Ativia

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

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

Atywia(Velafee)

0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest
Atywia and Velafee are different trade names for the same medicine.

Important information about combined hormonal contraceptives

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See point 4.

Table of contents of the leaflet

• 1. What is Atywia and what is it used for
• 2. Important information before using Atywia
• 3. How to use Atywia
• 4. Possible side effects
• 5. How to store Atywia
• 6. Contents of the package and other information

1. What is Atywia and what is it used for

Atywia is a combined oral contraceptive.
Each tablet contains two different hormones. These are: dienogest (progestogen) and ethinylestradiol (estrogen). When using Atywia according to the recommendations listed in this leaflet, the likelihood of becoming pregnant is very low.

Indications for use

Prevention of pregnancy.
Treatment of women with moderate acne who have decided to use oral contraceptives and who have not responded to appropriate local treatment or oral antibiotic treatment.

2. Important information before using Atywia

General notes

Before starting to take Atywia, you should read the information about blood clots in point 2. It is especially important to read about the symptoms of blood clots (see point 2 "Blood clots").
Improvement of acne symptoms usually occurs after three to six months of treatment, but skin condition may continue to improve even after six months of treatment. The patient should discuss with their doctor the need to continue treatment after three to six months of treatment, and then at regular intervals.

When not to use Atywia

Do not use Atywia if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable.

• If you are allergic to ethinylestradiol or dienogest or any of the other ingredients of this medicine (listed in point 6).
• If you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs.
• If you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need to have surgery or will be immobilized for a long time (see point 2 "Blood clots").
• If you have had a heart attack or stroke.
• If you have (or have had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms).
• If you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a disease called hyperhomocysteinemia
• If you have (or have had) a type of migraine called "migraine with aura"
• If you have (or have had) severe liver disease (until liver function tests return to normal)
• If you have (or have had) benign or malignant liver tumors
• If you have (or have had) a hormone-dependent tumor (breast or genital cancer)
• If you have unexplained vaginal bleeding
• If you are pregnant or think you may be pregnant.

If any of the above symptoms occur for the first time while taking Atywia, the medicine should be stopped immediately and a doctor consulted. In the meantime, non-hormonal methods of contraception should be used.
Do not use Atywia if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Atywia and other medicines").

Warnings and precautions

Before starting to use Atywia, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?
You should contact your doctor immediately

• if you notice any symptoms that may indicate the occurrence of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see point 2 below "Blood clots (thrombosis)").

To find a description of the serious side effects listed, see "How to recognize blood clots".
If you are taking oral contraceptives in any of the situations listed below, you will need regular medical check-ups.

You should tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Atywia, you should also tell your doctor.

• if you smoke
• if you have diabetes
• if you are overweight
• if you have high blood pressure
• if you have heart valve problems or heart rhythm disorders
• if you have superficial thrombophlebitis (inflammation of the veins under the skin)
• if you have varicose veins
• if there have been cases of blood clots, heart attack, or stroke in close relatives
• if you have migraines
• if you have epilepsy
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis
• if you or a close relative have had breast cancer
• if you have liver or gallbladder disease
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases)
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system)
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure)
• if you have sickle cell anemia (a genetic disease of red blood cells)
• if you need to have surgery or will be immobilized for a long time (see point 2 "Blood clots")
• if you have recently given birth, as you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Atywia after giving birth
• if you have a disease that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea)
• if you have or have had skin discoloration (yellow-brown pigment spots, so-called chloasma); in this case, you should avoid excessive exposure to the sun or ultraviolet radiation
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and difficulty swallowing or skin rash with possible breathing problems, you should contact your doctor immediately. Estrogen-containing medicines may cause or worsen symptoms of hereditary or acquired angioedema.

If any of the above symptoms occur for the first time, recur, or worsen while taking Atywia, you should contact your doctor.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Atywia, is associated with an increased risk of blood clots, compared to not using the therapy. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

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

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

Remember that the overall risk of harmful blood clots caused by Atywia is small.

HOW TO RECOGNIZE BLOOD CLOTS

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

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

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

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

The risk of forming blood clots in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not using combined hormonal contraceptives.
If you stop using Atywia, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.

• During the year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During the year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During the year, about 8-11 out of 10,000 women who use combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Atywia, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots" below).

Factors that increase the risk of blood clots in veins

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

• if you are severely overweight (body mass index (BMI) over 30 kg/m²)
• if someone in your immediate family has had blood clots in their legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have a hereditary blood clotting disorder
• if you need to have surgery or will be immobilized for a long time (see point 2 "Blood clots"). It may be necessary to stop using Atywia for a few weeks before surgery or immobilization. If you need to stop using Atywia, you should ask your doctor when you can resume using the medicine
• with age (especially over 35 years old)
• if you have recently given birth

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these factors apply to you, even if you are not sure. Your doctor may decide to stop using Atywia.
You should tell your doctor if any of the above conditions change while using Atywia, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

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

Factors that increase the risk of blood clots in arteries

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

• with age (over 35 years old)
• if you smoke. While using a hormonal contraceptive like Atywia, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend a different type of contraception

if you are overweight

• if you have high blood pressure
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke
• if you or someone in your immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides)
• if you have migraines, especially migraines with aura
• if you have heart disease (valve damage, heart rhythm disorder called atrial fibrillation)
• if you have diabetes

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher. You should tell your doctor if any of the above conditions change while using Atywia, e.g., if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

In case of symptoms suggesting a blood clot, you should stop taking the tablets and consult your doctor immediately (see also "When to contact your doctor").

Oral contraception and cancer

Women who use oral contraceptives have a slightly higher incidence of breast cancer than women of the same age who do not use them. It is not known whether this difference is due solely to the use of hormonal contraceptives. The reason may also be that women who use hormonal contraceptives are more frequently examined and breast cancer is detected earlier in them. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years of stopping oral contraceptives.
Rarely, cases of benign or, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, you should inform your doctor as soon as possible.
Cancer can be life-threatening or cause death.
There are reports of a higher incidence of cervical cancer in women who use oral contraceptives for a long time. However, this relationship may not be related to the use of the tablets but to sexual behavior or other factors.

Psychiatric disorders

Some women who use hormonal contraceptives, including Atywia, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible to receive further medical advice.

Atywia and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, even those that are available without a prescription.
Some medicines may affect the level of this medicine in your blood, reduce the effectiveness of contraception, and cause unexpected bleeding.
These include

• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis (e.g., rifampicin)
• HIV and HCV infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• fungal infections (griseofulvin, azole antifungals, such as itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics, such as clarithromycin, erythromycin)
• certain heart conditions, high blood pressure (calcium channel blockers, such as verapamil, diltiazem)
• arthritis, degenerative joint disease (etoricoxib)
• St. John's wort (Hypericum perforatum)
• grapefruit juice

Oral contraceptives may affect the metabolism of other medicines, such as lamotrigine, cyclosporine, melatonin, midazolam, theophylline, and tizanidine.
Do not use Atywia if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results in the blood (increased liver enzyme activity). Before starting these medicines, your doctor will prescribe a different type of contraception.
You can start taking Atywia again about 2 weeks after finishing the above-mentioned treatment. See point "When not to use Atywia".
When to contact your doctor
You should contact your doctor immediately if:

• you notice any worrying changes in your health, especially any of the symptoms listed in this leaflet (see also "Warnings and precautions" and "How to use Atywia")
• there have been cases of blood clots, heart attack, or stroke in close relatives
• a breast lump has been detected
• you plan to use other medicines (see also "Atywia and other medicines")
• you will be immobilized or plan to have surgery (you should inform your doctor at least 4 weeks in advance)
• you experience heavy vaginal bleeding
• you missed tablets in the first week of the cycle (every first week of the month) and had sex during the previous 7 days
• you experience severe diarrhea
• you do not experience withdrawal bleeding within 2 months or suspect pregnancy (you should not start the next pack without consulting your doctor)

You should stop taking Atywia and consult your doctor immediately if you notice symptoms suggesting a blood clot, heart attack, or stroke:

• cough without an obvious cause
• severe chest pain that may radiate to the left arm
• shortness of breath
• headache with unprecedented severity or migraine attack
• partial or complete loss of vision or double vision
• slurred speech or loss of speech ability
• sudden disturbances of sensory organs (hearing, smell, or sensation)
• dizziness or fainting
• numbness or paralysis of part of the body
• severe abdominal pain
• severe leg pain or swelling

The situations and symptoms listed above are described in more detail in other parts of this leaflet.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Do not take Atywia if you are pregnant or suspect you may be pregnant. If you suspect pregnancy, you should consult your doctor as soon as possible.
Atywia is not recommended for use during breastfeeding.

Driving and using machines

No effects of Atywia on the ability to drive and use machines have been observed.

