Ativia Daili

Leaflet attached to the packaging: patient information

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

Atywia Daily(Ceciliana Diario)

0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest
Atywia Daily and Ceciliana Diario 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 taking the medicine, as it contains important information for the patient

• You should keep this leaflet so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

You should not take Atywia Daily if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable.

• If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6)
• If you have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs
• If you know that you have disorders that affect blood clotting - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies
• If you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots")
• If you have had a heart attack or stroke
• If you have (or have had in the past) angina pectoris (a 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 you have 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 you have (or have had in the past) a type of migraine called migraine with aura
• If you smoke (see section 2 "Blood clots")
• If you have (or have had in the past) a condition of inflammation of the pancreas associated with high levels of triglycerides (lipid metabolism disorders)
• If you have (or have had in the past) severe liver disease (until liver function test results return to normal) (also in cases of Dubin-Johnson syndrome and Rotor syndrome)
• If you have (or have had in the past) benign or malignant liver tumors
• If you have (or have had in the past) a hormone-dependent tumor (breast or genital cancer)
• If you have bleeding from the genital tract of unknown cause
• If you do not have menstrual bleeding for unknown reasons
• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Atywia Daily and other medicines").

Warnings and precautions

Before starting to take Atywia Daily, 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 , you should stop taking Atywia Daily and consult a doctor. During this time, non-hormonal methods of contraception should be used.
When should you contact a doctor?

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

You should tell your doctor if you have any of the following conditions.

If these symptoms appear or worsen while taking Atywia Daily, you should also tell your doctor.

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• if you have systemic lupus erythematosus (a disease that affects the natural defense system),
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure),
• if you have sickle cell anemia (a hereditary disease of red blood cells),
• if you have been diagnosed with 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 you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots")
• if you have recently given birth, in which case you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start taking Atywia Daily after giving birth,
• if you have superficial thrombophlebitis (blood clots in the veins under the skin),
• if you have varicose veins,
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or rash and breathing problems, you should contact your 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 contraceptives. 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 thrombotic events"). Not all people 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.

Remember that the overall risk of having a harmful blood clot due to taking Atywia Daily is small.

HOW TO RECOGNIZE BLOOD CLOTS

You should contact a doctor immediately if you notice any of the following symptoms.

Are you experiencing any of these symptoms? Why might you be suffering from them?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which 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 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 you are unsure, you should contact 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).
Symptoms usually occur in one eye:

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

loss of vision.

• chest pain, discomfort, or pressure, or a feeling of heaviness or tightness in the chest, arm, or below the breastbone
• a feeling of fullness, indigestion, or choking in the chest, arm, or below the breastbone
• feeling of discomfort in the lower part of the 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, speech disturbances, or difficulty 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, you should contact a doctor immediately, as you may be at risk of having another stroke.

• swelling and slight bluish 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 you stop 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 taking Atywia Daily is small.

• During a year, about 2 in 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 in 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 8-11 in 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 taking Atywia Daily is small, but some factors can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m);
• if someone in your 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, you may have inherited blood clotting disorders;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Atywia Daily for a few weeks before surgery or immobilization. If you need to stop taking Atywia Daily, you should ask your doctor when you can start taking it again;
• with age (especially over 35 years old);
• if you smoke (see section 2 "Blood clots")

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

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

Factors that increase the risk of blood clots in arteries

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

• with age (over about 35 years old);
• if you smoke. While taking a hormonal contraceptive like Atywia Daily, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has had high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

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

You should stop taking Atywia Daily immediately:

• if you are pregnant or think you may be pregnant;
• if you have symptoms of phlebitis or blood clots (see section 2 "Blood clots")
• if your blood pressure remains above 140/90 mmHg (your doctor may recommend resuming the medicine after your blood pressure returns to normal with the help of antihypertensive drugs);
• if you are scheduled to have surgery or will be immobilized for a long time (you should stop taking the medicine at least 4 weeks before surgery or immobilization) (see section 2 "Blood clots")
• if you experience a migraine for the first time or if it worsens;
• if you experience exceptionally frequent, severe, persistent headaches that start suddenly with symptoms of so-called aura (sensory, visual, motor disturbances);
• if you experience severe abdominal pain (see also "Oral contraceptives and cancer")
• if your skin and eyes turn yellow, your urine is brown, or your stools are very pale (jaundice) or if you feel itching all over your body;
• if you have diabetes (diabetes mellitus) and your blood sugar levels rise unexpectedly;
• if you have a blood disorder that causes kidney damage (hemolytic uremic syndrome);

Situations requiring special medical attention:

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

Psychiatric disorders

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

Oral contraceptives and cancer

In women taking oral contraceptives, breast cancer is slightly more common than in women of the same age who do not take them. The risk of 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 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 controversy over the significance of additional factors (e.g., differences in the number of sexual partners and the use of mechanical contraceptives).
In very rare cases, a benign liver tumor may develop. Such a tumor can cause life-threatening bleeding into the abdominal cavity. You should contact a doctor
in case of severe abdominal pain.Some studies suggest an increased risk of liver tumors in women taking oral contraceptives, but these tumors are very rare.

Other diseases

Hypertension

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

Chloasma (yellow-brown discoloration)

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

Irregularities in the menstrual cycle

While taking oral contraceptives, irregular bleeding (spotting or intermenstrual bleeding) may occur, especially in the first few months of taking the pills. You should consult your doctor 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 take Atywia Daily.
After stopping hormonal contraceptives, it may take some time for the natural menstrual cycle to return.

