Atywia daily

Package leaflet: Information for the patient

Atywia Daily, 0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Important information about combined hormonal contraceptives

• When used correctly, they are among 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 longer
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots")

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Atywia Daily is and what it is 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 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 ingredients (so-called placebo tablets).

Atywia Daily is effective in alleviating symptoms of acne caused by androgenic hormonal 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 take Atywia Daily if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative method of contraception may 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 disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies
• If you require 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 that 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 hyperhomocysteinaemia
• 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) pancreatitis associated with elevated triglyceride levels (lipid metabolism disorders (fats))
• If you have (or have had in the past) severe liver disease (until liver function tests return to normal) (including Dubin-Johnson syndrome and Rotor syndrome)
• If you have had or currently have benign or malignant liver tumours
• If you have had or currently have a hormone-dependent cancer (e.g. breast or genital organ cancer)
• If you have vaginal bleeding 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 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, you must stop taking Atywia Daily immediately and consult your doctor. During this time, use non-hormonal methods of contraception.

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

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

Tell your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Atywia Daily, you should also 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 causing kidney failure)
• If you have sickle cell anaemia (an inherited disorder of red blood cells)
• If you have high levels of fats in the blood (hypertriglyceridaemia) or a 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 are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Atywia Daily after childbirth
• If you have phlebitis (inflammation of 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, 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 is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.
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 events"). 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 is important to remember that the overall risk of harmful blood clots associated with the use of Atywia Daily is small.

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

Do you have any of these symptoms? What is the likely cause?

• Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis, especially if accompanied by:
  • Pain or tenderness in the leg, which may occur only when standing or walking
  • Increased temperature in the affected leg
  • Change in skin colour of the leg, such as pallor, redness, or blueness
  • Sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
  • Sudden cough without obvious cause, possibly accompanied by coughing up blood
  • Sudden sharp chest pain, which may worsen on deep breathing
  • Severe dizziness or vertigo
  • Rapid or irregular heartbeat
  • Severe abdominal pain

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as a respiratory tract infection (e.g. cold).

Symptoms usually occur in one eye: Retinal vein thrombosis (blood clot in the eye)

• Sudden loss of vision
• Painless visual disturbances that may progress to vision loss

Heart attack

• Chest pain, discomfort, pressure, heaviness
• Sensation of squeezing or fullness in the chest, arm, or below the breastbone
• Feeling of fullness, indigestion, or choking
• Discomfort in the upper 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

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

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in the veins (venous thrombosis). Although these adverse events are rare, they occur most frequently 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 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 the veins highest?
The risk of developing blood clots in the 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 within a few weeks.

What factors influence the risk of developing blood clots in the veins?
The risk depends on the 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 are not using 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 contraceptives containing dienogest and ethinylestradiol, such as Atywia Daily, will develop blood clots.
• The risk of developing blood clots depends on the individual medical history of the woman (see "Factors that increase the risk of developing blood clots," 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 has significant 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). In this case, the patient may have inherited clotting disorders;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Atywia Daily several weeks before surgery or 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 the patient has another risk factor. It is important to inform the doctor if any of these 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, e.g., if a close family member develops unexplained thrombosis or if the patient gains significant weight.

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

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Atywia Daily, it is recommended to stop smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend another type of contraception;
• if the patient has overweight;
• if the patient has high blood pressure;
• if a close family member has had myocardial infarction or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of myocardial infarction 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, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, arrhythmia known 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, e.g., if the patient starts smoking, a close family member is diagnosed with
unexplained thrombosis, or if the patient gains significant weight.
Stop taking Atywia Daily immediately:

• if the patient is pregnant or suspects she may be pregnant;
• if the patient has symptoms of vein inflammation 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 (discontinue the medication 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 exceptionally frequent, severe, persistent headaches that start suddenly with symptoms of aura (sensory, visual, or motor disturbances);
• if the patient has severe pain in the upper abdomen (see also "Oral contraceptives and cancer");
• if the patient's skin and whites of the eyes turn yellow, urine becomes dark brown, stools are very pale (jaundice), or if the patient experiences generalized itching;
• if the patient has diabetes mellitus and blood sugar levels rise unexpectedly;
• if the patient has disorders of blood pigment formation (porphyria) and a relapse occurs during treatment with Atywia Daily.

