Atywia

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Atywia (Velafee)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Atywia and Velafee are different trade names for the same medicinal product.
Important information regarding combined hormonal contraceptives

• When used correctly, they are among the most reliable reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clots (see section 2 "BLOOD CLOTS").

Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If in doubt, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. The medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Atywia is and what it is used for
2. Important information before taking Atywia
3. How to take Atywia
4. Possible side effects
5. How to store Atywia
6. Contents of the pack and other information

1. What Atywia is and what it is used for

Atywia is a combined oral contraceptive.
Each tablet contains two different hormones: dienogest (a progestogen) and ethinylestradiol (an oestrogen). When Atywia is taken according to the recommendations provided in this leaflet, the likelihood of becoming pregnant is very low.
Indications
Contraception.
Treatment of women with moderate acne who have decided to use oral contraceptive tablets and in whom adequate topical treatment or oral antibiotic therapy has failed.

2. Important information before using Atywia

General notes
Before starting treatment with Atywia, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "BLOOD CLOTS").
Improvement in 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, and then at regular intervals.

When not to use Atywia
Do not use Atywia if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative method of contraception would be more suitable.

• If you are allergic to ethinylestradiol or dienogest, or to any of the other ingredients of this medicine (listed in section 6).
• If you currently have (or have ever had) a blood clot in the deep veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs.
• If you know you have blood clotting disorders—such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies.
• If you are undergoing surgery or will be immobile for a prolonged period (see section 2 "BLOOD CLOTS").
• If you have had a heart attack or stroke.
• If you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms).
• If you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• If you have (or have previously had) a type of migraine called "migraine with aura"
• If you have (or have previously had) severe liver disease (until liver function tests return to normal)
• If you have (or have previously had) benign or malignant liver tumours
• If you have (or have previously had) a hormone-dependent cancer (e.g. breast or genital organ cancer)
• If you have vaginal bleeding of unknown cause
• If you are pregnant or suspect you may be pregnant.

If any of the above conditions occur for the first time while taking Atywia, stop taking the medicine immediately and consult your doctor. During this time, use non-hormonal methods of contraception.

Do not use Atywia if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Atywia and other medicines").

Warnings and precautions
Talk to your doctor or pharmacist before starting Atywia.

When to contact your doctor?
Seek immediate medical advice if:

• You notice possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "BLOOD CLOTS").

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

If you are taking oral hormonal contraceptives and have any of the conditions listed below, careful and regular medical monitoring is required.

Tell your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Atywia, inform your doctor.

• If you smoke,
• If you have diabetes,
• If you are obese,
• If you have high blood pressure,
• If you have heart valve disorders or heart rhythm problems,
• If you have inflammation of the veins under the skin (superficial thrombophlebitis),
• If you have varicose veins,
• If there has been a history of blood clots, heart attack, or stroke in close relatives,
• If you suffer from migraines,
• If you have epilepsy,
• If you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis,
• If you have a personal or family history of 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 affecting the body's natural immune system),
• If you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure),
• If you have sickle cell anaemia (an inherited disorder of red blood cells),
• If you require surgery or will be immobile for a prolonged period (see section 2 "BLOOD CLOTS"),
• If you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Atywia,
• If you have a condition that first appeared or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes gestationis, Sydenham's chorea),
• If you develop symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or skin rash with possible breathing difficulties,

seek immediate medical advice. 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 during treatment with Atywia, contact your doctor.

BLOOD CLOTS
Using combined hormonal contraceptives such as Atywia increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.

Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

Remember: the overall risk of harmful blood clots associated with the use of Atywia is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience 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 venous blood clots (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.

• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.

• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.

• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking
combined hormonal contraceptives for the first time. The risk may also be
elevated when restarting combined hormonal contraceptives (the same or a different product)
after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not
use combined hormonal contraceptives.
If a patient stops taking Atywia, the risk of blood clots returns to normal
within a few weeks.

What factors influence the risk of blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type
of combined hormonal contraceptive being used.

• In the course of one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who are using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 8–11 out of 10,000 women who are using combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Atywia, will develop blood clots.
• The risk of developing blood clots depends on the individual’s medical history (see “Factors that increase the risk of venous blood clots” below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Atywia is low, however,
some factors may increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Atywia several weeks before surgery or immobilization. If the patient must stop taking Atywia, ask the doctor when it is safe to resume;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of venous blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue Atywia.
Inform the doctor if any of the above conditions change during treatment with Atywia, e.g. if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious
consequences, such as myocardial infarction (heart attack) or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Atywia is very small, but may increase:

• with age (over 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Atywia, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve disease, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Atywia, e.g. if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

If symptoms suggesting thrombosis occur, stop taking the tablets and consult a doctor immediately (see also “When to contact a doctor”).

