Ativia Daili

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Atywia Daily(Ceciliana Diario)

0.03 mg + 2 mg, coated tablets

Ethinyl estradiol + Dienogest
Atywia Daily and Ceciliana Diario are different trade names for the same medicine.

IMPORTANT INFORMATION ABOUT COMBINED CONTRACEPTIVE METHODS

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

IT IS NECESSARY TO CAREFULLY READ THE CONTENT OF THE LEAFLET BEFORE USING THE MEDICINE, AS IT CONTAINS IMPORTANT INFORMATION FOR THE PATIENT

• The leaflet should be kept in case it needs to be read again.
• 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 using Atywia Daily
• 3. How to use 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 hormonal combined oral contraceptive.

• Each of the 21 white tabletscontains a small amount of two different sex hormones: progesterone derivatives (dienogest) and estrogen (ethinyl estradiol);
• 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 the action of androgen 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 USING ATYWIA DAILY

GENERAL NOTES

Before starting to take Atywia Daily, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Improvement of acne symptoms usually occurs after three to six months of treatment, but skin condition may continue to improve even after six months of treatment. The patient should discuss with their doctor the need to continue treatment after three to six months of treatment, and then at regular intervals.

WHEN NOT TO USE ATYWIA DAILY:

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

• If the patient is allergic to 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 have 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 transient ischemic attack (transient stroke symptoms).
• If the patient has any of the following diseases, which may increase the risk of arterial thrombosis:
• severe diabetes with vascular 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) pancreatitis associated with high triglyceride levels (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 the case 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) hormone-dependent tumors (breast or genital tumors).
• If the patient has bleeding from the genital tract of unknown cause.
• If the patient does not have menstrual bleeding of unknown cause.
• If the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also "Atywia Daily and other medicines").

WARNINGS AND PRECAUTIONS

Before starting to take Atywia Daily, you should discuss it with your 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 any symptoms that may indicate the occurrence 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 the occurrence of blood clots".

THE DOCTOR SHOULD BE TOLD IF THE PATIENT HAS ANY OF THE FOLLOWING CONDITIONS.

If these symptoms appear or worsen while taking Atywia Daily, the doctor should also be told.

• 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 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 been found to have high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis,
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots"),
• if the patient has recently given birth, in which case she is at increased risk of blood clots. The doctor should be consulted to determine how soon Atywia Daily can be started after childbirth,
• if the patient has superficial thrombophlebitis (inflammation of 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, and/or skin rash, and/or breathing problems, they should contact their doctor immediately. Estrogen-containing medicines may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Atywia Daily, is associated with an increased risk of blood clots, compared to a situation where therapy is not used. In rare cases, a blood clot can block a blood vessel and cause serious complications. Blood clots can occur:

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease")
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease"). Not all patients who have had a blood clot will fully recover. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

IT SHOULD BE REMEMBERED THAT THE TOTAL RISK OF HARMFUL BLOOD CLOTS CAUSED BY ATYWIA DAILY IS SMALL.

HOW TO RECOGNIZE THE OCCURRENCE OF 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 to suffer
from these symptoms?
Swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
Deep vein thrombosis

• pain or tenderness in the leg, which may only be felt while standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, such as pallor, redness, or cyanosis.
• 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 cough 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 may 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 upper body that radiates 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
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden disturbances of gait, dizziness, loss of balance, or coordination;
• sudden, severe, or prolonged headaches without a known cause;
• loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be transient with almost immediate and complete recovery, but a doctor should be consulted immediately, as the patient may be at risk of having another stroke.
Stroke

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

WHEN IS THE RISK OF BLOOD CLOTS IN VEINS THE HIGHEST?

The risk of forming blood clots in veins is highest during the first year of using combined hormonal contraceptives. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to a situation where combined hormonal contraceptives are not used. If the patient stops using 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 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 hereditary coagulation disorders;
• if the patient needs to have 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 using Atywia Daily for a few weeks before surgery or immobilization. If the patient needs to stop using Atywia Daily, they should ask their doctor when they can resume using 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 unsure. The doctor may decide to stop using Atywia Daily. The patient should tell the doctor if any of the above conditions change while using Atywia Daily, e.g., if someone in their immediate family is diagnosed with thrombosis without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

WHAT CAN HAPPEN IF BLOOD CLOTS FORM IN ARTERIES?

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

FACTORS THAT INCREASE THE RISK OF BLOOD CLOTS IN ARTERIES

It is essential to emphasize that the risk of heart attack or stroke associated with Atywia Daily is very small, but some factors can increase this risk. The risk may increase:

• with age (over approximately 35 years old);
• if the patient smokes. While using a hormonal contraceptive like Atywia Daily, it is recommended to quit smoking. If the patient is unable to 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, arrhythmia 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 using Atywia Daily, e.g., if they start smoking, someone in their immediate family is diagnosed with thrombosis without a known cause, or if they gain significant weight.

WHEN SHOULD ATYWIA DAILY BE STOPPED IMMEDIATELY?

