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 trade names for the same medicinal product.
Please read the entire 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. It may harm others, 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 represent one of 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 treatment following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clot formation (see section 2 "Blood clots").

Table of 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 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 pills"
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 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 cases, you should not have sexual intercourse or you should 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 HIV (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 regularly thereafter.

When not to use Dionelle
Do not use 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 other contraceptive method 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 disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a long time (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, 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 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 have (or have ever 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 listed conditions occur for the first time while taking Dionelle, stop taking the medicine immediately and consult your doctor. During this time, use non-hormonal contraceptive methods. 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?
You should contact your doctor immediately
if you notice any probable symptoms of blood clots, which may indicate a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots").
Description of symptoms of these serious adverse reactions, see "How to recognize blood clots".

Tell your doctor if you have any of the following conditions.
In certain situations, special care may be needed when 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 while taking 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 (a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing 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 (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 long time (see section 2 "Blood clots");
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor about how soon after childbirth 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 disturbances;
• if breast cancer has occurred in your immediate family;
• if you have liver or gallbladder disease, 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 of 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 a previous early pregnancy (pemphigoid gestationis);
• if you have experienced hearing loss in the inner ear (hearing loss associated with otosclerosis).
• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, potentially with breathing difficulties, contact your doctor immediately. Medicinal 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 them.
In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur

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

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 small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Are any of these symptoms present? Likely 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 occur only when standing or walking,
• increased warmth in the affected leg,
• change in skin colour of the leg, e.g. paleness, redness, or blueness.

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 venous blood clots (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 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 another product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than when not using 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 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 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 blood clots,” below).

Risk of blood clots within one year
Women who do not use combined hormonal tablets and are not pregnant: About 2 per 10,000 women
Women using combined hormonal contraceptive tablets containing levonorgestrel, norethisterone, or norgestimate: 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 blood clots associated with using 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 inherited clotting disorders;
• 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 past 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.
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.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as myocardial infarction 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 using Dionelle is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Dionelle, smoking should be discontinued. If the patient cannot 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 family member has had myocardial infarction or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of myocardial infarction or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraine, particularly migraine with aura;
• if the patient has heart disease (valve disorder, 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 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

In women using combined hormonal contraceptives, a slightly higher incidence of breast cancer has been observed. It is not known whether this is caused by the treatment. The reason may be, for example, that tumors are detected more frequently in women using combined hormonal contraceptives because they are examined more regularly by doctors. 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 the doctor.

Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women using contraceptive tablets. 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 tablets 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 tablets, the doctor will recommend regular 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 consider 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 unprotected intercourse occurred in the previous 7 days;
• there is no withdrawal bleeding 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 heavier bleeding resembling a normal period or light spotting lasting several days occurs, consult the doctor.

Absence of normal menstruation

If the patient has taken the tablets correctly, without vomiting or severe diarrhea, and has not taken any other medications, the likelihood of pregnancy is very low. Continue taking Dionelle as before.

If two consecutive withdrawal bleeds 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 between periods and/or reduce the contraceptive effectiveness of Dionelle.

• Effect of other medicines on Dionelle

Always inform the doctor about all 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) 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 effect;
• 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 (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 being treated with any medicine from the above list, temporarily use a mechanical method (e.g., condom) or choose another contraceptive method. Use additional local contraception during treatment with another 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, 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).

Dionelle must not be used 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 they 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 information 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 gland, 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, taken 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 have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
If the patient is pregnant, Dionelle must 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 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 lactose monohydrate

If the patient has previously been diagnosed with intolerance to certain sugars, she should consult a doctor before taking the medicine.

Dionelle contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e., 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 you are unsure,
you should consult your doctor or pharmacist.
Take one tablet daily, swallowing it whole with a small amount of water if necessary. 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. If, for example,
your period begins on Friday, take the tablet marked with the symbol "Fr" (indicating Friday; see
"Translation of symbols for days of the week on the immediate packaging" at the end of this leaflet),
pressing it through the aluminium foil. Take one tablet every day in the correct order.
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 this, do not take any
tablets for 7 days. During these 7 tablet-free days, a withdrawal bleed (menstruation) 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 begin on the same day of the week, and bleeding will occur approximately on
the same days each month.
If you take Dionelle as directed, you are protected against pregnancy during the 7 days when you
are not taking tablets.

