Ativia

Leaflet accompanying the packaging: patient information

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

Atywia(Denille)

0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest
Atywia and Denille are different trade names for the same drug.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• 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 drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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. Package contents 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). During the use of Atywia in accordance with 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 drug (listed in section 6).
• If the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs.
• If the patient knows they have 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 had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (reversible stroke 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 had in the past) a type of migraine called "migraine with aura"
• If the patient has (or has had in the past) severe liver disease (until liver function test results return to normal)
• If the patient has (or has had in the past) benign or malignant liver tumors
• If the patient has (or has had in the past) a hormone-dependent tumor (breast or genital cancer)
• If the patient has bleeding from the genital tract 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 drug 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 drugs containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir/pibrentaswir (see also "Atywia and other drugs").

Warnings and precautions

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

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

To find a description of the serious side effects listed, see "How to recognize blood clots".
If one is taking oral contraceptives in any of the following situations, regular medical check-ups are 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 vein thrombosis
• 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 found to have high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis
• if 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 natural defense system)
• if they have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure)
• if they have sickle cell anemia (a hereditary disease of 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, in which case they are at increased risk of blood clots. One should consult their doctor for information on how soon they can start taking Atywia after giving birth
• if they have a disease that occurred for the first time or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea)
• if they have or have had skin discoloration (yellow-brown pigment spots, so-called chloasma); in this case, one should avoid excessive exposure to sunlight or ultraviolet radiation
• if they have hepatitis C and are taking drugs containing

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

• if they experience symptoms of angioedema such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or skin rash with possible breathing problems, they should contact their doctor immediately. Drugs 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 when no therapy is used. 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 thrombotic events")
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thrombotic events").

There may not always be a full recovery after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

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

HOW TO RECOGNIZE BLOOD CLOTS

One should contact their doctor immediately if they 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 use of combined hormonal contraceptives.
• If blood clots form in the veins of 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 the 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 drug) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to when combined hormonal contraceptives are not used.
If the patient stops taking Atywia, the risk of blood clots returns to a normal level 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 in 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During the year, about 5-7 in 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During the year, about 8-11 in 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 in veins" 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 the patient is significantly overweight (body mass index (BMI) over 30 kg/m)
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have hereditary blood clotting disorders
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS"). It may be necessary to stop taking Atywia for a few weeks before surgery or immobilization. If the patient needs to stop taking Atywia, they should ask their doctor when they can resume taking the drug
• with age (especially over 35 years old)
• if the patient has recently given birth

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (over 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 one is not sure. The doctor may decide to stop Atywia.
One should tell the doctor if any of the above conditions change while taking Atywia, e.g., if someone in the patient's immediate family is diagnosed with a blood clot without a known cause or if the patient gains 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 have 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 heart attack or stroke associated with Atywia is very small, but it may increase:

• with age (over about 35 years old)
• if the patient smokes. While taking 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 using a different type of contraception
• if the patient is overweight
• if the patient has high blood pressure
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). 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 immediate family has been found to have 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 particularly severe, the risk of blood clots may be even higher.
One should tell the doctor if any of the above conditions change while taking Atywia, e.g., if the patient starts smoking, someone in the patient's immediate family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

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

Oral contraception and cancer

Women who take oral contraceptives have a slightly higher incidence of breast cancer than women of the same age who do not take 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 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 after stopping oral contraceptives.
Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women taking combined oral contraceptives, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, one should inform their doctor as soon as possible.
Cancer can be life-threatening or fatal.

Mental disorders

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

Atywia and other drugs

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

• drugs 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 antifungal drugs, such as itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics, such as clarithromycin, erythromycin)
• certain heart diseases, 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 drugs, such as lamotrigine, cyclosporine, melatonin, midazolam, theophylline, and tizanidine.
Atywia should not be used if the patient has hepatitis C and is taking antiviral drugs containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir/pibrentaswir, as this may cause elevated liver function test results (elevated liver enzyme ALT). The doctor will recommend a different type of contraception before starting these drugs. Atywia can be resumed about 2 weeks after finishing the treatment. See "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 has been found
• they plan to take other drugs (see also "Atywia and other drugs")
• they plan to have surgery or be immobilized (they should inform their doctor at least 4 weeks in advance)
• they experience heavy vaginal bleeding
• they miss tablets in the first week of taking Atywia 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 (they should not start the next pack without consulting their doctor)

One should stop taking Atywia and contact their doctor immediately if they 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 of unprecedented severity or 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 paralysis of part of the body
• severe stomach 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
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 and use machines have been found.