Situations requiring special medical attention:

• if the patient has heart or kidney diseases;
• if the patient has vein inflammation (phlebitis) or varicose veins;
• if the patient has circulatory disorders in hands and/or feet;
• if the patient's blood pressure is above 140/90 mm Hg;
• if the patient has had lipid metabolism disorders;
• if the patient has sickle cell anemia (a hereditary red blood cell disorder);
• if the patient has had liver diseases;
• if the patient has had gallbladder diseases;
• if the patient has migraines;
• if the patient has depression;
• if the patient has diabetes mellitus or impaired glucose metabolism (reduced glucose tolerance). Dose adjustments of insulin and antidiabetic medications may be necessary during concomitant 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, consider using alternative contraceptive methods;
• 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 a benign tumor in the uterine muscle layer (uterine fibroid);
• if the patient has otosclerosis;
• in case of prolonged immobilization (see section 2 "Blood clots");
• if the patient has overweight;
• if the patient has a systemic autoimmune disorder (systemic lupus erythematosus);
• if the patient is 40 years 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 taking oral contraceptives than in women of the same age who do not use them. The risk decreases after stopping treatment and, after 10 years, is the same as in women who have never taken oral contraceptives.
Since breast cancer is rare in women under 40, the increased number of diagnoses in women currently or recently using combined oral contraceptives is small relative to the overall risk of breast cancer.
Some epidemiological studies suggest that long-term use of combined oral contraceptives in women infected with human papillomavirus (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 contraception).
In very rare cases, a benign liver tumor may develop. Such a tumor may cause life-threatening intra-abdominal bleeding. Contact the doctor immediately in case of severe abdominal pain. 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 those using hormonal contraceptives long-term. The increased incidence 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", "Stop taking Atywia Daily immediately", "Situations requiring special medical attention").
Chloasma (yellow-brown skin discoloration)
Yellow-brown patches (chloasma) may occasionally appear, especially in women who previously had chloasma during pregnancy. Women predisposed to chloasma should avoid exposure to sunlight and ultraviolet radiation while using combined oral contraceptives.
Menstrual cycle irregularities
Irregular bleeding (spotting or intermenstrual bleeding) may occur during use of oral contraceptives, especially during the first months of treatment. Consult the doctor if irregular bleeding persists for more than three cycles or if bleeding recurs after a completed regular cycle.
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, the patient may be pregnant. Pregnancy must be ruled out before continuing Atywia Daily.
After discontinuation of hormonal contraceptives, return to a regular natural cycle may not occur immediately.
Reduced effectiveness
The effectiveness of Atywia Daily may be reduced if tablets are missed, vomiting occurs, severe diarrhea develops, or certain medications are taken concomitantly.
If Atywia Daily is taken 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 clinical examination, including breast examination, is 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 all other medications she is taking.
Atywia Daily does not protect against HIV infection or other sexually transmitted diseases.
Atywia Daily and other medicines
Do not use Atywia Daily if the patient has hepatitis C and is taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased liver enzyme activity AlAT). Before starting these medications, the doctor will prescribe another type of contraception.
Atywia Daily may be restarted approximately 2 weeks after completing the above 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 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).
• Some 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 pregnancy prevention. When using Atywia Daily with any of the above medicines, additional contraceptive methods should be used for 7 to 28 days after stopping the medicine, depending on the drug. The patient should consult the doctor or pharmacist if in doubt. If the period of 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.
Concomitant 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 (antibiotic),
• Antifungal medicines, derivatives of imidazole (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 analgesic),
• Lamotrigine (used to treat epilepsy).

Refer to the package leaflets of all concomitantly used medicines.
Diabetes
In patients with diabetes, dose adjustments of antidiabetic medications and insulin may be necessary.
Laboratory tests
Use of hormonal contraceptives may affect the results of certain laboratory tests, e.g., biochemical parameters of liver, adrenal, and kidney function, thyroid function, as well as plasma concentrations of certain proteins such as lipid-binding proteins or lipoproteins, proteins involved in carbohydrate metabolism, and proteins of the coagulation and fibrinolytic systems.
However, these changes are usually within normal limits.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, if pregnancy is suspected, or if pregnancy is planned, consult the doctor or pharmacist before using this medicine.
Pregnancy
Do not take Atywia Daily during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult the 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 effect on concentration, driving, or operating machinery.
Atywia Daily contains lactose
Atywia Daily contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult the doctor before taking the medicine.

