ATYWIA

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

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in the veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in the veins the highest?
The risk of developing blood clots in the veins is greatest during the first year of using combined hormonal contraceptives for the first time. 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 compared to not using combined hormonal contraceptives at all.
If a patient stops taking Atywia, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in the veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.

• 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, will develop blood clots.
• The risk of developing blood clots depends on the individual’s personal medical history (see “Factors that increase the risk of blood clots”, below).

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

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²)
• if a close family member has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, the patient may have inherited clotting disorders
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Atywia several weeks before surgery or periods of reduced mobility. If the patient must stop taking Atywia, she should consult her doctor about when it is safe to resume the medication
• with increasing age (especially over 35 years)
• if the patient has given birth within the last few weeks

The risk of developing 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.
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.
Inform the doctor if any of the above conditions change during treatment with Atywia, for example, if a close family member develops unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as myocardial infarction (heart attack) or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with Atywia is very low, but may increase:

• with age (over 35 years)
• if the patient smokes. Smoking should be discontinued while using a hormonal contraceptive such as Atywia. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend 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 such cases, the patient may also be at increased risk of heart attack or stroke
• if the patient or a family member has high levels of blood lipids (cholesterol or triglycerides)
• if the patient suffers from migraines, especially migraines with aura
• if the patient has heart disease (valve disease, heart rhythm disorder such as atrial fibrillation)
• if the patient has diabetes

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased. Inform the doctor if any of these conditions change during treatment with Atywia, for example, if the patient starts smoking, a close family member develops unexplained thrombosis, or if the patient gains significant weight.

If symptoms suggesting thrombosis occur, stop taking the tablets and consult a doctor immediately (see also “When to contact the doctor”).

Oral contraception and cancer
Women using oral contraceptives have a slightly higher incidence of breast cancer compared to women of the same age who do not use them. It is unclear whether this difference is solely due to hormonal contraceptives. It may also be due to more frequent medical examinations in women using hormonal contraception, leading to earlier detection of breast cancer. This difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.

Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives. These tumors may lead to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, the doctor should be informed immediately.
Malignant tumors may be life-threatening or fatal.

There are reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be directly related to the use of the pills, but rather to sexual behavior or other factors.

Psychiatric disorders
Some women using hormonal contraceptives, including Atywia, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Atywia and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those available without a prescription.

Some medicines may affect the blood concentration of Atywia, reduce contraceptive effectiveness, and cause unexpected bleeding. These include:

• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis (e.g., rifampicin)
• HIV and HCV infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• fungal infections (griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin)
• certain heart conditions, hypertension (calcium channel blockers, e.g., verapamil, diltiazem)
• arthritis, osteoarthritis (etoricoxib)
• St. John’s wort ( Hypericum perforatum )
• grapefruit juice

Oral contraceptives may affect the metabolism of other medicines such as lamotrigine, cyclosporine, melatonin, midazolam, theophylline, and tizanidine.

Do not use Atywia if the patient has hepatitis C and is taking antiviral medicines 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 antiviral treatments, the doctor will prescribe a different form of contraception.

Atywia may be restarted approximately 2 weeks after completing the above-mentioned antiviral treatment. See section “When not to use Atywia”.

When to contact the doctor
Contact the doctor immediately if:

• worrying changes in health occur, especially any of the symptoms listed in this leaflet (see also: “Warnings and precautions” and “How to take Atywia”)
• there is a history of thrombosis, heart attack, or stroke in close relatives
• a breast lump is detected
• other medicines are planned (see also “Atywia and other medicines”)
• immobilization or planned surgery is expected (inform the doctor at least 4 weeks in advance)
• heavy vaginal bleeding occurs
• tablets are missed in the first week of the cycle (each first week of consecutive months of Atywia use) and intercourse occurred in the previous 7 days
• acute diarrhoea occurs
• withdrawal bleeding does not occur in two consecutive months or pregnancy is suspected (do not start the next pack without consulting a doctor)

Stop taking Atywia and contact the doctor as soon as possible if any symptoms suggesting thrombosis, heart attack, or stroke occur:

• cough without apparent cause
• severe chest pain, possibly radiating to the left arm
• shortness of breath
• headache of unusual severity or a migraine attack
• partial or complete loss of vision or double vision
• slurred speech or loss of speech
• sudden sensory disturbances (hearing, smell, or touch)
• dizziness or fainting
• numbness or weakness of part of the body
• severe abdominal pain
• severe pain or swelling in the legs

The situations and symptoms listed above are described in more detail in other sections of this leaflet.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not take Atywia during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult a doctor immediately.
Atywia is not recommended during breastfeeding.

