Atywia daily

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet. The information on the immediate packaging is 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 medicinal product.
Important information regarding combined hormonal contraceptives

• When used correctly, they represent one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Atywia Daily is a combined oral hormonal contraceptive.

• Each of the 21 white tablets contains a small amount of two different sex hormones: a progestogen derivative (dienogest) and an oestrogen (ethinylestradiol);
• Each of the 7 green tablets contains no active substances (so-called placebo tablets).

Atywia Daily is effective in alleviating symptoms of acne caused by androgenic hormone activity.
Atywia Daily is used:

• for prevention of pregnancy;
• for the treatment of women with moderate acne who have decided to use oral contraceptives and in whom adequate local treatment or oral antibiotic therapy has failed.

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 particularly important to become familiar with 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. You should discuss with your doctor the need to continue treatment after three to six months, and then at regular intervals.

When not to use Atywia Daily:
Do not use Atywia Daily if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception would 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), in the lungs (pulmonary embolism), or in other organs.
• If you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or presence of antiphospholipid antibodies.
• If you are due to undergo surgery or will be immobile for a prolonged period (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 condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms).
• If you have any of the following diseases, which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia.
• If you have (or have ever had) 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) pancreatitis associated with elevated triglyceride levels (lipid metabolism disorders (fats)).
• If you have had or currently have severe liver disease (until liver function test results return to normal) (including Dubin-Johnson syndrome and Rotor syndrome).
• If you have had or currently have benign or malignant liver tumours.
• If you currently have or have had in the past a hormone-dependent cancer (breast or genital organ cancer).
• If you have vaginal bleeding of unknown cause.
• If you have absence of menstrual bleeding for unknown reasons.
• If you currently have or have had hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Atywia Daily and other medicines").

Warnings and precautions
Before starting to take Atywia Daily, discuss this with your doctor, pharmacist, or nurse.
If any of the symptoms listed below occur for the first time while taking Atywia Daily, Atywia Daily must be stopped immediately and you should contact your doctor. During this time, use non-hormonal methods of contraception.

When to contact your doctor:
Seek immediate medical attention if:

• You notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or stroke (see section below "Blood clots"). For a description of symptoms of serious adverse reactions, see "How to recognize blood clots".

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Atywia Daily, inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• If you have systemic lupus erythematosus (a disease affecting the body's natural defence system),
• If you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure),
• If you have sickle cell anaemia (an inherited disorder of red blood cells),
• If you have elevated levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis,
• If you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots"),
• If you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Atywia Daily,
• If you have inflammation of the veins under the skin (superficial thrombophlebitis),
• 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, skin rash, or breathing difficulties, seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Atywia Daily increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious problems. Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic disorders"). Full recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal. It should be remembered that the overall risk of harmful blood clots caused by using Atywia Daily is small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.

| Are you experiencing any of these symptoms? | What might be the likely cause? | |-------------------------------------------|----------------------------------| | Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by: | Deep vein thrombosis | | - pain or tenderness in the leg, which may only be felt when standing or walking, | | | - increased warmth in the affected leg, | | | - change in skin colour of the leg, such as paleness, redness, or blueness. | | | Sudden onset of unexplained shortness of breath or rapid breathing; | Pulmonary embolism | | Sudden coughing without an obvious cause, possibly accompanied by coughing up blood; | | | Sudden sharp chest pain, which may worsen with deep breathing; | | | Severe dizziness or lightheadedness; | | | Rapid or irregular heartbeat; | | | Severe abdominal pain. | | | Symptoms occurring in one eye: | Retinal vein thrombosis | | - sudden loss of vision, or (blood clot in the eye) | | | - painless visual disturbances that may progress to vision loss. | | | Chest pain, discomfort, pressure, heaviness; | Myocardial infarction | | Sensation of tightness or fullness in the chest, arm, or below the breastbone; | | | Feeling of fullness, indigestion, or choking; | | | Discomfort in the lower body radiating to the back, jaw, throat, arm, or stomach; | | | Sweating, nausea, vomiting, or dizziness; | | | Extreme weakness, anxiety, or shortness of breath; | | | Rapid or irregular heartbeat. | | | Sudden weakness or numbness of the face, arms, or legs, | Stroke | | especially on one side of the body; | | | Sudden confusion, speech disturbances, or difficulty understanding; | | | Sudden visual disturbances in one or both eyes; | | | Sudden difficulty walking, dizziness, loss of balance, or coordination; | | | Sudden, severe, or prolonged headache without known cause; | | | Loss of consciousness or fainting with or without seizures. | |

