Bonadea

Leaflet accompanying the packaging: patient information

Bonadea, 2.0 mg + 0.03 mg, film-coated tablets
Dienogest + Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception;
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more;
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person.
• If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Bonadea and what is it used for
• 2. Important information before using Bonadea
• 3. How to use Bonadea
• 4. Possible side effects
• 5. How to store Bonadea
• 6. Contents of the packaging and other information

1. What is Bonadea and what is it used for

Bonadea is an oral combined contraceptive (a contraceptive taken by mouth). Each tablet contains a small amount of two different female sex hormones. These are: dienogest (progestogen) and ethinylestradiol (estrogen).
Since all tabletsin the packaging contain these two hormones in identical doses, this medicine is called a monophasic combined contraceptive. Due to the low hormone content, Bonadea is considered an oral contraceptive with a low hormone dose.

What is Bonadea used for

• as a contraceptive to prevent pregnancy;
• To treat women with moderate acne who have decided to use oral contraceptives and have not responded to appropriate local treatment or oral antibiotic treatment;
• Oral contraceptives are a very effective method of family planning. When used regularly (without missing tablets), they minimize the risk of pregnancy.
• Longer use is also possible after consulting a doctor.

The use of a combined contraceptive may also have health benefits other than preventing pregnancy.

• Bleeding may become shorter and less heavy, which in turn reduces the risk of anemia. Menstrual cramps may be less severe or completely disappear.
• Additionally, in women using tablets containing 50 micrograms of ethinylestradiol (high-dose contraceptives), a lower incidence of certain serious diseases has been observed. These include benign breast diseases, ovarian cysts, pelvic infections (inflammatory diseases of the pelvic organs), ectopic pregnancy (embryo developing outside the uterus), and endometrial and ovarian cancer. This phenomenon may also apply to low-dose contraceptives, but it has only been confirmed for endometrial and ovarian cancer so far.

2. Important information before using Bonadea

General notes

Before starting to use Bonadea, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
This leaflet lists situations where it is necessary to stop using the contraceptive or where its reliability may be reduced. In these cases, you should abstain from sexual intercourse or use an additional, non-hormonal method of contraception, such as a condom or another mechanical method. You should not use the calendar method or the temperature method. They can be unreliable because the contraceptive affects body temperature and cervical mucus changes that normally occur during the menstrual cycle.
Bonadea, like other oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Improvement in acne symptoms usually occurs after 3 to 6 months of treatment, but skin condition may continue to improve even after 6 months of treatment. The patient should discuss with their doctor the need to continue treatment after 3 to 6 months of treatment, and then at regular intervals.

When not to use Bonadea

Bonadea should not be used if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.
The doctor may prescribe a different type of contraceptive or a completely different (non-hormonal) method of contraception.

• if the patient is allergic to estrogen or progestogen or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently 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 blood coagulation disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases that 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);
• hyperhomocysteinemia;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) a tumor that may be affected by sex hormones (e.g., breast or genital tumors);
• if the patient has (or has had in the past) a benign or malignant liver tumor;
• if the patient has (or has had in the past) any liver disease (which may manifest as yellow skin or itching all over the body) and liver function is still not normal;
• if the patient has vaginal bleeding of unknown origin;
• if the patient is pregnant or suspects pregnancy.
• if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Bonadea and other medicines").

If any of these symptoms or disorders occur for the first time while using the medicine, you should stop using it immediately and consult a doctor. In the meantime, you should use non-hormonal methods of contraception. See also "General notes".

Additional information for special populations

Children
Bonadea is not intended for use in girls who have not yet started menstruating.
Elderly patients
Bonadea is not intended for use in women after menopause.
Patients with liver function disorders
Bonadea should not be used in women with liver function disorders. See also section "When not to use Bonadea".
Patients with kidney function disorders
Patients should inform their doctor. Available data do not indicate a need to change treatment in this patient group.

Warnings and precautions

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

• if you notice any of the following symptoms that may indicate a blood clot, such as a clot in the leg (deep vein thrombosis), a clot in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots"). To find a description of these serious side effects, see "How to recognize a blood clot".

If the patient is using a combined oral contraceptive and has any of the following diseases, caution should be exercised. The pharmacist will provide the patient with detailed explanations.

Tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while using Bonadea, you should also tell your doctor.