Atywia contains lactose, glucose, and soy lecithin

Atywia contains lactose and glucose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the drug.
Atywia contains soy lecithin. It should not be used in case of known hypersensitivity to peanuts or soy.

3. How to use Atywia

This drug should always be used in accordance with 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 the effectiveness of the drug may be reduced. It also lists circumstances in which one should not have sex or should use additional contraceptive methods, e.g., condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used because Atywia affects temperature changes and properties of cervical mucus 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 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 small amount of liquid if necessary.
For 21 consecutive days, one tablet should be taken 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 each subsequent pack should always be started 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 oral contraceptives have not been used in the last month
Taking the tablets should be started on the 1st day of the natural menstrual cycle (i.e., on the 1st day of menstrual bleeding). Taking 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 is recommended for the first 7 days of taking the tablets.
If another combined oral contraceptive has been used before
It is recommended to start taking Atywia on the 1st day after taking the last tablet containing active substances of the previous combined oral contraceptive, but no later than on the 1st day of the usual break in taking tablets containing active substances or placebo of the previous combined oral contraceptive.
If a progestogen-only pill (minipill) has been used before
One can stop taking the minipill on any day and start taking Atywia at the same time. If sex is had during the first 7 days of taking Atywia, additional contraceptive methods (mechanical methods) should be used.
If an injection, implant, or intrauterine system has been used before

• After an injection

Taking 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 taking the tablets, additional contraceptive methods (mechanical methods) should be used.
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy

Taking Atywia can be started immediately. In this case, additional contraceptive methods are not necessary.

• After childbirth or miscarriage in the second trimester of pregnancy

For breastfeeding women, see section 2 "Pregnancy and breastfeeding".
The doctor should inform that taking the tablets should be started 21-28 days after childbirth or miscarriage in the second trimester of pregnancy. If the tablets are started later, the doctor should inform about the need to use additional mechanical contraception for the first 7 days of taking the tablets. If sex has occurred before starting the combined oral contraceptive, the doctor should confirm that the patient is not pregnant or wait for the first menstrual period.

Taking a higher dose of Atywia than recommended

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 drug by mistake.
There have been no reports of serious side effects after taking multiple Atywia tablets at the same time. If a higher dose of Atywia has been taken than recommended or someone else has taken it, one should inform their doctor.

Stopping Atywia

The drug can be stopped at any time. The doctor will recommend other contraceptive methods. If one stops taking 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 birth.

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 one 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 consecutive tablets 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 1 tablet from the pack

One should consult their doctor.

Missing 1 tablet in the first week of taking 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 take the next ones at the usual time. For the next 7 days, additional mechanical contraceptive methods should be used.
If sex was had during the week preceding the missed tablet, it is possible that one has become pregnant. One should contact their doctor immediately. One should also see "Scheme of action in case of a missed tablet".

Missing 1 tablet in the second week of taking 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 take the next ones at the usual time. The contraceptive effectiveness of Atywia is maintained, and there is no need to use additional contraceptive methods.
However, if there were errors in dosing earlier or if more than 1 tablet was missed, one should use an additional (mechanical) contraceptive method for 7 days.

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

One can choose one of the following options, without the need to use additional contraceptive methods, provided that the dosing has been correct 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 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 during the tablet-taking days, spotting or bleeding may occur.
• 2. One can also not take the remaining 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 forgets to take the tablets and does not have the expected withdrawal bleeding during the first break, it is possible that one is pregnant. Before starting the next pack of Atywia, one should contact their doctor.

