Mirgi

Package leaflet: Information for the user

Mirgi, (0.12 mg + 0.015 mg)/24 h, vaginal therapeutic system
Etonogestrelum + Ethinylestradiolum
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 a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents
1. What Mirgi is and what it is used for
2. What you need to know before using Mirgi
2.1 When not to use Mirgi
2.2 Warnings and precautions
Blood clots
Tumours
2.3 Children and adolescents
2.4 Mirgi with other medicines
Diagnostic tests
2.5 Pregnancy and breastfeeding
2.6 Driving and operating machinery

3. How to use Mirgi

3.1 Insertion and removal of Mirgi
3.2 Three weeks of use, one week break
3.3 When to insert the first Mirgi vaginal therapeutic system
3.4 What to do…
If the system accidentally falls out of the vagina
If the system has been outside the vagina for some time
If the vaginal therapeutic system is damaged
If more than one vaginal therapeutic system has been inserted
If the patient forgets to insert a new vaginal therapeutic system after the one-week break
If the patient forgets to remove the vaginal therapeutic system on time
If there is no bleeding during the break
If unexpected bleeding occurs
If the day of bleeding changes
If the patient wishes to delay the onset of bleeding

3.5 What to do if the patient wishes to stop using Mirgi
4. Possible side effects
5. How to store Mirgi
6. Contents of the pack and other information
What Mirgi contains
What Mirgi looks like and contents of the pack Responsible
entity and manufacturer

1. What Mirgi is and what it is used for

Mirgi is a contraceptive medicinal product in the form of a vaginal contraceptive system,
which prevents pregnancy. Each vaginal contraceptive system contains a small amount of two
female sex hormones – etonogestrel and ethinylestradiol. These hormones are slowly released
from the system into the bloodstream. Due to the low dose of hormones released, Mirgi is
classified as a low-dose hormonal contraceptive. Since Mirgi releases two different hormones, it is also referred to as a combined hormonal contraceptive.

Mirgi works in the same way as a combined oral contraceptive pill (combined pill). However, unlike the pill, which must be taken every day, Mirgi is used continuously for 3 weeks. Mirgi releases two female sex hormones that inhibit the release of oocytes from the ovaries. As oocytes are not released, the woman cannot become pregnant.

2. Important information before taking Mirgi

General notes
Before starting to take Mirgi, 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 leaflet describes situations in which you should stop taking Mirgi or when
its effectiveness may be reduced. In such situations, you should avoid sexual intercourse or use an additional non-hormonal contraceptive method,
such as a male condom or another mechanical method. Do not use
calendar-based methods or body temperature monitoring. These may be ineffective because Mirgi
affects changes in body temperature and cervical mucus consistency throughout the month.
Mirgi, like other hormonal contraceptives, does not protect against HIV infection (AIDS)
or other sexually transmitted infections.

2.1 When not to use Mirgi

Do not use Mirgi if the patient has any of the conditions listed below. If any of the following conditions apply to the patient, she must inform her doctor. The doctor will discuss with the patient which alternative method of contraception would be more suitable.

• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs,
• if the patient knows she has blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies,
• if the patient requires surgery or will be immobile for a prolonged period (see section “Blood clots”),
• if the patient has had a heart attack or stroke,
• if the patient has (or has previously had) angina pectoris (a condition causing severe chest pain, which may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms),
• if the patient has 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 the patient currently has or has previously had a type of migraine called “migraine with aura”,
• if the patient currently has or has previously had pancreatitis associated with high fat levels in the blood,
• if the patient currently has or has previously had severe liver disease and liver function has not returned to normal,
• if the patient currently has or has previously had a benign or malignant liver tumour,
• if the patient currently has or has previously had breast cancer or genital organ cancer, or if such cancers are suspected,
• if the patient has unexplained vaginal bleeding,
• if the patient is allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the symptoms listed above occur for the first time during treatment with Mirgi, the vaginal system must be removed immediately and the patient should consult her doctor. During this time, a non-hormonal method of contraception should be used.
If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, the Mirgi vaginal therapeutic system must not be used (see also section 2.4 “Mirgi and other medicines”).