Atywia contains lactose monohydrate

Atywia contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to use Atywia

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The leaflet describes many situations in which you should stop using Atywia or in which the effectiveness of the medicine may be reduced. It also lists circumstances in which you should not have sex or use additional contraceptive methods, such as condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used because Atywia affects temperature changes and cervical mucus properties characteristic of the menstrual cycle.

Atywia, like other oral contraceptives, does not protect against HIV (AIDS) or sexually transmitted diseases.

How to use Atywia

• When and how to take the tablets?

The blister pack contains 21 coated tablets. On the packaging, each tablet is marked with the day of the week it should be taken. The tablets should be taken in the order indicated on the packaging, every day, at about the same time, with a small amount of liquid if necessary. For 21 consecutive days, take 1 tablet per day.
Each subsequent pack should be started after a 7-day break, during which no tablets are taken and withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last tablet and may still occur after starting the next pack. This means that you should always start each subsequent pack on the same day of the week, and bleeding will occur at about the same time every month.

• Using Atywia for the first time

If you did not use oral contraceptives in the last month
Take the tablets on the 1st day of your natural menstrual cycle (i.e., the 1st day of menstrual bleeding). You can also start taking the tablets between the 2nd and 5th day of the menstrual cycle; in this case, during the first cycle, additional mechanical contraception is recommended for the first 7 days of tablet use.
If you used another combined oral contraceptive before
It is recommended to start using Atywia on the 1st day after taking the last active tablet of the previous combined oral contraceptive, but no later than the 1st day of the usual break in taking active tablets or placebo from the previous combined oral contraceptive.
If you used a progestogen-only tablet (minipill) before
You can stop taking the minipill on any day and start taking Atywia at the same time. If you have sex during the first 7 days of taking Atywia, you should also use other contraceptive methods (mechanical methods).
If you used injectable, implant, or intrauterine contraception before

• Start taking Atywia on the day you would have had your next injection or on the day the implant or intrauterine system is removed. If you have sex during the first 7 days of taking the tablets, you should also use other contraceptive methods (mechanical methods).

After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy

You can start taking Atywia immediately. In this case, you do not need to use additional contraceptive methods.

• After childbirth or miscarriage in the second trimester of pregnancy

For breastfeeding women, see point 2 "Breastfeeding".
Your doctor should inform you that you should start taking the tablets 21-28 days after childbirth or miscarriage in the second trimester of pregnancy. If you start using the tablets later, your doctor should inform you about the need to use additional mechanical contraception for the first 7 days of tablet use. If you have had sex before starting to use the combined oral contraceptive, you should make sure you are not pregnant or wait for your first menstrual period.

Using more than the recommended dose of Atywia

Nausea, vomiting, or vaginal bleeding may occur. This type of bleeding may occur even in girls who have not yet started menstruating but have taken the medicine by mistake. There are no reports of serious side effects after taking multiple tablets of Atywia at the same time. If you have taken more of the medicine than recommended or someone else has taken it, you should inform your doctor.

Stopping Atywia

You can stop taking the medicine at any time. Your doctor will recommend other contraceptive methods. If you stop taking the medicine because you want to become pregnant, you should wait until you have had a natural menstrual period. This will help determine the expected date of delivery.

Missing a dose of Atywia

If it has been less than 12 hourssince you missed a tablet, the contraceptive effectiveness of Atywia is maintained. You should take the missed tablet as soon as possible and take the next one at the usual time.
If it has been more than 12 hourssince you missed a tablet, the contraceptive effectiveness of Atywia may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness. The risk of becoming pregnant is especially high if you miss tablets at the beginning or end of the pack. In this case, you should follow the rules listed below (see also the scheme below).

Missing more than 1 tablet from the pack

You should consult your doctor.

Missing 1 tablet in the first week of taking Atywia from the current pack

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. For the next 7 days, you should use additional contraceptive methods (mechanical methods).
If you had sex during the week before missing the tablet, it is possible that you may become pregnant. You should contact your doctor immediately. You should also read "Scheme of action in case of a missed tablet".

Missing 1 tablet in the second week of taking Atywia from the current pack

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. The contraceptive effectiveness of Atywia is maintained, and you do not need to use additional contraceptive methods.
However, if you made mistakes in dosing earlier or missed more than 1 tablet, you should use additional (mechanical) contraceptive methods for 7 days.

Missing 1 tablet in the third week of taking Atywia from the current pack

You can choose one of the following options without the need for additional contraceptive methods, provided that you have been taking the tablets correctly for the 7 days preceding the missed dose. If not, you should follow the first of the two options listed below and use an additional contraceptive method for 7 days.

1.

Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, i.e., without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but you may experience spotting or bleeding during tablet use.

2.

Alternatively, you can stop taking the tablets from the current pack, take a break (not more than 7 days, counting from the day you missed the tablet), and then continue taking the tablets from the next pack.
If you miss a tablet and do not experience withdrawal bleeding during the first break, you may be pregnant. Before starting the next pack of Atywia, you should consult your doctor.

Scheme of action in case of a missed tablet

4. Possible side effects

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

Severe side effects

Severe side effects related to the use of Atywia and their accompanying symptoms have been described in the following sections of the leaflet: "Oral contraception and thrombosis" and "Oral contraception and tumors". These sections should be read to obtain additional information and, if necessary, consult a doctor immediately.

Other possible side effects

The following symptoms have been reported by patients taking Atywia, although they may not have been caused by the drug.

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

Uncommon (may occur less frequently than in 1 in 100 people):

• Vaginitis and (or) vulvovaginitis (inflammatory conditions of the genital organs),
• Vaginal candidiasis (yeast infection) or other fungal infections of the vagina,
• Increased appetite,
• Decreased mood,
• Dizziness,
• Migraine,
• High or low blood pressure,
• Abdominal pain, including upper and lower abdominal pain, discomfort, and (or) bloating,
• Nausea, vomiting, or diarrhea,
• Acne,
• Hair loss (alopecia),
• Rash (including patchy rash), itching (sometimes all over the body),
• Changes in bleeding patterns, such as heavy, scanty, or infrequent menstrual bleeding, and complete absence of bleeding,
• Intermenstrual bleeding, metrorrhagia (irregular bleeding between periods),
• Breast enlargement, including breast congestion and swelling,
• Breast tenderness,
• Painful menstruation (dysmenorrhea),
• Vaginal discharge,
• Ovarian cysts,
• Pelvic pain,
• Fatigue, including asthenia (weakness) and malaise,
• Weight changes (including weight gain, weight loss, and weight fluctuations).

Rare (may occur less frequently than in 1 in 1000 people):

• Oophoritis and (or) salpingitis,
• Urinary tract infections,
• Cystitis (urinary bladder infection),
• Mastitis (breast infection),
• Cervicitis (inflammation of the cervix),
• Fungal infections,
• Oral thrush,
• Flu,
• Bronchitis,
• Sinusitis,
• Upper respiratory tract infections,
• Viral infections,
• Uterine fibroids,
• Breast fibroadenoma,
• Anemia,
• Hypersensitivity (allergic reaction),
• Masculinization in women (development of male secondary sex characteristics),
• Anorexia (severe loss of appetite),
• Depression,
• Psychiatric disorders,
• Insomnia,
• Sleep disorders,
• Aggression,
• Stroke (reduced or interrupted blood flow to part of the brain),
• Cerebral circulatory disorders (disorders of blood flow to part of the brain),
• Dystonia (persistent muscle contractions causing, e.g., twisting or abnormal posturing),
• Dry or irritated eyes,
• Oscillopsia (subjective sensation of visual blur) or other visual disturbances,
• Sudden hearing loss,
• Tinnitus,
• Dizziness,
• Hearing disorders,
• Cardiovascular disorders (disorders of blood flow to the heart),
• Tachycardia (rapid heart rate),
• Venous and arterial thromboembolic events*
• Pulmonary embolism (blood clot moving to the lungs),
• Phlebitis (inflammation of a vein, including blood clots),
• Increased diastolic blood pressure (lowest level to which blood pressure drops between heartbeats),
• Orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position),
• Hot flashes,
• Varicose veins,
• Vein disorders or vein pain,
• Asthma,
• Hyperventilation,
• Gastritis,
• Enteritis,
• Indigestion,
• Skin reactions,
• Skin diseases, including allergic dermatitis, neurodermatitis, and (or) atopic dermatitis, eczema, psoriasis,
• Excessive sweating,
• Chloasma (skin discoloration on the face),
• Pigmentation changes and (or) discoloration,
• Seborrhea,
• Dandruff,
• Excessive hair growth,
• Skin disorders, skin reactions, "orange peel" skin appearance,
• Spider angioma,
• Back pain,
• Musculoskeletal disorders,
• Muscle pain,
• Pain in arms and legs,
• Cervical dysplasia (abnormal cell growth on the surface of the cervix),
• Pain or cysts on the adnexa (ovaries and fallopian tubes),
• Breast cysts,
• Fibrocystic breast disease,
• Painful intercourse,
• Milk secretion,
• Menstrual disorders,
• Chest pain,
• Swelling of the feet and hands,
• Flu-like illnesses,
• Inflammation,
• Fever,
• Irritability,
• Hypercholesterolemia,
• Increased triglyceride levels in the blood,
• Discovery of an accessory breast.