Oral contraception and cancer
Breast cancer occurs slightly more frequently in women who take oral contraceptives than in women of the same age who do not. It is not known whether this difference is solely due to the use of hormonal contraceptives. It may also be due to the fact that women using hormonal contraception are examined more frequently, leading to earlier detection of breast cancer. The difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.

Rare cases of benign or, even more rarely, malignant liver tumours have been reported in women using combined oral contraceptives, which have led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, inform the doctor as soon as possible.
Malignant tumours may be life-threatening or fatal.

There have been reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be related to taking the tablets, but rather to sexual behaviour or other factors.

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

Atywia and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

Some medicines may affect the blood concentration of this drug, reduce contraceptive effectiveness, and cause unexpected bleeding. These include:

• medicines used to treat:
  • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
  • tuberculosis (e.g. rifampicin)
  • HIV and HCV infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
  • fungal infections (griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole)
  • bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin)
  • certain heart conditions, hypertension (calcium channel blockers, e.g. verapamil, diltiazem)
  • arthritis, osteoarthritis (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.

Do not use Atywia 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 these may cause abnormal liver function test results (increased liver enzyme activity, AlAT). Before starting these antiviral treatments, the doctor will prescribe another form of contraception.

Atywia may be restarted approximately 2 weeks after completing the above-mentioned antiviral treatment. See section “When not to use Atywia”.

When to contact a doctor
Contact the doctor immediately if:

• worrying changes in health occur, particularly any of the symptoms listed in this leaflet (see also: “Warnings and precautions” and “How to use Atywia”);
• there is a history of thrombosis, heart attack, or stroke in close relatives;
• a breast lump is detected;
• the patient plans to take other medicines (see also “Atywia and other medicines”);
• immobilization or surgery is planned (inform the doctor at least 4 weeks in advance);
• there is heavy vaginal bleeding;
• tablets are missed in the first week of the cycle (each first week of consecutive months of Atywia use), and intercourse occurred in the preceding 7 days;
• acute diarrhoea occurs;
• withdrawal bleeding does not occur in two consecutive months, or pregnancy is suspected (do not start the next pack without consulting a doctor).

Stop taking Atywia and contact a doctor as soon as possible if any symptoms suggesting possible thrombosis, heart attack, or stroke occur:

• cough without apparent cause,
• severe chest pain, possibly radiating to the left arm,
• shortness of breath,
• headache of unusual severity or a migraine attack,
• partial or complete loss of vision or double vision,
• slurred speech or loss of speech,
• sudden sensory disturbances (hearing, smell, or touch),
• dizziness or fainting,
• numbness or weakness of any part of the body,
• severe abdominal pain,
• severe pain or swelling in the legs.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult a doctor or pharmacist before using this medicine.
Do not take Atywia during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult a doctor as soon as possible.
Atywia is not recommended during breastfeeding.

Driving and operating machinery
No effect of Atywia on the ability to drive or operate machinery has been observed.

Atywia contains monohydrate lactose
Atywia contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Atywia

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The leaflet describes many situations in which you should stop taking Atywia or in which the
effectiveness of the medicine may be reduced. It also specifies circumstances in which sexual
intercourse should be avoided or additional contraceptive methods should be used, such as
condoms or other mechanical methods. The calendar method and temperature measurement method
cannot be used, as Atywia affects changes in body temperature and cervical mucus properties
typical of the menstrual cycle.
Atywia, like other oral contraceptives, does not protect against infection with the HIV virus (AIDS)
or sexually transmitted diseases.

How to take Atywia

• When and how should the tablets be taken?

The blister pack contains 21 coated tablets. Each tablet is marked on the pack with the symbol of the
day of the week on which it should be taken (see "Translation of day-of-the-week symbols located next
to each tablet on the immediate packaging" at the end of this leaflet). The tablets should be taken in
the order indicated on the pack, every day at approximately the same time, with a small amount of
fluid if needed.
One tablet should be taken daily for 21 consecutive days.
Each subsequent pack should be started after a 7-day break, during which no tablets are taken and
withdrawal bleeding usually occurs. Bleeding usually begins 2–3 days after the last tablet and may
continue into the start of the next pack. This means that each new pack should always be started on
the same day of the week, and bleeding will occur on approximately the same days each month.

