Dionelle

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Dionelle (Finic 0.03 mg/2 mg Film Tablets)
0.03 mg + 2 mg, film-coated tablets
Ethinylestradiolum + Dienogestum
Dionelle and Finic 0.03 mg/2 mg Film Tablets are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, 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 one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, 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. What you need to know 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 (oral contraceptive pill).
• for the treatment of women with moderate acne who have decided to use oral contraceptives, and in whom adequate topical treatment or systemic antibiotic therapy has not been successful.

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".
Clinical studies have shown that Dionelle alleviates symptoms in women whose acne is caused by excessive levels of male sex hormones (so-called androgens).

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 the information about 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 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 either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the calendar method or temperature method. These methods may be unreliable because Dionelle modifies monthly changes in body temperature and cervical mucus.
Like all other hormonal contraceptives, Dionelle does not protect against infection with HIV (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 would 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 blood clotting disorders – 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 heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that 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 previously had) a type of migraine called "migraine with aura";
• if you have (or have previously had) pancreatitis associated with very high levels of fats in the blood (lipids) (hypertriglyceridemia);
• if you have had or currently have severe liver disease (until liver function tests return to normal);
• if you have had or currently have benign or malignant liver tumours;
• if you currently have, have previously had, or are suspected of having a hormone-dependent malignant tumour 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 particular caution when using Dionelle
When should you contact your doctor?
Seek immediate medical advice
if you notice symptoms that may indicate a blood clot, which could suggest deep vein thrombosis in the leg, pulmonary embolism, heart attack, or stroke (see section below "Blood clots").
Description of symptoms of these serious adverse effects is provided in "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 perform regular check-ups.
If any of these conditions develop 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 defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or if such a condition runs in your immediate family. Hypertriglyceridaemia 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 abnormalities;
• if breast cancer has occurred in your close family;
• if you have liver or gallbladder disease, or gallstones;
• if you have jaundice or itching due to bile stasis;
• if you have brownish, patchy 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 affecting haemoglobin production (porphyria);
• if you have depression;
• if you have epilepsy;
• if you have Sydenham's chorea (St. Vitus' dance);
• if you developed blistering rash during an earlier pregnancy (herpes gestationis);
• if you 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 attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Dionelle is associated with an increased risk of blood clots compared to not using any contraceptive.
In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots may occur

• in veins (called venous thrombosis or venous thromboembolic disease);
• in arteries (called arterial thrombosis or arterial thromboembolic disease).

Recovery from 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 low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience 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 colour of the leg, such as pallor, redness, or blueness.

• sudden unexplained shortness of breath or rapid breathing, Pulmonary embolism

• sudden coughing without apparent cause, possibly with coughing up blood,

• sharp chest pain, which may worsen on deep breathing,

BLOOD CLOTS IN VEINS
What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). 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 the development of 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 developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. 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 developing blood clots?
The risk depends on the individual's natural risk of venous thromboembolic disease 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 taking Dionelle is small.

• 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 norgestimat 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 developing blood clots
within one year
Women who do not use combined hormonal contraceptives and are not pregnant: About 2 per 10,000 women
Women using combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimat: About 5–7 per 10,000 women
Women using Dionelle: About 8–11 per 10,000 women

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

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, 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 discontinue Dionelle several weeks before surgery or during immobilization. If Dionelle must be stopped, ask the doctor when it is safe to resume taking it;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

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

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in an artery?
As with venous blood clots, arterial clots may cause 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 (above approximately 35 years);
• if the patient smokes cigarettes. When 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 relative 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 relative has high blood lipid levels (cholesterol or triglycerides);
• if the patient suffers from migraine, particularly migraine with aura;
• if the patient has heart disease (valvular heart disease, arrhythmia 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 developing 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, if a close relative is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

Dionelle and cancer
A slightly higher incidence of breast cancer has 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 tumors are detected more frequently in women using combined hormonal contraceptives because these women are examined more often by a doctor. 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.

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 may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible 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 take place at least once a year.

Additionally, contact the doctor immediately if:

• any concerning changes in health occur, especially any of the symptoms listed under "When not to use Dionelle" and "When to exercise special caution when using Dionelle". Remember to consider family medical history;
• a breast lump is detected;
• other medicines 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 sexual intercourse occurred in the previous 7 days;
• no withdrawal bleeding occurs in two consecutive months 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 (usually after about 3 cycles). If bleeding resembling a normal period occurs or if light spotting lasts for several days, consult the doctor.

Absence of normal menstruation
If the patient has taken the tablets correctly, has not vomited or had severe diarrhea, and has not taken other medications, the likelihood of pregnancy is very low. Continue taking Dionelle as before.
If two consecutive withdrawal bleeds do not occur, 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 be used only after menstruation has started.

Dionelle and other medicines
Inform the doctor or pharmacist about all medicines currently or recently used, as well as any medicines the patient plans to 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 the pharmacist) that Dionelle is being used. 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.

