Atywia daily

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging 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 trade names for the same medicine.
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more
• 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, so that you can read it again if necessary.
• If you have any doubts, please 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 the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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 substances (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 topical treatment or systemic antibiotic therapy has failed.

2. Important information before using Atywia Daily

General notes
Before starting treatment with 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 beyond six months of treatment. You should discuss with your doctor the need to continue treatment after three to six months, and thereafter 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 alternative method of contraception would be more suitable.

• If you are allergic to the active substances or to 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 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, 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 currently 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 currently 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 blood fats (cholesterol or triglycerides)
  • a condition called hyperhomocysteinaemia
• If you currently 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 currently have (or have had in the past) pancreatitis associated with increased triglyceride levels (lipid metabolism disorders (fats))
• If you have had or currently have 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 currently have or have previously had a hormone-dependent cancer (e.g. 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 medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Atywia Daily and other medicines").

Warnings and precautions
Before starting Atywia Daily, discuss this with your doctor, pharmacist, or nurse.
If any of the listed symptoms occur for the first time while taking Atywia Daily, stop taking Atywia Daily immediately and contact 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 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 adverse reactions, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
If any of these symptoms develop 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 defense system)
• If you have hemolytic uremic syndrome (a blood clotting disorder causing kidney failure)
• If you have sickle cell anemia (an inherited red blood cell disorder)
• If you have elevated blood lipid levels (hypertriglyceridemia) or a positive family history of this condition. Hypertriglyceridemia 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 then 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 or skin rash, and breathing difficulties, contact your doctor immediately. 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 such therapy. 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 should be remembered that the overall risk of harmful blood clots caused by 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? 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 warmth in the affected leg
  • Change in skin color of the leg, e.g., paleness, redness, or blueness
• Sudden unexplained shortness of breath or rapid breathing Pulmonary embolism
• Sudden cough without obvious cause, possibly accompanied by coughing up blood
• Sharp chest pain, which may worsen with deep breathing
• Severe dizziness or lightheadedness
• Rapid or irregular heartbeat
• Severe abdominal pain
• Sudden vision loss or painless visual disturbances that may progress to vision loss Retinal vein thrombosis (blood clot in the eye)
• Chest pain, discomfort, pressure, heaviness Heart attack
• 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, especially Stroke on one side of the body
• Sudden confusion, speech or comprehension difficulties
• 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
• Swelling and slightly bluish discoloration of the skin of the legs or arms Blood clots blocking other blood vessels
• Severe abdominal pain (so-called acute abdomen)

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

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

• Using combined hormonal contraceptives is associated with an increased risk of venous blood clots (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 deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, this 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 venous blood clots highest?
The risk of venous blood clots 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 not using combined hormonal contraceptives. If you stop taking Atywia Daily, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots depend on?
The risk depends on your natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used. The overall risk of blood clots associated with using Atywia Daily is small.

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a year, about 8–11 out of 10,000 women who use combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Atywia Daily, will develop blood clots.
• The risk of blood clots depends on your individual medical history (see "Factors increasing the risk of blood clots" below).

Factors increasing the risk of venous blood clots
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 a close relative of the patient has been diagnosed with blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have inherited clotting disorders;
• if the patient is due to undergo surgery, if she is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Atywia Daily for several weeks before surgery or immobilisation. If the patient must stop taking Atywia Daily, she should consult her doctor about when she can resume taking the medicine;
• with increasing age (particularly above 35 years of age);
• if the patient has recently given birth (within the last few weeks). The risk of blood clots increases with the number of risk factors present in the patient. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another mentioned risk factor. It is important to inform the doctor if any of the listed factors apply to the patient, 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 relative is diagnosed with thrombosis of unknown cause or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial blood clots can cause 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 the use of
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, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has been diagnosed with myocardial infarction or stroke at a young age (under 50 years of age). In this case, the patient may also be at increased risk of myocardial infarction or stroke;
• if the patient or a close relative has been diagnosed with high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes mellitus.

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. the patient starts smoking, a close relative is diagnosed with thrombosis of unknown cause, 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 phlebitis or blood clots (see section 2 "Blood clots");
• if blood pressure remains above 140/90 mm Hg (the doctor may recommend resuming the medicine after blood pressure returns to normal with antihypertensive medication);
• if surgery is planned (the medicine should be discontinued at least 4 weeks before surgery), or in case of prolonged immobilisation (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 disturbances, vision problems, movement difficulties);
• 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 are very pale (jaundice), or if the patient experiences itching of the entire body;
• if the patient has diabetes mellitus and blood sugar levels increase unexpectedly;
• if the patient has disorders of haem pigment formation (porphyria) and the disease recurs during treatment with Atywia Daily.

