Asubtela

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Asubtela (Etindros)
3 mg + 0.03 mg, coated tablets
Drospirenone + Ethinylestradiol
Asubtela and Etindros are different trade names for the same medicine.
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots")

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet
1. What Asubtela is and what it is 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 Asubtela is and what it is used for
Asubtela is a contraceptive tablet used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones: drospirenone and
ethinylestradiol.
Contraceptive tablets containing two hormones are known as "combined" pills.

2. Important information before taking Asubtela

General notes
Before starting to take Asubtela, read the information regarding blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Before starting Asubtela, the doctor will ask several questions about the patient’s health and that of close relatives. The doctor will also measure blood pressure and, depending on the individual case, may perform additional tests.
This leaflet describes several situations in which Asubtela should be discontinued or in which its effectiveness may be reduced.
In such cases, sexual intercourse should be avoided or additional non-hormonal contraceptive methods (e.g. condoms or other mechanical methods) should be used.
During this time, do not use calendar-based or temperature-based methods. These methods may be unreliable because Asubtela alters monthly body temperature changes and cervical mucus patterns.
Asubtela, like other hormonal contraceptives, does not protect against HIV (AIDS) or other
sexually transmitted infections.

When not to take Asubtela:
Do not take Asubtela if the patient has any of the conditions listed below. If any of these conditions apply, inform the doctor. The doctor will discuss with the patient which alternative contraceptive method 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 currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows she has clotting disorders — for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobile for a prolonged period (see section "Blood clots");
• if the patient currently has (or has ever had) myocardial infarction or stroke;
• if the patient has (or has had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if the patient has any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of blood lipids (cholesterol or triglycerides)
• a condition called hyperhomocysteinemia
• if the patient currently has (or has ever had) migraine (with so-called focal neurological symptoms);
• if the patient currently has (or has ever had) a type of migraine called "migraine with aura";
• if the patient currently has (or has ever had) pancreatitis;
• if the patient currently has (or has ever had) liver disease and liver function has not returned to normal;
• if the patient’s kidneys are not functioning properly (renal failure);
• if the patient currently has (or has ever had) liver tumour;
• if the patient currently has (or has ever had) or is suspected of having breast cancer or genital organ cancer;
• if the patient has any unexplained vaginal bleeding;
• if the patient has hepatitis C virus and is taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir (see section "Asubtela with 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 particular caution when taking Asubtela
When should the patient contact the doctor?
Seek immediate medical advice if:

• the patient experiences symptoms suggesting a blood clot, which may indicate deep vein thrombosis in the leg, pulmonary embolism in the lungs, heart attack, or stroke (see section below "Blood clots").

For descriptions of the symptoms of these serious adverse effects, see "How to recognize blood clots".

Inform the doctor if the patient has any of the following conditions.
If symptoms develop or worsen during treatment with Asubtela, inform the doctor. Regular medical monitoring is necessary if Asubtela or other oral contraceptives are used in any of the following conditions. Discuss these with the doctor before starting Asubtela:

• if a close relative currently has or has ever had breast cancer
• if the patient has cancer
• if the patient has liver disease (e.g. biliary obstruction, which may cause jaundice or itching) or gallbladder disease (e.g. gallstones)
• if the patient has other kidney disorders and is taking medicines that increase blood potassium levels
• 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 affecting the natural defence system)
• if the patient has haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure)
• if the patient has a blood disorder called sickle cell anaemia (an inherited red blood cell disorder)
• if the patient has hypertriglyceridaemia (elevated blood lipid levels) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis.
• if the patient requires surgery or will be immobile for a prolonged period (see

section 2 "Blood clots")

• if the patient has recently given birth, as she is then at increased risk of blood clots. Consult the doctor for advice on how soon after delivery Asubtela can be started
• if the patient has superficial thrombophlebitis (inflammation of veins under the skin)
• if the patient has varicose veins
• if the patient has epilepsy (see "Asubtela with other medicines")
• if the patient has a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, a blistering skin rash occurring during pregnancy (herpes gestationis), a nervous system disorder causing uncontrolled body movements (Sydenham’s chorea))
• if the patient has high blood pressure while taking the medicine, which is not well controlled by antihypertensive drugs
• if the patient currently has or has ever had chloasma (skin pigmentation, especially on the face and neck, also known as "melasma"). In such cases, avoid direct exposure to sunlight and ultraviolet radiation.
• if the patient has hereditary angioedema, products containing estrogens may trigger or worsen angioedema symptoms. If symptoms such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with breathing difficulties occur, seek immediate medical attention.

