Aidee

Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Aidee (ladonna)
2 mg + 0.03 mg, coated tablets
Dienogest + Ethinylestradiol
Aidee and ladonna are different brand names for the same medicine.

Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, particularly during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of a blood clot (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Aidee is and what it is used for
2. Important information before taking Aidee
3. How to take Aidee
4. Possible side effects
5. How to store Aidee
6. Contents of the pack and other information

1. What Aidee is and what it is used for

Aidee is used for:

• preventing pregnancy (a "pill" contraceptive);
• treating moderate acne in women who have decided to use oral contraceptive tablets and in whom adequate topical treatment or oral antibiotic therapy has failed.

Each of the 21 coated tablets of Aidee contains a low dose of female sex hormones:
an oestrogen (ethinylestradiol) and a progestogen (dienogest).
Since Aidee contains two hormones, it is called a "combined oral contraceptive".
Clinical studies have shown that a medicine containing dienogest in combination with ethinylestradiol improves acne symptoms caused by increased levels 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 particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Before you start taking Aidee, your doctor will ask you several questions about your health and/or medical history, as well as that of your close relatives. Your doctor will also measure your blood pressure and may carry out additional tests, depending on your health status.
This leaflet describes several situations when you should stop taking Aidee or when the effectiveness of Aidee may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use fertility awareness-based methods (calendar method) or body temperature measurements. These methods are unreliable because the contraceptive tablet affects changes in body temperature and cervical mucus that occur during the menstrual cycle.
Aidee, like all contraceptive pills, does not protect against infection with HIV (AIDS) or other sexually transmitted infections.
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. You should discuss with your doctor the need to continue treatment after three to six months, and then at regular intervals.

When not to use Aidee:
Do not use Aidee if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which other method of contraception may be more suitable:

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots: severe diabetes with blood vessel damage; very high blood pressure; very high levels of fats in the blood (cholesterol or triglycerides); a condition called hyperhomocysteinemia;
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you are allergic to ethinylestradiol, dienogest, or any of the other ingredients of this medicine (listed in section 6);
• if you currently have or have previously had pancreatitis associated with severe hypertriglyceridemia;
• if you currently have or have previously had liver disease and liver function has not yet returned to normal;
• if you currently have or have previously had a benign or malignant liver tumour;
• if you have or have previously had hormone-dependent malignant tumours, e.g. breast cancer or genital organ cancers;
• if you have vaginal bleeding of unknown cause;
• if you have hepatitis C and are taking medications containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section 2 "Aidee with other medicines").

Warnings and precautions
When to exercise special caution when using Aidee
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots").

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".
If thrombosis is suspected or confirmed, stop using Aidee immediately and contact your doctor without delay. If anticoagulant therapy is initiated, due to the teratogenic effects of anticoagulant therapy (e.g. coumarins), your doctor will recommend an appropriate alternative contraceptive method.
Tell your doctor if you have any of the following conditions. If any of these conditions develop or worsen during treatment with Aidee, you should also inform your doctor:

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have elevated blood lipid levels (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor about when it is safe to start taking Aidee after delivery;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you are not young;
• if you smoke;
• 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 disturbances;
• if close relatives have had episodes of thrombosis, myocardial infarction, or stroke;
• 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 developed herpes gestationis during pregnancy;
• if you have depression;
• if there is a family history of breast cancer;
• if you have liver or gallbladder disease;
• if you have a certain type of hearing loss (hearing loss associated with otosclerosis);
• if you currently have or have previously had chloasma (dark brown patches of irregular shape and varying size, particularly on the face); in such cases, avoid excessive exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, potentially with breathing difficulties, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Aidee contains a substance, a progestogen, which is an aldosterone antagonist with potassium-sparing properties. In most cases, increased potassium concentration is not expected. Serum potassium levels should be monitored during the first treatment cycle in patients with renal impairment and in patients previously treated with potassium-correcting therapy if serum potassium is at the upper limit of normal, especially when concomitantly using potassium-sparing drugs.
If any of the conditions listed above occur for the first time, recur, or worsen during treatment with Aidee, consult your doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Aidee, have reported depression or depressed mood. Depression can be severe and, in some cases, may lead to suicidal thoughts. If mood changes or symptoms of depression occur, 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 such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

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

Complete recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
It is important to remember that the overall risk of harmful blood clots caused by using Aidee is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.

