Ativia Daili

Leaflet accompanying the packaging: patient information

Atywia Daily, 0.03 mg + 2 mg, film-coated tablets

Ethinylestradiol + Dienogest

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots")

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient

• The leaflet should be kept in case it needs to be re-read.
• In case of any doubts, a doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Atywia Daily and what is it used for

Atywia Daily is a combined hormonal oral contraceptive.

• Each of the 21 white tabletscontains a small amount of two different sex hormones: progesterone derivatives (dienogest) and estrogen (ethinylestradiol);
• Each of the 7 green tabletsdoes not contain active substances (so-called placebo tablets).

Atywia Daily is effective in alleviating symptoms of acne resulting from androgenic hormones.
Atywia Daily is used in:

• preventing pregnancy
• treating women with moderate acne who have decided to use oral contraceptives and have not responded to appropriate local treatment or oral antibiotic treatment.

2. Important information before taking Atywia Daily

General notes

Before starting to take Atywia Daily, the information about blood clots in section 2 should be read.
It is especially important to read about 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 their doctor the need to continue treatment after three to six months of treatment, and then at regular intervals.

When not to take Atywia Daily:

Atywia Daily should not be taken if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6)
• If the patient has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs
• If the patient knows they have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies
• If the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots")
• If the patient has had a heart attack or stroke
• If the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms)
• If the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a disease called hyperhomocysteinemia
• If the patient has (or has had in the past) a type of migraine called migraine with aura
• If the patient smokes (see section 2 "Blood clots")
• If the patient has (or has had in the past) a condition of inflammation of the pancreas associated with high levels of triglycerides (lipid metabolism disorders)
• If the patient has (or has had in the past) severe liver disease (until liver function test results return to normal) (also in cases of Dubin-Johnson syndrome and Rotor syndrome)
• If the patient has (or has had in the past) benign or malignant liver tumors
• If the patient has (or has had in the past) a hormone-dependent tumor (breast or genital cancer)
• If the patient has bleeding from the genital tract of unknown cause
• If the patient does not have menstrual bleeding for unknown reasons
• If the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Atywia Daily and other medicines").

Warnings and precautions

Before starting to take Atywia Daily, the patient should discuss it with their doctor, pharmacist, or nurse.
If any of the following symptoms occur for the first time while taking Atywia Daily , Atywia Daily should be stopped immediately and a doctor should be consulted. During this time, non-hormonal methods of contraception should be used.
When should a doctor be consulted?
A doctor should be consulted immediately

• if the patient notices possible symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots"). To get a description of serious side effects, see "How to recognize blood clots".

The patient should tell their doctor if they have any of the following conditions.

If these symptoms appear or worsen while taking Atywia Daily, the patient should also tell their doctor.

• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system),
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure),
• if the patient has sickle cell anemia (a hereditary disease of red blood cells),
• if the patient has elevated levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis,
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots"),
• if the patient has recently given birth, in which case they are at increased risk of blood clots. The patient should consult their doctor to find out how soon they can start taking Atywia Daily after giving birth,
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin),
• if the patient has varicose veins,
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing, they should contact their doctor immediately. Estrogen-containing medicines may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Atywia Daily, is associated with an increased risk of blood clots, compared to not taking the therapy.
Blood clots can form

• in veins (called "venous thromboembolism" or "venous thrombotic event")
• in arteries (called "arterial thromboembolism" or "arterial thrombotic event"). Not all patients who have had a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

It should be remembered that the overall risk of harmful blood clots caused by taking Atywia Daily is small.

HOW TO RECOGNIZE BLOOD CLOTS

A doctor should be consulted immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
Why is the patient
likely suffering
from this?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which can be felt when standing or walking;

increased temperature in the affected leg;

• change in skin color of the leg, such as pallor, redness, or discoloration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If the patient is unsure, they should consult a doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which can lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, heaviness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• a feeling of discomfort in the lower part of the body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

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

When is the risk of blood clots in a vein highest?