Scheme of action in case of a missed tablet

Missed more than
1 tablet from the current
pack
Consult a doctor
Had sex in the week preceding the missed tablet
Week 1.
Did not have sex

• take the missed tablet
• use an additional contraceptive method for 7 days
• finish taking the tablets from the pack

Missed only 1
tablet (delay of more
than 12 hours, but less
than 24 hours)

• take the missed tablet
• finish taking the tablets from the pack
• take the missed tablet
• finish the pack
• do not take a 7-day break
• continue taking the tablets from the next pack

or
Week 2.

• stop taking the remaining tablets from the pack
• take a break (not more than 7 days, counting from the day the tablet was missed)
• 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 you experience any side effects, especially serious or persistent ones, or changes in your health that you think are related to the use of Atywia, you should consult a doctor. All women using combined hormonal contraceptives are at an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the 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 associated with 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". You should read these sections 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.

• 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 patchy rash), itching (sometimes of the whole body),
• changes in bleeding patterns, such as menorrhagia, metrorrhagia, oligomenorrhea, and amenorrhea,
• intermenstrual bleeding, metrorrhagia (irregular bleeding between periods),
• breast enlargement, including breast engorgement and swelling,
• breast tenderness,
• dysmenorrhea (painful menstruation),
• vaginal discharge,
• ovarian cysts,
• pelvic pain,
• fatigue, including asthenia (weakness) and malaise,
• weight changes (including weight gain, weight loss, and fluctuations in weight).

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

• ovarian and fallopian tube inflammation,
• urinary tract infections,
• cystitis (urinary bladder inflammation),
• mastitis (breast inflammation),
• cervicitis (cervical inflammation),
• 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),
• cerebrovascular disorders (disorders of blood flow to the brain),
• dystonia (persistent muscle contractions causing, e.g., twisting or abnormal posturing),
• dry or irritated eyes,
• oscillopsia (subjective sensation of visual disturbance) or other vision disorders,
• sudden hearing loss,
• tinnitus,
• vertigo,
• 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 (stomach inflammation),
• enteritis (intestinal inflammation),
• indigestion,
• skin reactions,
• skin diseases, including allergic dermatitis, neurodermatitis, and (or) atopic dermatitis,
• psoriasis,
• excessive sweating,
• chloasma (skin discoloration on the face),
• changes in pigmentation and (or) discoloration,
• seborrhea,
• dandruff,
• excessive hair growth,
• skin disorders, skin reactions, "orange peel" skin appearance,
• hemangioma (a type of non-cancerous growth),
• 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 (ovarian and fallopian tube disorders),
• breast cysts,
• fibrocystic breast disease,
• painful intercourse,
• galactorrhea (milk secretion),
• menstrual disorders,
• chest pain,
• edema of the arms and legs,
• 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 clot in the deep peripheral veins, clots moving through the bloodstream (e.g., to the lungs, called pulmonary embolism or pulmonary infarction), myocardial infarction caused by blood clots, stroke caused by obstruction of blood vessels to or in the brain. Frequency not known (cannot be estimated from the available data):

• mood changes,
• decreased or increased libido (sexual desire),
• intolerance to contact lenses,
• skin changes (hives, erythema multiforme, Stevens-Johnson syndrome),
• breast discharge,
• fluid retention.

The likelihood of developing blood clots may be higher if you have other risk factors (see section 2 "How to recognize the occurrence of blood clots"). You should immediately contact your doctor if you experience 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 of symptoms that are considered related to the group of combined oral contraceptives have been 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 levels of fats 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 established: jaundice and (or) itching associated with cholestasis (blocked bile flow); cholelithiasis; 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

InteractionsIntermenstrual bleeding and (or) reduced contraceptive effectiveness may be caused by the effect of other medicines 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 medicines".

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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. By reporting side effects, you can help provide more information on the safety of the medicine.

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 month. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. 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, talc. Tablet coating Opaglos 2 clear: sodium carboxymethylcellulose, glucose monohydrate, maltodextrin, sodium citrate, soybean lecithin.

What Atywia looks like and what the package contains

Atywia is available in packages: 1x21, 3x21, 6x21 film-coated tablets. 1 blister pack contains 21 film-coated tablets. The package includes a cardboard sachet in which the blister pack should be placed.