ARTILLA 0.075 mg/0.020 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION
2. Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!
   1. 075 mg + 0.020 mg, effervescent tablets
   2. Important information about combined hormonal contraceptives
   3. The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.
   4. Table of contents of the leaflet:
3. What is Artilla and what is it used for
4. Important information before taking Artilla
   1. General notes
   2. Artilla, like other contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.
   3. When not to take Artilla
   4. Warnings and precautions
   5. The doctor should be told if the patient has any of the following conditions.
   6. BLOOD CLOTS
   7. Where can blood clots occur?
   8. It should be remembered that the overall risk of a harmful blood clot due to Artilla is small.
   9. HOW TO RECOGNIZE A BLOOD CLOT
   10. BLOOD CLOTS IN VEINS
   11. What can happen if a blood clot forms in a vein?
   12. When is the risk of blood clots in a vein highest?
   13. What affects the risk of blood clots?
   14. Factors that increase the risk of blood clots in veins
   15. BLOOD CLOTS IN ARTERIES
   16. What can happen if a blood clot forms in an artery?
   17. Factors that increase the risk of blood clots in arteries
   18. CONTRACEPTIVE AND CANCER
   19. MENTAL DISORDERS
   20. Artilla and other medicines
   21. Artilla with food and drink
   22. Pregnancy and breastfeeding
   23. Driving and using machines
   24. Artilla contains lactose monohydrate, sucrose, and sodium.
5. How to take Artilla
   1. How and when to take Artilla
   2. Taking the first pack of Artilla
   3. Taking more than the recommended dose of Artilla
   4. Missing a dose of Artilla
   5. Missing more than one tablet
   6. Stopping Artilla
6. Possible side effects
   1. Severe side effects
   2. Other possible side effects
   3. Reporting side effects
7. How to store Artilla
   1. Translation of day of the week symbols on each tablet on the immediate packaging:
8. Package contents and other information
   1. What Artilla contains
   2. What Artilla looks like and what the package contains
   3. Marketing authorization holder in Romania, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Date of leaflet approval: 08.11.2024

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Artilla(Artizia)

0.075 mg + 0.020 mg, effervescent tablets

Gestodene + Ethinylestradiol
Artilla and Artizia are different trade names for the same medicine.

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 point 2. "Blood clots").

The leaflet should be read carefully before taking 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, pharmacist, or nurse. See point 4.

Table of contents of the leaflet:

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

1. What is Artilla and what is it used for

Artilla is a combined oral contraceptive. Each effervescent tablet contains a small amount of two different female sex hormones. These are gestodene (progestogen) and ethinylestradiol.
Since all the effervescent tablets in the pack 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 taking Artilla

General notes

Before starting to take Artilla, you should read the information about blood clots (thrombosis) in point 2. It is especially important to read about the symptoms of blood clots (see point 2. "Blood clots").
This leaflet provides information on situations where the contraceptive should be stopped or where its reliability may be reduced.
In these cases, sexual intercourse should be avoided or a non-hormonal method of contraception, such as a condom or another mechanical method of contraception, should be used. The calendar method or temperature method should not be used. They can 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 take Artilla

Artilla should not be taken 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 medicine (listed in point 6);
• If the patient currently has (or has ever had) a blood clot in the deep 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, deficiency of protein C, protein S, antithrombin III, presence of factor V Leiden, or antiphospholipid antibodies;
• If the patient needs to have surgery or will be immobilized for a long time (see point 2. "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, which 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 (or has had in the past) bleeding from the genitals of unknown origin;
• If the patient is pregnant or suspects they are pregnant.
• 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 "Artilla and other medicines").

If any of the conditions or symptoms listed above occur for the first time while taking Artilla, the medicine should be stopped immediately and a doctor should be consulted. In the meantime, non-hormonal methods of contraception should be used.

Warnings and precautions

When should a doctor be contacted?
A doctor should be contacted 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 a stroke (see below "Blood clots (thrombosis)"). To find a description of these serious side effects, see "How to recognize a blood clot".

The doctor should be told if the patient has any of the following conditions.

If these symptoms occur or worsen while taking Artilla, the doctor should also be told 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 found to have high levels of fats in the blood (hypertriglyceridemia) or 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 point 2 "Blood clots");
• the patient has recently given birth, in which case they are at increased risk of blood clots. The doctor should be consulted for information on how soon Artilla can be started 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 a disease that has occurred for the first time or has worsened during pregnancy or previous use of sex hormones (e.g., any hearing disorders, metabolic disorders of porphyrins, a skin disease called porphyria cutanea tarda, a nervous system disease called Sydenham's chorea);
• the patient has chloasma (yellow-brown patches 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 difficulty 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.