BLOOD CLOTS
Using combined hormonal contraceptives such as Asubtela is associated with an increased risk of blood clots compared to not using such products. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

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

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by taking Asubtela is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if any of the following symptoms occur.
Is the patient experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, such as pallor, redness or cyanosis.
• sudden unexplained shortness of breath or rapid breathing; pulmonary embolism

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptive products.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (either the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Asubtela, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive product used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Asubtela is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Asubtela, will develop blood clots.
• The risk of developing blood clots depends on the individual medical history of the patient (see "Factors increasing the risk of venous blood clots" and "Factors increasing the risk of arterial blood clots" below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Asubtela is small, however,
some factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Asubtela several weeks before surgery or immobilization. If the patient must stop taking Asubtela, consult the doctor about when it is safe to restart.
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of these risk factors apply to the patient,
even if uncertain. The doctor may decide to discontinue Asubtela.
Inform the doctor if any of the above conditions change during treatment with Asubtela, e.g., if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots can lead to serious
consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with Asubtela
is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Asubtela, smoking should be discontinued. If the patient is unable to stop 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 a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, heart rhythm disorder such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is
particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Asubtela, e.g., if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Asubtela and cancer
Breast cancer has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is caused by these medications. It is possible, for example, that more cancers are detected in women using hormonal contraceptives because they are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to regularly examine the breasts and contact the doctor if any lumps are detected.
Benign liver tumors have been observed rarely, and malignant liver tumors very rarely, in women using combined hormonal contraceptives.
Contact the doctor if the patient experiences severe abdominal pain or notices abdominal swelling (which may be due to liver enlargement), vomiting blood, blood in stool, or black tarry stools (which may indicate gastrointestinal bleeding).

Psychiatric disorders:
Some women using hormonal contraceptives, including Asubtela, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Asubtela, unexpected bleeding (outside the tablet-free week) may occur. If bleeding persists beyond the first few months or occurs after several months of use, consult the doctor, who must determine the cause.

What to do if withdrawal bleeding does not occur during the tablet-free interval
If all tablets were taken correctly, there were no episodes of vomiting or severe diarrhea, and no other medications were taken, it is unlikely that the patient is pregnant.
If two consecutive withdrawal bleeds do not occur, the patient may be pregnant. In this case, contact the doctor immediately. Pregnancy must be ruled out before starting the next blister pack of Asubtela.

Asubtela and other medicines
Always inform the doctor about all medicines or herbal products the patient is currently taking, has recently taken, or plans to take. Also inform any other doctor or dentist (or pharmacist) prescribing another medicine that Asubtela is being used. They may advise whether additional contraceptive methods (e.g., condoms) should be used and for how long.
Do not use Asubtela in patients with hepatitis C virus infection who are taking medications containing ombitasvir/paritaprevir/ritonavir or dasabuvir, as this may cause abnormalities in liver function tests (increased liver enzyme AlAT activity).
The doctor will recommend using another method of contraception before starting these medications.
Asubtela may be restarted approximately 2 weeks after stopping these medications.
See section “When not to use Asubtela”.

• Some medicines may reduce the effectiveness of Asubtela 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 infection (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, osteoarthritis (etoricoxib)
• medicines used to treat pulmonary hypertension (bosentan)
• herbal products containing St. John’s wort ( Hypericum perforatum )

If the patient is taking any of the above medicines concurrently with Asubtela,
an additional contraceptive method (e.g., condom) should be used during concomitant use and for 28 days after discontinuation of the interacting medicine.
Asubtela may affect the action of other medicines, for example:

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

The doctor may recommend monitoring blood potassium levels if the patient is taking certain medications due to heart disease (e.g., diuretics).

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that the patient is taking a hormonal contraceptive, as oral contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Asubtela must not be used during pregnancy. If the patient becomes pregnant while taking Asubtela, she should stop taking the medicine immediately and contact her doctor. If the patient plans to become pregnant, she may discontinue Asubtela at any time (see also “Discontinuing Asubtela”).

Breastfeeding
Asubtela is generally not recommended during breastfeeding. If the patient wishes to use a contraceptive during breastfeeding, she should consult her doctor.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
There is no information indicating that Asubtela affects the ability to drive or operate machinery.

Asubtela contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Asubtela

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
One tablet of Asubtela should be taken daily, if necessary with a small amount of water. The tablets
may be taken with or without food, but they should be taken daily at approximately the same time.
One blister contains 21 tablets. Next to each tablet is printed the day of the week on which the tablet
should be taken. For example, if treatment starts on Wednesday, take the tablet marked
“Trečiadienis/Trešdiena” next to it (indicating Wednesday, see “Translation of weekday markings
adjacent to each tablet in the immediate packaging” at the end of this leaflet). Tablets should be
taken in the direction indicated by the arrows on the blister until all 21 tablets have been taken.
Then, no tablets should be taken for 7 days. During this 7-day break from taking tablets (referred to
as the weekly break), withdrawal bleeding should occur. This bleeding, also called “withdrawal
bleeding”, usually begins on the 2nd or 3rd day of the break.
On the 8th day after taking the last tablet of Asubtela (i.e. after the 7-day break), start a new blister,
even if bleeding has not stopped. This means starting the next blister on the same day of the week,
and bleeding should occur on the same day each month.
If Asubtela is taken as directed, protection against pregnancy continues during the 7-day tablet-free
period.