Starting Dionelle for the first time

• If you have not used any oral hormonal contraceptives in the previous month: Start taking the tablets on day 1 of your natural menstrual cycle (i.e. the first day of menstrual bleeding).
• If you previously used 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, but no later than on day 1 after the usual tablet-free interval or after the last hormone-free tablet of your previous combined oral contraceptive.
• If you previously used a vaginal ring or transdermal patch: Start taking Dionelle preferably on the day of removal of the last ring or patch from the cycle pack, but no later than the day the next application would have been due.
• If you previously used a progestogen-only product (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), 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 between days 21 and 28 after delivery or second-trimester abortion. If you start later, you must also 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 section "Breastfeeding".

Taking more Dionelle than recommended
There have been no reports of serious adverse effects following the ingestion of multiple Dionelle tablets at once.
If several tablets are taken together, 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 take more tablets than recommended or if a child has taken any 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 is maintained. 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 contraceptive 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 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 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. Inform your doctor in such a case.
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 your usual time. Contraceptive effectiveness is not reduced, provided the medicine has been taken correctly for the 7 days prior to the missed tablet. Additional mechanical contraceptive methods are not necessary. However, if more than 1 tablet is 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 you have taken the tablets 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 your usual time. Instead of having a tablet-free break, start the next pack immediately. It is unlikely that a withdrawal bleed will occur after finishing the second pack, but spotting or breakthrough bleeding may occur during the days you take tablets from the second pack.
   OR:
2. You may also stop taking tablets from the current pack and begin the 7-day tablet-free interval immediately (including the day on which you missed the tablet). If you wish to start the new pack on the day you usually do, the tablet-free interval may be shorter than 7 days. If you missed tablets and no expected bleeding occurs 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. This situation is similar to missing a tablet. If vomiting occurs within 3 to 4 hours of taking a tablet, take another (extra) tablet as soon as possible. If possible, take this extra 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 extra tablet from a spare blister pack, which you should keep available.

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

Changing the day of the week on which withdrawal bleeding occurs: important information
If you take the tablets as directed, bleeding occurs approximately on the same day every 4 weeks. To change the day of bleeding, 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 new blister pack 3 days earlier than usual. If you make a very short tablet-free interval (e.g. 3 days or less), bleeding may not occur during this time. Light bleeding may occur later.
If you have any further doubts about how to proceed, 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 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 liver impairment
Dionelle is contraindicated in women with severe liver disease (see also section 2 "When not to use Dionelle").
Patients with kidney impairment
Specific studies with Dionelle have not been conducted in patients with renal impairment. Available data do not indicate a need for dose 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 and persistent ones, or 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 venous blood clots (venous thromboembolic disease) or arterial blood clots (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 the use of Dionelle are listed in the section "When to be cautious when using Dionelle".
Immediate medical attention is required 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 difficulty breathing (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 (fungal 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,
• menstrual disorders, including heavy menstrual bleeding (menorrhagia), scanty menstrual bleeding (hypomenorrhoea), infrequent menstruation (oligomenorrhoea), and absence of menstruation (amenorrhoea),
• intermenstrual bleeding including vaginal bleeding 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 less than 1 in 1000 people)

• ovarian and fallopian tube inflammation, urinary tract infections, cystitis (bladder inflammation), 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, fibroadenoma of the breast,
• 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 disturbances,
• tachycardia (rapid heartbeat),
• phlebitis, 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 mucosa), enteritis (inflammation of the intestine), 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 peel skin (cellulite), spider-like clusters of blood vessels with a central red spot on the skin (spider angioma),
• back pain, bone, joint and muscle pain (e.g. myalgia), 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 or 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,
• presence 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 blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).
Other adverse effects observed in women taking tablets, for which the exact frequency is unknown, include:
mood changes, decreased or increased libido (sex drive), contact lens intolerance, skin reactions (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 risk of developing breast cancer relative to the overall risk of 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 (blocked 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;
• chloasma.

Interactions
Intermenstrual bleeding and/or reduced contraceptive efficacy may result from interactions with other medications affecting 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 your 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.
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.
Translation of some information on the immediate packaging:
Ch.-B./Verw. bis: see imprint – batch number/expiry date: see imprint
Do not store above 30⁰C.
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 Dionelle are ethinylestradiol and dienogest. One coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
Other ingredients are:

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

What Dionelle looks like and contents of the packaging
Dionelle is a white, round, biconvex coated tablet.
Dionelle is available in packs of 21 and 3 x 21 coated tablets.
A cardboard pouch is included with the packaging, in 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
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Germany, the country of export: 85862.00.00
Parallel import authorisation number: 332/20
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Viola 0.03 mg/2 mg Filmtabletten
Germany Finic 0.03 mg/2 mg Filmtabletten
Poland Dionelle
Translation of the weekday symbols printed next to each tablet in the immediate packaging:
Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday