Bonadea

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language

Bonadea,

2 mg + 0.03 mg, 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").

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. 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 pack and other information

1. What is Bonadea and what is it used for

Bonadea is an oral combined contraceptive (taken orally to prevent pregnancy). Each tablet contains a small amount of two different female sex hormones. These are: dienogest (progestogen) and ethinylestradiol (estrogen). Since all tabletsin the package 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 dose of hormones.

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 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 possibility of pregnancy.
• Longer use is also possible after consulting a doctor.

The use of a combined contraceptive can also bring 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 taking 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 inflammatory disease (inflammatory diseases of the pelvic organs), ectopic pregnancy (embryo developing outside the uterus), and endometrial cancer (uterine lining cancer) and ovarian cancer. This phenomenon may also apply to low-dose drugs, but so far it has only been confirmed for endometrial and ovarian cancer.

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 in which it is necessary to stop using the contraceptive or situations in which 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 changes and cervical mucus composition that normally occur during the menstrual cycle. Bonadea, like other oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Bonadea

Bonadea should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive 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 have 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 a transient ischemic attack (transient 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);
• a disease called 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 color 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
The medicinal product Bonadea is not intended for use in girls who have not yet started menstruating.
Elderly patients
The medicinal product 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 tell 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 see your doctor immediately
if you notice any of the following symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood clots").
To get a description of the serious side effects listed, see "How to recognize a blood clot".
If a combined oral contraceptive is used in a patient who also has any of the following diseases, special caution is required. 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 hereditary disease of red blood cells);
• if you have a high level of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have recently given birth, 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; metabolic disorders of blood pigment called porphyria; a skin disease called herpes gestationis; a nervous system disease called Sydenham's chorea);
• if you have or have had brown spots on the skin (chloasma) during pregnancy, you should avoid sunbathing or exposure to ultraviolet radiation while using Bonadea;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, 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

During the entire 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. In rare cases, a blood clot can block a blood vessel and cause serious complications. Blood clots can occur:

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

Remember that the overall risk of serious blood clots caused by using Bonadea is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should see your doctor immediately if you notice any of the following symptoms.
Do you experience any of these symptoms?
Why is the patient likely to suffer

• Swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt while standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or cyanosis. Deep vein thrombosis
• Sudden unexplained shortness of breath or rapid breathing;
• Sudden unexplained cough, 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 see your doctor, because some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold). Pulmonary embolism

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 side 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 moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

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

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

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) caused by using Bonadea is small.

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimat will develop blood clots.
• So far, it has not been determined how the risk of blood clots associated with using Bonadea compares to the risk associated with using 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 in veins" below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with using 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/m2);
• 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 hereditary coagulation disorders;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop 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 tell the doctor if any of the above factors apply to the patient, even if they are not sure. The doctor may decide to stop using Bonadea. If any of the above conditions change while using Bonadea, the patient should tell their doctor (e.g., if someone in their 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 cause 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 using Bonadea is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. When 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 (heart 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 severe, the risk of blood clots may be even higher. If any of the above conditions change while using Bonadea, the patient should tell their doctor (e.g., if they start 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 In women using oral contraceptives, breast cancer has been diagnosed slightly more often than in women of the same age who do not use oral contraceptives. The small increase in the number of diagnosed cases of breast cancer gradually disappears within 10 years of stopping the use of oral contraceptives. It is not known whether this difference is caused by the use of oral contraceptives. The reason for this relationship may be that women using oral contraceptives are more likely to have regular check-ups and therefore breast cancer is diagnosed earlier. In individual cases, women using oral contraceptives have been observed to have benign (non-cancerous) and, much more rarely, life-threatening (cancerous) liver tumors. These tumors can cause internal bleeding. If severe abdominal pain occurs, the patient should consult a doctor. The most important risk factor for cervical cancer is persistent infection with the human papillomavirus. The results of 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 cause death.

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, the patient should contact their doctor as soon as possible to receive further medical advice.

Bonadea and other medicines

Always inform your doctor about the medicines or herbal products you are already taking. Additionally, 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 cause it to be less effective in preventing pregnancyor may 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 infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or other infections;
• medicines used to treat fungal infections (griseofulvin, azole antifungal medicines, e.g., itraconazole, voriconazole, fluconazole);
• medicines used to treat arthritis, degenerative joint disease (etoricoxib);
• medicines used to treat certain heart diseases, 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 an increase in liver function test results (increase in 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, Bonadea can be used again. See section "When not to use Bonadea". If the patient plans to start taking other medicines, they should contact their doctor immediately.

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 tell 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, the patient should consult their doctor or pharmacist. Bonadea should not be used during pregnancy or if pregnancy is suspected. If pregnancy is suspected while using Bonadea, the patient should stop using the medicine and consult their 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, the patient should consult their doctor.

