Gestodene + Ethinylestradiol
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.
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 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 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
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.
If these symptoms occur or worsen while taking Artilla, the patient should also tell their doctor if:
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
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? |
| Deep vein thrombosis |
| 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). | |
| Retinal vein thrombosis (blood clot in the eye) |
| Heart attack |
| Stroke |
| Blood clots blocking other blood vessels |
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.
The risk of blood clots associated with Artilla is small, but some factors can increase this risk. The risk is higher:
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.
Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.
It is essential to note that the risk of a heart attack or stroke associated with Artilla is very small, but it may increase:
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.
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.
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.
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:
The contraceptive may also affect the action of other medicines, e.g.:
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.
The tablets should be swallowed whole, with a small amount of water if necessary.
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.
No effects on the ability to drive and use machines have been observed.
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".
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.
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.
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.
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.
or
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 cycle | The patient should consult their doctor | |
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Yes
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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.
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.
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".
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) :
Uncommon(may occur in 1 to 10 out of 1000 people) :
Rare(may occur in 1 to 10 out of 10,000 people) :
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
Other diseases
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.
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.
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.
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.
Zentiva k.s., U kabelovny 130, Dolni Měcholupy, 102 37 Prague 10, Czech Republic
Zentiva k.s., U kabelovny 130, Dolni Měcholupy, 102 37 Prague 10, Czech Republic
Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany
Czech Republic, Slovakia: ARTIZIA
Romania: ARTIZIA 0.075 mg / 0.020 mg drajeuri
Lithuania: ARTIZIA 75 mikrogramai / 20 mikrogramų dengtos tabletės
Poland: ARTILLA
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
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