• Starting to take Atywia for the first time

If no oral hormonal contraceptives have been used in the past month
Tablets should be started on day 1 of the natural menstrual cycle (i.e. the first day of menstrual
bleeding). Tablets may also be started between day 2 and day 5 of the menstrual cycle; in such a case,
during the first cycle, additional mechanical contraception is recommended for the first 7 days of
tablet intake.
If previously using another combined oral contraceptive
It is recommended to start taking Atywia on day 1 after the last active tablet of the previous combined
oral contraceptive, but no later than day 1 after the usual tablet-free or placebo interval of the
previous combined oral contraceptive.
If previously using a progestogen-only pill (mini-pill)
You may stop taking the mini-pill on any day and start taking Atywia at the same time instead. If
sexual intercourse occurs during the first 7 days of taking Atywia, additional contraceptive methods
(mechanical methods) should be used simultaneously.
If previously using injectable contraception, implant, or intrauterine hormonal system releasing
progestogen
Start taking Atywia on the day the next injection was due or on the day of removal of the implant or
system. If sexual intercourse occurs during the first 7 days of tablet intake, additional contraceptive
methods (mechanical methods) should be used simultaneously.
After childbirth, miscarriage, or induced abortion

• After a first-trimester miscarriage

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

• After childbirth or second-trimester miscarriage

Breastfeeding women: see section 2. "Breastfeeding".
Your doctor should advise that tablet intake should begin between 21 and 28 days after childbirth or
second-trimester miscarriage. If tablet use is started later, your doctor should advise the use of
additional mechanical contraception for the first 7 days of tablet intake. If intercourse occurred before
starting the combined oral contraceptive, pregnancy should be ruled out or wait until the first
natural menstrual bleeding occurs.

Taking more Atywia than recommended
Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have
not yet started menstruating but have accidentally taken this medicine. There are no reports of
severe adverse effects after taking multiple tablets of Atywia at once. If you or someone else has taken
more than the recommended dose, inform your doctor.

Stopping further use of Atywia
The medicine may be discontinued at any time. Your doctor will then suggest alternative
contraceptive methods. If you stop taking the medicine because you wish to become pregnant, wait
until the next natural menstrual period occurs. This will help determine the expected date of delivery.

Missed dose of Atywia
If less than 12 hours have passed since the missed tablet, the contraceptive effectiveness of Atywia
is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.
If more than 12 hours have passed since the missed tablet, the contraceptive effectiveness of
Atywia may be reduced. The more consecutive tablets missed, the greater the risk of reduced
contraceptive effect. The risk of pregnancy is particularly high if tablets are missed at the beginning
or end of the pack. In such cases, follow the rules below (see also the chart below).
More than 1 tablet missed from the pack
Consult your doctor.
One tablet missed in the first week of taking the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and take the
next tablets at the usual time. Use additional contraceptive methods (mechanical methods) for the
next 7 days.
If sexual intercourse occurred in the week before the missed tablet, pregnancy may have occurred.
Inform your doctor immediately. Also refer to the "Missed tablet management chart".
One tablet missed in the second week of taking the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and take the
next tablets at the usual time. The contraceptive effectiveness of Atywia is maintained, and no
additional pregnancy prevention methods are necessary.
However, if previous dosing errors occurred or more than one tablet was missed, use an additional
(mechanical) contraceptive method for 7 days.
One tablet missed in the third week of taking the current pack
You may choose one of the following options without needing additional contraceptive methods,
provided correct dosing was maintained for the 7 days preceding the missed dose. Otherwise, follow
the first of the two options below and use additional contraception for the next 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at once), and continue taking tablets at the usual time. Start the next pack immediately after finishing the current pack, i.e. without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but spotting or bleeding may occur during tablet intake.
2. Alternatively, stop taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), and then continue with tablets from the next pack.

If you forget to take tablets and no expected bleeding occurs during the first tablet-free interval,
pregnancy may be possible. Contact your doctor before starting the next pack.

Missed tablet management chart
More than one tablet
Consult your doctor
missed from the current
pack
Sexual intercourse occurred
in the week before the
Week 1.
missed tablet
Did not occur

• Take the missed tablet
• Use additional contraception for 7 days
• Finish the pack

Only one tablet missed
(taken more than 12 hours
Week 2. - Finish the pack
but less than 24 hours late)

• Take the missed tablet
• Finish the pack
• Do not take a 7-day break
• Continue with the next pack

or
Week 3.

