Dionelle

Patient Information Leaflet

Dionelle
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Please read all of this leaflet carefully before you start using this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

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

Contents of the leaflet

1. What Dionelle is and what it is 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 Dionelle is and what it is used for

Dionelle is a medicinal product

• used to prevent pregnancy (a contraceptive tablet).
• for the treatment of women with moderate acne who have decided to use oral contraceptives, and in whom adequate topical treatment or oral antibiotic therapy has failed.

Each of the 21 tablets contains a small amount of female hormones called ethinylestradiol
and dienogest. Contraceptive tablets containing two hormones are known as "combined"
or "combined hormonal contraceptives".
In women whose acne is caused by excessive activity of male sex hormones
(so-called androgens), clinical studies have shown that Dionelle alleviates the symptoms of this condition.

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 particularly important to read about the symptoms of blood clots – see section 2 "Blood clots".
Before starting to take Dionelle, your doctor will ask you several questions to obtain your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other tests.
This leaflet describes several situations in which you should stop using Dionelle or in which the effectiveness of Dionelle may be reduced. In such situations, you should not have sexual intercourse or you should use additional non-hormonal contraceptive methods, such as a condom or other mechanical methods. Do not use the calendar method or the temperature method. These methods may be unreliable because Dionelle alters the monthly changes in body temperature and cervical mucus.
Like other hormonal contraceptives, Dionelle does not protect against infection with the HIV virus (AIDS) or other sexually transmitted infections.
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 and at regular intervals thereafter.

When not to use Dionelle
Do not use Dionelle if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.
Do not use Dionelle:

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if you currently 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 (lipids) (hypertriglyceridemia);
• if you have previously had or currently have severe liver disease (until liver function test results return to normal);
• if you have previously had or currently have benign or malignant liver tumors;
• if you currently have (or have previously had) or are suspected of having a hormone-dependent malignant tumor of the genital organs or breast;
• if you have vaginal bleeding 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 taking Dionelle, stop taking the medicine immediately and consult your doctor. During this time, use non-hormonal methods of contraception. For more information – see also section "Warnings and precautions".
Do not use Dionelle in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Dionelle with other medicines").

Warnings and precautions
When to exercise special caution when using Dionelle
When should you contact your doctor?
Seek immediate medical advice
if you notice symptoms suggesting a blood clot, which may indicate a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or stroke (see section below "Blood clots").
Description of symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
In certain situations, special care may be needed while taking Dionelle or any other combined oral contraceptive, and your doctor may carry out regular check-ups.
If any of these conditions appear or worsen during treatment with Dionelle, inform your doctor:

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridemia) or if such a condition runs in your immediate family. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis.
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Dionelle.
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have heart valve disorders or heart rhythm disorders;
• if breast cancer has occurred 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 brownish-yellow skin discoloration, especially on the face (chloasma), or if such discoloration occurred during a previous pregnancy; in such cases, 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 (St. Vitus' dance);
• if you developed a blistering rash during a previous early pregnancy (herpes gestationis);
• if you have experienced hearing loss in the inner ear (hearing loss associated with otosclerosis).
• If symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, potentially with breathing difficulties, seek immediate medical advice. Medicinal products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS
Using 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 health problems.
Blood clots can occur

• in veins (known as venous thrombosis or venous thromboembolic disease);
• in arteries (known as arterial thrombosis or arterial thromboembolic disorders).

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Dionelle is small.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Are any of these symptoms present? Probable cause of this condition

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
  • pain or tenderness in the leg, which may only be felt when standing or walking,
  • increased warmth in the affected leg,
  • change in skin color of the leg, e.g., pallor, redness, or bluish discoloration.
• sudden onset of unexplained shortness of breath or rapid breathing, Pulmonary embolism
• sudden coughing without an obvious cause, which may be associated with coughing up blood,
• sharp chest pain, which may worsen on deep breathing,
• severe dizziness or vertigo,
• rapid or irregular heartbeat,
• severe stomach pain. If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath,

VENOUS BLOOD CLOTS
What can happen if blood clots form in the veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). However, such adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots highest?
The risk of developing venous blood clots is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting 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 remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Dionelle, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual's natural risk of venous thromboembolic disease and on the type of combined hormonal contraceptive used.
The overall risk of developing a blood clot in the leg or lungs (deep vein thrombosis or pulmonary embolism) while using Dionelle is low.