Are you experiencing any of these symptoms? Likely reason
for your symptoms

• Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:

• pain or tenderness in the leg, felt only when standing or walking;

• increased warmth in the affected leg;

• skin discoloration of the leg, e.g. pallor, redness, or bluish tint.

• Sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism

• sudden cough without an obvious cause, possibly with coughing up blood;

• sharp chest pain, which may worsen with deep breathing;

• severe dizziness or lightheadedness;

• rapid or irregular heartbeat;

• severe abdominal pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shallow breathing, may be mistaken for milder conditions such as a respiratory tract infection (e.g. cold).

Symptoms most commonly affecting one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision, or

• painless visual disturbances, which may progress to vision loss.

• Chest pain, discomfort, pressure, heaviness; Myocardial infarction

• squeezing or fullness in the chest, arm, or below the breastbone;

• feeling of fullness, indigestion, or choking;

• discomfort in the upper body radiating to the back, jaw, throat, arm, or stomach;

• sweating, nausea, vomiting, or dizziness;

• extreme weakness, anxiety, or shallow breathing;

• rapid or irregular heartbeat.

• Sudden weakness or numbness of the face, arms, or legs, especially Stroke on one side of the body;

• sudden confusion, speech disturbances, or difficulty understanding;

• sudden visual disturbances in one or both eyes;

• sudden difficulty walking, dizziness, loss of balance, or coordination;

• sudden, severe, or prolonged headache without 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; however, you should seek immediate medical attention, as you may be at risk of a subsequent stroke.

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

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis), although these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in a venous vessel of another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is highest during the first year of using
combined hormonal contraceptives for the first time. The risk may also
be higher when restarting a combined hormonal contraceptive
(the same or a different product) after a break of 4 weeks or longer.
After the first year, the risk decreases, but it will always remain higher compared to
when not using combined hormonal contraceptives.
If a patient stops taking Aidee, the risk of blood clots returns to
normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual's risk of venous thromboembolic disease and the type of
combined hormonal contraceptive used.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) associated with using Aidee is small.

• In a one-year period, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a one-year period, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a one-year period, 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 developing blood clots depends on the patient's individual medical history (see
"Factors that increase the risk of blood clots", below).

Factors increasing the risk of venous blood clots
The risk of venous blood clots associated with the use of Aidee is small, but certain factors may increase this risk. The risk is higher:

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

The risk of venous blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots, particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue Aidee.
Inform the doctor if any of the above conditions change during treatment with Aidee, for example, if a close relative develops thrombosis without a known cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial blood clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Aidee is very small, but it may increase:

• with age (over 35 years);
• if the patient smokes cigarettes. When using a hormonal contraceptive such as Aidee, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of 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 suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Aidee, for example, if the patient starts smoking, a close relative develops thrombosis without a known cause, or if the patient gains significant weight.

Other diseases that may affect blood vessels include systemic lupus erythematosus (an autoimmune disease), hemolytic uremic syndrome (a blood disorder leading to kidney damage), chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis), and sickle cell anemia (a genetic blood disorder characterized by abnormally shaped red blood cells).

Aidee and cancer
Breast cancer is detected slightly more frequently in women using combined oral contraceptives than in women of the same age who do not use contraceptive pills. This small increase in breast cancer diagnoses gradually decreases and disappears within 10 years after stopping oral contraceptives. Since breast cancer is rare in women under 40 years of age, the additional number of breast cancer cases in women currently or recently using oral contraceptives is small compared to the overall risk of developing breast cancer. It is not known whether this difference is caused by the use of oral contraceptives. The reason may be that women using the medicine were examined more frequently, leading to earlier detection of breast cancer.