The risk of forming blood clots in a vein is highest during the first year of taking combined hormonal contraceptives. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not taking combined hormonal contraceptives. If the patient stops taking Atywia Daily, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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

• if the patient is overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop taking Atywia Daily for a few weeks before surgery or immobilization. If the patient needs to stop taking Atywia Daily, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years old);
• if the patient has recently given birth. The risk of blood clots increases with the number of risk factors present in the patient. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor. It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop Atywia Daily. The patient should tell their doctor if any of the above conditions change while taking Atywia Daily, e.g., if someone in their immediate family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

Factors that increase the risk of blood clots in veins

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

• if the patient has a large body mass index (BMI) (over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old);
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast;
• with age (especially over 35 years old);
• if the patient has recently given birth;

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

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

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with taking Atywia Daily is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. While taking a hormonal contraceptive like Atywia Daily, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disturbance called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should tell their doctor if any of the above conditions change while taking Atywia Daily, e.g., if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain weight significantly.

When to stop taking Atywia Daily immediately:

• if the patient is pregnant or thinks they may be pregnant;
• if the patient has symptoms of phlebitis or blood clots (see section 2 "Blood clots");
• if their blood pressure remains above 140/90 mm Hg (the doctor may recommend resuming the medicine after blood pressure returns to normal with the help of antihypertensive drugs);
• if surgery is planned (the patient should stop taking the medicine at least 4 weeks before surgery) or if they will be immobilized for a long time (see section 2 "Blood clots");
• if they experience a migraine for the first time or if it worsens;
• if the patient experiences extremely frequent, severe, persistent headaches that start suddenly with symptoms of aura (visual, sensory, or motor disturbances);
• if the patient experiences severe abdominal pain (see also "Oral contraceptives and cancer");
• if the patient's skin and eyes turn yellow, their urine is brown, or their stools are very pale (jaundice) or if they feel itching all over their body;
• if the patient has diabetes (diabetes mellitus) and their blood sugar levels rise unexpectedly;
• if the patient has porphyria (a blood disorder) and an attack occurs while taking Atywia Daily.

Situations requiring special medical attention:

• if the patient has heart or kidney disease;
• if the patient has inflammatory conditions of the veins (phlebitis) or varicose veins;
• if the patient has circulatory problems in their arms and/or legs;
• if the patient's blood pressure is above 140/90 mm Hg;
• if the patient has had lipid metabolism disorders (disorders of fat metabolism);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has had liver disease;
• if the patient has had gallbladder disease;
• if the patient has migraines;
• if the patient has depression;
• if the patient has diabetes (diabetes mellitus) or has impaired glucose tolerance (reduced glucose tolerance). The patient's insulin dose and antidiabetic drugs may need to be adjusted while taking Atywia Daily;
• if the patient smokes (see section 2 "Blood clots");
• if the patient has epilepsy. If the frequency of seizures increases while taking Atywia Daily, the patient should consider using other contraceptive methods;
• if the patient has movement disorders, also known as "Saint Vitus' Dance" (Sydenham's chorea);
• if the patient has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis);
• if the patient has a blood disorder that causes kidney damage (hemolytic uremic syndrome);
• if the patient has been diagnosed with a benign tumor in the muscular layer of the uterus (uterine fibroid);
• if the patient has otosclerosis;
• if the patient will be immobilized for a long time (see section 2 "Blood clots");
• if the patient is overweight;
• if the patient has an autoimmune disease (systemic lupus erythematosus);
• if the patient is 40 years old or more.

Psychiatric disorders:

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

Oral contraceptives and cancer

Women taking oral contraceptives have a slightly higher risk of breast cancer than women of the same age who do not take them. The risk of cancer decreases after stopping the medicine and returns to the same level as in women who have never taken the pills after 10 years of stopping.
Since breast cancer is rare in women under 40, the increased number of breast cancer diagnoses in women currently or recently taking combined oral contraceptives is small compared to the overall risk of breast cancer.
Some epidemiological studies suggest that long-term use of combined oral contraceptives by women infected with the human papillomavirus (HPV) may increase the risk of cervical cancer. However, there is ongoing debate about the significance of additional factors (e.g., differences in the number of sexual partners and the use of mechanical contraceptives).
In very rare cases, a benign liver tumor may develop. Such a tumor can cause life-threatening bleeding into the abdominal cavity. The patient should consult their doctor
in case of severe abdominal pain.Some studies suggest an increased risk of liver tumors in women taking oral contraceptives, but these tumors are very rare.