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

The risk of developing blood clots depends on the patient’s individual medical history (see “Factors increasing the risk of venous blood clots” below).

Risk of venous blood clots
within one year
Women who do not use combined hormonal contraceptives and are not pregnant: Approximately 2 per 10,000 women
Women using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate: Approximately 5–7 per 10,000 women
Women using Dionelle: Approximately 8–11 per 10,000 women

Factors increasing the risk of venous blood clots
The risk of venous blood clots associated with the use of Dionelle is low, but certain factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Dionelle several weeks before surgery or immobilization. If the patient must stop taking Dionelle, ask the doctor when it is safe to restart;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the last few weeks).

The risk of venous blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots, especially if the patient has another risk factor.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Dionelle.
Inform the doctor if any of the above conditions change during treatment with Dionelle, e.g., if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

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

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Dionelle is very low, but it may increase:

• with age (especially over approximately 35 years);
• if the patient smokes cigarettes. While using a hormonal contraceptive such as Dionelle, it is recommended to stop smoking. If the patient cannot stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high blood lipid levels (cholesterol or triglycerides);
• if the patient suffers from migraine, especially migraine with aura;
• if the patient has heart disease (valvular heart disease, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of arterial blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Dionelle, e.g., if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Dionelle and cancer
Slightly more frequent cases of breast cancer have been observed in women using combined hormonal contraceptives. It is not known whether this is caused by the treatment. It may be, for example, that breast tumors are detected more often in these women because they undergo more frequent medical examinations. The risk of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to perform regular breast examinations, and if the patient detects a lump in the breast, she should contact her doctor.

Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women using contraceptive pills. In isolated cases, these tumors have caused life-threatening intra-abdominal bleeding. If severe abdominal pain occurs, the doctor should be informed immediately.

Some studies suggest that long-term use of these pills increases a woman’s risk of developing cervical cancer. However, it is unclear to what extent sexual behavior (e.g., frequent partner change) and other factors, such as human papillomavirus (HPV), contribute to this risk.

Psychiatric disorders
Some women using hormonal contraceptives, including Dionelle, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor immediately for further medical advice.

When to contact the doctor
Regular check-ups
When using the tablets, the doctor will recommend regular medical examinations. Usually, a visit to the doctor should occur at least once a year.

Additionally, contact the doctor immediately if:

• any concerning changes in health occur, particularly any of the symptoms listed under “When not to use Dionelle” and “When to exercise caution with Dionelle.” Remember to mention any family medical history;
• a breast lump is detected;
• other medications are being used (see also “Dionelle and other medicines”);
• the patient is bedridden for a prolonged period or is scheduled for surgery (consult the doctor at least four weeks in advance);
• unusual, heavy vaginal bleeding occurs between periods;
• tablets are missed in the first week of a new pack and intercourse occurred in the previous 7 days;
• there is no bleeding during two consecutive cycles despite regular tablet intake, and pregnancy is suspected.

Unexpected bleeding between periods
During the first few months of taking Dionelle, unexpected bleeding may occur. Irregular vaginal bleeding usually resolves as the body adjusts to the tablets (typically after about 3 cycles). If heavier bleeding resembling a normal period or light spotting lasting several days occurs, consult the doctor.

Absence of a normal period
If the patient has taken the tablets correctly, without vomiting or severe diarrhea, and has not taken other medications, the likelihood of pregnancy is very low. Continue taking Dionelle as before.
If two consecutive periods are missed, or if the patient did not take Dionelle according to instructions before the missed period, pregnancy is possible. Contact the doctor immediately. Do not take Dionelle until the doctor has ruled out pregnancy.