• if the patient is pregnant or suspects they may be pregnant;
• if the patient has symptoms of phlebitis or blood clots (see section 2 "Blood clots");
• if 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 hypertension medications);
• if surgery is planned (it is necessary to stop using the medicine at least 4 weeks before surgery), or in case of prolonged immobilization (see section 2 "Blood clots");
• in case of a new migraine or worsening of migraines;
• 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 tumors");
• if the patient's skin and eyes turn yellow, urine is brown, or stools are very pale (jaundice) or if the patient feels itching all over their body;
• if the patient has diabetes ( Diabetes mellitus), and blood sugar levels rise unexpectedly;
• if the patient has porphyria, a blood disorder that causes liver damage, and the disease recurs while using 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 disorders of the 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 if they have impaired glucose tolerance (reduced glucose tolerance). It may be necessary to change the dose of insulin and diabetes medications while using Atywia Daily;
• if the patient smokes (see section 2 "Blood clots");
• if the patient has epilepsy. If the frequency of seizures increases while using Atywia Daily, it may be necessary to 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 myoma);
• if the patient has otosclerosis;
• in case of prolonged immobilization (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 using 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 TUMORS

In women who take oral contraceptives, breast cancer is slightly more common than in women of the same age who do not take them. The risk of breast cancer decreases after stopping the medicine and after 10 years of stopping the medicine, it is the same as in women who have never taken the pills.
Since breast cancer is rare in women who have not reached the age of 40, the increased number of breast cancer diagnoses in women who are currently or have recently used combined oral contraceptives is small compared to the overall risk of breast cancer. The results of 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 contraceptive methods).
In very rare cases, a benign liver tumor may develop. Such a tumor can cause life-threatening bleeding into the abdominal cavity. A doctor should be consulted in case of severe abdominal pain.The results of 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 the frequency of high blood pressure is related to the progestin effect. Patients who have diseases related to high blood pressure and some kidney diseases should use other contraceptive methods (consult a doctor, see also "When not to use Atywia Daily", "When to stop using Atywia Daily", 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 using combined oral contraceptives.

IRREGULARITIES IN THE MENSTRUAL CYCLE

While taking oral contraceptives, irregular bleeding (spotting or intermenstrual bleeding) may occur, especially in the first few months of taking the pills. The doctor should be consulted if irregular bleeding persists for more than three cycles or if it recurs after a completed regular cycle.
In some women, withdrawal bleeding may not occur during the 7 days of taking placebo tablets. If Atywia Daily was taken correctly, pregnancy is unlikely. However, if Atywia Daily was not taken correctly and withdrawal bleeding did not occur or two consecutive withdrawals did not occur, the patient may be pregnant. Pregnancy should be ruled out before continuing to use 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 medications are taken at the same time. If Atywia Daily is taken with herbal products containing St. John's Wort ( Hypericum perforatum), additional contraceptive methods should be used (e.g., condoms) (see "Atywia Daily and other medicines").

MEDICAL EXAMINATIONS

Before taking Atywia Daily for the first time or after a break in its use, a thorough medical and family history should be taken, and a control examination should be performed, including a breast examination. Pregnancy should be ruled out. Women taking oral hormonal contraceptives should be regularly examined. The patient should inform their doctor if they smoke and about any other medications 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 used if the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause an increase in liver enzyme activity (increase in ALT enzyme activity).
The doctor will prescribe a different type of contraception before starting treatment with these medicines.
Atywia Daily can be started again after about 2 weeks after the end of this treatment. See section "When not to use Atywia Daily".
The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Some medicines may reduce the contraceptive effect 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 virus (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 treated with any of these medicines should temporarily use a non-hormonal method of contraception (e.g., condoms) or choose another method of contraception. When taking these medicines with Atywia Daily, additional contraceptive methods should be used for 7 to 28 days after the end of treatment, depending on the medicine. The patient should consult their doctor or pharmacist if they have any doubts. If the period of using a non-hormonal method of contraception exceeds the duration of one pack of Atywia Daily, the next pack should be started immediately, skipping the placebo tablets. If it is necessary to take medicines containing the above-mentioned active substances for a long time, it may be necessary to consider using non-hormonal methods of contraception.

THE USE OF 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 lipid levels in the blood),
• 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 EFFECTIVENESS 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 lipid levels in the blood),
• Paracetamol (used for pain and fever),
• Morphine (a very strong pain reliever),
• Lamotrigine (used to treat epilepsy).

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

DIABETES

In diabetic patients, it may be necessary to adjust the dose of diabetes medications and insulin.

LABORATORY TESTS

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

PREGNANCY AND BREASTFEEDING

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

PREGNANCY

Atywia Daily should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected, the patient should consult their doctor as soon as possible.

BREASTFEEDING

Using Atywia Daily during breastfeeding may lead to a decrease in milk production, and small amounts of active substances may pass into breast milk. Non-hormonal methods of contraception should be used during breastfeeding.

DRIVING AND USING MACHINES

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

ATYWIA DAILY CONTAINS LACTOSE MONOHYDRATE

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

3. HOW TO USE ATYWIA DAILY

This medicine should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
If the doctor does not recommend otherwise, one tablet should be taken daily.

