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, coated tablets
Ethinylestradiolum + Dienogestum
Dionelle and Finic 0.03 mg/2 mg Film Tablets are different trade names for the same medicinal product.
Please read this leaflet carefully before taking this medicine, because 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 other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. 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, particularly 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 medicine:

• used to prevent pregnancy (a contraceptive tablet).
• used 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 take Dionelle, you should read the information about blood clots in section 2. It is especially important to read the information about symptoms of blood clots – see section 2 "Blood clots".
Before you start taking 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 tests.
This leaflet describes several situations in which you should stop taking Dionelle or in which the effectiveness of Dionelle may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms 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 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 and periodically thereafter.

When not to use Dionelle
Do not take Dionelle if you have any of the conditions listed below. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.
Do not take 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 had in the past) 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 diseases 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 ever had) a type of migraine called "migraine with aura";
• if you have (or have ever 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 had in the past, or are suspected of having a hormone-dependent malignant tumour of the reproductive organs or breast;
• if you have vaginal bleeding of unknown cause;
• if you have hepatitis C and are taking medicinal products containing ombitasvir, paritaprevir, ritonavir and dasabuvir or glecaprevir/pibrentasvir (see section "Dionelle with other medicines");
• 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 symptoms 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 the section "Warnings and precautions".

Warnings and precautions
When to exercise special caution when taking Dionelle
When should you contact your doctor?
Seek immediate medical advice
if you notice possible symptoms of blood clots, which may indicate deep vein thrombosis (blood clot in the leg), pulmonary embolism (blood clot in the lungs), heart attack, or stroke (see section below "Blood clots").
Description of symptoms of these serious adverse reactions, 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 develop or worsen during treatment with Dionelle, you should also inform your doctor:

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (an autoimmune disease);
• 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 to find out how soon after delivery you can start taking Dionelle.
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have heart valve disorders or heart rhythm problems;
• if breast cancer has occurred in your close family in the past or is currently present;
• 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 affecting haemoglobin 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 an early pregnancy (pemphigoid gestationis);
• if you experienced hearing loss in the inner ear (hearing loss associated with otosclerosis);
• if you have hereditary angioedema, products containing estrogens may trigger or worsen angioedema symptoms. If symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives and breathing difficulties, seek immediate medical advice.

BLOOD CLOTS
Using combined hormonal contraceptives such as Dionelle increases the risk of blood clots compared to not using them.
In rare cases, a blood clot may block a blood vessel and cause serious health problems.
Blood clots may occur

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

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 associated with taking Dionelle is low.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

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

• The use of combined hormonal contraceptives is associated with an increased risk of developing 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 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 compared to not using combined hormonal contraceptives at all.
If a patient stops taking the medicine Dionelle, the risk of developing blood clots returns to normal levels 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 on the type of combined hormonal contraceptive being used.
The overall risk of developing a blood clot in the lower limb or lung (deep vein thrombosis or pulmonary embolism) while using Dionelle is low.

• In the course of one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who are using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimat will develop blood clots.
• In the course of one year, about 8–11 out of 10,000 women who are using combined hormonal contraceptives containing dienogest and ethinylestradiol, such as the medicine 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 blood clots” below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Dionelle is small, however,
some factors may increase this risk. The risk is higher:

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

The risk of 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,
particularly if the patient has another risk factor listed above.
It is important to tell the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to stop the use of Dionelle.
Tell the doctor if any of the above conditions change during treatment with Dionelle, for example, if a close relative is diagnosed with thrombosis without a known cause, 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 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 myocardial infarction or stroke associated with the use of Dionelle is very small, but may increase:

• with age (over 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 is unable to stop smoking and is over 35 years of age, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a myocardial infarction or stroke at a young age (under 50 years of age). In this case, the patient may also be at increased risk of myocardial infarction or stroke;
• if the patient or a close relative has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraine, especially migraine with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Tell the doctor if any of the above conditions change during treatment with Dionelle, for example, if the patient starts smoking, if a close relative is diagnosed with thrombosis without a known 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. The reason may be, for example, that tumours are detected more frequently in women using combined hormonal contraceptives because these women are examined more frequently by a doctor. The risk of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and if the patient detects a lump in the breast, she should contact the doctor.