When to start the first pack?

• If no hormonal contraceptives have been used in the previous month:
  You may start taking Asubtela on the first day of your cycle (i.e. the first day of menstruation). If you start taking Asubtela on the first day of your period, you will be immediately protected against pregnancy. You may also start between the 2nd and 5th day of the cycle, but in this case, you must use additional contraceptive methods (e.g. a condom) for the first 7 days.

• Switching from a combined hormonal contraceptive or from a vaginal ring or transdermal patch:
  Start taking Asubtela the day after taking the last active tablet (the last tablet containing active ingredients) of the previously used contraceptive, but no later than the day after the break from the previous tablets (or after taking the last inactive tablet of the previous product). When switching from a vaginal ring or transdermal patch, start taking Asubtela on the day of removal of the previous system, but no later than the day when the next application of the previous system would have been due.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen IUS):
  Switching from progestogen-only pills can occur at any time (from an implant or intrauterine device on the day of removal; from injectable forms on the day the next injection would have been due), but in all cases, additional contraceptive methods (e.g. a condom) should be used for the first 7 days of taking the tablets.

• After miscarriage:
  Follow your doctor’s advice.

• After childbirth:
  You may start taking Asubtela between 21 and 28 days after delivery. If you start taking Asubtela later than 28 days after giving birth, you should use a mechanical method (e.g. a condom) for the first 7 days of taking Asubtela. If you have had sexual intercourse after giving birth before starting (or restarting) Asubtela, you should first ensure that you are not pregnant or wait until the next menstrual bleeding occurs.

• If you are breastfeeding and wish to start (or restart) taking Asubtela after childbirth:
  See section: “Breast-feeding”.

If in doubt about when to start taking the medicine, consult your doctor.

Taking more Asubtela than you should

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

Missed dose of Asubtela

• If less than 12 hours have passed since you missed a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and take the next tablets at your usual time.
• If more than 12 hours have passed since you missed a tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is greatest if a tablet is missed at the beginning or end of a pack. Therefore, follow the rules below (see also the diagram below):

• More than one tablet missed from the blister:
  Contact your doctor.

• One tablet missed in Week 1:
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time and use additional contraception (e.g. a condom) 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, contact your doctor.

• One tablet missed in Week 2:
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time. Protection against pregnancy is not reduced, and there is no need for additional contraception.

• One tablet missed in Week 3:
  You have two options:

  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time. Instead of taking the 7-day break, start the next blister immediately.

  Withdrawal bleeding will most likely occur towards the end of the second blister, but spotting or bleeding may also occur during the intake of tablets from the second blister.

  2. Alternatively, stop taking tablets from the current blister and immediately begin the 7-day tablet-free break (note the day on which the dose was missed). If you wish to start the new pack on the day you usually start, the tablet-free break should be shorter than 7 days.

  If you follow either of these recommendations, protection against pregnancy will be maintained.

• If you missed any tablet from the current blister and no bleeding occurred during the tablet-free break, this may indicate that you are pregnant. In this case, consult your doctor before starting the next blister.

Diagram showing what to do if you miss a tablet(s):
Missed more than
one tablet from
one pack
→ Seek advice from your doctor

Missed only one tablet
→ Take the missed tablet
After less than 12 hours
→ Continue current pack

In Week 1
→ Did you have sexual intercourse in the week before missing the tablet?
Yes → Take the missed tablet, use mechanical method (condom) for next 7 days, and finish current blister
No → Take the missed tablet and finish current blister

In Week 2
→ Take the missed tablet and finish current blister

In Week 3
→ Take the missed tablet and immediately start next blister
OR
→ Immediately stop current blister, start 7-day break (no longer than 7 days, including the day the tablet was missed), then start next blister

What to do if you vomit or have severe diarrhoea
If you vomit or have severe diarrhoea within 3–4 hours of taking a tablet, there is a risk that the active substances in the tablet have not been completely absorbed, which may require the use of additional contraception (e.g. a condom) to avoid pregnancy. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister as soon as possible. If possible, take the tablet within 12 hours of your usual dosing time. If this is not possible, or if more than 12 hours have passed, follow the instructions under “Missed dose of Asubtela”.