2.2 Warnings and precautions

Before starting to use Mirgi, you should discuss this with your doctor or pharmacist.
When should you contact your doctor?
You should seek immediate medical attention

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

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Mirgi, you should also
inform your doctor.

• if breast cancer is currently present or has occurred in close family members;
• if you have epilepsy (see section 2.4 “Mirgi and other medicines”);
• if you have liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (an autoimmune disease affecting the body’s natural defense system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, as you are then at increased risk of developing blood clots. You should consult your doctor for advice on how soon after delivery you can start using Mirgi;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have conditions that first occurred or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [a blistering skin rash during pregnancy], Sydenham’s chorea [a nervous system disorder characterized by involuntary, sudden movements of the body]);
• if 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;
• if you currently have or have previously had chloasma (yellowish-brown pigmentation patches, so-called “melasma”, especially on the face). If such patches occur, avoid excessive exposure to sunlight and ultraviolet radiation;
• if you have conditions that make the use of Mirgi difficult – e.g. frequent constipation, uterine prolapse, or pain during intercourse;
• if you experience sudden, frequent urges to urinate with a burning sensation and (or) pain, or if you cannot locate the vaginal ring inside the vagina. These symptoms may indicate accidental insertion of the Mirgi vaginal ring into the urinary bladder.

BLOOD CLOTS
Using combined hormonal contraceptives, such as the Mirgi vaginal ring, increases the risk of developing blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots may occur

• in veins (referred to below as “venous thrombosis” or “venous thromboembolic disease”);
• in arteries (referred to below as “arterial thrombosis” or “arterial thromboembolic disorders”).

Complete 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.
It should be remembered that the overall risk of harmful blood clots associated with the use of Mirgi is small.
HOW TO RECOGNIZE THE FORMATION OF BLOOD CLOTS
Seek immediate medical attention if you notice any of the following symptoms.
Are you experiencing any of these symptoms? What might
be the likely
cause?

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
  • pain or tenderness in the leg, which may occur only when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, e.g. pallor, redness, or cyanosis
• sudden onset of unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden coughing without an obvious cause, which may be accompanied by coughing up blood;
• sudden sharp chest pain, which may worsen on deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as a respiratory tract infection (e.g. a cold).
Symptoms most commonly occur in one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless visual disturbances, which may progress to vision loss
• chest pain, discomfort, or pressure, heaviness; Myocardial infarction
• sensation of tightness or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the lower body radiating to the back, jaw, throat, arm, or stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.

BLOOD CLOTS IN VEINS
What could happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). Although these adverse effects 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 the development of 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 medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops using Mirgi, the risk of 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 Mirgi is low.

• In the course of one year, about 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, about 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, about 6 to 12 out of 10,000 women who use combined hormonal contraceptives containing norelgestromin or etonogestrel, such as the Mirgi vaginal contraceptive system, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors increasing 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 the Mirgi vaginal ring is small, but certain factors may increase this risk.
The risk is higher:

• if the patient is very overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited blood clotting disorder;
• if the patient needs to undergo surgery, if she is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop using Mirgi several weeks before surgery or immobilization. If the patient needs to stop using Mirgi, she should consult her doctor about when she can resume use;
• 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 risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Mirgi.
The patient should inform her doctor if any of the above conditions change during treatment with Mirgi, for example, if a close family member is diagnosed with unexplained thrombosis 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 blood clots can cause 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 the Mirgi vaginal ring is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as the Mirgi vaginal ring, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years of age). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, 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 are particularly severe, the risk of blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with the Mirgi vaginal ring, for example, if she starts smoking, if a close family member is diagnosed with unexplained thrombosis, or if she gains significant weight.