In some cases, stroke symptoms may be transient with almost immediate and complete recovery, but you should seek immediate medical attention, as you may be at risk of a subsequent stroke.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives. If a woman stops taking Atywia Daily, the risk of developing blood clots returns to normal levels within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots due to the use of Atywia Daily is low.

• 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 developing blood clots depends on the individual's medical history (see "Factors that increase the risk of developing blood clots in veins" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Atywia Daily is small,
however, certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In such cases, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Atywia Daily several weeks before surgery or during immobilization. If the patient must stop taking Atywia Daily, consult the doctor about when it is safe to resume;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks). The risk of blood clots increases with the number of risk factors present. Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if another risk factor is present. It is important to inform the doctor if any of the listed factors apply, even if uncertain. The doctor may decide to discontinue Atywia Daily. Inform the doctor if any of the above conditions change during treatment with Atywia Daily, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots may lead to serious
consequences, such as myocardial infarction (heart attack) or stroke.
Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of
Atywia Daily is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Atywia Daily, it is recommended to stop smoking. If the patient cannot stop smoking and is over 35 years of age, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve abnormalities, heart rhythm disorders such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is
particularly severe, the risk of blood clots may be further increased. Inform the doctor if any of the above conditions change during treatment with
Atywia Daily, for example, if the patient starts smoking, a close family member is diagnosed
with unexplained thrombosis, or if the patient gains significant weight.
Atywia Daily must be discontinued immediately:

• if the patient is pregnant or suspects she may be pregnant;
• if the patient experiences symptoms of phlebitis or blood clots (see section 2 "Blood clots");
• if blood pressure remains above 140/90 mm Hg (the doctor may recommend resuming the medication after blood pressure returns to normal with antihypertensive treatment);
• if surgery is planned (the medication should be discontinued at least 4 weeks before surgery), or in case of prolonged immobilization (see section 2 "Blood clots");
• if migraine occurs for the first time or worsens;
• if the patient experiences new, severe, persistent headaches that start suddenly with aura symptoms (sensory disturbances, vision changes, motor difficulties);
• if the patient experiences severe upper abdominal pain (see also "Oral contraceptives and cancer");
• if the patient's skin or whites of the eyes become yellow, urine becomes dark brown, stools become very pale (jaundice), or if the patient experiences generalized itching;
• if the patient has diabetes (Diabetes mellitus) and blood sugar levels rise unexpectedly;
• if the patient has porphyria (a disorder affecting pigment formation in blood) and experiences a recurrence during treatment with Atywia Daily.

Situations requiring special medical attention:

• if the patient has heart or kidney disease;
• if the patient has venous inflammation (phlebitis) or varicose veins;
• if the patient has circulatory disorders in the hands and/or feet;
• if the patient's blood pressure is above 140/90 mm Hg;
• if the patient has had lipid metabolism disorders (lipid metabolism disturbances);
• if the patient has sickle cell anemia (an inherited disorder of red blood cells);
• if the patient has had liver disease;
• if the patient has had gallbladder disease;
• if the patient suffers from migraines;
• if the patient has depression;
• if the patient has diabetes (Diabetes mellitus) or impaired glucose metabolism (reduced glucose tolerance). Insulin or antidiabetic medication doses may need to be adjusted during concurrent use of Atywia Daily;
• if the patient smokes (see section 2 "Blood clots");
• if the patient has epilepsy. If seizure frequency increases during treatment with Atywia Daily, alternative contraceptive methods should be considered;
• if the patient has movement disorders known as Sydenham's chorea;
• if the patient has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis);
• if the patient has a blood disorder causing 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;
• in case of prolonged immobilization (see section 2 "Blood clots");
• if the patient is overweight;
• if the patient has an autoimmune disorder (systemic lupus erythematosus);
• if the patient is 40 years of age or older.