In rare cases, benign liver tumors have been reported in women using oral contraceptives, and even more rarely, malignant liver tumors. These tumors may cause bleeding into the abdominal cavity. Seek immediate medical attention if severe abdominal pain occurs.

Some studies suggest that long-term use of hormonal contraception may be a risk factor for cervical cancer in women whose cervix is infected with certain sexually transmitted viruses (human papillomavirus). However, the extent to which other factors (e.g., differences in the number of sexual partners or use of mechanical contraceptive methods) influence this result has not yet been determined.

Medical consultations and (or) examinations
Before the patient starts using Aidee, the doctor will conduct a thorough medical history interview regarding the patient and her close relatives. A general medical examination and gynecological examination, including breast and cervical examination, will be performed. Pregnancy must be ruled out. These examinations should be repeated regularly while the patient is taking oral contraceptives.
Inform the doctor if the patient smokes and if she is taking any other medicines.

When to contact the doctor
Contact the doctor immediately if:

• the patient notices any concerning changes in her health, particularly any of the symptoms listed in this leaflet (section: "When to exercise particular caution when using Aidee" and "How to use Aidee"), and also consider the points related to close relatives;
• the patient detects a lump in her breast;
• the patient intends to take other medicines (see section: "Aidee and other medicines");
• immobilization or planned surgical procedure is expected (inform the doctor at least 4 weeks in advance);
• heavy vaginal bleeding occurs;
• the patient misses one or more tablets in the first week of the cycle (each first week in consecutive months of Aidee use) and had intercourse in the preceding 7 days;
• withdrawal bleeding does not occur in two consecutive months, or if the patient suspects she is pregnant (do not start the next pack without the doctor's advice).

Intermenstrual bleeding
Irregular vaginal bleeding (intermenstrual bleeding) may occur during use of combined oral contraceptives, especially during the first few months of tablet use. The patient may need sanitary pads or tampons, but should not interrupt taking Aidee. Bleeding is usually light and stops as the body adjusts to the oral contraceptive, which typically takes about 3 months. If bleeding persists for longer than a few months or starts after several months, consult the doctor.

What to do if no bleeding occurs during the tablet-free week
If the patient has taken all tablets correctly, has not vomited or had severe diarrhea, and has not taken any other medicines, it is unlikely that she is pregnant. Continue taking Aidee as usual.
If expected withdrawal bleeding does not occur in two consecutive cycles, or if tablet intake was incorrect in the previous cycle, the patient may be pregnant. Contact the doctor immediately. Do not take Aidee until the doctor has ruled out pregnancy.

Children and adolescents
Aidee is indicated only after the onset of menstruation.

Aidee and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently or recently taking, as well as any medicines she plans to take.

Some medicines:

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

These include:

• medicines used to treat epilepsy (e.g., primidone, phenytoin, felbamate, barbiturates, carbamazepine, topiramate, oxcarbazepine);
• medicines used to treat tuberculosis (e.g., rifampicin, rifabutin);
• medicines used in the treatment of HIV infection and hepatitis C (e.g., ritonavir, efavirenz, nevirapine, nelfinavir);
• a medicine prescribed for certain infections (e.g., griseofulvin);
• some painkillers used to treat inflammatory conditions and osteoarthritis (etoricoxib, NSAIDs);
• some 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-mentioned medicines, she may continue taking Aidee but must use mechanical contraception (e.g., condom) or another contraceptive method. During concomitant use of Aidee with the above-mentioned medicines and for 28 days after stopping treatment, the patient should use additional mechanical contraception.
If concomitant use of the above-mentioned medicine continues beyond the end of the current Aidee pack, start the next pack without observing the 7-day tablet-free interval.

If long-term treatment with any of the above-mentioned medicines is required, a reliable non-hormonal contraceptive method should be used.

