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 (Velafee 21+7)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Atywia Daily and Velafee 21+7 are different brand names for the same medicine.
Important information regarding combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, particularly during the first year of use or after restarting following a break of 4 weeks or longer.
• Be vigilant and consult your 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 for future reference.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
• 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 hormonal activity.
Atywia Daily is used:

• to prevent pregnancy
• for the treatment of women with moderate acne who have decided to use oral contraceptives and in whom adequate topical 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. The patient should discuss with her 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 these conditions, inform your doctor. Your doctor will discuss with you which other 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 currently have (or have ever had) a blood clot in the veins of your 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, 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 previously had) 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 currently have (or have previously had) a type of migraine called migraine with aura.
• If you smoke (see section 2 "Blood clots").
• If you currently have (or have previously had) pancreatitis associated with elevated triglyceride levels (lipid metabolism disorder (fats)).
• If you have previously had or currently have severe liver disease (until liver function tests return to normal values) (including Dubin-Johnson syndrome and Rotor syndrome).
• If you have previously had or currently have benign or malignant liver tumours.
• If you currently have or have previously had a hormone-dependent cancer (such as 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 have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Atywia Daily and other medicines").

Warnings and precautions
Before starting to use 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 contact your doctor. During this time, use non-hormonal methods of contraception.

When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of a blood clot, 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 section "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
If these conditions appear or worsen while taking 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 delivery,
• if you have superficial thrombophlebitis (inflammation of veins under the skin),
• if you have varicose veins,
• if you develop symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or skin rash, and breathing difficulties—seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
The use of combined hormonal contraceptives such as Atywia Daily is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in the veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in the 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 should be remembered that the overall risk of harmful blood clots associated with the use of Atywia Daily is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? If so, why might you be suffering?

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 patient stops taking Atywia Daily, the risk of blood clots returns to normal 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 venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of blood clots associated with the use of Atywia Daily is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one 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 increasing the risk of blood clots", below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Atywia Daily is low,
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 someone in the patient’s immediate family has been diagnosed with 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 requires 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 above 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, especially 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, for example, if a family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can 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 (above approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Atywia Daily, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient has overweight;
• if the patient has high blood pressure;
• if someone in the patient’s immediate family 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 family member has high blood lipid levels (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, arrhythmia 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 are 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 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 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 exceptionally frequent, severe, persistent headaches that start suddenly with symptoms of aura (sensory, visual, or motor disturbances);
• if the patient experiences 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 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 of heme synthesis) and symptoms recur 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;
• if the patient has sickle cell anemia (a hereditary red blood cell disorder);
• if the patient has had liver disease;
• if the patient has had gallbladder disease;
• if the patient has migraines;
• if the patient has depression;
• if the patient has diabetes (Diabetes mellitus) or impaired glucose metabolism (reduced glucose tolerance). Insulin or antidiabetic medication doses may need adjustment 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 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 an 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 a doctor as soon as possible for further medical advice.
Oral contraceptives and cancer
Women who take oral contraceptives have a slightly higher incidence of breast cancer compared to women of the same age who do not use them. The risk decreases after stopping treatment and after 10 years, it 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.
Results of some epidemiological studies suggest that long-term use of combined oral contraceptives by 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 a 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 for a long time. The increased frequency of hypertension is associated with the action of progestogen. Women with conditions related to high blood pressure and certain kidney diseases should use alternative contraceptive methods (consult a 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 on the skin, especially in women who previously experienced pregnancy-related chloasma. Women predisposed to chloasma should avoid exposure to sunlight and ultraviolet radiation during treatment with combined oral contraceptives.
Menstrual irregularities
During use of oral contraceptives, irregular bleeding (spotting or intermenstrual bleeding) may occur, especially during the first months of tablet use. Consult a doctor if irregular bleeding persists for more than three cycles or if bleeding recurs after a 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 bleedings are missed, the patient may be pregnant. Pregnancy must be excluded 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, in case of vomiting, severe diarrhea, or concomitant use of certain medications.
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 control 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 and other sexually transmitted diseases.
Atywia Daily and other medicines
Do not use Atywia Daily if the patient has hepatitis C and is taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause increased liver function blood test results (elevated liver enzyme AlAT activity).
The doctor will prescribe another type of contraception before starting treatment with these drugs.
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 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 peristalsis (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 in 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 treated with 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 medication, depending on the drug. The patient should consult a 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.
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 (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 used.
Diabetes
In patients with diabetes, adjustment of antidiabetic medications and insulin dosage may be necessary.
Laboratory tests
Use of hormonal contraceptives may affect results of certain laboratory tests, e.g. biochemical parameters of liver, adrenal, and kidney function, thyroid function, and levels of certain plasma 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, or if pregnancy is suspected or planned, consult a 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 a doctor immediately.
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 monohydrate lactose
Atywia Daily contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should contact her 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 advised by your doctor, take 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 intake.
Take one tablet daily at the same time each day, 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 blisters.
Due to the different composition of the tablets, treatment must be started with the first tablet in the upper left corner (located near the label “Start Wochenaufkleber hier aufkleben”) and tablets should be taken in the order indicated by the arrows on the blister.