• if you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have heart problems, such as heart valve diseases or heart rhythm disorders;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disease of red blood cells);
• if you have elevated levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to undergo surgery or will be immobilized for a long time (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 to find out how soon you can start using Bonadea after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you or any of your close relatives have had a blood clot in the past (deep vein thrombosis, pulmonary embolism, or blood clots in other organs), a heart attack, or a stroke at a young age;
• if you have migraines;
• if you have epilepsy;
• if you or any of your close relatives have had breast cancer;
• if you have liver or gallbladder disorders;
• if you have any other diseases or conditions that have occurred for the first time or worsened during pregnancy or while using sex hormones (e.g., any hearing disorders; porphyria, a disorder of pigment metabolism; herpes gestationis, a skin disease; or Sydenham's chorea, a neurological disorder);
• if you have or have had chloasma (yellow-brown spots on the skin) during pregnancy, you should avoid sunbathing or exposure to ultraviolet radiation while using Bonadea;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or hives that may cause breathing difficulties, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

If any of the above symptoms occur for the first time or worsen while using Bonadea, you should consult your doctor.

Regular check-ups

Throughout the period of using the medicine, the patient should have regular check-ups.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Bonadea, is associated with an increased risk of blood clots compared to not using the therapy.
Blood clots can occur:

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also known as "arterial thromboembolism" or "arterial thrombosis"). Not all patients who have had a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Bonadea is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why might the patient be suffering from

• Swelling or a large bruise in the leg or 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;
• skin discoloration of the leg, such as pallor, redness, or cyanosis.

• Sudden unexplained shortness of breath or rapid breathing;
• Sudden unexplained cough without an obvious cause, which may be accompanied by coughing up blood;
• Sudden severe chest pain, which may worsen with deep breathing;
• Severe dizziness or fainting;
• Rapid or irregular heartbeat;
• Severe abdominal pain.
• If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).

BLOOD CLOTS IN VEINS

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these adverse effects are rare. They most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If the patient stops using Bonadea, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs (deep vein thrombosis or pulmonary embolism) due to Bonadea is small.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• It has not been established how the risk of blood clots associated with Bonadea compares to the risk associated with combined hormonal contraceptives containing levonorgestrel.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots" below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Bonadea 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^2);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have a hereditary blood coagulation disorder;
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop using Bonadea for a few weeks before surgery or immobilization. If the patient needs to stop using Bonadea, they should ask their doctor when they can resume using the medicine;
• with age (especially over 35 years old);
• if the patient has recently given birth. The risk of blood clots increases with the number of risk factors present in the patient. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor. It is essential to inform the doctor if any of these factors apply to the patient, even if they are not sure. The doctor may decide to stop the use of Bonadea.

Tell your doctor if any of the above conditions change while using Bonadea, e.g., if someone in the patient's immediate family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

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

Similarly to blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with Bonadea is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. While using a combined hormonal contraceptive like Bonadea, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has had 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, 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 even higher. Tell your doctor if any of the above conditions change while using Bonadea, e.g., if the patient starts smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

Oral contraception and cancer
Women using oral contraceptives have been found to have a slightly higher incidence of breast cancer than women of the same age who do not use oral contraceptives. The small increase in the number of diagnosed cases of breast cancer is likely due to the fact that women who use oral contraceptives are more likely to have regular check-ups, which can lead to earlier detection of breast cancer.
In rare cases, women using oral contraceptives have been found to have benign (non-cancerous) and, very rarely, malignant (cancerous) liver tumors. These tumors can cause internal bleeding. If severe abdominal pain occurs, you should consult a doctor.
The most important risk factor for cervical cancer is persistent infection with human papillomavirus. Some epidemiological studies suggest that long-term use of combined oral contraceptives may further increase this risk. However, it is not yet known to what extent other known factors (e.g., regular cervical screening and sexual behavior, including the use of barrier methods of contraception) contribute to this.
The above-mentioned cancers can be life-threatening or fatal.

