Dionelle

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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 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 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 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 pack 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 who have 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 you should stop taking 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. 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

You should not take Dionelle if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable.
You should not take 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 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 (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 ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) pancreatitis with very high levels of fats in the blood (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 have ever had) a suspected or known hormone-dependent malignant tumor of the genital organs or breast;
• if you have unexplained vaginal bleeding;
• 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 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 the section "Warnings and precautions".
You should not take Dionelle if you have hepatitis C and are taking medicines that contain ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Dionelle and other medicines").

WARNINGS AND PRECAUTIONS

When to be extra careful while 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 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, extra precautions need to be taken, and your doctor may need to monitor you regularly.
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 elevated 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, as you are at a higher risk of blood clots. You should consult your doctor to find out 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 had a rash with blisters during early pregnancy (pregnancy pemphigoid);
• if you have had a loss of hearing in the inner ear (hearing loss associated with otosclerosis);
• In case of 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

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 thrombosis).

Not everyone who has a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

REMEMBER THAT THE OVERALL RISK OF HAVING A HARMFUL BLOOD CLOT WHILE TAKING 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, 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. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing,
• sudden unexplained cough without an obvious cause, which may be accompanied by coughing up blood,
• sharp chest pain, which may worsen with deep breathing, Pulmonary embolism

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 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 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 you stop taking Dionelle, the risk of blood clots returns to normal within a few weeks.

What factors can increase the risk of blood clots in veins?

The risk depends on your natural risk of developing venous thromboembolism and the type of combined hormonal contraceptive you are taking.
General risk of developing a blood clot in the leg or lung (deep vein thrombosis or pulmonary embolism) while taking Dionelle is small.

• In a year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop a blood clot.
• In a year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop a blood clot.
• In a year, about 8-11 out of 10,000 women who take combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Dionelle, will develop a blood clot.

The risk of developing a blood clot depends on your individual medical history (see "Factors that increase the risk of blood clots", below).

Risk of developing a blood clot in a year

Women who do not takecombined hormonal pills and are not pregnant
About 2 out of 10,000 women
Women taking combined hormonal contraceptive pills containing levonorgestrel,
norethisterone or norgestimate
About 5–7 out of 10,000 women
About 8–11 out of 10,000 women

Factors that increase the risk of blood clots in veins

The risk of developing a blood clot while taking Dionelle is small, but some factors can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m);
• if someone in your close family has had a blood clot in the legs, lungs, or other organs at a young age (e.g., under 50 years old). 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 taking Dionelle for a few weeks before surgery or immobilization. If you need to stop taking Dionelle, you should ask your doctor when you can start taking it again;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of developing a blood clot increases with the number of risk factors present.
Traveling by air (>4 hours) may temporarily increase the risk of developing a blood clot, especially if you have another risk factor.
It is important to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop you from taking Dionelle.
You should tell your doctor if any of the above conditions change while taking Dionelle, e.g., if someone in your close family is diagnosed with 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 important 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 you smoke. While taking a hormonal contraceptive like Dionelle, it is recommended to quit smoking. If you are unable to quit 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 years old). 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 developing a blood clot may be even higher.
You should tell your doctor if any of the above conditions change while taking Dionelle, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

DIONELLE AND CANCER

In women taking 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 risk may be due to the fact that women taking combined hormonal contraceptives are examined by a doctor more often, so breast tumors are detected more frequently.
The risk of breast cancer decreases gradually after stopping combined hormonal contraceptives.
It is important to regularly examine your breasts and consult a doctor if you feel a lump in your breast.
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 you experience severe abdominal pain, you should consult a 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, you should consult a doctor as soon as possible for further medical advice.

WHEN TO CONTACT A DOCTOR

Regular check-ups
If you are taking the pill, your doctor will advise you to have regular check-ups.
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 take Dionelle" and "When to be extra careful while taking Dionelle". Remember to mention any diseases that occur in your family;
• a lump is found in your breast;
• you are taking other medicines (see also the section "Dionelle and other medicines");
• you will be immobilized in bed for a long time or will have surgery (you should consult your doctor at least 4 weeks in advance);
• you experience unusual, heavy vaginal bleeding between periods;
• you miss a period and have not taken your pills correctly in the previous 7 days;
• you do not have a period for two consecutive months and have taken your pills correctly.

UNEXPECTED VAGINAL BLEEDING

During the first few months of taking Dionelle, unexpected vaginal bleeding may occur. Irregular vaginal bleeding usually stops once your body gets used to taking the pills (usually after about 3 cycles of pill-taking). If you experience heavier vaginal bleeding that resembles a normal period or light vaginal bleeding that lasts for several days, you should consult your doctor.

MISSING A PERIOD

If you have taken your 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 take Dionelle as before.
If you do not have two consecutive periods or if you did not take Dionelle as directed before the missed period, there is a possibility of pregnancy.
You should consult your doctor immediately. Do not take Dionelle until your doctor has ruled out pregnancy.

CHILDREN AND ADOLESCENTS

Dionelle can only be taken if you have already started your period.

DIONELLE AND OTHER MEDICINES

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

• Effect of other medicines on Dionelle

You should always inform your doctor about the medicines you are taking or herbal products. Additionally, you should inform any doctor or dentist who prescribes other medicines (or pharmacist) that you are taking Dionelle. They will inform you 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.
Some medicines

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

These include:

• medicines used to treat:
• 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 medicine St. John's Wort.