Driving and using machines

No effect of the medicine on the ability to drive and use machines has 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 the doctor or pharmacist. In case of doubt, the patient should consult their 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.
• One tablet should be taken every day at the same time, 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, the patient should stop taking the tablets. During these 7 days, withdrawal bleeding should occur, similar to a menstrual period. It usually starts 2-3 days after taking the last tablet of Bonadea.
• After this 7-day break, the patient 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 approximately on the same days every month.
• The patient should continue to take the medicine regularly and not forget to take the tablets.
• When following the above instructions, Bonadea works immediately, and there is no need to use other contraceptive methods. When used correctly, combined oral contraceptives have a failure rate of about 1% per year. If a tablet is missed during use or the tablets are not taken correctly, the failure rate may be higher.

Using the first package of Bonadea

• In case of not using hormonal contraception in the previous month The patient should start using Bonadea on the first day of their menstrual cycle, i.e., the first day of menstrual bleeding. They should take the tablet marked with the corresponding day of the week. For example, if the bleeding starts on a Friday, the patient should take the tablet marked with the abbreviation "Friday" (see "Translation of day of the week symbols on the packaging" at the end of the leaflet). For the next days, the patient should continue taking the tablets in the correct order. This way of using the medicine ensures that Bonadea works immediately, and there is no need to use other contraceptive methods.

The use of the medicine can also be started between the 2nd and 5th day of the menstrual cycle, but in this case, the patient should use additional barrier methods of contraception during the first 7 days of the first cycle.

• Changing from another combined contraceptive, vaginal ring, or transdermal patch The patient can start using Bonadea the day after taking the last tablet from the previous package (this means no break in taking the tablets). If the previous package contained tablets without active substances (tablets that do not have a contraceptive effect), the patient can start using Bonadea the day after taking the last tablet containing an active substance (if in doubt about which tablets contain an active substance, the patient should ask their doctor or pharmacist). The use of tablets can also be started later, but no 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 an active substance). In the case of a transdermal patch or vaginal ring, the patient should start using Bonadea on the day they are removed and no later than the day they are to be reapplied.

When following the above instructions, there is no need to use any additional contraceptive methods.

• Changing from a progestogen-only medicine (minipill) The patient can stop taking the minipill at any time, and the first tablet of Bonadea should be taken at the same time the next day. However, the patient should use additional barrier methods of contraception (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 The patient should start using Bonadea at the time of the scheduled injection or on the day the implant or IUD is removed. However, the patient should use additional barrier methods of contraception (mechanical methods) during sexual intercourse during the first 7 days of the first cycle.
• Using Bonadea after childbirth

Bonadea should not be used after childbirth until the first natural menstrual period has occurred. Sometimes it is possible to start using the medicine earlier. In such a case, the patient should consult their doctor. If the patient has had sexual intercourse after childbirth before starting to use Bonadea, it is necessary to rule out pregnancy or wait for the first menstrual period. During breastfeeding, the possibility of using Bonadea should also be discussed with the doctor.

• Using Bonadea after a miscarriage or abortion The patient should consult their doctor.

Taking a higher dose of Bonadea than recommended

There are no reports of serious health disorders in case of accidentally taking a higher dose of Bonadea tablets. In case of accidentally taking several tablets, the patient may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur in girls who have not yet started menstruating but have taken the medicine by mistake. If a child has taken Bonadea, the patient should contact their doctor.

Missing a dose of Bonadea

The patient should not take a double dose to make up for the missed dose.

• If the tablet is delayed by less than 12 hours, contraceptive protection is maintained. The patient should take the tablet as soon as they 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 especially high if a tablet is missed at the beginning or end of the package. Therefore, the patient should follow these rules (see also the scheme below).
• Missing more than one tabletThe patient should consult their doctor.

The patient should not take more than 2 tablets in one day.

If the patient forgets to take even one tablet from the package and does not experience withdrawal bleeding, it is possible that they are pregnant. Before starting the next package of Bonadea, the patient should consult their doctor.

Missing 1 tablet in the first week.

If the patient forgets to start a new package or misses a tablet during the first 7 days, it is possible that they are pregnant (if they had sexual intercourse during the 7 days before missing the tablet). In this case, the patient should consult their doctor. The patient 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. For the next 7 days, the patient should continue taking the tablets at the usual time and use additional contraceptive methods (e.g., condoms).

Missing 1 tablet in the second week.

The patient 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 Bonadea is maintained, and there is no need to use additional contraceptive methods.

4. Possible Side Effects

Like all medications, Bonadea 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, you should consult a doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should 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, are described in the "Important information before taking Bonadea" / "Blood clots" / "Oral contraception and tumors" sections.
You should read these sections of the leaflet to get detailed information and, if necessary, consult a doctor.
You should stop taking the pills immediately and consult a doctor if you experience
any symptoms of angioedema, such as:swelling of the face, tongue, and (or) throat, and
(or) difficulty swallowing or hives, which can cause difficulty breathing (see also the "Warnings and precautions" section).