Psychiatric disorders:
Some women using hormonal contraceptives, including Atywia Daily, have reported
depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, contact the doctor promptly for further medical advice.
Oral contraceptives and cancer
Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. The risk decreases after stopping treatment and, 10 years after discontinuation, is the same as in women who have never taken oral contraceptives.
Since breast cancer is rare in women under 40 years of age, the increased number of diagnoses in women currently or recently using combined oral contraceptives is small relative to the overall risk of breast cancer.
Results of some epidemiological studies suggest that long-term use of combined oral contraceptives by women infected with human papillomavirus (Human Papilloma Virus, HPV) may increase the risk of cervical cancer. However, debate continues regarding the significance of additional factors (e.g., differences in number of sexual partners and use of mechanical contraceptive methods).
In very rare cases, a benign liver tumor may develop. Such a tumor may cause life-threatening intra-abdominal bleeding. Contact the doctor
in case of severe abdominal pain. Results of some studies indicate an increased risk of liver tumors in women using oral contraceptives, although these tumors are very rare.
Other diseases
Hypertension
Cases of hypertension have been reported in older women and in those using hormonal contraceptives long-term. The increased incidence of hypertension is associated with the progestogen component.
Women with conditions related to high blood pressure and certain kidney diseases should use alternative contraceptive methods (consult the doctor; see also "When not to use Atywia Daily", "Atywia Daily must be discontinued immediately", "Situations requiring special medical attention").
Chloasma (yellowish-brown pigmentation)
Yellowish-brown patches (chloasma) may occasionally appear, especially in women who previously experienced chloasma during pregnancy. Women predisposed to chloasma should avoid exposure to sunlight and ultraviolet radiation during treatment with combined oral contraceptives.
Menstrual irregularities
Irregular bleeding (spotting or intermenstrual bleeding) may occur during use of oral contraceptives, especially during the first few months of tablet use. Consult the doctor if irregular bleeding persists for more than three cycles or recurs after regular cycles have been established.
Some women do not experience withdrawal bleeding during placebo tablet intake. If Atywia Daily has been taken correctly, pregnancy is unlikely. However, if Atywia Daily has not been taken correctly and no withdrawal bleeding occurs, or two consecutive withdrawal bleeds are missed, pregnancy may be possible. Pregnancy must be excluded before continuing Atywia Daily.
After discontinuation of hormonal contraceptives, return to a regular natural cycle may not occur immediately.
Reduced efficacy
The effectiveness of Atywia Daily may be reduced if tablets are missed, if vomiting or severe diarrhea occurs, or if certain medications are taken concurrently. If Atywia Daily is used simultaneously 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 starting Atywia Daily for the first time or after a break in use, a thorough medical and family history should be taken. A physical examination, including breast examination, is also necessary. Pregnancy must be excluded. Women using hormonal oral contraceptives should be examined regularly. The patient should inform the doctor if she smokes and about any other medications being taken.
Atywia Daily does not protect against HIV infection or other sexually transmitted diseases.
Atywia Daily and other medicines
Atywia Daily must not be used if the patient has hepatitis C and is taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may lead to increased liver function test results (increased liver enzyme AlAT activity).
The doctor will prescribe another type of contraception before starting treatment with these medications.
Atywia Daily may be restarted approximately 2 weeks after completing this treatment. See section "When not to use Atywia Daily".
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Some medicines may reduce the contraceptive effect of Atywia Daily and/or cause intermenstrual bleeding.
Medicines that may reduce the effectiveness of Atywia Daily:

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

Women taking any of the above medicines should temporarily use a mechanical contraceptive method (condoms) in addition to Atywia Daily or choose another method of contraception. When Atywia Daily is used with the above medicines, additional contraceptive methods should be used for 7 to 28 days after stopping the concomitant medication, depending on the drug. The patient should consult the doctor or pharmacist if in doubt. If the period requiring mechanical contraception extends beyond one pack of Atywia Daily, the next pack should be started immediately, skipping the placebo tablets. If long-term use of medicines containing the above active substances is required, non-hormonal contraceptive methods should be considered.
Concurrent use of the following medicines with Atywia Daily may increase
the risk of adverse effects:

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

Atywia Daily may affect the action of other medicines:

• Cyclosporine (used to suppress the immune system),
• Theophylline (used to treat asthma),
• Glucocorticoids (e.g., cortisone),
• Some benzodiazepines (sedatives), such as diazepam, lorazepam,
• Clofibrate (used to reduce blood lipid levels),
• Paracetamol (used for pain and fever),
• Morphine (a very strong painkiller),
• Lamotrigine (used to treat epilepsy).

Refer to the package leaflets of all medicines being used.
Diabetes
In patients with diabetes, dosage adjustments of antidiabetic medications and insulin may be necessary.
Laboratory tests
Use of hormonal contraceptives may affect results of certain laboratory tests, such as biochemical parameters of liver, adrenal, and kidney function, thyroid function, and levels of certain plasma proteins (e.g., lipid-binding proteins or lipoproteins, proteins involved in carbohydrate metabolism, and proteins of the coagulation and fibrinolysis systems).
However, such changes are usually within normal limits.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Pregnancy
Atywia Daily must not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult a doctor promptly.
Breastfeeding
Use of Atywia Daily during breastfeeding may reduce milk production, and small amounts of active substances may pass into breast milk. Non-hormonal contraceptive methods should be used during breastfeeding.
Driving and operating machinery
Atywia Daily has no influence on concentration, driving ability, or operating machinery.
Atywia Daily contains monohydrate lactose
Atywia Daily contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult a doctor before taking the medicine.

3. How to use Atywia Daily

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Unless otherwise directed by your doctor, take 1 tablet daily.
How to use Atywia Daily
Each blister contains 28 tablets: 21 white tablets containing active substances and 7 green tablets containing placebo.
The two differently coloured tablets of Atywia Daily are arranged in the order of administration.
Take one tablet daily at the same time each day, swallowing it with a small amount of water if needed.
Do not confuse the tablets: take one white tablet daily for the first 21 days, followed by one green tablet daily for the next 7 days. Then immediately start a new blister (21 white tablets followed by 7 green tablets). There is no break between blisters—tablets should be taken continuously.
Due to the different composition of the tablets, treatment must begin with the first tablet in the upper left corner (located near the words “Inicio. Pegue aqui la tira adhesiva – Początek. Przyklej tutaj pasek samoprzylepny.”) and proceed daily in the direction indicated by the arrows on the blister.
Preparing the blister
To help the patient remember to take a tablet, each package contains 7 adhesive labels with the names of the days of the week for each blister. Choose the appropriate label starting with the day corresponding to the day the patient begins taking the tablets. For example, if starting on Wednesday, select the label beginning with “śr.”
Apply the label to the top of the blister marked “Inicio. Pegue aqui la tira adhesiva – Początek. Przyklej tutaj pasek samoprzylepny.”
This will place a day symbol above each tablet, indicating the day it should be taken. Arrows indicate the order of tablet intake.
During the 7 days when the patient takes the green placebo tablets (placebo days), withdrawal bleeding (also known as "withdrawal bleeding") should occur. This bleeding usually begins 2 or 3 days after taking the last white tablet containing active substances. After taking the last green tablet from the blister, start the next blister immediately, regardless of whether bleeding has stopped.
This means that new blisters will always be started on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.
If the patient uses Atywia Daily as directed, it provides protection against pregnancy, including during the 7 days when taking the green placebo tablets.
When to start the first blister of Atywia Daily
If no hormonal contraceptive has been used in the previous month:
Begin taking Atywia Daily on the first day of the menstrual cycle (i.e., the first day of menstruation). If the patient starts on the first day of her period, contraceptive protection is immediate. Alternatively, treatment may begin on days 2–5 of the cycle, but in this case, additional contraceptive methods (e.g., condoms) must be used for the first 7 days.
Switching from a combined hormonal contraceptive or a combined hormonal vaginal ring or transdermal system:

• If the patient has been using an oral contraceptive with a 21-day active tablet regimen followed by a 7-day break, Atywia Daily may be started the day after the break period ends.
• If the patient has been using an oral contraceptive containing 28 tablets (21 active and 7 placebo), Atywia Daily may be started the day after taking the last inactive (hormone-free) tablet from the current pack. In case of doubt, consult your doctor or pharmacist.
• If the patient has been using a transdermal patch or vaginal ring, Atywia Daily should be started the day after the break period following the removal of the last patch or ring.

Switching from a progestogen-only method (progestogen-only "mini-pill"):
The mini-pill may be discontinued at any time. Atywia Daily may be started the next day. Additional contraceptive methods (e.g., condoms) must be used for the first 7 days.
Switching from a progestogen-only method (implant or intrauterine system releasing progestogen):
Atywia Daily may be started on the day the next injection would have been due or on the day the implant is removed. Additional contraceptive methods (e.g., condoms) must be used for the first 7 days.
After childbirth, when not breastfeeding:
Atywia Daily may be started between 21 and 28 days after delivery. Additional contraceptive methods (e.g., condoms) must be used for the first 7 days. If sexual intercourse occurred after childbirth and before starting Atywia Daily, ensure pregnancy has not occurred or wait for the onset of withdrawal bleeding.
If the patient is breastfeeding:
If the patient is breastfeeding and wishes to start Atywia Daily, she should consult her doctor (see “Pregnancy and breastfeeding”).
Use after miscarriage or childbirth:
Discuss the use of Atywia Daily with your doctor.
Duration of use
Atywia Daily may be used for as long as hormonal contraception is desired, provided it does not pose a health risk to the patient (see “When not to use Atywia Daily”, “Discontinue Atywia Daily immediately”). Regular medical check-ups are recommended.
Overdose of Atywia Daily
If more tablets than recommended have been taken, contact your doctor or pharmacist.
Possible symptoms of overdose include: nausea, vomiting (usually within 12 to 24 hours, sometimes lasting several days), breast tenderness, dizziness, abdominal pain, drowsiness, fatigue; vaginal bleeding may occur in women and young girls. Contact your doctor if an excessive number of tablets has been taken.
Missed dose of Atywia Daily
The last green tablets in the 4th row of the blister are placebo tablets. If one of these is missed, contraceptive efficacy of Atywia Daily remains unchanged. Discard the missed placebo tablet.
If a white tablet containing active substances (in the first, second or third row) is missed, follow the instructions below:

• If less than 12 hours have passed since the missed tablet, contraceptive efficacy is not reduced. Take the missed tablet as soon as possible, then continue with the next tablets at the usual time.
• If more than 12 hours have passed since the missed tablet, contraceptive efficacy may be reduced. If no withdrawal bleeding occurs during the placebo tablet period, the patient may be pregnant. Consult your doctor before starting the next pack.

Therefore, follow these rules (see also the chart below):

• The break between tablet intakes must never exceed 7 days.
• A continuous 7-day intake period is required for adequate contraceptive effect after a missed tablet.

Guidelines for missed tablets:
Missed one tablet in the first week:
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue with the next tablets at the usual time and use additional protection (e.g., condoms) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, be aware that pregnancy may have occurred. The risk of reduced contraceptive efficacy is highest if a tablet is missed at the beginning or end of a pack.
Missed one tablet in the second week:
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue with the next tablets at the usual time. If the patient has taken Atywia Daily correctly in the preceding week, contraceptive efficacy is not reduced and no additional protection is needed. If more than one tablet is missed, use another contraceptive method (e.g., condoms) for the next 7 days.
Missed one tablet in the third week:
Contraceptive efficacy is not guaranteed. Continuing for 7 days with placebo tablets can maintain contraceptive action. If the patient follows the recommendations below, additional contraceptive methods are not necessary—but only if Atywia Daily was taken correctly during the 7 days preceding the missed tablet. If not, follow the instructions below under point 1. Additionally, use additional contraceptive methods (e.g., condoms) for the next 7 days.
Two options are available:

1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue with the next tablets at the usual time. Discard the green placebo tablets and immediately start the next blister. Withdrawal bleeding will most likely occur at the end of the second blister, but breakthrough bleeding or spotting may occur during the second blister.
2. Alternatively, stop taking the white tablets from the current blister and proceed directly to the green placebo tablets (note the day the tablet was missed before starting the placebo period), then start the next blister. If the patient wishes to start the new blister on a specific day, the placebo period may be shortened.