• Discard remaining tablets in the pack
• Take a break (no longer than 7 days, including the day of the missed tablet)
• Continue with the next pack

What to do in the following situations:

• Gastrointestinal disturbances (vomiting)

If vomiting occurs, the active ingredients of Atywia may not be completely absorbed. If vomiting
occurs within 3 to 4 hours after taking a tablet, follow the recommendations for a missed tablet. If
severe gastrointestinal disturbances occur, use additional contraceptive methods.

• Desire to delay the onset of bleeding

To delay the onset of bleeding, start the next pack immediately after finishing the current pack,
without a 7-day break. Tablets may be taken continuously until the pack is finished. If you wish
bleeding to occur, simply stop taking tablets. Spotting or light bleeding may occur during intake of
tablets from the next pack. The next pack should be started after a 7-day break.

• Desire to change the day of bleeding to another day of the week

If tablets are taken as directed, bleeding occurs approximately every 4 weeks on the same day. To
change the bleeding day to another day of the week, shorten the next tablet-free interval by the
number of days you wish to shift the bleeding. For example, if bleeding usually starts on Fridays and
you wish it to start on Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. If the
tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not occur during this
interval. Light bleeding or spotting may occur during the next pack.

• Unexpected bleeding

During the first few months of taking Atywia, irregular vaginal bleeding (spotting or intermenstrual
bleeding) may occur. Despite this, continue taking the tablets. Irregular vaginal bleeding usually
resolves after 3 cycles of Atywia use. If bleeding persists, becomes heavy, or recurs, inform your
doctor.

• Absence of bleeding

If all tablets were taken on time, there were no vomiting or severe diarrhoea, and no other medicines
were taken concurrently, the likelihood of pregnancy is very low. Continue taking Atywia.
If withdrawal bleeding does not occur in two consecutive months, pregnancy is possible. Inform
your doctor immediately. Do not start the next pack of Atywia until your doctor has ruled out
pregnancy.

Additional information for specific patient groups
Children and adolescents
Atywia is indicated only after the onset of menstruation.
Elderly patients
Not applicable. Atywia is not indicated in postmenopausal women.
Patients with hepatic impairment
Atywia is contraindicated in women with severe liver disease. See also section 2 "When not to use
Atywia".
Patients with renal impairment
No specific studies with Atywia have been conducted in patients with renal impairment. Available data
do not indicate the need to modify treatment in this patient group.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers to be related to the use of Atywia, medical advice should be sought immediately.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using Atywia".

Serious adverse effects
Serious adverse effects associated with taking Atywia and their accompanying symptoms are described in the following sections of this leaflet: “BLOOD CLOTS” and “ORAL CONTRACEPTION AND CANCER”. Please read these sections carefully for additional information and consult your doctor immediately if necessary.

Other possible adverse effects
The symptoms listed below have been reported by patients taking Atywia, although they may not necessarily have been caused by the medicine.

Common (may affect fewer than 1 in 10 people):

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

Uncommon (may affect fewer than 1 in 100 people):

• vaginal inflammation and (or) vulvovaginitis (inflammatory conditions of the genital organs),
• vaginal candidiasis (yeast infection) 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 diarrhoea,
• acne,
• hair loss (loss of hair),
• skin rash (including macular rash), itching (sometimes of the whole body),
• changes in menstrual bleeding such as heavy, scanty, infrequent or absent periods,
• intermenstrual vaginal bleeding, uterine haemorrhage (irregular bleeding between periods),
• breast enlargement, including breast congestion and swelling,
• breast swelling,
• painful menstruation (painful periods),
• vaginal discharge,
• ovarian cysts,
• pelvic pain,
• fatigue, including asthenia (weakness) and malaise,
• changes in body weight (including weight gain, weight loss and weight fluctuations).

Rare (may affect fewer than 1 in 1000 people):