Children and adolescents
Dionelle may only be used once menstruation has started.

Dionelle and other medicines
Inform the doctor or pharmacist about all medicines currently or recently used, as well as any medicines planned for use.

Some medicines may cause breakthrough bleeding and/or reduce the contraceptive effectiveness of Dionelle.

• Effect of other medicines on Dionelle

Always inform the doctor about any medicines or herbal products being taken. Also, inform any doctor or dentist prescribing other medicines (or a pharmacist) about the use of Dionelle. They will advise whether additional contraceptive methods (e.g., condoms) are needed, and if so, for how long, or whether the dosing schedule of other medicines should be changed.

Some medicines:

• may affect the blood concentration of Dionelle;
• 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 hepatitis C virus infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
  • fungal infections (griseofulvin, ketoconazole);
  • arthritis, osteoarthritis (etoricoxib);
• the herbal product – St. John’s wort (Hypericum perforatum).

When taking any of the above-listed medicines, use an additional mechanical method (e.g., condom) temporarily or choose another contraceptive method. Use additional local contraceptive methods during co-administration of another medicine with Dionelle and for 28 days after stopping the other medicine.
If treatment exceeds the duration of one blister pack of Dionelle, start the next blister pack immediately without a break.

If long-term treatment with any of the above-listed medicines is required, choose another effective, non-hormonal contraceptive method.

• Effect of Dionelle on other medicines

Dionelle may affect the action of other medicines, e.g.:

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

Do not use Dionelle in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may cause abnormal liver function test results (increased activity of liver enzymes AlAT).
Before starting these medicines, the doctor will prescribe another type of contraception.
Dionelle may be restarted approximately 2 weeks after stopping the above-mentioned treatment. See section “When not to use Dionelle.”
Also refer to the patient leaflets of other prescribed medicines.

Effect on laboratory test results
The use of Dionelle may affect the results of certain laboratory tests, including liver function, adrenal cortex, kidney and thyroid function, as well as levels of certain blood proteins, e.g., proteins affecting fat digestion, carbohydrate metabolism, blood coagulation, and fibrinolysis. However, these changes usually remain within normal ranges.

Dionelle with food and drink
Dionelle may be taken with or without food, and if needed, with a small amount of water.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Dionelle must not be used during pregnancy. If pregnancy occurs while taking Dionelle, stop taking the medicine immediately and contact the doctor. If the patient plans to become pregnant, she may stop taking Dionelle at any time (see also “Discontinuation of 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 the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
No effect of Dionelle on the ability to drive and operate machinery has been observed.

Dionelle contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

Dionelle contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free."

3. How to take Dionelle

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Take one tablet daily, with or without water, swallowing it whole. The tablets may be taken with or
without food, at approximately the same time each day.
The blister pack contains 21 coated tablets. Each tablet is marked with the day of the week on which
it should be taken. Take one tablet every day, following the order indicated. Take the tablet marked
with the corresponding day of the week. For example, if your period starts on Friday, take the tablet
marked with "Fr" (Friday), pressing it through the aluminium foil. Take one tablet each day in the
order indicated.
The time of day is not important, but once chosen, it should be consistently adhered to. Follow the
direction of the arrow on the pack until all 21 tablets have been taken. Then, do not take any tablets
for 7 days. During these 7 tablet-free days, withdrawal bleeding (a "period") should occur, usually
2–3 days after taking the last tablet.
On the 8th day, start a new pack, regardless of whether bleeding has stopped or not. This means that
each new pack should be started on the same day of the week, and bleeding will generally occur
around the same time each month.
If Dionelle is taken as directed, you are also protected against pregnancy during the 7 days when no
tablets are taken.

Starting Dionelle for the first time

• If no oral hormonal contraceptives have been taken in the previous month: Start taking the tablets on the first day of your natural menstrual cycle (i.e. the first day of menstrual bleeding).
• If previously using another combined hormonal contraceptive: Start taking Dionelle preferably on the first day after taking the last active tablet of the previous combined oral contraceptive, but no later than the first day after the usual tablet-free interval or after the last hormone-free tablet of the previous combined oral contraceptive.
• If previously using a vaginal ring or transdermal patch: Start taking Dionelle preferably on the day of removal of the last ring or patch from a one-cycle pack, but no later than the day the next application would have occurred.
• If previously using a progestogen-only contraceptive (mini-pill, implant, injection) or an intrauterine system releasing progestogen (hormonal IUD): Switching from a progestogen-only pill can occur on any day (from an implant or intrauterine system on the day of removal, from an injection on the day of the next scheduled injection); however, in all these cases, additional contraceptive precautions (e.g. condoms) must be used during the first 7 days of taking Dionelle.
• After a first-trimester abortion: Consult your doctor. In principle, Dionelle may be started immediately.
• After a second-trimester abortion or childbirth: If you wish to start taking Dionelle, your doctor will advise starting between 21 and 28 days after childbirth or second-trimester abortion. If starting later, use a mechanical method (e.g. condoms) for the first 7 days of taking Dionelle. If you have had sexual intercourse, ensure you are not pregnant before starting Dionelle, or wait until the first menstrual bleeding occurs.
• If you wish to breastfeed and start taking Dionelle: Please refer to the section "Breast-feeding".

Taking more Dionelle than you should
There have been no reports of serious adverse effects after taking multiple tablets of Dionelle at once.
If several tablets are taken simultaneously, nausea, vomiting, or vaginal bleeding may occur. Such
bleeding may even occur in girls who have not yet started menstruating but have accidentally taken
the medicine. If an excessive number of Dionelle tablets have been taken, or if a child has taken any
tablets, consult your doctor or pharmacist immediately.

If you forget to take Dionelle

• If less than 12 hours have passed since the missed tablet, contraceptive effectiveness is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.
• If more than 12 hours have passed since the missed tablet, contraceptive effectiveness may be reduced. The more tablets missed consecutively, the greater the risk of reduced contraceptive protection.

The risk of pregnancy is particularly high if tablets are missed at the beginning or end of a pack. In such cases, follow the instructions below.
More than 1 tablet missed from the pack:
Consult your doctor.
1 tablet missed in the first week of the current pack:
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Continue taking the following tablets at the usual time and use additional contraceptive methods (e.g. condoms) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, pregnancy may have occurred. In this case, inform your doctor.
1 tablet missed in the second week of the current pack:
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Continue taking the following tablets at the usual time. Contraceptive effectiveness is not reduced, provided the tablets were taken correctly for the 7 days prior to the missed tablet. There is no need to use additional mechanical contraceptive methods. However, if more than 1 tablet has been missed, use an additional contraceptive method for 7 days.
1 tablet missed in the third week of the current pack:
You may choose one of the following options without needing additional contraceptive methods, provided the tablets were taken correctly during the 7 days prior to the missed dose.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Continue taking the following tablets at the usual time. Instead of the usual 7-day break, immediately start the next pack. It is unlikely that withdrawal bleeding will occur after finishing the second pack, but spotting or breakthrough bleeding may occur during the days when taking tablets from the second pack.

OR:

2. Alternatively, stop taking tablets from the current pack and start the 7-day tablet-free break immediately (including the day the tablet was missed). If you wish to start the new pack on your usual starting day, the tablet-free break may be shorter than 7 days.

If you forget to take tablets and do not experience the expected bleeding during the first tablet-free break, you may be pregnant. Contact your doctor before starting the next pack.

Important information if you have diarrhoea or severe vomiting
If you experience severe vomiting or diarrhoea, there is a risk that the active substances in the tablet may not be fully absorbed. This situation is similar to missing a tablet. If vomiting occurs within 3 to 4 hours after taking a tablet, take another (additional) tablet as soon as possible. If possible, take this additional tablet within 12 hours of your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the advice given under "If you forget to take Dionelle". If you wish to maintain your usual dosing schedule, take the additional tablet from a spare blister pack, which may be kept as a backup.

Delaying the onset of bleeding: important information
Although not recommended, you may delay the onset of bleeding by starting the next pack immediately, without a break, i.e. directly after finishing the current blister pack. You may continue taking tablets until you wish for bleeding to occur. However, do not take tablets for longer than two packs in a row. Breakthrough bleeding may occur during the second pack. After the second pack, take a 7-day tablet-free break before starting the next pack.
You may consult your doctor for advice before deciding to delay bleeding.

Changing the day of bleeding to another day of the week: important information
If tablets are taken as directed, bleeding usually occurs approximately on the same day every 4 weeks. To change the day of bleeding, shorten (but never extend) the tablet-free break. For example, if bleeding usually starts on Fridays and you wish it to start on Tuesdays (3 days earlier), start the new blister pack 3 days earlier than usual. If the tablet-free break is very short (e.g. 3 days or less), bleeding may not occur during the break, but light bleeding may occur later.
If in doubt about further steps, consult your doctor.

Stopping Dionelle
You may stop taking this medicine at any time. Your doctor will then suggest alternative contraceptive methods.
If you plan to become pregnant, stop taking the medicine and have sexual intercourse after the next menstrual period. This will help determine the expected date of delivery.

Additional information for specific patient groups
Children and adolescents
Dionelle is indicated only after menstruation has started.
Elderly patients
Dionelle is not indicated for postmenopausal women.
Patients with hepatic impairment
Dionelle is contraindicated in women with severe liver disease (see also section 2 "When not to take Dionelle").
Patients with renal impairment
No specific studies with Dionelle have been conducted in patients with renal impairment. Available data do not indicate a need for dosage adjustment in this patient group.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders).
For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Dionelle".

Serious adverse effects
Serious adverse effects associated with taking Dionelle are listed in the section "When to be cautious when using Dionelle".
Immediate medical attention should be sought if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria, potentially with breathing difficulties (see also section "Warnings and precautions").

The following adverse effects were reported in clinical trials using tablets containing 0.03 mg ethinylestradiol and 2 mg dienogest:

Common (may affect less than 1 in 10 people)

• Headache,
• Breast pain, including breast discomfort and tenderness.

Uncommon (may affect 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 diarrhoea,
• Acne, alopecia (hair loss), rash, itching,
• Irregular menstrual bleeding, including heavy menstrual bleeding (menorrhagia), light menstrual bleeding (hypomenorrhoea), infrequent menstruation (oligomenorrhoea), and absence of menstruation (amenorrhoea),
• Intermenstrual bleeding including vaginal haemorrhage and irregular intermenstrual bleeding (metrorrhagia), painful menstruation (dysmenorrhoea), genital/vaginal discharge, fluid-filled structures (cysts) in the ovaries, internal genital organ pain, breast enlargement, breast swelling,
• Fatigue, weakness, malaise,
• Weight gain.

Rare (may affect less than 1 in 1,000 people)

