ATYWIA

Package leaflet: Information for the patient

Warning! Keep this leaflet. The 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 brand names of the same medicine.
Important information regarding combined hormonal contraceptives

• When used correctly, they represent one of 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 longer.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

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

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

Leaflet contents:

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

2. Important information before using Atywia

General notes
Before starting to take Atywia, you should read the information about blood clots in section 2. It is particularly important to be aware of 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 any of the following conditions apply to you. If any of these conditions apply, inform your doctor. Your doctor will discuss with you which alternative method of contraception may 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 veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs.
• If you know you have a condition affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies.
• If you are due to have 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 suffer (or have suffered in the past) from 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 suffer from 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 currently have (or have ever had) a type of migraine called "migraine with aura".
• If you have had or currently have severe liver disease (until liver function tests return to normal).
• If you have had or currently have benign or malignant liver tumours.
• If you currently 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 pregnancy has been confirmed or is suspected.

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 with other medicines").

Warnings and precautions
Talk to your doctor or pharmacist before starting Atywia.
When should you contact your doctor?
Seek immediate medical advice if:

• You notice possible symptoms of blood clots, 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 events, see "How to recognize the occurrence of blood clots".
Special and regular medical monitoring is necessary if you are taking oral contraceptives and any of the following apply.
Tell your doctor if you have any of the following conditions.
If these symptoms develop or worsen during treatment with Atywia, you should also 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 have been cases of thrombosis, 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 (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of pancreatitis,
• If you have a 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 are immediately postpartum, as you are at increased risk of blood clots. Consult your doctor to determine how soon after delivery you can start taking Atywia,
• If you have a condition that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes gestationis, Sydenham's chorea),
• If you currently have or have previously had skin discolouration (yellow-brown pigmentation, so-called chloasma); in such cases, avoid excessive exposure to sunlight or ultraviolet radiation,
• 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 attention. 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 such medicines. 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 that the overall risk of harmful blood clots associated with taking Atywia is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (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 developing 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 higher 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 woman stops taking Atywia, the risk of developing blood clots returns to normal within a few weeks.

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

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a 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 developing blood clots in veins depends on the individual's medical history (see "Factors that increase the risk of developing blood clots in veins" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Atywia is small, but certain factors may increase this risk. The risk is higher:

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

The risk of developing 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 present.
It is important to inform the doctor if any of the above risk 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, for example, 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 may 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 Atywia is very small, but may increase:

• with age (over 35 years),
• if the patient smokes. When 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 of age, the doctor may recommend using a different 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 blood lipid levels (cholesterol or triglycerides),
• if the patient suffers from migraines, particularly migraines with aura,
• if the patient has heart disease (valve disorder, heart rhythm disorder such 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, for example, 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 the doctor”).

Oral contraception and cancer
Women using oral contraceptives have a slightly higher incidence of breast cancer compared to women of the same age who do not use them. 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 undergo more frequent examinations, leading to earlier detection of breast cancer. The difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.

Benign or, more rarely, malignant liver tumours have been reported in women using combined oral contraceptives. These tumours may lead to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, the doctor should be informed immediately.
Malignant tumours may be life-threatening or lead to death.

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 depressed 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 used, as well as any medicines the patient plans to take, including those available without a prescription.

Some medicines may affect the blood concentration of Atywia, 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 AlAT activity). Before starting these medicines, 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 the 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”),
• a close relative has had thrombosis, heart attack, or stroke,
• a breast lump is detected,
• other medicines are to be used (see also “Atywia and other medicines”),
• immobilization is expected or surgery is planned (inform the doctor at least 4 weeks in advance),
• heavy vaginal bleeding occurs,
• tablets are missed in the first week of the cycle (each first week of consecutive months of Atywia use) and intercourse occurred in the previous 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 the doctor).

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

• cough without apparent cause,
• severe chest pain, possibly radiating to the left arm,
• shortness of breath,
• unusually severe headache or 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, 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 immediately.
Atywia is not recommended during breastfeeding.

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

Atywia contains lactose monohydrate
Atywia contains lactose monohydrate. 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,
consult your doctor or pharmacist.
This 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 under which sexual
intercourse should be avoided or additional contraceptive methods (e.g. condoms or other mechanical
methods) should be used. Calendar-based methods and temperature measurement methods must not
be used, as Atywia affects temperature changes and cervical mucus characteristics 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 on the pack is marked with the day of the
week on which it should be taken. The tablets must be taken in the order indicated on the pack, every
day at approximately the same time, with a small amount of liquid if necessary. 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 taking 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 approximately on the same days each month.

• Starting Atywia for the first time

If no oral contraceptives have been used in the past month
Tablet-taking should begin on day 1 of the natural menstrual cycle (i.e. the first day of menstrual
bleeding). Tablet-taking may also begin between day 2 and day 5 of the cycle; in this 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 taking the last active tablet of the previous
combined oral contraceptive, but no later than day 1 after the usual tablet-free interval (including
placebo tablets) 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 instead take 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 simultaneously.
If previously using injectable, implant, or intrauterine hormonal contraception releasing a progestagen
Start taking Atywia on the day the next injection would have been administered, or on the day of
implant or system removal. 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 you to start taking tablets between 21 and 28 days after childbirth or
second-trimester miscarriage. If tablet use is started later, your doctor should advise using 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 than the recommended dose of Atywia
Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have
not yet started menstruating but accidentally took the 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 immediately.

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 Atywia 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 especially 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 the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time),
and continue taking 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 is possible. Inform
your doctor immediately. Also refer to the "Missed tablet management chart" below.