Other diseases

Hypertension

High blood pressure has been reported in women taking hormonal contraceptives, especially in older women and those taking them for a longer period. The increase in blood pressure is associated with the progestin effect.
Patients with diseases related to high blood pressure and certain kidney diseases should use other contraceptive methods (consult a doctor, see also "When not to take Atywia Daily", "When to stop taking Atywia Daily immediately", and "Situations requiring special medical attention").

Chloasma (yellow-brown discoloration)

Yellow-brown spots (chloasma) may occasionally occur on the skin, especially in women who have had chloasma during pregnancy. Women prone to chloasma should avoid exposure to sunlight and ultraviolet radiation while taking combined oral contraceptives.

Irregularities in the menstrual cycle

While taking oral contraceptives, irregular bleeding (spotting or intermenstrual bleeding) may occur, especially during the first few months of taking the pills. The patient should consult their doctor if irregular bleeding persists for more than three cycles or if it recurs after a regular cycle has been established.
In some women, withdrawal bleeding may not occur during the 7 days when they take the greenplacebo tablets. If Atywia Daily has been taken correctly, pregnancy is unlikely. However, if Atywia Daily has not been taken correctly and withdrawal bleeding has not occurred or if two consecutive withdrawals have occurred, the patient may be pregnant. Pregnancy should be ruled out before continuing to take Atywia Daily.
After stopping hormonal contraceptives, it may take some time for the natural menstrual cycle to return.

Reduced effectiveness

The effectiveness of Atywia Daily may be reduced if pills are missed, vomiting occurs, severe diarrhea occurs, or certain medicines are taken at the same time.
If Atywia Daily is taken with herbal products containing St. John's Wort ( Hypericum perforatum), additional contraceptive methods (e.g., condoms) should be used (see "Atywia Daily and other medicines").

Medical examinations

Before taking Atywia Daily for the first time or after a break in taking it, a thorough medical and family history should be taken, and a physical examination, including a breast examination, should be performed. Pregnancy should be ruled out. Women taking oral contraceptives should be regularly examined. The patient should inform their doctor if they smoke and about any other medicines they are taking.

Atywia Daily does not protect against HIV infection and other sexually transmitted diseases.

Atywia Daily and other medicines

Atywia Daily should not be taken if the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results in the blood (increased liver enzyme activity). Before starting these medicines, the doctor will prescribe a different contraceptive method.
Taking Atywia Daily can be resumed after about 2 weeks after finishing the above-mentioned treatment. See section "When not to take Atywia Daily".
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Certain medicines may reduce the contraceptive effectiveness of Atywia Daily and/or cause intermenstrual bleeding.
Medicines that may reduce the effectiveness of Atywia Daily:

• Medicines that increase intestinal motility (e.g., metoclopramide).
• Medicines used to treat epilepsy, such as phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate.
• Medicines used to treat high blood pressure in the blood vessels of the lungs (bosentan).
• Certain antibiotics used to treat tuberculosis (e.g., rifampicin) or fungal infections (e.g., griseofulvin).
• Medicines used to treat HIV and hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz).
• Medicines used to treat narcolepsy, central nervous system disorders (modafinil).
• Herbal medicines containing St. John's Wort ( Hypericum perforatum).

Women taking any of these medicines should use temporary additional non-hormonal contraceptive methods (e.g., condoms) or choose a different contraceptive method. When taking any of these medicines with Atywia Daily, additional contraceptive methods should be used for 7 to 28 days after finishing the treatment, depending on the medicine. The patient should consult their doctor or pharmacist if they are unsure. If the period of using a non-hormonal contraceptive method exceeds the duration of one pack of Atywia Daily, the next pack should be started immediately, skipping the placebo tablets. If long-term use of medicines containing the above-mentioned active substances is required, the use of non-hormonal contraceptive methods should be considered.

Taking the following medicines at the same time as Atywia Daily may increase the risk of side effects:

• Paracetamol (used for pain and fever),
• Vitamin C (ascorbic acid),
• Atorvastatin (used to lower blood lipid levels),
• Troleandomycin (an antibiotic),
• Antifungal medicines that are imidazole derivatives (used to treat fungal infections), such as fluconazole,
• Indinavir (used to treat HIV infection).