Situations requiring special medical attention:

• if the patient has heart or kidney diseases;
• if the patient has venous 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 (lipid metabolism disturbances);
• if the patient has sickle cell anaemia (a hereditary disorder affecting red blood cells);
• 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 has impaired glucose metabolism (reduced glucose tolerance). It may be necessary to adjust the dose of insulin and antidiabetic medications 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 also known as "St. Vitus' dance" (Sydenham's chorea);
• if the patient has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis);
• if the patient has a blood disorder causing kidney damage (haemolytic-uraemic syndrome);
• if the patient has been diagnosed with a benign tumour in the muscular layer of the uterus (uterine fibroid);
• if the patient has otosclerosis;
• in case of prolonged immobilisation (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 a doctor as soon as possible for further medical advice.
Oral contraceptives and cancer
In women taking oral contraceptives, breast cancer occurs slightly
more frequently than in women of the same age who do not use them. The risk of cancer
decreases after stopping treatment and after 10 years from 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 (HPV)
(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 tumour may develop. Such a tumour may
cause life-threatening bleeding into the abdominal cavity. Contact a doctor
in case of severe abdominal pain. Results of some studies indicate an increased risk
of liver tumours in women using oral contraception, although these tumours are very rare.
Other diseases
Hypertension
Cases of hypertension have been reported in older women and in women using hormonal
contraceptives for prolonged periods. The increased incidence of hypertension is associated with the action of progestogen.
Women with diseases 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 pigmentation)
Yellow-brown patches (chloasma) may occasionally appear on the skin, particularly 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
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 has ended.
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 should 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 in case of missed tablets, vomiting, severe diarrhoea, 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 also necessary. Pregnancy must be excluded. Women using oral hormonal 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 (increased activity of liver enzyme AlAT).
The doctor will prescribe another type of contraception before starting treatment with these medicines.
Atywia Daily may be restarted approximately 2 weeks after completion of 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 the patient plans to take.
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).
• Some antibiotics used to treat tuberculosis (e.g. rifampicin) or fungal infections (e.g. griseofulvin).
• Medicines used in HIV infection and hepatitis C virus infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz).
• Medicines used to treat narcolepsy, central nervous system disorders (modafinil).
• Herbal medicines containing St. John's wort (Hypericum perforatum).

Women treated with any of the listed medicines should temporarily use, in addition to Atywia Daily, a mechanical contraceptive method (condoms) or choose another method of pregnancy prevention. When using Atywia Daily with the medicines listed above, additional contraceptive methods should be used for 7 to 28 days after completion of treatment, depending on the medicine. The patient should consult a doctor or pharmacist if in doubt. If the period of using a mechanical contraceptive method 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, consider using non-hormonal contraceptive methods.
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 agents, 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 (very strong analgesic),
• Lamotrigine (used to treat epilepsy).

Refer to the package leaflets of all medicines used.
Diabetes
In patients with diabetes, it may be necessary to adjust the dose of antidiabetic medications and insulin.
Laboratory tests
Use of hormonal contraceptive products may affect the results of certain laboratory tests, e.g. biochemical parameters of liver, adrenal gland and kidney function, thyroid function, as well as concentrations of certain plasma proteins such as lipid-binding proteins or lipoproteins, proteins involved in carbohydrate metabolism, and proteins of the coagulation and fibrinolysis system.
However, these changes are usually within normal limits.
Pregnancy and breastfeeding
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 as soon as possible.
Breastfeeding
Use of Atywia Daily during breastfeeding may lead to reduced 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 ability 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 contact her doctor before taking the medicine.

3. How to take Atywia Daily

This medicine should always be taken exactly as prescribed 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 administration.
Tablets should be taken daily at the same time of day, with a small amount of water if necessary.
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 two blisters – tablets should be taken continuously.
Due to the different composition of the tablets, it is essential to start from the first tablet in the upper left corner (located near the word "Start") and take one tablet daily. To maintain the correct order of tablet intake, follow the direction of the arrow on the blister.
Preparing the blister
To help the patient remember to take a tablet, each package contains 7 self-adhesive labels with abbreviations of the days of the week for each blister. Choose the appropriate label starting with the day of the week corresponding to the day the patient will start taking the tablets. For example, if the patient starts taking tablets on Wednesday, select the label where the abbreviations of the days of the week begin with "Wed".
Place the label on the top part of the blister marked "Wochenaufkleber hier aufkleben", meaning: "Place the label here".
This way, each tablet will have a day symbol indicating the day it should be taken. Arrows show the order of tablet intake.
During the 7 days when the patient takes green placebo tablets (placebo days), bleeding (so-called 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, start the next blister 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 the patient takes Atywia Daily as described above, pregnancy is prevented, including during the 7 days when green placebo tablets are taken.
When to start the first blister of Atywia Daily
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 menstruation, 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 combined vaginal contraceptive system or transdermal system:

• If the patient has been taking an oral contraceptive (with a regimen of 21 active tablets and a 7-day break), Atywia Daily may be started the day after the break period of the previous contraceptive regimen.
• If the patient has been taking an oral contraceptive containing 28 tablets, both active and placebo tablets, Atywia Daily may be started the day after taking the last inactive (hormone-free) tablet from the previous oral contraceptive 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 break period resulting from the vaginal system or transdermal patches regimen.

