Ativia

Leaflet accompanying the packaging: patient information

Atywia, 0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of blood clots in veins and arteries, 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 section 2 "Blood clots")

It is essential 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, a doctor or pharmacist should be consulted.
• 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. They are: dienogest (progestogen) and ethinylestradiol (estrogen). When used according to the recommendations 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 have not responded to appropriate local or oral antibiotic treatment.

2. Important information before using Atywia

General precautions

Before starting to use Atywia, you 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 her 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 conditions listed below. If the patient has any of the conditions listed below, she should inform her 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 veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs.
• If the patient knows she has blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If the patient needs to undergo 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 (transient 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 she may be pregnant

If any of these symptoms occur for the first time while using Atywia, the medicine should be stopped immediately and a doctor should be 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 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, the patient should discuss it with her doctor or pharmacist.
When should the patient contact her doctor?

• if the patient notices possible symptoms of blood clots, which may indicate that she has blood clots in her leg (deep vein thrombosis), blood clots in her lungs (pulmonary embolism), heart attack, or stroke (see section 2 below "Blood clots (thrombosis)".

To find a description of the serious side effects listed, see "How to recognize blood clots".
If the patient is using oral contraceptives in any of the situations listed below, close medical supervision is necessary.

The patient should tell her doctor if she has any of the following conditions.

If these symptoms occur or worsen while using Atywia, the patient should also tell her doctor.

• if she smokes
• if she has diabetes
• if she is overweight
• if she has high blood pressure
• if she has heart valve problems or heart rhythm disorders
• if she has superficial thrombophlebitis (inflammation of the veins under the skin)
• if she has varicose veins
• if there have been cases of blood clots, heart attack, or stroke in her close relatives
• if she has migraines
• if she has epilepsy
• if she has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis
• if she or a close relative has had breast cancer
• if she has liver or gallbladder disease
• if she has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases)
• if she has systemic lupus erythematosus (a disease that affects the body's natural defense system)
• if she has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure)
• if she has sickle cell anemia (a genetic disorder of red blood cells)
• if she needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots")
• if she has recently given birth, as she is at increased risk of blood clots. The patient should consult her doctor about how soon she can start using Atywia after giving birth
• if she has 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 she has or has had skin discoloration (yellow-brown pigment spots, so-called chloasma); she should then avoid excessive exposure to the sun or ultraviolet radiation
• if she experiences symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or skin rash with possible breathing difficulties, she should contact her 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 using Atywia, the patient should contact her 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 thrombosis" or "venous thromboembolic disease")
• in arteries (hereinafter referred to as "arterial thrombosis" 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.

It is essential to remember that the overall risk of harmful blood clots caused by Atywia is small.

HOW TO RECOGNIZE BLOOD CLOTS

The patient should contact her doctor immediately if she notices 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 thrombosis). 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 of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges 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 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 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)
• 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 coagulation disorders
• if the patient needs to undergo 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, she should ask her doctor when she can resume using the medicine.

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.
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 inform the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop using Atywia.
The patient should inform her doctor if any of the above conditions change while using Atywia, e.g., if someone in her close 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?

Similar to blood clots in veins, blood clots in an artery 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 heart attack or stroke associated with Atywia is very small, but it may increase:

• with age (over 35 years old)
• if the patient smokes. When 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 her close family has high levels of fats in the blood (cholesterol or triglycerides)
• if the patient has migraines, especially migraines with aura
• if the patient has heart disease (valve damage, heart rhythm disorder 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.
The patient should inform her doctor if any of the above conditions change while using Atywia, e.g., if she starts smoking, someone in her close family is diagnosed with a blood clot without a known cause, or if she gains significant weight.

In case of symptoms suggesting a blood clot, thrombosis, or stroke, the patient should stop using Atywia and consult her doctor immediately (see also "When to contact a doctor").

Oral contraception and cancer

Women who use oral contraceptives may 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 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 the use of oral contraceptives.
Rare 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, the patient should inform her doctor as soon as possible.
Malignant tumors can be life-threatening or cause death.
There are reports of a higher incidence of cervical cancer in women who have used 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 using hormonal contraceptives, including Atywia, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact her doctor as soon as possible for further medical advice.

