Dionelle

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

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

0.03 mg + 2 mg, film-coated tablets

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

You should carefully read the contents of the leaflet before taking 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they 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 the patient suspects that blood clot symptoms have occurred (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 taking Dionelle
• 3. How to take 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 medicine:

• used to prevent pregnancy (contraceptive pill).
• for the treatment of 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 containing 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 taking Dionelle

General notes
Before starting to take 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 the patient a few questions to gather personal and family medical history. The doctor will also measure blood pressure and, depending on the individual situation, may perform other tests.
This leaflet describes several situations in which Dionelle should not be taken 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, e.g. 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. The patient should discuss with the doctor the need to continue treatment after three to six months of treatment and regularly thereafter.

When not to take Dionelle

Dionelle should not be taken 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.
Dionelle should not be taken:

• 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 a blood clotting disorder - 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 ever had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischaemic 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 ever had) a type of migraine called "migraine with aura";
• if the patient has (or has ever had) pancreatitis with very high levels of fats in the blood (hypertriglyceridemia);
• if the patient has (or has ever had) severe liver disease (until liver function tests return to normal);
• if the patient has (or has ever had) benign or malignant liver tumors;
• if the patient has (or has ever had) or is suspected to have a malignant hormone-dependent genital or breast tumor;
• if the patient has abnormal vaginal bleeding of unknown cause;
• if the patient has hepatitis C and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir/pibrentasvir (see section "Dionelle and other medicines");
• if the patient is allergic to ethinylestradiol or dienogest or any of the other ingredients of this medicine (listed in section 6).

If any of the conditions listed above occur for the first time while taking Dionelle, the medicine should be stopped immediately and a doctor consulted. During this time, non-hormonal methods of contraception should be used. For more information, see also section "Warnings and precautions".

Warnings and precautions

When to be careful when taking Dionelle

When to contact a doctor?
You should contact a doctor immediately
if you notice any of the 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 section 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, while taking Dionelle or any other combined pill, it is necessary to be careful, and the doctor may perform regular check-ups on the patient.
If any of the following conditions occur or worsen while taking 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 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 "Blood clots");
• if you have just given birth, as you are at a higher risk of blood clots. You should consult your doctor about how soon you can start taking 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 pigmentation, 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 have had a rash with blisters during early pregnancy (pregnancy pemphigoid);
• if you have sudden hearing loss in the inner ear (hearing loss associated with otosclerosis);
• if you have hereditary angioedema, estrogen products may cause or worsen the symptoms of angioedema. If symptoms of angioedema occur, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or breathing, you should contact your doctor immediately.

BLOOD CLOTS

Taking combined hormonal contraceptives like Dionelle is associated with an increased risk of blood clots compared to not taking 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 occlusive disease).

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

Remember that the overall risk of a blood clot caused by taking Dionelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN VEINS

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

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, such side effects are rare. They most often occur in the first year of taking 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 taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming 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 taking combined hormonal contraceptives.
If the patient stops taking Dionelle, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk of blood clots associated with taking Dionelle 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 close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery, is immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Dionelle for a few weeks before surgery or immobilization. If the patient stops taking Dionelle, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (>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 the patient from taking Dionelle.
If any of the above conditions change while taking Dionelle, e.g., the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or the patient gains significant weight, they should tell their doctor.

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 taking Dionelle is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes. While taking a hormonal contraceptive like Dionelle, 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 close family has had a heart attack or stroke at a young age (under 50). In this case, the patient may also be at a higher risk of having a heart attack or stroke;
• if the patient or someone in their close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraine, especially migraine with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
If any of the above conditions change while taking Dionelle, e.g., the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or the patient gains significant weight, they should tell their doctor.

Dionelle and cancer

In women taking combined contraceptives, a slightly higher incidence of breast cancer has been observed. It is not known whether this is caused by the treatment. The reason may be, for example, that women taking combined contraceptives are more often examined by a doctor, so tumors are more likely to be detected. The risk of breast cancer decreases gradually after stopping combined hormonal contraceptives. It is essential to regularly perform breast self-examination, and if the patient finds a lump in the breast, they should contact their doctor.
In women taking contraceptive pills, rare cases of benign or, even more rarely, malignant liver tumors have been reported. In isolated cases, these tumors have caused life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, the patient should contact their 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 taking 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, the patient should contact their doctor as soon as possible for further medical advice.

When to contact a doctor

Regular check-ups
In the case of taking pills, the doctor will recommend that the patient undergo regular check-ups.
Usually, the patient should visit the doctor at least once a year.
In addition, the patient should contact their doctor immediately if:

• they notice any worrying changes in their health, especially any of the symptoms listed in sections "When not to take Dionelle" and "When to be careful when taking Dionelle". The patient should also remember to tell their doctor about any family history of diseases;
• a lump is found in the breast;
• the patient is taking other medicines (see also section "Dionelle and other medicines");
• the patient will be immobilized in bed for an extended period or will undergo surgery (the patient should contact their doctor at least four weeks in advance);
• there is unusual, heavy vaginal bleeding between periods;
• the patient missed a pill in the first week of taking a new pack, and they had sexual intercourse during the previous 7 days;
• there is no bleeding within two months, despite regular pill intake, and the patient suspects they may be pregnant.

Unexpected bleeding between periods

During the first few months of taking Dionelle, unexpected bleeding may occur. Irregular vaginal bleeding will stop when the body gets used to taking the pills (usually after about 3 cycles of pill intake). If there is heavier vaginal bleeding resembling a normal period or slight vaginal bleeding lasting a few days, the patient should contact their doctor.

No normal period

If the patient has taken the pills correctly, has not vomited, or has not had severe diarrhea, and has not taken any other medicines, the likelihood of pregnancy is very low.
The patient should continue taking Dionelle as before.
If two consecutive periods are missed or if the patient has not taken Dionelle as directed before the missed period, there is a possibility of pregnancy.
The patient should contact their doctor immediately. The patient should not take Dionelle until the doctor has ruled out pregnancy.

Children and adolescents

Dionelle can only be taken when menstruation has already occurred.

Dionelle and other medicines

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

• •Effect of other medicines on DionelleThe patient should always inform their doctor about the medicines they are taking or herbal products. Additionally, the patient should inform any doctor or dentist prescribing other medicines (or pharmacist) that they are taking Dionelle. They will provide information on whether to use additional contraceptive methods (e.g., condoms) and for how long, or whether to change the schedule of taking other medicines.

Some medicines

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

These include:

• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV infection and viral hepatitis C (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
• fungal infections (griseofulvin, ketoconazole);
• arthritis, degenerative joint disease (etoricoxib);
• the herbal medicine St. John's Wort.

If the patient is taking any of the medicines listed above, they should also use a mechanical method (e.g., a condom) for the entire time they are taking the other medicine, as well as for 28 days after stopping the other medicine.
If the treatment period exceeds the duration of one pack of Dionelle, the patient should start a new pack immediately, without a break in taking the pills.
If the patient needs to take any of the medicines listed above for an extended period, they should choose a different, effective non-hormonal contraceptive method.

• •Effect of Dionelle on other medicinesDionelle may affect the action of other medicines, e.g.,
• the antiepileptic medicine lamotrigine (which may lead to an increased frequency of seizures);
• cyclosporin;
• theophylline (used to treat respiratory disorders);
• tizanidine (used to treat muscle pain or muscle spasms).

Dionelle should not be taken if the patient has hepatitis C and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir/pibrentasvir, as this may cause elevated liver function test results (increased liver enzyme ALT). The doctor will prescribe a different contraceptive method to the patient before starting treatment with these medicines. Dionelle can be started again about 2 weeks after the end of this treatment. See section "When not to take Dionelle".
The patient should also read the patient information leaflets of other prescribed medicines.

Effect on laboratory tests

Taking Dionelle may affect the results of some laboratory tests, including liver, adrenal, kidney, and thyroid function tests, as well as the levels of certain proteins in the blood, e.g., proteins that affect 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.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
If the patient is pregnant, they should not take Dionelle. If the patient becomes pregnant while taking Dionelle, they should stop taking the medicine immediately and contact their doctor. If the patient plans to have a child, they can stop taking Dionelle at any time (see also "Stopping Dionelle").
Breastfeeding
Generally, Dionelle should not be taken while breastfeeding, as it may reduce milk production and small amounts of the active substance may pass into breast milk.
If the patient is pregnant or breastfeeding, they should consult their doctor or pharmacist before taking 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 the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

Dionelle contains sodium

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

3. How to take Dionelle

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The patient should take one tablet a day, washed down with a small amount of water if necessary, and swallow whole. The tablets can be taken with or without food, approximately at the same time every day.
The blister pack contains 21 film-coated tablets. Each tablet is marked with a symbol of the day of the week on which it should be taken. The patient should take one tablet a day. The patient should take the tablet marked with the symbol of the current day of the week. For example, if the menstrual period starts on a Friday, the patient should take the tablet marked Fr (Fr=Friday; see "Translation of the day of the week symbols on each tablet on the immediate packaging" at the end of the leaflet), by pressing it through the aluminum foil. The patient should take one tablet every day, following the direction of the arrows on the blister pack, until all 21 tablets have been taken. Then, the patient should not take any tablets for 7 days. During these 7 tablet-free days, menstrual bleeding (withdrawal bleeding) should occur, 2-3 days after taking the last tablet.
On the 8th day, the patient should start a new blister pack, regardless of whether the menstrual period has ended or not. This means that the patient should start each new blister pack on the same day of the week, as well as that the bleeding will occur approximately on the same day every month.
If the patient takes Dionelle in this way, they are also protected against pregnancy during the 7 days when they are not taking tablets.