PSYCHIATRIC DISORDERS

Some women using hormonal contraceptives, including Bonadea, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Bonadea and other medicines

Always inform your doctor about any medicines or herbal products you are already taking.
Additionally, you should tell any doctor or dentist who prescribes you any other medicine (or pharmacist) that you are using Bonadea. They may inform you about the need to use additional contraceptive methods (e.g., condoms) and how long to use them, and whether the use of another medicine you are taking needs to be changed.
Some medicines may affect the level of Bonadea in the blood and make it less effective in preventing pregnancyor cause unexpected bleeding. These include:

• medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, and felbamate);
• medicines used to treat tuberculosis (e.g., rifampicin);
• medicines used to treat HIV and hepatitis C virus (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or other infections;
• medicines used to treat fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole);
• medicines used to treat arthritis, degenerative joint disease (etoricoxib);
• medicines used to treat certain heart conditions, high blood pressure in the blood vessels of the lungs (pulmonary hypertension) (bosentan) - calcium channel blockers (e.g., verapamil, diltiazem);
• products containing St. John's Wort (Hypericum perforatum).

There have been reports of pregnancy after concurrent use of hormonal contraception and antibiotics, such as penicillins and tetracyclines. The mechanism of this action has not been explained.
Bonadea may also affect the action of other medicines, such as:

• lamotrigine
• cyclosporine
• theophylline
• tizanidine

Bonadea should not be used if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as this may lead to increased liver function test results (increased liver enzyme ALT). The doctor will recommend a different type of contraception before starting treatment with these medicines. About 2 weeks after finishing such treatment, you can resume using Bonadea. See section "When not to use Bonadea". You should contact your doctor immediately if you plan to start taking other medicines.

Bonadea with food and drink

Bonadea can be taken with or without food, and if necessary, the tablets can be washed down with a small amount of water.

Lab tests

If the patient is to have blood tests, they should inform their doctor or laboratory staff that they are taking Bonadea, as hormonal contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Before using any medicine, you should consult your doctor or pharmacist.
Bonadea should not be used during pregnancy or if pregnancy is suspected. If pregnancy is suspected while using Bonadea, you should stop using the medicine and consult your doctor immediately. If the patient wants to become pregnant, they can stop using Bonadea at any time (see section Stopping Bonadea)
Bonadea is not recommended during breastfeeding.
Before using a contraceptive during breastfeeding, you should consult your doctor.

Driving and using machines

No effects of the medicine on the ability to drive have been observed.

Bonadea contains lactose monohydrate and sodium

Patients who have been diagnosed with intolerance to some sugars should consult their doctor before starting to use this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to use Bonadea

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Dosage and administration

• The medicine should be taken orally. If necessary, the tablets can be washed down with a small amount of water.
• You should take one tablet a day at the same time every day (when the risk of missing a tablet is minimal), for 21 consecutive days in the order indicated by the arrows on the blister pack. One package contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken.
• For the next 7 days, you should stop taking the tablets. During these 7 days, you should have withdrawal bleeding, similar to a menstrual period. It usually occurs 2-3 days after taking the last tablet of Bonadea.
• After this 7-day break, you should start taking the medicine from the next package, regardless of whether the bleeding has stopped. This means that the next package will always be started on the same day of the week, and the withdrawal bleeding will occur around the same days every month.
• You should continue to take the medicine regularly and not forget to take the tablets.
• If you follow the above instructions, Bonadea will work immediately, and you will not need to use any other contraceptive methods. When used correctly, the failure rate of combined oral contraceptives is about 1% per year. If you miss a tablet during use or do not use the tablets correctly, the failure rate may be higher.

Using the first package of Bonadea

• -If you are not using hormonal contraception in the previous month You should start using Bonadea on the first day of your menstrual cycle, i.e., the first day of menstrual bleeding. You should take the tablet marked with the corresponding day of the week. For example, if your bleeding starts on a Friday, you should take the tablet marked "Friday". For the next days, you should continue taking the tablets in the correct order. This way of using the medicine ensures that Bonadea works immediately, and you will not need to use any other contraceptive methods.

You can also start using the medicine from the 2nd to 5th day of your menstrual cycle, but in this case, you should use additional (barrier) contraceptive methods during the first 7 days of the first cycle.

