Aidee

Leaflet accompanying the packaging: information for the patient

Aidee, 2 mg + 0.03 mg, film-coated tablets

Dienogest + Ethinylestradiol

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 blood clot symptoms have occurred (see section 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 in case it needs to be re-read.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This 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 adverse effects, including any adverse effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 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. Contents of the packaging and other information

1. What is Aidee and what is it used for

Aidee is used for:

• preventing pregnancy ("the pill" contraception);
• treating moderate acne in women who have decided to use contraceptive pills and have not responded to appropriate local 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 section 2. It is especially important to read about the symptoms of blood clots (see section 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 in which 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. Improvement in acne symptoms usually occurs after three to six months of treatment. Acne symptoms may continue to improve even after six months of treatment. The patient should discuss with her doctor the need to continue treatment after three to six months of treatment, and then at regular intervals.

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 her 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 veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows she has blood clotting disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs surgery or will be immobilized for a long time (see section "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 transient ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of arterial thrombosis:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• 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 section 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 type C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section 2 "Aidee and other medicines").

Warnings and precautions

When to exercise special caution when using Aidee

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 you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that leads to kidney failure);
• if you have sickle cell anemia (a genetic disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you are immediately postpartum, you are at increased risk of blood clots. You should consult your doctor about how soon you can start taking Aidee after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you are not young;
• if you are a smoker;
• if you have diabetes or impaired glucose tolerance (reduced glucose tolerance);
• if you are overweight;
• if you have high blood pressure;
• if you have a heart valve disorder or any heart rhythm disorders;
• if there are cases of thrombosis, heart attack, or stroke in your close relatives;
• if you have porphyria (a disorder of blood pigment metabolism);
• if you have migraines;
• if you have epilepsy;
• if you have Sydenham's chorea;
• if you had herpes during pregnancy;
• if you have depression;
• if there is a history of breast cancer in your close relatives;
• if you have liver or gallbladder disease;
• if you have a certain type of hearing loss (hearing loss associated with otosclerosis);
• if you have chloasma (extensive brown spots of irregular shape and size, especially on the face) currently or in the past; you should avoid excessive sun exposure or ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives, potentially with breathing difficulties, you should contact your 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. Potassium levels in the serum should be monitored during the first treatment cycle in patients with renal insufficiency and before treatment that corrects serum potassium levels, if it is at 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, you should consult your doctor.

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, you should contact your doctor 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 not using therapy. In rare cases, a blood clot can block a blood vessel and cause serious complications. Blood clots can occur:

• in veins (also called "venous thromboembolism" or "deep vein thrombosis"),
• in arteries (also called "arterial thromboembolism").

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

Remember that the overall risk of having a harmful blood clot due to Aidee is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should immediately contact a doctor if you notice any of the following symptoms.

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 of 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 of 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 not using combined hormonal contraceptives. If the patient stops using Aidee, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

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

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During 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 close 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 inherited blood clotting disorders;
• if the patient needs surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to discontinue Aidee for a few weeks before surgery or immobilization. If the patient must discontinue Aidee, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years old);
• if the patient has given birth in the past 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, 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 unsure. The doctor may decide to discontinue Aidee. If any of the above conditions change while using Aidee, e.g. someone in the patient's close family is diagnosed with thrombosis 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 cause 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 heart attack or stroke associated with Aidee is very small, but it may increase:

• with age (over 35 years old);
• if the patient smokes. When using a hormonal contraceptive like Aidee, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35 years old, the doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close 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 close 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 close family is diagnosed with thrombosis 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 the pill. This small increase in the frequency of breast cancer diagnoses decreases gradually and disappears within 10 years after stopping the pill. Since breast cancer is rare in women under 40 years old, the additional number of breast cancer cases in women who are currently taking or have recently taken the pill is small compared to the overall risk of breast cancer. It is not known whether the difference is caused by the pill. The reason may be that women taking the pill are examined more frequently, 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 the pill. These tumors can cause bleeding into the abdominal cavity. You should immediately contact a doctor if you experience 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 outcome.

Consultations and/or medical examinations

Before the patient uses Aidee, the doctor will conduct a thorough medical history and examination 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 the pill. You should tell your doctor if you smoke or take other medicines.

