ASUBTELA

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Asubtela (Estrofix), 3 mg + 0,03 mg, coated tablets
Drospirenone + Ethinylestradiol
Asubtela and Estrofix are different brand names for the same medicinal product.
Important information regarding combined oral contraceptives

• When used correctly, they are among the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, particularly during the first year of use or after restarting following an interruption of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Please read this leaflet carefully before taking the medicine, as it contains
important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 combined oral 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" oral contraceptives.

2. Important information before using Asubtela

General notes
Before starting to take Asubtela, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before starting to take Asubtela, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out some additional tests.
This leaflet describes several situations in which you should stop taking Asubtela or when the effectiveness of Asubtela may be reduced.
In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other barrier methods.
During this time, you should not use the calendar method or the temperature method. These methods may be unreliable because Asubtela alters the monthly changes in body temperature and cervical mucus.
Asubtela, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

When not to use Asubtela:
Do not take Asubtela if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may 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 your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have (or have ever had) a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a condition called hyperhomocysteinemia
• if you have (or have ever had) migraine with focal neurological symptoms;
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) pancreatitis;
• if you have (or have ever had) liver disease and liver function has not returned to normal;
• if your kidneys are not working properly (kidney failure);
• if you have (or have ever had) liver tumour;
• if you currently have (or have ever had) breast cancer or cancer of the genital organs, or if such cancer is suspected;
• if you have any unexplained vaginal bleeding;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir (see section "Asubtela and other medicines").

Additional information for special patient groups
Children and adolescents
Asubtela is not indicated for use in girls who have not yet had their first menstrual period.

Warnings and precautions
When to exercise special caution with Asubtela
When should you contact your doctor?
You should contact your doctor immediately

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack or stroke (see section below "Blood clots").

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".
You should tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Asubtela, you should also inform your doctor. If you are taking Asubtela or other oral contraceptives in any of the situations listed below, regular medical monitoring is required.
You should discuss this with your doctor before starting Asubtela:

• if a close relative has or has ever had breast cancer
• if you have cancer
• if you have liver disease (such as biliary obstruction, which may cause jaundice or itching) or gallbladder disease (such as gallstones)
• if you have other kidney disorders and are taking medicines that increase potassium levels in the blood
• if you have diabetes
• if you have depression
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases)
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system)
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure)
• if you have a blood disorder called sickle cell anaemia (an inherited disorder of red blood cells)
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots")
• if you have recently given birth, as you are at increased risk of blood clots. You should consult your doctor for advice on how soon after delivery you can start taking Asubtela
• if you have inflammation of the veins under the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have epilepsy (see "Asubtela and other medicines")
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, skin rash with blistering occurring during pregnancy (herpes gestationis), a nervous system disorder causing uncontrolled body movements (Sydenham's chorea)
• if you have high blood pressure during treatment that is not well controlled by antihypertensive medicines
• if you have chloasma (skin discoloration, especially on the face and neck, also known as "pregnancy mask"). In such cases, avoid direct exposure to sunlight and ultraviolet radiation
• if you have hereditary angioedema, products containing estrogens may trigger or worsen angioedema symptoms. If symptoms of angioedema occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with breathing difficulties, seek medical attention immediately.

BLOOD CLOTS
Using combined hormonal contraceptives such as Asubtela increases the 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 below as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic disorders").

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 THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.

| Do you have any of these symptoms? | What might be the likely cause? | |-----------------------------------|----------------------------------| | Swelling in the leg or swelling along a vein in the leg, or in the foot, especially if accompanied by: | Deep vein thrombosis | | 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, e.g. pallor, redness, or blueness. | | | sudden unexplained shortness of breath or rapid breathing; | Pulmonary embolism | | sudden cough without obvious cause, which may be associated with coughing up blood; | | | sharp chest pain, which may worsen on deep breathing; | | | severe dizziness or vertigo; | | | rapid or irregular heartbeat; | | | severe pain in the stomach. | |

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 developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to 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 developing 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 higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women 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 developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Asubtela is low.

• In the course of 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 the course of 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 the course of 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 patient's individual medical history (see "Factors that increase the risk of developing blood clots in veins", below).

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

• if the patient is very overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited clotting disorder;
• if the patient is due to undergo surgery, is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Asubtela several weeks before surgery or immobilisation. If the patient needs to stop taking Asubtela, she should consult her doctor about when she can restart taking the medicine.
• with increasing age (especially over 35 years of age);
• if the patient has given birth within the last few weeks.