Benign or, even more rarely, malignant liver tumours have been reported rarely in women using contraceptive pills. In isolated cases, these tumours 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 behaviour (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 to obtain further medical advice.

When to contact the doctor
Regular check-ups
When taking the pills, the doctor will recommend regular examinations.
Usually, a visit to the doctor should take place at least once a year.

Additionally, contact the doctor immediately if:

• any worrying changes in health occur, particularly any of the symptoms listed under “When not to use Dionelle” and “When to be cautious with Dionelle”. Remember family medical history;
• a breast lump is detected;
• other medicines are being used (see also “Dionelle with other medicines”);
• the patient is immobilised in bed for a prolonged period or is due to undergo surgery (consult the doctor at least four weeks in advance);
• unusual, heavy vaginal bleeding occurs between periods;
• pills are missed in the first week of starting a new pack and sexual intercourse occurred in the previous 7 days;
• there is no withdrawal bleeding for two consecutive months despite regular pill 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 stops as the body adjusts to the pills (usually after about 3 cycles). If heavier bleeding occurs, resembling a normal period, or light spotting lasting several days, consult the doctor.

Absence of normal menstruation
If the patient has taken the pills correctly, has not vomited or had severe diarrhoea, and has not taken any other medicines, the likelihood of pregnancy is very low. Continue taking Dionelle as before.

If two consecutive withdrawal bleeds do not occur, or if the patient has not taken Dionelle according to instructions before the missed period, pregnancy may have occurred. Contact the doctor immediately. Do not take Dionelle until the doctor has ruled out pregnancy.

Children and adolescents
Dionelle should only be used after menstruation has started.

Dionelle with other medicines
Tell 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 pharmacist) that Dionelle is being used. They will advise whether additional contraceptive methods (e.g. condoms) should be used, and if so, for how long, or whether the dosing schedule of other medicines should be changed.

Medicines that may affect Dionelle 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, degenerative joint disease (etoricoxib);
• the herbal remedy - St John's wort (Hypericum perforatum).

When being treated with any medicine from the above list, a temporary additional mechanical method (e.g. condom) should be used or another contraceptive method chosen. Additional local contraceptive methods should be used during treatment with the other medicine together with Dionelle, and for 28 days after stopping the other medicine.
If treatment extends beyond 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 medicine from the above list is required, choose another effective, non-hormonal contraceptive method.

• Effect of Dionelle on other medicines Dionelle may affect the action of other medicines, for example:
• the antiepileptic drug lamotrigine (this may lead to increased frequency of seizures);
• cyclosporine;
• theophylline (used in the treatment of breathing disorders);
• tizanidine (used in the treatment of muscle pain or muscle spasms).

Do not use Dionelle if the patient has hepatitis C and is taking medicinal products containing ombitasvir, paritaprevir, ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause elevated liver function test results (increased activity of the liver enzyme AlAT). The doctor will prescribe another type of contraceptive before starting treatment with these medicinal products. Dionelle may be restarted approximately 2 weeks after stopping this 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, or blood coagulation and fibrinolysis. However, these changes usually remain within normal reference ranges.

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

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

Pregnancy
If the patient is pregnant, Dionelle should not be taken. If pregnancy occurs during treatment with Dionelle, stop taking the medicine immediately and contact the doctor. If the patient plans to have a child, 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 the 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 lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult the 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 use 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, swallowing it whole with a small amount of water if needed. 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 symbol of the day of the
week on which it should be taken. Take one tablet each day. Take the tablet marked with the symbol
corresponding to the day of the week. For example, if menstruation begins on Friday, take the tablet
marked "Fr" (Fr = Freitag = Friday; see "Translation of the day-of-the-week symbols on each tablet
on 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 followed consistently. Follow the
direction of the arrow on the blister pack until all 21 tablets have been taken. After that, 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 a new blister pack, regardless of whether bleeding has stopped or not. This
means that each new blister pack should be started on the same day of the week, and bleeding will
occur approximately on the same day each month.
If Dionelle is taken as described above, protection against pregnancy is maintained during the 7
tablet-free days.

