Artilla

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Artilla (Artizia)

0.075 mg + 0.02 mg, chewable 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.
• They slightly 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.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

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

• One should keep the leaflet so that it can be re-read if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• 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 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 chewable tablet contains a small amount of two different female sex hormones. These are gestodene (progestogen) and ethinylestradiol.
Because all the chewable 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

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 blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If the patient requires surgery or will be immobilized for a long time (see "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 (transient 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 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 or genital cancer);
• If the patient has (or has had in the past) a benign or malignant liver tumor;
• If the patient has bleeding from the genitals of unknown etiology;
• If the patient is pregnant or suspects pregnancy.

General notes

Before starting to take Artilla, one 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 provides situations in which one should stop using the contraceptive or in which its reliability may be reduced.
In these cases, one should abstain from sexual intercourse or use another, non-hormonal method of contraception, e.g., a condom or another mechanical method of contraception. One should not use the calendar method or the temperature method. They may be unreliable because the contraceptive affects temperature changes and cervical mucus composition that usually occur during the menstrual cycle.

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

• If the patient has hepatitis C and is taking drugs containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also "Artilla and other drugs").

If any of the symptoms or disorders occur for the first time while taking Artilla, one should stop taking it and consult a doctor. In the meantime, one should use non-hormonal methods of contraception.

One should tell the doctor if the patient has any of the following conditions.

If these symptoms appear or worsen while taking Artilla, one should also tell the doctor if:

• the patient has Crohn's disease or ulcerative colitis

Warnings and precautions

When should one contact a doctor?
One should immediately contact a doctor

• if the patient notices possible symptoms of blood clots, which may indicate that the patient has 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".

(chronic inflammatory bowel disease);

• 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 positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• the patient requires 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. One should consult a doctor to find out 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 developed a new disease or condition that has worsened during pregnancy or while taking sex hormones (e.g., any hearing disorders, metabolic disorders of porphyrin, 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, 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 (also called "venous thromboembolism" or "venous thrombotic event")
• in arteries (also called "arterial thromboembolism" or "arterial thrombotic event"). Not everyone who has had a blood clot will make a full recovery. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

One should remember that the overall risk of harmful blood clots caused by Artilla is small.

HOW TO RECOGNIZE BLOOD CLOTS

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

BLOOD CLOTS IN VEINS

What can happen if blood clots form 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. They most often 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 moves from the leg to 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 the highest?

The risk of forming blood clots 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 drug) 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?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Artilla is small.

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

Factors that increase the risk of blood clots in veins

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). In this case, the patient may have hereditary blood coagulation disorders;
• if the patient must undergo surgery, is 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 must stop taking Artilla, they should ask their doctor when they can resume taking it;
• with age (especially over 35);
• 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 air travel (>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 not sure. The doctor may decide to stop Artilla.
One should inform the doctor if any of the above conditions change while taking Artilla, e.g., if someone in the patient's immediate family is diagnosed with thrombosis 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 emphasize that the risk of heart attack or stroke associated with Artilla is very small, but it may increase:

• with age (over about 35 years);
• 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, 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). In this case, the patient may also be at increased risk of 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 severe, the risk of blood clots may be even higher.
One should inform the doctor if any of the above conditions change while taking Artilla, e.g., if the patient starts smoking, someone in the patient's immediate family is diagnosed with thrombosis without a known cause, or if the patient gains 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. 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 examinations and therefore have breast cancer diagnosed earlier.
In individual cases, patients taking contraceptives have been observed to develop benign (non-cancerous) and, much more rarely, malignant liver tumors. These tumors can cause internal bleeding.
If severe stomach pain occurs, one should consult a doctor.
The most important risk factor for the development of cervical cancer is persistent infection with the human papillomavirus. 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 cancer screening or sexual behavior associated with the use of mechanical methods of contraception).

PSYCHIATRIC DISORDERS

Some women taking hormonal contraceptives, including the product 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, one should contact a doctor as soon as possible for further medical advice.

Artilla and other drugs

One should always inform their doctor about the drugs or herbal products they are currently taking. One should also tell any other doctor, including a dentist, who prescribes another drug (or pharmacist) that they are taking Artilla. They may inform whether additional contraceptive methods should be used (e.g., condoms) and for how long, or whether the use of other drugs that the patient needs should be changed.
Some drugs may affect the level of Artilla in the blood and reduce its contraceptive effectiveness or cause unexpected bleeding. These include:

• drugs used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, and felbamate),
• drugs used to treat tuberculosis (e.g., rifampicin),
• drugs used to treat HIV and hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• drugs used to treat fungal infections (griseofulvin, ketoconazole),
• drugs used to treat arthritis, degenerative joint disease (etoricoxib),
• drugs used to treat high blood pressure in the lungs (bosentan),
• products containing St. John's wort (Hypericum perforatum) (used to treat depression).

The contraceptive may also affect the action of other drugs, such as:

• products containing cyclosporine (immunosuppressive drugs),
• antiepileptic drugs - lamotrigine (may lead to an increased frequency of seizures),
• theophylline (used for breathing difficulties),
• tizanidine (used to treat muscle pain and/or muscle spasms).

Artilla should not be used if the patient has hepatitis C and is taking drugs containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may lead to an increase in liver enzyme test results (increase in liver enzyme ALT). The doctor will recommend a different type of contraception before starting treatment with these drugs. About 2 weeks after finishing such treatment, one can resume taking Artilla. See section "When not to use Artilla".
Before taking any drug, one should consult their doctor or pharmacist.

Artilla with food and drink

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

Pregnancy and breastfeeding

Before taking any drug, one 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, one should immediately consult a doctor.
Taking Artilla during breastfeeding is not recommended. If one plans to use a contraceptive during breastfeeding, they should consult a 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 drug should always be used as directed by a doctor or pharmacist. In case of doubts, one should consult a doctor or pharmacist.

