Ativia

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Atywia(Velafee)

0.03 mg + 2 mg, film-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.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "BLOOD CLOTS").

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, one should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 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 packaging 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, one should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "BLOOD CLOTS").
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

Atywia should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• If the patient is allergic to ethinylestradiol or dienogest or any of the other ingredients of this medicine (listed in section 6).
• If the patient currently has (or has ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs.
• If the patient knows they have blood clotting disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS").
• If the patient has had a heart attack or stroke.
• If the patient has (or has ever had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischaemic attack (temporary stroke-like symptoms).
• If the patient has 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 the patient has (or has ever had) a type of migraine called "migraine with aura"
• If the patient has (or has ever had) severe liver disease (until liver function tests return to normal)
• If the patient has (or has ever had) benign or malignant liver tumors
• If the patient has (or has ever had) a hormone-dependent tumor (breast or genital cancer)
• If the patient has bleeding from the genitals of unknown cause
• If the patient is pregnant or suspects they may be pregnant.

If any of these symptoms occur for the first time while taking Atywia, the medicine should be stopped immediately and a doctor consulted. During this time, non-hormonal methods of contraception should be used.
Atywia should not be used if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir/pibrentasvir (see also "Atywia and other medicines").

Warnings and precautions

Before starting to use Atywia, one should discuss it with their doctor or pharmacist.
When should one contact their doctor?
One should see their doctor immediately

• if the patient notices possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), a blood clot in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "BLOOD CLOTS").

To find a description of the serious side effects listed, see "How to recognize a blood clot".
If one is taking oral contraceptives in any of the following situations, close medical supervision is necessary.

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

If these symptoms occur or worsen while taking Atywia, one should also tell their doctor.

• if they smoke
• if they have diabetes
• if they are overweight
• if they have high blood pressure
• if they have heart valve problems or heart rhythm disorders
• if they have superficial thrombophlebitis (inflammation of the veins just under the skin)
• if they have varicose veins
• if there have been cases of blood clots, heart attack, or stroke in close relatives
• if they have migraines
• if they have epilepsy
• if they 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 they or a close relative have had breast cancer
• if they have liver or gallbladder disease
• if they have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases)
• if they have systemic lupus erythematosus (a disease that affects the body's natural defense system)
• if they have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure)
• if they have sickle-cell anemia (an inherited disease of the red blood cells)
• if they need to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS")
• if they have recently given birth, as they are at increased risk of blood clots. One should consult their doctor to find out how soon they can start taking Atywia after giving birth
• if they have a disease that first occurred or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea)
• if they have skin discolorations (yellow-brown pigment spots, so-called chloasma); in this case, one should avoid excessive exposure to the sun or ultraviolet radiation
• if they have hepatitis C and are taking medicines containing

ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir/pibrentasvir (see section 2 "Atywia and other medicines")

• if they experience symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing, one should contact their doctor immediately. Medicines containing estrogens 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, one should contact their 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 them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

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

Not everyone who has a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

It is essential to remember that the overall risk of having a harmful blood clot due to Atywia is small.

HOW TO RECOGNIZE A BLOOD CLOT

One should see their doctor immediately if they notice any of the following symptoms.

BLOOD CLOTS IN VEINS

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur, especially 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 deep vein thrombosis.
• If a blood clot moves from the leg to 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 a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming 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 than when not using combined hormonal contraceptives.
If the patient stops using Atywia, the risk of blood clots returns to normal within a few weeks.