Atywia and other medicines

The patient should tell her doctor or pharmacist about all medicines she is currently taking or has recently taken, as well as any medicines she plans to take, even those that are available without a prescription.
Some medicines may affect the level of this medicine in the 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 (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• fungal infections (griseofulvin, azole antifungal medicines, 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 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, the doctor will prescribe a different type of contraception.
The patient can resume using Atywia about 2 weeks after stopping the above-mentioned treatment. See section "When not to use Atywia".
When to contact a doctor

• if the patient notices any worrying changes in her health, especially any of the symptoms listed in this leaflet (see also "Warnings and precautions" and "How to use Atywia")
• if there have been cases of blood clots, heart attack, or stroke in her close relatives
• if a breast lump is detected
• if she plans to use other medicines (see also "Atywia and other medicines")
• if she needs to undergo surgery or plans to be immobilized (she should inform her doctor at least 4 weeks in advance)
• if she experiences heavy vaginal bleeding
• if she misses tablets in the first week of her cycle (every first week of the month) and has had sexual intercourse during the previous 7 days
• if she experiences severe diarrhea
• if she does not have withdrawal bleeding within two months or suspects she may be pregnant (she should not start the next pack without consulting her doctor)

The patient should stop using Atywia and contact her doctor immediately if she notices 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 ability
• sudden disturbances of sensory organs (hearing, smell, or sensation)
• dizziness or fainting
• numbness or weakness of part of the body
• severe abdominal 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 she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Atywia should not be used during pregnancy or if pregnancy is suspected. If pregnancy is suspected, the patient should consult her doctor as soon as possible.
The use of Atywia is not recommended during breastfeeding.

Driving and using machines

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

Atywia contains lactose and glucose

Atywia contains lactose and glucose. If the patient has been diagnosed with intolerance to some sugars, she should consult her 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, the patient should consult her doctor or pharmacist.
The leaflet describes many situations in which the patient should stop using Atywia or in which the effectiveness of the medicine may be reduced. It also lists circumstances in which the patient should not have sexual intercourse or should 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. Each tablet on the packaging is marked with the day of the week on which 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, the patient should take 1 tablet per day.
The next 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 the patient should always start the next pack on the same day of the week, as well as that 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 patient should start taking the tablets on the 1st day of her natural menstrual cycle (i.e., on the 1st day of menstrual bleeding). The patient can also start taking the tablets between the 2nd and 5th day of her 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 1st day after taking the last tablet containing active substances of the previous combined oral contraceptive, but no later than on the 1st day after the usual break in taking tablets containing active substances or placebo of the previous combined oral contraceptive.
If the patient has used a progestogen-only tablet (mini-pill)
The patient can stop taking the mini-pill on any day and start taking Atywia at the same time. If the patient has sexual intercourse during the first 7 days of using Atywia, she should also use other contraceptive methods (mechanical methods).
If the patient has used injections, an implant, or an intrauterine system releasing progestogen
The patient should start using Atywia on the day when the next injection was scheduled or on the day the implant or intrauterine system is removed. If the patient has sexual intercourse during the first 7 days of tablet use, she should also use other contraceptive methods (mechanical methods).
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy

The patient can start using Atywia 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 "Breastfeeding".
The doctor should inform the patient that she 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 her about the need to use additional mechanical contraception for the first 7 days of tablet use. If the patient has had sexual intercourse before starting to use the combined oral contraceptive, she should make sure she is not pregnant or wait for her first menstrual period.

Using more than the recommended dose of Atywia

The patient may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not started menstruating yet 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 the patient has taken more tablets than recommended or someone else has taken them, she should inform her doctor.

Stopping Atywia

The patient can stop using the medicine at any time. The doctor will then recommend other contraceptive methods. If the patient stops using Atywia because she wants to become pregnant, she should wait until she has 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 patient missed a tablet, the contraceptive effectiveness of Atywia is maintained. The patient 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 patient missed a tablet, the contraceptive effectiveness of Atywia may be reduced. The more tablets the patient misses, the higher the risk of reduced contraceptive effectiveness. The risk of becoming pregnant is especially high if the patient misses tablets at the beginning or end of the pack. In this case, the patient should follow the rules below (see also the scheme below).