• inflammation of the ovaries and fallopian tubes,
• urinary tract infections,
• cystitis (bladder inflammation),
• mastitis (inflammation of the breast),
• cervicitis (inflammation of the cervix),
• fungal infections,
• oral herpes,
• influenza,
• bronchitis,
• sinusitis,
• upper respiratory tract infections,
• viral infection,
• uterine leiomyoma,
• breast lipoma,
• anaemia,
• hypersensitivity (allergic reaction),
• virilization (development of male secondary sexual characteristics in women),
• anorexia (severe loss of appetite),
• depression,
• psychiatric disorders,
• insomnia,
• sleep disorders,
• aggression,
• stroke (reduced or interrupted blood supply to part of the brain),
• cerebral circulation disorders (disorders of blood flow to part of the brain),
• dystonia (sustained muscle contractions causing twisting or abnormal postures),
• dry or irritated eyes,
• oscillopsia (subjective sensation of oscillating vision) or other visual disturbances,
• sudden hearing loss,
• tinnitus,
• dizziness,
• hearing disorders,
• cardiovascular disorders (disorders of blood flow to the heart),
• tachycardia (rapid heartbeat),
• venous and arterial thromboembolic events*
• pulmonary embolism (blood clot travelling to the lungs),
• thrombophlebitis (vein inflammation, including blood clots),
• elevated 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 flushes,
• varicose veins,
• venous dysfunction or vein pain,
• asthma,
• hyperventilation,
• gastritis (inflammation of the stomach lining),
• enteritis (inflammation of the intestine),
• dyspepsia,
• skin reactions,
• skin disorders, including allergic dermatitis, neurodermatitis and (or) atopic dermatitis,
• rash, psoriasis,
• excessive sweating,
• chloasma (pigmented facial patch),
• pigmentary disorders and (or) discoloration,
• seborrhoea,
• pityriasis,
• hirsutism,
• skin disorders, skin reactions, “orange peel” skin appearance,
• spider angioma,
• back pain,
• bone and muscle discomfort,
• 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 changes,
• painful sexual intercourse,
• galactorrhea (milk secretion),
• menstrual disorders,
• chest pain,
• swelling of arms and legs,
• flu-like illnesses,
• inflammation,
• fever,
• irritability,
• hypercholesterolaemia,
• increased blood triglyceride levels,
• presence of supernumerary breast tissue.

* Estimated frequency from epidemiological studies covering the group of combined oral contraceptives. The term “venous and arterial thromboembolic events” includes: any obstruction and blood clot in deep peripheral veins, clots travelling through the circulatory system (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 available data):

• mood changes,
• decreased or increased libido (sexual drive),
• intolerance to contact lenses,
• skin changes (urticaria, nodular erythema, erythema multiforme),
• breast discharge,
• fluid retention.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 “HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS”).
Seek immediate medical advice if the patient develops symptoms of angioedema, such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or skin rash possibly accompanied by breathing difficulties (see also section “Warnings and precautions”).

Description of selected adverse effects
Adverse effects with low frequency or delayed onset, considered to be associated with the group of combined oral contraceptives, are listed below (see also sections “When not to use Atywia” and “Warnings and precautions”):

Neoplasms

• A slightly increased number of diagnosed cases of breast cancer has been observed in women using combined oral contraceptives. However, since breast cancer is rare in women under 40 years of age, the number of diagnoses is small in relation to the overall risk of breast cancer. A causal relationship between breast cancer and combined oral contraceptives is not known.
• Liver tumours (benign and malignant).

Other

• Women with hypertriglyceridaemia (increased blood fat levels, increasing the risk of pancreatitis during use of combined oral contraceptives)
• High blood pressure
• Occurrence or worsening of symptoms, the relationship of which to COC use is not established: jaundice and (or) pruritus associated with cholestasis (blocked bile flow); gallstones; metabolic disorders such as porphyria; systemic lupus erythematosus (chronic autoimmune disease); haemolytic uraemic syndrome (a blood clotting disorder); neurological disorders called Sydenham's chorea; herpes gestationis (a type of skin disease occurring 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) reduced contraceptive efficacy may result from interactions between other medicines and oral contraceptives (e.g. St. John's wort (Hypericum perforatum), or drugs used for epilepsy, tuberculosis, HIV infection and other infections). See section “Atywia with other medicines”.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Atywia

Keep the medicine out of the 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 stated month.
Do not store above 30°C. Keep the blister in the original packaging to protect from light.
Translation of some information on the immediate packaging:
Ch.-B. und verw. bis: siehe Prägung – Batch number and expiry date: see imprint
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Atywia contains

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

What Atywia looks like and contents of the pack
Atywia is available in packs of: 1x21, 3x21, 6x21 coated tablets.
1 blister contains 21 coated tablets.
A cardboard sleeve is included with the packaging, in which the blister should be placed.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Germany, the country of export:
Exeltis Germany GmbH
Adalperostraße 84
85737 Ismaning
Germany
Manufacturer:
Laboratorios León Farma SA
C/La Vallina s/n, Pol. Ind. Navatejera
24193, Villaquilambre (León)
Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export: 87088.00.00
Parallel import authorization number: 347/21

Translation of the day-of-the-week symbols printed next to each tablet in the immediate packaging:
Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday