Aidee

Leaflet attached to the packaging: information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Aidee(ladonna)

2 mg + 0.03 mg, film-coated tablets

Dienogest + Ethinylestradiol
Aidee and ladonna are different trade names for the same medicine.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see point 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• The medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See point 4.

Table of contents of the leaflet

• 1. What is Aidee and what is it used for
• 2. Important information before using Aidee
• 3. How to use Aidee
• 4. Possible side effects
• 5. How to store Aidee
• 6. Package contents and other information

1. What is Aidee and what is it used for

Aidee is used for:

• preventing pregnancy ("the pill" contraceptive);
• treating moderate acne in women who have decided to use contraceptive pills and have not responded to appropriate local treatment or oral antibiotic treatment.

Each of the 21 film-coated Aidee tablets contains a small dose of female sex hormones: estrogen (ethinylestradiol) and progestogen (dienogest). Since Aidee contains two hormones, it is called a "combined oral contraceptive". Clinical trials have shown that the medicine containing dienogest in combination with ethinylestradiol improves acne symptoms caused by an increased amount of male hormones (so-called androgens).

2. Important information before using Aidee

General notes

Before starting to take Aidee, you should read the information about blood clots in point 2. It is especially important to read about the symptoms of blood clots (see point 2 "Blood clots"). Before starting to take Aidee, the doctor will ask the patient several questions about her health and (or) medical history and that of her close relatives. The doctor will also measure blood pressure and, depending on the patient's health, may perform additional tests. The leaflet describes several situations in which Aidee should not be taken or when the effectiveness of Aidee is reduced. In such situations, sexual intercourse should not be maintained or additional non-hormonal contraceptive methods should be used, e.g. a condom or other mechanical methods. Methods based on the menstrual cycle (calendar method) or body temperature measurements should not be used. These methods are unreliable because the contraceptive pill affects changes in body temperature and changes in cervical mucus that occur during the menstrual cycle. Aidee, like all contraceptive pills, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Aidee

Aidee should not be used if the patient has any of the following conditions. If any of the following conditions occur, the patient should inform the doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable:

• if the patient currently has (or has ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows she has a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases that may increase the risk of a blood clot in an artery: severe diabetes with blood vessel damage; very high blood pressure; very high levels of fats in the blood (cholesterol or triglycerides); a disease called hyperhomocysteinemia;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient is allergic to ethinylestradiol, dienogest, or any of the other ingredients of this medicine (listed in point 6);
• if the patient has (or has had in the past) pancreatitis associated with severe hypertriglyceridemia;
• if the patient has (or has had in the past) liver disease and liver function is not yet normal;
• if the patient has (or has had in the past) a benign or malignant liver tumor;
• if the patient has (or has had in the past) hormone-dependent malignant tumors, e.g. breast cancer or genital organ cancer;
• if the patient has vaginal bleeding of unknown cause;
• if the patient has liver disease C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see point 2. "Aidee and other medicines").

Warnings and precautions

When to exercise special caution when using Aidee

When should you contact your doctor?

• if the patient notices possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), a blood clot in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots").

In order to get a description of the serious side effects listed, see "How to recognize a blood clot".

In case of suspected or confirmed thrombosis, Aidee should be discontinued and a doctor should be contacted immediately. In case of starting anticoagulant therapy due to the teratogenic effect of anticoagulant therapy

(coumarins) the doctor will recommend an appropriate, alternative method of contraception.

Tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while using Aidee, you should also tell your doctor:

• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that leads to kidney failure);
• if the patient has sickle cell anemia (a genetic disorder of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see point 2 "Blood clots");
• if the patient has recently given birth, she is at increased risk of blood clots. The patient should consult a doctor to find out how soon she can start taking Aidee after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if the patient is not young;
• if the patient smokes;
• if the patient has diabetes or impaired glucose tolerance (reduced glucose tolerance);
• if the patient is overweight;
• if the patient has high blood pressure;
• if the patient has a heart valve disorder or any heart rhythm disorder;
• if the patient has a family history of blood clots, heart attack, or stroke;
• if the patient has porphyria (a disorder of blood pigment metabolism);
• if the patient has migraines;
• if the patient has epilepsy;
• if the patient has Sydenham's chorea;
• if the patient had herpes during pregnancy;
• if the patient has depression;
• if the patient has a family history of breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has a certain type of hearing loss (hearing loss associated with otosclerosis);
• if the patient has chloasma (extensive brown spots of irregular shape and size, especially on the face) currently or in the past; in this case, excessive exposure to sunlight or ultraviolet radiation should be avoided;
• if the patient experiences symptoms of angioedema, such as: facial swelling, tongue and (or) throat swelling and (or) difficulty swallowing or hives, potentially with breathing difficulties, should contact a doctor immediately. Products containing estrogens may cause or exacerbate symptoms of hereditary and acquired angioedema.

Aidee contains a progestogen that is an aldosterone antagonist with potassium-sparing properties. In most cases, an increase in potassium levels is not expected. It is recommended to monitor serum potassium levels during the first treatment cycle in patients with renal failure and before treatment that corrects serum potassium levels if it is in the upper limit of normal, especially during concomitant use of potassium-sparing drugs. If any of the above conditions occur for the first time, recur, or worsen while using Aidee, a doctor should be consulted.

Psychiatric disorders

Some women using hormonal contraceptives, including Aidee, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, a doctor should be contacted as soon as possible for further medical advice.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Aidee, is associated with an increased risk of blood clots, compared to when no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications. Blood clots can form:

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease"),
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

Not all patients recover fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the overall risk of harmful blood clots caused by Aidee is small.

HOW TO RECOGNIZE A BLOOD CLOT

A doctor should be contacted immediately if any of the following symptoms are noticed.

Is the patient experiencing any of these symptoms? What is the likely cause of the patient's condition?

• Swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• skin color change in the leg, such as pallor, redness, or cyanosis. Deep vein thrombosis

Pulmonary embolism

• Sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain.

If the patient is unsure, they should contact a doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g. a cold). Symptoms usually occur in one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or
• painless vision disturbances, which can lead to loss of vision. Heart attack
• Chest pain, discomfort, pressure, heaviness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Stroke
• Sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disorders, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden, severe, or prolonged headaches without a known cause;
• loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be transient with almost immediate and complete recovery, but a doctor should be contacted immediately, as the patient may be at risk of having another stroke.

BLOOD CLOTS IN VEINS

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism), although these side effects are rare. They most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of a combined hormonal contraceptive (the same or a different medicine) after a 4-week or longer break. After the first year, the risk decreases, but it will always be higher compared to when combined hormonal contraceptives are not used. If the patient stops using Aidee, the risk of blood clots returns to a normal level within a few weeks.

What factors increase the risk of blood clots in a vein?

The risk depends on the individual risk of venous thromboembolism and the type of combined hormonal contraceptive used. The overall risk of a blood clot in the leg or lung (DVT or PE) associated with Aidee is small.

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

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

Factors that increase the risk of blood clots in a vein

The risk of blood clots associated with Aidee is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see point 2 "Blood clots");
• with age (especially over 35 years old);
• if the patient has recently given birth.

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, especially if the patient has another risk factor. It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop using Aidee. If any of the above conditions change while using Aidee, e.g. someone in the patient's immediate family is diagnosed with a blood clot without a known cause or the patient gains significant weight, the doctor should be informed.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with Aidee is very small, but it may increase:

• with age (over 35 years old);
• if the patient smokes. While using a hormonal contraceptive like Aidee, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, 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 even higher. If any of the above conditions change while using Aidee, e.g. the patient starts smoking, someone in the patient's immediate family is diagnosed with a blood clot without a known cause, or the patient gains significant weight, the doctor should be informed. Other diseases that may affect blood vessels include systemic lupus erythematosus (an immune system disease), hemolytic uremic syndrome (a blood disease that leads to kidney damage), and sickle cell anemia (a genetic blood disease characterized by abnormal red blood cells).

Aidee and cancer

Breast cancer is slightly more common in women taking combined oral contraceptives than in women of the same age who do not take contraceptive pills. This small increase in the number of breast cancer diagnoses decreases gradually and disappears within 10 years after stopping the use of contraceptive pills. Since breast cancer is rare in women under 40 years old, the additional number of breast cancer cases in women who are currently using or have recently used contraceptive pills is small compared to the overall risk of breast cancer. It is not known whether the difference is caused by the use of contraceptive pills. The reason may be that women taking the medicine are examined more often, so breast cancer is detected earlier. In rare cases, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in women taking contraceptive pills. These tumors can cause bleeding into the abdominal cavity. A doctor should be contacted immediately in case of severe abdominal pain. Some studies suggest that long-term use of hormonal contraception is a risk factor for the development of cervical cancer in women whose cervix is infected with certain sexually transmitted viruses (human papillomavirus). However, it has not yet been determined to what extent other factors (e.g. differences in the number of sexual partners or the use of mechanical contraceptive methods) affect this result.

Consultations and/or medical examinations

Before the patient uses Aidee, the doctor will take a thorough medical history of the patient and her close relatives. A general medical examination and gynecological examination, including a breast and cervical examination, will be performed. Pregnancy must be ruled out. These examinations should be repeated regularly while the patient is taking contraceptive pills. The patient should tell the doctor if they smoke or take other medicines.

When to contact a doctor

A doctor should be contacted immediately if:

• the patient notices worrying changes in their health, especially any of the symptoms listed in this leaflet (point: "When to exercise special caution when using Aidee" and "How to use Aidee"), and also remember the points about close relatives;
• the patient finds a lump in their breast;
• the patient intends to use other medicines (point "Aidee and other medicines");
• the patient is to be immobilized or is planning to have surgery (the doctor should be informed at least 4 weeks in advance);
• there is heavy vaginal bleeding;
• the patient misses one or more tablets in the first week of the cycle (every first week of the following months of using Aidee), and there was sexual intercourse during the preceding 7 days;
• there is no withdrawal bleeding within the next two months or the patient suspects they are pregnant (a new pack of Aidee should not be started without the doctor's decision).

Intermenstrual bleeding

During the use of combined oral contraceptives, irregular vaginal bleeding (intermenstrual bleeding) may occur, especially in the first months of pill use. The patient may need to use sanitary pads or tampons, but they do not need to stop taking Aidee. The bleeding is usually minor and stops when the body gets used to taking oral contraceptives, which usually takes about 3 months. If the bleeding lasts longer than a few months or starts after a few months, a doctor should be consulted.

What to do if withdrawal bleeding does not occur

If the patient has taken all the tablets correctly, has not vomited, or had severe diarrhea, and has not taken any other medicines, it is unlikely that they are pregnant. Aidee should be taken as usual. If the expected bleeding does not occur within two consecutive cycles or the use of Aidee in the previous cycle was incorrect, the patient may be pregnant. A doctor should be contacted immediately. Aidee should not be taken until the doctor has ruled out pregnancy.

Children and adolescents

Aidee is indicated only after the onset of menstruation.

Aidee and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines:

• may affect the level of Aidee in the blood;
• may make Aidee less effective in preventing pregnancy;
• may cause unexpected bleeding.

These include:

• medicines used to treat epilepsy (e.g. primidone, phenytoin, felbamate, barbiturates, carbamazepine, topiramate, and oxcarbazepine);
• medicines used to treat tuberculosis (e.g. rifampicin, rifabutin);
• medicines used to treat HIV and hepatitis C virus (e.g. ritonavir, efavirenz, nevirapine, nelfinavir);
• a medicine prescribed to treat certain infections (e.g. griseofulvin);
• certain painkillers used to treat inflammatory and degenerative joint diseases (etoricoxib, NSAIDs);
• certain natural products or herbal preparations containing St. John's wort (Hypericum perforatum tea).

If the patient is taking or starts taking any of the above medicines, they may take Aidee, but they should also use mechanical contraception (e.g. a condom) or another method of contraception. During concomitant use of Aidee with the above medicines and 28 days after stopping treatment, the patient should use additional mechanical contraception. If concomitant use of the above medicine lasts after using all the tablets from the current pack of Aidee, the patient should start the next pack without the usual 7-day break in tablet use. If long-term treatment with any of the above medicines is necessary, a different, reliable non-hormonal method of contraception should be used. Aidee may also affect the action of other medicines, such as:

• medicines containing cyclosporin;
• the antiepileptic medicine lamotrigine (this may lead to an increased frequency of seizures);
• theophylline (used to treat breathing difficulties);
• tizanidine (used to treat pain and/or muscle spasms).

Aidee should not be used in patients with liver disease C who are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may increase liver function test results (increase in alanine aminotransferase activity). The doctor will prescribe a different type of contraception before starting the above treatment regimen. Aidee can be started again 2 weeks after stopping the above medicines. See point 2. "When not to use Aidee". The patient should also inform any other doctor or dentist who prescribes medicines that they are taking Aidee. Doctors may tell the patient whether to use additional contraceptive measures and, if so, for how long.

Effect on laboratory test results

Taking Aidee may affect the results of laboratory tests of liver, adrenal, kidney, and thyroid function, as well as the levels of certain proteins in the blood, carbohydrate metabolism, blood clotting, and fibrinolysis. However, despite these changes, the results usually remain within the normal range.

Regular check-ups

The doctor may recommend that the patient attend regular check-ups while taking Aidee. The frequency and nature of these check-ups depend on the patient's health.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine. Pregnancy Aidee should not be used in pregnant women or when pregnancy is suspected. If the patient becomes pregnant while taking Aidee, they should stop taking the medicine immediately and contact a doctor. Breastfeeding Aidee should not be taken by breastfeeding women, as it may reduce the amount of milk produced, and small amounts of the medicine may be excreted into human milk. During breastfeeding, non-hormonal methods of contraception should be used.

Driving and using machines

The effect of concomitant use of dienogest and ethinylestradiol on the ability to drive and use machines is not known.

Aidee contains lactose monohydrate

This medicine contains lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to use Aidee

This medicine should always be taken as directed by the doctor. In case of doubt, the doctor or pharmacist should be consulted. Aidee should be used in accordance with the following information for oral contraception and also for the treatment of moderate acne in women. The information in the "What to do if you miss a dose of Aidee" section should be taken into account to maintain contraceptive effectiveness.

When and how to take the tablets?

• The Aidee pack contains 21 film-coated tablets. On the pack, each tablet is marked with a symbol of the day of the week on which it should be taken. The tablets should be taken at approximately the same time every day, with a small amount of water. The tablets should be taken in the direction of the arrows, until all 21 film-coated tablets have been taken. For the next 7 days, no tablets are taken. During these 7 days, withdrawal bleeding should start. It usually starts 2-3 days after taking the last tablet of Aidee. A new pack should be started on the 8th day, even if bleeding is still present. This means that the patient will always start a new pack on the same day of the week, and the withdrawal bleeding will occur approximately on the same days every month.

Using Aidee for the first time

If the patient has not used oral contraceptives in the last month

Taking Aidee should be started on the 1st day of the menstrual cycle, i.e. on the first day of bleeding. The tablet marked with the day of the week should be taken. For example, if bleeding starts on a Friday, one tablet marked as Friday should be taken. Then the tablets should be taken in the order of the days.

If the patient has previously used another combined oral contraceptive, an intrauterine system, or a transdermal system

Aidee can be started the next day after taking the last tablet from the current pack of tablets (this means that there will be no break in tablet use) or after removing the intrauterine system or transdermal system. If the pack of the medicine currently used by the patient also contains inactive tablets, Aidee can be started the next day after taking the last active tablet (if the patient is not sure which tablet it is, they should ask their doctor or pharmacist). Aidee can also be started on the last day of the usual tablet-free interval, patch-free interval, or after the placebo tablets from the previous treatment.

If the patient has previously used a progestogen-only tablet (minipill)

The minipill can be stopped on any day, and Aidee can be started the next day at the same time.

If the patient has previously used injectable contraception, an implant, or an intrauterine system releasing progestogen

Aidee should be started on the day when the next injection was to be given or on the day the implant or intrauterine system is removed. However, if the patient has had sexual intercourse during the first 7 days of tablet use, they should always use additional mechanical contraceptive methods.

After childbirth

Aidee should not be started until at least 21-28 days after childbirth. During the first 7 days of tablet use, mechanical methods of contraception (e.g. a condom) should also be used. If the patient has had sexual intercourse, before starting Aidee, they should rule out pregnancy or wait for the first menstrual period. Use during breastfeeding, see "Pregnancy and breastfeeding".

After miscarriage or abortion

The patient should follow the doctor's instructions.

What to do in case of gastrointestinal disorders (e.g. vomiting, severe diarrhea)

If the patient has vomited within 3-4 hours of taking a tablet of Aidee, the active substances may not have been fully absorbed. This is a situation similar to missing a tablet. Therefore, the patient should follow the instructions for missing a tablet. If the patient has severe diarrhea, they should consult a doctor.

What to do if the patient wants to delay the onset of bleeding

The patient can delay the onset of bleeding if they start the next pack of Aidee immediately after finishing the current pack. The patient can continue taking tablets from this pack for as long as they want, until the pack is finished. If the patient wants to have bleeding, they simply stop taking the tablets. During the use of the second pack, the patient may experience irregular bleeding. The next pack should be started after the usual 7-day break.

What to do if the patient wants to change the day of the onset of bleeding

If the patient takes the tablets as directed, bleeding will occur approximately every 4 weeks. If the patient wants to change the day of the onset of bleeding, they should shorten (never lengthen) the break between taking the next pack of Aidee. For example, if bleeding usually starts on a Friday, and the patient wants it to start on a Tuesday (3 days earlier), they should start taking the tablets from the next pack 3 days earlier than they usually do. If the patient makes the break without tablets very short (e.g. 3 days or less), bleeding may not occur during this break. The patient may experience irregular bleeding during the use of tablets from the next pack.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Aidee, a doctor should be consulted.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important information before using Aidee".

Severe side effects

A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with difficulty breathing (see also section "Warnings and precautions").
Severe reactions related to taking dienogest/ethinylestradiol tablets have been described in the section "When to exercise special caution when using Aidee". The patient can find more information there. If necessary, a doctor should be consulted immediately.

Other possible side effects

The following side effects have been reported by patients taking dienogest/ethinylestradiol tablets:
Common (may affect up to 1 in 10 women):

• headache;
• breast pain, including discomfort and tenderness of the breast.

Uncommon (may affect up to 1 in 100 women):

• genital tract infections (vaginitis/vulvovaginitis), vaginal fungal infections (vaginal candidiasis, vulvovaginal candidiasis);
• increased appetite;
• depressed mood;
• migraine;
• dizziness;
• high blood pressure (hypertension) or low blood pressure (hypotension);
• abdominal pain (including upper and lower abdominal pain, discomfort, bloating);
• nausea, vomiting, diarrhea;
• acne;
• rash (including rash, erythema);
• itching (sometimes all over the body);
• hair loss (alopecia);
• irregular withdrawal bleeding (including heavy bleeding (menorrhagia), scanty bleeding, infrequent bleeding, or complete absence of bleeding);
• intermenstrual bleeding (intermenstrual bleeding; characterized by vaginal bleeding and prolonged vaginal bleeding);
• breast enlargement (including breast swelling and breast edema);
• painful bleeding (dysmenorrhea);
• vaginal discharge;
• ovarian cysts;
• pelvic pain;
• fatigue, including weakness, tiredness, and malaise;
• weight gain.

Rare (may affect up to 1 in 1000 women):

• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis);
• in the lungs (e.g., pulmonary embolism);
• heart attack;
• stroke;
• mini-stroke or transient stroke-like symptoms, known as transient ischemic attack;
• blood clots in the liver, stomach/intestine, kidneys, or eye. The likelihood of blood clots may be higher if the patient has other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots);
• inflammation of the ovaries and fallopian tubes (adnexitis);
• urinary tract infections, cystitis (urinary tract infection);
• breast inflammation (mastitis);
• cervicitis (inflammation of the cervix);
• fungal infections (e.g., candidiasis), viral infections, herpes simplex;
• flu, bronchitis, upper respiratory tract infections, sinusitis;
• benign tumors of the uterus (fibroids);
• benign tumor of breast tissue (breast lipoma);
• anemia;
• allergic reactions (hypersensitivity);
• development of male secondary sex characteristics in a woman (virilization);
• loss of appetite (anorexia);
• depression, mental disorders, irritability, aggression;
• insomnia, sleep disorders;
• dystonia (persistent muscle contractions causing, for example, abnormal posture);
• dry or irritated eyes;
• blurred vision;
• sudden hearing loss, hearing disorders;
• tinnitus;
• dizziness;
• accelerated heart rate;
• phlebitis (thrombophlebitis);
• varicose veins, venous disorders, vein pain;
• dizziness or fainting when standing up from a sitting or lying position (orthostatic hypotension);
• hot flashes;
• asthma;
• increased breathing rate (hyperventilation);
• gastritis (gastric inflammation), enteritis;
• indigestion;
• skin reactions/skin disorders, including allergic dermatitis, neurodermatitis/atopic dermatitis, eczema, psoriasis;
• excessive sweating;
• chloasma (melasma), especially on the face, skin pigmentation disorders/increased pigmentation;
• oily skin (seborrhea);
• dandruff;
• excessive hair growth of male type (hirsutism);
• "orange peel" skin appearance (cellulite);
• spider angioma - spider nevus (reticular blood vessels with a central red spot on the skin);
• back pain, chest pain;
• musculoskeletal disorders, muscle pain, arm and leg pain;
• abnormal cell growth on the surface of the cervix (cervical dysplasia);
• pain or cysts of the uterine appendages (ovaries and fallopian tubes);
• cysts in the breast, benign breast tumors (breast dysplasia), presence of an additional breast;
• involuntary milk secretion (galactorrhea);
• pain during sexual intercourse (dyspareunia);
• bleeding disorders;
• fluid retention in the body (peripheral edema);
• flu-like symptoms, inflammation, fever;
• increased triglyceride and cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia);
• weight loss;
• changes in body weight.

