Artilla

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

ARTILLA (ARTIZIA)

0.075 mg + 0.020 mg, sugar-coated tablets

Gestodene + Ethinylestradiol
ARTILLA and ARTIZIA are different trade names for the same drug.

Important information about combined hormonal contraceptives.

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "BLOOD CLOTS").

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Artilla and what is it used for
• 2. Important information before using Artilla
• 3. How to use Artilla
• 4. Possible side effects
• 5. How to store Artilla
• 6. Contents of the packaging and other information

1. What is Artilla and what is it used for

Artilla is a combined oral contraceptive. Each sugar-coated tablet contains a small amount of two different female sex hormones. These are gestodene (progestogen) and ethinylestradiol.
Because all the sugar-coated tablets in the packaging contain the same dose of the mentioned hormones, this tablet is referred to as a monophasic combined contraceptive.
Due to the low hormone content, it is considered a low-dose oral contraceptive.
Artilla is used to prevent pregnancy. When used as directed, becoming pregnant is very unlikely.

2. Important information before using Artilla

General notes

Before starting to take Artilla, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "BLOOD CLOTS").
This leaflet contains situations in which the contraceptive should be stopped or its reliability may be reduced. In these cases, sexual intercourse should be avoided or another non-hormonal method of contraception should be used, e.g. a condom or another mechanical method of contraception. The calendar method or temperature method should not be used. They may be unreliable because the contraceptive affects temperature changes and cervical mucus changes that normally occur during the menstrual cycle.

Artilla, like other contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

When not to use Artilla

Artilla should not be used if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• If the patient is allergic to ethinylestradiol, gestodene, or any of the other ingredients of this drug (listed in section 6);
• If the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• If the patient knows they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If the patient needs to have surgery or will be immobilized for a long time (see section "BLOOD CLOTS");
• If the patient has had a heart attack or stroke;
• If the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• If the patient has any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• hyperhomocysteinemia;
• If the patient has (or has had in the past) a type of migraine called "migraine with aura";
• If the patient has (or has had in the past) pancreatitis associated with high levels of fats in the blood;
• If the patient has jaundice or other severe liver disease;
• If the patient has (or has had in the past) a tumor that may be influenced by sex hormones (e.g. breast cancer or genital organ cancer);
• If the patient has (or has had in the past) a benign or malignant liver tumor;
• If the patient has bleeding from the genital organs of unknown origin;
• If the patient is pregnant or suspects pregnancy;
• 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 (see also section "Artilla and other medicines").

If any of these symptoms or disorders occur for the first time while taking Artilla, the patient should stop taking the drug and consult a doctor. In the meantime, non-hormonal methods of contraception should be used.
When to contact a doctor?
The patient should contact a doctor immediately

• if they notice possible symptoms of blood clots, which may indicate that they have blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "BLOOD CLOTS"). To get a description of these serious side effects, see "HOW TO RECOGNIZE BLOOD CLOTS".

Special patient groups Children and adolescents

Artilla is not intended for women before their first menstrual period.
Women of advanced age
Artilla is not indicated after menopause.
Patients with liver function disorders
The medicinal product Artilla should not be used in case of liver function disorders. See also section "When not to use Artilla" and "Warnings and precautions".
Patients with kidney function disorders
A doctor's advice should be sought. Available data suggest that there is no need to change the use of Artilla.

Warnings and precautions

The patient should tell their doctor if they have any of the following conditions.

If these symptoms occur or worsen while taking Artilla, the patient should also tell their doctor if:

• the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• the patient has sickle cell anemia (a hereditary disease of red blood cells);
• the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• the patient has recently given birth, and is therefore at increased risk of blood clots. The patient should consult a doctor for information on how soon they can start taking Artilla after giving birth;
• the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• the patient has varicose veins;
• the patient has epilepsy;
• someone in the patient's immediate family has had breast cancer;
• the patient has liver or gallbladder disorders;
• the patient has a disease that has occurred for the first time or has worsened during pregnancy or while taking sex hormones (e.g. hearing disorders, porphyria, a skin disease called pemphigoid gestationis, a nervous system disease called Sydenham's chorea);
• the patient currently has or has had chloasma (yellow-brown spots on the skin, mainly on the face), and should avoid sunbathing or exposure to ultraviolet radiation;
• the patient has symptoms of angioedema, such as facial, lingual, or laryngeal edema, and difficulty swallowing or breathing, and should contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Artilla, is associated with an increased risk of blood clots, compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also known as "arterial thromboembolism" or "arterial thrombosis"). Not everyone recovers fully from a blood clot, and in rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the overall risk of harmful blood clots caused by taking Artilla is small.

HOW TO RECOGNIZE BLOOD CLOTS

The patient should contact a doctor immediately if they notice any of the following symptoms.

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. They most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming blood clots in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different drug) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.
If the patient stops taking Artilla, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots in a vein?

The risk of blood clots associated with taking Artilla is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Artilla for a few weeks before surgery or immobilization. If the patient needs to stop taking Artilla, they should ask their doctor when they can resume taking the drug;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a flight of more than 4 hours can temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop the patient from taking Artilla.
The patient should inform their doctor if any of the above conditions change while taking Artilla, e.g. if someone in their immediate family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with taking Artilla is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. While taking a hormonal contraceptive like Artilla, it is recommended to quit 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 someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia called 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 even higher.
The patient should inform their doctor if any of the above conditions change while taking Artilla, e.g. if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

CONTRACEPTIVE AND CANCER

In patients taking contraceptives, breast cancer has been diagnosed slightly more often than in patients of the same age who do not take oral contraceptives. The small increase in the number of diagnosed breast cancer cases should gradually disappear within 10 years after stopping the contraceptive.
The reason for this relationship may be that patients taking contraceptives are more likely to undergo medical examinations and therefore have breast cancer diagnosed earlier.
In individual cases, patients taking contraceptives have been found to have benign (non-cancerous) and, much more rarely, malignant liver tumors.
These tumors can cause internal bleeding.
If severe abdominal pain occurs, the patient should consult a doctor.
The most important risk factor for the development of cervical cancer is chronic human papillomavirus infection. In some epidemiological studies, it has been reported that long-term use of combined contraceptives may further increase this risk. It is not clear whether the increased risk is caused by the contraceptive or whether it results from other factors (e.g. regular cervical screening or sexual behavior associated with the use of mechanical contraception methods). The occurrence of these cancers can be life-threatening or fatal.

PSYCHIATRIC DISORDERS

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

Artilla and other medicines

The patient should always inform their doctor about any medicines or herbal products they are currently taking. They should also tell any other doctor, including a dentist, who prescribes another medicine (or pharmacist) that they are taking Artilla. They may inform the patient whether they need to use additional contraception methods (e.g. condoms) and, if so, for how long, or whether the use of other medicines the patient needs should be changed.
Some medicines may affect the level of Artilla in the blood and reduce its 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 infections (so-called 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, degenerative joint disease (etoricoxib),
• used to treat high blood pressure (e.g. bosentan or calcium channel blockers such as 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, e.g.:

• containing cyclosporine (immunosuppressive drugs),
• antiepileptic - lamotrigine (may lead to an 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.

Artilla should not be taken 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 they may lead to an increase in liver function test results (increase in liver enzyme ALT). The doctor will recommend a different type of contraception before starting treatment with these medicines. About 2 weeks after the end of such treatment, the patient can start taking Artilla again. See section "When not to use Artilla".
Before taking any medicine, the patient should consult their doctor or pharmacist.

Artilla with food and drink

The tablets should be swallowed whole, with a small amount of water if necessary.

Pregnancy and breastfeeding

Before taking any medicine, the patient should consult their doctor or pharmacist.
Artilla should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected while taking Artilla, the patient should consult their doctor immediately.
Taking Artilla during breastfeeding is not recommended. If the patient plans to use a contraceptive during breastfeeding, they should consult their doctor.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

Artilla contains lactose monohydrate, sucrose, and sodium.

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the drug.
The drug contains less than 1 mmol (23 mg) of sodium per tablet, which means the drug is considered "sodium-free".

3. How to use Artilla

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

How and when to take Artilla

When taken correctly, combined oral contraceptives have a failure rate of about 1% per year. If a sugar-coated tablet is missed or not taken correctly, the failure rate may be higher.
One packaging of Artilla contains 21 sugar-coated tablets. Each sugar-coated tablet is marked with a symbol of the day of the week on which it should be taken. The patient should try to take the tablets every day at the same time, e.g. after breakfast. The patient should take 21 sugar-coated tablets for 21 days (one sugar-coated tablet per day), and then stop taking Artilla for 7 days. During these 7 days, withdrawal bleeding should occur.
It usually occurs 2-3 days after the last intake of Artilla. The next packaging should be started on the 8th day, regardless of whether the bleeding is still present. This means that the patient should start the next packaging on the same day of the week every week and, similarly, experience withdrawal bleeding on the same days of the month.
Taking the first packaging of Artilla
If the patient did not use hormonal contraception in the previous month
Artilla should be started on the first day of the menstrual cycle, i.e. the first day of menstrual bleeding. The patient should start with the tablet marked with the correct day of the week. For example, if the menstrual period starts on a Wednesday, the patient should start with the tablet marked "Wednesday" (Wednesday, see "Translation of day of the week symbols on the packaging" at the end of the leaflet and on the sachet). After taking the first tablet, the patient should take the next tablets according to the direction of the arrows on the packaging until all 21 tablets from the packaging have been taken. This method of use ensures the immediate effect of Artilla and eliminates the need for additional contraception methods. Artilla can also be started between days 2 and 5 of the menstrual cycle, but in this case, additional mechanical contraception methods should be used during the first 7 days of the first cycle.

• The patient should take the tablet as soon as they remember they missed it (even if it means taking two tablets at the same time), and take the next tablet at the usual time. During the next 7 days, the patient should use additional mechanical contraception methods.

Changing from another combined contraceptive or transdermal systems
Artilla can be started immediately after taking the last tablet from the previous packaging (which means no break in taking tablets). If the previous packaging also contains tablets without active substances, Artilla can be started the day after taking the last tablet containing active substances (if in doubt, which tablets contain active substances, the patient should consult their doctor or pharmacist). The tablets can also be started later, but no later than the day after the break in taking the previous contraceptive (or after taking the last tablet of the previous contraceptive that does not contain active substances).
In the case of previous use of transdermal systems, Artilla should be started preferably on the day the transdermal system is removed and no later than the day the next transdermal system is to be applied.
Provided the above rules are followed, there is no need to use additional contraception methods.
Changing from a progestogen-only pill (minipill)
The minipill can be stopped at any time, and the first tablet of Artilla should be taken at the same time the next day. During the first 7 days, the patient should use additional mechanical contraception methods during sexual intercourse.
Changing from injections, implants, or an intrauterine device releasing progestogen (IUD)
Artilla should be started at the time of the scheduled injection or on the day the implant or IUD is removed. During the first 7 days, the patient should use additional mechanical contraception methods during sexual intercourse.
Use after childbirth
After childbirth, it is recommended to delay the use of Artilla until the first normal menstrual period occurs. Sometimes it is possible to start earlier. The patient should consult their doctor. During breastfeeding, the possibility of using Artilla should also be discussed with the doctor.
Use after spontaneous or induced abortion
The patient should consult their doctor.

Using more than the recommended dose of Artilla

There are no reports of any serious health disorders in case of accidental intake of more than one tablet of Artilla. In case of accidental intake of several tablets of Artilla, nausea, vomiting, or genital bleeding may occur. If a child takes Artilla, the patient should consult their doctor.

Missing a dose of Artilla

• If the intake of a sugar-coated tablet is delayed by less than 12 hours, the contraceptive protection is not changed. The sugar-coated tablet should be taken as soon as the patient remembers they missed it, and the next sugar-coated tablet should be taken at the usual time.
• If the intake of a sugar-coated tablet is delayed by more than 12 hours, the contraceptive protection may be reduced. The more sugar-coated tablets are missed, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is particularly high if a sugar-coated tablet is missed at the beginning or end of the packaging. Therefore, the patient should follow the following rules.

Missing more than one sugar-coated tablet

The patient should consult their doctor.
Missing 1 sugar-coated tablet in the first week
The patient should take the sugar-coated tablet as soon as they remember they missed it (even if it means taking two sugar-coated tablets at the same time), and take the next sugar-coated tablet at the usual time. During the next 7 days, the patient should use additional mechanical contraception methods.
If sexual intercourse occurred during the week when the sugar-coated tablet was missed, there is a possibility of pregnancy. The patient should consult their doctor immediately.
Missing 1 sugar-coated tablet in the second week
The patient should take the sugar-coated tablet as soon as they remember they missed it (even if it means taking two sugar-coated tablets at the same time), and take the next sugar-coated tablet at the usual time. The effectiveness of Artilla remains unchanged, and there is no need to use additional contraception methods.
Missing 1 sugar-coated tablet in the third week
The patient can choose one of the following options, without the need for additional contraception methods.

• 1) The patient should take the sugar-coated tablet as soon as they remember they missed it (even if it means taking two sugar-coated tablets at the same time), and take the next sugar-coated tablet at the usual time. The patient should start taking the tablets from the next packaging immediately after taking the last sugar-coated tablet from the current packaging, without a break between packagings. Withdrawal bleeding may occur only after the end of the second packaging, but during the intake of sugar-coated tablets, spotting or intermenstrual bleeding may occur.

or

• 2) The patient should stop taking the sugar-coated tablets from the current packaging and start a 7-day break without taking Artilla, including the day the sugar-coated tablet was missed. Then, the patient should continue taking the sugar-coated tablets from the next packaging.

If the patient chooses this option and wants to start taking the sugar-coated tablets from the next packaging on the same day as usual, they should have a shorter than 7-day break in taking the drug.
If the patient misses a sugar-coated tablet and does not experience the expected withdrawal bleeding, there is a possibility of pregnancy. Before starting the next packaging, the patient should consult their doctor.
Missing more than 1 sugar-coated tablet during the cycle
The patient should consult their doctor.

• Week of missing the sugar-coated tablet

No

• The patient should take the missed sugar-coated tablet
• The patient should use another contraception method for 7 days
• The patient should finish taking the sugar-coated tablets from the packaging

Missing only 1 sugar-coated tablet (delay of more than 12 hours)

• The patient should take the missed sugar-coated tablet
• The patient should finish taking the sugar-coated tablets from the packaging
• 2. week
• The patient should take the missed sugar-coated tablet
• The patient should finish taking the sugar-coated tablets from the packaging
• The patient should skip the break in taking the drug
• The patient should continue taking the sugar-coated tablets from the next packaging

• 3. week Or
• The patient should stop taking the sugar-coated tablets from the packaging
• The patient should start a 7-day break in taking the drug
• The patient should continue taking the sugar-coated tablets from the next packaging

Stopping Artilla

Artilla can be stopped at any time. If the reason for stopping is to become pregnant, it is recommended to wait until the first normal menstrual period occurs. This will make it easier to determine the due date.
If the reason for stopping is not to become pregnant, the patient should consult their doctor to choose another contraception method.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health status that the patient considers related to the use of Artilla, consult a doctor.

Severe side effects

Consult a doctor immediately if any of the following symptoms of angioedema occur: swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria potentially with breathing difficulties (see also "Warnings and precautions").
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important information before taking Artilla".

Other possible side effects

During the use of the gestodene and ethinylestradiol combination, the following side effects have been observed, although this combination may not have been the cause of their occurrence. These side effects occur mainly during the first few months of use and usually decrease during use.
Side effects are grouped by frequency of occurrence:
Common(may occur in 1 to 10 out of 100 people):

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

Uncommon(may occur in 1 to 10 out of 1000 people):

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

Rare(may occur in 1 to 10 out of 10,000 people):

• harmful 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 stroke-like symptoms, known as a transient ischemic attack, blood clots in the liver, stomach and/or intestine, kidneys or eye (the risk of blood clots may be higher if the patient has any other risk-increasing factors - see section 2 for further information on risk-increasing factors and symptoms of blood clots);

weight loss;
erythema nodosum, erythema multiforme;
intolerance to contact lenses;
hypersensitivity reactions;
vaginal discharge, breast discharge;
increased libido;
presence of gallstones in the gallbladder.

• weight loss;
• erythema nodosum, erythema multiforme;
• intolerance to contact lenses;
• hypersensitivity reactions;
• vaginal discharge, breast discharge;
• increased libido;
• presence of gallstones in the gallbladder.

Description of selected side effects
The following side effects occur with a very low frequency or with a delayed onset of symptoms, related to the group of combined oral contraceptives (see also "Contraindications" and "Important information before taking Artilla").
Tumors

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

Other diseases

• Women with hypertriglyceridemia (elevated levels of certain fats in the blood) may have an increased risk of pancreatitis when using combined hormonal contraceptives;
• Increased blood pressure;
• Occurrence and worsening of conditions, the relationship of which to combined hormonal contraceptives is not clear: jaundice and/or itching associated with cholestasis (the flow of bile from the liver is slowed down or blocked), gallstones, porphyria (a metabolic disorder), systemic lupus erythematosus (a chronic autoimmune disease), hemolytic-uremic syndrome (a disease caused by blood clots), Sydenham's chorea (a nerve disease), herpes gestationis (a blistering disease that occurs during pregnancy), hearing loss caused by otosclerosis;
• Liver function disorders;
• Changes in glucose tolerance or peripheral insulin resistance;
• Crohn's disease, ulcerative colitis;
• Chloasma (brown skin discoloration).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Artilla

Store the medicine out of sight and reach of children.
Do not store above 30°C. The blister pack should be stored in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month.
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 Artilla contains

The active substances of Artilla are 0.075 mg gestodene and 0.020 mg ethinylestradiol.
Other ingredients are: calcium sodium edetate, lactose monohydrate, corn starch, povidone K 25, magnesium stearate; coating: sucrose, povidone 90 F, macrogol 6000, calcium carbonate, talc, montan wax.

What Artilla looks like and what the pack contains

White, biconvex, round, shiny, sugar-coated tablets with a diameter of approximately 5.5 - 5.7 mm.
Pack sizes: 21 sugar-coated tablets.
A cardboard sachet for the blister pack is included.
For more detailed information, 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number, country of export: 7462/2015/01

Parallel import authorization number: 167/20

Translation of day of the week symbols on the packaging:

Lu

• Monday Ma
• Tuesday Mi
• Wednesday Jo
• Thursday Vi
• Friday Sb
• Saturday Du
• Sunday

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Slovakia: ARTIZIA
Romania: ARTIZIA 0.075 mg / 0.020 mg tablets
Lithuania: ARTIZIA 75 micrograms / 20 micrograms coated tablets
Poland: ARTILLA

Date of approval of the leaflet: 18.06.2025

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