Asubtela

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Asubtela (Estrofix), 3 mg + 0.03 mg, film-coated tablets

Drospirenonum + Ethinylestradiolum
Asubtela and Estrofix 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 blood clot symptoms have occurred (see section 2 "Blood clots").

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

• The leaflet should be kept 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 to a specific person. It should not be passed on 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Asubtela and what is it used for
• 2. Important information before taking Asubtela
• 3. How to take Asubtela
• 4. Possible side effects
• 5. How to store Asubtela
• 6. Contents of the pack 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 that contain two hormones are called "combined" pills.

2. Important information before taking Asubtela

General notes

Before starting to take Asubtela, the information about blood clots in section 2 should be read.
It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before starting to take Asubtela, the doctor will ask a few questions about the patient's health and the health of their close relatives. The doctor will also measure blood pressure and, depending on the individual case, may also perform some other tests.
This leaflet describes several situations in which Asubtela should be stopped or in which the effectiveness of Asubtela may be reduced.
In such situations, sexual intercourse should not be had or additional non-hormonal contraceptive products should not be used during that time, e.g. condoms or other mechanical methods.
During that time, the calendar method or temperature method should not be used either. 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 take Asubtela:

Asubtela should not be taken if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive measure would 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 they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, 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 taking Asubtela for a few weeks before surgery or immobilization. If the patient needs to stop taking Asubtela, they should ask their doctor when they can resume taking it.
• if the patient has (or has ever had) a heart attack or stroke;
• if the patient has (or has ever had) angina pectoris (a disease that causes severe chest pain and may be a sign 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 ever had) a type of migraine called "migraine with aura";
• if the patient has (or has ever had) pancreatitis;
• if the patient has (or has ever had) liver disease and liver function has not yet returned to normal;
• if the patient's kidneys do not work properly (renal insufficiency);
• if the patient has (or has ever had) liver cancer;
• if the patient has (or has ever had) cancer of the breast or genital organs;
• 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 taking Asubtela

When should a doctor be contacted?
A doctor should be contacted immediately

• if the patient notices any of the following symptoms, which could indicate a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)").

To find a description of the serious side effects mentioned, see "How to recognize a blood clot".

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

If symptoms occur or worsen while taking Asubtela, the doctor should also be told. If Asubtela or other oral contraceptives are used in any of the following situations, regular medical check-ups are necessary.
Before starting to take Asubtela, the following should be discussed with a doctor:

• if a close relative has had breast cancer
• if the patient has cancer
• if the patient has liver disease (such as bile duct obstruction, which can cause jaundice or itching) or gallbladder disease (such as gallstones)
• if the patient has other kidney problems and is taking medicines that increase potassium levels in the blood
• if the patient has diabetes
• if the patient has depression
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases)
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system)
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that can cause kidney failure)
• if the patient has sickle cell disease (a genetic disorder that affects red blood cells)
• if the patient has elevated levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots")
• if the patient is immediately postpartum, she is at an increased risk of blood clots. A doctor should be consulted to find out how soon Asubtela can be started after childbirth
• if the patient has superficial thrombophlebitis (inflammation of veins just under the skin)
• if the patient has varicose veins
• if the patient has epilepsy (see "Asubtela and other medicines")
• if the patient has a disease that first appeared during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disease called porphyria, a skin rash with blisters that occurs during pregnancy (pregnancy pemphigoid), a nervous system disease that causes uncontrollable body movements (Sydenham's chorea)

ciężarnych), choroba układu nerwowego, wywołująca niekontrolowane ruchy ciała (pląsawica
Sydenhama)

• jeśli pacjentka ma wysokie ciśnienie tętnicze krwi podczas stosowania leku, które nie jest dobrze kontrolowane przez leki przeciwnadciśnieniowe
• jeśli u pacjentki występuje lub kiedykolwiek w przeszłości wystąpiła ostuda (przebarwienia skóry, zwłaszcza twarzy i szyi zwane również „plamami ciążowymi”). W takim wypadku należy unikać bezpośredniej ekspozycji na światło słoneczne oraz promieniowanie ultrafioletowe
• jeśli u pacjentki występuje dziedziczny obrzęk naczynioworuchowy, produkty zawierające estrogeny mogą wywoływać lub nasilać objawy obrzęku naczynioworuchowego. Jeśli wystąpią objawy obrzęku naczynioworuchowego, takie jak obrzęk twarzy, języka i (lub) gardła, i (lub) jeśli wystąpią trudności w przełykaniu lub pokrzywka wraz z trudnościami w oddychaniu, należy niezwłocznie udać się do lekarza.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Asubtela, is associated with an increased risk of blood clots, compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also known as "arterial thromboembolism").