When to contact a doctor

You should immediately contact a doctor if:

• you notice any worrying changes in your health, especially any of the symptoms listed in this leaflet (section "When to exercise special caution when using Aidee" and "How to use Aidee"), and also remember the sections about close relatives;
• you find a lump in your breast;
• you plan to take other medicines (see section "Aidee and other medicines");
• you will be immobilized or plan to have surgery (you should inform your doctor at least 4 weeks in advance);
• you experience heavy vaginal bleeding;
• you miss one or more pills in the first week of the cycle (every first week of the months of using Aidee), and you had sexual intercourse during the previous 7 days;
• you do not experience withdrawal bleeding within 2 weeks or you suspect you are pregnant (you should not start the next pack without your doctor's decision).

Intermenstrual bleeding

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

What to do if withdrawal bleeding does not occur

If you have taken all the pills correctly, have not vomited or had severe diarrhea, and have not taken any other medicines, it is unlikely that you are pregnant. You should continue taking Aidee as usual. If the expected bleeding does not occur within 2 consecutive cycles or if you have taken Aidee incorrectly in the previous cycle, you may be pregnant. You should immediately contact your doctor. You should not take Aidee until your doctor has ruled out pregnancy.

Children and adolescents

Aidee is indicated only after the onset of menstruation.

Aidee and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Some medicines:

• may affect the level of Aidee in your 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 infections (e.g. ritonavir, efavirenz, nevirapine, nelfinavir);
• a medicine prescribed for the treatment of certain infections (e.g. griseofulvin);
• certain pain relievers used to treat inflammatory and degenerative joint diseases (etoricoxib, NSAIDs);
• certain natural products or herbal preparations containing St. John's Wort (Hypericum perforatum).

If you are taking or start taking any of the above medicines, you may take Aidee, but you should also use a mechanical contraceptive method (e.g. a condom) or another contraceptive method. During concomitant use of Aidee with the above medicines and 28 days after stopping treatment, you should use additional mechanical contraception. If concomitant use of the above medicine continues after using all the pills from the current pack of Aidee, you should start the next pack without the usual 7-day break. If long-term treatment with any of the above medicines is necessary, you should use other reliable non-hormonal contraceptive methods. 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 hepatitis 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 (elevation of alanine aminotransferase). The doctor will prescribe a different contraceptive method before starting the above treatment regimen. Aidee can be started again 2 weeks after stopping the above medicines. See section 2 "When not to use Aidee". You should also tell any other doctor or dentist who prescribes you medicines that you are taking Aidee. Doctors may tell you whether you need to use additional contraceptive methods and, if so, for how long.

Effect on laboratory tests

Taking Aidee may affect the results of laboratory tests for liver function, adrenal function, kidney function, 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

Your doctor may recommend that you attend regular check-ups while you are taking Aidee. The frequency and nature of these check-ups depend on your health.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before using this medicine. Pregnancy Aidee should not be used in pregnant women or when pregnancy is suspected. If you become pregnant while taking Aidee, you should stop taking the medicine immediately and contact your 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 contraceptive methods 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 you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use Aidee

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. Aidee should be used in accordance with the following information for oral contraception and also for the treatment of moderate acne in women. You should consider the information in the section "If you forget to take Aidee" to maintain contraceptive efficacy.

When and how to take the pills?

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

Starting Aidee for the first time

If you have not used oral contraceptives in the last month

You should start taking Aidee on the 1st day of your menstrual cycle, i.e. on the 1st day of bleeding. You should take the pill marked with the day of the week on which your bleeding starts. For example, if your bleeding starts on a Friday, you should take the pill marked Friday. Then, you should continue taking the pills in the order of the days.

If you have used another combined oral contraceptive, an intrauterine system, or a transdermal patch

You can start taking Aidee on the next day after taking the last pill from your current pack(this means that there will be no break in taking the pills) or after removing the intrauterine system or transdermal patch. If the pack of your current medicine contains inactive pills, you can start taking Aidee on the next day after taking the last active pill(if you are unsure which pill is active, you should ask your doctor or pharmacist). You can also start taking Aidee on the last day of the usual pill-free period or after removing the patch or intrauterine system. If you have used a progestogen-only pill (minipill)You can stop taking the minipill at any time and start taking Aidee the next day at the same time.

If you have used injectable contraception, an implant, or an intrauterine system that releases progestogen

You should start taking Aidee on the day you would have had your next injectionor on the day the implant or intrauterine system is removed. However, if you have had sexual intercourse during the first 7 days of taking the pills, you should always use additional mechanical contraceptive methods (e.g. a condom).

After childbirth

You should not start taking Aidee at least 21-28 days after giving birth. During the first 7 days of taking the pills, you should also use mechanical contraceptive methods (e.g. a condom). If you have had sexual intercourse, before starting Aidee, you should rule out pregnancy or wait for your first menstrual period. For use during breastfeeding, see the section "Pregnancy and breastfeeding".

After miscarriage or abortion

You should follow your doctor's instructions.

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

If you have vomited within 3-4 hours after taking a pill, the active substances may not have been fully absorbed. This is a situation similar to missing a pill. Therefore, you should follow the instructions for missing pills. If you have severe diarrhea, you should consult your doctor.

What to do if you want to delay your period

You can delay your period if you start the next pack of Aidee immediately after finishing the current pack. You can continue taking the pills from this pack for as long as you want, until you finish the pack. If you want to have your period, you simply stop taking the pills. During the second pack, you may experience irregular bleeding. You should start the next pack after the usual 7-day break.

What to do if you want to change the day you start your period

If you take the pills as directed, your period will start approximately every 4 weeks. If you want to change the day your period starts, you should shorten (never lengthen) the break between packs. For example, if your period usually starts on a Friday, and you want it to start on a Tuesday (3 days earlier), you should start the next pack 3 days earlier than usual. If you make the break without pills very short (e.g. 3 days or less), you may not have your period during the break. You may experience irregular bleeding during the next pack.

4. Possible side effects

Like all medications, this medication 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.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see point 2.

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 breathing difficulties (see also "Warnings and precautions").
Severe reactions related to taking tablets with dienogest/ethinylestradiol have been described in the "When to be careful when taking Aidee" section. 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 tablets with dienogest/ethinylestradiol:
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):

• inflammatory conditions of the genital organs (vaginitis/vulvovaginitis), fungal infections of the vagina (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; vaginal bleeding and prolonged vaginal bleeding);
• breast enlargement (including breast swelling and breast edema);
• painful bleeding (dysmenorrhea);
• vaginal discharge;
• ovarian cysts;
• pelvic pain;
• exhaustion, including weakness, fatigue, 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 developing blood clots may be higher if the patient has other risk factors (see point 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, bladder infection (cystitis);
• breast inflammation (mastitis);
• cervicitis (inflammation of the cervix);
• fungal infections (e.g., candidiasis), viral infections, oral herpes;
• flu, bronchitis, upper respiratory tract infections, sinusitis;
• benign tumors of the uterus (fibroids);
• benign tumor in the 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 impairment;
• tinnitus;
• dizziness;
• rapid heartbeat;
• 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;
• golden-brown pigment spots (chloasma), especially on the face (melasma), skin pigmentation disorders/increased pigmentation;
• oily skin (seborrhea);
• dandruff;
• excessive hair growth of the male type (hirsutism);
• "orange peel" skin appearance (cellulite);
• spider-like rash - spider angioma (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 in the uterine appendages (ovaries and fallopian tubes);
• cysts in the breast, benign breast tumors (breast dysplasia), detection of an additional breast;
• involuntary milk secretion (galactorrhea);
• pain during sexual intercourse (dyspareunia);
• bleeding disorders;
• fluid accumulation in the body (peripheral edema);
• flu-like symptoms, inflammation, fever;
• increased triglyceride and cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia);
• weight loss;
• weight changes.

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, 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. More information can be found in the "Aidee and cancer" section;
• 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, gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea, herpes gestationis, hearing loss associated with otosclerosis;
• 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., natural products containing St. John's Wort or medications used to treat epilepsy, tuberculosis, HIV infection, and other infections; see "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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information 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 stated on the carton after:
EXP. The expiration date refers to the last day of the given month.
Medications should not be disposed of in wastewater or household waste containers. 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, macrogol 3350, titanium dioxide (E171), polyvinyl alcohol, talc (E553b).

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 and is available in calendar packages.
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)
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.
Koszykowa 65 Street
00-667 Warsaw

Manufacturer

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

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

Countries:

Spain:
Dienogest/Ethinylestradiol goibela, 2.0 mg / 0.03 mg, film-coated tablet EFG
Czech Republic:
AIDEE, 2.0 mg / 0.03 mg coated tablet
Germany:
ladonna, 2.0 mg / 0.03 mg film-coated tablets
Poland:
Aidee, 2 mg + 0.03 mg, film-coated tablets
Slovakia:
AIDEE, 2.0 mg / 0.03 mg film-coated tablets
Date of last revision of the leaflet:April 2025