Tumors (Cancer)
The following information is based on studies using combined oral contraceptives and may also apply to Mirgi. Information regarding vaginal use of hormonal contraceptives (as with Mirgi) is not available.
Among women using combined hormonal contraceptives, a slightly higher incidence of breast cancer has been observed, although it is not known whether this is caused by the contraceptives. It is possible that tumors are detected more frequently in these women because they undergo medical examinations more regularly. The increased incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Regular breast examinations are very important. If any lump is detected, the patient should contact her doctor. She should also inform her doctor if any close relatives have had or have breast cancer (see section 2.2 "Warnings and precautions").
In rare cases, benign liver tumors have been reported in women using combined hormonal contraceptives, and very rarely, malignant liver tumors. If unusual, severe abdominal pain occurs, the patient should contact her doctor.
There are reports that women using combined hormonal contraceptives have a lower incidence of endometrial cancer (cancer of the lining of the uterus) and ovarian cancer. This may also apply to Mirgi, but has not yet been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including Mirgi, 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, the patient should contact her doctor as soon as possible for further medical advice.

2.3 Children and adolescents

The safety and efficacy of Mirgi in adolescents under 18 years of age have not been studied.

2.4 Mirgi and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. You should also inform any specialist doctor, dentist, or pharmacist prescribing other medicines that you are using Mirgi. They may advise you whether additional contraceptive methods (e.g. male condoms) are needed, how long they should be used, and whether any adjustment in the use of other medicines is required.

Some medicines:

• may affect the blood concentration of Mirgi;
• may reduce its contraceptive effectiveness;
• may cause unexpected bleeding.

This applies to medicines used in the treatment of:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g. boceprevir, telaprevir);
• other infectious diseases (e.g. griseofulvin);
• pulmonary arterial hypertension (bosentan);
• depressive mood disorders (St John's wort (Hypericum perforatum)).

If you are taking medicines or herbal products that may reduce the effectiveness of Mirgi, you should also use a mechanical contraceptive method. Because the effect of another medicine on Mirgi may persist for up to 28 days after stopping the medicine, additional mechanical contraception must be used during this time. Note: Mirgi should not be used with a diaphragm, cervical cap, or female condom.

Mirgi may affect the action of other medicines such as:

• medicines containing cyclosporine;
• the antiepileptic medicine lamotrigine (this may lead to increased frequency of seizures).

If you have hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, do not use the Mirgi vaginal therapeutic system, as they may cause increased liver function parameters in blood laboratory tests (increased activity of the liver enzyme AlAT). Before starting these medicines, your doctor will prescribe another type of contraceptive.

The Mirgi vaginal therapeutic system may be restarted approximately 2 weeks after completion of such treatment. See section 2.1 "When not to use Mirgi".

Before taking any medicine, consult your doctor or pharmacist.

During use of Mirgi, tampons may be used. Insert Mirgi before inserting the tampon. Be careful when removing the tampon to avoid accidentally removing Mirgi as well. If Mirgi comes out, rinse the vaginal therapeutic system with cool or lukewarm water and reinsert it as soon as possible.

Damage to the vaginal therapeutic system has occurred during use of vaginal products such as lubricants or treatments for infections (see section 3.4 "What to do... Management in case more than one vaginal therapeutic system has been inserted").

The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of Mirgi.

Diagnostic tests

If laboratory blood or urine tests are to be performed, inform the person conducting the test that you are using Mirgi, as use of the vaginal therapeutic system may influence the results of certain laboratory tests.

2.5 Pregnancy and breastfeeding

Mirgi must not be used during pregnancy or if pregnancy is suspected. If a patient becomes pregnant while using Mirgi, the vaginal delivery system should be removed and a physician should be consulted.
If a patient wishes to discontinue Mirgi because she intends to become pregnant, refer to section 3.5 "Instructions when the patient wishes to discontinue Mirgi".
Mirgi is not recommended during breastfeeding. If a patient wishes to use Mirgi while breastfeeding, she should consult her physician beforehand.

2.6 Driving and operating machinery

Mirgi does not affect the ability to drive vehicles or operate machinery.