Atywia Daily may affect the action of other medicines:

• Cyclosporin (used to weaken the immune system),
• Theophylline (used to treat asthma),
• Corticosteroids (e.g., cortisone),
• Certain benzodiazepines (sedatives), such as diazepam, lorazepam,
• Clofibrate (used to lower blood lipid levels),
• Paracetamol (used for pain and fever),
• Morphine (a strong pain reliever),
• Lamotrigine (used to treat epilepsy).

The patient should read the package leaflets of all medicines they are taking.

Diabetes

Patients with diabetes may need to adjust their insulin and antidiabetic drug doses.

Laboratory tests

Taking hormonal contraceptives may affect the results of certain laboratory tests, such as liver function tests, adrenal function tests, kidney function tests, thyroid function tests, as well as the levels of certain blood proteins, such as lipid-binding proteins or lipoproteins, proteins involved in carbohydrate metabolism, and proteins involved in blood clotting and fibrinolysis.
However, these changes are usually within normal limits.

Pregnancy and breastfeeding

In pregnancy, while breastfeeding, or if the patient thinks they may be pregnant or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Atywia Daily should not be taken during pregnancy or if the patient thinks they may be pregnant. If the patient thinks they may be pregnant, they should consult their doctor as soon as possible.

Breastfeeding

Taking Atywia Daily while breastfeeding may reduce the amount of milk produced and small amounts of the active substances may pass into the breast milk.
Non-hormonal contraceptive methods should be used while breastfeeding.

Driving and using machines

Atywia Daily does not affect the ability to concentrate, drive a car, or operate machinery.

Atywia Daily contains lactose

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

3. How to take Atywia Daily

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
If the doctor does not recommend otherwise, one tablet should be taken daily.

How to take Atywia Daily

Each blister pack contains 28 tablets: 21 white tablets containing active substances and 7 green tablets containing placebo.
The two differently colored tablets of Atywia Daily are arranged in the order they should be taken.
The tablets should be taken daily at the same time, with a small amount of water if necessary.
The tablets should not be mixed up: one whitetablet should be taken for the first 21 days, followed by one greentablet, once daily for 7 days. Then, a new blister pack should be started immediately (21 whitetablets, followed by 7 greentablets). There is no break between the two blister packs.
Due to the different composition of the tablets, it is essential to start taking the medicine from the first tablet in the top left corner (located near the word "Start") and take one tablet daily.
To maintain the correct order of taking the tablets, the patient should follow the direction of the arrow on the blister pack.

Preparing the blister pack

To help the patient remember to take a tablet, each pack of Atywia Daily contains 7 self-adhesive strips with the names of the days of the week for each blister pack. The patient should choose a strip that starts with the day of the week they will start taking the tablets. For example, if they start taking the tablets on a Wednesday, they should choose a strip that starts with "Wed".
The strip should be placed in the top part of the blister pack marked "Place the day-of-the-week sticker here".
Then, each tablet will have a symbol of the day, indicating the day it should be taken. The arrows show the order of taking the tablets.
During the 7 days when the patient takes the greenplacebo tablets (placebo days), withdrawal bleeding should occur. This bleeding usually starts 2 or 3 days after taking the last whitetablet containing active substances. After taking the last greentablet from the blister pack, the patient should start a new blister pack, regardless of whether the bleeding has stopped or not.
This means that new blister packs will be started on the same day of the week, and the bleeding will occur at approximately the same time every month.
If the patient takes Atywia Daily in this way, they will be protected against pregnancy, including during the 7 days when they take the greenplacebo tablets.

When to start the first blister pack of Atywia Daily

If the patient has not taken a hormonal contraceptive in the previous month.

Taking Atywia Daily should be started on the first day of the menstrual cycle (i.e., the first day of menstruation). If the patient starts taking Atywia Daily on the first day of their period, they will be immediately protected against pregnancy. The patient can also start taking Atywia Daily on days 2-5 of their menstrual cycle, but in this case, they should use additional contraceptive methods (e.g., condoms) for the first 7 days.

Changing from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or transdermal patch.

