Atywia daily: detailed information

Package leaflet: information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Atywia Daily (Serisima Diário)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Atywia Daily and Serisima Diário are different brand names of the same medicine.
Important information regarding combined hormonal contraceptives

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

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

Keep this leaflet for future reference.
If in doubt, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If the patient experiences any adverse effects, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Atywia Daily is and what it is used for
What you need to know before taking Atywia Daily
How to take Atywia Daily
Possible side effects
How to store Atywia Daily
Contents of the pack and other information

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

Atywia Daily is a combined oral hormonal contraceptive.

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

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

preventing pregnancy
treating 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 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 after six months of treatment. You should discuss with your doctor the need to continue treatment after three to six months, and then at regular intervals.

When not to use Atywia Daily:
Do not use Atywia Daily if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6)
If you have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs
If you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies
If you require surgery or will be immobile for a long time (see section 2 "Blood clots")
If you have had a heart attack or stroke
If you suffer from (or have suffered from 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 suffer from any of the following diseases which may increase the risk of arterial blood clots:
severe diabetes with blood vessel damage
very high blood pressure
very high levels of fats in the blood (cholesterol or triglycerides)
a condition called hyperhomocysteinaemia
If you have (or have had in the past) a type of migraine called migraine with aura
If you smoke (see section 2 "Blood clots")
If you have (or have had in the past) pancreatitis associated with elevated triglyceride levels (lipid metabolism disorders (fats))
If you have 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 had or currently have benign or malignant liver tumours
If you have had or currently have a hormone-dependent cancer (e.g. breast or genital organ cancer)
If you have vaginal bleeding of unknown cause
If you do not have menstrual bleeding for unknown reasons
If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Atywia Daily and other medicines").

Warnings and precautions
Before starting 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 to contact your doctor?
Contact your doctor immediately:

if you notice possible symptoms of blood clots, which may indicate you have blood clots 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 blood clots".

Tell your doctor if you have any of the following conditions.
If 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 immune 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 pancreatitis
if you require surgery or will be immobile for a long time (see section 2 "Blood clots")
if you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Atywia Daily after childbirth
if you have 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, 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 is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic disorders"). Recovery after a blood clot is not always complete. 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 taking Atywia Daily is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms? Likely reason
why you may be
affected?

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 colour of the leg, such as pallor, redness, or blueness.
sudden unexplained shortness of breath or rapid breathing Pulmonary embolism
sudden coughing without an 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.

If you are unsure, contact your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).
Symptoms most commonly affect one eye: Retinal vein thrombosis

sudden loss of vision or (blood clot in the eye)
painless visual disturbances, which may progress to vision loss.
chest pain, discomfort, pressure, heaviness Myocardial infarction
squeezing or fullness in the chest, arm, or below the breastbone
feeling of fullness, indigestion, or choking
discomfort in the lower part of the 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 disturbances, or difficulty understanding
sudden visual disturbances in one or both eyes
sudden difficulty walking, dizziness, loss of balance or coordination
sudden, severe, or prolonged headache without known cause
loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be transient with almost immediate and complete recovery, but you should contact your doctor immediately, as you may be at risk of a subsequent stroke.

swelling and slightly blue discolouration of the skin of the arms or legs Blood clots blocking other
severe abdominal pain (so-called acute abdomen) blood vessels

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

Using combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). Although these adverse effects 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 highest 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 using 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 caused by taking 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).

	Risk of developing blood clots within one year
Women who are not using combined hormonal pills/patches/vaginal rings and are not pregnant	About 2 in 10,000 women
Women using combined oral contraceptive pills containing levonorgestrel, norethisterone or norgestimate	About 5-7 in 10,000 women
Women using the medicine Atywia Daily	About 8-11 in 10,000 women

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

if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such a case, the patient may have inherited coagulation 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
discontinue Atywia Daily, she should consult her doctor about when it is safe to resume taking
the medication;
with increasing age (especially over 35 years);
if the patient has recently given birth. 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 venous blood clots, particularly if the patient has another risk factor listed above. It is important to inform the doctor if any of these factors apply to the patient, even if uncertain. The doctor may decide to discontinue Atywia Daily. The patient should inform the doctor if any of the above conditions change during treatment with Atywia Daily, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots 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 the use of
Atywia Daily is very small, but it may increase:

with age (over approximately 35 years);
if the patient smokes cigarettes. When using a hormonal contraceptive such as Atywia Daily, it is recommended to stop smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
if the patient has overweight;
if the patient has high blood pressure;
if a close relative has had myocardial infarction or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of myocardial infarction or stroke;
if the patient or a close relative has high levels of blood lipids (cholesterol or triglycerides);
if the patient suffers from migraines, especially migraines with aura;
if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
if the patient has diabetes.