One tablet missed in the second week of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time),
and continue taking the next tablets at the usual time. The contraceptive effectiveness of Atywia is
maintained, and additional pregnancy prevention methods are not necessary.
However, if previous dosing errors occurred or more than one tablet was missed, use additional
(mechanical) contraception for 7 days.

One tablet missed in the third week of the current pack
You may choose one of the following options without needing additional contraceptive methods,
provided correct dosing was maintained during the 7 days prior to the missed dose. Otherwise,
follow the first of the two options listed 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 the same time),
   and continue taking the next tablets at the usual time. Start 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 spotting or bleeding may occur during tablet intake.

2. Alternatively, stop taking the remaining tablets in the current pack, take a 7-day or shorter break
   (including the day the tablet was missed), then continue with the next pack.

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

Missed tablet management chart
Missed more than Consult your doctor
1 tablet from the current
pack
Sexual intercourse occurred
in the week before the
missed tablet
No sexual intercourse
occurred

Week 1.

• take the missed tablet
• use additional contraception for 7 days
• finish the pack

Missed only 1
tablet (delayed by
more than 12 hours
but less than 24
hours)
Week 2.

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

Week 3.
or

• discard remaining tablets in the pack
• take a break (no more than 7 days, including the day of the missed tablet)
• continue with the next pack

Special situations:

• Gastrointestinal disturbances (vomiting)

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

• Delaying withdrawal bleeding

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

• Changing the day of withdrawal bleeding to another day of the week

When tablets are taken as directed, bleeding occurs approximately on the same day every 4 weeks.
To change the day of bleeding 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 want 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 period. Spotting or light bleeding 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 as directed. Irregular vaginal bleeding
usually resolves after 3 cycles of Atywia use. If bleeding persists, becomes heavy, or recurs, inform
your doctor.

• Absence of withdrawal bleeding

If all tablets were taken on time, there were no episodes of vomiting or severe diarrhoea, and no
other medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking
Atywia as scheduled.
If withdrawal bleeding does not occur for 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 for women after menopause.

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 a need for dose adjustment in this patient group.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status which the patient considers to be related to the use of Atywia, medical advice should be sought.
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Atywia".
Serious adverse reactions
Serious adverse reactions 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 for additional information and consult your doctor immediately if necessary.
Other possible adverse reactions
The symptoms listed below have been reported by women taking Atywia, although they may not 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,
• alopecia (hair loss),
• skin rash (including macular rash), itching (sometimes affecting 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 (breast inflammation),
• cervicitis (inflammation of the cervix),
• fungal infections,
• oral herpes,
• influenza,
• bronchitis,
• sinusitis,
• upper respiratory tract infections,
• viral infection,
• uterine leiomyoma,
• breast fibroadenoma,
• 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 flow 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 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 insufficiency or vein pain,
• asthma,
• hyperventilation,
• gastritis (inflammation of the stomach lining),
• enteritis (inflammation of the intestine),
• dyspepsia,
• skin reactions,
• skin disorders, including allergic dermatitis, neurodermitis and (or) atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (pigmented facial patch),
• pigmentary disorders and (or) discoloration,
• seborrhoea,
• dandruff,
• hirsutism (excessive hair growth),
• 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 uterine appendages (ovaries and fallopian tubes),
• breast cysts,
• fibrocystic breast changes,
• painful sexual intercourse,
• galactorrhea (milk discharge),
• menstrual disorders,
• chest pain,
• swelling of legs and arms,
• influenza-like illnesses,
• inflammation,
• fever,
• irritability,
• hypercholesterolaemia,
• increased blood triglyceride levels,
• presence of supernumerary breast.

* 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, known as 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),
• nipple discharge,
• fluid retention.

The risk of blood clots may be higher if the patient has any other risk factors (see section 2, "Factors increasing the risk of venous blood clots").
Seek immediate medical advice if the patient experiences symptoms of angioedema, such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or skin rash with possible breathing difficulties (see also section "Warnings and precautions").
Description of selected adverse reactions
Adverse reactions with low frequency or delayed onset, considered to be associated with the group of combined oral contraceptives, are listed below (see also section "When Atywia must not be used" and "Warnings and precautions"):
Cancers

• The number of diagnosed cases of breast cancer in women using combined oral contraceptives is slightly increased. 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).

Others

• 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 known as 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 effectiveness may be caused by interactions of other medicines with oral contraceptives (e.g. St John's wort (Hypericum perforatum), or medicines for epilepsy, tuberculosis, HIV infection and other infections). See section "Atywia with other medicines".
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 reactions helps provide more information on the safety of this medicine.

5. How to store Atywia

Keep this 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.
Translation of the labels appearing on the blister:
Ch.-B. und verw. bis: siehe Prägung – Batch number and expiry date: see embossing
Do not store above 30°C. Store in the original packaging to protect from light.
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 package and other information

What Atywia contains

• The active substances are ethinylestradiol and dienogest.
• Other components of the medicine are:
  Tablet core: monohydrate lactose, magnesium stearate, corn starch, povidone K 30.
  Coating: hypromellose 2910, macrogol 400, titanium dioxide (E 171).

1 blister contains 21 coated tablets.
1 coated tablet contains 0.03 mg ethinylestradiol and 2 mg dienogest.

What Atywia looks like and contents of the pack
White, round coated tablets.
Atywia is available in packs of: 1x21, 3x21, 6x21 coated tablets.
A cardboard pouch is included with the pack, in which the blister should be placed.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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, Poland

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

German marketing authorisation number (country of export): 87088.00.00
Parallel import authorisation number: 413/19

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