Artilla

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
ARTILLA (ARTIZIA)
0.075 mg + 0.020 mg, coated tablets
Gestodenum + Ethinylestradiolum
ARTILLA and ARTIZIA are different brand names for the same medicinal product.
Important information regarding combined hormonal contraceptives.

• When used correctly, they are among the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, particularly during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "BLOOD CLOTS").

Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What Artilla is and what it is used for
2. What you need to know before taking Artilla
3. How to take Artilla
4. Possible side effects
5. How to store Artilla
6. Contents of the pack and other information

1. What Artilla is and what it is used for

Artilla is an oral combined hormonal contraceptive. Each coated tablet contains a small amount of two different female sex hormones: gestodene (a progestogen) and ethinylestradiol.
Since all coated tablets in the pack contain the same dose of these hormones, this tablet is referred to as a monophasic combined oral contraceptive.
Due to its low hormone content, it is considered a low-dose oral contraceptive.
Artilla is used to prevent pregnancy. When taken according to instructions, the likelihood of becoming pregnant is very low.

2. Important information before using Artilla

General remarks
Before starting to take Artilla, you should read the information about
blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms
of blood clots (see section 2 "BLOOD CLOTS").
This patient information leaflet describes situations in which you should stop taking
the contraceptive or when its effectiveness may be reduced. In these
cases, you should avoid sexual intercourse or use another, non-hormonal method
of contraception, such as a condom or another mechanical contraceptive method. You should not use
the calendar method or the temperature method. These methods may be unreliable because the
contraceptive affects temperature changes and cervical mucus composition that normally
occur during the menstrual cycle.
Artilla, like other contraceptive medicines, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Artilla
Do not use Artilla if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other method of birth control would be more suitable.

• If you are allergic to ethinylestradiol, gestodene, or any of the other ingredients of this medicine (listed in section 6);
• If you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• If you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• If you are undergoing surgery or will be immobile for a prolonged period (see section "BLOOD CLOTS");
• If you have had a heart attack or stroke;
• If you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• If you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol or triglycerides);
  • a condition called hyperhomocysteinemia;
• If you currently have (or have had in the past) a type of migraine called "migraine with aura";
• If you currently have or have had in the past pancreatitis associated with increased fat levels in the blood;
• If you currently have jaundice or any other severe liver disease;
• If you currently have or have had in the past a tumour that may be influenced by sex hormones (e.g. breast or genital organ tumour);
• If you currently have or have had in the past a benign or malignant liver tumour;
• If you have unexplained vaginal bleeding;
• If you are pregnant or suspect you may be pregnant;
• If you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Artilla with other medicines").

If any of the listed symptoms or disorders occur for the first time while
taking the medicine, you should stop taking it immediately and consult your doctor. In the meantime, you should 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 that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "BLOOD CLOTS"). For a description of symptoms of these serious adverse effects, see "HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS".

Special patient groups
Children and adolescents
Artilla is not intended for use in women before the onset of menstruation.
Elderly women
Artilla is not indicated after menopause.
Patients with liver function disorders
Do not use Artilla if you have liver function disorders. See also section "When not to use Artilla" and "Warnings and precautions".
Patients with kidney function disorders
Consult your doctor. Available data suggest that no dosage adjustment of Artilla is required.

Warnings and precautions
Tell your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Artilla, you should also inform your doctor:

• You have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• You have systemic lupus erythematosus (a disease affecting the body's natural immune system);
• You have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• You have sickle cell anaemia (an inherited disorder of red blood cells);
• 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;
• You require surgery or will be immobile for a prolonged period (see section 2 "BLOOD CLOTS");
• You have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Artilla;
• You have phlebitis (inflammation of superficial veins);
• You have varicose veins;
• You have epilepsy;
• Anyone in your immediate family has had breast cancer;
• You have liver or gallbladder disorders;
• You develop a new illness or a condition that previously worsened during pregnancy or previous use of sex hormones (e.g. any hearing disorders, disorders of haem pigment metabolism called porphyria, a skin blistering condition called herpes gestationis, or a nervous system disorder called Sydenham's chorea);
• You currently have or have had chloasma (yellowish-brown patches on the skin, mainly on the face); avoid sunbathing or exposure to ultraviolet radiation;
• You experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or urticaria that may cause breathing difficulties—seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Artilla increases the 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 events").
  Full recovery from a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

Please remember that the overall risk of harmful blood clots caused by
using Artilla is low.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you notice any of the following symptoms.

