Ativia

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Atywia (Velafee), 0.03 mg + 2 mg, film-coated tablets

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

Important information about combined hormonal contraceptives

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

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

• One should keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be passed on 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, pharmacist, or nurse. 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). When using Atywia according to the recommendations listed in this leaflet, the likelihood of becoming pregnant is very low.

Indications for use

Prevention of pregnancy.
Treatment of women with moderate acne who have decided to use oral contraceptives and for whom local or oral antibiotic treatment has not been successful.

2. Important information before using Atywia

General notes

Before starting to take Atywia, one should familiarize themselves with the information about blood clots in point 2. It is especially important to familiarize oneself 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 medicine (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 coagulation disorders - for example, 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 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 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 the above symptoms occur for the first time while taking Atywia, the medicine should be stopped immediately and a doctor consulted. During this time, non-hormonal methods of contraception should be used.
Atywia should not be used if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir 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, one should discuss it with their doctor or pharmacist.
When should one contact their doctor?
One should immediately contact their doctor

• 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").

In order to obtain a description of the serious side effects mentioned, see "How to recognize the occurrence of blood clots".
If one is taking oral contraceptives in any of the following cases, 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 defects or heart rhythm disorders,
• if they have superficial thrombophlebitis (inflammation of the veins under the skin),
• if they have varicose veins,
• if there have been cases of blood clots, heart attack, or stroke in close relatives,
• if they have migraines,
• if they have epilepsy,
• if they have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a 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 body's natural defense system),
• if they have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure),
• if they have sickle cell anemia (a hereditary disease of red blood cells),
• if they need to undergo surgery or will be immobilized for a long time (see point 2 "Blood clots"),
• if they have recently given birth, as they are at increased risk of blood clots. One should consult their doctor to find out how soon they can start taking Atywia after giving birth,
• if they have a disease that occurred for the first time or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, herpes gestationis, 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 the sun or ultraviolet radiation,
• if they experience symptoms of angioedema, such as facial swelling, tongue or throat swelling, and difficulty swallowing or skin rash with possible breathing problems, one should immediately contact their doctor. Estrogen-containing medicines may cause or worsen symptoms of hereditary or acquired angioedema.

If any of the above symptoms occur for the first time, recur, or worsen while taking Atywia, 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 thromboembolic disease"),
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

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

One should remember that the total risk of harmful blood clots caused by Atywia is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

One should immediately contact their doctor 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 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 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 when combined hormonal contraceptives are not used.
If the patient stops using Atywia, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

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

• During the year, about 2 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", 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/m2);
• 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). In this case, the patient may have hereditary coagulation disorders;
• if the patient needs to undergo surgery or will be immobilized for a long time (see point 2 "Blood clots"). It may be necessary to stop using Atywia for a few weeks before surgery or immobilization. If the patient needs to stop using Atywia, they should ask their doctor when they can resume using the medicine;
• with age (especially over 35);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of the above factors are present, even if one is not sure. The doctor may decide to stop using Atywia.
One should tell the doctor if any of the above conditions change while using Atywia, e.g., if someone in the patient's 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 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),
• if the patient smokes. While using a hormonal contraceptive, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35, 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). 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.
One should tell the doctor if any of the above conditions change while using Atywia, e.g., if the patient starts smoking, someone in their 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

In women who use oral contraceptives, breast cancer is slightly more common than in women of the same age who do not use them. It is not known if 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. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after stopping the use of oral contraceptives.
Rarely, cases of benign or, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, one should immediately inform their doctor.
Malignant tumors can be life-threatening or cause death.
There have been reports of a more frequent occurrence of cervical cancer in women who use oral contraceptives for a long time. However, this relationship may not be related to the use of tablets, but to sexual behavior or other factors.

Psychiatric disorders

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

Atywia and other medicines

One should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, even those that are available without a prescription.
Some medicines may affect the 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 (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 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 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 (elevated liver enzyme activity). Before starting to take these medicines, the doctor will prescribe a different type of contraception.
Atywia can be taken again after about 2 weeks from the end of the above-mentioned treatment. See point "When not to use Atywia".

When to contact a doctor

One should immediately contact their doctor 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 detected,
• they plan to use other medicines (see also "Atywia and other medicines"),
• they plan to undergo surgery or be immobilized (one should inform their doctor at least 4 weeks in advance),
• they experience heavy vaginal bleeding,
• they missed tablets in the first week of the cycle (every first week of each month of using Atywia), and they had sexual intercourse during the previous 7 days,
• they experience severe diarrhea,
• they do not experience withdrawal bleeding or suspect they may be pregnant (one should not start the next package without their doctor's decision).

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, which 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 ability,
• sudden disturbances of sensory organs (hearing, smell, or touch),
• dizziness or fainting,
• numbness or weakness of part of the body,
• severe stomach pain,
• severe leg pain.

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 medicine.
Atywia should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected, one should immediately consult their doctor.
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 monohydrate

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

3. How to use Atywia

This medicine should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, one should consult their doctor or pharmacist.
The leaflet describes many situations in which one should stop using Atywia or in which the effectiveness of the medicine may be reduced. It also lists circumstances in which one should not have sexual intercourse or use additional contraceptive methods, such as condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used, as Atywia affects temperature changes and cervical mucus properties characteristic of the menstrual cycle.

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

How to use Atywia

• When and how to take the tablets?

