines (e.g. diuretics).

Laboratory tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you 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 you become pregnant while using Asubtela, you should stop using the medicine immediately and contact your doctor.
If you plan to become pregnant, you can stop using Asubtela at any time (see also "Stopping Asubtela").
Breastfeeding
Asubtela is not recommended during breastfeeding. If you want to use a contraceptive during breastfeeding, you should consult your doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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 you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.
10/19

3. How to use Asubtela

This medicine should always be used as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
One Asubtela tablet should be taken daily, 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, you start taking the medicine on a Wednesday, you should take the tablet with "WED" printed next to it. The tablets should be taken in the direction indicated by the arrows on the blister pack until all 21 tablets have been taken.
Then, you should not take any tablets for 7 days. During this 7-day break (also called the weekly break), you should experience bleeding. Bleeding, also called "withdrawal bleeding", usually starts on the 2nd or 3rd day of the weekly break.
On the 8th day after taking the last Asubtela tablet (i.e. after the 7-day break), you should start a new blister pack, even if the bleeding has not stopped. This means that you should start a new blister pack on the same day of the week as before, and the bleeding should occur on the same day every month.
If you are taking Asubtela as directed, you will also be protected against pregnancy during the 7-day break.

When can you start the first pack?

• If you have not used any hormonal contraceptives in the previous monthYou can start taking Asubtela on the first day of your menstrual cycle (i.e. on the first day of your period). If you start taking Asubtela on the first day of your period, you will be immediately protected against pregnancy. You can also start taking the medicine from the 2nd to the 5th day of your cycle, but you should use additional contraceptive methods (e.g. condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a vaginal ring or a transdermal patchYou should start taking Asubtela on the day after taking the last active tablet (the last tablet containing active substances) of your previous contraceptive, but no later than the day after the break in taking your previous tablets (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal ring or a transdermal patch, you should start taking Asubtela on the day the ring or patch is removed, but no later than the day the next ring or patch would have been applied.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS))You can switch from a progestogen-only pill at any time (from an implant or IUS on the day it is removed; from injections when the next injection would have been due) but in all cases, it is recommended to use additional contraceptive methods (e.g. condoms) for the first 7 days of taking Asubtela.

11/19
You should consult your doctor if you are unsure when to start taking Asubtela.

• After a miscarriageYou should follow your doctor's advice.
• After childbirthYou can start taking Asubtela between the 21st and 28th day after giving birth. If you start taking the medicine later than 28 days after giving birth, you should use a mechanical method (e.g. condoms) for the first 7 days of taking Asubtela. If you have had sexual intercourse after giving birth before starting to use Asubtela again, you should first make sure that you are not pregnant or wait for your next menstrual period.
• If you are breastfeeding and want to start taking Asubtela again after giving birthSee the section "Breastfeeding".

If you are unsure when to start taking Asubtela, you should consult your doctor.

What to do if you take more Asubtela than you should

There are no reports of serious harmful effects from taking too many Asubtela tablets at once.
If you have taken too many tablets, you may experience nausea or vomiting. In young girls, vaginal bleeding may occur.
If you have taken too many Asubtela tablets or think that a child has swallowed some tablets, you should contact your doctor or pharmacist.

What to do if you miss a dose of Asubtela

• If it has been less than 12 hourssince you missed a tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as you remember and take the next tablets at the usual time.
• If it has been more than 12 hourssince you missed a tablet, your protection against pregnancy may be reduced. The more tablets you have missed, the higher the risk of pregnancy.

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

You have missed more than one tablet in the pack

You should contact your doctor.

You have missed one tablet in week 1.

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

You have missed one tablet in week 2.

You should take the missed tablet as soon as you remember, even if it means taking two tablets at once. Take the next tablets at the usual time. Your protection against pregnancy has not been reduced, and you do not need to use additional protection.

You have missed one tablet in week 3.

There are two options to choose from:

• 1. Take the missed tablet as soon as you remember, even if it means taking two tablets at once. Take the next tablets at the usual time. Instead of the weekly break, start the next pack immediately.

It is likely that bleeding will occur at the end of the second pack, but you may also experience spotting or bleeding while taking the tablets from the second pack.