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

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial blood clots can cause 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 the use of Asubtela
is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes cigarettes. While using a hormonal contraceptive product such as Asubtela, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another 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 of age). 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 fats (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are
particularly severe, the risk of blood clots may be further increased.
The patient should inform the doctor if any of the above conditions change during
treatment with Asubtela, e.g. if the patient starts smoking, if a close family member is diagnosed with thrombosis of unknown cause, 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 taking these medicines. 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 tumours have been observed rarely in women using combined hormonal contraceptives, and malignant liver tumours have been observed even more rarely.
The patient should contact her doctor if she experiences severe abdominal pain or notices abdominal swelling (which may be due to liver enlargement), vomiting blood, blood in the stool, or black, tarry stools (which may be signs of stomach 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, the patient should contact her doctor as soon as possible for further medical advice.

Breakthrough 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, the patient should consult her doctor, who must determine the cause.

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

Asubtela and other medicines
The patient should always inform her doctor about all medicines or herbal products she is currently taking, has recently taken, or plans to take. She should also inform any other doctor or dentist prescribing another medicine (or pharmacist) that she is taking Asubtela. They may advise whether additional contraceptive methods (e.g. condoms) should be used, and if so, for how long.

Asubtela must not be used in patients with hepatitis C virus infection who are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir, as this may cause abnormalities in liver function tests (increased activity of the liver enzyme AlAT).
The doctor will recommend using another method of contraception before starting these medicines.
Asubtela may be restarted approximately 2 weeks after stopping these medicines.
See section "When not to use Asubtela".

• 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 virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g. griseofulvin, ketoconazole)
• arthritis, osteoarthritis (etoricoxib)
• pulmonary hypertension (bosentan)
• herbal products containing St. John's wort (Hypericum perforatum)

If the patient is taking any of the above medicines together with Asubtela,
she should use additional contraceptive methods (e.g. condoms) during concomitant use of these medicines and for 28 days after stopping treatment.

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, due to heart disease, the patient
is taking certain medicines (e.g. diuretics).

Laboratory tests
If blood tests are required, the patient should inform the doctor or laboratory staff that she is taking a contraceptive product, 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 stop taking Asubtela at any time (see also "Stopping Asubtela").

Breastfeeding
Asubtela is generally not recommended during breastfeeding. If the patient wishes to use a contraceptive product while breastfeeding, she should consult her doctor.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

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

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

3. How to use Asubtela

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Take one Asubtela tablet daily, swallowing it with a small amount of water if necessary. The tablets may be taken with or without food, but they should be taken daily at approximately the same time.
One blister pack contains 21 tablets. Next to each tablet is printed the day of the week on which the tablet should be taken. For example, if you start taking the medicine on Wednesday, take the tablet marked “TET/WED” next to it (see “Translation of symbols for days of the week printed next to each tablet on the immediate packaging” at the end of this leaflet). Take the tablets in the order indicated by the arrows on the blister pack, until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During this 7-day break from tablets (called the weekly break), withdrawal bleeding is expected to occur. This bleeding, also known as “withdrawal bleeding,” usually begins on the 2nd or 3rd day of the break week.
On the 8th day after taking the last Asubtela tablet (i.e., after the 7-day break), start a new blister pack, even if bleeding has not stopped. This means you should start the new pack on the same day of the week as before, and bleeding should occur on approximately the same day each month.
If you take Asubtela as directed, protection against pregnancy continues during the 7-day tablet-free period.

When to start the first pack?

• If no hormonal contraceptives were used in the previous month
  You may start taking Asubtela on the first day of your cycle (i.e., the first day of your menstrual period). If you start taking Asubtela on the first day of your period, you will be immediately protected against pregnancy. You may also start between days 2 and 5 of your cycle, but in this case, you must 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 patch
  Start taking Asubtela the day after the last active tablet (the last tablet containing active ingredients) of your previous contraceptive. However, you may start no later than the day after the tablet-free interval of your previous contraceptive (or after the last inactive tablet). If switching from a vaginal ring or a transdermal patch, it is best to start Asubtela on the day the previous system is removed, but no later than the day 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)
  You may switch to Asubtela at any time (from an implant or intrauterine device on the day of removal; from an injectable on the day 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 tablets.

• After a miscarriage
  Follow your doctor’s advice.

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

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

If you are unsure 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 you discover that a child has swallowed several tablets, contact your doctor or pharmacist immediately.

Missing a dose of Asubtela

• If less than 12 hours have passed since you missed a tablet, your protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and take the next tablet at the 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 inadequate protection against pregnancy is greatest if a tablet is missed at the beginning or end of the pack. Therefore, follow the rules below (see also the diagram below):

• More than one tablet missed from the blister pack
  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 the usual time and use additional contraception (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, 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 the 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 the usual time. Instead of the tablet-free break, immediately start the next blister pack.
     Withdrawal bleeding will most likely occur at the end of the second pack, but spotting or bleeding may also occur during the second pack.

