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
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see point 2 "Blood clots")

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This 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 adverse effects, including any adverse effects not listed in this leaflet, they should tell their doctor or pharmacist. See point 4.

Table of contents of the leaflet

• 1. What is Atywia and what is it used for
• 2. Important information before using Atywia
• 3. How to use Atywia
• 4. Possible side effects
• 5. How to store Atywia
• 6. 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, you should familiarize yourself with the information about blood clots in point 2. It is especially important to familiarize yourself with the symptoms of blood clots (see point 2 "Blood clots").
Improvement of acne symptoms usually occurs after three to six months of treatment, but skin condition may continue to improve even after six months of treatment. The patient should discuss with their doctor the need to continue treatment after three to six months of treatment, and then at regular intervals.

When not to use Atywia

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 point 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 - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If the patient requires surgery or will be immobilized for a long time (see point 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 arterial thrombosis:
• severe diabetes with vascular damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• 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) hormone-dependent tumors (breast or genital tumors)
• 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 the above symptoms occur for the first time while taking Atywia, the drug should be stopped immediately and a doctor should be consulted. In the meantime, 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 with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Atywia and other drugs").

Warnings and precautions

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

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

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

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

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

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

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Atywia, is associated with an increased risk of blood clots, compared to a situation where 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 thrombosis")
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thrombosis").

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

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

HOW TO RECOGNIZE BLOOD CLOTS

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

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

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

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

Factors that increase the risk of blood clots in veins

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

• if the patient is severely 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 inherited blood clotting disorders
• if the patient needs to have surgery or will be immobilized for a long time (see point 2 "Blood clots"). It may be necessary to stop taking Atywia for a few weeks before surgery or immobilization. If the patient stops 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 the above factors are present, even if the patient is unsure. The doctor may decide to stop Atywia.
The patient should tell the doctor if any of the above conditions change while taking Atywia, e.g., if someone in their immediate family is diagnosed with thrombosis without a known cause or if the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

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

Factors that increase the risk of blood clots in arteries

It is essential to emphasize 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. While taking a hormonal contraceptive, 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 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. The patient should tell their doctor if any of the above conditions change while taking Atywia, e.g., if they start smoking, someone in their immediate family is diagnosed with thrombosis without a known cause, or if the patient gains weight significantly.

In case of symptoms suggesting a blood clot, thrombosis, or stroke, the patient should stop taking Atywia and consult their doctor immediately (see also "When to contact your 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.
Women who use combined oral contraceptives have rarely reported cases of benign or, even more rarely, malignant liver tumors, which have caused life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, the patient should inform their doctor as soon as possible.
Cancer can be life-threatening or fatal.

Mental disorders

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

Atywia and other drugs

The patient 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 Atywia in the blood, reduce its contraceptive effectiveness, 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 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 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 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 to take these drugs, the doctor will prescribe a different type of contraception.
Atywia can be taken again after about 2 weeks after the end of the above-mentioned treatment. See point "When not to use Atywia".
When to contact your doctor

• if you notice any worrying changes in your health, especially any of the symptoms listed in this leaflet (see also "Warnings and precautions" and "How to use Atywia")
• if there have been cases of thrombosis, heart attack, or stroke in close relatives
• if a breast lump is detected
• if you plan to use other drugs (see also "Atywia and other drugs")
• if you are going to be immobilized or plan to have surgery (you should inform your doctor at least 4 weeks in advance)
• if you experience heavy vaginal bleeding
• if you miss tablets in the first week of taking Atywia and had sex during the previous 7 days
• if you experience severe diarrhea
• if you do not experience withdrawal bleeding within two months or suspect you may be pregnant (you should not start the next pack without consulting your doctor)

You should stop taking Atywia and contact your doctor immediately if you notice any symptoms suggesting a blood clot, thrombosis, or stroke:

• cough without an obvious cause
• severe chest pain, which may radiate to the left arm
• shortness of breath
• headache with unprecedented severity or migraine attack
• partial or complete loss of vision or double vision
• slurred speech or loss of speech
• sudden disturbances of sensory organs (hearing, smell, or sensation)
• dizziness or fainting
• numbness or paralysis 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, suspects 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, the patient should consult their doctor as soon as possible.
Atywia is not recommended during breastfeeding.

