Background pattern
Artilla

Artilla

About the medicine

How to use Artilla

Leaflet accompanying the packaging: patient information

ARTILLA

0.075 mg + 0.020 mg, sugar-coated tablets

Gestodene + Ethinylestradiol

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").

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

  • The leaflet should be kept in case it needs to be read again.
  • In case of any doubts, a doctor or pharmacist should be consulted.
  • This medicine has been prescribed to a specific person. It should not be given to others. The medicine 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 or pharmacist. 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 information leaflet presents situations in which the contraceptive should be discontinued 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 composition 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 following conditions. If the patient has any of the following conditions, 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 medicine (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 ever had) 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).
    • A disease called hyperhomocysteinemia.
  • If the patient has (or has ever had) a type of migraine called "migraine with aura";
  • If the patient has (or has ever had) 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 ever had) a tumor that may grow under the influence of sex hormones (e.g. breast cancer or genital organs);
  • If the patient has (or has ever had) a benign or malignant liver tumor;
  • If the patient has (or has ever had) unexplained vaginal bleeding;
  • 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 conditions occur for the first time while taking Artilla, the patient should stop taking the medicine and consult a doctor. In the meantime, non-hormonal methods of contraception should be used.
When should the patient contact a doctor?
The patient should contact a doctor immediately

  • -if the patient notices possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack or stroke (see below "Blood clots (thrombosis)"). To get a description of these serious side effects, see "How to recognize a blood clot".

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
Artilla should not be used in case of liver function disorders. See also sections "When not to use" and "Precautions and warnings".
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.

Precautions and warnings

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 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 has a family history of 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 to find out how soon they can start taking Artilla after giving birth;
  • the patient has superficial thrombophlebitis (inflammation of veins under the skin);
  • the patient has varicose veins;
  • the patient has epilepsy;
  • a close relative of the patient has had breast cancer;
  • the patient has liver or gallbladder disorders;
  • the patient has developed a disease or condition that has worsened during pregnancy or previous use of sex hormones (e.g. hearing disorders, porphyria, a skin disease called herpes 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 swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause breathing difficulties, and should contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema

BLOOD CLOTS

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

  • in veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease")
  • in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease"). Not all patients who have had a blood clot will recover fully. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

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

Is the patient experiencing any of these symptoms?Why is the patient likely to be suffering from this condition?
  • swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:

  • pain or tenderness in the leg, which may only be felt while standing or walking,
  • increased temperature in the affected leg
  • skin color change in the leg, such as pallor, redness, or cyanosis
Deep vein thrombosis
  • sudden unexplained shortness of breath or rapid breathing;
  • sudden unexplained cough, which may be accompanied by coughing up blood;
  • sharp chest pain, which may worsen with deep breathing;
  • severe dizziness or fainting;
  • rapid or irregular heartbeat;
  • severe abdominal pain;
Pulmonary embolism
If the patient is unsure, they should contact a doctor, because some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g. a cold).
  • symptoms usually occur in one eye:

  • sudden loss of vision or
  • painless vision disturbances, which may lead to loss of vision
Retinal vein thrombosis (blood clot in the eye)
  • chest pain, discomfort, feeling of pressure, heaviness
  • feeling of squeezing or fullness in the chest, arm, or below the breastbone;
  • feeling of fullness, indigestion, or choking;
  • discomfort in the lower body radiating to the back, jaw, throat, arm, and stomach;
  • sweating, nausea, vomiting, or fainting;
  • extreme weakness, anxiety, or shortness of breath;
  • rapid or irregular heartbeat.
Heart attack
  • sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
  • sudden confusion, speech or understanding disorders;
  • sudden vision disturbances in one or both eyes;
  • sudden walking, dizziness, loss of balance, or coordination;
  • sudden, severe, or prolonged headaches without a known cause;
  • loss of consciousness or fainting with or without seizures. In some cases, stroke symptoms may be transient with almost immediate and complete recovery, however, the patient should contact a doctor immediately, as they may be at risk of having another stroke.
Stroke
  • swelling and slight bluish discoloration of the skin of the legs or arms
  • severe abdominal pain (acute abdomen)
Blood clots blocking other blood vessels

