Ativia Daili

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Atywia Daily (Velafee 21+7)

0.03 mg + 2 mg, coated tablets

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

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").

You should carefully read the contents of the leaflet before using the medicine, 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.
• The 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 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 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 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 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 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)
• 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 increased 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/pibrentaswir (see also "Atywia Daily and other medicines").

Warnings and precautions

Before starting to use 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 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 the section "How to recognize blood clots".

The doctor should be told if the patient has any of the following conditions.

If these symptoms appear or worsen while using 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 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 genetic disease that affects 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 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 doctor should be consulted to determine how soon Atywia Daily can be started 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, and skin rash, and 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 when no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also called "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also called "arterial thromboembolism" or "arterial thrombosis"). Not all patients who have had a blood clot will make a full recovery. 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 harmful blood clots caused by 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 to be suffering
from?

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur, most often 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 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 using 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 when 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 affects the risk of blood clots?

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.

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a year, about 8-11 out of 10,000 women who use combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Atywia 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 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 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 their doctor if any of the above conditions change while using Atywia Daily, e.g. if someone in their immediate family is found to have 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 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 been found to have 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 particularly 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, if someone in their immediate family is found to have a blood clot without a known cause, or if they gain weight significantly.

When to stop using Atywia Daily 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 mmHg (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 using the medicine at least 4 weeks before surgery), or in the case of prolonged immobilization (see section 2 "Blood clots");
• in the event of a first migraine or worsening of migraines;
• if the patient experiences extremely frequent, severe, persistent headaches that start suddenly with symptoms of aura (visual, sensory, motor, or speech disturbances);
• if the patient has severe abdominal pain (see also "Oral contraceptives and cancer");
• if the patient's skin and eyes turn yellow, urine is brown, 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 condition worsens 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 mmHg;
• if the patient has had lipid metabolism disorders (disorders of fat metabolism);
• if the patient has been found to have sickle cell anemia (a genetic disease that affects 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). The dose of insulin and antidiabetic drugs may need to be changed while using Atywia Daily;
• if the patient smokes (see section 2 "Blood clots");
• if the patient has epilepsy. If the frequency of epileptic seizures increases while using Atywia Daily, the use of other contraceptive methods should be considered;
• 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 found to have a benign tumor in the muscular layer of the uterus (uterine fibroid);
• if the patient has otosclerosis;
• in the case of prolonged immobilization (see section 2 "Blood clots");
• if the patient is overweight;
• if the patient has a type of 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 cancer

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 tablets.
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.
Some epidemiological studies have suggested 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 can develop. Such a tumor can cause life-threatening bleeding into the abdominal cavity. A doctor should be consulted
in case of severe abdominal pain. Some studies have suggested 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 hormonal contraceptives for a longer period. The increase in the frequency of high blood pressure is associated with the effect of progesterone. 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 using 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 using combined oral contraceptives.

Menstrual cycle disorders

While using oral contraceptives, irregular bleeding (spotting or intermenstrual bleeding) may occur, especially in the first few months of tablet use. A 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 has been taken correctly, pregnancy is unlikely. However, if Atywia Daily has not been taken correctly and withdrawal bleeding has not occurred or two consecutive withdrawal bleedings have occurred, 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 efficacy

The efficacy of Atywia Daily may be reduced if tablets are missed, vomiting occurs, severe diarrhea occurs, and 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 its use, a thorough medical history 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 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 used if the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentaswir, as this may cause an increase in liver function test results (increase in liver enzyme ALT).
The doctor will prescribe a different type of contraception 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 effect of Atywia Daily and/or cause intermenstrual bleeding.
Medicines that may reduce the efficacy 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 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 are unsure. If the period of using a non-hormonal method of contraception exceeds the duration of one package of Atywia Daily, the next package 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.

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 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 lipid levels in the blood),
• 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

In diabetic patients, it may be necessary to adjust the 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 pregnancy is suspected, before using this medicine, the patient should consult their doctor or pharmacist.
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 reduce the amount of milk produced and small amounts of active substances may pass into the 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 doubt, the patient should consult their doctor or pharmacist.
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 they should be taken.
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 using the first tablet in the top left corner (located near the "Start" label) 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.
During the 7 days when the patient takes the greenplacebo tablets, 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 immediately, regardless of whether the withdrawal bleeding has stopped or not.
This means that new blister packs will be started on the same day of the week, and the withdrawal 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 to start the first blister pack of Atywia Daily

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. on 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 (e.g. condoms) should be used for the first 7 days.