* Estimated frequency, from epidemiological studies, including a group of combined oral contraceptives. The term "Venous and arterial thromboembolic events" includes: any obstruction and blood clot in the deep veins of the limbs, blood clots moving through the bloodstream (e.g., to the lungs, called pulmonary embolism or pulmonary infarction), heart attack caused by blood clots, stroke caused by obstruction of blood vessels to or in the brain.
Frequency not known (cannot be estimated from available data):

• Mood changes,
• Decreased or increased libido (sex drive),
• Intolerance to contact lenses,
• Skin changes (hives, erythema multiforme, Stevens-Johnson syndrome),
• Breast secretion,
• Fluid retention.

The likelihood of blood clots may be higher if the patient has other risk factors (see section 2 "For more information on risk factors for blood clots and symptoms of blood clots").
A doctor should be contacted immediately if the patient experiences symptoms of angioedema, such as facial swelling, tongue and (or) throat swelling, and (or) difficulty swallowing or skin rash with possible breathing problems (see also "Warnings and precautions").
Description of selected side effects
Side effects with low frequency or delayed onset, which are considered related to the group of combined oral contraceptives, are listed below (see also "When not to use Atywia" and "Warnings and precautions"):
Tumors

• The number of breast cancer cases in women using combined oral contraceptives is slightly increased. Since breast cancer is rare in women under 40 years of age, the number of diagnoses is small compared to the overall risk of breast cancer. The causal relationship between breast cancer and combined oral contraceptives is unknown.
• Liver tumors (benign and malignant).

Other

• Women with hypertriglyceridemia (increased blood fat levels, increasing the risk of pancreatitis when using combined oral contraceptives)
• Hypertension
• Occurrence or worsening of symptoms, whose relationship to the use of COCs is not resolved: jaundice and (or) itching associated with cholestasis (blocked bile flow); cholelithiasis; metabolic disorders, such as porphyria; systemic lupus erythematosus (chronic autoimmune disease); hemolytic uremic syndrome (blood clotting disorder); neurological disorders called Sydenham's chorea; herpes gestationis (a type of skin disease that occurs during pregnancy); otosclerosis associated with hearing loss.
• Liver function disorders
• Changes in glucose tolerance or effects on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

Interactions
Intermenstrual bleeding and (or) reduced contraceptive efficacy may be caused by the effect of other medications on oral contraceptives (e.g., St. John's wort (Hypericum perforatum) or medications for epilepsy, tuberculosis, HIV, and other infections). See section "Atywia and other medications".

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 492 13 01, fax: +48 22 492 13 09; Website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medication.

5. How to store Atywia

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging and blister.
The expiration date refers to the last day of the specified month.
Translation of some information on the immediate packaging:
Ch.-D. und verw. bis: see embossing – batch number and expiration date: see embossing.
Do not store above 30°C. Store blisters in the outer packaging to protect from light.
Medications should not be disposed of in wastewater or household waste containers. A pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Atywia contains

• The active substances of Atywia are ethinylestradiol and dienogest
• Other ingredients of Atywia are: Tablet core: lactose monohydrate, magnesium stearate, corn starch, povidone K 30. Tablet coating: hypromellose, macrogol 400, titanium dioxide (E 171).

1 blister contains 21 film-coated tablets.
1 film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.

What Atywia looks like and what the package contains

White, round film-coated tablets.
Atywia is available in cardboard packages: 21, 63, or 126 film-coated tablets.
A cardboard sachet is attached to the packaging, in which the blister should be placed.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Exeltis Germany GmbH
Adalperostrasse 84
85737 Ismaning
Germany

Manufacturer:

Laboratorios León Farma SA
La Vallina s/n, Pol. Ind. Navatejera
Navatejera-24008 León
Spain

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
02-234 Warsaw
Marketing authorization number in Germany, the country of export: 87088.00.00
Parallel import authorization number: 248/24

Date of leaflet approval: 18.06.2024

[Information about the trademark]