Dionelle

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dionelle (Finic 0.03 mg/2 mg Film-coated Tablets)

0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest
Dionelle and Finic 0.03 mg/2 mg Film-coated Tablets are different trade names for the same medicine.

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

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.
• You should be vigilant and see a doctor if you suspect that you have symptoms of a blood clot (see section 2 "Blood clots").

Table of contents of the leaflet

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

1. What is Dionelle and what is it used for

Dionelle is a medicinal product

• used to prevent pregnancy (contraceptive pill).
• to treat women with moderate acne who have decided to use the contraceptive pill and have not responded to appropriate local treatment or oral antibiotic treatment.

Each of the 21 tablets contains a small amount of female hormones called ethinylestradiol and dienogest. Contraceptive pills that contain two hormones are called "combined pills" or "combined hormonal contraceptives". In women with acne caused by the increased activity of male sex hormones (so-called androgens), clinical trials have shown that Dionelle alleviates the symptoms of this disease.

2. Important information before using Dionelle

General notes
Before starting to use Dionelle, you should read the information about blood clots in section 2. It is especially important to read the information about the symptoms of a blood clot - see section 2 "Blood clots".
Before starting to take Dionelle, the doctor will ask you a few questions to gather your personal and family medical history. The doctor will also measure your blood pressure and, depending on the individual situation, may perform other tests.
This leaflet describes several situations in which you should stop using Dionelle or in which the effectiveness of Dionelle may be reduced. In such situations, you should not have sexual intercourse or use additional non-hormonal contraceptive methods, such as a condom or other mechanical methods. You should not use the calendar method or the temperature method. These methods may be unreliable because Dionelle modifies the monthly changes in body temperature and cervical mucus.

Like other hormonal contraceptives, Dionelle does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Improvement in acne symptoms usually occurs between the third and sixth month of treatment, but skin condition may continue to improve even after six months of treatment. You should discuss with your doctor the need to continue treatment after three to six months of treatment and regularly thereafter.

When not to use Dionelle

You should not use Dionelle if you have any of the following conditions. If you have any of the following conditions, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable for you.
You should not use Dionelle:

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized 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 disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• if you have 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 you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) pancreatitis with very high levels of fats in the blood (lipids) (hypertriglyceridemia);
• if you have had severe liver disease (until liver function tests return to normal);
• if you have had or have benign or malignant liver tumors;
• if you have (or are suspected to have) a malignant hormone-dependent cancer of the genital organs or breast;
• if you have bleeding from the genital tract of unknown cause;
• if you are allergic to ethinylestradiol or dienogest or any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions occur for the first time while using Dionelle, you should stop using the medicine immediately and consult a doctor. During this time, use non-hormonal methods of contraception. For more information, see also the section "Warnings and precautions".
You should not use Dionelle in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Dionelle and other medicines").

Warnings and precautions

When to be particularly careful when using Dionelle

When to contact a doctor?
You should contact a doctor immediately
if you notice possible symptoms of a blood clot, which may indicate a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots").
Description of the symptoms of these serious side effects, see "How to recognize a blood clot".

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

In some situations, when using Dionelle or any other combined pill, it is necessary to be particularly careful, and your doctor may perform regular check-ups on you.
If a condition occurs or worsens while using Dionelle, you should also tell your doctor:

• 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 been told you have high levels of fats in the blood (hypertriglyceridemia) or if this condition occurs in your close family. 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 just given birth, you are at a higher risk of blood clots. You should consult your doctor to find out how soon you can start using Dionelle after giving birth.
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have heart valve problems or heart rhythm disorders;
• if there is a history of breast cancer in your close family;
• if you have liver or gallbladder disease, gallstones;
• if you have jaundice or itching due to bile duct obstruction;
• if you have patchy, brown skin discoloration, especially on the face (chloasma), or if it occurred in early pregnancy; in this case, you should avoid strong sunlight and UV radiation;
• if you have certain blood disorders (porphyria);
• if you have depression;
• if you have epilepsy;
• if you have Sydenham's chorea (a disease that affects movement);
• if you had a rash with blisters in early pregnancy (pregnancy pemphigoid);
• if you have had a loss of hearing in the inner ear (hearing loss associated with otosclerosis).
• If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with difficulty breathing, you should contact a doctor immediately. Estrogen-containing products may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives such as Dionelle is associated with an increased risk of blood clots, compared to not using them.
In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (so-called venous thromboembolism or deep vein thrombosis);
• in arteries (so-called arterial thromboembolism or arterial thrombosis).