• If the patient was taking an oral contraceptive (with a regimen that includes 21 active tablets and a 7-day break), they can start taking Atywia Daily the day after the break in their previous contraceptive regimen.
• If the patient was taking an oral contraceptive that contains 28 tablets, both active and placebo, they can start taking Atywia Daily the day after taking the last inactive tablet (without hormones) from the pack of their previous contraceptive. If in doubt, the patient should consult their doctor or pharmacist.
• In the case of a transdermal patch or vaginal ring, the patient can start taking Atywia Daily the day after the break in the regimen of the vaginal ring or transdermal patch.

Changing from a progestin-only method (mini-pill containing only progestin)

The patient can stop taking the mini-pill on any day. They can start taking Atywia Daily the next day. Additional contraceptive methods (e.g., condoms) should be used for the first 7 days.

Changing from a progestin-only method (implant or intrauterine system that releases progestin)

The patient can start taking Atywia Daily on the day they would have had their next injection or on the day the implant is removed. Additional contraceptive methods (e.g., condoms) should be used for the first 7 days.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Atywia Daily, a doctor should be consulted.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see point 2 "Important information before using Atywia Daily".
Detailed information on serious side effects related to the use of the medicine is described in point 2 of the Patient Information Leaflet in the section "Important information before using Atywia Daily". You should read these sections to obtain additional information and, if necessary, consult a doctor immediately.
A doctor should be contacted 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, as well as breathing problems (see "Warnings and precautions").
Side effects that may be related to the use of Atywia Daily:

• Frequent(occurring in less than 1 in 10 people):
• headache,
• breast pain, including discomfort and breast tenderness.

Infrequent(occurring in less than 1 in 100 people):

• vaginitis and/or vulvovaginitis (inflammatory conditions of the genital organs), vaginal candidiasis (thrush) or other fungal infections of the vagina,
• increased appetite,
• depressed mood,
• dizziness,
• migraine,
• high or low blood pressure, in rare cases, an increase in diastolic blood pressure (the lowest level to which blood pressure drops between heartbeats),
• abdominal pain, including upper and lower abdominal pain, abdominal discomfort, and/or bloating,
• nausea, vomiting, or diarrhea,
• acne,
• alopecia (hair loss),
• rash (including patchy rash),
• pruritus (sometimes all over the body),
• changes in bleeding, such as menorrhagia, metrorrhagia, oligomenorrhea, and amenorrhea,
• intermenstrual bleeding, menorrhagia (irregular bleeding between periods),
• dysmenorrhea (painful menstruation, painful periods), lower abdominal pain
• breast enlargement, including congestion and swelling of the breast,
• vaginal discharge,
• ovarian cysts,
• fatigue, including asthenia (weakness) and malaise,
• weight changes (including weight gain, weight loss, and fluctuations in weight).

Rare(occurring in less than 1 in 1000 people):

• ovarian and fallopian tube inflammation,
• cervicitis (inflammation of the cervix),
• urinary tract infections, cystitis (inflammation of the bladder),
• mastitis (breast inflammation),
• fungal infections (candidiasis), viral infections, oral herpes,
• influenza, bronchitis, upper respiratory tract infections, sinusitis,
• asthma,
• hyperventilation,
• uterine fibroids,
• breast fibroadenoma,
• anemia,
• hypersensitivity (allergic reaction),
• virilization (development of male secondary sex characteristics),
• anorexia (severe loss of appetite),
• depression, mood swings, irritability, aggression
• insomnia, sleep disorders,
• cerebrovascular disorders (disorders of blood flow to parts of the brain or heart), stroke (reduced or interrupted blood flow to part of the brain), cardiovascular disorders (disorders of blood flow to the heart), dystonia (persistent muscle contractions causing, e.g., twisting or abnormal posturing),
• dry or irritated eyes,
• vision disorders,
• sudden hearing loss, hearing disorders,
• tinnitus,
• balance disorders
• tachycardia (rapid heart rate),
• thrombosis (blood clots in blood vessels), pulmonary embolism (a blood clot moving to the lungs),
• phlebitis (inflammation of a vein, including blood clots),
• varicose veins, venous disorders, or vein pain,
• orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position),
• hot flashes,
• gastritis, enteritis,
• indigestion,
• skin reactions, including allergic dermatitis, neurodermatitis, and/or atopic dermatitis, urticaria, psoriasis,
• excessive sweating,
• chloasma (yellow-brown spots on the skin, most often on the face), pigmentation disorders, and/or discoloration,
• seborrhea,
• dandruff,
• hirsutism (excessive hair growth),
• skin disorders, "orange peel" skin appearance,
• telangiectasia,
• back pain, chest pain,
• musculoskeletal disorders, muscle pain, arm and leg pain,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• adnexal pain or cysts (ovaries and fallopian tubes),
• breast cysts, breast fibrocysts, breast swelling,
• painful intercourse,
• galactorrhea (milk secretion), breast discharge,
• menstrual disorders,
• edema of the legs and hands (fluid retention),
• flu-like illnesses, inflammation, fever
• increased levels of triglycerides and cholesterol in the blood (hypertriglyceridemia, hypercholesterolemia),
• blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis),
• in the lungs (e.g., pulmonary embolism),
• myocardial infarction,
• stroke,
• mini-stroke or transient stroke symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, and/or intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see point 2 for further information on risk factors for blood clots and symptoms of blood clots).
Frequency not known(cannot be estimated from the available data):