3. How to take Atywia Daily

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is 1 tablet daily.
How to take 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.
Tablets should be taken every day at the same time, 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 7 days. Then immediately start a new blister (21 white tablets followed by 7 green tablets). There is no break between packs—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 word “Start”), taking one tablet daily.
To maintain the correct sequence, follow the direction of the arrow printed on the blister.
Preparing the blister
To help the patient remember to take a tablet, each package contains 7 self-adhesive labels with the names of the days of the week, one for each blister. Choose the appropriate label starting with the name of the day corresponding to the day the patient will start taking the tablets. For example, if starting on Wednesday, select the label beginning with “Śr”.
Attach the label to the top of the blister marked “Stick day labels here”.
Each tablet will then be marked with the symbol of the day indicating when it should be taken. Arrows show the order of tablet intake.
During the 7 days when the patient takes green placebo tablets (placebo days), withdrawal bleeding should occur. This bleeding usually starts 2 or 3 days after taking the last white tablet containing active substances. After taking the last green tablet from the blister, the next blister should be started immediately, regardless of whether bleeding has stopped or not.
This means that new blisters will always be started on the same day of the week, and bleeding will occur approximately on the same days each month.
If Atywia Daily is taken as described above, it provides contraceptive protection, including during the 7 days when green placebo tablets are taken.
When to start the first Atywia Daily blister
If no hormonal contraceptive has been used in the previous month:
Start taking Atywia Daily on the first day of the menstrual cycle (i.e. the first day of menstruation). If the patient starts taking the medicine on the first day of her period, contraceptive protection is immediate. Alternatively, Atywia Daily may be started 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 pill or a combined vaginal contraceptive system or transdermal patch:

• If the patient has been taking a combined 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 (i.e. the day after the last inactive tablet or break).
• If the patient has been taking a 28-tablet combined oral contraceptive containing both active and placebo tablets, Atywia Daily should be started the day after the last inactive (hormone-free) tablet of the previous pack.
• If the patient has been using a transdermal patch or vaginal ring, Atywia Daily should be started the day after the break from the patch or ring regimen.

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) should be used for the first 7 days.
Switching from a progestogen-only method (implant or progestogen-releasing intrauterine system):
Atywia Daily may be started on the day the next injection would have been due, or on the day of implant removal. Additional contraceptive methods (e.g. condoms) should 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) should be used for the first 7 days. If sexual intercourse has occurred since delivery, pregnancy should be ruled out or the patient should wait for withdrawal bleeding before starting Atywia Daily.
If the patient is breastfeeding:
If the patient is breastfeeding and wishes to start taking Atywia Daily, she should consult her doctor (see “Pregnancy and breastfeeding”).
Use after miscarriage or abortion:
The use of Atywia Daily should be discussed with a 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 use immediately”). Regular medical check-ups are recommended.
Overdose of Atywia Daily
In case of taking more tablets than recommended, 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 a doctor if more tablets than recommended have 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, the contraceptive efficacy of Atywia Daily remains unchanged. The missed placebo tablet should be discarded.
If a white tablet containing active substances (in rows 1, 2, or 3) 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 taking the next tablets at the usual time.
• If more than 12 hours have passed since the missed tablet, contraceptive efficacy may be reduced. If withdrawal bleeding does not occur during the placebo tablet period, the patient may be pregnant. Contact a doctor before starting the next pack.

Therefore, the following rules must be observed (see also the chart below):

• The break in tablet intake must never exceed 7 days.
• An uninterrupted 7-day period of tablet intake is necessary for adequate contraceptive effect.

Guidelines for missed tablets:
Missing 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 taking the remaining tablets at the usual time and use additional contraception (e.g. condoms) for the next 7 days. If the patient had sexual intercourse in the week before missing the tablet, she should 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.
Missing 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 taking the remaining 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 contraception is needed. However, if more than one tablet is missed, use another contraceptive method (e.g. condoms) for the next 7 days.
Missing one tablet in the third week:
Contraceptive efficacy is not guaranteed. Continuing with the 7-day placebo period may still maintain contraceptive protection. If the patient follows the recommendations below, additional contraceptive methods are not required—but only if Atywia Daily was taken correctly during the 7 days preceding the missed tablet. If not, follow the instructions under point 1 below. 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 taking the remaining 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 immediately start the green placebo tablets (note the day the tablet was missed before starting the placebo period), then begin the next blister. If the patient wishes to start the new blister on the usual day, the placebo period may be shortened.

