Artilla

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the outer packaging in a foreign language!
Artilla (Artizia)
0.075 mg + 0.020 mg, coated tablets
Gestodenum + Ethinylestradiolum
Artilla and Artizia are different brand names of the same medicinal product.
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2. "Blood clots").

Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Artilla is and what it is used for
2. What you need to know 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 Artilla is and what it is used for

Artilla is a combined oral contraceptive. Each coated tablet contains a small amount of two different female sex hormones: gestodene (a progestogen) and ethinylestradiol.
Since all the coated tablets in the pack contain the same dose of these hormones, this preparation is known as a monophasic combined oral contraceptive.
Due to its low hormone content, it is considered a low-dose oral contraceptive.
Artilla is used to prevent pregnancy. When taken according to instructions, the likelihood of becoming pregnant is very low.

2. Important information before using Artilla

General remarks
Before starting to take Artilla, you should read the information about
blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms
of blood clots (see section 2. "Blood clots").
This patient information leaflet describes situations in which you should stop
using the contraceptive or when its effectiveness may be reduced.
In such cases, you should avoid sexual intercourse or use another, non-hormonal
contraceptive method, such as a condom or another mechanical contraceptive method. You should not
use calendar-based or temperature-based methods. These may be unreliable because the
contraceptive affects temperature changes and cervical mucus composition that normally occur
during the menstrual cycle.
Artilla, like other contraceptive medicines, does not protect against infection with the HIV virus (AIDS) or other sexually transmitted diseases.

When not to use Artilla
Do not use Artilla if any of the following conditions apply to you. If any of the following conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• If you are allergic to ethinylestradiol, gestodene, or any of the other ingredients of this medicine (listed in section 6);
• If you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• If you know you have a disorder affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• If you are undergoing surgery or will be immobile for a prolonged period (see section 2. "Blood clots");
• If you have had a heart attack or stroke;
• If you suffer from (or have suffered in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• If you suffer from any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• If you currently have (or have had in the past) a type of migraine called "migraine with aura";
• If you currently have or have had in the past pancreatitis associated with increased levels of fats in the blood;
• If you currently have jaundice or another severe liver disease;
• If you currently have or have had in the past a tumour that may be influenced by sex hormones (e.g. breast or genital organ tumour);
• If you currently have or have had in the past a benign or malignant liver tumour;
• If you have vaginal bleeding of unknown cause;
• If you are pregnant or suspect you may be pregnant;
• If you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Artilla with other medicines").

If any of the above symptoms or disorders occur for the first time while
taking Artilla, you should stop taking it immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.
Warnings and precautions
When should you contact your doctor?
You should seek immediate medical advice

• if you notice symptoms suggesting a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots (thrombosis)"). For a description of the symptoms of these serious adverse effects, see "How to recognize a blood clot".

You should tell your doctor if any of the following conditions apply to you.
If these symptoms appear or worsen during treatment with Artilla, you should also inform
your doctor if:

• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• you have systemic lupus erythematosus (a disease affecting the body's natural defence system);
• you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• you have sickle cell anaemia (an inherited disorder of red blood cells);
• you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• you have recently given birth, as you are then at increased risk of blood clots. You should consult your doctor to find out how soon after delivery you can start taking Artilla;
• you have phlebitis (inflammation of veins under the skin);
• you have varicose veins;
• you suffer from epilepsy;
• anyone in your immediate family has had breast cancer;
• you have liver or gallbladder disorders;
• you develop a new illness or a condition that worsened during pregnancy or during previous use of sex hormones (e.g. any hearing disorders, disorders of blood pigment metabolism called porphyria, a skin blistering condition called herpes gestationis, a nervous system disorder called Sydenham's chorea);
• you currently have or have had chloasma (yellowish-brown patches on the skin, mainly on the face); you should avoid sunbathing or exposure to ultraviolet radiation;
• you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, which may cause breathing difficulties, seek immediate medical attention. 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 hormonal contraception. In rare cases, a blood clot may block a blood vessel and
cause serious health problems.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events"). Full recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

Please remember that the overall risk of harmful blood clots caused by
taking Artilla is small.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you 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 veins (venous thrombosis). However, these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives at all.
If a patient stops taking Artilla, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots in veins?
The risk depends on the individual's natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Artilla is low.

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

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Artilla is small, however, some factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such a case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Artilla several weeks before surgery or immobilization. If the patient must stop taking Artilla, ask the doctor when it is safe to resume taking the medicine.
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing 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, particularly if the patient has another mentioned risk factor.
It is important to inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue Artilla.
Inform the doctor if any of the above conditions change during treatment with Artilla, e.g., if a close relative 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 arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with the use of Artilla is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Artilla, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient has overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In such a case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Artilla, e.g., if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

CONTRACEPTIVE AND CANCER
Breast cancer has been diagnosed slightly more frequently in women using hormonal contraceptives than in women of the same age not using oral contraceptives. This slight increase in diagnosed cases of breast cancer gradually disappears within 10 years after stopping the contraceptive. This may be due to the fact that women using contraceptives are examined more frequently, leading to earlier detection of cancer.
In rare cases, benign (non-malignant) and, much more rarely, malignant liver tumors have been observed in women using hormonal contraceptives. These tumors may cause internal bleeding.
If severe abdominal pain occurs, consult a doctor.

The most important risk factor for developing cervical cancer is persistent infection with human papillomavirus (HPV). Some epidemiological studies have suggested that long-term use of combined oral contraceptives may increase this risk. It is unclear whether the increased risk is caused by the contraceptive itself, as it may result from other factors (e.g., regular preventive cervical screening or sexual behavior related to the use of barrier contraceptive methods).

PSYCHIATRIC DISORDERS
Some women using hormonal contraceptives, including Artilla, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.

Artilla and other medicines
Always inform your doctor about any medicines or herbal products you are currently taking. Also, inform any other doctor, including a dentist, or pharmacist prescribing another medicine that you are using Artilla. They will advise whether additional contraceptive methods (e.g., condoms) are needed, and if so, for how long, or whether the use of other medicines the patient requires should be changed.
Some medicines may affect the blood concentration of Artilla and reduce its effectiveness in preventing pregnancy 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 infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• used to treat fungal infections (griseofulvin, ketoconazole);
• used to treat arthritis, osteoarthritis (etoricoxib);
• used to treat pulmonary hypertension (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 cyclosporine (immunosuppressive medicines);
• antiepileptic lamotrigine (may lead to increased frequency of seizures);
• theophylline (used for breathing difficulties);
• tizanidine (used to treat muscle pain and/or muscle spasms).

Do not use Artilla 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 function test results (elevated levels of the liver enzyme AlAT).
The doctor will recommend another type of contraception before starting treatment with these medicines. Artilla may be restarted approximately 2 weeks after completion of such treatment.
See section 2. "When not to use Artilla".

Before taking any medicine, consult your doctor or pharmacist.

Artilla with food and drink
Tablets should be swallowed whole, with a small amount of water if needed.

Pregnancy and breastfeeding
Before taking any medicine, consult your doctor or pharmacist.
Artilla must not be used during pregnancy or if pregnancy is suspected. If pregnancy is suspected while taking Artilla, consult a doctor immediately.
Use of Artilla during breastfeeding is not recommended. If planning to use a contraceptive during breastfeeding, consult a doctor.

Driving and using machines
No effects on the ability to drive and use machines have been observed.

Artilla contains monohydrate lactose, sucrose, and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Artilla

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
How and when to take Artilla
When taken correctly, combined oral contraceptives have a failure rate of about 1% per year. If a
coated tablet is missed or the medicine is used incorrectly, the failure rate may be higher.
One pack of Artilla contains 21 coated tablets. Each coated tablet is marked with the day of the week
on which it should be taken. Try to take the tablets at the same time each day, for example after
breakfast. Take 21 coated tablets over 21 days (one coated tablet each day), then stop taking Artilla
for the next 7 days. During these 7 days, a withdrawal bleed should occur. This usually occurs 2–3
days after the last tablet of Artilla is taken. Start the next pack on the 8th day, regardless of whether
bleeding has stopped. This means that each new pack should be started on the same day of the
week, and withdrawal bleeding will usually occur on the same days each month.
Starting the first pack of Artilla
If not using hormonal contraception in the previous month
Begin taking Artilla on the first day of your cycle, i.e. the first day of menstrual bleeding. Start with
the tablet marked with the correct day of the week. For example, if your period starts on a
Wednesday, begin with the tablet marked “Mi” (indicating Wednesday; see “ Translation of day-of-the-week symbols on each tablet in the immediate packaging ” at the end of the leaflet and on the sachet). After taking the first tablet, continue taking the tablets in the direction of the arrows on the pack until all 21 tablets have been taken. This method ensures immediate contraceptive protection and no additional contraceptive methods are needed.
You may also start taking Artilla between days 2 and 5 of your cycle, but in this case, you must use
an additional mechanical (barrier) method of contraception for the first 7 days of the first cycle.
Switching from another combined oral contraceptive or transdermal system
You may start taking Artilla the day after taking the last tablet of your previous pack (i.e. without a
tablet-free interval). If your previous pack also contains inactive (placebo) tablets, start Artilla the day
after taking the last tablet containing active substance (if in doubt about which tablets contain active
substance, consult your doctor or pharmacist). You may also start later, but not later than the day
after the tablet-free interval of your previous contraceptive ends (or after taking the last inactive
tablet of your previous contraceptive).
If switching from a transdermal system, start taking Artilla on the day the patch is removed, and no
later than the day the next patch would have been applied.
If the above rules are followed, no additional contraceptive methods are necessary.
Switching from a progestogen-only pill (mini-pill)
You may stop the mini-pill at any time and take the first tablet of Artilla at the same time the next
day. However, during the first 7 days of intercourse, you must use an additional mechanical
(barrier) method of contraception.
Switching from an injection, implant, or intrauterine device releasing progestogen (IUD)
Begin taking Artilla at the time the next injection is due, or on the day the implant or IUD is
removed. However, during the first 7 days of intercourse, you must use an additional mechanical
(barrier) method of contraception.
Use after childbirth
After childbirth, it is recommended to delay starting Artilla until the first normal menstrual period.
Earlier initiation may sometimes be possible. Consult your doctor. During breastfeeding, the use
of Artilla should also be discussed with your doctor.
Use after spontaneous or induced abortion
Consult your doctor.
Taking more Artilla than you should
There have been no reports of serious health problems following a single intake of more than one
tablet of Artilla. If several tablets of Artilla are taken at once, nausea, vomiting, or genital bleeding
may occur. If a child takes Artilla, consult a doctor immediately.
If you forget to take Artilla

• If a coated tablet is taken less than 12 hours late , contraceptive protection is not reduced. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time), and continue taking the next tablet at the usual time.
• If a coated tablet is taken more than 12 hours late , contraceptive protection may be reduced. The more consecutive tablets 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 pack. Therefore, follow the rules below.

Missing more than one tablet
Consult your doctor.
Missing 1 tablet in the first week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same
time), and take the next tablet at the usual time. For the next 7 days, use an additional mechanical
(barrier) method of contraception.
If you had intercourse during the week in which you missed a tablet, there is a risk of pregnancy.
Consult your doctor immediately.
Missing 1 tablet in the second week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same
time), and take the next tablet at the usual time. Contraceptive effectiveness remains unchanged,
and no additional contraceptive methods are needed.
Missing 1 tablet in the third week
You may choose one of the following options, without needing additional contraceptive methods.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the
   same time), and take the next tablet at the usual time. Start the next pack immediately after taking
   the last tablet of the current pack, without a break between packs . Withdrawal bleeding may
   occur only after finishing the second pack, but spotting or breakthrough bleeding may occur
   during tablet intake.
   or
2. Stop taking tablets from the current pack and take a 7-day break without taking Artilla, including
   the day on which the tablet was missed . Then continue with the next pack.
   If you choose this option and wish to start the next pack on the same day as usual, you must have
   a shorter than 7-day break .
   If tablets are missed and expected withdrawal bleeding does not occur, pregnancy is possible.
   Consult your doctor before starting the next pack.

Consult a doctor
Yes

1. Sexual intercourse occurred in the week prior to missing a tablet

No

• Take the missed tablet as soon as possible
• Use another method of contraception for 7 days
• Continue taking tablets from the pack Missed only 1 tablet 2.
• Take the missed tablet (delay longer than 12 hours)
• Continue taking tablets from the pack
• Take the missed tablet
• Continue taking tablets from the pack
• Skip the break
• Continue taking tablets from the next pack 3. week or
• Stop taking tablets from the pack
• Begin a 7-day break
• Continue taking tablets from the next pack