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

It should be remembered that the overall risk of a serious blood clot caused by taking Asubtela is small.

HOW TO RECOGNIZE A BLOOD CLOT
A doctor should be contacted immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these
symptoms?
Why is the patient likely to be suffering
from these symptoms?

• 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 the color of the leg, such as paleness, redness, or discoloration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain.

BLOOD CLOTS IN VEINS

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

• Taking combined hormonal contraceptives, such as Asubtela, is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. They are most likely to occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and travels to 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 a blood clot in a vein is highest 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, but it is always higher than when not taking combined hormonal contraceptives.
If the patient stops taking 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 of a blood clot in a vein is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had a blood clot in the leg, lung, or other organ at a young age (e.g. under 50 years old). In this case, the patient may have a genetic 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 taking Asubtela for a few weeks before surgery or immobilization. If the patient needs to stop taking Asubtela, they should ask their doctor when they can resume taking it.
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of a blood clot increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop Asubtela.
If any of these conditions change while taking Asubtela, the doctor should be informed, e.g. if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains a lot of weight.

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.

What factors increase the risk of blood clots in arteries?

It is essential to note that the risk of a heart attack or stroke caused by taking Asubtela is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. If the patient is taking a hormonal contraceptive, such as Asubtela, they should stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years 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 close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, irregular heartbeat called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of these conditions or if any of them are severe, the risk of a blood clot may be even higher.
If any of these conditions change while taking Asubtela, the doctor should be informed, e.g. if the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if the patient gains a lot of weight.

Asubtela and cancer

Women taking combined hormonal contraceptives, such as Asubtela, have a slightly higher risk of breast cancer than women who do not take them. However, it is not known whether this is caused by the medicines or other factors.
It is possible that more breast cancers are detected in women taking combined hormonal contraceptives because they are examined by their doctor more often. The risk of breast cancer decreases gradually after stopping combined hormonal contraceptives.
It is essential to regularly check the breasts and contact the doctor if any lumps are found.
Women taking combined hormonal contraceptives have a rare risk of benign liver tumors, and even more rarely, malignant liver tumors.
A doctor should be contacted if the patient experiences severe abdominal pain or liver enlargement (which may cause yellowing of the skin and eyes, or dark-colored urine).

Psychiatric disorders

Some women taking hormonal contraceptives, including Asubtela, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, a doctor should be contacted as soon as possible for further medical advice.

Irregular bleeding

During the first few months of taking 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, a doctor should be consulted to determine the cause.

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

If all the pills have been taken correctly, there has been no vomiting or severe diarrhea, and the patient has not taken any other medicines, it is unlikely that the patient is pregnant.
If two consecutive withdrawal bleeds are missed, the patient may be pregnant. In this case, a doctor should be contacted immediately.
Before starting the next pack of Asubtela, pregnancy should be ruled out.

Asubtela and other medicines

A doctor should always be told about all medicines or herbal products the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The doctor should also be told if the patient is taking any other medicines that have been prescribed by another doctor or dentist (or pharmacist).
Some 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)
• HIV or hepatitis C infections (protease inhibitors or non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g. griseofulvin, ketoconazole)
• arthritis or arthrosis (etoricoxib)
• pulmonary hypertension (bosentan)
• herbal products containing St. John's Wort (Hypericum perforatum)

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

• medicines containing cyclosporin
• antiepileptic medicines, lamotrigine (this may lead to an increased risk 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 doctor or laboratory staff should be told that the patient is taking a contraceptive. Oral contraceptives may affect the results of some lab tests.