3. How to use Mirgi

Mirgi can be inserted and removed by yourself. Your doctor will advise you when to start using Mirgi. The vaginal ring should be inserted on the correct day of the cycle (see section 3.3 "When to insert the first Mirgi vaginal ring") and left in place continuously for three weeks. You should regularly check that the Mirgi vaginal ring is in the vagina (for example, before and after sexual intercourse) to ensure contraceptive protection. After three weeks, remove the Mirgi ring and take a one-week break. During this break, withdrawal bleeding usually occurs. Do not use certain female barrier contraceptive methods, such as a diaphragm, cervical cap, or female condom, while using Mirgi. These barrier methods should not be used as additional contraception because Mirgi may interfere with the correct placement and positioning of an intrauterine device, cervical cap, or female condom. However, a male condom may be used as an additional mechanical contraceptive method.

3.1 Insertion and removal of Mirgi

1. Before inserting the system, check the expiry date (see section 5 "How to store Mirgi").
2. Wash your hands before inserting or removing the system.
3. Choose a comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
4. Remove Mirgi from the pouch.
5. Holding the system between your thumb and index finger, squeeze it together and insert into the vagina (see Figures 1–4). Mirgi is correctly positioned when it is not felt. If the system causes discomfort, gently adjust its position (e.g., push it slightly deeper into the vagina) until comfortable. The exact position of Mirgi within the vagina does not affect its contraceptive effectiveness.
6. After three weeks, remove the system from the vagina by hooking your index finger under the edge of the system or by grasping it between your index and middle fingers and pulling it out (Figure 5). If the user can locate the system in the vagina but is unable to remove it, she should contact her doctor.
7. Dispose of the used system with household waste, preferably in the original pouch. Do not dispose of Mirgi in the toilet.

3.2 Three weeks of use, one week break

1. The system must remain in the vagina continuously for three weeks, starting from the day of insertion.
2. After three weeks, the system must be removed on the same day of the week and approximately at the same time as it was inserted. For example, if Mirgi was inserted on a Wednesday at around 10:00 PM, it should be removed also on a Wednesday, three weeks later, at around 10:00 PM.
3. After removal of the system, a one-week break should be taken. During this time, bleeding may occur. It usually starts 2-3 days after removal.
4. A new system must be inserted exactly one week after the break (on the same day of the week as usual and approximately at the same time), even if bleeding is still ongoing. If insertion of the new system is delayed by more than 3 hours, contraceptive efficacy may be reduced. In such a case, follow the instructions provided in section 3.4 "What to do... Instructions if after the one-week break the patient has forgotten to insert a new vaginal therapeutic system".

If Mirgi is used according to the above recommendations, subsequent bleedings will occur
every month approximately on the same days of the week.

3.3 When to insert the first Mirgi vaginal ring

• If no hormonal contraceptive has been used in the previous cycle: Insert Mirgi on the first day of the natural cycle (i.e. the first day of menstruation). Mirgi is effective from the moment of insertion. There is no need to use any additional contraceptive methods. Alternatively, Mirgi may be started between day 2 and day 5 of menstruation; however, in this case, an additional contraceptive method (such as a male condom) must be used during the first 7 days of Mirgi use. This recommendation applies only when starting Mirgi for the first time.
• If the patient has previously used combined oral contraceptives: Begin using Mirgi no later than the day following the end of the current contraceptive cycle. If the current contraceptive includes inactive (placebo) tablets, start Mirgi no later than the day after taking the last inactive tablet. In case of uncertainty about which tablet is the last, consult a physician or pharmacist. Do not extend the tablet-free interval beyond the recommended period. If the patient has taken her pills regularly and is certain she is not pregnant, she may stop taking the pills at any time and immediately start using Mirgi.
• If the patient has previously used a transdermal patch: Begin using Mirgi no later than the day following the patch-free interval. Do not extend the patch-free interval beyond the recommended period. If the patient has used the transdermal system regularly and is certain she is not pregnant, she may discontinue the patch at any time and immediately start using Mirgi.
• If the patient has previously used a progestogen-only contraceptive (mini-pill): The mini-pill may be stopped at any time, and Mirgi should be started the next day at the same time the mini-pill was usually taken. An additional contraceptive method (such as a male condom) must be used during the first 7 days of Mirgi use.
• If the patient has previously used progestogen-only injections, an implant, or an intrauterine system (IUS) releasing progestogen: Begin using Mirgi on the day the next injection is due, or on the day of removal of the implant or intrauterine system. An additional contraceptive method (such as a male condom) must be used during the first 7 days of Mirgi use.
• After childbirth: After childbirth, the physician may recommend starting Mirgi only after the first menstrual period. Sometimes Mirgi may be started earlier; the physician will advise when. If breastfeeding and considering using Mirgi, this should first be discussed with a physician.
• After miscarriage: As advised by the physician.