Driving and operating machinery

No effect of Atywia on the ability to drive and operate machinery has been found.

Atywia contains lactose, glucose, sodium, and soy lecithin

Atywia contains lactose, glucose, and sodium. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the drug.
The drug contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".
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, the patient should consult their doctor or pharmacist.
The leaflet describes many situations in which the patient should stop taking Atywia or in which the drug's effectiveness may be reduced. It also lists circumstances in which the patient 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 because Atywia affects temperature changes and cervical mucus properties characteristic of the menstrual cycle.

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

How to use Atywia

• When and how to take the tablets?

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

• Using Atywia for the first time

If the patient did not take oral contraceptives in the last month
Tablet intake should be started on the 1st day of the natural menstrual cycle (i.e., on the 1st day of menstrual bleeding). Tablet intake 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 tablet intake.
If the patient previously took another combined oral contraceptive
It is recommended to start taking Atywia on the 1st day after taking the last active tablet of the previous combined oral contraceptive, but no later than on the 1st day of the usual break in taking active tablets or placebo in the previous combined oral contraceptive.
If the patient previously took a progestogen-only pill (minipill)
The minipill can be stopped at any time, and Atywia can be taken at the same time. If sex is had during the first 7 days of taking Atywia, additional mechanical contraceptive methods should be used.
If the patient previously used injections, an implant, or an intrauterine system
Atywia intake should be started on the day when 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 tablets, additional mechanical contraceptive methods should be used.
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy

Atywia intake 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 point 2 "Breastfeeding".
The doctor should inform the patient that tablet intake should be started 21-28 days after childbirth or miscarriage in the second trimester of pregnancy. If tablet intake is started later, the doctor should inform the patient about the need to use additional mechanical contraception for the first 7 days of tablet intake. 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 bleeding.

Taking 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 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, the patient should inform their doctor.

Stopping Atywia

The drug can be stopped at any time. The doctor will then recommend other contraceptive methods. If the patient 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 delivery.

Missing a dose of Atywia

If it has been less than 12 hourssince the missed 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 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 especially high if tablets are missed at the beginning or end of the pack. In this case, the patient should follow the rules listed below (see also the scheme below).

Missing more than one tablet from the pack

The patient should consult their doctor.

Missing one tablet in the first week of taking 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 subsequent tablets should be taken 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 the patient may become pregnant. The patient should contact their doctor immediately. The patient should also review the "Scheme for missing a tablet".

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

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

The patient can choose one of the following options without the need for additional contraceptive methods, provided that proper dosing was followed for the 7 days preceding the missed dose. If not, the patient should follow the first of the two options listed below and use an additional contraceptive method for 7 days.
Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and subsequent tablets should be taken at the usual time. Start taking 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 tablet intake, spotting or bleeding may occur.
Alternatively, the patient can stop taking 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 tablets from the next pack.
If the patient misses a tablet and does not experience the expected withdrawal bleeding during the first break after taking Atywia, it is possible that they are pregnant. Before starting the next pack, the patient should consult their doctor.

Scheme for missing a tablet

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Atywia, a doctor should be consulted.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial 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 associated with the use of Atywia and their symptoms have been described in the following sections of the leaflet: "Oral contraception and thrombosis" and "Oral contraception and tumors". These sections should be read to obtain additional information and, if necessary, consult a doctor immediately.