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

• If the patient was taking an oral contraceptive (with a regimen that includes 21 active tablets and a 7-day break) taking Atywia Daily can be started the day after the break in the regimen of the previous contraceptive product.
• 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 package of the combined oral contraceptive. In case of doubt, the patient should consult their doctor or pharmacist.
• In the case of a transdermal patch or vaginal ring, taking Atywia Daily should be started the day after the break in the regimen of the vaginal ring or transdermal patch.

Changing from a progestogen-only method (mini-pill)

The mini-pill can be stopped at any time. Atywia Daily can be started the next day. Additional contraceptive methods (e.g. condoms) should be used 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 and persistent ones or changes in health that the patient considers 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 different risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before taking Atywia Daily". Detailed information on serious side effects related to the use of Atywia Daily is described in section 2 of the Patient Information Leaflet in the section "Important information before taking Atywia Daily". The patient should read these sections to obtain additional information and consult a doctor if necessary. The patient should immediately consult a doctor if she experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or skin rash, and breathing difficulties (see "Special warnings and precautions for use"). Side effects that may be associated with the use of Atywia Daily:

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

Less frequent(occurring in less than 1 in 100 users):

• vaginitis and/or vulvovaginitis (inflammatory conditions of the genital organs), vaginal candidiasis (fungal infection) 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,
• alopecia (hair loss),
• rash (including patchy rash),
• pruritus (sometimes whole-body pruritus),
• changes in bleeding patterns, such as menorrhagia, metrorrhagia, oligomenorrhea, and amenorrhea,
• intermenstrual bleeding, menorrhagia (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 users):

• ovarian and fallopian tube inflammation,
• cervicitis (inflammation of the cervix),
• urinary tract infections, cystitis (inflammation of the bladder),
• mastitis (breast inflammation),
• fungal infections, 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 disturbances,
• sudden hearing loss, hearing disturbances,
• tinnitus,
• balance disorders
• tachycardia (rapid heartbeat),
• thrombosis (blood clots in blood vessels), pulmonary embolism (blood clot traveling to the lungs),
• thrombophlebitis (inflammation of a vein with blood clot formation),
• 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 patches on the skin, most commonly on the face), pigmentation disorders, and/or discoloration,
• seborrhea,
• dandruff,
• hirsutism (excessive hair growth),
• skin disorders, "peau d'orange" (orange peel skin),
• hemangioma,
• 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 (ovarian and fallopian tube disorders),
• breast cysts, breast fibroadenoma, breast swelling,
• dyspareunia (painful intercourse),
• galactorrhea (milk secretion), breast discharge,
• menstrual disorders,
• edema (fluid retention) of the hands and feet,
• flu-like symptoms, inflammation, fever
• increased levels of triglycerides and cholesterol in the blood (hypertriglyceridemia, hypercholesterolemia),
• blood clots in a vein or artery, such as:
• 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-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, and/or intestine, kidneys, or eye.

The likelihood of developing blood clots may be higher if the patient has other risk factors that increase this risk (see section 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, Stevens-Johnson syndrome.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should tell her doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, 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 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. The expiry date refers to the last day of the month stated. Do not store above 30°C. Store the blister pack in the outer packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask her pharmacist how to dispose of medicines no longer required. 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 pills in the first, second, and third rows and 7 green placebo pills in the fourth row. The white active pills contain:

• 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: lactose monohydrate, cornstarch, povidone K 30, magnesium stearate. Coating: hypromellose, macrogol 400, titanium dioxide (E 171).

The placebo pills do not contain active substances:

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

What Atywia Daily looks like and contents of the pack

Active pills: white, round, film-coated pills. Placebo pills: green, round, film-coated pills. Atywia Daily is available in packs containing 28 and 3x28 film-coated tablets (21 active pills and 7 placebo pills). Each pack of Atywia Daily contains a blister pack and a set of 7 self-adhesive labels with abbreviations of the days of the week, in a different arrangement, depending on when the patient starts taking the pills. 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 Germany, the country of export:

Exeltis Germany GmbH, Adalperostraße 84, 85737 Ismaning, Germany

Manufacturer:

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

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, German authorization number: 87090.00.00

Parallel import authorization number: 296/22

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: 03.08.2022[Information on trademark] Detailed information on 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