Not everyone who has a blood clot will recover completely. 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 Dionelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact a doctor immediately if you notice any of the following symptoms.

Do you have any of these symptoms? Likely cause of the condition

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis, 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,
• change in skin color in the affected leg, such as pallor, redness, or discoloration.

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 veins (venous thromboembolism). However, such 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 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 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 product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not using combined hormonal contraceptives.
If you stop using Dionelle, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots associated with Dionelle is small, but some factors may increase this risk. The risk is higher:

• if you are severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time or have a leg in a cast. It may be necessary to stop using Dionelle for a few weeks before surgery or immobilization. If you need to stop using Dionelle, you should ask your doctor when you can resume using the medicine;
• with age (especially over 35 years);
• if you have just given birth.

The risk of blood clots increases with the number of risk factors present in you.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is important to tell your doctor if any of the above factors apply to you, even if you are not sure. Your doctor may decide to stop using Dionelle.
You should tell your doctor if any of the above conditions change while using Dionelle, e.g. if you start smoking, if someone in your close family has a blood clot without a known cause, or if you gain weight significantly.

Risk of blood clots in a year

Women who do not usecombined hormonal pills and are not pregnant
About 2 in 10,000 women
Women using combined hormonal contraceptive pills containing levonorgestrel, norethisterone,
or norgestimate
About 5-7 in 10,000 women
Women using Dionelle
About 8-11 in 10,000 women

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Dionelle is small, but some factors may increase this risk. The risk is higher:

• if you are severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time or have a leg in a cast. It may be necessary to stop using Dionelle for a few weeks before surgery or immobilization. If you need to stop using Dionelle, you should ask your doctor when you can resume using the medicine;
• with age (especially over 35 years);
• if you have just given birth.

The risk of blood clots increases with the number of risk factors present in you.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of the above factors apply to you, even if you are not sure. Your doctor may decide to stop using Dionelle.
You should tell your doctor if any of the above conditions change while using Dionelle, e.g. if you start smoking, if someone in your close family has a blood clot without a known cause, or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

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

Like blood clots in veins, blood clots in arteries can cause serious complications, 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 Dionelle is very small, but it may increase:

• with age (over about 35 years);
• if you smoke.While using a hormonal contraceptive like Dionelle, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraine, especially migraine with aura;
• if you have heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of a blood clot may be even higher.
You should tell your doctor if any of the above conditions change while using Dionelle, e.g. if you start smoking, if someone in your close family has a blood clot without a known cause, or if you gain weight significantly.

Dionelle and cancer

In women using combined hormonal contraceptives, a slightly increased risk of breast cancer has been observed. It is not known if this is caused by the treatment. The reason may be, for example, that women using combined hormonal contraceptives are examined by a doctor more often, so tumors are detected more frequently. The risk of breast cancer decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to regularly perform breast self-examination, and if you feel a lump in your breast, you should contact your doctor.
Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women using the pill. In isolated cases, these tumors have caused life-threatening bleeding into the abdominal cavity. If you experience severe abdominal pain, you should contact your doctor as soon as possible.
Some studies suggest that long-term use of these pills increases the risk of cervical cancer in women. However, it is not clear to what extent sexual behavior (e.g. frequent change of partners) and other factors, such as human papillomavirus (HPV), increase this risk.

Psychiatric disorders

Some women using hormonal contraceptives, including Dionelle, 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.

