Aidee

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Aidee (ladonna sanol)

2 mg + 0.03 mg, coated tablets

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

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").

The leaflet contents should be carefully read before taking 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.
• 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Aidee and what is it used for
• 2. Important information before taking Aidee
• 3. How to take 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 Aidee coated 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 drug containing dienogest in combination with ethinylestradiol improves acne symptoms caused by an increased amount of male hormones (so-called androgens).

2. Important information before taking Aidee

General notes

Before starting to take Aidee, the patient 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 their health and medical history, as well as that of their 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 its effectiveness may be reduced. In such situations, sexual intercourse should not be maintained or additional non-hormonal contraceptive methods should be used, such as 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 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 their doctor the need to continue treatment after three to six months, and then at regular intervals.

When not to take Aidee:

Aidee should not be taken if the patient has any of the following conditions. If any of the following conditions occur, the patient should inform their 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 they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient is about 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) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which 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);
• hyperhomocysteinemia;
• if the patient has (or has had) 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) pancreatitis associated with severe hypertriglyceridemia;
• if the patient has (or has had) liver disease and liver function is not yet normal;
• if the patient has (or has had) a benign or malignant liver tumor;
• if the patient has (or has had) hormone-dependent malignant tumors, such as breast or genital cancer;
• if the patient has unexplained vaginal bleeding;
• 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 section 2 "Aidee and other medicines").

Warnings and precautions

When to exercise special caution when taking Aidee

When should the patient contact their doctor?

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

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

In case of suspected or confirmed thrombosis, Aidee should be discontinued and the 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 contraceptive method.

The patient should tell their doctor if they have any of the following conditions.

If these symptoms occur or worsen while taking Aidee, the patient should also tell their 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 elevated levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient is about to have surgery or will be immobilized for a long time (see "Blood clots");
• if the patient has recently given birth, they are at increased risk of blood clots. The patient should consult their doctor for information on how soon they 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 disorders;
• if the patient's close relatives have had blood clots, heart attacks, or strokes;
• 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 (large brown patches of irregular shape and size, especially on the face) currently or in the past; in this case, they should avoid excessive sun exposure or ultraviolet radiation;
• 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, they should contact their doctor immediately. Products containing estrogens may cause or worsen 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 blood serum should be monitored during the first treatment cycle in patients with renal impairment and before treatment that corrects potassium levels in the blood serum, if it is at the upper limit of normal, especially when taking potassium-sparing drugs. If any of the above conditions occur for the first time, recur, or worsen while taking Aidee, the patient should consult their doctor.

Psychiatric disorders

Some women taking 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, the patient should contact their doctor as soon as possible for further medical advice.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Aidee, is associated with an increased risk of blood clots, compared to not taking them. 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" or "arterial thrombosis").

Not all patients recover fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

The patient should contact their doctor immediately if they notice any of the following symptoms. Does the patient experience any of these symptoms? Why is the patient likely to be suffering from them?

BLOOD CLOTS IN VEINS

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

• Taking 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 taking 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 a 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 taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (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 taking combined hormonal contraceptives. If the patient stops taking Aidee, the risk of blood clots returns to normal within a few weeks.

What affects 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 taking Aidee is small.

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

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 the risk factors are present, even if the patient is unsure. The doctor may decide to stop Aidee. If any of the above conditions change while taking Aidee, such as the patient starting to smoke, a close relative being diagnosed with a blood clot without a known cause, or the patient gaining 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 complications, 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 taking Aidee is very small, but it may increase:

• with age (over 35 years);
• if the patient smokes.When taking 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 a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or a close relative has 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 severe, the risk of blood clots may be even higher. The patient should tell their doctor if any of the above conditions change while taking Aidee, such as starting to smoke, a close relative being diagnosed with a blood clot without a known cause, or gaining significant weight. 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 disorder characterized by abnormal red blood cell shape).

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 number of breast cancer diagnoses decreases gradually and disappears within 10 years of stopping the pill. Since breast cancer is rare in women under 40, the additional number of breast cancer cases in women taking 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 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 the pill. These tumors can cause bleeding into the abdominal cavity. The patient should contact their doctor immediately if they 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) contribute to this result.

Consultations and/or medical examinations

Before the patient takes Aidee, the doctor will conduct a thorough medical history and examination of the patient and their 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. The patient should tell their doctor if they smoke or take other medicines.

