Dionelle

Leaflet accompanying the packaging: information for the user

Dionelle

0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest

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 you need to.
• If you have 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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.
• 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 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 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 due to 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, your doctor will ask you a few questions to gather your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may perform other examinations.
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 conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your 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 blood coagulation disorders - 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 "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 (transient 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 have had in the past) or are suspected of having a malignant hormone-dependent tumor 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 conditions listed above 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 "Warnings and precautions".
You should not use Dionelle in patients with hepatitis C and taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "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 symptoms of these serious side effects, see "How to recognize a blood clot".

You should 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 diagnosed with 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, as you are at increased 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 defects 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 stasis;
• if you have patchy, yellow-brown skin discoloration, especially on the face (chloasma), or if you had it during an early pregnancy; in this case, you should avoid strong sunlight and UV radiation;
• if you have certain disorders of hemoglobin production (porphyria);
• if you have depression;
• if you have epilepsy;
• if you have Sydenham's chorea (a disease that affects the nervous system);
• if you had a rash with blisters during an 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. Products containing estrogens 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 venous thrombosis);
• in arteries (so-called arterial thromboembolism or arterial thrombosis).

Not all people who have a blood clot will recover completely. In rare cases, the effects of a blood clot can be permanent 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 while standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, such as pallor, redness, or cyanosis.
• sudden unexplained shortness of breath or rapid breathing, Pulmonary embolism
• sudden unexplained cough, which may be accompanied by coughing up blood,
• sharp chest pain, which may worsen with deep breathing,
• severe dizziness or fainting,
• rapid or irregular heartbeat,
• severe abdominal pain. If you are unsure, you should contact a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).

BLOOD CLOTS IN VEINS

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, 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 the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

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

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different 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 affects the risk of blood clots?

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

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

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

Risk of blood clots in a year

Women who do not usecombined hormonal pills and are not pregnant
About 2 out of 10,000 women
Women using combined hormonal contraceptive pills
About 5–7 out of 10,000 women
Women using Dionelle
About 8–11 out of 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 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 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 old);
• if you have given birth in the last few weeks.

The risk of blood clots increases with the number of risk factors present in you.
Long-haul flights (>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 these risk 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 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?

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 Dionelle is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke. While using a hormonal contraceptive like Dionelle, it is recommended to quit smoking. If you cannot quit smoking and are over 35 years old, your doctor may recommend using 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 blood clots 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 is diagnosed with 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 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 using combined hormonal contraceptives are more often examined by a doctor, and therefore, tumors are more often detected. 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.
In women using the contraceptive pill, 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 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 you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible to receive 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 "When not to use Dionelle" and "When to be particularly careful when using Dionelle" sections. Remember to mention any diseases that occur in your family;
• a lump is found in your breast;
• you are using other medicines (see also "Dionelle and other medicines");
• you will be immobilized in bed for a long time 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 sexual intercourse during the previous 7 days;
• you do not experience bleeding within the next two months, and you suspect you may be pregnant.

Unscheduled vaginal bleeding

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

Absence of withdrawal bleeding

If you have used the pills correctly, have not vomited, or have not had severe diarrhea, and have not used any other medicines, the likelihood of pregnancy is very low.
You should continue to use Dionelle as before.
If you do not experience two consecutive periods or if you do not use Dionelle as recommended before the missed period, there is a possibility of pregnancy.
You should contact your doctor immediately. Do not use 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 using or have recently used, as well as any medicines you plan to use.
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 or herbal products you are using. Additionally, you should inform any doctor or dentist who prescribes other medicines (or pharmacist) that you are using 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 using other medicines.
Some medicines

• may affect the level of Dionelle in your blood;
• may reduce its contraceptive effectiveness;
• may cause unscheduled 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 using any of the medicines listed above, you should also use a mechanical method (e.g., a condom) for the duration of treatment with the other medicine and for 28 days after stopping the other medicine. If the treatment period exceeds the duration of one pack of Dionelle, you should start the next pack immediately without a break. If prolonged treatment with any of the medicines listed above is required, you should choose a different, effective non-hormonal method of contraception.

• Effect of Dionelle on other medicines

Dionelle may affect the action of other medicines, such as

• 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).