Medicines that may:

• affect the blood concentration of Dionelle;
• reduce its contraceptive effect;
• cause unexpected bleeding;

include:

• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV infection and hepatitis C (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
• fungal infections (griseofulvin, ketoconazole);
• arthritis, osteoarthritis (etoricoxib);
• herbal remedy – St. John's wort (Hypericum perforatum).

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

If long-term treatment with any of the 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 (this 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 liver enzyme AlAT activity).
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, adrenal cortex, kidney, and thyroid function parameters, 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, swallowing with a small amount of water if needed.

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
If the patient is pregnant, do not take Dionelle. 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 or operate machinery has been observed.

Dionelle contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should contact her doctor before taking the 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 you are unsure,
you should consult your doctor or pharmacist.
Take one tablet daily, swallowing it whole with a small amount of water if needed. The tablets may be
taken with or without food, but should be taken at approximately the same time each day.
The blister pack contains 21 coated tablets. Each tablet is marked with the symbol of the day of the
week on which it should be taken. Take one tablet each day, following the order indicated on the
pack. Take the tablet marked with the symbol corresponding to the current day of the week. For
example, if your period starts on Friday, take the tablet marked with "Fr" (indicating Friday; see
"Translation of day-of-the-week symbols on each tablet in the immediate packaging" at the end of
this leaflet), pressing it through the aluminium foil. Take one tablet every day in the order indicated.
The time of day is not important, but once chosen, it should be consistently followed. Follow the
direction of the arrow on the packaging until all 21 tablets have been taken. After completing the pack,
do not take any tablets for 7 days. During these 7 tablet-free days, a withdrawal bleed (menstrual
bleeding) should occur, usually 2–3 days after taking the last tablet.
On the 8th day, start the next 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 on
approximately the same day each month.
If you take Dionelle as directed, you will also be protected against pregnancy during the 7 days when
you are not taking tablets.

Starting Dionelle for the first time

• If you have not taken any oral hormonal contraceptives in the past month: Start taking tablets on day 1 of your natural menstrual cycle (i.e. the first day of menstrual bleeding).

• If you were previously using another combined hormonal contraceptive: You should start taking Dionelle preferably on day 1 after taking the last active tablet of your previous combined oral contraceptive, and at the latest on day 1 after the usual tablet-free interval or after the last hormone-free tablet of your previous combined oral contraceptive.

• If you were previously using a vaginal ring or transdermal patch: Start taking Dionelle preferably on the day of removing the last ring or patch from the cycle pack, but no later than the day the next application would have been due.

• If you were previously using a progestogen-only product (mini-pill, implant, injection) or a progestogen-releasing intrauterine system (hormonal IUD): Switching from a progestogen-only pill can be done 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), but in all these cases, you must use additional contraceptive precautions (e.g. condoms) during the first 7 days of taking Dionelle.

• After a first-trimester abortion: Consult your doctor. In principle, you may start taking Dionelle immediately.

• After a second-trimester abortion or childbirth: If you wish to start taking Dionelle, your doctor will advise you to begin taking tablets between 21 and 28 days after delivery or second-trimester abortion. If you start later, you should also use a mechanical method (e.g. condom) for the first 7 days of taking Dionelle. If you have had sexual intercourse before starting Dionelle, you should ensure that you are not pregnant, or wait until the onset of your first menstrual bleeding.

• If you wish to breastfeed and start taking Dionelle after childbirth: Please refer to the section "Breastfeeding".

Taking more Dionelle than prescribed
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
this medicine. If you or a child has taken too many Dionelle tablets, consult your doctor or pharmacist
immediately.

Missed dose of Dionelle

• If less than 12 hours have passed since you missed a tablet, the contraceptive effectiveness of Dionelle remains unchanged. Take the missed tablet as soon as possible and take the next tablet at your usual time.
• If more than 12 hours have passed since you missed a tablet, the effectiveness of Dionelle may be reduced. The more tablets you miss 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.
One tablet missed during 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 remaining tablets at your 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.
One tablet missed during 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 remaining tablets at your usual time. Contraceptive effectiveness is not reduced,
provided that you have taken the tablets correctly for the 7 days preceding the missed tablet. There is
no need to use additional mechanical contraceptive methods. However, if more than one tablet has
been missed, use an additional contraceptive method for 7 days.
One tablet missed during the third week of the current pack:
You may choose one of the following options without needing additional contraceptive methods,
provided that you have taken the tablets correctly for the 7 days preceding 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 remaining tablets at your usual time. Instead of taking the usual 7-day break, immediately start the next pack. It is unlikely that a withdrawal bleed will occur after finishing the second pack, but you may experience spotting or breakthrough bleeding during the days you take tablets from the second pack.

OR:

2. You may also stop taking tablets from the current pack and immediately begin the 7-day tablet-free interval (including the day on which you missed the tablet). If you wish to start the next pack on your usual starting day, the tablet-free interval may be shorter than 7 days.

If you miss tablets and do not have the expected bleeding during the first tablet-free interval, 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 into your body. 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 tablet within 12 hours of your usual tablet-taking time. If this is not possible or more than 12
hours have passed, follow the instructions under "Missed dose of Dionelle". If you do not wish to
change your dosing schedule, take the additional tablet from a spare blister pack, which can serve as a
backup.

Delaying the onset of bleeding: important information
Although not recommended, you may delay the onset of bleeding by immediately starting the next
pack without a break, i.e. directly after finishing the current blister pack. You may continue taking
tablets until you wish for your period to occur. However, do not take tablets from more than two
blister packs consecutively. Light bleeding may occur during the second blister pack. After the second
blister pack, take a 7-day 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 you take the tablets as directed, bleeding occurs approximately on the same day every 4 weeks. To
change the bleeding day, shorten (but never extend) the tablet-free interval. For example, if bleeding
usually starts on Fridays and you wish it to start on Tuesdays (3 days earlier), start the first tablet of
the new blister pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or
less), bleeding may not occur during this time, but light bleeding may occur later.
If you have any further doubts about what to do, consult your doctor.

Stopping Dionelle
You may stop taking Dionelle at any time. Your doctor will then suggest alternative contraceptive
methods.
If you plan to become pregnant, stop taking Dionelle and have sexual intercourse after your 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 liver impairment
Dionelle is contraindicated in women with severe liver disease (see also section 2 "When not to take Dionelle").

Patients with kidney impairment
No specific studies with Dionelle have been conducted in patients with renal impairment. Available
data do not indicate a need to modify treatment in this patient group.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe or persistent ones, or any changes in health which the patient considers to be related to the use of Dionelle, medical advice should be sought.
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 reactions
Serious adverse reactions associated with the use of Dionelle are listed in the section "When to exercise special caution 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 in swallowing or urticaria, potentially with difficulty breathing (see also section "Warnings and precautions").

The following adverse reactions 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,
• menstrual disorders, including heavy menstrual bleeding (menorrhagia), scanty 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 1000 people)

• ovarian and fallopian tube inflammation, urinary tract infections, cystitis (bladder infection), mastitis (inflammation of the breast), cervicitis (inflammatory condition of the cervix), fungal infections, viral infection (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 disorders, aggression,
• circulatory disorders in the brain or heart, muscle disorders which may lead, for example, to abnormal posture (dystonia),
• dry or irritated eyes, oscillopsia (subjective sensation of oscillating vision) or other visual disturbances,
• sudden hearing loss, tinnitus, dizziness, hearing disorders,
• tachycardia (rapid heartbeat),
• phlebitis, high diastolic blood pressure, dizziness or fainting upon standing from a sitting or lying position (orthostatic dysregulation), hot flushes, varicose veins, venous disorders, vein pain,
• asthma, rapid or deep breathing (hyperventilation),
• gastritis (inflammation of the stomach lining), enteritis (inflammation of the intestine), indigestion (dyspepsia),
• allergic dermatitis (skin inflammation), atopic dermatitis, eczema, skin disease with thickened red patches (psoriasis), excessive sweating, changes or disorders in skin pigmentation (e.g. melasma), excessive sebum production by sebaceous glands (seborrhoea), dandruff, skin changes, 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), milk-like discharge from the mammary glands (galactorrhoea), menstrual disorders,
• chest pain, swelling of hands, ankles or feet (peripheral oedema), influenza-like symptoms, inflammation, fever, irritability,
• elevated blood lipid levels (increased triglyceride and cholesterol levels), weight loss, weight fluctuations,
• presence 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 other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Other adverse reactions observed in women taking tablets, for which the exact frequency is unknown, include:
mood changes, decreased or increased libido (sex 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 among women using Dionelle is slightly increased. However, 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 has not been 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 with other medications affecting oral contraceptives (e.g. St John's wort (Hypericum perforatum), or drugs used to treat 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Reporting adverse reactions 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 packaging. The expiry date refers to the last day of the stated month.
Do not store above 30℃.
Translation of some information on the immediate packaging:
Ch.-B./Verw. bis: see imprint – batch number/expiry date: refer to imprint
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Dionelle contains
The active substances in this medicinal product are ethinylestradiol and dienogest. One coated tablet contains 0.03 mg ethinylestradiol and 2 mg dienogest.
Other components 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 of 21 and 3 x 21 coated tablets.
A cardboard sachet is included in the package, into which the blister should be placed.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Germany, the country of export: 85862.00.00
Parallel Import Licence Number: 197/20
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Austria Viola 0.03 mg/2 mg Film Tablets
Germany Finic 0.03 mg/2 mg Film Tablets
Poland Dionelle