• decreased or increased libido (sexual desire),
• intolerance to contact lenses,
• urticaria,
• erythema multiforme, erythema nodosum.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Atywia Daily

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
After the abbreviation "Lot" on the carton and blister, the batch number is given.
Do not store above 30°C.
Store the blister in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Atywia Daily contains

The blister of Atywia Daily contains 21 white film-coated tablets in the first, second, and third rows and 7 green film-coated tablets in the fourth row.
The white film-coated tablets containing active substances:

• The active substances of the medicine are ethinylestradiol and dienogest. One film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
• The excipients are:
• Core: lactose monohydrate, corn starch, povidone K-30, magnesium stearate
• Coating: hypromellose 2910, macrogol 400, titanium dioxide (E171)

Tablets without active substances:

• Core: lactose monohydrate, corn starch, povidone K-30, magnesium stearate, colloidal silica anhydrous
• Coating: hypromellose 2910, triacetin, polysorbate 80, titanium dioxide (E171), indigo carmine lake (E132), yellow iron oxide (E172)

What Atywia Daily looks like and contents of the pack

Active substance tablets: white, round, film-coated tablets.
Placebo tablets: green, round, film-coated tablets.
Atywia Daily is available in packs containing 28, 3x28, and 6x28 film-coated tablets (21 active substance tablets and 7 placebo tablets).
Not all pack sizes may be marketed.
Each pack of Atywia Daily contains a blister and a set of 7 self-adhesive stickers with the names of the days of the week, in a different arrangement, depending on when the patient starts taking the tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw

Manufacturer

Laboratorios León Farma SA
C/La Vallina s/n, Pol. Ind. Navatejera
24193 Villaquilambre, León
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Serisima Continu 2 mg / 0.03 mg film-coated tablet
Bulgaria:
Dienorette 2mg/0,03 mg
Czech Republic:
Diecyclen 2 mg/0,03 mg film-coated tablets
Estonia:
Diecyclen
France:
Serisima Continu 2 mg / 0.03 mg film-coated tablet
Italy:
Serisima Diario 2 mg and 0.03 mg film-coated tablet
Lithuania:
Diecyclen 2mg/0.03 mg film-coated tablets
Latvia:
Diecyclen 2mg/0.03 mg coated tablets
Luxembourg:
Serisima Continu 2 mg / 0.03 mg film-coated tablet
Hungary:
Diedita 2 mg/0.03 mg, film-coated tablets
Poland:
Atywia Daily
Austria:
Dienorette 0,03 mg / 2 mg 21+7 film-coated tablets
Romania:
Dienorette 2 mg/0,03mg film-coated tablets
Slovakia:
Diecyclen 2mg/0,03mg film-coated tablets
Spain:
Ceciliana Diario, 2 mg/0.03 mg film-coated tablets EFG
Date of last revision of the leaflet:21.11.2024

Other sources of information:

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, http://www.urpl.gov.pl