Ativia Daili

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Atywia Daily (Velafee 21+ 7)

0.03 mg + 2 mg, film-coated tablets

Ethinylestradiol + Dienogest
Atywia Daily and Velafee 21+ 7 are different trade names for the same drug.

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 symptoms of blood clots have occurred (see section 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient

• The leaflet should be kept so that it can be re-read if necessary.
• 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 disease 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 packaging 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 (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 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 that they have disorders that affect blood clotting - 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 symptoms of stroke)
• If the patient has any of the following diseases that 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)
• 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) 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 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) 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 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, 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 the patient contact their doctor?

• if the patient notices any of the following symptoms, which may indicate that they have a blood clot in their leg (deep vein thrombosis), blood clot in their lungs (pulmonary embolism), heart attack, or stroke (see below)

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

If these symptoms occur 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 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 diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of 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, as they are at increased risk of blood clots. The patient should consult their doctor about how soon they can start taking Atywia Daily after giving birth,
• 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 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

Taking combined hormonal contraceptives, such as Atywia Daily, is associated with an increased risk of blood clots, compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

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

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

HOW TO RECOGNIZE BLOOD CLOTS

The patient should contact their doctor immediately if they notice any of the following symptoms.

Is the patient experiencing any of these symptoms? What might be causing them?

• swelling of the leg or swelling along a vein in the leg or foot, deep vein thrombosis, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased temperature in the affected leg
• change in the color of the skin of the leg, such as pallor, redness, or cyanosis
• sudden onset of unexplained shortness of breath or rapid breathing
• sudden onset of coughing without an obvious cause, 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 contact their 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).
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may progress to retinal vein thrombosis(blood clot in the eye)

loss of vision

• chest pain, discomfort, feeling of pressure, tightness
• feeling of squeezing or fullness in the chest, arm, or below the breastbone
• feeling of fullness, indigestion, or choking
• feeling of discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach
• sweating, nausea, vomiting, or fainting
• extreme weakness, anxiety, or shortness of breath,
• rapid or irregular heartbeat.
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body
• sudden confusion, difficulty speaking or understanding
• sudden vision disturbances in one or both eyes
• sudden difficulty walking, 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,
however, the patient should contact their doctor immediately, as they may be at risk of having another stroke.

• swelling and slight blue discoloration of the skin of the legs or arms
• severe abdominal pain (so-called acute abdomen) Blood clots blocking other blood vessels

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. They most often 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 a blood clot 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 affects the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots caused by Atywia Daily is small.

• During a year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestrel will develop blood clots.
• During a year, about 8-11 out of 10,000 women who take combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Atywia Daily, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors that 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 their 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 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 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.

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 cause 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 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, their 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);
• 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.

The patient should stop taking Atywia Daily immediately:

• if they are pregnant or think they may be pregnant;
• if they have symptoms of phlebitis or blood clots (see section 2 "Blood clots");
• if their blood pressure remains above 140/90 mm Hg (their doctor may recommend resuming the medicine after their blood pressure returns to normal with the help of antihypertensive drugs);
• if they are scheduled to have surgery or will be immobilized for a long time (they should stop taking the medicine at least 4 weeks before surgery or immobilization), (see section 2 "Blood clots");
• if they experience a migraine for the first time or if their migraines worsen;
• if they experience extremely frequent, severe, persistent headaches that start suddenly with symptoms of aura (disturbances of sensation, vision, or movement);
• if they experience severe abdominal pain (see also "Oral contraceptives and cancer");
• if their skin and the whites of their eyes turn yellow, their urine is brown, or their stools are very pale (jaundice) or if they feel itching all over their body;
• if they have diabetes (diabetes mellitus) and their blood sugar levels rise unexpectedly;
• if they have porphyria (a blood disorder) and experience a recurrence of the disease 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 disorders of the arms and/or legs;
• if the patient's blood pressure is above 140/90 mm Hg;
• if the patient has experienced disorders of lipid metabolism (lipid disorders);
• if the patient has been diagnosed with 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). It may be necessary to adjust the dose of insulin and antidiabetic drugs 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, 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 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 older.

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 contact 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 breast cancer decreases after stopping the medicine and returns to the same level as in women who have never taken the pill after 10 years of stopping.
Because 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 contraceptive methods).
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 contact their doctor immediately if they experience 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 use Atywia Daily", "When to stop taking Atywia Daily", "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 in 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 the patient misses pills, vomits, has severe diarrhea, or takes certain medicines.
If Atywia Daily is taken with herbal products containing St. John's Wort ( Hypericum perforatum), the patient should use additional contraceptive methods (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 history and family history should be taken, and a physical examination should be performed, including a breast examination. 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 or glecaprevir/pibrentasvir, as this may cause an increase in liver enzyme test results (increase in alanine aminotransferase activity).
The doctor will prescribe a different contraceptive method before starting treatment with these medicines.
Atywia Daily can be started again about 2 weeks after the end of this treatment. See section "When not to use 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 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 infection and hepatitis C (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 a non-hormonal method of contraception (e.g., condoms) or choose a different contraceptive method. When taking these medicines with Atywia Daily, additional contraceptive methods should be used for 7 to 28 days after stopping the medicine, 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, without taking the placebo tablets. If the patient needs to take medicines containing the above active substances for a long time, they should consider using non-hormonal contraceptive methods.

The following medicines may increase the risk of side effects when taken with Atywia Daily:

• 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 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 reduce 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

Patients with diabetes may need to adjust their dose of antidiabetic drugs and insulin.

Laboratory tests

Taking hormonal contraceptives may affect the results of certain laboratory tests, such as biochemical parameters of liver, adrenal, and kidney function, thyroid function, as well as the levels of certain proteins in the blood, 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, 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 during breastfeeding.