Missing more than one tablet from a blister
If the patient misses more than one tablet, 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 completing the blister, the patient may be pregnant. In this case, contact a doctor.
Recommendations in case of gastrointestinal disturbances
If severe gastrointestinal disturbances (e.g. vomiting, diarrhoea) occur within 4 hours after taking an Atywia Daily tablet, absorption of the active substances may not be complete, and additional contraceptive methods should be used. Follow the recommendations for a single missed tablet. If the patient does not wish to change the current 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 the doctor.
How to delay withdrawal bleeding
To delay withdrawal bleeding, skip the placebo tablets from the current pack and immediately start taking tablets from the next Atywia Daily pack. The delay in bleeding can last as long as needed, even until the end of the active tablets in the second pack. During the extended cycle, light bleeding or breakthrough spotting may occur. Regular intake of Atywia Daily should resume after the placebo tablet period.
Stopping Atywia Daily
Atywia Daily may be discontinued at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective contraceptive methods.
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 blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 “Important information before use of Atywia Daily”.
Detailed information on serious adverse reactions associated with the use of this medicine is described in section 2 of the Patient Leaflet under “Important information before use of Atywia Daily”. Please read these sections 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, or 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 the 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 values (the lowest level to which blood pressure drops between heartbeats),
• abdominal pain, including in the upper and lower abdomen, stomach aches, discomfort and/or bloating,
• nausea, vomiting or diarrhoea,
• acne,
• hair loss (loss of hair),
• rash (including maculopapular rash),
• itching (sometimes of the whole body),
• changes in menstrual bleeding such as heavy, light, infrequent or completely absent 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 the brain or heart), stroke (reduced or interrupted blood supply to part of the brain), cardiovascular disorders (disorders of blood flow to the heart), dystonia (sustained muscle contractions causing, for example, 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 a sitting or lying position),
• hot flushes,
• gastritis (inflammation of the stomach lining), enteritis (inflammation of the intestine),
• indigestion,
• skin reactions, including allergic dermatitis, neurodermitis and/or atopic dermatitis, rash, psoriasis,
• excessive sweating,
• chloasma (yellow-brown skin patches, usually on the face), pigmentary disorders and/or discoloration,
• seborrhoea,
• dandruff,
• excessive hair growth (hirsutism),
• skin disorders, “orange peel” skin appearance,
• spider angioma,
• back pain, chest pain,
• musculoskeletal complaints, muscle pain, pain in arms and legs,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• pain or cysts of the uterine adnexa (ovaries and fallopian tubes),
• breast cysts, fibrocystic breast changes, breast swelling,
• painful sexual intercourse,
• galactorrhea, breast discharge,
• menstrual disorders,
• swelling of hands and feet (fluid retention),
• flu-like illnesses, inflammation, fever,
• increased blood levels of triglycerides and cholesterol (hypertriglyceridemia, hypercholesterolemia),
• blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis),
• in the lungs (e.g. pulmonary embolism),
• myocardial infarction,
• stroke,
• mini-stroke or transient stroke symptoms, known as transient ischaemic 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 any other factors that increase this risk (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clot occurrence).
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 adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Atywia Daily

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated after the abbreviation "Lot" on the carton and on the blister.
Do not store above 30°C.
Keep the blister in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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 coated tablets in the first, second and third
row, and 7 green coated tablets in the fourth row.
White coated tablets containing active substances:

• The active substances in this medicine are ethinylestradiol and dienogest. Each coated tablet contains 0.03 mg ethinylestradiol and 2 mg dienogest.
• Excipients:
• Tablet core: Lactose monohydrate, Corn starch, Povidone K-30, Magnesium stearate
• Coating: Hypromellose 2910, Macrogol 400, Titanium dioxide (E171)

Tablets without active substances:

• Tablet core: Lactose monohydrate, Corn starch, Povidone K-30, Magnesium stearate, Anhydrous colloidal silica
• Coating: Hypromellose 2910, Triacetin, Polysorbate 80, Titanium dioxide (E171), Indigo carmine (E132), Iron oxide yellow (E172)

What Atywia Daily looks like and contents of the pack
Tablets containing active substances: white, round, coated tablets.
Tablets without active substances (placebo): green, round, coated tablets.
Atywia Daily is available in packs containing 28, 3x28 and 6x28 coated tablets (21 tablets containing active substances and 7 placebo tablets).
Not all pack sizes may be marketed.
Each pack of Atywia Daily 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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
Szamocka Street 8
01-748 Warsaw, Poland

Manufacturer
Laboratorios León Farma SA
C/La Vallina s/n, Pol. Ind. Navatejera
24193 Villaquilambre, León
Spain

This medicinal product is authorised for marketing in the European Economic Area 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
Spain: Ceciliana Diario, 2 mg/0.03 mg comprimidos recubiertos con película EFG

Other sources of information:
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, http://www.urpl.gov.pl