What factors 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 the patient is severely overweight (body mass index (BMI) over 30 kg/m^2)
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, the patient may have inherited blood clotting disorders
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop using Atywia for a few weeks before surgery or immobilization. If the patient needs to stop using Atywia, they should ask their doctor when they can resume using it
• with increasing age (especially over 35 years)
• if the patient has recently given birth

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop using Atywia.
One should tell the doctor if any of the above conditions change while using Atywia, e.g., if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

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

Factors that increase the risk of blood clots in arteries

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

• with age (over approximately 35 years)
• if the patient smokes. While using a hormonal contraceptive like Atywia, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend a different type of contraception
• if the patient is overweight
• if the patient has high blood pressure
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50). In this case, the patient may also be at increased risk of having a heart attack or stroke
• if the patient or someone in their close family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides)
• if the patient has migraines, especially migraines with aura
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation)
• if the patient has diabetes

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
One should tell the doctor if any of the above conditions change while using Atywia, e.g., if the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if the patient gains weight significantly.

In case of symptoms suggesting a blood clot, one should stop taking Atywia and consult their doctor immediately (see also "When to contact a doctor").

Oral contraception and cancer

Women who use oral contraceptives may have a slightly higher risk of breast cancer than women of the same age who do not use them. It is not known whether this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women who use hormonal contraceptives are more likely to have regular check-ups and breast cancer may be detected earlier.
The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after stopping oral contraceptives.
Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives. If severe abdominal pain occurs, one should inform their doctor as soon as possible.
Malignant tumors can be life-threatening or cause death.
There have been reports of a higher incidence of cervical cancer in women who use oral contraceptives for a long time. However, this association 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 mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, one should consult their doctor as soon as possible for further medical advice.

Atywia and other medicines

One should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, even those that are available without a prescription.
Some medicines may affect the levels of Atywia in the blood, reduce its contraceptive effectiveness, 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 (so-called 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.
Atywia should not be used if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir/pibrentasvir, as this may cause elevated liver function tests (increased levels of the liver enzyme ALT). The doctor will recommend a different type of contraception before starting these medicines. One can resume using Atywia about 2 weeks after finishing the treatment. See section "When not to use Atywia".

When to contact a doctor

One should contact their doctor immediately if:

• they notice any worrying changes in their 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 is found
• they plan to use other medicines (see also "Atywia and other medicines")
• they plan to have surgery or will be immobilized (one should inform their doctor at least 4 weeks in advance)
• they experience heavy vaginal bleeding
• they miss tablets in the first week of the cycle (every first week of the month) and have had sex in the previous 7 days
• they experience severe diarrhea
• they do not have withdrawal bleeding within 2 months or suspect they may be pregnant (one should not start the next pack without consulting their doctor)

One should stop taking Atywia and contact their doctor immediately if they notice any symptoms suggesting a blood clot, heart attack, or stroke:

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

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Atywia should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected, one should consult their doctor as soon as possible.
Atywia is not recommended during breastfeeding.

Driving and using machines

No effects of Atywia on the ability to drive or use machines have been found.

Atywia contains lactose monohydrate

Atywia contains lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use Atywia

This medicine should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, one should consult their doctor or pharmacist.
The leaflet describes many situations in which one should stop taking Atywia or in which its effectiveness may be reduced. It also lists situations in which one should not have sex or should use additional contraceptive methods, such as condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used, as 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 other sexually transmitted diseases.

How to use Atywia

• When and how to take the tablets?

The blister pack contains 21 film-coated tablets.
On the packaging, each tablet is marked with a symbol of the day of the week on which it should be taken (see "Translation of day-of-the-week symbols on the packaging" at the end of the leaflet). The tablets should be taken in the order indicated on the packaging, every day, at about the same time, with a little water if necessary.
For 21 consecutive days, one tablet should be taken daily.
Each subsequent pack should be started after a 7-day break, during which no tablets are taken and withdrawal bleeding usually occurs. Bleeding starts usually 2-3 days after taking the last tablet and may continue after starting the next pack. This means that one 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 the patient has not used oral contraceptives in the last month
The tablets should be started on the first day of the natural menstrual cycle (i.e., the first day of menstrual bleeding). The tablets can also be started between the 2nd and 5th day of the menstrual cycle; in this case, during the first cycle, additional mechanical contraception should be used for the first 7 days of tablet use.
If the patient has used another combined oral contraceptive
It is recommended to start using Atywia on the first day after taking the last tablet containing active substances from the previous combined oral contraceptive, but no later than the first day of the usual break in taking tablets containing active substances or placebo from the previous combined oral contraceptive.
If the patient has used a progestogen-only tablet (mini-pill)
The mini-pill can be stopped at any time and replaced with Atywia at the same time. If sex is had during the first 7 days of using Atywia, additional contraceptive methods (mechanical methods) should be used.
If the patient has used injections, an implant, or an intrauterine system
Atywia should be started on the day the next injection was scheduled or on the day the implant or intrauterine system is removed. If sex is had during the first 7 days of tablet use, additional contraceptive methods (mechanical methods) should be used.
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy

Atywia can be started immediately. In this case, no additional contraceptive methods are necessary.

• After childbirth or miscarriage in the second trimester of pregnancy

For breastfeeding women, see section 2 "Pregnancy and breastfeeding".
The doctor should inform the patient that they should start taking the tablets 21-28 days after childbirth or miscarriage in the second trimester of pregnancy. If the patient starts using the tablets later, the doctor should inform them about the need to use additional mechanical contraception for the first 7 days of tablet use. If the patient has had sex before starting the combined oral contraceptive, the doctor should ensure that the patient is not pregnant or wait for the 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 have been no reports of serious side effects after taking multiple Atywia tablets at the same time. If more than the recommended dose of Atywia has been taken, one should inform their doctor.

Stopping Atywia

The medicine can be stopped at any time. The doctor will recommend other contraceptive methods. If one stops using Atywia because they want to become pregnant, they should wait until they 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 the missed tablet, the contraceptive effectiveness of Atywia is maintained. One should take the missed tablet as soon as possible and take the next tablet at the usual time.
If it has been more than 12 hourssince the missed tablet, the contraceptive effectiveness of Atywia may be reduced. The more tablets that are missed, the higher the risk of reduced contraceptive effectiveness. The risk of becoming pregnant is particularly high if tablets are missed at the beginning or end of the pack. In this case, one should follow the rules below (see also the scheme below).

Missing more than one tablet from the pack

One should consult their doctor.

Missing one tablet in the first week of using Atywia from the current pack

One should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the tablets at the usual time. For the next 7 days, additional contraceptive methods (mechanical methods) should be used.
If one has had sex during the week before missing the tablet, it is possible that they may become pregnant. One should consult their doctor as soon as possible. One should also see "Scheme for missing a tablet".

Missing one tablet in the second week of using Atywia from the current pack

One should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the tablets at the usual time. The contraceptive effectiveness of Atywia is maintained, and there is no need to use additional contraceptive methods.
However, if one has made mistakes in taking the tablets before or has missed more than one tablet, one should use an additional (mechanical) contraceptive method for 7 days.

Missing one tablet in the third week of using Atywia from the current pack

One can choose one of the following options without the need for additional contraceptive methods, provided that the correct dosing schedule has been followed for the 7 days preceding the missed dose. If not, one should follow the first of the two options 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 continue taking the tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but during tablet use, spotting or bleeding may occur.
• 2. One can also stop taking the tablets from the current pack, take a break (not more than 7 days, counting from the day the tablet was missed), and then continue taking the tablets from the next pack. If one misses a tablet and does not have withdrawal bleeding during the first break after taking the tablets, it is possible that they are pregnant. Before starting the next pack of Atywia, one should consult their doctor.

Scheme for missing a tablet

Missed more than one tablet from the current pack
Consult a doctor
Had sex during the week before missing the tablet
Tell the doctor
Week 1.
Did not have sex

• take the missed tablet
• use additional contraceptive methods for 7 days
• finish the pack

Missed only one tablet (delay of more than 12 hours, but less than 24 hours)

• take the missed tablet
• finish the pack

Week 2.

• take the missed tablet
• finish the pack

Week 3.

• 1. Take the missed tablet (even if it means taking two tablets at the same time), and continue taking the tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, without a 7-day break.
• 2. Stop taking the tablets from the current pack, take a break (not more than 7 days, counting from the day the tablet was missed), and then continue taking the tablets from the next pack.

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.
All women using combined hormonal contraceptives are at increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thromboembolism). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, see 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: "BLOOD CLOTS" 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

Below are symptoms reported by patients taking Atywia, although they may not have been caused by the drug.
Common (may occur in less than 1 in 10 people):

• headache,
• breast pain, including discomfort and breast tenderness.

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

• vaginitis and (or) vulvovaginitis (inflammatory conditions of the genital organs),
• vaginal candidiasis (thrush) or other fungal infections of the vagina,
• increased appetite,
• depressed 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 rash with spots), itching (sometimes all over the body),
• changes in bleeding patterns, such as heavy, scanty, or infrequent menstrual bleeding, and complete absence of menstrual bleeding,
• intermenstrual bleeding, metrorrhagia (irregular bleeding between periods),
• breast enlargement, including breast congestion and swelling,
• breast swelling,
• 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 in less than 1 in 1000 people):

• ovarian and fallopian tube inflammation,
• urinary tract infections,
• bladder inflammation (cystitis),
• breast inflammation (mastitis),
• 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 image vibration) or other vision 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),
• thrombophlebitis (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,
• venous disorders or vein pain,
• asthma,
• hyperventilation,
• gastritis,
• enteritis,
• indigestion,
• skin reactions,
• skin diseases, including allergic dermatitis, neurodermatitis, and (or) atopic dermatitis,
• hives, psoriasis,
• excessive sweating,
• chloasma (pigmentation on the face),
• skin discoloration and (or) hyperpigmentation,
• seborrhea,
• dandruff,
• excessive hair growth,
• skin disorders, skin reactions, "orange peel" skin appearance,
• hemangioma,
• back pain,
• musculoskeletal disorders,
• muscle pain,
• arm and leg pain,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• adnexal pain or cysts (ovaries and fallopian tubes),
• breast cysts,
• fibrocystic breast disease,
• painful intercourse,
• galactorrhea (milk secretion),
• menstrual disorders,
• chest pain,
• swelling of the arms and legs,
• flu-like illnesses,
• inflammation,
• fever,
• irritability,
• hypercholesterolemia,
• increased triglyceride levels in the blood,
• accessory breast tissue.

* Estimated frequency, from epidemiological studies, including a group of combined oral contraceptives. The term "Venous and arterial thromboembolic events" includes: any blockage 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 blockage 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 discharge,
• fluid retention.

The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 "How to recognize the occurrence 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 of 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 old, 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 fat levels in the blood, 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); gallstones; metabolic disorders, such as porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (a 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) contraceptive failure 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 the leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects will help gather more information on the safety of the medication.

5. How to store Atywia

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Do not store above 30°C. Store the blister in the original packaging to protect from light.
Translation of some information on the immediate packaging:
Ch.-B. und verw. bis: siehe Prägung – Batch number and expiry date: see imprint
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Atywia contains

• The active substances of Atywia are ethinylestradiol and dienogest. One film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
• Other ingredients are: Tablet core: lactose monohydrate, magnesium stearate, corn starch, povidone K 30. Tablet coating: hypromellose, macrogol 400, titanium dioxide (E 171).

What Atywia looks like and what the package contains

Atywia is available in packages: 1x21, 3x21, 6x21 film-coated tablets.
1 blister contains 21 film-coated tablets.
A cardboard sachet is attached to the packaging, in which the blister should be placed.

To obtain more detailed information, please 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 S.A.
La Vallina s/n, Pol. Ind. Navatejera
Navatejera-24008 León
Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
License number in Germany, the country of export:87088.00.00
License number for parallel import:347/21
Translation of day of the week symbols on the packaging:
Mo- Monday
Di- Tuesday
Mi- Wednesday
Do- Thursday
Fr- Friday
Sa- Saturday
So- Sunday.
Date of leaflet approval: 30.06.2022
[Information about the trademark]