  2. Alternatively, stop taking tablets from the current pack 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 have missed any tablet from the current blister pack and no withdrawal bleeding occurs during the tablet-free break, this may indicate that you are pregnant. In this case, consult your doctor before starting the next blister pack.

The diagram below shows what to do if you miss a tablet (or tablets):

What to do if you vomit or have severe diarrhoea
If you vomit or have severe diarrhoea within 3–4 hours after 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., condoms) to avoid pregnancy. The situation is almost the same as missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible, take the tablet within 12 hours of your usual time of taking the tablet. If this is not possible, or if more than 12 hours have passed, follow the instructions described in the section “Missing a 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 pack of Asubtela immediately, without taking the tablet-free break, and continuing until the pack is finished. Spotting or bleeding may occur during the second pack. After the usual 7-day tablet-free period, you must start taking tablets from the next blister pack.
Before deciding to delay withdrawal bleeding, consult your doctor.

Changing the first day of withdrawal bleeding: what you should know
If you take the tablets as directed, bleeding will occur during the tablet-free week. If you need to change this day, shorten (but never extend – the maximum break length is 7 days!) 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 pack 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 instead.
If you are unsure how to proceed, consult your doctor.

Stopping 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 your expected delivery date.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions 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 the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Asubtela".

Immediate medical attention is required if any of the following adverse reactions occur.
You must stop taking Asubtela immediately and contact your doctor or go to the nearest hospital.

Rare adverse reactions (may occur in up to 1 in 1,000 people):

• Allergic reactions (with symptoms such as: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with accompanying breathing difficulties)
• Harmful blood clots in veins or arteries, 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-like symptoms, known as transient ischaemic attack
• 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 factors that increase this risk (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 inflammation of 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 (a benign tumour growing in the muscular tissue of the uterus)
• Blood pigment disorder (porphyria)
• Blistering rash (herpes gestationis) during pregnancy
• Sydenham's chorea (a nervous system disorder causing sudden involuntary movements of the body)
• 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 caused by blockage of bile ducts (cholestatic jaundice)

In addition, breast cancer has been observed (see section 2, "Asubtela and cancer"), as well as non-neoplastic (benign) and neoplastic (malignant) liver tumours (with symptoms such as abdominal swelling, weight loss, liver function abnormalities detectable in blood tests), and chloasma (yellowish-brown skin patches, especially on the face, so-called "pregnancy mask"), which may be permanent, particularly in women who previously had chloasma during pregnancy.

Other possible adverse reactions

Common adverse reactions (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 reactions (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 reactions (may occur in up to 1 in 1,000 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-shaped lesions or sores)
• Breast discharge
• Harmful blood clots in veins or arteries, 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-like symptoms, known as transient ischaemic attack
• 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 factors that increase this risk (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Asubtela

Keep this medicine out of the sight and reach of children.
Store below 30ºC.
Do not use Asubtela after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Asubtela contains

• The active substances in this medicine are ethinylestradiol 0.03 mg and drospirenone 3 mg.
• Other components of the medicine are:
  Tablet core: Lactose monohydrate, maize starch, pregelatinized maize starch, povidone K 30, crospovidone (type A and type B), polysorbate 80, magnesium stearate.
  Tablet coating: Opadry II 85F32450 Yellow, which contains: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol 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 packs containing 1 blister with 21 tablets.
A cardboard sachet is included in the pack, in which the blister should be placed.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Greece, the country of export:
Ioulia and Irene Tsetis Pharmaceutical Laboratories S.A. (INTERMED S.A.)
Kalyftaki 27
145 64 Kifisia
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
Poland

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

Marketing Authorisation Number in Greece, the country of export: 14414/12-02-2019
Parallel Import Licence Number: 411/22

This medicinal product is authorised 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 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
Slovenia: Etindros 0.03 mg/3 mg filmsko obložene tablete
Slovakia: KarHla
Hungary: Jangee 3 mg/0.03 mg filmtabletta

Translation of the weekday symbols printed next to each tablet on the immediate packaging:

ΔΕΥ/MON - Monday
ΤΡΙ/TUE - Tuesday
ΤΕΤ/WED - Wednesday
ΠΕΜ/THU - Thursday
ΠΑΡ/FRI - Friday
ΣΑΒ/SAT - Saturday
ΚΥΡ/SUN - Sunday