Bonadea

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Bonadea,
2 mg + 0,03 mg, coated tablets
Dienogestum + Ethinylestradiolum
Important information about combined hormonal contraceptives

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

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

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Bonadea is and what it is used for
2. What you need to know before taking Bonadea
3. How to take Bonadea
4. Possible side effects
5. How to store Bonadea
6. Contents of the pack and other information

1. What Bonadea is and what it is used for

Bonadea is a combined oral contraceptive (a hormonal preparation taken by mouth to prevent pregnancy). Each tablet contains a small amount of two different female sex hormones: dienogest (a progestogen) and ethinylestradiol (an oestrogen).
Since all tablets in the pack contain these two hormones in identical doses, this medicine is known as a monophasic combined oral contraceptive. Due to its low hormone content, Bonadea is considered a low-dose oral contraceptive.

What Bonadea is used for

• As a contraceptive to prevent pregnancy.
• For the treatment of women with moderate acne who have decided to use oral contraceptives and in whom adequate topical treatment or oral antibiotic therapy has failed.
• Oral contraceptives are a highly effective method of family planning. When taken regularly (without missing tablets), they reduce the chance of pregnancy to a minimum.
• Prolonged use is also possible after consultation with a doctor.

The use of combined hormonal contraceptives may offer additional health benefits beyond pregnancy prevention.

• Menstrual bleeding may become shorter and lighter, thereby reducing the risk of iron-deficiency anaemia. Menstrual pain may decrease or disappear completely.
• Furthermore, in women using contraceptives containing 50 micrograms of ethinylestradiol (high-dose contraceptives), a reduced incidence of certain serious conditions has been observed. These include benign breast disorders, ovarian cysts, pelvic infections (pelvic inflammatory disease), ectopic pregnancy (pregnancy developing outside the uterus), and cancers of the endometrium (uterine lining) and ovary. This protective effect may also apply to low-dose contraceptives, although it has so far only been confirmed for cancers of the endometrium and ovary.

2. Important information before using Bonadea

General notes
Before starting to take Bonadea, 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").
This leaflet lists situations in which you should stop taking the contraceptive medicine, or situations in which its reliability may be reduced. In such cases, you should avoid sexual intercourse or use an additional non-hormonal contraceptive method, such as a condom or another mechanical method. Do not use the calendar method or the temperature method. These methods may be unreliable because the contraceptive medicine affects changes in body temperature and cervical mucus, which 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 three to six months of treatment, but skin condition may continue to improve even after six months of treatment. You should discuss with your doctor the need for continuing treatment after three to six months, and then at regular intervals.

When not to use Bonadea
Do not use Bonadea 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 would be more suitable.
Your doctor may prescribe a different type of contraceptive or a completely different (non-hormonal) method of contraception.

• if you are allergic to oestrogen or progestagen, or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have a disorder affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a long time (see section "Blood clots");
• if you have 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 diseases 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 hyperhomocysteinaemia;
• if you currently have or have had in the past a type of migraine called "migraine with aura";
• if you currently have or have had in the past a hormone-sensitive cancer (e.g. breast or genital organ cancers);
• if you currently have or have had in the past a benign or malignant liver tumour;
• if you currently have or have had in the past any liver disease (which may present as yellowing of the skin or itching of the whole body) and liver function is still abnormal;
• if you have vaginal bleeding of unknown origin;
• if you are pregnant or suspect you may be pregnant;
• if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Bonadea with other medicines").

If any of these symptoms or conditions occur for the first time while taking the medicine, stop taking it immediately and consult your doctor. During this time, use non-hormonal contraceptive methods. See also "General notes".

Additional information for specific populations
Children
Bonadea is not indicated for use in girls who have not yet started menstruating.

Women of advanced age
Bonadea is not indicated for use in postmenopausal women.

Patients with hepatic impairment
Do not use Bonadea in women with impaired liver function. See also section "When not to use Bonadea".

Patients with renal impairment
Inform your doctor. Available data do not indicate a need to modify treatment in this patient group.

Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if you notice any probable symptoms of blood clots, which may indicate that you have blood clots in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots").
For a description of the symptoms of these serious adverse effects, see "How to recognize blood clots".