Driving and operating machinery
No influence of Atywia on the ability to drive or operate machinery has been observed.

Atywia contains lactose, glucose, sodium, and soy lecithin
Atywia contains lactose, glucose, and sodium. If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered “sodium-free”.
Atywia contains soy lecithin. Do not use if hypersensitivity to peanuts or soy has been diagnosed.

3. How to use Atywia

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
This leaflet describes many situations in which you should stop taking Atywia or in which the
effectiveness of the medicine may be reduced. It also describes circumstances in which sexual
intercourse should be avoided or additional contraceptive methods (e.g. condoms or other
mechanical methods) should be used. The calendar method and temperature measurement method
cannot be used, as Atywia affects temperature changes and cervical mucus characteristics typical
of the menstrual cycle.
Atywia, like other oral contraceptives, does not protect against infection with the HIV virus (AIDS)
or sexually transmitted diseases.

How to take Atywia tablets

• When and how should the tablets be taken?

The blister pack contains 21 coated tablets. Each tablet on the pack is marked with the day of the
week on which it should be taken. The tablets should be taken in the order indicated on the pack,
daily at approximately the same time, with a small amount of liquid if necessary. One tablet should
be taken every day for 21 consecutive days.
Each subsequent pack should be started after a 7-day break, during which no tablets are taken and
withdrawal bleeding usually occurs. Bleeding usually begins 2–3 days after taking the last tablet and
may continue into the next pack. This means that each new pack should always be started on the
same day of the week, and bleeding will occur approximately on the same days each month.

• Starting Atywia for the first time

If no oral contraceptives have been used in the previous month
Tablet-taking should begin on day 1 of the natural menstrual cycle (i.e. the first day of menstrual
bleeding). Tablets may also be started between day 2 and day 5 of the cycle; in such a case, during
the first cycle, additional mechanical contraception is recommended for the first 7 days of tablet
intake.
If previously using another combined oral contraceptive
It is recommended to start taking Atywia on the first day after taking the last active tablet of the
previous combined oral contraceptive, but no later than the first day after the usual tablet-free or
placebo interval of the previous combined oral contraceptive.
If previously using a progestogen-only pill (mini-pill)
You may stop taking the mini-pill on any day and instead start taking Atywia at the same time. If
sexual intercourse occurs during the first 7 days of taking Atywia, additional contraceptive methods
(mechanical methods) should be used simultaneously.
If previously using injectable, implant, or intrauterine hormonal contraceptive system releasing
progestogen
Atywia should be started on the day when the next injection was due or on the day of implant or
intrauterine system removal. If sexual intercourse occurs during the first 7 days of tablet-taking,
additional contraceptive methods (mechanical methods) should be used simultaneously.
After childbirth, miscarriage, or induced abortion

• After first-trimester miscarriage

Atywia may be started immediately. In this case, additional contraceptive methods are not
necessary.

• After childbirth or second-trimester miscarriage

Breastfeeding women: see section 2. "Breastfeeding".
Your doctor should advise you to start taking tablets between 21 and 28 days after childbirth or
second-trimester miscarriage. If tablet-taking is started later, your doctor should advise you to use
additional mechanical contraception for the first 7 days of tablet intake. If intercourse occurred
before starting the combined oral contraceptive, ensure that pregnancy has not occurred or wait
until the first natural menstrual bleed occurs.

Overdose of Atywia
Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have
not yet started menstruating but have accidentally taken this medicine. There are no reports of
serious adverse effects after taking multiple Atywia tablets at once. If more than the recommended
dose has been taken or if someone else has taken the medicine, inform your doctor.

Stopping Atywia
The medicine may be discontinued at any time. Your doctor will then suggest alternative
contraceptive methods. If you stop taking Atywia because you wish to become pregnant, wait until
the next natural menstrual period occurs. This will help determine the expected date of delivery.

Missed tablet(s)
If less than 12 hours have passed since the missed tablet, the contraceptive effectiveness of Atywia
is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.
If more than 12 hours have passed since the missed tablet, the contraceptive effectiveness of
Atywia may be reduced. The more consecutive tablets missed, the greater the risk of reduced
contraceptive effect. The risk of pregnancy is particularly high if tablets are missed at the beginning
or end of the pack. In such cases, follow the rules below (see also the chart below).

More than 1 tablet missed from the pack
Consult your doctor.

One tablet missed in the first week of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and take
subsequent tablets at the usual time. Use additional contraceptive methods (mechanical methods)
for the next 7 days.
If sexual intercourse occurred in the week before the missed tablet, pregnancy may have occurred.
Inform your doctor immediately. Also refer to the "Missed tablet management chart".

One tablet missed in the second week of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and take
subsequent tablets at the usual time. The contraceptive effectiveness of Atywia is maintained and
additional pregnancy prevention methods are not necessary.
However, if previous dosing errors occurred or more than one tablet was missed, use additional
(mechanical) contraception for 7 days.

One tablet missed in the third week of the current pack
You may choose one of the following options without needing additional contraceptive methods,
provided correct dosing was maintained during the 7 days preceding the missed dose. Otherwise,
apply the first of the two options listed below and use additional contraception for the next 7 days.
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and take
subsequent tablets at the usual time. Start the next pack immediately after finishing the current
one, i.e. without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but
spotting or bleeding may occur during tablet-taking days.
Alternatively, you may stop taking tablets from the current pack, take a 7-day or shorter break (also
including the day the tablet was missed), and then continue with tablets from the next pack.
If tablets are forgotten and no expected withdrawal bleeding occurs during the first tablet-free
interval, pregnancy may be possible. Contact your doctor before starting the next pack.

Missed tablet management chart

More than missed

Seek medical advice

tablet from current

pack

Sexual intercourse occurred
in the week
preceding missed tablet
Week 1.
Did not occur

Take missed tablet

Use additional
contraceptive method for

days

Finish taking
tablets from pack
Only 1 tablet
missed

Take missed tablet
(delay longer than

Finish taking
Week 2.
hours but less than
tablets from pack
hours)

Take missed tablet

Finish pack

• • day break

Do not take 7

• Continue taking

tablets from next

pack
or
Week 3.

Discontinue remaining tablets
from pack

Take break (no more

than 7 days, including day
of missed tablet)

• Continue taking
  tablets from next
  pack

What to do in the following situations:

• Gastrointestinal disturbances (vomiting)

If vomiting occurs, the active ingredients of Atywia may not be completely absorbed. If vomiting
occurs within 3 to 4 hours after taking the tablet, follow the instructions for a missed tablet. In case
of severe gastrointestinal disturbances, additional contraceptive methods should be used.

• Intention to delay withdrawal bleeding

To delay withdrawal bleeding, start the next pack immediately after finishing the current one,
without a 7-day break. Tablets may be taken continuously until the pack is finished. If you wish
bleeding to occur, simply stop taking tablets. During intake of tablets from the next pack, light
bleeding or spotting may occur. The next pack should be started after a 7-day break.

• Intention to change the day of withdrawal bleeding to another day of the week

If tablets are taken as directed, bleeding occurs approximately on the same day every 4 weeks. To
change the bleeding day to another day of the week, shorten the next tablet-free interval by the
number of days by which you wish to shift the bleeding. For example, if bleeding usually starts on
Fridays and you wish it to start on Tuesdays (3 days earlier), start the new pack 3 days earlier than
usual. If the tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not
occur during this interval. Light bleeding or spotting may occur during the next pack.

• Unexpected bleeding

During the first few months of taking Atywia, irregular vaginal bleeding (spotting or intermenstrual
bleeding) may occur. Despite this, continue taking the tablets as directed. Irregular vaginal
bleeding usually resolves after 3 cycles of Atywia. If bleeding persists, becomes heavy, or recurs,
inform your doctor.