Aidee may also affect the action of other medicines, for example:

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

Do not use Aidee 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 these may falsely elevate blood test results indicating liver function (increased alanine aminotransferase enzyme activity).
The doctor will prescribe another type of contraception before starting the above treatment regimen. Aidee may be restarted 2 weeks after completing treatment with the above-mentioned medicines. See section 2. "When not to use Aidee."

Also inform any other doctor or dentist prescribing medicines to the patient that she is taking Aidee. Doctors may advise the patient whether additional contraceptive measures are needed and, if so, for how long.

Effect on laboratory test results
Taking Aidee may affect laboratory test results for liver function, adrenal cortex, kidney and thyroid function, as well as levels of certain blood proteins, carbohydrate metabolism, blood coagulation, and fibrinolysis. However, despite these changes, results usually remain within the normal range.

Regular check-ups
The doctor may recommend regular follow-up examinations while the patient is taking Aidee. The frequency and nature of these check-ups depend on the patient's health status.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Aidee must not be used during pregnancy or if pregnancy is suspected.
If the patient becomes pregnant while taking Aidee, stop taking the medicine immediately and contact the doctor.

Breastfeeding
Aidee should generally not be taken by breastfeeding women, as it may reduce the amount of milk produced and small amounts of the drug may be excreted in human milk. Non-hormonal contraceptive methods should be used during breastfeeding.

Driving and operating machinery
The effect of the combined use of dienogest and ethinylestradiol on the ability to drive and operate machinery is unknown.

Aidee contains monohydrate lactose
This medicine contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to take Aidee

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Aidee should be taken according to the information below for oral contraception and for the treatment of moderate acne in women. Please consider the information provided in the section "Missed dose of Aidee" to maintain contraceptive effectiveness.
When and how to take the tablets?

• The Aidee pack contains 21 coated tablets. Each tablet in the pack is marked with the day of the week on which it should be taken. Tablets should be taken at approximately the same time each day, with a small amount of water. Tablets should be taken in the order indicated by the arrows until all 21 coated tablets have been consumed. No tablets should be taken for the following 7 days. During these 7 days, withdrawal bleeding is expected. It usually starts 2 to 3 days after taking the last Aidee tablet. The next pack should be started on day 8, even if bleeding has not yet stopped. This means that the patient will always start a new pack on the same day of the week and withdrawal bleeding will occur approximately on the same days each month.