Delayed withdrawal bleeding: what you should know
Although not recommended, it is possible to delay withdrawal bleeding by starting a new blister of Asubtela immediately without taking the tablet-free break, continuing until the blister is finished. Spotting or bleeding may occur during the intake of tablets from the second blister. After the usual 7-day tablet-free period, start taking tablets from the next blister.
Before deciding to delay withdrawal bleeding, consult your doctor.

Changing the day of withdrawal bleeding: what you should know
If you take the tablets as directed, bleeding will start during the tablet-free week. If it is necessary to change this day, shorten (but never extend – 7 days is the maximum break length!) the tablet-free interval. For example, if the tablet-free break starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new blister 3 days earlier than usual. If you significantly shorten the tablet-free period (e.g. to 3 days or less), withdrawal bleeding may not occur during this time. However, light bleeding or spotting may occur.
If you are unsure what to do, consult your doctor.

Stopping treatment with Asubtela
You may stop taking Asubtela at any time. If you do not wish to become pregnant, consult your doctor about other effective contraceptive methods.
If you plan to become pregnant, stop taking the tablets and wait until you have a menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Asubtela, medical advice should be sought immediately.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using Asubtela".
In the event of the following adverse effects, immediate medical assistance is required.
The use of Asubtela must be discontinued immediately and the patient should contact a doctor or go to the nearest hospital without delay.
Rare adverse 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 accompanied by 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 ischaemic attack (TIA)
  o blood clots in the liver, stomach and intestine, kidneys or eye.

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

• systemic lupus erythematosus (SLE, an autoimmune disease)
• ulcerative colitis or other parts of the intestine (with symptoms such as bloody diarrhoea, pain during defecation, abdominal pain) (Crohn's disease and ulcerative colitis)
• epilepsy
• uterine fibroids (benign tumour growing in the muscular tissue of the uterus)
• blood pigment disorder (porphyria)
• blistering rash (herpes gestationis) during pregnancy
• Sydenham's chorea (a neurological disorder with sudden involuntary movements)
• certain blood disorders causing kidney damage (haemolytic uraemic syndrome with symptoms such as reduced urine output, blood in urine, reduced number of red blood cells, nausea, vomiting, confusion and diarrhoea)
• yellowing of the skin or whites of the eyes due to bile duct obstruction (cholestatic jaundice).

Additionally, breast cancer has been observed (see section 2 "Asubtela and cancer"), as well as benign (non-cancerous) and malignant (cancerous) liver tumours (with symptoms such as abdominal swelling, weight loss, liver function abnormalities detectable in blood tests), and chloasma (yellow-brown skin patches, especially on the face, commonly known as "pregnancy mask"), which may be permanent, particularly in women who previously experienced chloasma during pregnancy.
Other possible adverse effects
Common adverse effects (may occur in up to 1 in 10 people):

• depressed mood
• headache
• migraine
• nausea
• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• thick, whitish vaginal discharge and yeast infection of the vagina.

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

• breast enlargement, decreased interest in sex
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• vaginal infection
• fluid retention, weight decrease or increase.

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

• allergic reactions (hypersensitivity), asthma
• hearing impairment
• skin disorders: nodular erythema (characterized by painful red nodules on the skin) or erythema multiforme (rash with redness resembling target-like lesions or sores)
• nipple 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 ischaemic attack (TIA)
  o blood clots in the liver, stomach and/or intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Asubtela

Keep the medicine out of sight and reach of children.
Store 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Asubtela contains

• The active substances are ethinylestradiol 0.03 mg and drospirenone 3 mg.
• The other components are:
  Tablet core: Monohydrate lactose, corn starch, gelatinized corn starch, povidone K 30, crospovidone, polysorbate 80, magnesium stearate.
  Tablet coating: Partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171),
  macrogol 3350, talc, yellow iron oxide (E 172).

What Asubtela looks like and contents of the pack

Yellow, round film-coated tablets with a diameter of approximately 5.7 mm.
Asubtela is available in packaging containing 1 or 3 blisters, each containing 21 tablets.
A cardboard sleeve is included with the package, in which the blister should be placed.

For more detailed information, please contact your doctor, the marketing authorisation holder, or the parallel importer.

Marketing Authorisation Holder in Lithuania, 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 – León
Spain

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Lithuania, country of export: LT/1/10/1891/006
Parallel Import Authorisation Number: 338/21

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Austria Jangee 0.03 mg/3 mg Filmtabletten
Bulgaria Jangee 0.03 mg/3 mg филмирани таблетки
Denmark Movinella film-coated tablets
Estonia Jangee 0.03 mg/3 mg ohukese polümeerikilega kaetud tablett
Greece Estrofix 0.03 mg/3 mg δiσkio εττikαλνμμένo με λεττό νμένio
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 weekday abbreviations printed next to 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