• 2. You can also stop taking the tablets from the current pack and start the 7-day break immediately ( you should note the day you missed the tablet). If you want to start the next pack on the day you usually start taking the tablets, the break should be less than 7 days.

If you follow one of the above instructions, your protection against pregnancy will be maintained.

• If you have missed any tablets from the current pack and do not experience withdrawal bleeding during the break, you may be pregnant. In this case, you should consult your doctor before starting the next pack.

13/19
The diagram shows what to do if you miss a tablet (tablets):
14/19

What to do if you vomit or have severe diarrhea

If vomiting or severe diarrhea occur within 3-4 hours of 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 result in the need for additional protection (e.g. condoms) to prevent pregnancy. The situation is almost the same as if you had missed a tablet. After vomiting or diarrhea, you should take another tablet from the spare pack as soon as possible. If possible, you 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, you should follow the instructions described in the section "What to do if you miss a dose of Asubtela".

Delaying withdrawal bleeding: what you need to know

Although it is not recommended, you can delay withdrawal bleeding by starting a new pack of Asubtela immediately, without taking the weekly break, until the pack is finished. While taking the tablets from the second pack, you may experience spotting or bleeding.
Before deciding to delay withdrawal bleeding, you should consult your doctor.

Changing the first day of withdrawal bleeding: what you need to know

If you are taking the tablets as directed, bleeding will start during the weekly break. If you need to change this day, you should shorten ( but never extend - 7 days is the maximum length of the break!) the break in taking the tablets. For example, if the break starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start the new pack 3 days earlier than usual. If you significantly shorten the break, you may not experience withdrawal bleeding during that time. You may experience spotting or bleeding instead.
If you are unsure what to do, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Asubtela, a doctor should be consulted.
15/19
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 thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important information before using Asubtela".

In case of the following side effects, immediate medical attention is required. Use of Asubtela should be discontinued and a doctor or the nearest hospital should be contacted immediately.

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

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

• 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 blistering rash) during pregnancy
• Sydenham's chorea (a nerve disease characterized by sudden body movements)
• certain blood diseases that cause kidney damage (hemolytic-uremic syndrome with symptoms such as decreased urine output, blood in urine, decreased red blood cell count, nausea, vomiting, disorientation, and diarrhea)
• jaundice 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 dysfunction, 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 previously had chloasma during pregnancy.

Other possible side effects

Common side effects(may occur in up to 1 in 10 people):
16/19

• 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 impairment
• skin disorders: erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (rash with redness, resembling targets, or sores)
• breast discharge
• harmful blood clots in a vein or artery, for example: in the leg or foot (e.g., deep vein thrombosis) in the lungs (e.g., pulmonary embolism) heart attack stroke mini-stroke or transient stroke symptoms, known as a transient ischemic attack 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).
A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling and/or difficulty swallowing, or hives with accompanying breathing difficulties (see also "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. 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, e-mail: ndl@urpl.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 Asubtela

17/19
The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Asubtela should not be used after the expiry date stated on the blister and carton, after the words: "Expiry date:" or "EXP:". The expiry date refers to the last day of the month.
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. Package contents and other information

What Asubtela contains

• -The active substances of Asubtela are ethinylestradiol 0.03 mg and drospirenone 3 mg.
• Other ingredients of Asubtela are: Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K 30, crospovidone, polysorbate 80, magnesium stearate. Tablet coating: Opadry II 85F32450 Yellow with the composition: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

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, 2, and 3 blisters, each containing 21 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw

Manufacturer

Laboratorios León Farma, S.A.
C/ La Vallina s/n
Pol. Ind. Navatejera.

• 24193 - Villaquilambre, León, Spain

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

18/19
Estonia
Jangee 0.03 mg/3 mg film-coated tablets
Lithuania
Etindros 0.03 mg/3 mg film-coated tablets
Latvia
Etindros 0.03 mg/3 mg coated tablets
Poland
Asubtela
Slovakia
KarHla
Hungary
Jangee 3 mg/0.03 mg film tablet
Date of last revision of the leaflet: 19.11.2024
19/19