Starting Aidee for the first time
If no oral contraceptives have been used in the past month
Start taking Aidee on day 1 of the menstrual cycle, i.e. the first day of menstrual bleeding. Take the tablet marked with that day of the week. For example, if bleeding starts on Friday, take the tablet marked Friday. Then continue taking tablets in the correct order of days.
If previously using another combined oral contraceptive, vaginal contraceptive system, or transdermal contraceptive system
Aidee may be started the next day after taking the last active tablet from the current pack (meaning no break between packs), or the day after removing the vaginal contraceptive system or transdermal patch. If the current pack contains inactive tablets, Aidee may be started the day after the last active tablet is taken (if the patient is unsure which tablet is active, she should consult her doctor or pharmacist).
Alternatively, Aidee may be started on the last day of the usual tablet-free interval, patch-free interval, or ring-free interval, or after the placebo tablets of the previous treatment.
If previously using a progestogen-only pill (mini-pill)
The mini-pill may be stopped on any day, and Aidee should be started the next day at the same time.
If previously using injectable contraception, implant, or intrauterine system releasing progestogen
Start taking Aidee on the day the next injection would have been due, or on the day of removal of the implant or intrauterine system. However, if sexual intercourse occurs during the first 7 days of taking Aidee tablets, additional contraceptive methods (barrier methods) should always be used.
After childbirth
Do not start taking Aidee earlier than 21 to 28 days after delivery. During the first 7 days of taking the tablets, mechanical contraceptive methods (e.g. condom) should also be used. If sexual intercourse occurred before starting Aidee, pregnancy must be ruled out or wait until the first menstrual bleed occurs. For use during breastfeeding, see section "Pregnancy and breastfeeding".
After spontaneous or induced abortion
Follow your doctor's advice.
What to do in case of gastrointestinal disturbances (e.g. vomiting, severe diarrhoea)
If vomiting occurs within 3 to 4 hours after taking an Aidee tablet, the active ingredients may not have been completely absorbed. This situation is similar to a missed tablet. Therefore, follow the instructions for missed tablets. If the patient has severe diarrhoea, consult a doctor.
What to do if the patient wishes to delay withdrawal bleeding
The patient may delay withdrawal bleeding by starting the next pack of Aidee immediately after finishing the current pack. The patient may continue taking tablets from this pack as long as desired, until the pack is finished. If the patient wishes for bleeding to occur, she simply stops taking tablets. Irregular bleeding may occur during the second pack. The next pack should be started after the usual 7-day break.
What to do if the patient wishes to change the day on which withdrawal bleeding starts
If the patient takes tablets as directed, withdrawal bleeding occurs approximately every 4 weeks on the same day. To change the day on which bleeding starts, the patient should shorten (but never extend) the break between packs. For example, if bleeding usually starts on Friday and the patient wishes it to start on Tuesday (3 days earlier), she should start the next pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), bleeding may not occur during this interval. Irregular bleeding may occur during the next pack.
What to do if unexpected bleeding occurs
With all contraceptive pills, breakthrough (irregular) bleeding may occur during the first few months. The use of sanitary towels or tampons may be necessary, but tablets should still be taken as usual. Irregular bleeding usually stops once the body adjusts to the contraceptive pill (usually after 3 cycles). If bleeding continues, becomes heavier, or recurs, inform your doctor.
What to do if withdrawal bleeding does not occur
If all tablets were taken correctly, without vomiting or use of other medications, it is unlikely that the patient is pregnant. Continue taking Aidee according to the usual schedule. If withdrawal bleeding does not occur twice in succession, the patient may be pregnant. Inform your doctor immediately. Do not start the next pack of Aidee until your doctor confirms that you are not pregnant.
Taking more Aidee than prescribed
There are no reports of severe harmful adverse effects after taking too many Aidee tablets at once. If several tablets are taken at the same time, nausea, vomiting, and vaginal bleeding may occur. If a patient has taken too many Aidee tablets or if a child has accidentally taken Aidee, consult a doctor for advice.
Missed dose of Aidee

• If a tablet is taken less than 12 hours late, contraceptive protection remains. Take the missed tablet as soon as remembered and continue taking the next tablets at the usual time.
• If a tablet is taken more than 12 hours late, contraceptive effectiveness may be reduced. The more consecutive tablets missed, the greater the risk of reduced contraceptive effectiveness. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of the pack. Therefore, follow the rules below (see also the flowchart below).

More than 1 tablet missed from the pack
Consult your doctor for advice.
One tablet missed in the first week
Take the missed tablet as soon as remembered (even if this means taking two tablets at the same time), and take the next tablet at the usual time. Use additional contraceptive methods (barrier methods) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, there is a risk of pregnancy. Inform your doctor immediately.
One tablet missed in the second week
Take the missed tablet as soon as remembered (even if this means taking two tablets at the same time), and take the next tablet at the usual time. Contraceptive effectiveness is maintained. There is no need to use additional contraceptive methods.
One tablet missed in the third week
Either of the following options may be chosen, without the need for additional precautions:

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and take the next tablet at the usual time. Start the next pack immediately after finishing the current pack, without leaving a break between packs. Bleeding may not occur until after finishing the second pack, but irregular bleeding may occur during tablet-taking days.

Or:

2. Stop taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), then continue with the next pack. Using this method, the patient can always start the next pack on the same day of the week as usual.