Missed more than one tablet from a blister
If more than one tablet from a blister is missed, contraceptive efficacy is reduced. The risk of contraceptive failure is highest if tablets are missed at the beginning or end of a pack. Use additional contraceptive methods until withdrawal bleeding occurs. If withdrawal bleeding does not occur after finishing the blister, the patient may be pregnant. In this case, contact your doctor.
Gastrointestinal disturbances
If severe gastrointestinal disturbances (e.g., vomiting, diarrhoea) occur within 4 hours of taking an Atywia Daily tablet, absorption of the active substances may be incomplete and additional contraceptive methods should be used. Follow the recommendations for a single missed tablet. If the patient does not wish to alter her usual dosing schedule, she should take an additional tablet(s) from a new pack. In case of persistent or recurring gastrointestinal problems, use additional non-hormonal contraceptive methods and inform your doctor.
Delaying withdrawal bleeding
To delay withdrawal bleeding, skip the placebo tablets in the current pack and immediately start tablets from the next Atywia Daily pack. The delay in bleeding may last as long as needed, up to the end of the second pack’s active tablets. During the extended cycle, light bleeding or spotting may occur. Resume regular Atywia Daily use after completing the placebo tablet period.
Stopping Atywia Daily
The patient may stop taking Atywia Daily at any time. If pregnancy is not desired, discuss other effective contraceptive methods with your doctor.
If in doubt about how to use this medicine, the patient should consult her doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health which the patient considers to be related to the use of Atywia Daily, medical advice should be sought from a doctor.

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before taking Atywia Daily".

Detailed information on serious adverse reactions associated with the use of Atywia Daily is described in section 2 of the Patient Leaflet under "Important information before taking Atywia Daily". Please read these sections carefully to obtain additional information and consult your doctor immediately if necessary.

Seek immediate medical attention if the patient experiences symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, skin rash, and breathing difficulties (see section "Warnings and precautions").

Adverse reactions that may be associated with the use of Atywia Daily:

Common (occur in fewer than 1 in 10 people):

• headache,
• breast pain, including breast discomfort and tenderness.

Uncommon (occur in fewer than 1 in 100 people):

• vaginal inflammation and/or vulvovaginitis (inflammatory conditions of genital organs), vaginal candidiasis (yeast infection) or other fungal infections of the vagina,
• increased appetite,
• depressed mood,
• dizziness,
• migraine,
• high or low blood pressure, in rare cases increase in diastolic blood pressure (the lowest level to which blood pressure drops between heartbeats),
• abdominal pain, including upper and lower abdominal pain, discomfort and/or bloating,
• nausea, vomiting or diarrhoea,
• acne,
• alopecia (hair loss),
• rash (including maculopapular rash),
• itching (sometimes affecting the whole body),
• changes in bleeding patterns such as heavy, light, infrequent or absent menstrual periods,
• intermenstrual vaginal bleeding, uterine haemorrhage (irregular bleeding between periods),
• painful menstruation (painful periods), lower abdominal pain,
• breast enlargement, including breast congestion and swelling,
• vaginal discharge,
• ovarian cysts,
• fatigue, including asthenia (weakness) and malaise,
• changes in body weight (including weight gain, weight loss and weight fluctuations).

Rare (occur in fewer than 1 in 1000 people):