Switching from a progestogen-only method (progestogen-only minipill)
The progestogen-only 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 of implant removal. 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 day 21 and 28 after childbirth. 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 withdrawal bleeding occurs.
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 childbirth
The use of Atywia Daily should be discussed with the doctor.
Duration of use
Atywia Daily may be used for as long as hormonal contraceptive protection 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 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, the contraceptive efficacy of Atywia Daily remains unchanged. Discard the missed placebo tablet.
If a white tablet containing active substances (tablets in the first, second and third rows) is missed, follow the instructions below:

• If less than 12 hours have passed since the missed tablet, the contraceptive efficacy of Atywia Daily is not reduced. Take the tablet as soon as possible, then continue taking subsequent 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 green placebo tablets period, the patient may be pregnant. Consult your doctor before starting the next pack.

Therefore, observe the following rules:

• The tablet-taking break should never exceed 7 days.
• After missing a tablet, a continuous 7-day tablet-taking period is necessary for adequate contraceptive effect.

Recommendations 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 subsequent tablets at the usual time and use additional protection (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 she may be pregnant. 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 subsequent tablets at the usual time. If the patient has taken Atywia Daily tablets 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.
Missing one tablet in the third week:
Contraceptive efficacy is not ensured. By taking placebo tablets for the next 7 days, contraceptive protection can still be maintained. If the patient follows the recommendations described below, additional contraceptive methods are not necessary, but only if Atywia Daily has been taken correctly during the 7 days preceding the missed tablet. If this is not the case, follow the instructions below under point 1. 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 subsequent tablets at the usual time. Instead of taking the green placebo tablets, discard them 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 proceed to the green placebo tablets (before starting the placebo tablet period, note the day the tablet was missed), then start the next blister. If the patient wishes to start the new blister on a specific day corresponding to the usual start of the placebo tablet period, the duration of placebo tablet intake may be shortened.

Missing more than one tablet from a blister
If the patient misses more than one tablet from a blister, contraceptive efficacy is reduced. The risk of reduced contraceptive efficacy 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 your doctor.
Recommendations in case of gastrointestinal disturbances
In case of severe gastrointestinal disturbances (e.g. vomiting, diarrhoea) 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 additional tablet(s) from a new pack. If gastrointestinal problems persist or recur, use additional non-hormonal contraceptive methods and inform your 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 pack of Atywia Daily. The extension period may last as needed, even until the end of 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 discuss other effective contraceptive methods with her doctor.
If in doubt about how to use this medicine, the patient should consult her doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers to be related to the use of Atywia Daily, medical advice should be sought immediately.
All women using combined hormonal contraceptives have an increased risk of blood clots in veins (venous thromboembolic disease) or blood clots in 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 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 problems (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 vaginal infections,
• 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 completely absent menstrual periods,
• intermenstrual vaginal bleeding, uterine haemorrhage (irregular bleeding between periods),
• painful menstruation (dysmenorrhoea), lower abdominal pain,
• breast enlargement, including breast engorgement 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 lipoma,
• 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 disturbances,
• 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 down),
• hot flushes,
• gastritis, enteritis,
• indigestion,
• skin reactions, including allergic dermatitis, neurodermatitis and/or atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (yellowish-brown skin patches, usually on the face), pigmentary disorders and/or skin discoloration,
• seborrhoea,
• dandruff,
• hirsutism (excessive hair growth),
• 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 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 levels of triglycerides and cholesterol in blood (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,
• transient ischaemic attack (mini-stroke or temporary stroke-like symptoms),
• 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 conditions that increase this risk (see section 2 for further information on risk factors for blood clots and symptoms of blood clot formation).
Frequency not known (cannot be estimated from available data):

• decreased or increased libido (sex drive),
• contact lens intolerance,
• 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 be reported directly to the Department of Monitoring of 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 the 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 packaging.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Keep the blister pack 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. Such measures help protect the environment.

6. Contents of the package 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. Each coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
• Excipients:
• Tablet core: monohydrate lactose, maize starch, povidone K 30, magnesium stearate
• Coating: hypromellose, polyethylene glycol 400, titanium dioxide (E 171)

Tablets not containing active substances:

• Tablet core: monohydrate lactose, maize starch, povidone K 30, magnesium stearate, anhydrous colloidal silica
• Coating: hypromellose, triacetin, polysorbate 80, titanium dioxide (E 171), indigo carmine, aluminium lake (E 132), 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 1x28 or 3x28 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 abbreviations of the days of the week, arranged differently depending on the day the patient starts taking the tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Germany, the country of export:
Exeltis Germany GmbH
Adalperostraße 84
85737 Ismaning, Germany
Manufacturer:
Laboratorios León Pharma SA
La Vallina s/n, Pol. Ind. Navatejera
Navatejera-24008 León, Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
German marketing authorisation number (country of export): 87090.00.00
Parallel import authorisation number: 406/21
This medicinal product is authorised 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
and https://inpharm.pl/do_pobrania/Atywia-Daily-LISTA-KONTROLNA.pdf and
https://inpharm.pl/do_pobrania/Atywia-Daily-MATERIALY-DLA-PACJENTOW.pdf .