You Should Contact 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"). You should also remember the information about close relatives.
a palpable lump is found in the breast
unusual, heavy vaginal bleeding occurs
pills from the next pack 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 ethinylestradiol (the active substances of Bonadea), the following side effects have been observed:
Frequent:may occur in 1 to 10 people
Headache
Breast pain, feeling of breast tension
Uncommon: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
Irregular withdrawal bleeding, including very heavy or very scarce bleeding, less frequent bleeding, or absence of bleeding, painful menstruation, breakthrough bleeding, breast engorgement, breast tenderness, discharge, ovarian cysts, pelvic pain
Fatigue, including weakness (asthenia) and malaise (general malaise)
Weight changes (increase or decrease)
Rare: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, sinusitis, upper respiratory tract infections, viral infections
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)
Loss 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 sound 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 a stroke, known as a 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 a blood clot 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 Gastroenteritis, indigestion Allergic reactions, including neurodermatitis/atopic dermatitis, rash, psoriasis, excessive sweating, chloasma (skin discoloration, mainly on the face, usually occurring during pregnancy), pigmentation disorders, seborrhea, dandruff, hirsutism, "orange peel" skin, telangiectasia Back pain, musculoskeletal disorders, muscle and limb pain Abnormal growth of cells on the cervix (cervical dysplasia), pain or cysts in the ovary or fallopian tube, breast cysts, benign breast tumors (fibroadenoma), painful intercourse (dyspareunia), galactorrhea, menstrual disorders Chest pain, peripheral edema, flu-like illnesses, inflammation, fever, irritability Increased triglyceride levels in the blood, hypercholesterolemia.

The frequency cannot be determined for the following side effects: mood changes, increased or decreased libido, intolerance to contact lenses, hives, skin disorders such as erythema multiforme and Stevens-Johnson syndrome, breast discharge, fluid retention.

Description of Selected Side Effects

Side effects with a very low frequency or delayed onset of symptoms that are considered related to the group of combined oral contraceptives are listed below (see also the "Important information before taking Bonadea" section):
Tumors

• The number of breast cancer cases in women using combined oral contraceptives is slightly increased. Since breast cancer is rare in women under 40 years old, the number of diagnoses is small compared to the overall risk of breast cancer. The causal relationship between combined oral contraceptives and breast cancer is unknown.
• liver tumors (benign and malignant)

Other conditions

• Increased risk of pancreatitis during the use of combined oral contraceptives in women with hypertriglyceridemia
• Hypertension
• Occurrence or worsening of symptoms, whose relationship to the use of combined oral contraceptives is not established: jaundice and (or) itching associated with cholestasis (a condition in which bile cannot flow out of the liver), gallstones, porphyria (a metabolic disorder), systemic lupus erythematosus (a chronic autoimmune disease), hemolytic-uremic syndrome (a disease caused by blood clots), Sydenham's chorea (a neurological disorder), herpes gestationis (a blistering skin disease in pregnancy), otosclerosis associated with hearing loss
• Liver function disorders
• Changes in glucose tolerance or effects on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma (brown or dark skin discoloration)

Interactions
The occurrence of breakthrough bleeding and (or) reduced 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; see also the "Bonadea and other medications" section].

Reporting Side Effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medication.

5. How to Store Bonadea

The medication should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use this medication after the expiration date stated on the packaging and blister. The expiration date refers to the last day of the given month.
Medications should not be disposed of in wastewater or household waste containers. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Bonadea Contains

The active substances of Bonadea are 2 mg dienogest and 0.03 mg ethinylestradiol in each tablet.
Other ingredients are:
Core: lactose monohydrate, cornstarch, povidone (30 LP), sodium carboxymethylcellulose (type A), magnesium stearate
Coating: AquaPolish white 014.17 MS [hypromellose (E 464), hydroxypropylcellulose (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 with a diameter of approximately 6.2 mm and a thickness of approximately 2.8 mm, packaged in PVC/PVDC-Aluminum blisters in a cardboard box.
Package sizes
1 × 21 film-coated tablets 3 × 21 film-coated tablets
A cardboard sleeve is attached to the packaging, in which the blister should be placed.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Germany, the Country of Export:

Zentiva Pharma GmbH
Brüningstraße 50
65926 Frankfurt am Main
Germany

Manufacturer:

Winthrop Arzneimittel GmbH
Brüningstraße 50
65926 Frankfurt am Main
Germany
Zentiva, k. s.
U Kabelovny 130, Dolní Mĕcholupy
102 37 Prague 10
Czech Republic

Parallel Importer:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Germany, the country of export:

• 85865.00.00

Parallel import authorization number: 162/24
Translation of day-of-the-week symbols on the packaging:
MO – Monday
DI – Tuesday
MI – Wednesday
DO – Thursday
FR – Friday
SA – Saturday
SO – Sunday

Date of Leaflet Approval: 22.04.2024

[Information about the trademark]