Frequency not known (cannot be estimated from the available data):

• mood changes;
• decreased or increased libido;
• intolerance to contact lenses;
• hives;
• erythema multiforme, erythema nodosum;
• breast discharge;
• fluid retention;
• onset or exacerbation of symptoms of hereditary or acquired angioedema.

Cancer

• breast cancer is diagnosed slightly more often in women using combined oral contraceptives. In women under 40 years of age, breast cancer is rare; the number of cases is small compared to the overall risk of breast cancer. The causal relationship between breast cancer and the use of oral hormonal contraception is unknown. Further information can be found in the section "Aidee and cancer";
• liver tumors;
• cervical cancer.

Other conditions

• venous thromboembolism;
• arterial thrombosis;
• cerebrovascular incidents;
• hypertriglyceridemia (increased risk of pancreatitis);
• hypertension;
• onset or exacerbation of diseases for which the relationship with the use of combined oral contraceptives is not clear: cholestatic jaundice, cholelithiasis, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss;
• liver function disorders;
• changes in glucose tolerance or effects on peripheral insulin resistance;
• Crohn's disease, ulcerative colitis;
• chloasma.

Interactions

Unexpected intermenstrual bleeding and/or reduced contraceptive effectiveness may be the result of interactions between oral contraceptives and other medications (e.g., herbal remedies containing St. John's Wort or medications used to treat epilepsy, tuberculosis, HIV, and other infections; see section "Aidee and other medications").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Aidee

The medication should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use this medication after the expiration date. The expiration date refers to the last day of the specified month.
Medications should not be disposed of in wastewater or household waste. A pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Aidee contains

• The active substances of Aidee are ethinylestradiol and dienogest. Each film-coated tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.
• Other ingredients are: povidone K30, cornstarch, lactose monohydrate, magnesium stearate, coating: macrogol 3350, titanium dioxide (E 171), polyvinyl alcohol, talc (E 553b).

What Aidee looks like and what the package contains

Aidee is a white, cylindrical, biconvex film-coated tablet, approximately 6 mm in diameter.
Aidee is packaged in PVC/Aluminum blisters.
Package sizes:
21 film-coated tablets (blister containing 21 tablets)
63 film-coated tablets (3 blisters containing 21 tablets each)
126 film-coated tablets (6 blisters containing 21 tablets each)
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Germany, the country of export:

Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock
Dublin 1
D01YE64
Ireland

Manufacturer:

Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz.
Avenida de Ágreda 31
Ólvega, 42110 Soria
Spain

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 84679.00.00
Parallel import authorization number: 76/24

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Other information:

Spain:
AILYN, 2.0 mg / 0.03 mg, comprimido recubierto con película EFG
Czech Republic:
AIDEE, 2.0 mg / 0.03 mg Potahovaná tableta
Germany:
ladonna, 2.0 mg / 0.03 mg Filmtabletten
Poland:
Aidee, 2 mg + 0.03 mg, tabletki powlekane
Slovakia:
AIDEE, 2.0 mg / 0.03 mg filmom obalené tablety

Translation of day-of-the-week symbols on the packaging:

MON - Monday
TUE

• Tuesday MIT
• Wednesday DON - Thursday FRE
• Friday SAM - Saturday SON - Sunday

Date of leaflet approval: 26.02.2024

[Information about the trademark]