First-time use of Dionelle

• If no oral hormonal contraceptives have been used in the previous month: Start taking tablets on the first day of the natural menstrual cycle (i.e. the first day of menstrual bleeding).
• If previously using another combined hormonal contraceptive: The patient should start taking Dionelle preferably on the first day after taking the last active tablet of the previous combined oral contraceptive, or at the latest on 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 using Dionelle preferably on the day of removal of the last ring or patch from the one-cycle pack, but no later than the day the next application would have been due.
• If previously using a progestogen-only product (mini-pill, implant, injection) or an intrauterine system releasing progestogen (hormonal IUD): Switching from a progestogen-only tablet 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), but in all these cases, additional contraceptive precautions must be used during the first 7 days of taking Dionelle.
• After a first-trimester abortion: Consult your doctor. Generally, taking Dionelle may be started immediately.
• After a second-trimester abortion or childbirth: If the patient wishes to start taking Dionelle, the doctor will advise starting between 21 and 28 days after childbirth or second-trimester abortion. If starting later, a mechanical method (e.g. condom) should be used for the first 7 days of taking Dionelle. If sexual intercourse has occurred, ensure that pregnancy has not occurred before starting Dionelle, or wait until the first menstrual bleeding occurs.
• If the patient wishes to breastfeed and start taking Dionelle: Refer to the section "Breast-feeding".

Overdose of Dionelle

There are 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 an excessive number of Dionelle tablets are taken, or if a child has taken the tablets,
consult a doctor or pharmacist immediately.

Missed dose of Dionelle

• If less than 12 hours have passed since the missed tablet, the contraceptive effectiveness of Dionelle 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, the effectiveness of Dionelle may be reduced. The more consecutive tablets missed, 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 the blister pack.
In such cases, follow the rules below.

More than 1 tablet missed from the blister pack:
Consult your doctor.

1 tablet missed in the first week of the current blister 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.
condom) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet,
pregnancy may have occurred. In this case, inform your doctor.

1 tablet missed in the second week of the current blister 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 medicine has been taken correctly for the 7 days prior to the missed tablet. No additional
mechanical contraceptive methods are necessary. 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 blister pack:
One of the following options may be chosen, without the need for additional contraceptive methods,
provided the medicine has been taken correctly for 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 tablet-free interval, start the next blister pack immediately. It is unlikely that a withdrawal bleed will occur after finishing the second blister pack, but spotting or intermenstrual bleeding may occur during the days of taking tablets from the second blister pack.

OR:

2. Alternatively, stop taking tablets from the current blister pack and start the 7-day tablet-free interval immediately (including the day the tablet was missed). If the patient wishes to start a new blister pack on the day she usually starts, the tablet-free interval may be shorter than 7 days.

If tablets are forgotten and no expected bleeding occurs during the first tablet-free interval, pregnancy may have occurred. Before starting the next blister pack, consult your doctor.

Important information in case of diarrhoea or severe vomiting

If severe vomiting or diarrhoea occurs, there is a risk that the active substances in the tablet may not be completely absorbed. This situation is similar to missing a tablet. If vomiting occurs within 3 to 4 hours after taking the tablet, take another (additional) tablet as soon as possible. If possible, take this additional tablet within 12 hours of the usual time of tablet intake. If this is not possible or more than 12 hours have passed, follow the instructions given under "Missed dose of Dionelle". If the patient does not wish to change her dosing cycle, take the additional tablet from a second blister pack, which may serve as a spare pack.