VENOUS BLOOD CLOTS
What could happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). However, 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 venous blood clots the highest?
The risk of developing venous blood clots is greatest during the first year of taking 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 Artilla, the risk of blood clots returns to normal within a few weeks.

What does the risk of venous blood clots depend on?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Artilla is small.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing gestodene, such as Artilla, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of venous blood clots" below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Artilla is small, however,
some 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 relative of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo 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 the use of Artilla several weeks before surgery or immobilization. If the patient must stop taking Artilla, ask the doctor when it is safe to resume taking the medication;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past 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 blood clots,
especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Artilla.
Inform the doctor if any of the above conditions change during treatment with Artilla, for example, if a close relative is diagnosed with thrombosis of unknown cause 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 cause serious
consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with the use of Artilla
is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Artilla, 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 is overweight;
• if the patient has high blood pressure;
• if a close relative 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 relative has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder called 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 blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Artilla, for example, if the patient starts smoking, a close relative is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

CONTRACEPTIVE AND CANCER
Breast cancer has been diagnosed slightly more frequently in women using hormonal contraceptives compared to women of the same age not using oral contraceptives. This small increase in diagnosed cases of breast cancer should gradually disappear within 10 years after stopping the contraceptive. This association may be due to the fact that women using hormonal contraceptives are examined more frequently, leading to earlier detection of cancer.
In rare cases, benign (non-malignant) and, even more rarely, malignant liver tumors have been observed in women using hormonal contraceptives.
These tumors may cause internal bleeding.
If severe abdominal pain occurs, consult a doctor immediately.
The most important risk factor for cervical cancer is chronic infection with human papillomavirus (HPV). In some epidemiological studies, long-term use of combined hormonal contraceptives has been associated with a higher risk. It is unclear whether this increased risk is caused by the contraceptive itself, as it may result from other factors (e.g. more frequent preventive cervical screening or sexual behavior related to the use of mechanical contraceptive methods). These cancers may lead to life-threatening conditions or death.

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

Artilla and other medicines
Always inform your doctor or pharmacist about any medicines or herbal products you are currently taking. Also inform any other doctor, including a dentist, or pharmacist prescribing another medicine that you are using Artilla. They will advise whether additional contraceptive methods (e.g. condoms) are needed, and if so, for how long, or whether the use of other required medications needs to be adjusted.
Some medicines may affect the blood concentration of Artilla, reduce its contraceptive effectiveness, or cause unexpected bleeding. These include:

• Medicines:
  • used to treat epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, and felbamate),
  • used to treat tuberculosis (e.g. rifampicin),
  • used to treat HIV and hepatitis C virus infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
  • used to treat fungal infections (griseofulvin, azole derivatives such as itraconazole, voriconazole, fluconazole, and ketoconazole),
  • used to treat arthritis, osteoarthritis (etoricoxib),
  • used to treat high blood pressure (such as bosentan or calcium channel blockers, e.g. verapamil or diltiazem), used to treat bacterial infections (macrolide antibiotics such as clarithromycin and erythromycin),
• Herbal medicines containing St. John's wort (Hypericum perforatum) (used to treat depression),
• Grapefruit juice.

The contraceptive may also affect the action of other medicines, for example:

• those containing cyclosporine (immunosuppressive drugs),
• antiepileptic drugs—lamotrigine (may lead to increased frequency of seizures),
• theophylline (used for breathing difficulties),
• tizanidine (used to treat muscle pain and/or muscle spasms),
• melatonin (used to treat insomnia),
• midazolam.

Do not use Artilla if the patient has hepatitis C and is taking medicines
containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or
sofosbuvir with velpatasvir and voxilaprevir, as these may lead to increased blood test results
assessing liver function (elevated levels of the liver enzyme AlAT).
The doctor will recommend another type of contraception before starting treatment with these medicines. Artilla may be restarted approximately 2 weeks after completing such treatment. See section "When not to use Artilla".
Before taking any medicine, consult your doctor or pharmacist.

Artilla with food and drink
Tablets should be swallowed whole, taking a small amount of water if necessary.