If tablets are missed and no withdrawal bleeding occurs during the next tablet-free interval, the patient may be pregnant. Consult your doctor before starting the next pack.
Missed more than 1 tablet Consult your doctor
yes
1st week Was there sexual intercourse in the week before the missed tablet?
no

• Take the missed tablet
• Use additional contraceptive methods for 7 days
• Finish taking all tablets in the pack
  Missed only 1 tablet 2nd week - Take the missed tablet
• Finish taking all tablets in the pack

(delay
more than
12 hours) - Take the missed tablet

• Finish taking all tablets in the pack
• Continue with the next pack

or
3rd week

• Stop taking tablets from the current pack
• Take a break from taking the medicine (no longer than 7 days, including the day the tablet was missed)
• Continue with the next pack

Stopping Aidee
The patient may stop taking Aidee at any time. If the patient does not wish to become pregnant, consult your doctor about other methods of birth control. If the patient stops taking Aidee because she wishes to become pregnant, it is usually recommended to wait for a natural menstrual period before trying to conceive. This makes it easier to determine whether absence of bleeding is due to pregnancy.
Use in children and adolescents
Aidee must not be used before the first menstrual period.
Elderly patients
Aidee must not be used in postmenopausal women.
Patients with hepatic impairment
Aidee is contraindicated in women with severe liver disease (see section "When not to use Aidee").
Patients with renal impairment
Studies on the use of Aidee in patients with renal impairment have not been conducted. Available data suggest that dosage adjustment is not necessary in this patient population.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Aidee, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Aidee".

Serious adverse effects
Seek immediate medical attention 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 section "Warnings and precautions").

Serious reactions associated with taking dienogest/ethinylestradiol tablets have been described in the section "When to take special care with Aidee". The patient may obtain further information there. Consult a doctor immediately if necessary.

Other possible adverse effects
The following adverse effects have been reported by women taking dienogest/ethinylestradiol tablets:

Common (may affect up to 1 in 10 women):

• Headache;
• Breast pain, including breast discomfort and tenderness.

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

• Inflammation of the genital organs (vaginitis/vulvovaginitis), fungal infections of the vagina (vaginal candidiasis, vulvovaginal infections);
• 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, diarrhoea;
• Acne;
• Rash (including maculopapular rash);
• Itching (sometimes generalized);
• Hair loss (alopecia);
• Irregular withdrawal bleeding (including heavy bleeding (hypermenorrhoea), scanty bleeding, infrequent bleeding or complete absence of bleeding);
• Bleeding between periods (intermenstrual bleeding; vaginal bleeding and prolonged vaginal bleeding);
• Breast enlargement (including breast swelling and breast oedema);
• Painful bleeding (dysmenorrhoea);
• Vaginal discharge;
• Ovarian cysts;
• Pelvic pain;
• Fatigue, including weakness, tiredness and malaise;
• Weight gain.