Taking Dionelle for the first time

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

Taking more than the recommended dose of Dionelle

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

Missing a dose of Dionelle

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

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

Missing more than 1 tablet from the blister pack:

The patient should contact their doctor.

Missing 1 tablet in the first week of taking the current blister pack:

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). The patient should then take the next tablets at the usual time and use additional mechanical contraceptive methods (e.g., a condom) for the next 7 days. If the patient had sexual intercourse during the week before missing the tablet, it is possible that they may become pregnant. In this case, the patient should inform their doctor.

Missing 1 tablet in the second week of taking the current blister pack:

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). The patient should then take the next tablets at the usual time. The contraceptive effectiveness is not reduced, assuming that the patient has taken the tablets correctly for the 7 days preceding the missed tablet. There is no need to use additional mechanical contraceptive methods. However, if the patient misses more than 1 tablet, they should use an additional contraceptive method for 7 days.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Dionelle, you should consult a doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis).
To get detailed information about the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using Dionelle".
Severe side effects related to the use of Dionelle have been listed in the section "When to exercise special caution when using Dionelle".
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:

Common (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), vaginal discharge, fluid-filled structures (cysts) in the ovaries, pain in the internal genital organs, breast enlargement, breast swelling,
• 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, stomach upset (indigestion),
• allergic skin inflammation (dermatitis), atopic dermatitis, rash, psoriasis (skin disease with thickened red patches), excessive sweating, skin pigmentation changes (e.g., chloasma), excessive sebum production by the 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), breast discharge similar to milk (galactorrhea), menstrual complaints,
• chest pain, swelling of hands, ankles, or feet (peripheral edema), flu-like symptoms, inflammation, fever, irritability,
• elevated levels of fats in the blood (increased triglyceride and cholesterol levels), weight loss, weight fluctuations,
• appearance 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, erythema nodosum), breast discharge, fluid retention.
Cancer

• The number of breast cancer cases in women taking Dionelle 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 section "Dionelle and cancer";
• liver tumors (benign and malignant);
• cervical cancer.

Other

• Women with hypertriglyceridemia (elevated levels of fats in the blood, increasing the risk of pancreatitis when using combined oral contraceptives);
• high blood pressure;
• the occurrence or worsening of symptoms whose connection to the use of COCs is not resolved: jaundice and (or) itching associated with cholestasis (blocked bile flow); gallstones; 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 type of skin disease that occurs during pregnancy);
  otosclerosis associated with hearing loss;

• in women with hereditary angioedema (characterized by sudden swelling, e.g., of the eyes, lips, throat, etc.), exogenous estrogens may provoke or exacerbate symptoms of angioedema;
• 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 ineffectiveness may be caused by the action of other medicines on oral contraceptives (e.g., St. John's wort (Hypericum perforatum) or drugs for epilepsy, tuberculosis, HIV infection, and other infections). See the section "Dionelle and other medicines".
Other severe reactions that may occur during the use of Dionelle, as well as related symptoms, are described in the section "Warnings and precautions".

Reporting side effects

If any side effects occur, 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 medicine.

5. How to store Dionelle

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Do not store above 30°C.

Translation of some information on the immediate packaging:

Ch.-B./Verw. bis: see imprint – Batch number/Expiry date: see imprint.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Dionelle contains

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

• tablet core: lactose monohydrate, corn starch, povidone, sodium carboxymethylcellulose (type A), magnesium stearate;
• coating: AquaPolish white, consisting of: hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, titanium dioxide (E 171).

What Dionelle looks like and what the packaging contains

Dionelle is a white, round, biconvex film-coated tablet.
Dionelle is available in packs of 21 and 3 x 21 film-coated tablets.
A sachet is attached to the packaging, in which the blister should be placed.
For more detailed information, you should 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

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German export license number: 85862.00.00

Parallel import license number: 160/21

Translation of day of the week symbols on each tablet on the immediate packaging:

Mo

• Monday Di
• Tuesday Mi
• Wednesday Do
• Thursday Fr
• Friday Sa
• Saturday So
• Sunday

This medicinal product is authorized 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
Leaflet approval date: 11.02.2022
[Information about the trademark]