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

if she is pregnant or suspects she may be pregnant;
if she has symptoms of vein inflammation or blood clots (see section 2 "Blood clots");
if blood pressure remains above 140/90 mm Hg (the doctor may recommend resuming the medication after blood pressure returns to normal with antihypertensive medication);
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 she experiences exceptionally frequent, severe, persistent headaches that start suddenly with symptoms of aura (sensory, visual, or motor disturbances);
if she has severe pain in the upper abdomen (see also "Oral contraceptives and cancer");
if her skin or the whites of her eyes turn yellow, urine becomes dark brown, stools are very pale (jaundice), or if she experiences generalized itching;
if she has diabetes (diabetes mellitus) and blood sugar levels rise unexpectedly;
if she has disorders of blood pigment formation (porphyria), and a relapse occurs during treatment with Atywia Daily.

Situations requiring special medical attention:

if the patient has heart or kidney disease;
if the patient has vein inflammation (phlebitis) or varicose veins;
if the patient has circulatory disorders in hands and/or feet;
if the patient's blood pressure is above 140/90 mm Hg;
if the patient has had lipid metabolism disorders (lipid metabolism disturbances);
if the patient has sickle cell anemia (a hereditary disorder affecting red blood cells);
if the patient has liver disease;
if the patient has 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 and antidiabetic medication doses may need adjustment 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, alternative contraceptive methods should be considered;
if the patient has movement disorders known as Sydenham's chorea;
if the patient has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis);
if the patient has a blood disorder causing kidney damage (hemolytic uremic syndrome);
if the patient has been diagnosed with a benign tumor in the muscular layer of the uterus (uterine fibroid);
if the patient has otosclerosis;
in case of prolonged immobilization (see section 2 "Blood clots");
if the patient 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, the patient should contact her doctor as soon as possible for further medical advice.
Oral contraceptives and cancer
Breast cancer occurs slightly more frequently in women who take oral contraceptives than in women of the same age who do not. The risk of breast cancer decreases after stopping the medication and, after 10 years of 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) may increase the risk of cervical cancer. However, debate continues regarding the significance of additional factors (e.g., differences in the 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. The patient should contact her 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 women using hormonal contraceptives for prolonged periods. The increased frequency of hypertension is associated with the action of progestogen.
Patients 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", "Immediately discontinue Atywia Daily", "Situations requiring special medical attention").
Chloasma (yellow-brown skin discoloration)
Yellow-brown patches (chloasma) may occasionally occur 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 cycle irregularities
Irregular bleeding (spotting or intermenstrual bleeding) may occur during use of oral contraceptives, especially during the first months of tablet use. The patient should 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 any 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 medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased liver enzyme activity, AlAT). Before starting these medications, the doctor will prescribe another type of contraception.
Atywia Daily may be restarted approximately 2 weeks after discontinuation of the above-mentioned treatment. See section "When not to use Atywia Daily".
The patient should inform her doctor or pharmacist about all medicines currently or recently taken, as well as any medicines she 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 and hepatitis C virus infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz).
Medicines used to treat narcolepsy and central nervous system disorders (modafinil).
Herbal medicines containing St. John's wort (Hypericum perforatum).

Women taking any of the above-mentioned 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 the above-mentioned medicines, additional contraceptive methods should be used for 7 to 28 days after discontinuation of treatment, depending on the medicine. The patient should consult her doctor or pharmacist if in doubt. If the period of using 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-mentioned 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, derivatives of imidazole (used in fungal infections), such as fluconazole,
Indinavir (used in HIV treatment).

Atywia Daily may affect the action of other medicines:

Cyclosporine (used to suppress the immune system),
Theophylline (used in asthma treatment),
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 in epilepsy treatment).