Preparing the blister
To help the patient remember to take the tablet, each pack contains 7 self-adhesive labels with abbreviations of the days of the week. Choose the appropriate label starting with the day of the week corresponding to the day the patient begins taking the tablets. For example, if starting on Wednesday, select the label beginning with “Wed.”
Apply the label to the top of the blister marked “Start Wochenaufkleber hier aufkleben – Początek Przyklej tutaj pasek samoprzylepny”.
Each tablet will then be marked with a day symbol 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 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 bleeding will occur approximately on the same days each month.
If the patient takes Atywia Daily as directed, pregnancy is prevented, including during the 7 days when taking the green placebo tablets.

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 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 or a combined contraceptive vaginal 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.
• If the patient has been taking a 28-tablet combined oral contraceptive (containing both active and placebo tablets), Atywia Daily may be started the day after taking the last inactive (hormone-free) tablet from the previous pack. In case of doubt, consult your doctor or pharmacist.
• If the patient has been using a transdermal patch or vaginal contraceptive system, Atywia Daily should be started the day after the scheduled break from the vaginal system or transdermal patches.

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, if 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, pregnancy must first be ruled out or wait until bleeding occurs.

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 abortion:
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 take Atywia Daily”, “Stop taking Atywia Daily immediately”). Regular medical check-ups are recommended.

Overdose of Atywia Daily
If more tablets than recommended are taken, contact your doctor or pharmacist.
Possible symptoms of overdose include: nausea, vomiting (usually 12 to 24 hours after ingestion, sometimes lasting several days), breast tenderness, dizziness, abdominal pain, drowsiness, fatigue; vaginal bleeding may occur in women and young girls. Contact a doctor if an overdose is suspected.

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 rows 1, 2, or 3) is missed, follow these instructions:

• 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 following 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 phase, the patient may be pregnant. Consult a doctor before starting the next pack.

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

• The tablet-taking interval must never exceed 7 days.
• A continuous 7-day tablet-taking period is required after a missed tablet to ensure adequate contraceptive effect.

Guidelines for a missed tablet:

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 taking the remaining tablets at the usual time and use additional contraception (e.g., condoms) for the next 7 days. If the patient had 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.

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 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. 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 effect. 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.

There are two options:

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 phase), then start the next blister. To begin the new blister on a specific day, the placebo phase may be shortened.

Missed more than one tablet from a blister
If more than one tablet 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, consult a doctor.

Gastrointestinal disturbances
In case of severe gastrointestinal disturbances (e.g., vomiting, diarrhoea) within 4 hours of taking Atywia Daily, 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 change her current dosing schedule, she should take additional tablet(s) from a new pack. If gastrointestinal problems persist or recur, use additional non-hormonal contraceptive methods and inform your doctor.