• Oophoritis and salpingitis, urinary tract infections, cystitis (bladder inflammation), mastitis (breast inflammation), cervicitis (inflammatory condition of the cervix), fungal infections, viral infections (e.g. oral herpes), influenza, bronchitis, sinusitis, upper respiratory tract infections,
• Uterine leiomyoma, breast fibroadenoma,
• Anaemia,
• Hypersensitivity (allergic reaction),
• Virilization (development of male secondary sexual characteristics in women),
• Anorexia (severe loss of appetite),
• Depression, psychiatric disorders, insomnia, sleep disturbances, aggression,
• Circulatory disorders in the brain or heart, muscle disorders which may lead to abnormal posture (dystonia),
• Dry or irritated eyes, oscillopsia (subjective sensation of oscillating vision) or other visual disturbances,
• Sudden hearing loss, tinnitus, dizziness, hearing disturbances,
• Tachycardia (rapid heartbeat),
• Phlebitis, high diastolic blood pressure, dizziness or fainting upon standing from sitting or lying positions (orthostatic dysregulation), hot flushes, varicose veins, venous disorders, vein pain,
• Asthma, rapid or deep breathing (hyperventilation),
• Gastritis, enteritis, stomach upset (dyspepsia),
• Allergic dermatitis (skin inflammation), atopic dermatitis, rash, skin disease with thickened red patches (psoriasis), excessive sweating, skin pigmentation changes or disorders (e.g. melasma), excessive sebum production by sebaceous glands (seborrhoea), dandruff, skin lesions, orange-coloured 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), pain in arms and legs,
• 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), milky discharge from breast glands (galactorrhoea), menstrual disorders,
• Chest pain, swelling of hands, ankles or feet (peripheral oedema), flu-like symptoms, inflammation, fever, irritability,
• Elevated blood lipid levels (increased triglycerides and cholesterol), weight loss, weight fluctuations,
• Discovery of supernumerary breast tissue,
• 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 ischaemic attack (TIA),
  • blood clots in the liver, stomach, intestine, kidneys or eye.

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

Other adverse effects observed in women taking tablets, for which the exact frequency is unknown, include:
Mood changes, decreased or increased libido (sexual drive), intolerance to contact lenses, skin changes (urticaria, nodular erythema, erythema multiforme), breast discharge, fluid retention.

Tumours

• The number of diagnosed cases of breast cancer in women using Dionelle is slightly increased. Since breast cancer is rare in women under 40 years of age, the overall risk of developing breast cancer remains small. For more information, see section "Dionelle and cancer";
• Liver tumours (benign and malignant);
• Cervical cancer.

Other

• Women with hypertriglyceridaemia (increased blood fat levels, increasing the risk of pancreatitis during use of combined oral contraceptives);
• High blood pressure;
• Occurrence or worsening of symptoms whose relationship to COC use is not established: jaundice and/or pruritus associated with cholestasis (impaired bile flow); gallstones; metabolic disorders such as porphyria; systemic lupus erythematosus (chronic autoimmune disease); haemolytic-uraemic syndrome (a blood clotting disorder); neurological disorders known as Sydenham's chorea; herpes gestationis (a type of skin disease occurring 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;
• Melasma.

Interactions
Intermenstrual bleeding and/or reduced contraceptive effectiveness may result from interactions between other medicinal products and oral contraceptives (e.g. St. John's wort (Hypericum perforatum) or drugs used for epilepsy, tuberculosis, HIV infection and other infections). See section "Dionelle with other medicines".

Other serious reactions that may occur during treatment with Dionelle, along with associated symptoms, are described in the section "Warnings and precautions".

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dionelle

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the package and other information

What Dionelle contains
The active substances in Dionelle are ethinylestradiol and dienogest. One coated tablet contains
0.03 mg of ethinylestradiol and 2 mg of dienogest.
The other ingredients are:

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

What Dionelle looks like and contents of the pack
Dionelle is a white, round, biconvex coated tablet.
Dionelle is available in packs containing 21, 3 x 21 and 6 x 21 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DR. KADE Pharmazeutische Fabrik GmbH
Rigistrasse 2
12277 Berlin, Germany
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
For further information, contact the representative of the Marketing Authorisation Holder:
Kadefarm Sp. z o.o.
Sierosław, ul. Gipsowa 18
62-080 Tarnowo Podgórne, Poland
Tel.: +48 61 862 99 43; e-mail: [email protected]
This medicinal product is authorised in the European Economic Area under the following names:
Austria Viola 0.03 mg/2 mg Filmtabletten
Germany Finic 0.03 mg/2 mg Filmtabletten
Poland Dionelle