Aidee

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Aidee (ladonna sanol)
2 mg + 0.03 mg, coated tablets
Dienogestum + Ethinylestradiolum
Aidee and ladonna sanol 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 developing blood clots in veins and arteries, especially 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 blood clots (see section 2 "Blood clots").

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

• Keep this leaflet so you can 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. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Aidee is and what it is used for
2. What you need to know before using 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 (the "pill" contraceptive);
• treatment of moderate acne in women who have decided to use oral contraceptives 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 starting to take Aidee, your doctor will ask you several questions about your health and (or) your personal and family medical history. Your doctor will also measure your blood pressure and may perform 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 cases, you should either abstain from 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 monitoring. These methods are unreliable because the contraceptive pill affects body temperature changes and cervical mucus changes occurring during the menstrual cycle.
Aidee, like all contraceptive pills, does not protect against HIV infection (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 alternative method of contraception would 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 long time (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 diseases that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of blood fats (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 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 medicines 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 particular caution when using Aidee
When should you contact your doctor?
Seek medical advice immediately if:

• you notice possible symptoms of blood clots, which may indicate that 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 symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".
If you suspect or confirm the occurrence of thrombosis, 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 causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have been diagnosed with high blood fat levels (hypertriglyceridaemia) or have 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 long time (see section 2 "Blood clots");
• if you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Aidee after childbirth;
• 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 metabolism (impaired 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 haem metabolism);
• if you have migraines;
• if you have epilepsy;
• if you have Sydenham's chorea;
• if you developed chloasma 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 (extensive brown patches with irregular shapes and varying sizes, 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, an increase in potassium concentration is not expected. Monitoring of serum potassium concentration is recommended during the first treatment cycle in patients with renal impairment and in patients previously treated with potassium-correcting therapy, especially if potassium levels are at the upper limit of normal, particularly when concomitant potassium-sparing drugs are used.
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 low mood. Depression can be severe and may sometimes 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 events").

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.
Remember that the overall risk of harmful blood clots associated with the use of 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 and, if so, why might you be affected?

VENOUS BLOOD CLOTS
What can happen if blood clots form in a vein?

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

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Aidee is low, however,
some factors may increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member 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, is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Aidee several weeks before surgery or immobilisation. If the patient needs to stop taking Aidee, ask the doctor when it is safe to restart;
• with increasing age (especially above 35 years of age);
• if the patient has recently given birth (within the last 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,
particularly if the patient has any other risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if the patient is uncertain. The doctor may decide to discontinue the use of
Aidee.
Inform the doctor if any of the above conditions change during treatment with Aidee, e.g. if a close family member is diagnosed with thrombosis of unknown 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 clots can cause 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 may increase:

• with age (above 35 years);
• if the patient smokes. While 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 family member 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 family member 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 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 is
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, e.g. if the patient starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.
Other diseases that may affect blood vessels include systemic lupus erythematosus
(autoimmune disease), haemolytic uraemic syndrome (a blood disorder leading to
kidney damage), chronic inflammatory bowel diseases (Crohn's disease and
ulcerative colitis), and sickle cell anaemia (a genetic blood disorder characterised by
abnormally shaped red blood cells).

Aidee and cancer
Breast cancer is diagnosed 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. As breast cancer is rare in women under 40 years of age, the additional number of breast cancer cases in women who currently use or recently used oral contraceptives is small compared to the overall risk of breast cancer. It is not known whether the difference is caused by the use of contraceptive pills. The reason may be that women using the pill are examined more frequently, leading to earlier detection of breast cancer.
In rare cases, benign liver tumours have been reported in women using contraceptive pills, and even more rarely, malignant liver tumours.
These tumours may cause bleeding into the abdominal cavity. Seek immediate medical advice in case of severe abdominal pain.
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, it has not yet been established to what extent other factors (e.g. differences in number of sexual partners or use of mechanical contraceptive methods) influence this result.

Medical consultations and (or) examinations
Before the patient starts using Aidee, the doctor will take a detailed medical history, including information about diseases in the patient and her close relatives. A general medical examination and a gynaecological examination, including breast and cervical examination, will be performed. Pregnancy must be excluded. These examinations should be repeated regularly while the patient is taking contraceptive pills.
Inform the doctor if the patient smokes or is taking other medicines.