The blister pack contains 21 film-coated tablets. On the packaging, each tablet is marked with 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, one tablet should be taken per day.
Each subsequent package 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 package. This means that one should always start each subsequent package 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
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 another combined oral contraceptive has been used before
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 of the usual break in taking tablets containing active substances or placebo of the previous combined oral contraceptive.
If a progestogen-only tablet (minipill) has been used before
One can stop taking the minipill on any day and start taking Atywia at the same time. If sexual intercourse occurs 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 abortion in the first trimester of pregnancy

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

• After childbirth or abortion in the second trimester of pregnancy

For breastfeeding women, see point 2 "Breastfeeding".
The doctor should inform that tablet intake should be started 21-28 days after childbirth or abortion in the second trimester of pregnancy. If tablet intake is started later, the doctor should inform about the need to use additional mechanical contraception for the first 7 days of tablet intake. If sexual intercourse has occurred before starting to use the combined oral contraceptive, one should make sure they are not pregnant or wait for the first menstrual bleeding.

Using more than the recommended dose of Atywia

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

Stopping Atywia

The medicine can be stopped at any time. The doctor will then recommend other contraceptive methods. If one stops taking the medicine 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 especially high if tablets are missed at the beginning or end of the package. In this case, one should follow the rules listed below (see also the scheme below).

Missing more than 1 tablet from the package

One should consult their doctor.

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

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 sexual intercourse occurred during the week preceding the missed tablet, it is possible that one has become pregnant. One should immediately inform their doctor. One should also read "Scheme of action in case of a missed tablet".

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

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 mistakes were made 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 package

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 listed below and use an additional contraceptive method for 7 days.

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

• 2. One can also stop taking the tablets from the current package, take a break (not more than 7 days, counting from the day the tablet was missed), and then continue taking tablets from the next package.

If one forgets to take tablets and does not experience the expected withdrawal bleeding during the first break, it is possible that they are pregnant. Before starting the next package of Atywia, one should consult their doctor.

Scheme of action in case of a missed tablet

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

• take the missed tablet
• use an additional contraceptive method for 7 days
• finish the package

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

• take the missed tablet
• finish the package

Week 2.
take the missed tablet

• finish the package
• do not take a 7-day break
• continue with the next package

Week 3.
or

• stop taking the tablets from the package
• take a break (not more than 7 days, counting from the day the tablet was missed)
• continue with the next package

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 may be 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 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

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.

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

• Vaginitis and (or) vulvovaginitis (inflammatory conditions of the genital organs),
• Vaginal candidiasis (yeast infection) or other fungal infections of the vagina,
• Increased appetite,
• Decreased mood,
• Dizziness,
• Migraine,
• High or low blood pressure,
• Abdominal pain, including upper and lower abdominal pain, discomfort, and (or) bloating,
• Nausea, vomiting, or diarrhea,
• Acne,
• Alopecia (hair loss),
• 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,
• 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 (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 image vibration) or other vision disturbances,
• Sudden hearing loss,
• Tinnitus,
• Dizziness,
• Hearing disorders,
• Cardiovascular disorders (disorders of blood flow to the heart),
• Tachycardia (rapid heart rate),
• Venous and arterial thromboembolic events*
• Pulmonary embolism (blood clot moving to the lungs),
• Thrombophlebitis (inflammation of the 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,
• Disorders of vein function or vein pain,
• Asthma,
• Hyperventilation,
• Gastritis,
• Enteritis,
• Indigestion,
• Skin reactions,
• Skin diseases, including allergic dermatitis, neurodermatitis, and (or) atopic dermatitis, eczema, psoriasis,
• Excessive sweating,
• Chloasma (pigmentation 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,
• Galactorrhea (milk secretion),
• Menstrual disorders,
• Chest pain,
• Swelling of the legs and arms,
• 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 along 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 (sex drive),
• Intolerance to contact lenses,
• Skin changes (hives, erythema multiforme, Stevens-Johnson syndrome),
• Breast discharge,
• Fluid retention.

The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 "Factors increasing the risk of blood clots in the veins").
You should immediately contact 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 of low frequency or with delayed onset of symptoms, which are considered to be 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.

Other

• Women with hypertriglyceridemia (increased levels of fats in the blood, increasing the risk of pancreatitis when using combined oral contraceptives).
• Hypertension.
• Onset or worsening of symptoms, whose relationship to the use of COCs is not established: jaundice and (or) itching associated with cholestasis (obstructed 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, 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, pharmacist, or nurse. 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 stated.

Translation of the inscriptions on the blister pack:

Ch.-B. und verw. bis: see imprint – Batch number and expiry date: see embossing
Do not store above 30°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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, cornstarch, povidone K 30. Coating: hypromellose 2910, macrogol 400, titanium dioxide (E 171).

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 what the package contains

White, round film-coated tablets.
Atywia is available in packages of: 1x21, 3x21, 6x21 film-coated tablets.
A cardboard box containing a blister pack is included in the package.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Exeltis Germany GmbH, Adalperostraße 84, 85737 Ismaning, Germany

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German authorization number: 87088.00.00

Parallel import authorization number: 413/19

Translation of the day of the week symbols on the blister pack:

Mo

• Monday Di
• Tuesday Mi
• Wednesday Do
• Thursday Fr
• Friday Sa
• Saturday So
• Sunday

Date of leaflet approval: 24.10.2024

[Information about the trademark]