HOW TO USE 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 of intake.
Tablets should be taken daily at the same time, with a small amount of water if necessary.
The tablets should not be confused: one whitetablet should be taken for the first 21 days, and then one greentablet, once a day 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 necessary to start using the medicine from the first tablet in the top left corner (located near the words "Inicio. Pegue aqui la tira adhesiva – Start. Stick the adhesive strip here.") 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 adhesive strips for each blister pack, with the names of the days of the week. The patient should choose the appropriate strip, starting with the day of the week on which they will start taking the tablets. For example, if they start taking the tablets on Wednesday, they should choose the strip that starts with "Wed".
The strip should be placed in the top part of the blister pack marked " Inicio. Pegue aqui la tira adhesiva – Start. Stick the adhesive strip here.".
Then, a symbol of the day will be above each tablet, indicating the day on which the tablet should be taken.
The arrows indicate the order of taking the tablets.
During the 7 days when the patient takes the greenplacebo tablets (placebo days), withdrawal bleeding should occur (so-called withdrawal bleeding). 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 withdrawal bleeding has ended or not.
This means that new blister packs will be started on the same day of the week, and the withdrawal bleeding will occur approximately on the same days every month.
If the patient uses Atywia Daily in the above manner, they will be protected against pregnancy, including during the 7 days of taking the greenplacebo tablets.

WHEN CAN THE FIRST BLISTER PACK OF ATYWIA DAILY BE STARTED?

IF NO HORMONAL CONTRACEPTIVE WAS USED 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 using the medicine on the first day of menstruation, they will be immediately protected against pregnancy. The medicine can also be started on days 2-5 of the menstrual cycle, but in this case, additional contraceptive methods should be used (e.g., condoms) for the first 7 days.

CHANGING FROM A COMBINED HORMONAL CONTRACEPTIVE OR A COMBINED HORMONAL INTRAUTERINE SYSTEM OR TRANSDERMAL SYSTEM.

• If the patient was taking an oral contraceptive (with a regimen that includes 21 active tablets and a 7-day break), Atywia Daily can be started the day after the break from the previous contraceptive regimen.
• If the patient was taking an oral contraceptive that contains 28 tablets, both active and placebo, Atywia Daily can be started the day after taking the last inactive tablet (without hormones) from the pack of the combined oral contraceptive. In case of doubts, the doctor or pharmacist should be consulted.
• In the case of a transdermal patch or intrauterine system, Atywia Daily should be started the day after the break from the regimen of the intrauterine system or transdermal patches.

CHANGING FROM A PROGESTOGEN-ONLY METHOD (MINI-PILL CONTAINING ONLY PROGESTOGEN)

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

4. Possible side effects

Like all medicines, Atywia Daily can cause side effects, although not everybody gets them. If any side effects occur, especially serious or persistent ones, or changes in health that the patient considers to be related to the use of Atywia Daily, the patient should consult a doctor, pharmacist, or nurse. 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. By reporting side effects, more information can be collected on the safety of the medicine.

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 packaging and blister. The expiry date refers to the last day of the month. 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. The patient should ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Atywia Daily contains

The Atywia Daily blister pack contains 21 white active tablets in the 1st, 2nd, and 3rd rows and 7 green placebo tablets in the 4th row. The white active tablets contain:

• The active substances are ethinylestradiol and dienogest. One film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
• The excipients are lactose monohydrate, cornstarch, povidone K-30, magnesium stearate; coating: hypromellose 2910, macrogol 400, titanium dioxide (E 171).

Placebo tablets:

• Lactose monohydrate, cornstarch, povidone K-30, magnesium stearate, colloidal silicon dioxide; coating: hypromellose 2910, triacetin, polysorbate 80, titanium dioxide (E 171), aluminum lake FD & C Blue 2, iron oxide yellow (E 172).

What Atywia Daily looks like and contents of the pack

Active tablets: white, round, film-coated tablets. Placebo tablets: green, round, film-coated tablets. Atywia Daily is available in packs containing 28, 3 x 28 film-coated tablets (21 active tablets and 7 placebo tablets). Each pack of Atywia Daily contains a blister pack and a set of 7 self-adhesive stickers with the names of the days of the week, in a different order, depending on when the patient starts taking the tablets. The pack includes a cardboard wallet in which the blister pack should be placed. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte Edificio Roble C/ Serrano Galvache, 56 28033 Madrid Spain

Manufacturer:

Laboratorios León Farma, S.A. Pol. Ind. Navatejera La Vallina s/n 24008 Villaquilambre, León Spain

Parallel importer:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warsaw Pharma Innovations Sp. z o.o. ul. Jagiellońska 76 03-301 Warsaw Synoptis Industrial Sp. z o.o. ul. Szosa Bydgoska 58 87-100 Toruń CANPOLAND SPÓŁKA AKCYJNA ul. Beskidzka 190 91-610 Łódź Marketing authorization number in Spain, the country of export: 701770.7

• 701773.8

Parallel import authorization number: 51/22

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 e 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 Germany: Velafee 21+7, 0.03 mg / 2 mg film-coated tablets Spain: Ceciliana Diario, 2 mg/0.03 mg film-coated tablets EFG Date of revision of the leaflet: 19.01.2022

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 [Information about the trademark].