Atywia

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging 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 medicine.
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• 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 taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Atywia is and what it is used for
2. What you need to know 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 recommendations in this leaflet, the likelihood of becoming pregnant is very low.
Indications for use
Prevention of pregnancy.
Treatment of women with moderate acne who have decided to use oral contraceptives and in whom adequate topical treatment or oral antibiotic therapy has failed.

2. Important information before using Atywia

General information
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. You should discuss with your 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 veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs.
• If you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies.
• If you require 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 had in the past) 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 currently have (or have had in the past) 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 have had or currently have 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 conditions listed above 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
Before starting Atywia, discuss this with your doctor or pharmacist.

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 2 below "Blood clots (thrombosis)").

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

Special and regular medical monitoring is necessary if you take oral hormonal contraceptives and any of the following conditions apply.

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 disorders,
• 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 family members,
• If you have 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 breast cancer has occurred in your close family,
• 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 defence system),
• If you have haemolytic uraemic syndrome (a blood clotting disorder leading to 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 then 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 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 experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or a skin rash with possible breathing difficulties, seek immediate medical advice. Medicines containing estrogens may trigger or worsen symptoms of hereditary or acquired angioedema.

If any of the symptoms listed above 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 (called "venous thrombosis" or "venous thromboembolic disease"),
• in arteries (called "arterial thrombosis" or "arterial thromboembolic events").

Full recovery from a blood clot does not always occur. 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 caused by taking Atywia is small.

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 blood clots in the 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 blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using 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 compared to not using 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 used.

• Among women who are not using combined hormonal contraceptives and are not pregnant, about 2 out of 10,000 will develop blood clots in a one-year period.
• Among women using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate, about 5–7 out of 10,000 will develop blood clots in a one-year period.
• Among women using combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Atywia, about 8–11 out of 10,000 will develop blood clots in a one-year period.
• The risk of developing blood clots in veins also 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 developing blood clots associated with the use of Atywia is small, however,
some factors may increase this risk. The risk is higher:

• if the patient has significant 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 clotting disorder.
• if the patient requires 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 periods of limited mobility. 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 venous blood clots,
particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of these 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?
Similar to venous blood clots, arterial clots can cause 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, smoking should be discontinued. 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 has 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 fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, 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 particularly severe, the risk of arterial 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 taking oral contraceptives than in 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 described 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. These tumours may lead to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, the doctor should be informed as soon as possible.
Malignant tumours may be life-threatening or fatal.

Reports suggest a higher 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 pills 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, 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.
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 they 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 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”);
• cases of thrombosis, heart attack or stroke occur in close relatives;
• 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 subsequent 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 a doctor).

Stop taking Atywia and contact the doctor as soon as possible if 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 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 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 influence of Atywia on the ability to drive or operate machinery has been observed.

Atywia contains monohydrate lactose and glucose
Atywia contains lactose and glucose. 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 used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The leaflet describes many situations in which use of Atywia should be discontinued or in
which the effectiveness of the medicine may be reduced. It also indicates circumstances under which
sexual intercourse should be avoided or additional contraceptive methods (e.g. condoms or other
mechanical methods) should be used. The calendar method and temperature-based methods must not
be used, as Atywia affects body 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 use 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. 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 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 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 were used in the previous month
Tablet intake should begin 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 taking 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)
The mini-pill may be discontinued at any time and replaced with Atywia at the same time of day. 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 contraceptive system releasing progestogen
Atywia should be started on the day the next injection was due 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 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".
The 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, the 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 more than the recommended dose has been taken, or if someone else has taken the medicine, inform a doctor.
Stopping further use of Atywia
The medicine may be discontinued at any time. The doctor will then suggest alternative contraceptive methods. If stopping the medicine due to planning pregnancy, wait until the next natural menstrual period. 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 diagram below).
More than 1 tablet missed from the pack
Consult your doctor.
1 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 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 the doctor immediately. Also refer to the "Missed tablet management chart".
1 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 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 1 tablet was missed, use an additional (mechanical) contraceptive method for 7 days.
1 tablet missed in the third week of taking the current pack
One of the following options may be chosen without the need for additional contraceptive methods, provided correct dosing was maintained during the 7 days preceding the missed dose. Otherwise, the first of the two options below should be followed, and an additional contraceptive method used 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 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 tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), then continue with tablets from the next pack.