When to contact a doctor

Regular check-ups
Your doctor will recommend that you have regular check-ups while using the pill.
Usually, you should visit your doctor at least once a year.
In addition, you should contact your doctor immediately if:

• you notice any changes in your health, especially any of the symptoms listed in the sections "When not to use Dionelle" and "When to be particularly careful when using Dionelle". Remember to mention any diseases that occur in your family;
• you find a lump in your breast;
• you are using other medicines (see also the section "Dionelle and other medicines");
• you will be immobilized in bed for a longer period or will have surgery (you should contact your doctor at least 4 weeks before surgery or immobilization);
• you experience unusual, heavy vaginal bleeding between periods;
• you miss pills in the first week of using a new pack, and you had sex in the previous 7 days;
• you do not have bleeding for two consecutive months and you have taken the pills correctly and do not suspect you are pregnant.

Unscheduled bleeding

During the first few months of using Dionelle, you may experience unscheduled bleeding. Irregular vaginal bleeding usually stops when your body adjusts to taking the pill (usually after about 3 cycles of taking the pill). If you experience heavier bleeding or prolonged bleeding, you should consult your doctor.

Missed period

If you have taken the pills correctly and have not vomited or had severe diarrhea and have not taken any other medicines, the likelihood of pregnancy is very low.
You should continue to use Dionelle as before.
If you do not have two consecutive periods or if you do not have a period before the missed period, and you have not taken the pills as directed, there is a possibility of pregnancy.
You should contact your doctor immediately. Do not take Dionelle until your doctor has ruled out pregnancy.

Children and adolescents

Dionelle can only be used when menstruation has already occurred.

Dionelle and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may cause bleeding between periods and/or reduce the contraceptive effectiveness of Dionelle.

• Effect of other medicines on Dionelle

Some medicines

• may affect the level of Dionelle in your blood;
• may reduce its contraceptive effectiveness;
• may cause unscheduled bleeding.

These include:

• medicines used to treat: You should always inform your doctor about the medicines or herbal products you are taking. Additionally, you should inform any doctor or dentist prescribing other medicines (or pharmacist) that you are taking Dionelle. They will provide information on whether you should use additional contraceptive methods (e.g. condoms) and for how long, or whether you should change the schedule of taking other medicines.
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV infection and hepatitis C virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
• fungal infections (griseofulvin, ketoconazole);
• arthritis, degenerative joint disease (etoricoxib);
• the herbal remedy St. John's Wort.

If you are taking any of the medicines listed above, you should also use a mechanical method (e.g. condom) or choose another contraceptive method. You should use additional local contraceptive methods during and for 28 days after stopping the treatment with the above medicines.
If the treatment period exceeds the duration of one pack of Dionelle, you should start the next pack of Dionelle immediately, without a break in taking the pills.
If you need to take any of the medicines listed above for a longer period, you should choose another effective, non-hormonal contraceptive method.

• Effect of Dionelle on other medicines

Dionelle may affect the action of other medicines, such as

• the antiepileptic drug lamotrigine (this may lead to an increased frequency of seizures);
• cyclosporin;
• theophylline (used to treat respiratory disorders);
• tizanidine (used to treat muscle pain or muscle spasms).

You should not use Dionelle in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as they may cause abnormal liver function test results (increased liver enzyme activity).
Before starting to take these medicines, your doctor will prescribe another type of contraception.
You can start taking Dionelle again about 2 weeks after stopping the above treatment. See the section "When not to use Dionelle".
You should also read the patient information leaflets for other prescribed medicines.

Effect on laboratory tests

The use of Dionelle may affect the results of some laboratory tests, including liver, adrenal, kidney, and thyroid function tests, as well as the levels of some proteins in the blood, such as those involved in fat digestion, carbohydrate metabolism, or blood clotting and fibrinolysis. However, these changes usually remain within the normal range.

Dionelle with food and drink

Dionelle can be taken with or without food, washed down with a small amount of water if necessary, and swallowed whole.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, you should not take Dionelle. If you become pregnant while using Dionelle, you should stop taking the medicine immediately and contact your doctor. If you plan to have a child, you can stop using Dionelle at any time (see also "Stopping Dionelle").
Breastfeeding
Generally, Dionelle should not be used during breastfeeding, as it may reduce milk production and small amounts of the active substance may pass into breast milk.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effects of Dionelle on the ability to drive or use machines have been observed.

Dionelle contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Dionelle.

Dionelle contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that it is essentially "sodium-free".

3. How to use Dionelle

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
You should take one tablet a day, washed down with a small amount of water if necessary, and swallowed whole. The tablets can be taken with or without food, at approximately the same time every day.
The blister pack contains 21 coated tablets. Each tablet is marked with a symbol of the day of the week on which it should be taken. You should take one tablet a day. You should take the tablet marked with the symbol of the current day of the week. For example, if your period starts on a Friday, you should take the tablet marked with the symbol "Fr" (meaning Friday; see "Translation of the day of the week symbols on the packaging" at the end of the leaflet), by pressing it through the aluminum foil. You should take one tablet every day, in the order indicated.
The time of day does not matter, but once you have chosen it, you should keep to it. You should follow the direction of the arrow on the packaging until you have taken all 21 tablets. Then, you should not take any tablets for 7 days. During these 7 tablet-free days, you should have a period (withdrawal bleeding), 2-3 days after taking the last tablet.
On the 8th day, you should start a new pack, regardless of whether your period has stopped or not. This means that you will start each new pack on the same day of the week, and your period will occur at approximately the same time every month.
If you use Dionelle in this way, you will also be protected against pregnancy during the 7 days when you are not taking tablets.

Starting to use Dionelle for the first time

• If you have not used oral contraceptives in the last month: You should start taking the tablets on the 1st day of your natural menstrual cycle (i.e. on the 1st day of menstrual bleeding).
• If you have used another combined hormonal contraceptive: You should start using Dionelle preferably on the 1st day after taking the last tablet containing active substances from your previous combined oral contraceptive, or at the latest on the 1st day after the usual tablet-free period or after taking the last inactive tablet from your previous combined oral contraceptive.
• If you have used a vaginal ring or transdermal patch: You should start using Dionelle preferably on the day of removal of the last ring or patch from the packaging intended for one cycle, but at the latest on the day when the next application would have been due.
• If you have used a progestogen-only product (minipill, implant, injection) or an intrauterine system releasing progestogen (hormonal intrauterine device): You can change from a progestogen-only pill on any day (from an implant or intrauterine system on the day of its removal, from an injection when the next injection would be due), but in all these cases, you should use additional mechanical contraceptive methods for the first 7 days of using Dionelle.
• After a miscarriage in the first trimester of pregnancy: You should talk to your doctor. Generally, you can start taking Dionelle immediately.
• After a miscarriage in the second trimester of pregnancy or after childbirth: If you want to start using Dionelle, your doctor will advise you to start taking the tablets 21-28 days after childbirth or miscarriage in the second trimester. When starting later, you should also use a mechanical method (e.g. condom) for the first 7 days of using Dionelle. However, if you have had sex, before starting Dionelle, you should make sure you are not pregnant or wait for your first period.
• If you want to start using Dionelle after giving birth and breastfeeding: You should read the section "Breastfeeding".

Overdose of Dionelle

There are no reports of serious side effects after taking multiple tablets of Dionelle at the same time.
If you take several tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not started menstruating yet but have taken the medicine by mistake. If you take too many tablets of Dionelle or if a child has taken the tablets, you should consult a doctor or pharmacist.

Missed dose of Dionelle

• If it has been less than 12 hourssince you missed a tablet, the contraceptive effectiveness of Dionelle is maintained. You should take the missed tablet as soon as possible and take the next one at the usual time.
• If it has been more than 12 hourssince you missed a tablet, the effectiveness of Dionelle may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness.

There is a particularly high risk of pregnancy if you miss tablets at the beginning or end of the pack.
In this case, you should follow the rules below.

Missed more than 1 tablet from the pack:

You should contact your doctor.

Missed 1 tablet in the first week of using the current pack:

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). You should take the next tablets at the same time and use additional mechanical contraceptive methods for the next 7 days, e.g. a condom. If you had sex in the week before missing the tablet, it is possible that you may become pregnant. In this case, you should inform your doctor.

Missed 1 tablet in the second week of using the current pack:

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). You should take the next tablets at the same time. The contraceptive effectiveness is not reduced, assuming that the medicine was taken correctly for the 7 days preceding the missed tablet. It is not necessary to use any additional mechanical contraceptive methods. However, if you miss more than 1 tablet, you should use an additional contraceptive method for 7 days.

4. Possible side effects

Like all medications, this medication can cause side effects, although they do not occur in everyone.
If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Dionelle medication, 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).
To obtain detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using Dionelle medication".

Serious side effects

Severe side effects related to taking Dionelle medication have been listed in the "When to exercise special caution when using Dionelle medication" section.
Consult a doctor immediately if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives, potentially with breathing difficulties (see also the "Warnings and precautions" section).
The following side effects have been reported in clinical trials in which tablets containing 0.03 mg of ethinylestradiol and 2 mg of dienogest were used:

Frequent (may occur in less than 1 in 10 people)

• headache,
• breast pain, including discomfort and breast tenderness.

Uncommon (may occur in less than 1 in 100 people)

• vaginitis and/or vulvovaginitis (inflammatory conditions of the genital organs), vaginal candidiasis (thrush) or other fungal infections of the vagina,
• increased appetite,
• depressed mood,
• migraine, dizziness,
• high or low blood pressure,
• abdominal pain, nausea, vomiting, or diarrhea,
• acne, hair loss (alopecia), rash, itching,
• abnormal menstrual bleeding, including heavy menstrual bleeding (menorrhagia), light menstrual bleeding (hypomenorrhea), infrequent menstrual bleeding (oligomenorrhea), and absence of menstrual bleeding (amenorrhea),
• intermenstrual bleeding, including vaginal hemorrhage and irregular intermenstrual bleeding (metrorrhagia), painful bleeding (dysmenorrhea), genital discharge, fluid-filled structures (cysts) in the ovaries, pelvic pain, breast enlargement, breast tenderness,
• fatigue, weakness, malaise,
• weight gain.

Rare (may occur in less than 1 in 1000 people)

• ovarian and fallopian tube inflammation, urinary tract infections, cystitis (urinary bladder inflammation), mastitis (breast inflammation), cervical inflammation (cervicitis), fungal infections, viral infections (e.g., oral herpes), flu, bronchitis, sinusitis, upper respiratory tract infections,
• uterine leiomyoma, breast lipoma,
• anemia,
• hypersensitivity (allergic reaction),
• masculinization in women (development of male secondary sex characteristics),
• anorexia (severe loss of appetite),
• depression, psychiatric disorders, insomnia, sleep disorders, aggression,
• cerebral or cardiac circulation disorders, muscle disorders that can lead to abnormal body posture (dystonia),
• dry or irritated eyes, oscillopsia (subjective sensation of image vibration) or other vision disorders,
• sudden hearing loss, tinnitus, dizziness, hearing disorders,
• tachycardia (rapid heart rate),
• phlebitis, high diastolic blood pressure, dizziness or fainting when standing up from a sitting or lying position (orthostatic dysregulation), hot flashes, varicose veins, venous disorders, vein pain,
• asthma, rapid or deep breathing (hyperventilation),
• gastritis, enteritis, gastrointestinal upset (indigestion),
• allergic skin inflammation (dermatitis), atopic dermatitis, eczema, psoriasis (skin disease with thickened red patches), excessive sweating, skin pigmentation changes (e.g., chloasma), excessive sebum production by sebaceous glands (seborrhea), dandruff, skin changes, orange peel skin (cellulite), spider-like clusters of blood vessels with a central red spot on the skin (spider angioma),
• back pain, bone, joint, and muscle pain (e.g., myalgia), arm and leg pain,
• abnormal cell growth on the surface of the cervix (cervical dysplasia), pain or fluid-filled structures in the fallopian tubes and ovaries, fluid-filled structures in the breasts, pain/spasms during sexual intercourse (dyspareunia), milk-like discharge from the breasts (galactorrhea), menstrual disorders,
• chest pain, swelling of the hands, ankles, or feet (peripheral edema), flu-like symptoms, inflammation, fever, irritability,
• elevated blood lipid levels (increased triglyceride and cholesterol levels), weight loss, weight fluctuations,
• presence of an additional breast,
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis),
• in the lungs (e.g., pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Other side effects observed in women taking tablets, the exact frequency of which is unknown, include:

mood changes, decreased or increased libido (sex drive), intolerance to contact lenses, skin changes (hives, erythema multiforme, Stevens-Johnson syndrome), breast discharge, fluid retention.
Cancer

• The number of breast cancer cases in women taking Dionelle medication is slightly increased. Since breast cancer is rare in women under 40, the risk of breast cancer in relation to the total risk of breast cancer is small. For more information, see the "Dionelle medication and cancer" section;
• liver tumors (benign and malignant);
• cervical cancer.

Other

• women with hypertriglyceridemia (elevated blood lipid levels, increasing the risk of pancreatitis when using combined oral contraceptives);
• high blood pressure;
• occurrence or worsening of symptoms whose connection to the use of COCs is not resolved: jaundice and/or itching associated with cholestasis (bile flow obstruction); cholelithiasis; metabolic disorders such as porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (a blood clotting disorder); neurological disorders known as Sydenham's chorea; herpes gestationis (a skin disease that occurs 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.

Interactions
Intermenstrual bleeding and/or contraceptive failure may be caused by the effect of other medications on oral contraceptives (e.g., St. John's Wort (Hypericum perforatum) or medications for epilepsy, tuberculosis, HIV, and other infections). See section "Dionelle medication and other medications".
Other severe reactions that may occur during the use of Dionelle medication, as well as related symptoms, are described in the "Warnings and precautions" section.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Dionelle medication

Store the medication in a place invisible and inaccessible to children.
Do not use this medication after the expiration date stated on the packaging. The expiration date indicates the last day of the given month.

Translation of some information on the immediate packaging:

Ch.-B./Verw. bis: see embossing - batch number/expiry date: see embossing
Do not store above 30°C.
Medications should not be disposed of in wastewater or household waste containers. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Dionelle medication contains

The active substances of the medication are ethinylestradiol and dienogest. One film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
Other ingredients are:

• tablet core:lactose monohydrate, cornstarch, povidone K 30, sodium carboxymethylcellulose (type A), magnesium stearate.
• tablet coating:AquaPolish white with the composition: hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, titanium dioxide (E 171).

Appearance and package contents of Dionelle medication

Dionelle medication is white, round, biconvex film-coated tablets.
Dionelle medication is available in packages of 21 and 3 x 21 film-coated tablets.
A cardboard sachet is attached to the packaging, in which the blister should be placed.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Besins Healthcare Germany GmbH
Mariendorfer Damm 3
12099 Berlin
Germany

Manufacturer:

DR. KADE Pharmazeutische Fabrik GmbH
Rigistraße 2
12277 Berlin
Germany
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:85862.00.00
Parallel import authorization number:332/20

This medicinal product is authorized for sale in the Member States of the European Economic Area under the following names:

Austria
Viola 0.03 mg/2 mg film-coated tablets
Germany
Finic 0.03 mg/2 mg film-coated tablets
Poland
Dionelle

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: 20.11.2023

[Information about the trademark]