The patient should read the package leaflets of all medicines being used.
Diabetes
In patients with diabetes, it may be necessary to adjust the dose of antidiabetic medications and insulin.
Laboratory tests
Use of hormonal contraceptives may affect the results of certain laboratory tests, e.g., biochemical parameters of liver, adrenal, and kidney function, thyroid function, as well as plasma concentrations of certain proteins such as lipid-binding proteins or lipoproteins, proteins involved in carbohydrate metabolism, and proteins of the coagulation and fibrinolysis system.
However, these changes are usually within normal limits.
Pregnancy and breastfeeding
During pregnancy, while breastfeeding, or if pregnancy is suspected or planned, the patient should 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 the amount of breast milk produced, 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 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 use Atywia Daily

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Unless otherwise directed by your doctor, take 1 tablet daily.
How to use Atywia Daily
Each blister contains 28 tablets: 21 white tablets containing active substances and 7 green tablets containing placebo.
The two differently coloured tablets of Atywia Daily are arranged in the order of administration.
Take one tablet daily at the same time each day, swallowing 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.
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 "INICIO") 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 of the medicine contains 7 self-adhesive labels with abbreviations of the days of the week for each blister. Choose the appropriate label starting with the day abbreviation corresponding to the day the patient will begin 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 start with "Wed".
Place the label on the top part of the blister marked "INICIO Colocar autocollante aqui", meaning: "START Place label here".
Each tablet will then 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), withdrawal bleeding (so-called 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 or not.
This means that new blisters will always be started on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.
If the patient uses Atywia Daily as 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, contraception is effective immediately. Alternatively, Atywia Daily may be started on days 2 to 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 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 associated with the previous contraceptive regimen.
If the patient has been taking an oral contraceptive containing 28 tablets, both active and placebo, Atywia Daily may be started the day after taking the last inactive (hormone-free) tablet from the pack of the previous combined oral contraceptive. 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 resulting from the regimen of the vaginal system or transdermal patches.

Switching from a progestogen-only method (progestogen-only minipill)
The progestogen-only minipill 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 the woman is not breastfeeding
Atywia Daily may be started between 21 and 28 days after childbirth. Additional contraceptive methods (e.g. condoms) must be used for the first 7 days. If sexual intercourse occurred after childbirth before starting Atywia Daily, ensure that pregnancy has not occurred or wait until 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
Discuss the use of Atywia Daily with your doctor.
Duration of use
Atywia Daily may be used for as long as hormonal contraception is desired, provided it does not pose a health risk to the patient (see "When not to use Atywia Daily", "Stop using 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; in women and young girls, vaginal bleeding may occur. Contact a 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 is maintained. 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 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 intake of green placebo tablets, the patient may be pregnant. Consult a doctor before starting the next pack.

Therefore, observe the following rules:

The break in tablet intake should never exceed 7 days.
After missing a tablet, an uninterrupted 7-day period of tablet intake is necessary for adequate contraceptive effectiveness.

Guidelines for missed tablets:
Missed one tablet in the first week:
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following 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 greatest if a tablet is missed at the beginning or end of the 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 following 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.
Missed one tablet in the third week:
Contraceptive efficacy is not guaranteed. Continuing for the next 7 days with placebo tablets may maintain contraceptive effectiveness. If the patient follows the recommendations described below, there is no need to use additional contraceptive methods, but only if Atywia Daily has been taken correctly during the 7 days preceding the missed tablet. If this has not occurred, follow the instructions below under point 1. Additionally, use additional contraceptive methods (e.g. condoms) for the next 7 days.
There are two options:

Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following 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 intake of tablets from the second blister.
Alternatively, stop taking the white tablets from the current blister and proceed directly 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 fixed day corresponding to the beginning of the placebo tablet period, the duration of placebo tablet intake may be shortened.

Missed more than one tablet from a blister
If the patient has missed more than one tablet from a blister, contraceptive efficacy is reduced. The risk of reduced contraceptive efficacy is greatest if tablets are missed at the beginning or end of the 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 such a case, consult a doctor.
Recommendations in case of gastrointestinal disturbances
If severe gastrointestinal disturbances (e.g. vomiting, diarrhoea) occur within the first 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 woman does not wish to change her current dosing regimen, 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 the onset of 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 long as needed, even until the end of the active tablets in the second pack. During the extended cycle, slight breakthrough bleeding or spotting may occur. Regular intake of Atywia Daily should resume after the placebo tablet period.
Stopping use of 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 the use of this medicine, the patient should consult her doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
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 from a physician.
All women using combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Atywia Daily".
Detailed information on serious adverse reactions related to the use of the medicine is described in section 2 of the Patient Information Leaflet under "Important information before taking Atywia Daily". Please read these sections carefully to obtain additional information and consult your doctor immediately if necessary.
Immediately contact a doctor if the patient experiences symptoms of angioedema, such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or skin rash, and breathing difficulties (see section "Warnings and precautions").