Delaying the withdrawal bleed: important information

Although not recommended, the withdrawal bleed can be delayed by starting the next blister pack immediately, without a tablet-free interval, i.e. directly after finishing the current blister pack. Continue taking tablets until the desired time for the bleed. However, tablet intake must be stopped no later than after finishing the second blister pack. During use of this second blister pack, light bleeding may occur. Start the next blister pack after a 7-day tablet-free interval.

The patient may consult her doctor before deciding to delay the withdrawal bleed.

Changing the day of the week for the withdrawal bleed: important information

If tablets are taken as directed, the withdrawal bleed occurs approximately on the same day every 4 weeks. To change the day of the withdrawal bleed, shorten (but never extend) the tablet-free interval. For example, if bleeding usually starts on Fridays and the patient wishes 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 interval, but light bleeding may occur afterwards.

If in doubt about further management, consult your doctor.

Stopping the use of Dionelle

The medicine may be discontinued at any time. Your doctor will then recommend alternative contraceptive methods.
If the patient plans 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 already 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 use Dionelle").

Patients with renal impairment
No specific studies with Dionelle have been conducted in patients with renal impairment. Available data do not indicate the need for dose adjustment in this patient group.

If you have any further doubts regarding 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 status that the patient considers 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 effects associated with the use of Dionelle are listed in the section "When to exercise special caution when using Dionelle".
The following adverse effects have been reported in clinical trials using tablets containing 0.03 mg ethinylestradiol and 2 mg dienogest:

Common (may affect fewer than 1 in 10 people)

• headache,
• breast pain, including breast discomfort and tenderness.

Uncommon (may affect fewer than 1 in 100 people)

• vaginal inflammation 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, pruritus (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, pain in internal genital organs, breast enlargement, breast swelling,
• fatigue, weakness, malaise,
• weight gain.

Rare (may affect fewer than 1 in 1000 people)

• ovarian and fallopian tube inflammation, 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, 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 (vein inflammation), elevated 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 (intestinal inflammation), indigestion (dyspepsia),
• allergic dermatitis (skin inflammation), atopic dermatitis, rash, skin disease with thickened red patches (psoriasis), excessive sweating, skin pigmentation changes or disorders (e.g. chloasma), 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), milky 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,
• revelation of supernumerary breast tissue,
• harmful blood clots in veins or arteries, 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 risk factors for blood clots and symptoms of clot formation).

Other adverse effects observed in women using tablets, for which the frequency is unknown, include:
mood changes, decreased or increased libido (sex drive), contact lens intolerance, 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. 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 the 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, the relationship of which to COC use has not been established: jaundice and/or pruritus associated with cholestasis (blocked bile flow); gallstones; metabolic disorders such as porphyria; systemic lupus erythematosus (a 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;
• in women with hereditary angioedema (characterized by sudden swelling, e.g. of eyes, lips, throat, etc.), exogenous estrogens may trigger or worsen angioedema symptoms;
• liver function disorders;
• changes in glucose tolerance or effects on peripheral insulin resistance;
• Crohn's disease, ulcerative colitis;
• chloasma.

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

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

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also 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
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this 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°C.
Translation of some information on the immediate packaging:
Ch.-B./Verw. bis: see embossing – Batch number/Expiry date: see embossing.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Dionelle contains
The active substances in this medicine 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, sodium carboxymethyl starch (type A), magnesium stearate;
• Coating: AquaPolish white, containing: 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 sachet is included in the packaging, into which the blister should be placed.
For more detailed information, please contact the marketing authorisation holder or the 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
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
German marketing authorisation number (country of export): 85862.00.00
Parallel import authorisation number: 160/21
Translation of the weekday symbols printed on each tablet in the immediate packaging:
Mo - Monday
Di - Tuesday
Mi - Wednesday
Do - Thursday
Fr - Friday
Sa - Saturday
So - Sunday
This medicinal product is authorised for supply 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