• -Changing from another combined contraceptive, vaginal ring, or transdermal patch You can start using Bonadea immediately after taking the last tablet from the previous package (i.e., without a break in taking the tablets). If the previous package contained tablets without active ingredients (tablets that do not have a contraceptive effect), you can start using Bonadea the next day after taking the last tablet with active ingredients (if you are unsure which tablets contain active ingredients, you should ask your doctor or pharmacist). You can also start taking the tablets later, but not later than the day after the break in taking the previous contraceptive (or after taking the last tablet of the previous contraceptive that does not contain active ingredients). When changing from a transdermal patch or vaginal ring, you should start using Bonadea on the day they are removed and no later than the day they would be reapplied.

If you follow the above instructions, you will not need to use any additional contraceptive methods.

• -Changing from a progestogen-only medicine (minipill) You can stop taking minipills (containing only progestogen) at any time, and you should take the first tablet of Bonadea at the same time the next day. However, you should use additional contraceptive methods (mechanical methods) during sexual intercourse during the first 7 days of the first cycle.
• Changing from injections, implants, or an intrauterine device (IUD) that releases progestogen You should start using Bonadea at the time of the scheduled injection or on the day the implant or IUD is removed. However, you should use additional contraceptive methods (mechanical methods) during sexual intercourse during the first 7 days of the first cycle.
• -Using Bonadea after childbirth It is not recommended to use Bonadea until the first natural menstrual period has occurred. Sometimes, it is possible to start using the medicine earlier. In such a case, you should consult your doctor. If you have had sexual intercourse after childbirth before starting to use Bonadea, you should exclude the possibility of pregnancy or wait for the first menstrual period. During breastfeeding, the possibility of using Bonadea should also be discussed with your doctor.
• Using Bonadea after a spontaneous or induced abortion You should consult your doctor.

Taking a higher dose of Bonadea than recommended

There are no reports of serious disorders due to taking a higher dose of Bonadea than recommended. If several tablets are taken at the same time, nausea, vomiting, or vaginal bleeding may occur. This type of bleeding may occur in girls who have not yet started menstruating but have taken the medicine by mistake. If a child takes Bonadea, you should contact a doctor.

Missing a dose of Bonadea

You should not take a double dose to make up for a missed dose.

• If the tablet is delayed by less than 12 hours, contraceptive protection is maintained. You should take the tablet as soon as you remember, and the next tablet should be taken at the usual time.
• If the tablet is delayed by more than 12 hours, contraceptive protection may be reduced. The more tablets that are missed, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is particularly high if a tablet is missed at the beginning or end of the package. Therefore, you should follow these rules (see also the scheme below).
• Missing more than one tabletYou should consult your doctor.

You should not take more than 2 tablets in one day.

If you forget to take even one tablet from the package and do not have withdrawal bleeding, it is possible that you are pregnant. Before starting the next package, you should contact your doctor.

Missing 1 tablet in the first week.

If you forget to start a new package or forget to take a tablet during the first 7 days, it is possible that you are pregnant (if you had sexual intercourse during the 7 days before missing the tablet). In this case, you should contact your doctor.
You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and subsequent tablets should be taken at the usual time. If you did not have sexual intercourse during the 7 days before missing the tablet, you should continue taking the tablets at the usual time, and for the next 7 days, you should use additional contraceptive methods (e.g., condoms).

Missing 1 tablet in the second week.

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and subsequent tablets should be taken at the usual time. The contraceptive effectiveness of the medicine is maintained, and you do not need to use additional contraceptive methods.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that you consider related to the use of Bonadea, consult a doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before taking Bonadea".

Severe side effects

Severe reactions related to the use of the contraceptive, as well as the corresponding symptoms associated with them, are described in the sections "Important information before taking Bonadea" / "Blood clots" / "Oral contraception and tumors".
Read these sections of the leaflet to get detailed information and, if necessary, consult a doctor.
Stop taking tablets and consult a doctor immediately
if any symptoms of angioedema occur, such as:swelling of the face, tongue, and
(or) throat and (or) difficulty swallowing or hives, which can cause difficulty breathing (see also "Warnings and precautions").

Consult a doctor immediately if:

a change in health occurs, especially one of the conditions described in this leaflet (see also "Important information before taking Bonadea"). Also, remember the information about close relatives.
a palpable lump in the breast appears
unusual, heavy vaginal bleeding occurs
tablets from the next package are missed during the first week of use, and during the previous 7 days, there was sexual intercourse
The above symptoms are described and explained in more detail in other parts of this leaflet.