Driving and using machines

Atywia Daily does not affect the patient's ability to concentrate, drive, or use machines.

Atywia Daily contains lactose

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

3. How to use Atywia Daily

This medicine should always be taken as directed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
If the doctor does not prescribe otherwise, the patient should take 1 tablet 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 in which they should be taken.
The tablets should be taken daily at the same time, with a small amount of water if necessary.
The patient should not confuse the tablets: they should take one whitetablet for the first 21 days, followed by one greentablet, once daily for 7 days. Then, they should start a new blister pack (21 whitetablets, followed by 7 greentablets). There is no break between the two blister packs.
Because the tablets have a different composition, it is essential to start with the first tablet in the top left corner (located near the word "Start") and take one tablet daily, following the direction of the arrows 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 stickers for each blister pack, with abbreviations of the days of the week. The patient should choose the sticker that starts with the abbreviation of the day they will start taking the tablets. For example, if the patient starts taking the tablets on a Wednesday, they should choose the sticker that starts with "Wed".
The sticker should be placed in the top part of the blister pack marked "Wochenaufkleber hier aufkleben", which means "Stick the weekly sticker here".
Then, there will be a symbol for each day of the week above each tablet, indicating the day on which the tablet should be taken. The arrows show the order in which the tablets should be taken.
During the 7 days when the patient takes the greenplacebo tablets (placebo days), they should experience withdrawal bleeding (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 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 uses Atywia Daily in this way, they will be protected against pregnancy, including during the 7 days when they take the greenplacebo tablets.

When can the patient start the first blister pack of Atywia Daily?

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

The patient should start taking Atywia Daily on the first day of their menstrual cycle (i.e., the first day of their period). 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.

Switching from a combined hormonal contraceptive or a combined hormonal contraceptive system (vaginal ring or transdermal patch).

• If the patient has been 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 has been taking an oral contraceptive that contains 28 tablets, including both active and placebo tablets, they can start taking Atywia Daily the day after taking the last inactive tablet (without hormones) from the pack of their previous contraceptive. If the patient is unsure, they 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 their previous contraceptive regimen.

Switching from a progestin-only method (minipill containing only progestin)

The patient can stop taking the minipill on any day. They can start taking Atywia Daily the next day. The patient should use additional contraceptive methods (e.g., condoms) for the first 7 days.

Switching from a progestin-only method (implant or intrauterine system releasing 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. The patient should use additional contraceptive methods (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 severe and 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. All women using combined hormonal contraceptives have 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 Atywia Daily is described in point 2 of the Patient Information Leaflet in the section "Important information before using Atywia Daily". The patient should read these sections to obtain additional information and, if necessary, consult a doctor immediately. The patient should contact a doctor immediately if they experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or skin rash, and breathing problems (see "Warnings and precautions"). Side effects that may be associated with the use of Atywia Daily:

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

Uncommon(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 falls between heartbeats),
• abdominal pain, including upper and lower abdominal pain, discomfort, and/or bloating,
• nausea, vomiting, or diarrhea,
• acne,
• hair loss (alopecia),
• rash (including patchy rash),
• itching (sometimes all over the body),
• changes in bleeding, such as heavy, scanty, or infrequent menstrual bleeding, and amenorrhea (absence of menstruation),
• vaginal bleeding, including intermenstrual bleeding and metrorrhagia (irregular bleeding between periods),
• dysmenorrhea (painful menstruation), pelvic 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 lipoma,
• anemia,
• hypersensitivity (allergic reaction),
• masculinization in women (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 disturbances,
• sudden hearing loss, hearing disturbances,
• tinnitus,
• balance disorders
• tachycardia (rapid heart rate),
• thrombosis (blood clots in blood vessels), pulmonary embolism (a blood clot moving to the lungs),
• thrombophlebitis (inflammation of a vein with a blood clot),
• 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, rash, psoriasis,
• excessive sweating,
• chloasma (yellow-brown spots on the skin, most commonly 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 growth of cells 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 arms (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 that increase this risk (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 (sex drive),
• 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, the patient should tell their 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 gathered on the safety of the medication.

5. How to store Atywia Daily

The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified 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 their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Atywia Daily contains

The Atywia Daily blister pack 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 Atywia Daily 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, cornstarch, povidone K 30, magnesium stearate
• Coating: hypromellose, macrogol 400, titanium dioxide (E 171).

Tablets without active substances:

• Core: lactose monohydrate, cornstarch, povidone K 30, magnesium stearate, colloidal silica anhydrous
• Coating: hypromellose, triacetin, polysorbate 80, titanium dioxide (E 171), indigo carmine, aluminum lake (E 132), yellow iron oxide (E 172).

What Atywia Daily looks like and what the pack contains

Active substance tablets: white, round, film-coated tablets. Placebo tablets: green, round, film-coated tablets. Atywia Daily is available in packs containing 1x28, 3x28 film-coated tablets (21 active substance tablets and 7 placebo tablets). Each pack of Atywia Daily contains a blister and a set of 7 self-adhesive stickers with abbreviations of the days of the week, in a different order, depending on when the patient starts taking the tablets. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Exeltis Germany GmbH, Adalperostraße 84, 85737 Ismaning, Germany

Manufacturer:

Laboratorios León Pharma SA, La Vallina s/n, Pol. Ind. Navatejera, Navatejera-24008 León, Spain

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw German authorization number:87090.00.00 Parallel import authorization number:406/21

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 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 leaflet approval: 31.01.2022

Other sources of information

Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, http://www.urpl.gov.pl, and https://inpharm.pl/do_pobrania/Atywia-Daily-LISTA-KONTROLNA.pdf and https://inpharm.pl/do_pobrania/Atywia-Daily-MATERIALY-DLA-PACJENTOW.pdf. [Information about the trademark]