• inflammation of the ovaries and fallopian tubes,
• cervicitis (inflammatory condition of the cervix),
• urinary tract infections, cystitis (bladder inflammation),
• mastitis (inflammation of the breast),
• fungal infections (candidiasis), viral infection, oral herpes,
• influenza, bronchitis, upper respiratory tract infections, sinusitis,
• asthma,
• hyperventilation,
• uterine leiomyoma,
• fibroadenoma of the breast,
• anaemia,
• hypersensitivity (allergic reaction),
• virilization (development of male secondary sexual characteristics in women),
• 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 supply to part of the brain), cardiovascular disorders (disorders of blood supply to the heart), dystonia (sustained muscle contractions causing twisting or abnormal postures),
• dry or irritated eyes,
• visual disturbances,
• sudden hearing loss, hearing disorders,
• tinnitus,
• balance disorders,
• tachycardia (rapid heartbeat),
• thrombosis (blood clots in blood vessels), pulmonary embolism (blood clot travelling to the lungs),
• thrombophlebitis (vein inflammation including blood clots),
• varicose veins, venous dysfunction or vein pain,
• orthostatic hypotension (dizziness or fainting when rising from sitting or lying position),
• hot flushes,
• gastritis (inflammation of the stomach lining), enteritis,
• indigestion,
• skin reactions, including allergic dermatitis, neurodermatitis and/or atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (yellow-brown skin patches, usually on the face), pigmentary disturbances and/or discoloration,
• seborrhoea,
• dandruff,
• excessive hair growth (hirsutism),
• skin disorders, "peau d'orange" (orange peel-like) skin appearance,
• spider angioma,
• back pain, chest pain,
• bone and muscle complaints, muscle pain, pain in arms and legs,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• pain or cysts of uterine appendages (ovaries and fallopian tubes),
• breast cysts, fibrocystic breast changes, breast swelling,
• painful sexual intercourse,
• galactorrhea, nipple discharge,
• menstrual disorders,
• swelling of hands and feet (fluid retention),
• influenza-like illnesses, inflammation, fever,
• increased levels of triglycerides and cholesterol in blood (hypertriglyceridaemia, hypercholesterolaemia),
• blood clots in veins or arteries, 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 ischaemic attack (TIA),
  • blood clots in the liver, stomach and/or intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors that increase this risk (see section 2 for further information on risk factors increasing the likelihood of blood clots and symptoms of blood clots).

Frequency not known (cannot be estimated from available data):

• decreased or increased libido (sex drive),
• intolerance to contact lenses,
• urticaria,
• nodular erythema, erythema multiforme.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Atywia Daily

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the blister.
The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Keep the blister in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

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

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

Tablets not containing active substances:

• Monohydrate lactose, corn starch, povidone K-30, magnesium stearate, anhydrous colloidal silicon dioxide; Coating: hypromellose 2910, triacetin, polysorbate 80, titanium dioxide (E 171), FD&C Blue No. 2 aluminum lake, yellow iron oxide (E 172).

What Atywia Daily looks like and contents of the pack
Tablets containing active substances: white, round, coated tablets.
Tablets not containing active substances (placebo): green, round, coated tablets.
Atywia Daily is available in packs containing 28 tablets and 3 x 28 coated tablets (21 tablets containing active substances and 7 placebo tablets).
Each Atywia Daily pack contains a blister and a set of 7 self-adhesive labels with the names of the days of the week, arranged differently depending on the day the patient starts taking the tablets.
A cardboard sleeve is included with the pack, into which the blister should be placed.
For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing authorization holder in Spain, country of export:
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer:
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
La Vallina s/n
24008 Villaquilambre, León
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization numbers in Spain, country of export: 701770.7
701773.8
Parallel import authorization number: 51/22
This medicinal product is authorized for marketing in the European Economic Area countries under the following names:
Belgium: Serisima Continu 2 mg / 0.03 mg comprimé pelliculé
Bulgaria: Dienorette 2mg/0,03 mg
Czech Republic: Diecyclen 2 mg/0,03 mg potahované tablety
Estonia: Diecyclen
France: Serisima Continu 2 mg / 0.03 mg comprimé pelliculé
Italy: Serisima Diario 2 mg e 0,03 mg compressa rivestita con film
Lithuania: Diecyclen 2mg/0.03 mg plėvele dengtos tabletės
Latvia: Diecyclen 2mg/0.03 mg apvalkotās tabletes
Luxembourg: Serisima Continu 2 mg / 0.03 mg comprimé pelliculé
Hungary: Diedita 2 mg/0.03 mg, film-coated tablets
Poland: Atywia Daily
Austria: Dienorette 0,03 mg / 2 mg 21+7 Filmtabletten
Romania: Dienorette 2 mg/0,03mg comprimate filmate
Slovakia: Diecyclen 2mg/0,03mg filmom obalené tablety
Germany: Velafee 21+7, 0.03 mg / 2 mg Filmtabletten
Spain: Ceciliana Diario, 2 mg/0.03 mg comprimidos recubiertos con película EFG
Other sources of information
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