If tablets are forgotten and no expected bleeding occurs during the first tablet-free interval, pregnancy may be possible. Contact a doctor before starting the next pack.
Missed tablet management chart

Management in case of:

• Gastrointestinal disturbances (vomiting) If vomiting occurs, the active substances in Atywia may not be fully absorbed. If vomiting occurs within 3 to 4 hours after taking the tablet, follow the recommendations for a missed tablet. In case of severe gastrointestinal disturbances, additional contraceptive methods should be used.
• Intention to delay the onset of bleeding To delay the onset of 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. During intake of tablets from the next pack, slight bleeding or spotting may occur. The next pack should be started after a 7-day break.
• Intention to change the day of bleeding to another day of the week If tablets are taken as directed, bleeding occurs approximately on the same day every 4 weeks. To change the bleeding day to another day of the week than indicated by the dosing schedule, shorten the next tablet-free interval by the number of days by which the bleeding date is to be shifted. For example, if bleeding usually starts on Fridays and should 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 time. Slight bleeding or spotting may occur during intake of the next pack.
• Unexpected bleeding During the first few months of taking Atywia, irregular genital bleeding (spotting or intermenstrual bleeding) may occur. Despite this, continue taking the tablets. Irregular genital bleeding usually resolves after 3 cycles of Atywia use. If bleeding persists, becomes heavy, or recurs, report this to a 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 the doctor immediately. Do not start the next pack of Atywia until the 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 have been conducted with Atywia in patients with renal impairment.
Available data do not indicate the need for dose adjustment in this patient group.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any adverse effects 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 immediately.

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 effects
Serious adverse effects associated with taking Atywia and their accompanying symptoms are described in the following sections of this leaflet: "Oral contraception and thrombosis" and "Oral contraception and cancer". Please read these sections carefully to obtain additional information and consult your doctor immediately if necessary.

Other possible adverse effects
The symptoms listed below have been reported by women 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,
• alopecia (hair loss),
• skin rash (including maculopapular rash), itching (sometimes generalized),
• 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,
• dysmenorrhoea (painful menstruation),
• 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 (inflammatory condition of the cervix),
• fungal infections,
• oral herpes,
• influenza,
• bronchitis,
• sinusitis,
• upper respiratory tract infections,
• viral infection,
• uterine leiomyoma,
• fibroadenoma of the breast,
• 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,
• vertigo,
• 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 upon standing 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),
• indigestion,
• skin reactions,
• skin disorders, including allergic dermatitis, neurodermatitis 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 adnexa (ovaries and fallopian tubes),
• breast cysts,
• fibrocystic breast changes,
• dyspareunia (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 lung 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 likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2, "For further information on factors increasing the risk of blood clots and symptoms of blood clots").

Seek medical advice immediately 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 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"):

Cancers

• A slightly increased number of cases of breast cancer diagnosis 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 remains small in relation to the overall risk of breast cancer. A causal relationship between combined oral contraceptives and breast cancer has not been established.
• 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 whose relationship with COC use is not established: jaundice and (or) pruritus associated with cholestasis (blocked bile flow); gallstones; metabolic disorders such as porphyria; systemic lupus erythematosus (a 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 with other medicines (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, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 492 13 01, fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorization holder or parallel importer.

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 information on the immediate packaging:
Ch.B. und verw. bis siehe Prägung – batch number and expiry date see embossing
Do not store above 30°C. Store blisters in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Atywia contains

• The active substances are ethinylestradiol and dienogest.
• The other ingredients are: monohydrate lactose, magnesium stearate, maize starch, povidone, hypromellose, macrogol, 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.
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, S.A.
Poligono Industrial Navatejera, C/La Vallina s/n
24193 Navatejera
Villaquilambre, LEÓN
Spain
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warszawa
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
German marketing authorisation number, country of export: 87088.00.00
Parallel import authorisation number: 85/26
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