• Absence of withdrawal bleeding

If all tablets were taken on time, there were no vomiting or severe diarrhoea, and no other
medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking Atywia.
If withdrawal bleeding does not occur for two consecutive months, pregnancy is possible. Inform
your doctor immediately. Do not start the next pack of Atywia until your doctor has ruled out
pregnancy.

Additional information for specific patient groups
Children and adolescents
Atywia is indicated only after the onset of menstruation.
Elderly patients
Not applicable. Atywia is not indicated in postmenopausal women.
Patients with hepatic impairment
Atywia is contraindicated in women with severe liver disease. See also section 2 "When not to use
Atywia".
Patients with renal impairment
No specific studies with Atywia have been conducted in patients with renal impairment. Available
data do not indicate a need for dose adjustment in this patient group.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers to be related to the use of Atywia, medical advice should be sought immediately.

All women using combined hormonal contraceptives have an increased risk of venous thrombosis (venous thromboembolic disease) or arterial thrombosis (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".

Serious adverse effects
Serious adverse effects associated with taking Atywia and their accompanying symptoms are described in the following sections of this leaflet: "Oral contraception and thrombosis" and "Oral contraception and cancer". Please read these sections carefully for additional information and consult your doctor immediately if necessary.

Other possible adverse effects
Below are symptoms reported by women taking Atywia, although they may not necessarily have been caused by the medicine.

Common (may affect up to 1 in 10 people):

• headache,
• breast pain, including breast discomfort and tenderness.

Uncommon (may affect up to 1 in 100 people):

• vaginitis 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,
• abdominal pain, including upper and lower abdominal pain, discomfort and (or) bloating,
• nausea, vomiting or diarrhoea,
• acne,
• alopecia (hair loss),
• rash (including maculopapular rash), itching (sometimes generalized),
• changes in menstrual bleeding such as heavy, light, infrequent or absent periods,
• intermenstrual vaginal bleeding, uterine haemorrhage (irregular bleeding between periods),
• breast enlargement, including breast congestion and swelling,
• breast swelling,
• dysmenorrhoea (painful periods),
• vaginal discharge,
• ovarian cysts,
• pelvic pain,
• fatigue, including asthenia (weakness) and malaise,
• changes in body weight (including weight gain, weight loss and weight fluctuations).

Rare (may affect up to 1 in 1,000 people):

• salpingo-oophoritis (inflammation of the ovaries and fallopian tubes),
• urinary tract infections,
• cystitis (bladder inflammation),
• mastitis (inflammation of the breast),
• cervicitis (inflammation of the cervix),
• fungal infections,
• oral herpes,
• influenza,
• bronchitis,
• sinusitis,
• upper respiratory tract infections,
• viral infection,
• 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,
• psychiatric disorders,
• insomnia,
• sleep disorders,
• aggression,
• stroke (reduced or interrupted blood supply to part of the brain),
• cerebral circulation disorders (disorders of blood flow to the brain),
• dystonia (sustained muscle contractions causing twisting or abnormal postures), dry or irritated eyes,
• oscillopsia (subjective sensation of visual image oscillation) or other visual disturbances,
• sudden hearing loss,
• tinnitus,
• vertigo,
• hearing disorders,
• cardiovascular disorders (impaired blood flow to the heart),
• tachycardia (rapid heartbeat),
• venous and arterial thromboembolic events*
• pulmonary embolism (blood clot travelling to the lungs),
• thrombophlebitis (vein inflammation, including blood clots),
• elevated diastolic pressure (lowest level to which blood pressure drops between heartbeats),
• orthostatic hypotension (dizziness or fainting upon standing from a sitting or lying position),
• hot flushes,
• varicose veins,
• venous insufficiency or vein pain,
• asthma,
• hyperventilation,
• gastritis (inflammation of the stomach lining),
• enteritis (inflammation of the intestine),
• indigestion,
• skin reactions,
• skin disorders, including allergic dermatitis, neurodermatitis and (or) atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (pigmented facial patch),
• pigmentary disorders and (or) skin discoloration,
• seborrhoea,
• dandruff,
• hirsutism (excessive hair growth),
• skin disorders, skin reactions, "orange peel" skin appearance,
• spider angioma,
• back pain,
• bone and muscle discomfort,
• muscle pain,
• pain in arms and legs,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• pain or cysts of adnexa (ovaries and fallopian tubes),
• breast cysts,
• fibrocystic breast changes,
• dyspareunia (painful sexual intercourse),
• galactorrhea (milk secretion),
• menstrual disorders,
• chest pain,
• swelling of hands and feet,
• influenza-like illness,
• inflammation,
• fever,
• irritability,
• hypercholesterolaemia,
• increased blood triglyceride levels,
• presence of supernumerary breast.