Other possible side effects

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

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

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

• Vaginitis and (or) vulvovaginitis (inflammatory conditions of the genital organs),
• Vaginal candidiasis (thrush) or other fungal infections of the vagina,
• Increased appetite,
• Decreased mood,
• Dizziness,
• Migraine,
• High or low blood pressure,
• Abdominal pain, including upper and lower abdominal pain, discomfort, and (or) bloating,
• Nausea, vomiting, or diarrhea,
• Acne,
• Hair loss (alopecia),
• Rash (including patchy rash), itching (sometimes 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 engorgement and swelling of the breast,
• Breast tenderness,
• Painful menstruation (dysmenorrhea),
• Vaginal discharge,
• Ovarian cysts,
• Pelvic pain,
• Fatigue, including asthenia (weakness) and malaise,
• Changes in body weight (including weight gain, weight loss, and fluctuations in body weight).

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

• Oophoritis and (or) salpingitis,
• Urinary tract infections,
• Cystitis (urinary bladder infection),
• Mastitis (breast infection),
• Cervicitis (inflammation of the cervix),
• Fungal infections,
• Oral thrush,
• Influenza,
• Bronchitis,
• Sinusitis,
• Upper respiratory tract infections,
• Viral infections,
• Uterine leiomyoma (fibroids),
• Breast lipoma,
• Anemia,
• Hypersensitivity (allergic reaction),
• Virilization 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 image vibration) or other vision disorders,
• 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 rising from a sitting or lying position),
• Hot flashes,
• Varicose veins,
• Vein disorders or vein pain,
• Asthma,
• Hyperventilation,
• Gastritis,
• Enteritis,
• Indigestion,
• Skin reactions,
• Skin diseases, including allergic dermatitis, neurodermatitis, and (or) atopic dermatitis, rash, psoriasis,
• Excessive sweating,
• Chloasma (skin discoloration on the face),
• Pigmentation changes and (or) discoloration,
• Seborrhea,
• Dandruff,
• Excessive hair growth,
• Skin disorders, skin reactions, "orange peel" skin appearance,
• Spider angioma,
• Back pain,
• Musculoskeletal disorders,
• Muscle pain,
• Pain in arms and legs,
• Cervical dysplasia (abnormal cell growth on the surface of the cervix),
• Pain or cysts of the adnexa (ovaries and fallopian tubes),
• Breast cysts,
• Fibrocystic breast disease,
• Painful intercourse,
• 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,
• Discovery of an extra breast.

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

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

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

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

Other

• Women with hypertriglyceridemia (increased 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 (chronic autoimmune disease); hemolytic uremic syndrome (blood clotting disorder); neurological disorders called Sydenham's chorea; herpes gestationis (a type of skin disease that occurs during pregnancy); otosclerosis associated with hearing loss.
• Liver function disorders
• Changes in glucose tolerance or effects on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

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

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather 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 given month.
Do not store above 25°C.
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. Contents of the pack and other information

What Atywia contains

• The active substances of Atywia are ethinylestradiol and dienogest
• Other ingredients of the medicine are: Tablet core: lactose monohydrate, magnesium stearate, corn starch, povidone K 30, talc. Tablet coating: opaglos 2 clear, containing the following ingredients: croscarmellose sodium, glucose, maltodextrin, sodium citrate dihydrate, soybean lecithin.

1 blister pack contains 21 film-coated tablets.
A cardboard sachet is attached to the packaging, in which the blister pack should be placed.
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.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Laboratórios Effik, Sociedade Unipessoal Lda.
Rua Dom António Ribeiro, nº 9
1495-049 Algés
Portugal

Manufacturer

Laboratorios León Farma S.A.
La Vallina s/n, Polígono Industrial Navatejera
Villaquilambre 24008
León
Spain

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
Translation of day symbols on the packaging:
Seg – Monday
Ter – Tuesday
Qua – Wednesday
Qui – Thursday
Sex – Friday
Sab – Saturday
Dom – Sunday
Marketing authorization number in Portugal, the country of export: 5279161
5279179
5279203
Parallel import authorization number: 313/18

Date of revision of the leaflet: 27.10.2023

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