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant should not take Asubtela. If the patient becomes pregnant while taking Asubtela, they should stop taking it immediately and contact their doctor.
If the patient plans to become pregnant, they can stop taking Asubtela at any time (see also "Stopping Asubtela").
Breastfeeding
Asubtela should not be taken during breastfeeding. If the patient wants to take a contraceptive while breastfeeding, they should consult their doctor.
If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Asubtela contains lactose monohydrate

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

3. How to take Asubtela

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
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 pack contains 21 tablets. The day of the week is printed next to each tablet. If, for example, the patient starts taking the tablets on a Wednesday, they should take the tablet with "WED" printed next to it (see "Translation of day-of-the-week symbols on the packaging" at the end of the leaflet). The tablets should be taken in the direction indicated by the arrows on the pack until all 21 tablets have been taken.
Then, no tablets should be taken for 7 days. During this 7-day break, withdrawal 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 next pack should be started, even if the bleeding has not stopped. This means that the next pack should be started on the same day of the week as before, and the bleeding should occur on the same day every month.
If Asubtela is taken as directed, protection against pregnancy is also provided during the 7-day break.

When can the first pack be started?

• If no hormonal contraceptive has been taken in the previous monthAsubtela can be started on the first day of the menstrual cycle (i.e. on the first day of menstruation). If Asubtela is started on the first day of menstruation, the patient will be immediately protected against pregnancy. Asubtela can also be started between the 2nd and 5th day of the cycle, but in this case, additional contraceptive methods (e.g. condoms) should be used for the first 7 days.
• Changing from a combined hormonal contraceptive or a vaginal ring or transdermal patchAsubtela should be started the next day after taking the last active tablet (i.e. the last tablet containing active ingredients) of the 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 contraceptive). When changing from a vaginal ring or transdermal patch, Asubtela should be started on the day the 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 it is removed; from an injection 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 taking Asubtela.
• After a miscarriageThe doctor's advice should be followed.
• After childbirthAsubtela can be started between the 21st and 28th day after childbirth. If Asubtela is started later than 28 days after childbirth, a barrier method (e.g. condoms) should be used for the first 7 days of taking Asubtela. If the patient has had sex since childbirth before starting Asubtela again, they should make sure they are not pregnant before starting Asubtela or wait until their next menstrual period.
• If the patient is breastfeeding and wants to start taking Asubtela again after childbirthSee the section on "Breastfeeding".

If in doubt about when to start, a doctor should be consulted.

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 a large number of tablets are taken at the same time, nausea or vomiting may occur. In young girls, vaginal bleeding may occur.
If the patient has taken too many Asubtela tablets or thinks a child has taken some, they should contact a doctor or pharmacist.

Missing a dose of Asubtela

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

The risk of reduced contraceptive protection is highest if a tablet is missed at the beginning or end of the pack. Therefore, the following rules should be followed (see also the diagram below):

• -More than one tablet has been missed from the packA doctor should be contacted.
• -One tablet has been missed in week 1.The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time, and additional contraceptive methods (e.g. condoms) should be used for the next 7 days. If the patient had sex during the week before missing the tablet, there is a risk of pregnancy. In this case, a doctor should be contacted.
• -One tablet has been missed in week 2.The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Contraceptive protection is not reduced, and there is no need to use additional contraceptive methods.
• -One tablet has been missed in week 3.There are two options to choose from:
• 1. The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Instead of the break, the next pack should be started immediately.

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

• 2. The patient can also stop taking the tablets from the current pack and have a 7-day break ( the day of the missed dose should be noted). If the patient wants to start the next pack on the day they usually start, the break should be less than 7 days.

If the patient follows one of these rules, contraceptive protection will be maintained.

• If a tablet is missed from the current pack and withdrawal bleeding does not occur during the break, the patient may be pregnant. In this case, before starting the next pack, a doctor should be consulted.

