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 (Ceciliana Diario)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Atywia Daily and Ceciliana Diario are different trade names for the same medicine.

Important information regarding combined hormonal contraceptives

When used correctly, they are one of the most reliable reversible methods of contraception.
They slightly increase the risk of 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 clot formation (see section 2 "Blood clots").

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

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

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 hormonal activity.

Atywia Daily is used:

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

2. Important information before using Atywia Daily

General notes
Before starting to take Atywia Daily, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Improvement in acne symptoms usually occurs after three to six months of treatment, but skin condition may continue to improve even after six months of treatment. 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 mutation, or antiphospholipid antibodies
If you require surgery or will not be able to walk for a prolonged period (see section 2 "Blood clots")
If you have had a heart attack or stroke
If you suffer (or have suffered in the past) from 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 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 do not have menstrual bleeding for unknown reasons
If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Atywia Daily and other medicines").

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

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

You notice possible symptoms of a blood clot, 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 these conditions develop or worsen while taking Atywia Daily, you should also inform your doctor.

If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases)
If you have systemic lupus erythematosus (a disease affecting the body’s natural defence system)
If you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure)
If you have sickle cell anaemia (a hereditary red blood cell disorder)
If you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis
If you require surgery or will not be able to walk for a prolonged period (see section 2 "Blood clots")
If you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Atywia Daily after childbirth
If you have superficial thrombophlebitis (inflammation of veins under the skin)
If you have varicose veins
If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or skin rash and breathing difficulties, seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

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

in 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. Remember that the overall risk of harmful blood clots caused by using Atywia Daily is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Are you experiencing any of these symptoms? Likely reason
for your symptoms

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 while standing or walking
Increased warmth in the affected leg
Change in skin colour 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

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

Symptoms most commonly affecting one eye: Retinal vein thrombosis (blood clot in the eye)

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

Chest pain, discomfort, pressure, tightness, heaviness Myocardial infarction

Sensation of pressure, fullness, or squeezing 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, restlessness, or shallow breathing
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 understanding 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

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

Swelling and slightly bluish discoloration of the skin of the arms or legs Blood clots blocking other blood vessels
Severe abdominal pain ("acute abdomen")

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

The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (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 the development of deep vein thrombosis.
If a blood clot travels from the leg and lodges in the lungs, it may cause a 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 factors influence the risk of blood clots?
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).

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

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

if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
if a close family member has had 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 blood clotting disorders;
if the patient is due to undergo surgery, is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Atywia Daily for several weeks before surgery or immobilisation. If the patient needs to stop taking Atywia Daily, ask the doctor when it is safe to restart;
with increasing age (especially over the age of 35);
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. Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor. It is important to inform the doctor if any of the above risk factors apply, even if uncertain. The doctor may decide to discontinue Atywia Daily. Inform the doctor if any of the above conditions change during treatment with Atywia Daily, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious
consequences such as heart attack or stroke.
Factors increasing the risk of blood clots in arteries
It is important to note that the risk of heart attack or stroke associated with Atywia Daily is very small, but may increase:

with age (over approximately 35 years);
if the patient smokes. While using a hormonal contraceptive such as Atywia Daily, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
if the patient is overweight;
if the patient has high blood pressure;
if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
if the patient or a close family member has high levels of blood fats (cholesterol or triglycerides);
if the patient suffers from migraines, particularly 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 are particularly severe, the risk of blood clots may be further increased. Inform the doctor if any of the above conditions change during treatment with Atywia Daily, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.
Stop taking Atywia Daily immediately:

if the patient is pregnant or suspects she may be pregnant;
if the patient has symptoms of vein inflammation or blood clots (see section 2 "Blood clots");
if blood pressure remains above 140/90 mm Hg (the doctor may recommend resuming the medication after blood pressure returns to normal with antihypertensive treatment);
if surgery is planned (the medication should be stopped 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, visual, motor disturbances);
if the patient has severe upper abdominal pain (see also "Oral contraceptives and cancer");
if the patient's skin or whites of the eyes turn yellow, urine becomes dark brown, stools are very pale (jaundice), or if the patient experiences itching all over the body;
if the patient has diabetes mellitus and blood sugar levels rise unexpectedly;
if the patient has disorders of pigment formation in the blood (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 the hands and/or feet;
if the patient's blood pressure is above 140/90 mm Hg;
if the patient has had lipid metabolism disorders (lipid metabolism disturbances);
if the patient has sickle cell anaemia (a hereditary disorder affecting red blood cells);
if the patient has had liver disease;
if the patient has had gallbladder disease;
if the patient has migraines;
if the patient has depression;
if the patient has diabetes mellitus or impaired glucose metabolism (impaired glucose tolerance). It may be necessary to adjust the dose of insulin or 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 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 (haemolytic uraemic syndrome);
if the patient has 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
Breast cancer occurs slightly more frequently in women taking oral contraceptives than in women of the same age who do not. The risk decreases after stopping treatment and, after 10 years, is the same as in women who have never taken oral contraceptives.
As breast cancer is rare in women under 40, the increased number of diagnoses in women currently or recently using combined oral contraceptives is small relative to the overall risk of breast cancer.
Results of some epidemiological studies suggest that long-term use of combined oral contraceptives in women infected with human papillomavirus (HPV) may increase the risk of cervical cancer. However, debate continues regarding the significance of additional factors (e.g. differences in number of sexual partners and use of mechanical contraception).
In very rare cases, a benign liver tumour may develop. Such tumours may cause life-threatening intra-abdominal bleeding. Contact a doctor
if severe abdominal pain occurs. Some studies suggest 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 progestogen component.
Women with conditions related to high blood pressure and certain kidney diseases should use alternative contraceptive methods (consult a doctor, see also "When not to use Atywia Daily", "Stop taking Atywia Daily immediately", "Situations requiring special medical attention").
Chloasma (yellow-brown skin pigmentation)
Yellow-brown patches (chloasma) may occasionally occur, particularly in women who previously had chloasma during pregnancy. Women predisposed to chloasma should avoid exposure to sunlight and ultraviolet radiation during treatment with combined oral contraceptives.
Menstrual irregularities
Irregular bleeding (spotting or intermenstrual bleeding) may occur during use of oral contraceptives, especially during the first months of treatment. 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 bleeds are missed, the patient may be pregnant. Pregnancy must be ruled out before continuing treatment with Atywia Daily.
After discontinuation of hormonal contraceptives, return to a regular natural cycle may not occur immediately.
Reduced effectiveness
The effectiveness of Atywia Daily may be reduced if tablets are missed, vomiting or severe diarrhoea occurs, or when certain medications are taken concomitantly.
If Atywia Daily is taken 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 treatment, a thorough medical and family history should be taken. A clinical examination including breast examination is necessary. Pregnancy must be excluded. Women using hormonal contraceptives should have regular check-ups. The patient should inform the doctor if she smokes and about any other medications being taken.
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 these may cause abnormal liver function test results (increased liver enzyme AlAT activity). Before starting these medications, the doctor will prescribe another type of contraception.
Atywia Daily may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to use Atywia Daily".
Inform the doctor or pharmacist about all medicines currently or recently taken, and any medicines planned for use.
Some medicines may reduce the contraceptive effect of Atywia Daily and/or cause intermenstrual bleeding.
Medicines that may reduce the effectiveness of Atywia Daily:

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

Women taking any of the above-mentioned medicines should temporarily use a mechanical contraceptive method (condoms) in addition to Atywia Daily or choose another method of contraception. When using Atywia Daily with any of the above medicines, additional contraceptive methods should be used for 7 to 28 days after stopping the medicine, depending on the drug. The patient should consult a doctor or pharmacist if in doubt. If the period requiring mechanical contraception extends beyond one pack of Atywia Daily, the next pack should be started immediately, skipping the placebo tablets. If long-term use of medicines containing the above active substances is required, non-hormonal contraceptive methods should be considered.
Taking the following medicines together 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, imidazole derivatives (used for fungal infections), such as fluconazole,
Indinavir (used to treat HIV infection).

Atywia Daily may affect the action of other medicines:

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

Refer to the package leaflets of all medicines being used.
Diabetes
In patients with diabetes, 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 levels of certain plasma proteins such as lipid-binding proteins or lipoproteins, proteins involved in carbohydrate metabolism, and proteins of the coagulation and fibrinolytic systems.
However, these changes are usually within normal limits.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Atywia Daily during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult a doctor immediately.
Breastfeeding
Use of Atywia Daily during breastfeeding may reduce 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 influence on the ability to concentrate, drive a car, or operate machinery.
Atywia Daily contains lactose
Atywia Daily contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult a doctor before taking this medicine.

3. How to take Atywia Daily

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Unless otherwise advised by your doctor, take 1 tablet daily.
How to take Atywia Daily
Each blister contains 28 tablets: 21 white tablets containing active substances and 7 green
tablets containing placebo.
The two differently coloured tablets of Atywia Daily are arranged in the order of administration.
Take one tablet daily at the same time each 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 blister packs.
Due to the different composition of the tablets, treatment must begin with the first tablet in the top
left corner (located near the word "INICIO") and one tablet must be taken daily.
To maintain the correct order of tablet intake, follow the direction of the arrow on the blister.
Preparing the blister pack
To help the patient remember to take a tablet, each medicine package contains 7 self-adhesive labels
with abbreviations of the days of the week. Choose the appropriate label starting with the day
abbreviation corresponding to the day the patient begins taking 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 "Pegue aquí la tira adhesiva", meaning "Attach
the adhesive strip here".
Each tablet will then have a day symbol indicating the day it should be taken. Arrows indicate the
order of tablet intake.
During the 7 days when the patient takes green placebo tablets (placebo days), withdrawal
bleeding should occur. This bleeding usually starts 2 or 3 days after taking the last white tablet
containing active substances. After taking the last green tablet from the blister, start the next
blister immediately, regardless of whether bleeding has stopped or not.
This means that new blister packs 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
begins immediately. Alternatively, Atywia Daily may be started between days 2 and 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 from 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 in 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 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 resulting from the vaginal system or transdermal patch 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 given or on the day the
implant is removed. Additional contraceptive methods (e.g. condoms) must be used for the first 7 days.
After childbirth, when 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, pregnancy must first be ruled out or wait for bleeding to occur.
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 a doctor.
Duration of use
Atywia Daily may be used for as long as hormonal contraception is desired, provided it does not pose
a health risk to the patient (see "When not to use Atywia Daily", "Stop using Atywia Daily immediately").
Regular medical check-ups are recommended.
Overdose of Atywia Daily
If more tablets than recommended are taken, contact your doctor or pharmacist.
Possible symptoms of overdose include: nausea, vomiting (usually 12 to 24 hours after ingestion,
sometimes lasting several days), breast tenderness, dizziness, abdominal pain, drowsiness, fatigue;
vaginal bleeding may occur in women and young girls. Contact your doctor if an excessive number of
tablets has been taken.
Missed dose of Atywia Daily
The last green tablets in the 4th row of the blister are placebo tablets. If one of these is missed,
contraceptive efficacy of Atywia Daily is maintained. Discard the missed placebo tablet.
If a white tablet containing active substances (in the first, second or third row) is missed, follow the
instructions below:

If less than 12 hours have passed since the missed tablet, contraceptive efficacy of Atywia Daily is not reduced. Take the missed tablet as soon as possible, then continue taking the following tablets at the usual time.
If more than 12 hours have passed since the missed tablet, contraceptive efficacy may be reduced. If withdrawal bleeding does not occur during the green placebo tablet days, the patient may be pregnant. Consult your doctor before starting the next pack.

Therefore, follow these rules:

The break between tablet intakes must never exceed 7 days.
After missing a tablet, an uninterrupted 7-day period of tablet intake is necessary for adequate contraceptive effect.

Guidelines for missed tablets:
Missing one tablet in the first week:
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time.
Continue taking the 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 highest if a
tablet is missed at the beginning or end of a pack.
Missing one tablet in the second week:
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time.
Continue taking the following tablets at the usual time. If the patient has taken Atywia Daily correctly in
the preceding week, contraceptive efficacy is not reduced and additional protection is not required.
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. Continuing with 7 days of placebo tablets may maintain
contraceptive protection. If the patient follows the recommendations below, additional contraceptive
methods are not required, 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:

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 pack. Withdrawal bleeding will most likely occur at the end of the second blister, but breakthrough bleeding or spotting may occur during the second blister.
Alternatively, stop taking the white tablets and immediately start the green placebo tablets (note the day the tablet was missed before starting the placebo period), then start the next blister. If the patient wishes to start the new blister on a specific day corresponding to the usual placebo 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 finishing the blister, the patient may be pregnant. In this case, consult your
doctor.
Gastrointestinal disturbances
If severe gastrointestinal disturbances (e.g. vomiting, diarrhoea) occur within 4 hours of taking an
Atywia Daily tablet, absorption of the active substances may be incomplete and additional
contraceptive methods should be used. Follow the recommendations for a single missed tablet. If
the patient does not wish to change the current dosing schedule, she should take an additional
tablet(s) from a new pack. If gastrointestinal problems persist or recur, use additional non-hormonal
contraceptive methods and inform your doctor.
Postponing withdrawal bleeding
To delay withdrawal bleeding, skip the placebo tablets in the current pack and immediately start
tablets from the next Atywia Daily pack. The delay in bleeding can last as long as needed, even until
the end of 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.
Discontinuing 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 effects

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

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

Detailed information on serious adverse effects associated with the use of Atywia Daily is described in section 2 of the Patient Leaflet under "Important information before using Atywia Daily". These sections should be read to obtain additional information and, if necessary, immediate medical advice should be sought.

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

Adverse effects 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 breast tenderness.

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

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

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

inflammation of the ovaries and fallopian tubes,
cervicitis (inflammatory condition of the cervix),
urinary tract infections, cystitis (bladder inflammation),
mastitis (inflammation of the breast),
fungal infections (candidiasis), viral infection, oral herpes,
influenza, bronchitis, upper respiratory tract infections, sinusitis,
asthma,
hyperventilation,
uterine leiomyoma,
fibroadenoma of the breast,
anaemia,
hypersensitivity (allergic reaction),
virilization (development of male secondary sexual characteristics in women),
anorexia (severe loss of appetite),
depression, mood swings, irritability, aggression,
insomnia, sleep 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 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 heart rate),
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, enteritis,
indigestion,
skin reactions, including allergic dermatitis, neurodermitis and/or atopic dermatitis, eczema, psoriasis,
excessive sweating,
chloasma (yellow-brown skin patches, usually on the face), pigmentary disturbances and/or discoloration,
seborrhoea,
dandruff,
hirsutism (excessive hair growth),
skin disorders, "orange peel" skin appearance,
spider angioma,
back pain, chest pain,
musculoskeletal complaints, muscle pain, pain in arms and legs,
cervical dysplasia (abnormal cell growth on the surface of the cervix),
pain or cysts of the 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 veins or arteries, for example:
- in the leg or foot (e.g. deep vein thrombosis),
- in the lungs (e.g. pulmonary embolism),
- myocardial infarction,
- stroke,
- mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack,
- blood clots in the liver, stomach and/or intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (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),
contact lens intolerance,
urticaria,
nodular erythema, erythema multiforme.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 effects helps to 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.
Do not store above 30°C.
Keep the blister in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the 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), FD & C Blue 2 aluminium lake, yellow iron oxide (E 172)

What Atywia Daily looks like and contents of the pack
Tablets containing active substances: white, round, coated tablets.
Tablets without 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 the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer:
Laboratorios León Pharma, S.A.
Pol. Ind. Navatejera
La Vallina s/n
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 Spain, the country of export: 701773.8
Parallel Import Authorisation Number: 126/25
This medicinal product is authorised for sale in the European Economic Area under the following names:
Belgium: Serisima Continu 2 mg / 0.03 mg comprimé pelliculé
Bulgaria: Dienorette 2mg/0,03 mg
Czech Republic: Diecyclen 2 mg/0,03 mg potahované tablety
Estonia: Diecyclen
France: Serisima Continu 2 mg / 0.03 mg comprimé pelliculé
Italy: Serisima Diario 2 mg e 0,03 mg compressa rivestita con film
Lithuania: Diecyclen 2mg/0.03 mg plėvele dengtos tabletės
Latvia: Diecyclen 2mg/0.03 mg apvalkotās tabletes
Luxembourg: Serisima Continu 2 mg / 0.03 mg comprimé pelliculé
Hungary: Diedita 2 mg/0.03 mg, film-coated tablets
Poland: Atywia Daily
Austria: Dienorette 0,03 mg / 2 mg 21+7 Filmtabletten
Romania: Dienorette 2 mg/0,03mg comprimate filmate
Slovakia: Diecyclen 2mg/0,03mg filmom obalené tablety
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,
https://www.gov.pl/web/urpl/ as well as https://inpharm.pl/do_pobrania/Atywia-Daily-LISTA-KONTROLNA.pdf and https://inpharm.pl/do_pobrania/Atywia-Daily-MATERIALY-DLA-PACJENTOW.pdf .