When to contact the doctor
Contact the doctor immediately if:

• the patient notices any concerning changes in her health status, particularly any of the symptoms mentioned in this leaflet (section: "When to be cautious when using Aidee" and "How to use Aidee"), and also consider the points regarding close relatives;

• the patient detects a lump in her breast;

• the patient plans to take other medicines (see section "Aidee and other medicines");

• the patient is likely to be immobilised or is scheduled for surgery (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 of consecutive months of Aidee use), and had unprotected intercourse in the preceding 7 days;

• withdrawal bleeding does not occur in two consecutive months, or the patient suspects she may be 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 taking the tablets. The patient may need to use sanitary pads or tampons, but does not need to stop taking Aidee. Bleeding is usually light and stops once 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 of use, consult the doctor.

What to do if no withdrawal bleeding occurs
If the patient has taken all tablets correctly, has not vomited or had severe diarrhoea, 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 irregular 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 taking, has recently taken, or 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 and oxcarbazepine);
• medicines used to treat tuberculosis (e.g. rifampicin, rifabutin);
• medicines used in HIV and hepatitis C virus infection (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 herbal products or natural supplements containing St. John's wort (Hypericum perforatum tea).

If the patient is taking or starts taking any of the above medicines, she may continue taking
Aidee, but must use mechanical contraception (e.g. a condom) or another contraceptive method. During concomitant use of Aidee with the above medicines and for 28 days after stopping treatment, the patient should use additional mechanical contraception.
If concomitant use of the above medicine continues beyond the end of the current pack of Aidee, start the next pack without a 7-day break.
If long-term treatment with any of the above medicines is required, use other reliable non-hormonal contraceptive methods.
Aidee may also affect the action of other medicines, e.g.:

• 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 stopping treatment with the above medicines. See section 2. "When not to use Aidee".
Inform any other doctor or dentist prescribing medicines to the patient that she is taking Aidee. Doctors may advise 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 check-ups 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 in pregnant women 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 concomitant 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 an intolerance to certain sugars, she should consult the doctor before taking the medicine.

3. How to take Aidee

This medicine should always be taken 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 blister pack contains 21 coated tablets. Each tablet on the blister is marked with the symbol of 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 direction of 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 usually occurs. It typically starts 2–3 days after the last Aidee tablet has been taken. The next pack should be started on day 8, even if bleeding continues. 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
Aidee should be started on day 1 of the menstrual cycle, i.e. the first day of menstrual bleeding. Take the tablet marked with the symbol of that day of the week. For example, if bleeding starts on Friday, take the tablet marked FRE (meaning Friday; see "Translation of day-of-the-week symbols on each tablet in the immediate packaging" at the end of the leaflet). Then continue taking tablets in the order of the days of the week.
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 in tablet intake), or after removal of the vaginal contraceptive system or transdermal system. 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 period, or vaginal ring-free period, or after the placebo tablets of the previously used contraceptive.
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 contraceptive injections, an implant, or an intrauterine system releasing progestogen
Aidee should be started on the day the next injection was 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 tablets, additional contraceptive methods (mechanical methods) must always be used.
After childbirth
Aidee should not be started earlier than 21 to 28 days after delivery. During the first 7 days of taking tablets, mechanical contraceptive methods (e.g. condoms) should also be used. If sexual intercourse occurred before starting Aidee, pregnancy must be ruled out or wait until the first bleeding 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 substances may not have been fully absorbed. This situation is similar to a missed tablet. Therefore, follow the instructions for missed tablets. If severe diarrhoea occurs, consult your doctor.
What to do if the patient wishes to delay the onset of bleeding
The patient may delay the onset of 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, up to the end of the pack. If the patient wishes for bleeding to occur, she simply stops taking tablets. Irregular bleeding may occur during the intake of 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 bleeding starts
If the patient takes tablets as directed, bleeding occurs approximately on the same day every 4 weeks. If the patient wishes to change the day on which bleeding starts, she 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 intake of the next pack.
What to do if unexpected bleeding occurs
With all contraceptive pills, breakthrough (intermenstrual) bleeding may occur during the first few months. The use of sanitary pads or tampons may be necessary, but tablets should be continued 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 no bleeding occurs
If all tablets were taken correctly, without vomiting or use of other medicines, it is unlikely that the patient is pregnant. Continue taking Aidee as usual. If 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 recommended
There are no reports of serious harmful 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 take the next tablet at the usual time.
• If any tablet from the pack is taken more than 12 hours late, contraceptive effectiveness may be reduced. The more consecutive tablets missed, the higher the risk of reduced contraceptive efficacy. 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 (mechanical methods) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, there is a possibility 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 the end of the second pack, but irregular bleeding may occur during tablet intake.