Discontinuation of Artilla
Artilla may be discontinued at any time. If discontinuation is due to planning pregnancy, attempting conception is recommended after the first normal menstrual period. This will facilitate determination of the due date.
If discontinuation is not due to planning pregnancy, consult a doctor to choose another method of contraception.
What to do if...
...gastrointestinal disturbances occur (e.g. vomiting, severe diarrhoea)
In case of vomiting or severe diarrhoea, the active substance of Artilla may not be completely absorbed. If vomiting occurs 3–4 hours after taking the tablet, the effect will be the same as if a tablet had been missed. Follow the instructions for missed tablets. In case of severe diarrhoea, contact your doctor.
...delaying the onset of bleeding is desired
To delay bleeding, continue taking coated tablets from the next pack of Artilla without a break. As needed, continue taking tablets until the end of the pack. Bleeding can be induced by stopping the tablets. Breakthrough bleeding or spotting may occur during intake of tablets from the next pack. Begin the next pack after the usual 7-day break.
...changing the day of bleeding onset is desired
Provided tablets are taken according to the instructions, bleeding should start approximately on the same day every 4 weeks. If changing the day of bleeding onset is desired, only shorten (never extend) the next tablet-free interval. For example, if bleeding usually starts on Friday, but occurrence on Tuesday (3 days earlier) is desired, start the next pack 3 days earlier than usual. If the break is too short (e.g. 3 days or less), bleeding may not occur during the break. However, spotting or intermenstrual bleeding may occur during intake of tablets from the next pack.
...unexpected bleeding occurs
While taking any contraceptive medication, irregular bleeding from the genital tract may occur between periods. Sanitary protection may be necessary, but continue taking Artilla as usual.
These irregularities usually resolve after the body adapts to the medication (usually after 3 cycles). However, if these problems persist, bleeding becomes heavier, or recurs after a period of regular occurrence, consult a doctor.
...menstruation does not occur
Provided tablets were taken correctly, without vomiting or severe diarrhoea, and no other medications were used, pregnancy is very unlikely. Continue taking Artilla as usual.
If bleeding does not occur for two consecutive periods, pregnancy is possible. Do not start the next pack until pregnancy has been excluded by a doctor.
Regular medical examinations
While taking Artilla, regular medical check-ups are necessary.
Consult a doctor immediately if:

• Your health condition changes, especially if any of the conditions described in this leaflet occur. Also remember to inform about family medical history;
• A palpable lump in the breast appears;
• Other medications are planned (see also section 2. "Artilla and other medicines");
• A period of limited mobility or planned surgical procedure occurs (consult your doctor at least four weeks in advance);
• Severe, unexplained genital bleeding occurs;
• Tablets are missed from the next pack during the first week of use, and sexual intercourse occurred within the previous 7 days;
• Severe diarrhoea occurs;
• Withdrawal bleeding does not occur for two consecutive periods or pregnancy is suspected (do not start the next pack without consulting a doctor).

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes
in health status which the patient considers to be related to the use of Artilla, a physician
should be consulted.
Serious adverse effects
Contact a doctor 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 accompanied by breathing difficulties (see also section 2. "Warnings and precautions").
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Artilla".
Other possible adverse effects
The following adverse effects have been observed during use of the combination of gestodene and ethinylestradiol, although this combination may not necessarily have caused them. These adverse effects usually occur during the first few months of use and typically diminish with continued use.
Adverse effects are grouped according to frequency of occurrence:
Common (may occur in 1 to 10 out of 100 people):

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

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

• migraine;
• vomiting, diarrhoea;
• rash, urticaria;
• fluid retention;
• 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 ischaemic attack (TIA), blood clots in the liver, stomach and (or) intestines, kidneys or eyes (the likelihood of blood clots may be higher if the patient has any other risk factors—see section 2 for further information on risk factors for blood clots and symptoms of their occurrence);
• weight loss;
• nodular erythema, erythema multiforme;
• contact lens intolerance;
• 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 of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49-21-301, Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Artilla

Keep this medicine 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 stated month.
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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Translation of the weekday symbols printed next to each tablet in the immediate packaging:
Lu - Monday
Ma - Tuesday
Mi - Wednesday
Jo - Thursday
Vi - Friday
Sb - Saturday
Du - Sunday

6. Contents of the packaging and other information

What Artilla contains
The active substances are 0.075 mg gestodene and 0.020 mg ethinylestradiol.
Other components: calcium sodium edetate, monohydrate lactose, corn starch, povidone 25, magnesium stearate; coating: sucrose, povidone 90 F, macrogol 6000, calcium carbonate, talc, glycol wax Montana.
What Artilla looks like and contents of the pack
White, biconvex, round, shiny coated tablets, approximately 5.5 – 5.7 mm in diameter.
Pack size: 21 coated tablets.
A cardboard sachet, in which the blister should be placed, is included in the package.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Romania, 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.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Romania, country of export: 7462/2015/01
7462/2015/02
Parallel import licence number: 1/20