Special caution is required if a combined oral contraceptive is used in a woman who also has any of the following conditions. Your pharmacist will provide you with full explanations.
Inform your doctor if you have any of the following conditions.
If any of these symptoms appear or worsen during treatment with Bonadea, inform your doctor as well.

• 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 disease 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 affecting the natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have hypertriglyceridaemia (elevated blood fat levels) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis;
• if you require surgery or will be immobile for a long time (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Bonadea;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you or any of your close relatives have previously had a blood clot (in the leg, lungs, or other organs), heart attack, or stroke at a young age;
• if you have migraine;
• 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 currently have or have previously had other diseases or health conditions that first appeared or worsened during pregnancy or during previous use of sex hormones (e.g. hearing disorders; pigment metabolism disorders called porphyria; a skin condition called pemphigoid gestationis; a nervous system disorder called Sydenham’s chorea);
• if you currently have or have previously had brownish patches on the skin during pregnancy (so-called chloasma), you should avoid sunbathing or exposure to ultraviolet radiation while taking this medicine;
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, which may cause breathing difficulties, seek immediate medical attention. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

If any of the listed symptoms occur for the first time, recur, or worsen during treatment with Bonadea, consult your doctor.

Regular check-ups
You should have regular medical check-ups throughout the period of taking this medicine.

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

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

Complete recovery after a blood clot does not always occur. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal. It should be remembered that the overall risk of harmful blood clots caused by taking Bonadea is small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Do you experience any of these symptoms?
What might be the likely cause?

• Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may occur only when standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as pallor, redness, or blueness.
• Sudden onset of unexplained shortness of breath or rapid breathing;
• Sudden cough without obvious cause, possibly accompanied by coughing up blood;
• Sudden sharp chest pain, which may worsen on deep breathing;
• Severe dizziness or vertigo;
• Rapid or irregular heartbeat;
• Severe abdominal pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).

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). However, 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 another 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 Bonadea, 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 (deep vein thrombosis or pulmonary embolism) due to the use of Bonadea 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.
• To date, it has not been established how the risk of blood clots associated with the use of Bonadea compares to the risk associated with combined hormonal contraceptives containing levonorgestrel.

The risk of developing blood clots in veins depends on the individual's medical history (see "Factors increasing the risk of venous blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Bonadea is small, 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 has had blood clots in the legs, lungs or other organs at a young age (e.g. below 50 years of age). In this case, the patient may have an inherited tendency to clotting;
• if the patient needs to undergo surgery, if she is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Bonadea several weeks before surgery or reduced mobility. If the patient has to stop taking Bonadea, ask the doctor when it is safe to restart;
• with increasing age (particularly over 35 years);
• if the patient has given birth within the last few weeks.

The risk of blood clots increases with the number of risk factors present in the
patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
especially if the patient has another risk factor present.
It is important to tell the doctor if any of these risk factors apply to the patient,
even if uncertain. The doctor may decide to stop the use of Bonadea.
Inform the doctor if any of the above conditions change during treatment with
Bonadea, e.g. if a close family member is diagnosed with thrombosis without
a known cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial clots can lead to serious
consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to note that the risk of heart attack or stroke associated with the use of Bonadea
is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a combined hormonal contraceptive such as Bonadea, 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 a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is
particularly severe, the risk of blood clots may be further increased. Inform the doctor if any of the above conditions change during treatment with
Bonadea, e.g. if the patient starts smoking, if a close family member is diagnosed with
thrombosis without a known cause, or if the patient gains significant weight.

Oral contraception and cancer
Breast cancer has been diagnosed slightly more frequently in women using hormonal contraceptives than in women of the same age not using oral contraception. This small increase in diagnosed cases gradually disappears within 10 years after stopping the contraceptive. It is not known whether this difference is caused by taking the contraceptive. The reason for this association may be that women using contraceptives are examined more frequently, leading to earlier detection of cancer.

In rare cases, benign (non-malignant) and, even more rarely, life-threatening (malignant) liver tumours have been observed in women using hormonal contraceptives. These tumours may cause internal bleeding (haemorrhage). If severe abdominal pain occurs, consult a doctor immediately.

The most important risk factor for cervical cancer is persistent infection with human papillomavirus. Results from some epidemiological studies suggest that long-term use of combined hormonal 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 behaviour, including use of barrier contraception) contribute to this.