Reduced effectiveness of action

The effectiveness of Atywia Daily may be reduced if you miss pills, vomit, have severe diarrhea, or take certain medicines.
Medicines that may reduce the 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 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 temporarily use a non-hormonal method of contraception (e.g., condoms) or choose another contraceptive method. When taking a medicine with the above active substances, additional contraceptive methods should be used for 7 to 28 days after stopping the treatment, depending on the medicine. You should consult your doctor or pharmacist if you have any doubts. 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 active substances is required, non-hormonal contraceptive methods should be considered.

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

• Paracetamol (used for pain and fever),
• Vitamin C (ascorbic acid),
• Atorvastatin (used to lower 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:

• Cyclosporine (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).

You should read the package leaflets of all the medicines you are taking.

Diabetes

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

Laboratory tests

Taking hormonal contraceptives may affect the results of some laboratory tests, e.g., biochemical parameters of liver, adrenal, and kidney function, thyroid function, as well as the levels of certain plasma proteins, e.g., 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, while breastfeeding, or if you think you may be pregnant, before taking this medicine, you should consult a doctor or pharmacist.
Pregnancy
You should not take Atywia Daily if you are pregnant or think you may be pregnant. If you suspect you are pregnant, you should contact your doctor as soon as possible.
Breastfeeding
Taking Atywia Daily while breastfeeding may lead to a decrease in the amount of milk produced and small amounts of active substances may pass into breast milk.
You should use non-hormonal methods of contraception while breastfeeding.

Driving and using machines

Atywia Daily does not affect your ability to concentrate, drive, or use machines.

Atywia Daily contains lactose

Atywia Daily contains lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Atywia Daily

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
If your doctor does not recommend otherwise, you should take 1 tablet daily.

How to take Atywia Daily

Each blister pack contains 28 tablets: 21 white tablets containing active substances and 7 green tablets containing placebo.
The two differently colored tablets of Atywia Daily are arranged in the order in which they should be taken.
Tablets should be taken daily at the same time, with a small amount of water if necessary.
You should not confuse the tablets: you should take one whitetablet for the first 21 days, and then one greentablet, once daily for 7 days. Then you should start a new blister pack (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 taking the tablets from the first tablet in the top left corner (located near the word "INICIO") and take one tablet daily.
To maintain the correct order of taking the tablets, you should follow the direction of the arrow on the blister pack.

Preparing the blister pack

To help you remember to take a tablet, each package of Atywia Daily contains 7 self-adhesive strips for each blister pack, with abbreviations of the days of the week. You should choose the appropriate strip, starting with the abbreviation of the day of the week on which you will start taking the tablets. For example, if you start taking the tablets on Wednesday, you should choose the strip with the abbreviations of the days of the week starting with "Wed".
The strip should be placed in the upper part of the blister pack marked "Pegue aquí la tira adhesiva", which means "Stick the strip here".
Then, each tablet will have a symbol of the day, indicating the day on which you should take the tablet. The arrows show the order in which the tablets should be taken.
During the 7 days when you take the greenplacebo tablets, you should experience 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, you 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 also occur around the same days every month.
If you take Atywia Daily in this way, you will be protected against pregnancy, even during the 7 days when you take the greenplacebo tablets.

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

If you did not take a hormonal contraceptive in the previous month.

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

Changing from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal system or transdermal system.

• If you were taking an oral contraceptive (with a regimen that includes 21 active tablets and a 7-day break), you can start taking Atywia Daily the day after the break that is part of the regimen of your previous contraceptive product.
• If you were taking an oral contraceptive that contains 28 tablets, both active and placebo, you can start taking Atywia Daily the day after taking the last inactive tablet (without hormones) from the package of your previous combined oral contraceptive. If you are unsure, you should consult your doctor or pharmacist.
• In the case of a transdermal patch or vaginal system, you should start taking Atywia Daily the day after the break that is part of the regimen of your previous contraceptive system.

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

You can stop taking the mini-pill at any time. You can start taking Atywia Daily the next day. You 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 serious 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 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 the product is described in section 2 of the Patient Information Leaflet in the "Important information before taking Atywia Daily" section. 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 she experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or skin rash, and breathing problems (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 people):
• headache,
• breast pain, including discomfort and tenderness.

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

• 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, abdominal discomfort, and/or bloating,
• nausea, vomiting, or diarrhea,
• acne,
• alopecia (hair loss),
• rash (including patchy rash),
• pruritus (sometimes whole-body),
• changes in bleeding patterns, such as menorrhagia, metrorrhagia, oligomenorrhea, and amenorrhea,
• intermenstrual bleeding, menorrhagia (irregular bleeding),
• 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/or 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 lipoma,
• 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 disorders,
• 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 cell growth on the surface of the cervix),
• adnexal pain or cysts (ovaries and fallopian tubes),
• breast cysts, breast fibroadenoma, 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, 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 any side effects 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 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 product.

5. How to store Atywia Daily

The product should be stored out of sight and reach of children. This product should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The product should not be stored above 30°C. The blister should be stored in the outer packaging to protect it from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask her 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 film-coated tablets in the 1st, 2nd, and 3rd rows and 7 green film-coated tablets in the 4th row. The white film-coated tablets containing active substances:

• The active substances of the product 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, maize starch, povidone K 30, magnesium stearate
• Coating: hypromellose 2910, macrogol 400, titanium dioxide (E 171).

Tablets without active substances:

• Core: lactose monohydrate, maize starch, povidone K 30, magnesium stearate, colloidal anhydrous silica
• 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 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 pack 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 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 Pharma, S.A. Pol. Ind. Navatejera La Vallina s/n 24193 Villaquilambre, 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 Spanish Authorization Number:701773.8

Parallel Import Authorization Number: 126/25

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 Spain: Ceciliana Diario, 2 mg/0.03 mg film-coated tablets

Date of revision of the leaflet: 19.05.2025

Other sources of information

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