When to contact a doctor

The patient should contact their doctor immediately if:

• they notice any worrying changes in their health, especially any of the symptoms mentioned in this leaflet (section "When to exercise special caution when taking Aidee" and "How to take Aidee"), and also remember the points about close relatives;

if the patient finds a lump in their breast; if the patient plans to take other medicines (see "Aidee and other medicines"); if the patient is about to have surgery or a surgical procedure is planned (the doctor should be informed at least 4 weeks in advance); if the patient experiences heavy vaginal bleeding; if the patient misses one or more pills in the first week of the cycle (every first week of the month while taking Aidee), and had intercourse in the preceding 7 days; if the patient does not experience withdrawal bleeding within the next two months or if the patient suspects they are pregnant (they should not start the next pack without their doctor's decision).

Intermenstrual bleeding

While taking combined oral contraceptives, irregular vaginal bleeding (intermenstrual bleeding) may occur, especially in the first few months of taking the pill. The patient may need to use sanitary pads or tampons, but they should not stop taking Aidee. The bleeding is usually minor and stops when the 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, the patient should consult their doctor.

What to do if withdrawal bleeding does not occur

If the patient has taken all the pills correctly, has not vomited, or had severe diarrhea, and has not taken any other medicines, it is unlikely that they are pregnant. The patient should continue taking Aidee as usual. If the expected bleeding does not occur in two consecutive cycles or if the patient took Aidee incorrectly in the previous cycle, the patient may be pregnant. The patient should contact their doctor immediately. The patient should not take Aidee until their 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 infections (e.g., ritonavir, efavirenz, nevirapine, nelfinavir);
• a medicine used to treat certain infections (e.g., griseofulvin);
• certain painkillers used to treat inflammatory and degenerative joint diseases (e.g., 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 use a mechanical contraceptive method (e.g., a condom) or another method of contraception. During concurrent use of Aidee with the above medicines and 28 days after stopping treatment, the patient should use additional mechanical contraception. If the patient is taking any of the above medicines for an extended period, they should use another reliable non-hormonal contraceptive method. Aidee may also affect the action of other medicines, such as:

• medicines containing cyclosporin;
• the antiepileptic medicine lamotrigine (which 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 taken by 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 enzyme test results (elevated 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 completing the above treatment. See section 2 "When not to take Aidee". The patient should also inform any other doctor or dentist who prescribes them medicines that they are taking Aidee. Doctors may tell the patient whether they 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, 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 their doctor or pharmacist before taking this medicine. Pregnancy Aidee should not be taken by women who are pregnant or think they may be pregnant. If the patient becomes pregnant while taking Aidee, they should stop taking the medicine immediately and contact their 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 concurrent 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 take Aidee

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. Aidee should be taken in accordance with the following information for oral contraception and for the treatment of moderate acne in women. The patient should consider the information provided in the "If you miss a dose of Aidee" section to maintain contraceptive efficacy.

When and how to take the tablets?

• The Aidee blister pack contains 21 coated tablets. On the blister 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 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. The patient should start taking the next pack 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 that withdrawal bleeding will occur at approximately the same time every month.

Taking Aidee for the first time

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

Taking Aidee should be started on the 1st day of the menstrual cycle, i.e., on the 1st day of bleeding. The patient should take the tablet marked with the symbol of that day of the week. For example, if bleeding starts on a Friday, the patient should take one tablet marked as FRI (which means Friday; see "Translation of day of the week symbols on the packaging" at the end of the leaflet). Then, the patient should take the tablets in the order of the days.

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

The patient can start taking Aidee the next day after taking the last tablet from the current pack (which means there will be no break in taking the tablets) or after removing the intrauterine system or transdermal system. If the pack of the medicine the patient is currently taking contains inactive tablets, the patient can start taking Aidee the next day after taking the last active tablet (if the patient is unsure which tablet is active, they should ask their doctor or pharmacist). The patient can also start taking Aidee on the last day of the usual tablet-free interval or after taking the placebo tablets from the previous treatment.

If the patient has previously taken a progestogen-only pill (minipill)

The patient can stop taking the minipill at any time and start taking Aidee the next day at the same time.

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

The patient should start taking Aidee on the day they would have had their next injection or on the day the implant or intrauterine system is removed. However, during the first 7 days of taking the tablets, the patient should always use a mechanical contraceptive method (e.g., a condom).