Postponing withdrawal bleeding
To delay the onset of withdrawal bleeding, skip the placebo tablets in the current pack and immediately start tablets from the next Atywia Daily pack. The delay in bleeding can last as long as needed, even until the end of the second pack’s active tablets. During the extended cycle, light bleeding or spotting may occur. Resume regular Atywia Daily intake after the placebo tablet phase.

Stopping Atywia Daily
Atywia Daily may be discontinued at any time. If the patient does not wish to become pregnant, she should discuss other effective contraceptive methods with her doctor.
If in doubt about how to use this medicine, consult your 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 status that the patient considers related to the use of Atywia Daily, medical advice should be sought immediately.

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 using 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 using 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, or 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 (inflammation 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 an increase in diastolic blood pressure values (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 diarrhea,
• acne,
• alopecia (hair loss),
• rash (including maculopapular rash),
• itching (sometimes affecting the whole body),
• changes in menstrual bleeding such as heavy, light, infrequent or absent periods,
• intermenstrual vaginal bleeding, uterine hemorrhage (irregular bleeding between periods),
• painful menstruation (dysmenorrhea), 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 (inflammation 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,
• breast adenoma,
• anemia,
• 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,
• cerebral circulation disorders (disorders of blood flow to parts of the brain or to the heart), stroke (reduced or interrupted blood supply to part of the brain), cardiovascular disorders (disorders of blood flow to the heart), dystonia (persistent 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 traveling 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 down),
• hot flushes,
• gastritis, 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 skin discoloration,
• seborrhea,
• dandruff,
• excessive hair growth (hirsutism),
• skin disorders, "orange peel" skin appearance,
• spider angioma,
• back pain, chest pain,
• bone and muscle discomfort, muscle pain, pain in arms and legs,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• pain or cysts in the adnexa (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 blood levels of triglycerides and cholesterol (hypertriglyceridemia, hypercholesterolemia),
• 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,
  • transient ischemic attack (mini-stroke) or transient stroke-like symptoms known as transient ischemic attack,
  • blood clots in the liver, stomach and/or intestine, kidneys or eye.

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

Frequency not known (cannot be estimated from 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 those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30ºC. Store the blister in the outer packaging to protect from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 rows, and 7 green coated tablets in the fourth row.

White coated tablets containing active substances:

• The active substances in this medicinal product are ethinylestradiol and dienogest. One coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
• Excipients: monohydrate lactose, corn starch, povidone K 30, magnesium stearate. Coating: hypromellose, polyethylene glycol 400, titanium dioxide (E 171).

Tablets not containing active substances:

• Excipients: monohydrate lactose, corn starch, povidone K 30, magnesium stearate, anhydrous colloidal silicon dioxide.
• Coating: hypromellose, triacetin, polysorbate 80, titanium dioxide (E 171), indigo carmine, aluminium 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 3x28 coated tablets (21 active tablets and 7 placebo tablets).
Each Atywia Daily package contains a blister and a set of 7 self-adhesive labels with abbreviations of the days of the week, arranged differently depending on the day the patient starts taking the tablets.
An accompanying cardboard sleeve is included with each package, in which the blister should be placed.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Germany, country of export:
Exeltis Germany GmbH
Adalperostraße 84
85737 Ismaning, Germany

Manufacturer:
Laboratorios León Farma S.A.
La Vallina s/n, Pol. Ind. Navatejera
Navatejera-24008 León
Spain

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

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

German Marketing Authorisation number (country of export): 87090.00.00
Parallel Import Authorisation number: 296/22

This medicinal product is authorised for sale 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
Germany: Velafee 21+7, 0.03 mg / 2 mg Filmtabletten
Spain: Ceciliana Diario, 2 mg/0.03 mg comprimidos recubiertos con película
EFG

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