Missing more than 1 tablet from the pack

The patient should consult her doctor.

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

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and then take the next tablets at the usual time. For the next 7 days, the patient should use additional contraceptive methods (mechanical methods).
If the patient had sexual intercourse during the week before missing the tablet, it is possible that she may become pregnant. The patient should contact her doctor as soon as possible. The patient should also see the "Scheme for missing a tablet".

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

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and then take the next tablets at the usual time. The contraceptive effectiveness of Atywia is maintained, and there is no need to use additional contraceptive methods.
However, if the patient has made other mistakes in dosing or missed more than 1 tablet, she should use additional (mechanical) contraceptive methods for 7 days.

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

The patient can choose one of the following options without the need for additional contraceptive methods, provided that she has been taking the tablets correctly for 7 days before missing the dose. If not, the patient 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 then take the next tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, i.e., without the usual 7-day break. Withdrawal bleeding will occur after finishing the second pack, but during tablet use, spotting or bleeding may occur.
• 2. The patient 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 the patient misses a tablet and does not have withdrawal bleeding during the first break after using Atywia, it is possible that she may be pregnant. Before starting the next pack, the patient should consult her doctor.

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 ones, or changes in health that you consider related to the use of Atywia, you should consult a doctor.
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 thromboembolism). For detailed information on the different 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 the accompanying symptoms have been described in the following sections of the leaflet: "Oral contraception and thrombosis" 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 medicine.

• 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 (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 heavy, scanty, or infrequent menstrual bleeding, and complete absence of menstrual bleeding,
• intermenstrual bleeding from the vagina, metrorrhagia (irregular bleeding between periods),
• breast enlargement, including breast engorgement 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 fluctuations in weight).

Rare (may occur less frequently than in 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,
• influenza,
• 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 a part of the brain),
• cerebral circulatory disorders (disorders of blood flow to a 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 vision disturbances,
• 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 traveling to the lungs),
• thrombophlebitis (inflammation of a vein, including blood clots),
• increased diastolic blood pressure (lowest level to which blood pressure falls 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, eczema, psoriasis,
• excessive sweating,
• chloasma (skin discoloration on the face),
• changes in pigmentation and (or) discoloration,
• seborrhea,
• dandruff,
• excessive hair growth,
• skin disorders, skin reactions, "peeling skin" on the skin,
• 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 (ovaries and fallopian tubes),
• breast cysts,
• fibrocystic breast disease,
• painful intercourse,
• galactorrhea (spontaneous milk production),
• menstrual disorders,
• chest pain,
• edema 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 obstruction and clot in the deep peripheral veins, clots traveling through the bloodstream (e.g., to the lungs, known as pulmonary embolism, or 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 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 blood clots may be higher if you have any other risk factors (see section 2 "For further information on risk factors for blood clots and symptoms of blood clots").
You should immediately consult a 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, which are considered related to 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 (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 medicines on oral contraceptives (e.g., St. John's Wort (Hypericum perforatum), or medications for epilepsy, tuberculosis, HIV infection, 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 this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 492 13 01, fax: +48 22 492 13 09; Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

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 carton and blister after: "Expiry date:" or "EXP:". The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package.
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 needed. This will help protect the environment.

6. Contents of the pack and other information

What Atywia contains

• The active substances of Atywia are ethinylestradiol and dienogest
• The other ingredients of Atywia are: Tablet core: lactose monohydrate, magnesium stearate, corn starch, povidone K30, talc. Tablet coating: croscarmellose sodium, glucose, maltodextrin, sodium citrate dihydrate, soybean phosphatidylcholine.

1 blister pack 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 contents of the pack

White, round film-coated tablets.
Atywia is available in packs of: 1x21, 3x21, 6x21 film-coated tablets.

Marketing authorization holder

Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw
biuro@exeltis.com

Manufacturer:

Laboratorios León Farma S.A.
C/La Vallina S/N, Pol. Ind. Navatejera,
24193-Villaquilambre, Leon.
Spain
Date of last revision of the leaflet: 05.11.2024