How and when to take Artilla

When used correctly, oral combined contraceptives have a failure rate of about 1% per year. If a tablet is missed or not taken correctly, the failure rate may be higher.
One pack of Artilla contains 21 chewable tablets. Each chewable tablet is marked with the day of the week on which it should be taken. One should try to take the tablets every day at the same time, e.g., after breakfast. One should take 21 chewable tablets for 21 days (one chewable 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 pack should be started on the 8th day, regardless of whether the bleeding has stopped. This means starting the next pack on the same day of the week every time and having withdrawal bleeding on the same days every month.
Starting the first pack of Artilla
If no hormonal contraception was used in the previous month
Artilla should be started on the first day of the menstrual cycle, i.e., the first day of menstrual bleeding. One should start with the tablet marked with the correct day of the week. For example, if the menstrual period starts on a Wednesday, one should start with the tablet marked "Wednesday" (see "Translation of day-of-the-week symbols on the packaging" at the end of the leaflet and pouch). After taking the first tablet, one should continue taking the next tablets according to the direction of the arrows on the packaging until all 21 tablets from the pack 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 contraceptive methods should be used during the first 7 days of the first cycle.

What to do if... ...gastrointestinal disorders occur (e.g., vomiting, severe diarrhea)

In case of vomiting or severe diarrhea, the active substance of Artilla may not be fully absorbed. If vomiting occurs within 3-4 hours after taking a tablet, the effect will be the same as if a tablet was missed. One should follow the instructions for missing a tablet. In case of severe diarrhea, one should contact a doctor.
...it is desired to delay the onset of bleeding
To delay the onset of bleeding, one should continue taking the chewable tablets from the next pack of Artilla without a break. As needed, one can continue taking the tablets until the end of the pack. Bleeding can be achieved by stopping the tablets. During the next pack, bleeding or spotting may occur. The next pack should be started after the usual 7-day break.
...it is desired to change the day of bleeding
As long as the tablets are taken as directed, bleeding should start around the same day every 4 weeks. If one wants to change the day of bleeding, they should only shorten (never prolong) the next break in taking the tablets. For example, if bleeding usually starts on a Friday and one wants it to start on a Tuesday (3 days earlier), the next pack should be started 3 days earlier than usual. If the break is too short (e.g., 3 days or less), bleeding may not occur during the break, but spotting or intermenstrual bleeding may occur during the next pack.

Stopping Artilla

One can stop taking Artilla at any time. If the reason for stopping is to plan a pregnancy, 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 is not to plan a pregnancy, one should consult a doctor to choose another contraceptive method.

What to do if... ...the patient experiences side effects

One should consult a doctor or pharmacist if they experience any side effects, including any side effects not listed in the leaflet.

4. Possible Undesirable Effects

Like all medicines, this medicine can cause undesirable effects, although they may not occur in everyone.
If any undesirable effects occur, especially severe and persistent ones or changes in health status that the patient considers related to the use of Artilla, a doctor should be consulted.

Severe Undesirable Effects

A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria potentially with breathing difficulties (see also "Warnings and Precautions").
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important Information Before Using Artilla".

Other Possible Undesirable Effects

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

• weight gain;
• headache;

Regular Medical Examinations

During the use of Artilla, regular medical examinations should be performed.

Consult a Doctor Immediately If:

• there is a change in health status, especially one of the conditions described in this leaflet. Also, remember the information about the nearest relatives;
• a palpable lump in the breast appears;
• the use of other medicines is planned (see also "Artilla and Other Medicines");
• there is a period of limited mobility or a planned surgical procedure (consult a doctor at least four weeks in advance);
• there is severe vaginal bleeding of unknown cause;
• tablets from the next package are missed during the first week of use, and sexual intercourse occurred during the preceding 7 days;
• there is severe diarrhea;
• withdrawal bleeding does not occur twice in a row or pregnancy is suspected (do not start the next package without consulting a doctor).
• nausea, abdominal pain;
• breast tension, breast pain;
• depressive mood, mood changes.

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

• migraine;
• vomiting, diarrhea;
• rash, urticaria;
• fluid retention in the body;
• breast enlargement;
• decreased libido;
• increased blood lipid levels.

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 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 more 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.

Very Rare(may occur in less than 1 out of 10,000 people) :

• pancreatitis.

Reporting Undesirable Effects

If any undesirable effects occur, including any undesirable effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of 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.
Reporting undesirable effects can help gather more information on the safety of the medicine.

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 packaging. The expiry date refers to the last day of the specified month.
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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Artilla Contains

The active substances of the medicine are 0.075 mg gestodene and 0.02 mg ethinylestradiol.
The other ingredients are: calcium sodium edetate, lactose monohydrate, corn starch, povidone 25, magnesium stearate, sucrose, povidone 90 F, macrogol 6000, calcium carbonate, talc, montan wax.

What Artilla Looks Like and What the Package Contains

White, biconvex, round, glossy, sugar-coated tablets with a diameter of approximately 5.5 - 5.7 mm.
Package sizes: 21 sugar-coated tablets or 3 x 21 sugar-coated tablets.
A sachet is attached to the packaging, in which the blister should be placed.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Romania, the Country of Export:

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

Manufacturer:

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

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization Number in Romania, the Country of Export:7462/2015/01
7462/2015/02
Parallel Import Authorization Number:737/12

Translation of Day of the Week Symbols on the Packaging:

Lu– Monday, Ma– Tuesday, Mi– Wednesday, Jo– Thursday, Vi– Friday, Sb– Saturday,
Du- Sunday.
Date of Leaflet Approval: 08.09.2022
[Information about the trademark]