After childbirth

Aidee should not be started until at least 21-28 days after childbirth. During the first 7 days of taking the tablets, the patient should also use a mechanical contraceptive method (e.g., a condom). If the patient has had intercourse, before starting Aidee, they should rule out pregnancy or wait for their first menstrual period. For information on use during breastfeeding, see the "Pregnancy and breastfeeding" section.

After a miscarriage or abortion

The patient should follow their doctor's instructions.

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

If the patient vomits within 3-4 hours of taking a tablet, 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 their doctor.

What to do if the patient wants to delay their period

The patient can delay their period 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 their period to occur, they simply stop taking the tablets. During the second pack, the patient may experience irregular bleeding. The next pack should be started after the usual 7-day tablet-free interval.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Aidee medication, the doctor should be consulted.

Severe side effects

The doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives, potentially with breathing difficulties (see also "Warnings and precautions").

Other possible side effects

The following side effects have been reported by patients taking dienogest/ethinylestradiol tablets:

• Frequent (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 (adnexal inflammation);
• urinary tract infections, cystitis (urinary bladder inflammation);
• 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 liver tumors (hepatic adenomas);
• benign fatty tumor of the breast (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 (vein inflammation);
• 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 (stomach inflammation), enteritis (intestinal inflammation);
• indigestion;
• skin reactions/skin disorders, including allergic dermatitis, neurodermatitis/atopic dermatitis, eczema, psoriasis;
• excessive sweating;
• chloasma (melasma), especially on the face (melasma), skin pigmentation disorders/increased pigmentation;
• oily skin (seborrhea);
• dandruff;
• excessive hair growth of male type (hirsutism);
• "orange peel" skin appearance (cellulite);
• spider nevus - 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 growth of cells on the surface of the cervix (cervical dysplasia);
• pain or cysts of the adnexa (ovaries and fallopian tubes);
• breast cysts, 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 sexual desire (libido);
• intolerance to contact lenses;
• hives;
• erythema multiforme, Stevens-Johnson syndrome;
• breast discharge;
• fluid retention;
• onset or exacerbation of symptoms of hereditary or acquired angioedema.

Cancers

• breast cancer is slightly more common in women taking 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 combined hormonal oral contraceptives is unknown. More information can be found in the "Aidee medication and cancer" section;
• liver tumors;
• cervical cancer.

Other conditions

• venous thromboembolic disorders;
• arterial thromboembolic disorders;
• 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, 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., natural products containing St. John's Wort or medications used to treat epilepsy, tuberculosis, HIV infection, and other infections; see "Aidee medication and other medications" for more information).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse 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.

5. How to store Aidee medication

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 packaging. The expiration date refers to the last day of the specified month.

Translation of some information on the immediate packaging:

Ch.-B. und Verw. bis: see imprint – batch number and expiration date: see imprint.

Medications should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging and other information

What Aidee medication contains

• The active substances of the medication are ethinylestradiol and dienogest. Each film-coated tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.
• Other ingredients are: povidone K 30, cornstarch, lactose monohydrate, magnesium stearate, coating: macrogol 3350, titanium dioxide (E 171), polyvinyl alcohol, talc (E 553b).

What Aidee medication looks like and what the packaging contains

Aidee medication is white, cylindrical, biconvex, film-coated tablets, approximately 6 mm in diameter.

Aidee medication is packaged in PVC/Aluminum blisters and is available in calendar packs.

A cardboard wallet is attached to the packaging, in which the blister should be placed.

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:

Apontis Pharma Deutschland GmbH & Co. KG

Alfred-Nobel-Straße 10

40789 Monheim, Germany

Manufacturer:

Cyndea Pharma S.L.

Polígono Industrial Emiliano Revilla Sanz.

Avenida de Ágreda 31

Ólvega, 42110 Soria

Spain

Parallel importer:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

German export license number: 84679.00.00

Parallel import license number: 392/17

Translation of day of the week symbols on each tablet on the immediate packaging:

MON

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

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

Spain: AILYN, 2.0 mg / 0.03 mg, film-coated tablet

Czech Republic:

AIDEE, 2.0 mg / 0.03 mg, film-coated tablet

Germany:

ladonna sanol, 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

Leaflet approval date: 26.04.2023

[Information about the trademark]