If you are taking any of the medicines listed above, you should also use a mechanical method (e.g., a condom) or choose another contraceptive method. You should use additional local contraceptive methods during and for 28 days after taking another medicine with Dionelle. 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 the treatment is to be longer, 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 medicine 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 take Dionelle if you have hepatitis C and are taking medicines that contain ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and 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 contraceptive method.
You can start taking Dionelle again about 2 weeks after finishing the above treatment. See the section "When not to take Dionelle".
You 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, 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.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, you should not take Dionelle. If you become pregnant while taking Dionelle, you should stop taking it immediately and consult your doctor. If you plan to have a baby, you can stop taking Dionelle at any time (see also "Stopping Dionelle").
Breastfeeding
Generally, Dionelle should not be taken 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 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 you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking Dionelle.

DIONELLE CONTAINS SODIUM

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

3. HOW TO TAKE DIONELLE

This medicine should always be taken exactly 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, with a small amount of water if necessary, and swallow it 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 (standing for 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), usually 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 that your period will occur on approximately the same day each month.
If you take Dionelle in this way, you will also be protected against pregnancy during the 7 days when you are not taking tablets.

TAKING DIONELLE FOR THE FIRST TIME

• If you have not taken 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 been taking another combined hormonal contraceptive: You should start taking Dionelle on the 1st day after taking the last active tablet of your previous combined hormonal contraceptive, or at the latest on the day after the usual tablet-free period or after taking the last inactive tablet of your previous combined hormonal contraceptive.
• If you have been using a vaginal ring or transdermal patch: You should start taking Dionelle on the day of removal of the last ring or patch from the packaging intended for one cycle, but no later than the day when the next application would have been due.
• If you have been taking a progestogen-only product (minipill, implant, injection) or a progestogen-releasing intrauterine system (hormonal coil): 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 taking Dionelle.
• After a miscarriage in the first trimester of pregnancy: You should consult 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 taking Dionelle, your doctor will advise you to start taking the tablets 21-28 days after childbirth or miscarriage in the second trimester. If you start taking Dionelle later, you should also use a mechanical method (e.g., a condom) for the first 7 days of taking Dionelle. If you have had sexual intercourse before starting Dionelle, you should make sure you are not pregnant or wait for your first period.

(e.g., a condom) for the first 7 days of taking Dionelle. If you have had sexual intercourse before starting Dionelle, you should make sure you are not pregnant or wait for your first period.

• If you want to start taking Dionelle after giving birth and are breastfeeding: You should read the section "Breastfeeding".

TAKE 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 case of taking several tablets at the same time, nausea, vomiting, or vaginal bleeding may occur. This type of bleeding can occur even in girls who have not started their periods yet but have taken the medicine by mistake. If you have taken too many tablets of Dionelle or suspect that a child has taken some tablets, you should consult a doctor or pharmacist.

MISS A 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 a pack. In such cases, you should follow the rules below.

MISS MORE THAN 1 TABLET FROM A PACK:

You should consult your doctor.

MISS 1 TABLET IN THE FIRST WEEK OF TAKING DIONELLE FROM 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 contraceptive methods (e.g., a condom) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, it is possible that you may become pregnant. In this case, you should inform your doctor.

MISS 1 TABLET IN THE SECOND WEEK OF TAKING DIONELLE FROM 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 tablets were taken correctly during the 7 days preceding the missed tablet. There is no need to use any additional mechanical methods of contraception. However, if you miss more than one tablet, you should use an additional method of contraception for 7 days.

4. Possible side effects

Like any medication, 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, you should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis).
To obtain detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using Dionelle medication".

Severe side effects

Severe side effects related to the use of Dionelle medication have been listed in the "When to exercise special caution when using Dionelle medication" section.
You should immediately contact a doctor 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 ethinyl estradiol 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 (yeast infection) 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 (hair loss), 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 (bladder inflammation), mastitis (breast inflammation), cervical inflammation (inflammatory condition of the cervix), 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, mental 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 (skin inflammation), atopic dermatitis, rash, psoriasis (skin disease with thickened red patches), excessive sweating, skin pigmentation changes (e.g., chloasma), excessive oil production by the sebaceous glands (seborrhea), dandruff, skin changes, orange peel skin (cellulite), spider-like clusters of blood vessels 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 further 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:

mood changes, decreased or increased libido (sexual desire), 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 (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; pregnancy herpes (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 ineffectiveness may be caused by the action of other medications on oral contraceptives (e.g., St. John's wort (Hypericum perforatum) or medications for epilepsy, tuberculosis, HIV infection, and other infections). See the "Dionelle medication and other medications" section.
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, you should tell your doctor or pharmacist. 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, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Dionelle medication

The medication should be stored out of sight and reach of 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.
Do not store above 30°C.
Translation of some information on the immediate packaging:
Ch.-B./Verw. bis: see embossing – batch number/expiry date: see embossing
Medications should not be disposed of via wastewater or household waste containers. You should 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 ethinyl estradiol and dienogest. One coated tablet contains 0.03 mg of ethinyl estradiol and 2 mg of dienogest.
Other ingredients are:

• tablet core:lactose monohydrate, cornstarch, povidone K 30, sodium carboxymethylcellulose (type A), magnesium stearate;
• coating:AquaPolish white 014.17 MS, consisting of: hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, titanium dioxide (E 171).

What Dionelle medication looks like and what the packaging contains

Dionelle medication is white, round, biconvex, coated tablets.
Dionelle medication is available in packages of 21 and 3 x 21 coated tablets.
A cardboard 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
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 85862.00.00
Parallel import authorization number: 197/20

Translation of day of the week symbols on the packaging:

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

This medication is authorized for marketing 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

Date of leaflet approval: 01.07.2025

[Information about the trademark]