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

  • The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. Most often, they occur in the first year of using 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 breaks loose 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 a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using 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 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 (see section 2 "Blood clots");
  • 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.
Long-haul flights (>4 hours) may 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 use of 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 a blood clot forms 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 Artilla is very small, but it may increase:

  • with age (over approximately 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 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, 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 are 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 using contraceptives, breast cancer has been diagnosed slightly more often than in patients of the same age who do not use oral contraception. A 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 using contraceptives are more likely to undergo medical examinations and therefore have breast cancer diagnosed earlier.
In individual cases, patients using contraceptives have developed benign (non-cancerous) and, much less frequently, 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 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 may result from other factors (e.g. regular cervical screening or sexual behavior associated with the use of mechanical methods of contraception). The occurrence of these tumors can be life-threatening or fatal.

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 and symptoms of depression occur, the patient should contact their doctor as soon as possible to receive 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 contraceptive methods (e.g. condoms) and, if so, for how long, or whether the use of other medicines they need should be changed.
Some medicines may affect the level of Artilla in the blood and 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 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 products 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 cyclosporin (immunosuppressive medicines),
  • 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 used 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 resume taking Artilla. 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 used 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 effects on the ability to drive and use machines have 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 medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to use Artilla

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their 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 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 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, for example 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 the next 7 days. During these 7 days, withdrawal bleeding should occur. It usually starts 2-3 days after the last tablet of Artilla. The next packaging should be started on the 8th day, regardless of whether the bleeding has stopped. This means that the patient will start the next packaging on the same day every week and, similarly, will have withdrawal bleeding on the same days every month.
Starting 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 "Wed". After taking the first tablet, the patient should continue taking the tablets in the direction of the arrows on the packaging until all 21 tablets from the packaging have been taken. This method of use ensures immediate effectiveness of Artilla and eliminates the need for additional contraceptive methods.
Artilla can also be started between the 2nd and 5th day of the menstrual cycle, but in this case, additional mechanical methods of contraception should be used during the first 7 days of the first cycle.

Overdose of Artilla

There are no reports of serious disorders due to taking more than one tablet of Artilla at a time. If more than one tablet of Artilla is taken at a time, nausea, vomiting, or vaginal bleeding may occur. If a child takes Artilla, the patient should consult a doctor.

Missed dose of Artilla

  • If the tablet is delayed by less than 12 hours, the contraceptive protection is not changed. The tablet should be taken as soon as the patient remembers, and the next tablet should be taken at the usual time.
  • If the tablet is delayed by more than 12 hours, the contraceptive protection may be reduced. The more tablets that are 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 packaging. Therefore, the patient should follow these rules.

Missing more than one tablet

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

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

or

  • 2) The patient should stop taking the tablets from the current packaging and start a 7-day break without taking the medicine, including the day when the tablet was missed. Then, the patient should continue taking the tablets from the next packaging. If the patient chooses this option and wants to start taking the tablets from the next packaging on the same day as usual, they should have a shorter than 7-day break in taking the medicine.

If the patient misses a 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 tablet during the cycleThe patient should consult their doctor


Yes

  • 1. In the week preceding the missed tablet, sexual intercourse occurred ⇓ No ⇓  The patient should take the missed tablet  The patient should use another method of contraception for 7 days  The patient should finish taking the tablets from the packaging Missing only 1 tablet in the 2nd week  The patient should take the missed tablet (delay of more than 12 hours)  The patient should finish taking the tablets from the packaging  The patient should take the missed tablet  The patient should finish taking the tablets from the packaging  The patient should skip the break in taking the medicine  The patient should continue taking the tablets from the next packaging
  • 3. week Or  The patient should stop taking the tablets from the packaging  The patient should start a 7-day break in taking the medicine  The patient should continue taking the tablets from the next packaging

Stopping Artilla

The patient can stop taking Artilla at any time. If the reason for stopping is to become pregnant, it is recommended to try to conceive after the first normal menstrual period. 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 method of contraception.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially severe and persistent ones, or changes in your health that you think are related to the use of Artilla, you should consult your doctor.