Pregnancy and breastfeeding
Before taking any medicine, consult a doctor or pharmacist.
Artilla must not be used during pregnancy or if pregnancy is suspected. If pregnancy is suspected during treatment with Artilla, consult a doctor immediately.
Use of Artilla during breastfeeding is not recommended. If planning to use a contraceptive during breastfeeding, consult a doctor.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

Artilla contains monohydrate lactose, sucrose, and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Artilla

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
How and when to take Artilla
When used correctly, combined oral contraceptives have a failure rate of about 1% per year. If a
coated tablet is missed or the medicine is used incorrectly, the failure rate may be higher.
One pack of Artilla contains 21 coated tablets. Each coated tablet is marked with the symbol of the
day of the week on which it should be taken. Try to take the tablets at the same time each day, for
example after breakfast. Take 21 coated tablets for 21 days (one coated tablet each day), then stop
taking Artilla for the next 7 days. During these 7 days, a withdrawal bleed should occur.
This usually occurs 2–3 days after the last dose of Artilla. Start the next pack on the 8th day,
regardless of whether bleeding is still occurring. This means starting each new pack on the same day
of the week and having withdrawal bleeding on the same days each month.
Starting the first pack of Artilla
If not using hormonal contraception in the previous month
Begin taking Artilla on the first day of your cycle, i.e. the first day of menstrual bleeding. Start with
the tablet marked with the correct day of the week. For example, if your period starts on a
Wednesday, begin with the tablet marked “Mi” (Mi = Wednesday, see “Translation of day-of-the-week
symbols on each tablet on the immediate packaging” at the end of the leaflet and on the sachet).
After taking the first tablet, continue taking the tablets in the direction of the arrows on the pack
until all 21 tablets in the pack have been taken. This method ensures immediate contraceptive
protection, and no additional contraceptive methods are needed. Artilla may also be started on
days 2 to 5 of the cycle, but in this case, additional mechanical contraceptive methods must be
used for the first 7 days of the first cycle.
Switching from another combined oral contraceptive or transdermal systems
Artilla may be started the day after taking the last active tablet from the previous pack (i.e. no
tablet-free interval). If the previous pack also contains inactive (placebo) tablets, start Artilla the day
after taking the last active tablet (if in doubt about which tablets contain active substance , consult
your doctor or pharmacist). Artilla may also be started later, but not later than the day after the
tablet-free interval of the previous contraceptive (or after the last inactive tablet of the previous
contraceptive).
If switching from transdermal systems, start Artilla preferably on the day of removal of the
transdermal system and no later than the day the next transdermal system would have been
applied.
If the above rules are followed, no additional contraceptive methods are necessary.
Switching from a progestogen-only pill (mini-pill)
The mini-pill may be stopped at any time, and the first tablet of Artilla should be taken at the same
time the next day. However, during the first 7 days, additional mechanical contraceptive methods
should be used during sexual intercourse.
Switching from an injection, implant, or intrauterine device releasing progestagen (IUD)
Start Artilla on the day the next injection is due or on the day of removal of the implant or IUD.
However, during the first 7 days, additional mechanical contraceptive methods should be used
during sexual intercourse.
Use after childbirth
After childbirth, it is recommended to delay starting Artilla until the first normal menstrual period.
Earlier initiation may sometimes be possible. Consult your doctor. The possibility of using Artilla
during breastfeeding should also be discussed with your doctor.
Use after spontaneous or induced abortion
Consult your doctor.
Taking more Artilla than recommended
There are no reports of any serious health problems following a single intake of more than one
tablet of Artilla. If several tablets of Artilla are taken at once, nausea, vomiting, or vaginal
bleeding may occur. If Artilla is taken by a child, consult a doctor.
Missed dose of Artilla

• If a coated tablet is taken less than 12 hours late , contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and take the next tablet at the usual time.
• If a coated tablet is taken more than 12 hours late , contraceptive protection may be reduced. The more tablets missed, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is particularly high if a tablet is missed at the beginning or end of the pack. Therefore, follow the rules below.