The above-mentioned tumours may be life-threatening or lead to 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 or symptoms of depression occur, contact the 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 currently taking.
Also, tell any doctor, dentist or pharmacist who prescribes you another medicine that you are taking Bonadea. They can advise you whether additional contraceptive methods (e.g. condoms) are needed, how long to use them, and whether your current treatment needs to be adjusted.

Some medicines may affect the blood levels of Bonadea and may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include medicines:

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

Cases of pregnancy have been reported with concomitant use of hormonal contraception and antibiotics such as penicillins and tetracyclines. However, the mechanism of this interaction has not been explained.

Bonadea may also affect the action of other medicines, such as:

• lamotrigine
• cyclosporine
• theophylline
• tizanidine

Do not take Bonadea 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 blood test results (elevated levels of the liver enzyme AlAT). The doctor will recommend another type of contraception before starting treatment with these medicines. Bonadea may be restarted approximately 2 weeks after completing such treatment. See section “When not to take Bonadea”. Contact the doctor immediately if the patient plans to start taking other medicines.

Bonadea with food and drink
Bonadea may be taken with or without food. If needed, tablets may be taken with a small amount of water.

Laboratory tests
If the patient is due to have blood tests, she should inform the doctor or laboratory staff that she is taking Bonadea, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Before taking any medicine, consult a doctor or pharmacist. Do not take Bonadea during pregnancy or if pregnancy is suspected. If pregnancy is suspected while taking Bonadea, stop taking the medicine and consult a doctor immediately. If the patient wishes to become pregnant, she may stop taking Bonadea at any time (see section Stopping Bonadea).
Bonadea is not recommended during breastfeeding.
Before using a contraceptive during breastfeeding, consult a doctor.

Driving and using machines
No effect on the ability to drive has been observed.

Bonadea contains lactose monohydrate and sodium
Patients diagnosed with intolerance to certain sugars should consult their doctor before starting this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Bonadea

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dosage and administration

• This medicine should be taken orally. If necessary, tablets may be taken with a small amount of water.
• Take one tablet daily at the same time each day (when the risk of missing a dose is minimal), for 21 consecutive days in the order indicated by the arrows on the blister pack. One pack contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken.
• For the following 7 days, stop taking tablets. During these 7 days, a withdrawal bleed, similar to menstruation, should occur. It usually appears 2–3 days after taking the last tablet of Bonadea.
• After this 7-day break, i.e. on the 8th day, start taking tablets from a new pack, regardless of whether bleeding is still ongoing. This means that each new pack will always be started on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.
• Continue taking the medicine regularly and do not forget to take the tablets.
• If the above instructions are followed correctly, Bonadea provides immediate contraceptive protection and there is no need to use additional contraceptive methods. When combined oral contraceptives are used correctly, the failure rate is approximately 1% per year. However, if a tablet is missed or the tablets are not taken correctly, the failure rate may be higher.

Starting the first pack of Bonadea

• If you have not used hormonal contraception in the previous month, start taking Bonadea on the first day of your cycle, i.e. the first day of menstrual bleeding. Take the tablet marked with the appropriate day of the week. For example, if bleeding starts on Friday, take the tablet marked with the abbreviation for "Friday" (see "Translation of symbols for days of the week on each tablet in the immediate packaging" at the end of the leaflet). Continue taking the tablets in the correct order on subsequent days. This method ensures immediate contraceptive effect, and no additional contraceptive methods are required.

You may also start taking the medicine between day 2 and day 5 of the cycle, but in this case,
additional barrier methods of contraception must be used for the first 7 days of the first cycle.

• Switching from another combined oral contraceptive, vaginal ring, or transdermal contraceptive patch You may start Bonadea the day after taking the last active tablet of your previous contraceptive (meaning no break between packs). If your previous pack also contained inactive tablets (tablets without contraceptive effect), start Bonadea the day after taking the last active tablet (if in doubt about which tablets contain active ingredients, consult your doctor or pharmacist). You may also start Bonadea later, but no later than the day after the break in your previous contraceptive method (or after taking the last inactive tablet of your previous contraceptive). If switching from a contraceptive patch or vaginal ring, start Bonadea preferably on the day of removal and no later than the day when reapplication would normally occur.

If the above recommendations are followed, no additional contraceptive methods are required.

• Switching from a progestogen-only pill (mini-pill) You may stop taking the mini-pill (containing only progestogen) at any time and take the first tablet of Bonadea at the same time the next day. However, you must use additional contraceptive methods (barrier methods) during sexual intercourse for the first 7 days of the first cycle.
• Switching from an injection, implant, or intrauterine device releasing progestogen (IUD) Start taking Bonadea on the day the injection is due or on the day the implant or IUD is removed. However, you must use additional contraceptive methods (barrier methods) during sexual intercourse for the first 7 days of the first cycle.
• Use after childbirth

Bonadea should not be used after childbirth until the first physiological menstruation occurs.
However, earlier initiation may sometimes be possible. In such cases, consult your doctor.
If sexual intercourse has occurred after childbirth before starting Bonadea, pregnancy must be
excluded or you must wait for the first menstrual bleed.
The use of Bonadea during breastfeeding should also be discussed with your doctor.

• Use after spontaneous or induced abortion Consult your doctor.

Accidental overdose of Bonadea
There are no reports of any serious health problems following a single ingestion of more than the
recommended number of Bonadea tablets. If several tablets are taken at once, nausea, vomiting, or
vaginal bleeding may occur. Such bleeding may occur in girls who have not yet started menstruating
but have accidentally taken this medicine. If a child has taken Bonadea, contact a doctor immediately.
Missed dose of Bonadea
Do not take a double dose to make up for a missed dose.

• If a tablet is taken less than 12 hours late, contraceptive protection remains effective. Take the tablet as soon as you remember, and take the next tablet at the usual time.
• If a tablet is taken more than 12 hours late, contraceptive protection may be reduced. The more consecutive tablets 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 pack. Therefore, follow the instructions below (see also the diagram below).
• Missing more than one tablet Consult your doctor.

Do not take more than 2 tablets in one day.
If you forget to take even one tablet from the pack and no withdrawal bleeding occurs, you may be
pregnant. Contact your doctor before starting the next pack.
Missing 1 tablet in the first week.
If you forget to start a new pack or forget to take a tablet during the first 7 days, you may be pregnant
(if you had sexual intercourse in the 7 days before missing the tablet). In this case, contact your doctor.
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time),
and continue taking the following tablets at the usual time, provided you did not have sexual
intercourse in the 7 days before the missed tablet. For the next 7 days, continue taking tablets at
the usual time and use additional contraceptive methods (e.g. condoms).
Missing 1 tablet in the second week.
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time),
and continue taking the next tablets at the usual time. Contraceptive effectiveness is maintained,
and no additional contraceptive methods are required.
Missing 1 tablet in the third week.
You may choose one of the following two options:

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the next tablets at the usual time. Start the next pack immediately after finishing the current one, without a break. Withdrawal bleeding will occur after finishing the second pack, but breakthrough bleeding or spotting may occur during tablet-taking days.
2. You may also stop taking tablets from the current pack, take a 7-day break (including the day the tablet was missed), and then continue with tablets from the next pack.

If you follow either of these two options, you will remain protected against pregnancy.

Stopping Bonadea
You may stop taking Bonadea at any time. If you plan to become pregnant, it is recommended to start
trying to conceive after the first normal menstrual period following discontinuation. This will help
determine the due date.
If you are not planning pregnancy, consult your doctor to choose another contraceptive method.
What to do if:

• gastrointestinal disturbances occur (e.g. vomiting, severe diarrhoea) If vomiting or severe diarrhoea occurs, the active ingredients in Bonadea may not be fully absorbed. If vomiting occurs more than 3–4 hours after taking the tablet, the effect is the same as missing a tablet. Follow the instructions for a missed tablet. In case of severe diarrhoea, contact your doctor.
• you wish to delay the onset of bleeding To delay bleeding, continue taking tablets from the next pack immediately after finishing the current pack. You may continue taking tablets as needed until the pack is finished. If you wish bleeding to occur, simply stop taking tablets. Breakthrough bleeding or spotting may occur during the intake of tablets from the next pack. Start the following pack after the usual 7-day break.
• you wish to change the day when bleeding starts If you take the tablets as directed, bleeding occurs on approximately the same days every 4 weeks. To change the bleeding days, shorten (but never extend) the next tablet-free interval. For example, if bleeding usually starts on Fridays and you wish it to start on Tuesdays (3 days earlier), start the next pack 3 days earlier than usual. If the break is too short (e.g. 3 days or less), bleeding may not occur during the break. However, spotting or breakthrough bleeding may occur during tablet intake from the next pack.
• unexpected bleeding occurs When using any contraceptive tablet, irregular vaginal bleeding (spotting or breakthrough bleeding) may occur between withdrawal bleeds, especially during the first few months of use. You may need to use sanitary pads, but continue taking tablets according to the regular schedule. These irregularities usually resolve after the body adjusts to the medicine (usually after 3 cycles). However, if these problems persist, bleeding becomes heavier, or recurs after a period of regular bleeding, consult your doctor.
• no bleeding occurs If all tablets were taken on time, there were no episodes of vomiting or severe diarrhoea, and no other medicines were taken, pregnancy is very unlikely. Continue taking Bonadea as usual. If bleeding does not occur for two consecutive months, pregnancy is possible. Contact your doctor immediately. Do not start the next pack until your doctor has ruled out pregnancy.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health which the patient considers to be related to the use of Bonadea, a doctor should be consulted.

All women using combined hormonal contraceptives have an increased risk of developing venous blood clots (venous thromboembolic disease) or arterial blood clots (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 taking Bonadea".

Serious adverse effects
Serious reactions related to contraceptive use, as well as associated symptoms, are described in the sections "Important information before taking Bonadea"/"Blood clots"/"Oral contraception and cancer".
Please read these sections of the leaflet for detailed information and contact your doctor if necessary.

Immediately stop taking the tablets and contact your doctor if any symptoms of angioedema occur, such as:
swelling of the face, tongue and (or) throat and (or) difficulty swallowing or hives, which may cause difficulty breathing (see also section "Warnings and precautions").

Contact your doctor promptly if:

• there is a change in health status, particularly any of the conditions described in this leaflet (see also "Important information before taking Bonadea"). Also remember to consider information regarding close relatives.
• a palpable lump in the breast appears
• unusual, heavy vaginal bleeding occurs
• tablets from the next pack are missed during the first week of use, and sexual intercourse occurred during the previous 7 days

The symptoms listed above are described and explained in more detail in other sections of this leaflet.

Other possible adverse effects
The following adverse effects have been observed during concomitant use of dienogest and ethinylestradiol (active substances in Bonadea):

Common: may occur in 1 to 10 users

• Headache
• Breast pain, breast tenderness

Uncommon: may occur in 1 to 100 users

• Vulvovaginal infections (vaginitis, vulvovaginitis), vaginal candidiasis or other fungal infections of the vulva and vagina
• Increased appetite
• Depressed mood
• Dizziness, migraine
• High or low blood pressure
• Abdominal pain and discomfort, nausea, vomiting, diarrhoea
• Acne, alopecia (hair loss), rash, itching
• Withdrawal bleeding abnormalities, including very heavy bleeding, very light bleeding, less frequent bleeding or absence of bleeding, painful menstruation, intermenstrual bleeding, breast swelling, breast tenderness, hot flushes, ovarian cysts, pelvic pain
• Fatigue, including weakness (asthenia) and malaise (general discomfort)
• Changes in body weight (increase or decrease)

Rare: may occur in 1 to 1,000 users

• Oophoritis and salpingitis, urinary tract infection, cystitis (bladder inflammation), mastitis (breast inflammation), cervicitis, fungal infections, candidiasis, oral herpes, influenza, bronchitis, sinusitis, upper respiratory tract infections, viral infection
• Uterine leiomyoma (benign uterine tumor), lipoma of the breast (benign fatty tissue tumor)
• Anaemia
• Hypersensitivity (allergic reaction)
• Development of male secondary sexual characteristics in women (virilization)
• Loss of appetite (anorexia)
• Depression, psychiatric disorders, sleep disorders (including insomnia), aggression
• Ischaemic stroke (reduced or interrupted blood supply to the brain), cerebral circulation disorders (disturbances in blood flow to the brain), muscle tone changes – dystonia (sustained muscle contractions causing twisting or abnormal postures)
• Dry or irritated eyes, oscillopsia (sensation that seen objects are oscillating), or other visual disturbances
• Sudden hearing loss, tinnitus (ringing or similar sound sensation in the ears), dizziness, hearing disturbances
• Cardiovascular disorders, tachycardia (rapid heartbeat)
• 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 stroke-like symptoms, known as transient ischaemic attack
  • blood clots in the liver, stomach or intestine, kidneys or eye