Adverse reactions that may be associated with the use of Atywia Daily:
Common (occur in fewer than 1 in 10 people):

headache,
breast pain, including breast discomfort and tenderness.

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

inflammation of the vagina and (or) vulva and vagina (inflammatory conditions of the genital organs), vaginal candidiasis (yeast infection) or other fungal infections of the vagina,
increased appetite,
depressed mood,
dizziness,
migraine,
high or low blood pressure, in rare cases increase in diastolic blood pressure values (the lowest level to which blood pressure drops between heartbeats),
abdominal pain, including in the upper and lower abdomen, abdominal pains, discomfort and (or) bloating,
nausea, vomiting or diarrhoea,
acne,
hair loss (loss of hair),
rash (including maculopapular rash),
itching (sometimes of the whole body),
changes in bleeding patterns such as heavy, light, infrequent or absent menstrual periods,
intermenstrual vaginal bleeding, uterine haemorrhage (irregular bleeding between periods),
painful menstruation (painful periods), lower abdominal pain,
breast enlargement, including breast 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,
fibroadenoma of the breast,
anaemia,
hypersensitivity (allergic reaction),
virilization (development of male secondary sexual characteristics in women),
anorexia (severe loss of appetite),
depression, mood swings, irritability, aggression,
insomnia, sleep disturbances,
cerebrovascular 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 (sustained muscle contractions causing twisting or abnormal postures),
dry or irritated eyes,
visual disturbances,
sudden hearing loss, hearing disorders,
tinnitus,
balance disorders,
tachycardia (rapid heartbeat),
thrombosis (blood clots in blood vessels), pulmonary embolism (blood clot travelling to the lungs),
thrombophlebitis (vein inflammation including blood clots),
varicose veins, venous dysfunction or vein pain,
orthostatic hypotension (dizziness or fainting when rising from sitting or lying position),
hot flushes,
gastritis (inflammation of the stomach lining), enteritis (inflammation of the intestine),
dyspepsia,
skin reactions, including allergic dermatitis, neurodermatitis and (or) atopic dermatitis, eczema, psoriasis,
excessive sweating,
chloasma (yellow-brown skin patches, usually on the face), pigmentary disturbances and (or) discoloration,
seborrhoea,
dandruff,
excessive hair growth (hirsutism),
skin disorders, "orange peel" skin appearance,
spider angioma,
back pain, chest pain,
musculoskeletal complaints, muscle pain, pain in arms and legs,
cervical dysplasia (abnormal cell growth on the surface of the cervix),
pain or cysts in the uterine appendages (ovaries and fallopian tubes),
breast cysts, fibrocystic breast changes, breast swelling,
painful sexual intercourse,
lactation, breast discharge,
menstrual disorders,
swelling of hands and feet (fluid retention),
flu-like illnesses, inflammation, fever,
increased blood levels of triglycerides and cholesterol (hypertriglyceridaemia, hypercholesterolaemia),
blood clots in a vein or artery, for example:
in the leg or foot (e.g. deep vein thrombosis),
in the lungs (e.g. pulmonary embolism),
myocardial infarction,
stroke,
mini-stroke or transient ischaemic attack (TIA),
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 increasing the likelihood of blood clots and symptoms of blood clots).
Frequency not known (cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 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.
Store below 25°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Atywia Daily contains
The Atywia Daily blister pack contains 21 white 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 2910, macrogol 400, titanium dioxide (E 171)

Tablets without active substances:

Tablet core: monohydrate lactose, maize starch, povidone K 30, magnesium stearate, anhydrous colloidal silicon dioxide
Coating: hypromellose 2910, 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 without active substances (placebo): green, round, coated tablets.
Atywia Daily is available in packs containing 1x28 and 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 Portugal, country of export:
Exeltis Healthcare S.L.
Ava. Miralcampo 7 - Poligono Ind. Miralcampo, Azuqueca de Henares
19200 Guadalajara
Spain
Manufacturer:
Laboratorios León Farma, S.A.
C/ La Vallina s/n, Pol. Ind. Navatejera
24193 Villaquilambre, León
Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Portugal, country of export: 5782768
Parallel import authorisation number: 401/25
This medicinal product is authorised 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
Spain: Ceciliana Diario, 2 mg/0.03 mg comprimidos recubiertos con película EFG
Educational materials for this medicine are available at the following websites:
https://inpharm.pl/do_pobrania/Atywia-Daily-LISTA-KONTROLNA.pdf and
https://inpharm.pl/do_pobrania/Atywia-Daily-MATERIALY-DLA-PACJENTOW.pdf.