Missing more than one tablet
Consult your doctor.
Missing 1 tablet in the first week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same
time), and take the next tablet at the usual time. Use additional mechanical contraception for the
next 7 days.
If you had sexual intercourse during the week when the tablet was missed, there is a risk of
pregnancy. Consult your doctor immediately.
Missing 1 tablet in the second week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same
time), and take the next tablet at the usual time. Contraceptive effectiveness remains unchanged,
and no additional contraceptive methods are needed.
Missing 1 tablet in the third week
You may choose one of the following options, without needing additional contraceptive methods.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the
   same time), and take the next tablet at the usual time. Start the next pack immediately after taking
   the last tablet of the current pack, without a break between packs . Withdrawal bleeding may
   only occur after finishing the second pack, but spotting or intermenstrual bleeding may occur
   during tablet intake.
   or
2. Stop taking tablets from the current pack and begin a 7-day break without taking the medicine,
   including the day the tablet was missed . Then continue with the next pack.
   If choosing this option and wishing to start the next pack on the same day as usual, you must have
   a shorter than 7-day break .
   If tablets are missed and expected withdrawal bleeding does not occur, pregnancy is possible.
   Consult your doctor before starting the next pack.
   Missing more than 1 tablet during the cycle
   Yes
   In the week before the missed tablet

1. week
   Sexual intercourse occurred
   No

• Take the missed tablet
• Use another contraceptive method for 7 days
• Finish the tablets in the pack

Missing only 1 tablet (delay >12 hours)
• Take the missed tablet
• Finish the tablets in the pack

2. week

• Take the missed tablet
• Finish the tablets in the pack
• Do not take a break
• Continue with the next pack

3. week
   Or

• Stop taking tablets from the pack
• Begin a 7-day break
• Continue with the next pack

Stopping Artilla
Artilla may be stopped at any time. If stopping to plan a pregnancy, it is recommended to wait until
after the first normal menstrual period before trying to conceive. This helps determine the due date.
If not planning a pregnancy, consult your doctor to choose another contraceptive method.
What to do if…
…gastrointestinal disturbances occur (e.g. vomiting, severe diarrhoea)
In case of vomiting or severe diarrhoea, the active substance of Artilla may not be fully absorbed. If
vomiting occurs 3–4 hours after taking the tablet, the effect is the same as missing a tablet. Follow
the instructions for a missed tablet. If severe diarrhoea occurs, contact your doctor.
…you wish to delay the onset of bleeding
To delay bleeding, continue taking coated tablets from the next pack of Artilla without a break. As
needed, continue taking tablets until the end of the pack. Bleeding can be induced by stopping the
tablets. Breakthrough bleeding or spotting may occur during intake from the next pack. Begin the
following pack after the usual 7-day break.
…you wish to change the day bleeding starts
If tablets are taken as directed, bleeding should start approximately on the same day every 4
weeks. To change the day bleeding starts, simply shorten (never extend) the next tablet-free
interval. For example, if bleeding usually starts on Friday and you wish it to occur on Tuesday (3
days earlier), start the next pack 3 days earlier than usual. If the tablet-free interval is too short (e.g.
3 days or less), bleeding may not occur during the break. However, spotting or intermenstrual
bleeding may occur during intake from the next pack.
…unexpected bleeding occurs
While using all contraceptive medicines, irregular bleeding between periods may occur. You may
need to use sanitary pads, but continue taking Artilla as usual. These irregularities usually resolve
after the body adjusts to the medicine (usually after 3 cycles). However, if problems persist, bleeding
becomes heavier, or recurs after a period of regularity, consult your doctor.
…menstruation does not occur
If tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medicines
have been used, pregnancy is very unlikely. Continue taking Artilla as usual.
If bleeding does not occur for two consecutive cycles, pregnancy is possible. Do not start the next
pack until pregnancy has been ruled out by a doctor.
Regular medical check-ups
Regular medical examinations are necessary while taking Artilla.
Consult your doctor immediately if:

• your health condition changes, especially if any of the conditions described in this leaflet occur. Also remember to inform your doctor about your family medical history;
• a lump is felt in the breast;
• you plan to take other medicines (see also “Artilla and other medicines”);
• you will have a period of limited mobility or a planned surgical procedure (consult your doctor at least four weeks in advance);
• you experience severe, unexplained vaginal bleeding;
• tablets are missed in the first week of a new pack and sexual intercourse occurred in the previous 7 days;
• you experience severe diarrhoea;
• withdrawal bleeding does not occur for two consecutive cycles or pregnancy is suspected (do not start the next pack without consulting your doctor).