You should not use Dionelle in patients with hepatitis C and taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (elevated liver enzyme levels).
Before starting to use these medicines, your doctor will prescribe a different contraceptive method.
You can start using Dionelle again about 2 weeks after stopping the above-mentioned treatment. See "When not to use Dionelle".
You should also read the patient information leaflets of 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, 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 child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, you should not use Dionelle. If you become pregnant while using Dionelle, you should stop using 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

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

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, with a small amount of water if necessary, and swallow it whole. The tablets can be taken with or without food, at about the same time every day.
The blister pack contains 21 coated tablets. Each tablet is marked with 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 current day of the week. For example, if your period starts on a Friday, you should take the tablet marked Fr (Friday), pressing it through the aluminum foil. You should take one tablet every day, following the direction of the arrows on the pack. 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 arrows on the pack 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 experience bleeding (withdrawal bleeding), 2-3 days after taking the last tablet.
In the 8th day, you should start a new pack, regardless of whether your period has stopped or not. This means that you should start each new pack on the same day of the week, and your bleeding will occur at about the same time every month.
If you use Dionelle in this way, you are also protected against pregnancy during the 7 days when you are not taking tablets.

Using 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 active tablet of your previous combined oral contraceptive, or at the latest on the 1st day after the usual tablet-free interval or after taking the last inactive tablet of 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, or at the latest when the next application would be due.
• If you have used a progestogen-only product (minipill, implant, injection) or a progestogen-releasing intrauterine system (hormonal IUD): You can switch from a progestogen-only pill on any day (from an implant or IUD 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 non-hormonal 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 using Dionelle immediately.
• After a miscarriage in the second trimester of pregnancy or after childbirth: If you want to start using Dionelle, your doctor will recommend that you start taking the tablets 21-28 days after childbirth or miscarriage in the second trimester. If you start using Dionelle later, you should also use a mechanical method (e.g., a condom) for the first 7 days of using the medicine. However, if you have had sexual intercourse, before starting to use Dionelle, you should make sure you are not pregnant or wait for your first menstrual period.
• If you want to start using Dionelle after giving birth and breastfeeding: You should read the "Breastfeeding" section.

Using 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.
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 suspect that a child has taken the tablets, you should consult your doctor or pharmacist.

Missing 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 the pack. In this case, you should follow the rules below.

Missing more than 1 tablet from the pack:

You should contact your doctor.

Missing 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 contraceptive methods (e.g., a condom) for the next 7 days. If you had sexual intercourse during the week before missing the tablet, it is possible that you may become pregnant. In this case, you should inform your doctor.

Missing 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 used correctly during the 7 days preceding the missed tablet. It is not necessary to use any additional mechanical methods of contraception. However, if you miss more than 1 tablet, you should use an additional method of contraception 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".

Serious side effects

Severe side effects related to the use of Dionelle have been listed in the section "When to exercise special caution when using Dionelle".
You should immediately contact a doctor if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or urticaria, potentially with breathing difficulties (see also the section "Warnings and precautions").
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, 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), cervicitis (cervical inflammation), 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),
• loss of appetite (severe loss of appetite),
• depression, mental disorders, insomnia, sleep disorders, aggression,
• cerebral or cardiac circulatory disorders, muscle disorders that can lead to abnormal 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 rash (skin inflammation), atopic dermatitis, eczema, 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 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, painful 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 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 about risk factors for blood clots and symptoms of blood clots).

Other side effects observed in women taking tablets, whose exact frequency is unknown, are:

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

• 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 tumors";
• 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); cholelithiasis; metabolic disorders such as porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (a blood clotting disorder); neurological disorders called Sydenham's chorea; herpes gestationis (a type of 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 medicines on oral contraceptives (e.g., St. John's wort (Hypericum perforatum) or medicines for epilepsy, tuberculosis, HIV, and other infections). See the section "Dionelle and other medicines".
Other severe reactions that may occur during the use of Dionelle, as well as the symptoms associated with them, 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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
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 package and blister after: "Expiry date" or "EXP". The expiry date refers to the last day of the given month.
Store below 30°C.
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. Package contents 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 K 30, sodium carboxymethylcellulose (type A), magnesium stearate;
• coating:AquaPolish white 014.17 MS, with the composition: hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, titanium dioxide (E 171).

What Dionelle looks like and what the package contains

Dionelle is a white, round, biconvex film-coated tablet.
Dionelle is available in packages of 21, 3 x 21, and 6 x 21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

DR. KADE Pharmazeutische Fabrik GmbH
Rigistrasse 2
12277 Berlin, Germany

Manufacturer

Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Kadefarm Sp. z o.o.
Sierosław, ul. Gipsowa 18
62-080 Tarnowo Podgórne, Poland
Phone: +48 61 862 99 43; e-mail: kadefarm@kadefarm.pl

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

Date of last revision of the leaflet: 26.10.2022