* Estimated frequency from epidemiological studies² covering the group of combined oral contraceptives. The term "venous and arterial thromboembolic events" includes: any obstruction and blood clots in deep peripheral veins, clots travelling through the circulatory system (e.g. to the lungs, known as pulmonary embolism or pulmonary infarction), myocardial infarction caused by blood clots, stroke caused by obstruction of blood vessels to or within the brain.

Frequency not known (cannot be estimated from available data):

• mood changes,
• decreased or increased libido (sexual drive),
• intolerance to contact lenses,
• skin changes (urticaria, nodular erythema, erythema multiforme),
• breast discharge,
• fluid retention.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2, "For further information on factors increasing the risk of blood clots and symptoms of thrombosis").

Seek immediate medical attention if the patient experiences symptoms of angioedema, such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or skin rash possibly accompanied by breathing difficulties (see also section "Warnings and precautions").

Description of selected adverse effects
Adverse effects with low frequency or delayed onset, considered to be associated with the group of combined oral contraceptives, are listed below (see also sections "When not to use Atywia" and "Warnings and precautions"):

Neoplasms

• The number of diagnosed cases of breast cancer among women using combined oral contraceptives is slightly increased. However, since breast cancer is rare in women under 40 years of age, the number of diagnoses is small relative to the overall risk of breast cancer. A causal relationship between combined oral contraceptives and breast cancer is not established.
• Liver tumours (benign and malignant).

Other

• Women with hypertriglyceridaemia (increased blood fat levels, increasing the risk of pancreatitis during use of combined oral contraceptives)
• High blood pressure
• Occurrence or worsening of symptoms, the relationship of which to COC use is not established: jaundice and (or) pruritus associated with cholestasis (impaired bile flow); gallstones; metabolic disorders such as porphyria; systemic lupus erythematosus (chronic autoimmune disease); haemolytic uraemic syndrome (a blood clotting disorder); neurological disorders known as Sydenham's chorea; herpes gestationis (a skin condition occurring during pregnancy); otosclerosis associated with hearing loss.
• Liver function disorders
• Changes in glucose tolerance or effects on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

Interactions
Intermenstrual bleeding and (or) reduced contraceptive efficacy may result from interactions between other medicines and oral contraceptives (e.g. St John's wort (Hypericum perforatum), or medicines for epilepsy, tuberculosis, HIV infection and other infections). See section "Atywia and other medicines".

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can 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, telephone: +48 22 492 13 01, fax: +48 22 492 13 09; 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

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 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Atywia contains

• The active substances are ethinylestradiol and dienogest.
• The other components are:
  Tablet core: monohydrate lactose, magnesium stearate, corn starch, povidone K 30, talc.
  Tablet coating: Opaglos 2 clear coating, containing the following substances: sodium croscarmellose, glucose, maltodextrin, disodium citrate dihydrate, soybean lecithin.

1 blister contains 21 coated tablets.
The package includes a cardboard pouch in which the blister should be placed.
1 coated tablet contains 0.03 mg ethinylestradiol and 2 mg dienogest.

What Atywia looks like and contents of the pack
White, round coated tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
Laboratórios Effik, Sociedade Unipessoal Lda.
Rua Dom António Ribeiro, nº 9
1495-049 Algés
Portugal

Manufacturer
Laboratorios León Farma S.A.
La Vallina s/n, Polígono Industrial Navatejera
Villaquilambre 24008
León
Spain

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa

Translation of the weekday symbols adjacent to each tablet in the immediate packaging:
Seg – Monday
Ter – Tuesday
Qua – Wednesday
Qui – Thursday
Sex – Friday
Sab – Saturday
Dom – Sunday

Marketing Authorisation Number in Portugal, country of export: 5279161
Parallel Import Licence Number: 313/18