A diagram shows how to proceed if a tablet is missed (tablets):

What to do if vomiting or severe diarrhea occurs

If vomiting or severe diarrhea occurs within 3-4 hours of taking a tablet, there is a risk that the active ingredients in the tablet may not have been fully absorbed into the bloodstream, which may require additional contraceptive methods (e.g. condoms) to be used to prevent pregnancy. The situation is almost the same as if a tablet is missed. After vomiting or diarrhea, another tablet should be taken from the reserve pack as soon as possible. If possible, the tablet should be taken 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 for missing a tablet (see "Missing a dose of Asubtela").

Delaying withdrawal bleeding: what to know

Although it is not recommended, it is possible to delay withdrawal bleeding by starting the next pack of Asubtela immediately, without a break, and continuing for as long as the pack lasts. During the second pack, spotting or bleeding may occur.
Before deciding to delay withdrawal bleeding, a doctor should be consulted.

Changing the first day of withdrawal bleeding: what to know

If the patient is taking the tablets as directed, withdrawal bleeding will occur during the week without tablets. If the patient wants to change this day, the break in taking the tablets should be shortened ( but never extended - 7 days is the maximum length of the break!). For example, if the break starts on a Friday and the patient wants to change it to a Tuesday (3 days earlier), the next pack should be started 3 days earlier than usual. If the patient significantly shortens the break, it is possible that withdrawal bleeding will not occur during that time. Instead, spotting or bleeding may occur.
If the patient is unsure what to do, they should contact a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effects, especially severe or persistent ones, or changes in your health that you think may be related to taking Asubtela, you should consult a doctor. All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with taking combined hormonal contraceptives, you should refer to section 2 "Important information before taking Asubtela".

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

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

• Allergic reactions (with symptoms such as: facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing, or urticaria 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 developing blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots). Conditions that may occur or worsen during pregnancy or while taking the pill:

• Systemic lupus erythematosus (SLE, a disease affecting the immune system)
• Colitis or other parts of the intestine (with symptoms such as bloody diarrhea, pain during bowel movements, abdominal pain) (Crohn's disease and ulcerative colitis)
• Epilepsy
• Uterine fibroids (a non-cancerous tumor that grows in the muscle tissue of the uterus)
• Porphyria (a blood disorder)
• Pemphigoid gestationis (a blistering rash) during pregnancy
• Sydenham's chorea (a nerve disorder characterized by sudden movements of the body)
• Certain blood disorders 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 eyes and skin 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"), which may be a permanent change, especially in women who have had chloasma during pregnancy.

Other possible side effects

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

• Depressed mood
• Headache
• Migraine
• Nausea
• Menstrual disorders, intermenstrual bleeding, breast tenderness, breast pain
• Thick, white vaginal discharge and vaginal yeast infection.

Uncommon side effects(may affect 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 affect 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:
• 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 developing blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 medication.

5. How to store Asubtela

The medication should be stored out of sight and reach of children. Store at a temperature below 30°C. Do not use Asubtela after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist 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.
• The other ingredients of Asubtela are: Core of the tablet: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K 30, crospovidone (type A and type B), polysorbate 80, magnesium stearate.

Coating of the tablet: Opadry II 85F32450 Yellow with the composition: partially hydrolyzed polyvinyl alcohol, 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 approximately 5.7 mm. Asubtela is available in packs containing 1 blister pack of 21 tablets. The pack includes a cardboard wallet in which the blister pack should be placed. For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Ioulia and Irene Tsetis Pharmaceutical Laboratories S.A. (INTERMED S.A.) Kalyftaki 27 145 64 Κifisia Greece

Manufacturer:

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

• 24008 - Villaquilambre, León. Spain

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Authorization number in Greece, the country of export: 14414/12-02-2019

Parallel import authorization number: 411/22

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 λετυτό νμένιο 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 Slovenia Etindros 0.03 mg/3 mg filmsko obložene tablete Slovakia KarHla Hungary Jangee 3 mg/0.03 mg filmtabletta

Translation of day-of-the-week symbols on the packaging:

ΔΕΥ/MON - Monday ΤΡΙ/TUE

• Tuesday ΤΕΤ/WED - Wednesday ΠΕΜ/THU - Thursday ΠΑΡ/FRI
• Friday ΣΑΒ/SAT - Saturday ΚΥΡ/SUN - Sunday

Date of leaflet approval: 22.11.2022
[Information about the trademark]