Rare (may affect up to 1 in 1,000 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 ischaemic attack (TIA);
  • Blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots);
• Inflammation of the ovaries and fallopian tubes (adnexitis);
• Urinary tract infections, cystitis (bladder inflammation);
• Mastitis (inflammation of the breast);
• Cervicitis (inflammation of the cervix);
• Fungal infections (e.g. candidiasis), viral infections, oral herpes;
• Influenza, bronchitis, upper respiratory tract infections, sinusitis;
• Benign uterine tumours (fibroids);
• Benign fatty tissue tumour of the breast (lipoma of the breast);
• Anaemia;
• Allergic reactions (hypersensitivity);
• Development of male secondary sexual characteristics in women (virilization);
• Loss of appetite (anorexia);
• Depression, psychiatric disorders, irritability, aggression;
• Insomnia, sleep disorders;
• Dystonia (sustained muscle contractions causing, for example, abnormal posture);
• Dry or irritated eyes;
• Blurred vision;
• Sudden hearing loss, hearing disturbances;
• Tinnitus;
• Dizziness;
• Rapid heartbeat;
• Inflammation of a vein (thrombophlebitis);
• Varicose veins, venous insufficiency, vein pain;
• Dizziness or fainting upon standing from a sitting or lying position (orthostatic hypotension);
• Hot flushes;
• Asthma;
• Increased breathing rate (hyperventilation);
• Inflammation of the stomach lining (gastritis), enteritis;
• Indigestion;
• Skin reactions/skin disorders including allergic dermatitis, neurodermatitis/atopic dermatitis, eczema, psoriasis;
• Excessive sweating;
• Brownish pigment spots (so-called chloasma), particularly on the face (melasma), pigmentary disturbances/increased pigmentation;
• Oily skin (seborrhoea);
• Dandruff;
• Excessive male-pattern hair growth (hirsutism);
• "Orange peel" skin appearance (cellulite);
• Spider angioma (spider naevus) – a network of blood vessels with a central red spot on the skin;
• Back pain, chest pain;
• Bone and muscle complaints, muscle pain, pain in arms and legs;
• Abnormal cell growth on the surface of the cervix (cervical dysplasia);
• Pain or cysts of the uterine adnexa (ovaries and fallopian tubes);
• Cysts in the breast, benign breast lumps (mastopathy), presence of supernumerary breast tissue;
• Spontaneous milk discharge (galactorrhoea);
• Pain during sexual intercourse (dyspareunia);
• Bleeding disorders;
• Fluid accumulation in the body (peripheral oedema);
• Flu-like symptoms, inflammation, fever;
• Increased blood levels of triglycerides and cholesterol (hypertriglyceridaemia, hypercholesterolaemia);
• Weight loss;
• Weight changes.

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

• Mood changes;
• Decreased or increased sexual desire (libido);
• Intolerance to contact lenses;
• Urticaria;
• Nodular erythema, erythema multiforme;
• Breast discharge;
• Fluid retention;
• Occurrence or worsening of symptoms of hereditary or acquired angioedema.

Tumours

• Breast cancer is diagnosed slightly more frequently among women using combined oral contraceptives. Among women under 40 years of age, breast cancer is rare; the number of cases is small compared to the overall risk of developing breast cancer. A causal relationship between breast cancer and the use of hormonal oral contraception is not known. Further information is provided in the section "Aidee and cancer";
• Liver tumours;
• Cervical cancer.

Other conditions

• Venous thromboembolic disorders;
• Arterial thromboembolic disorders;
• Cerebrovascular incidents;
• Hypertriglyceridaemia (increased risk of pancreatitis);
• Hypertension;
• Occurrence or worsening of diseases for which the relationship with the use of combined oral contraceptives is not clear: cholestatic jaundice, gallstones, porphyria, systemic lupus erythematosus, haemolytic-uraemic 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;
• Melasma.

Interactions
Unexpected intermenstrual bleeding and/or reduced contraceptive effectiveness may result from interactions between oral contraceptives and other medicines (e.g.: herbal remedies containing St. John's wort, or medicines used to treat epilepsy, tuberculosis, HIV infection and other infections; see section "Aidee and other medicines").

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aidee medicine

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Aidee contains

• The active substances are: ethinylestradiol and dienogest. Each coated tablet contains 2 mg dienogest and 0.03 mg ethinylestradiol.
• Other components: povidone K30, pregelatinized maize starch, lactose monohydrate, magnesium stearate, coating: macrogol 3350, titanium dioxide (E 171), polyvinyl alcohol, talc (E 553b).

What Aidee looks like and contents of the pack
Aidee is a white, cylindrical, biconvex coated tablet with a diameter of approximately 6 mm.
Aidee is packed in PVC/Aluminium blisters.
Pack sizes:
21 coated tablets (one blister containing 21 tablets)
63 coated tablets (three blisters containing 21 tablets each)
126 coated tablets (six blisters containing 21 tablets each)
For further detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Germany, the country of export: 84679.00.00
Parallel Import Licence Number: 76/24
This medicinal product is authorised in the European Economic Area countries under the following trade names:
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 the weekday symbols printed next to each tablet on the immediate packaging:
MON - Monday
DIE - Tuesday
MIT - Wednesday
DON - Thursday
FRE - Friday
SAM - Saturday
SON - Sunday