Where can blood clots occur?

• in veins (also called "venous thrombosis" or "venous thromboembolism")
• in arteries (also called "arterial thrombosis" or "arterial thromboembolism"). Not all survivors of a blood clot will recover fully, and in rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It should be remembered that the overall risk of a harmful blood clot due to Artilla is small.

HOW TO RECOGNIZE A BLOOD CLOT

A doctor should be contacted immediately if any of the following symptoms are noticed.

BLOOD CLOTS IN VEINS

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

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). 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 a blood clot 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 medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher than when 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?

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 due to Artilla is small.

• During a year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9-12 out of 10,000 women who take 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 due to Artilla is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely 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, 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 needs to stop taking Artilla, they should ask their doctor when they can resume taking it;
• 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.
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 unsure. The doctor may decide to stop Artilla.
The doctor should be informed if any of the above conditions change while taking Artilla, e.g., if someone in the patient's immediate family is found to have a blood clot without a known cause or if the patient gains weight significantly.

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 due to 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 found to have 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 a blood clot may be even higher.
The doctor should be informed if any of the above conditions change while taking Artilla, e.g., if the patient starts smoking, someone in their immediate family is found to have a blood clot without a known cause, or if the patient gains weight significantly.

CONTRACEPTIVE AND CANCER

Women taking contraceptives have been found to have a slightly higher incidence of breast cancer than women of the same age who do not take oral contraceptives. The small increase in the number of breast cancer cases diagnosed is likely to be due to the fact that women taking contraceptives are more likely to have regular check-ups, resulting in earlier detection of breast cancer.
In individual cases, benign (non-cancerous) and, much more rarely, malignant liver tumors have been observed in women taking contraceptives. These tumors can cause internal bleeding.
If severe stomach pain occurs, a doctor should be consulted.
The most important risk factor for cervical cancer is long-term infection with 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 due to the contraceptive or other factors (e.g., regular cervical screening or sexual behavior associated with the use of mechanical contraceptive methods).

MENTAL 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, a doctor should be contacted as soon as possible for further medical advice.

Artilla and other medicines

A doctor should always be informed about any medicines or herbal products currently being taken. The doctor should also be told if the patient is taking any other medicine (or the pharmacist), as they may inform whether additional contraceptive measures should be taken (e.g., condoms) and 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 contraceptive effectiveness or cause unexpected bleeding. This applies to 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• used to treat fungal infections (griseofulvin, ketoconazole),
• used to treat arthritis, degenerative joint disease (etoricoxib),
• used to treat high blood pressure in the blood vessels of the lungs (bosentan),
• containing St. John's Wort (Hypericum perforatum) (used to treat depression).

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).

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 increased liver enzyme levels in the blood (increased alanine aminotransferase level). The doctor will recommend a different type of contraception before starting treatment with these medicines. About 2 weeks after finishing such treatment, Artilla can be taken again.
See point 2. "When not to take Artilla".
A doctor or pharmacist should be consulted before taking any medicine.

Artilla with food and drink

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

Pregnancy and breastfeeding

A doctor or pharmacist should be consulted before taking any medicine.
Artilla should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected while taking Artilla, a doctor should be consulted immediately.
Taking Artilla during breastfeeding is not recommended. If a contraceptive is planned during breastfeeding, a doctor should be consulted.

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 medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is "sodium-free".

3. How to take Artilla

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

How and when to take Artilla

When taken correctly, combined oral 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 effervescent tablets. Each effervescent tablet is marked with the day of the week it should be taken. The tablets should be taken every day at the same time, e.g., after breakfast. The 21 effervescent tablets should be taken for 21 days (one effervescent tablet per day), and then the use of Artilla should be stopped for 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 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.

Taking 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. The tablet marked with the correct day of the week should be taken. For example, if the menstrual period starts on a Wednesday, the tablet marked with "Wednesday" should be taken (see "Translation of day-of-the-week symbols on the packaging" at the end of the leaflet and on the packaging). After taking the first tablet, the next tablets should be taken according to the direction of the arrows on the packaging until all 21 tablets have been taken. This method ensures immediate effectiveness of Artilla and eliminates the need for additional contraceptive methods.
Artilla can also be started between days 2 and 5 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.
Changing from another combined contraceptive or transdermal systems
Artilla can be started immediately after taking the last tablet from the previous pack (this means no break in tablet-taking). If the previous pack 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, a doctor or pharmacist should be consulted). The tablets can also be started later, but no later than the day after the break in 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 would be applied.
Provided the above rules are followed, there is no need to use any additional contraceptive methods.
Changing from a progestogen-only medicine (minipill)
The minipill can be stopped at any time, and the first tablet of Artilla should be taken the next day at the same time. During the first 7 days, additional mechanical methods of contraception should be used during sexual intercourse.
Changing from injections, implants, or an intrauterine device releasing progestogen (IUD)
Artilla should be started when the next injection would be due or on the day the implant or IUD is removed. During the first 7 days, additional mechanical methods of contraception should be used during sexual intercourse.
Use after childbirth
After childbirth, it is recommended to delay the use of Artilla until the first normal menstrual period has occurred. Sometimes it may be possible to start earlier. A doctor should be consulted. During breastfeeding, the possibility of using Artilla should also be discussed with a doctor.
Use after spontaneous or induced abortion
A doctor should be consulted.

Taking more than the recommended dose 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 bleeding from the genitals may occur. If a child takes Artilla, a doctor should be consulted.

Missing a dose of Artilla

• If the tablet is delayed by less than 12 hours, contraceptive protection is not changed. The tablet should be taken as soon as possible, and the next tablet should be taken at the usual time.
• If the tablet is delayed by more than 12 hours, contraceptive protection may be reduced. The more tablets that are missed, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is especially high if a tablet is missed at the beginning or end of the pack. Therefore, the following rules should be followed.

Missing more than one tablet

A doctor should be consulted.
Missing 1 tablet in the first week
The tablet should be taken as soon as possible (even if it means taking two tablets at the same time), and the next tablet should be taken at the usual time. During the next 7 days, additional mechanical methods of contraception should be used.
If sexual intercourse occurred during the week when the tablet was missed, there is a risk of pregnancy. A doctor should be consulted immediately.
Missing 1 tablet in the second week
The tablet should be taken as soon as possible (even if it means taking two tablets at the same time), and the next tablet should be taken at the usual time.
The effectiveness of Artilla remains unchanged, and there is no need to use additional contraceptive methods.
Missing 1 tablet in the third week
One of the following options can be chosen, without the need for additional contraceptive methods.

• 1) The tablet should be taken as soon as possible (even if it means taking two tablets at the same time), and the next tablet should be taken at the usual time. The tablets from the next pack should be started immediately after taking the last tablet from the current pack, without a break between packs. Withdrawal bleeding may only occur after finishing the second pack, but spotting or breakthrough bleeding may occur while taking the tablets.

or

• 2) The tablets from the current pack should be stopped, and a 7-day break in taking Artilla should be started, including the day the tablet was missed. Then, the tablets from the next pack should be continued. If this option is chosen and the patient wants to start the next pack on the same day as usual, the break in taking Artilla should be shorter than 7 days.

If a tablet is missed and withdrawal bleeding does not occur, there is a risk of pregnancy. Before starting the next pack, a doctor should be consulted.

Yes

• 1. week In the week before the tablet was missed, sexual intercourse occurred

No

• The missed tablet should be taken
• An additional contraceptive method should be used for 7 days
• The tablets from the current pack should be finished
• 2. week The only missed tablet is the one that was delayed by more than 12 hours
• The missed tablet should be taken
• The tablets from the current pack should be finished
• The missed tablet should be taken
• The tablets from the current pack should be finished
• The break in taking Artilla should be skipped
• The tablets from the next pack should be continued
• 3. week or
• The tablets from the current pack should be stopped
• A 7-day break in taking Artilla should be started
• The tablets from the next pack should be continued

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 has occurred. This will make it easier to determine the due date.
If the reason for stopping is not to become pregnant, a doctor should be consulted to choose another contraceptive 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 your health status that you consider to be 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 difficulty breathing (see also section 2. "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 more information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using 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 tension, breast pain;
• depressive mood, mood changes.

Uncommon(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-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-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;
• allergic 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 side effects

If you experience any side effects, including any 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, 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 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 packaging.
The expiry date refers to the last day of the month stated.
Do not store above 30°C. Store in the original packaging to protect 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 needed. This will help protect the environment.

Translation of day of the week symbols on each tablet on the immediate packaging:

Lu

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

6. Package contents 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 25, magnesium stearate; coating:sucrose, povidone 90 F, macrogol 6000, calcium carbonate, talc, montan glycol wax.

What Artilla looks like and what the package contains

White, biconvex, round, glossy dragee tablets with a diameter of approximately 5.5 - 5.7 mm.
Package size: 21 dragee tablets.
A cardboard sachet is attached to the packaging, in which the blister should be placed.
For more detailed information, you should 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:

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

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorization number in Romania, the country of export: 7462/2015/01
7462/2015/02
Parallel import authorization number: 1/20

Date of leaflet approval: 08.11.2024

[Information about the trademark]