The likelihood of developing a blood clot may be higher if other risk factors increasing this risk are present (more information on risk factors for blood clots and symptoms of blood clots can be found in section 2). Diastolic hypertension, orthostatic disturbances (feeling of fainting or dizziness in upright position), hot flushes, varicose veins, venous disorders, vein pain. Asthma, hyperventilation. Gastritis and enteritis, dyspepsia. Skin reactions, including allergic reactions, neurodermatitis/atopic dermatitis, rash, psoriasis, excessive sweating, chloasma (skin pigmentation, mainly on the face, usually occurring during pregnancy), pigmentary disorders, seborrhoea, dandruff, hirsutism, "orange peel" skin appearance, spider angioma. Back pain, musculoskeletal disorders, muscle and limb pain. Abnormal cell growth on the cervix (cervical dysplasia), pain or cysts in the ovary or fallopian tubes, breast cysts, benign breast lumps (fibroadenomas), pain during sexual intercourse (dyspareunia), galactorrhoea, menstrual disorders. Chest pain, peripheral oedema, influenza-like illnesses, inflammation, fever, irritability. Increased blood triglyceride levels, hypercholesterolaemia.

Frequency cannot be determined for the following adverse effects: mood changes, increased or decreased libido, intolerance to contact lenses, urticaria, skin disorders such as erythema nodosum and erythema multiforme, nipple discharge, fluid retention.

Description of selected adverse effects
Adverse effects with very low frequency or delayed onset, considered to be associated with the group of combined oral contraceptives, are listed below (see also section "Important information before taking Bonadea"):

Tumours

• A slightly increased number of breast cancer cases has been observed in women using combined oral contraceptives. Since breast cancer is rare in women under 40 years of age, the number of diagnosed cases is small in relation to the overall risk of breast cancer. A causal relationship between combined oral contraceptives and breast cancer is not known.
• Liver tumours (benign and malignant)

Other conditions

• Increased risk of pancreatitis in women with hypertriglyceridaemia during use of combined oral contraceptives
• Hypertension
• Occurrence or worsening of symptoms, the relationship of which to the use of combined oral contraceptives is not established: jaundice and (or) pruritus 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), haemolytic-uraemic syndrome (a disease caused by blood clots), a nervous system disorder called Sydenham's chorea, herpes gestationis (a blistering skin disease during 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 (brownish or dark skin pigmentation)

Interactions
Breakthrough bleeding and (or) reduced contraceptive effectiveness may result from the action of other medicines (inducing enzyme activity) on concomitantly used oral contraceptives [e.g. herbal products containing St. John's wort (Hypericum perforatum), medicines for epilepsy, tuberculosis, HIV infection or other infections; see also section "Bonadea with other medicines"].

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse effects helps to gather more information on the safety of this medicine.

5. How to store Bonadea

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Bonadea contains
The active substances are 2 mg dienogest and 0.03 mg ethinylestradiol in each tablet.
Other ingredients are:
Tablet core: lactose monohydrate, corn starch, povidone (30 LP), sodium carboxymethyl starch (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 contents of the pack
Bonadea coated tablets are white, round, film-coated tablets with a diameter of approximately 6.2 mm and a thickness of approximately 2.8 mm, packed in PVC/PVDC-Aluminium blisters in a cardboard box.

Pack sizes:
1 × 21 film-coated tablets
3 × 21 film-coated tablets

A cardboard pouch is included in the package, into which the blister should be placed.
For more detailed information, please contact the responsible entity or parallel importer.

Marketing Authorisation Holder in Germany, 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 Měcholupy
102 37 Prague 10
Czech Republic

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Number of Marketing Authorisation in Germany, country of export:
85865.00.00

Number of Parallel Import Authorisation: 162/24

Translation of weekday symbols printed on each tablet in the immediate packaging:
MO – Monday
DI – Tuesday
MI – Wednesday
DO – Thursday
FR – Friday
SA – Saturday
SO – Sunday