Other possible side effects

During the concurrent use of dienogest and ethinyl estradiol (the active substances of Bonadea), the following side effects have been observed:
Frequently:may occur in 1 to 10 people
Headache
Breast pain, feeling of breast tension
Less frequently:may occur in 1 to 100 people
Vaginal and vulvar infections (vaginitis, vulvovaginitis), vaginal candidiasis, or other fungal infections of the vulva and vagina
Increased appetite
Decreased mood
Dizziness, migraine
High or low blood pressure
Abdominal pain and discomfort, nausea, vomiting, diarrhea
Acne, hair loss (alopecia), rash, itching
Abnormal withdrawal bleeding, including very heavy bleeding, very scarce bleeding, less frequent bleeding, or absence of bleeding, painful menstruation, intermenstrual bleeding, breast swelling, breast tenderness, discharge, ovarian cysts, pelvic pain
Fatigue, including weakness (asthenia) and malaise (general malaise)
Changes in body weight (increase or decrease)
Rarely:may occur in 1 to 1,000 people
Ovarian and fallopian tube inflammation, urinary tract infections, bladder inflammation (cystitis), breast inflammation (mastitis), cervical inflammation, fungal infections, candidiasis, oral herpes, flu, bronchitis
Tuberculosis, HIV infection, or other infections; also, see the "Bonadea and other medicines" section
Uterine fibroids (benign tumor of the uterus), breast lipoma (benign tumor of fatty tissue)
Anemia
Hypersensitivity (allergic reaction)
Development of male secondary sex characteristics in a woman (virilization)
Lack of appetite (anorexia)
Depression, mental disorders, sleep disorders (including insomnia), aggression
Ischemic stroke (reduced or interrupted blood flow to the brain), cerebral circulation disorders (disorders of blood flow in the brain), muscle tone changes - dystonia (persistent muscle contractions causing twisting or abnormal posture)
Dry or irritated eyes, oscillopsia (feeling that seen objects are oscillating) or other vision disorders
Sudden hearing loss, tinnitus (ringing or similar sensation in the ears), dizziness, hearing disorders
Cardiovascular disorders, tachycardia (rapid heart rate)
Painful blood clots in veins or arteries, e.g.,

• in the foot or leg (e.g., deep vein thrombosis)
• in the lungs (pulmonary embolism)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to stroke, known as transient ischemic attack
• blood clots in the liver, stomach, or intestine, kidneys, or eye The likelihood of a blood clot may be higher if other risk factors are present (more information on risk factors for blood clots and symptoms of blood clots can be found in section 2). High diastolic blood pressure, orthostatic disorders (feeling of fainting or dizziness when standing), hot flashes, varicose veins, venous disorders, phlebitis, asthma, hyperventilation Gastritis, gastrointestinal disorders, nausea

Interactions
The occurrence of intermenstrual bleeding and/or decreased contraceptive effectiveness may result from the effect of other medications (increasing enzyme activity) on concurrently used oral contraceptives [e.g., herbal products containing St. John's Wort (Hypericum perforatum), medications for epilepsy, tuberculosis, HIV infection, or other infections; also, see the "Bonadea and other medicines" section].

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Bonadea

Store the medicine in a place invisible and inaccessible to children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the package and blister. The expiry date refers to the last day of the given month.
Medicines should 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. Package contents and other information

What Bonadea contains

The active substances of Bonadea are 2.0 mg dienogest and 0.03 mg ethinyl estradiol in each tablet.
Other ingredients are:
Core: lactose monohydrate, corn starch, povidone, sodium carboxymethyl starch (type A), magnesium stearate
Coating: Aqua Polish white 014.17 MS [hypromellose (E 464), hydroxypropyl cellulose (E 463), talc (E 553b), hydrogenated cottonseed oil, titanium dioxide (E 171)].

What Bonadea looks like and what the package contains

Bonadea film-coated tablets are white, round, film-coated tablets, approximately 6.2 mm in diameter and 2.8 mm in thickness, packaged in thermoformed blisters of rigid PVC/PVDC and heat-sealed aluminum foil.
Package sizes
1 × 21 film-coated tablets
3 × 21 film-coated tablets
Not all package sizes may be marketed.

Marketing authorization holder:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 307 Prague 10, Czech Republic

Manufacturer:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 307 Prague 10, Czech Republic

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:December 2022