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 taking tablets from 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 bleeding occurs during the next tablet-free interval, the patient may be pregnant. Consult your doctor before starting the next pack.
Missed more than Consult your doctor
1 tablet
yes
Was there sexual intercourse in the week
1st 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 - Take the missed tablet
(spacing more than - Finish taking all tablets
2nd week
12 hours) in the pack

• Take the missed tablet
• Finish taking all tablets in the pack
• Continue with the next pack

3rd week
or

• Stop taking tablets from the current pack
• Take a break from taking the medicine (no longer than 7 days, counting the day the tablet was missed)
• Continue taking tablets from 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 alternative 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 liver 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 dose 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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health 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 venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before using Aidee".
Serious adverse reactions
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 tablets containing dienogest/ethinylestradiol have been described in the section "When to take special care using Aidee". The patient may obtain further information there. Consult a doctor immediately if necessary.
Other possible adverse reactions
The following adverse reactions have been reported by patients using 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):

• genital infections (vaginitis/vulvovaginitis), fungal vaginal infections (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 (menorrhagia), scanty bleeding, infrequent bleeding or complete absence of bleeding);
• intermenstrual bleeding (breakthrough bleeding; vaginal bleeding and prolonged vaginal bleeding);
• breast enlargement (including breast swelling and breast oedema);
• painful bleeding (dysmenorrhoea);
• vaginal discharge;
• ovarian cysts;
• pelvic pain;
• exhaustion, including weakness, fatigue 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 stroke-like symptoms, known as transient ischaemic 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 further information on risk factors for blood clots and symptoms of blood clots);
• inflammation of the ovaries and fallopian tubes (salpingo-oophoritis);
• urinary tract infections, cystitis (bladder inflammation);
• mastitis (breast inflammation);
• 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 in the breast (lipoma of the breast);
• anaemia;
• allergic reactions (hypersensitivity);
• development of male secondary sexual characteristics in women (virilisation);
• 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 dysfunction, 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 pigmentation 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 discomfort, 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);
• breast cysts, benign breast lumps (mammary dysplasia), appearance of supernumerary breast tissue;
• spontaneous milk discharge (galactorrhoea);
• pain during sexual intercourse (dyspareunia);
• bleeding disorders;
• fluid retention 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);
• contact lens intolerance;
• 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 in women using combined oral contraceptives. In women under 40 years of age, breast cancer is rare; the number of cases is small compared to the overall risk of developing breast cancer. A causal relationship between breast cancer and the use of oral hormonal 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);
• arterial hypertension;
• occurrence or worsening of diseases for which the relationship with the use of combined oral contraceptives is not clear-cut: 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department for 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Aidee

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Ch.-B. und Verw. bis: siehe Prägung – Batch number and expiry date: see embossing.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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 are: povidone K 30, pregelatinized corn 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 and available in calendar packs.
A cardboard sleeve is included with the pack, in which the blister should be placed.
Pack sizes:
21 coated tablets (blister containing 21 tablets)
63 coated tablets (3 blisters containing 21 tablets each)
126 coated tablets (6 blisters containing 21 tablets each)
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Germany, the country of export: 84679.00.00
Parallel import licence number: 392/17
Translation of the weekday symbols printed next to each tablet in the immediate packaging:
MON - Monday
DIE - Tuesday
MIT - Wednesday
DON - Thursday
FRE - Friday
SAM - Saturday
SON - Sunday
This medicinal product is authorised for marketing in the European Economic Area member states under the following 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 sanol, 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