If you have any further doubts about using this medicine, consult your 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 status that the patient considers related to the use of Artilla, medical advice should be sought.
Serious adverse effects
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially accompanied by breathing difficulties (see also section "Warnings and precautions").
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, please refer to section 2 "Important information before taking Artilla".
Other possible adverse effects
The following adverse effects have been observed during use of the combination of gestodene and ethinylestradiol, although this combination may not necessarily have caused them. These adverse effects usually occur during the first few months of use and typically diminish with continued use.
Adverse effects are grouped according to frequency of occurrence:
Common (may affect 1 to 10 users in 100):

• weight gain;
• headache;
• nausea, abdominal pain;
• breast tenderness, breast pain;
• depressed mood, mood changes.

Uncommon (may affect 1 to 10 users in 1,000):

• migraine;
• vomiting, diarrhoea;
• rash, urticaria;
• fluid retention;
• breast enlargement;
• decreased libido.

Rare (may affect 1 to 10 users in 10,000):

• 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), heart attack, stroke, mini-stroke or transient ischaemic attack, known as transient ischaemic attack, blood clots in the liver, stomach and/or intestines, kidneys or eye (the likelihood of blood clots may be higher if the patient has any other risk factors – see section 2 for further information on risk factors for blood clots and symptoms of blood clots);

• weight loss;

• nodular erythema, erythema multiforme;

• intolerance to contact lenses;

• hypersensitivity reactions;

• vaginal discharge, breast discharge;

• increased libido;

• presence of gallstones in the gallbladder.

Description of selected adverse effects
Below are listed adverse effects occurring very rarely or with delayed onset, associated with the group of combined oral contraceptives (see also "When not to use Artilla" and "Important information before taking Artilla").
Tumours

• Women using oral contraceptives have a very slightly increased risk of developing breast cancer. As breast cancer is rare in women under 40 years of age, the number of cases is small in relation to the overall risk of breast cancer. It is not known whether there is any causal relationship with the use of combined contraceptives;
• Liver tumours (benign and malignant).

Other disorders

• Women with hypertriglyceridaemia (increased levels of certain fats in the blood) may have an increased risk of pancreatitis while using combined contraceptives;
• Increased blood pressure;
• Occurrence or worsening of conditions where the relationship to combined contraceptives is not clear: jaundice and/or pruritus associated with cholestasis (bile flow from the liver is slowed or blocked), gallstone formation, porphyria (a metabolic disorder), systemic lupus erythematosus (a chronic autoimmune disease), haemolytic-uraemic syndrome (a disease caused by blood clots), Sydenham's chorea (a neurological disorder), herpes gestationis (a blistering skin condition occurring during pregnancy), hearing loss due to otosclerosis;
• Liver function disorders;
• Changes in glucose tolerance or peripheral insulin resistance;
• Crohn's disease, ulcerative colitis;
• Chloasma (brownish skin pigmentation).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Artilla

Keep the medicine out of sight and reach of children.
Do not store above 30°C. The blister should be kept in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the specified month.
Medicines must 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 Artilla contains
The active substances are 0.075 mg gestodene and 0.020 mg ethinylestradiol.
Other components are: calcium sodium edetate, monohydrate lactose, corn starch, povidone K 25, magnesium stearate; coating: sucrose, povidone 90 F, macrogol 6000, calcium carbonate, talc, montan wax.

What Artilla looks like and contents of the pack
White, biconvex, round, glossy coated tablets with a diameter of approximately 5.5 – 5.7 mm.
Pack size: 21 coated tablets.
A cardboard pouch for the blister is included in the package.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Romania, the country of export:
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy, 102 37, Prague 10, Czech Republic

Manufacturer:
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy, 102 37, Prague 10, Czech Republic

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

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

Marketing Authorization Number in Romania, the country of export: 7462/2015/01
Parallel Import Authorization Number: 167/20

Translation of weekday symbols printed next to each tablet on the immediate packaging:
Lu - Monday
Ma - Tuesday
Mi - Wednesday
Jo - Thursday
Vi - Friday
Sb - Saturday
Du - Sunday

This medicinal product is authorized for sale in the European Economic Area countries under the following names:
Czech Republic, Slovakia: ARTIZIA
Romania: ARTIZIA 0.075 mg / 0.020 mg drajeuri
Lithuania: ARTIZIA 75 mikrogramai / 20 mikrogramų dengtos tabletės
Poland: ARTILLA