Severe side effects

You should contact your doctor immediately if you experience any of the following symptoms of angioedema: 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 more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to 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:
Frequent(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 you have any other risk factors - see section 2 for more information on risk factors for blood clots and symptoms of blood clots);
  • weight loss;
  • erythema nodosum, erythema multiforme;
  • intolerance to contact lenses;
  • allergic 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 while using combined hormonal contraceptives;
  • Increased blood pressure;
  • Occurrence and worsening of conditions, in which the relationship with 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 neurological 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Artilla

The medicine should be stored out of sight and reach of children.
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 month stated.
Do not store above 30°C.
The blister should be stored in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. 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.
The other ingredients are: calcium sodium edetate, lactose monohydrate, corn starch, povidone K 25, magnesium stearate, sucrose, povidone K 90, macrogol 6000, calcium carbonate, talc, montan wax.

What Artilla looks like and contents of the pack

White, biconvex, round, shiny, sugar-coated tablets with a diameter of approximately 5.5 - 5.7 mm.
Pack sizes: 21 sugar-coated tablets or 3 x 21 sugar-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolni Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva k.s., U kabelovny 130, Dolni Měcholupy, 102 37 Prague 10, Czech Republic
Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany

This medicinal product 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 drajeuri
Lithuania: ARTIZIA 75 mikrogramai / 20 mikrogramų dengtos tabletės
Poland: ARTILLA

To obtain more detailed information on this medicinal product, you should contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:April 2025

  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Manufacturer
  • Importer
    Zentiva, k.s.

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Ekaterina Agapova

Neurology8 years of experience

Dr. Ekaterina Agapova is a neurologist specialising in the diagnosis and treatment of neurological conditions and chronic pain. She provides online consultations for adults, combining evidence-based medicine with a personalised approach.

She offers expert care for:

  • Headaches and migraines, including tension-type and cluster headaches.
  • Neck and back pain, both acute and chronic.
  • Chronic pain syndromes – fibromyalgia, neuropathic pain, post-traumatic pain.
  • Mononeuropathies – carpal tunnel syndrome, trigeminal neuralgia, facial nerve palsy.
  • Polyneuropathies – diabetic, toxic, and other types.
  • Multiple sclerosis – diagnosis, monitoring, long-term support.
  • Dizziness and coordination disorders.
  • Sleep disturbances – insomnia, daytime sleepiness, fragmented sleep.
  • Anxiety, depression, and stress-related conditions.

Dr. Agapova helps patients manage complex neurological symptoms like pain, numbness, weakness, poor sleep, and emotional distress. Her consultations focus on accurate diagnosis, clear explanation of findings, and tailored treatment plans.

If you’re struggling with chronic pain, migraines, nerve disorders, or sleep problems, Dr. Agapova offers professional guidance to restore your well-being.

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Doctor

Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Jonathan Marshall Ben Ami

Family medicine8 years of experience

Dr. Jonathan Marshall Ben Ami is a licensed family medicine doctor in Spain. He provides comprehensive care for adults and children, combining general medicine with emergency care expertise to address both acute and chronic health concerns.

Dr. Ben Ami offers expert diagnosis, treatment, and follow-up for:

  • Respiratory infections (cold, flu, bronchitis, pneumonia).
  • ENT conditions such as sinusitis, ear infections, and tonsillitis.
  • Digestive issues including gastritis, acid reflux, and irritable bowel syndrome (IBS).
  • Urinary tract infections and other common infections.
  • Management of chronic diseases: high blood pressure, diabetes, thyroid disorders.
  • Acute conditions requiring urgent medical attention.
  • Headaches, migraines, and minor injuries.
  • Wound care, health check-ups, and ongoing prescriptions.

With a patient-focused and evidence-based approach, Dr. Ben Ami supports individuals at all stages of life — offering clear medical guidance, timely interventions, and continuity of care.

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Doctor

Salome Akhvlediani

Pediatrics11 years of experience

Dr Salome Akhvlediani is a paediatrician providing online consultations for children of all ages. She supports families with preventive care, diagnosis, and long-term management of both acute and chronic conditions.

Her areas of focus include:

  • Fever, infections, cough, sore throat, and digestive issues.
  • Preventive care – vaccinations, regular check-ups, and health monitoring.
  • Allergies, asthma, and skin conditions.
  • Nutritional advice and healthy development support.
  • Sleep difficulties, fatigue, and behavioural concerns.
  • Ongoing care for chronic or complex health conditions.
  • Guidance for parents and follow-up after medical treatment.

Dr Akhvlediani combines professional care with a warm, attentive approach – helping children stay healthy and supporting parents at every stage of their child’s growth.

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