3.4 What to do…

Action to take if the system accidentally falls out of the vagina
Mirgi may accidentally fall out of the vagina, for example if it was incorrectly inserted, during tampon removal, during sexual intercourse, in case of constipation, or due to uterine prolapse. Therefore, you should regularly check whether the system is still in place in the vagina (for example, before and after sexual intercourse).
Action to take if the system has been outside the vagina for some time
The Mirgi system may still provide protection against pregnancy, but this depends on how long it was outside the vagina.
If the system has been outside the vagina for:

• less than 3 hours , the woman is still protected against pregnancy. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted as soon as possible, but only if the system was outside the vagina for less than 3 hours.
• more than 3 hours during the first or second week of use , contraceptive effectiveness may have decreased. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted as soon as possible, and left in place continuously for at least 7 days. If sexual intercourse occurs during these 7 days, a male condom should also be used. If the woman is in the first week of her cycle and has already had intercourse in the past 7 days, there is a possibility she may be pregnant. In this case, she should contact her doctor.
• more than 3 hours during the third week of use , contraceptive effectiveness may have decreased. The vaginal therapeutic system should be removed and one of the two following options chosen:

1 - Insert a new vaginal therapeutic system as soon as possible.
Inserting a new vaginal therapeutic system means starting the next three-week period of use. This may result in the absence of the expected withdrawal bleeding, although mid-cycle bleeding or spotting may occur.
2 - Do not reinsert a vaginal therapeutic system. Wait for withdrawal bleeding to occur and insert a new vaginal therapeutic system no later than 7 days after removal or expulsion of the previous one.
This course of action may only be followed if the woman has used Mirgi continuously for the past 7 days.

• unknown duration , the woman may not be protected against pregnancy. A pregnancy test should be performed and medical advice sought before inserting a new vaginal therapeutic system.

Action to take if the vaginal therapeutic system is damaged
Very rarely, Mirgi may become damaged. Vaginal wall injury has been reported in association with damage to the vaginal therapeutic system. If the woman notices that Mirgi is damaged, she should remove it and insert a new one as soon as possible. For the next 7 days, an additional contraceptive method (e.g. male condom) should be used. If sexual intercourse occurred before the damage was noticed, she should contact her doctor.

Action to take if more than one vaginal therapeutic system has been inserted
There have been no reports of serious adverse effects related to overdose of the hormones contained in Mirgi. If more than one vaginal therapeutic system has been inserted by accident, nausea, vomiting, or genital bleeding may occur. The additional vaginal therapeutic system should be removed, and the woman should contact her doctor if symptoms persist.

Action to take if, after the weekly break, the woman forgot to insert a new vaginal therapeutic system
If the break in using the vaginal therapeutic system lasted longer than 7 days , a new system should be inserted as soon as possible. If sexual intercourse occurs during the next 7 days, an additional contraceptive method (e.g. male condom) should be used. If sexual intercourse occurred during the break in using the vaginal therapeutic system, there is a possibility of pregnancy . In this case, the woman should contact her doctor as soon as possible. The longer the break in using the vaginal therapeutic system, the greater the likelihood of pregnancy.

Action to take if the woman forgot to remove the vaginal therapeutic system on time

• If the system remained in the vagina longer than 3 weeks, but not longer than 4 weeks , the woman is still protected against pregnancy. The vaginal therapeutic system should be removed for a one-week break, after which a new one should be inserted.
• If the woman used the vaginal therapeutic system for longer than 4 weeks , there is a possibility of pregnancy. She should contact her doctor before inserting a new vaginal therapeutic system.

Action to take if withdrawal bleeding does not occur

• If the woman used Mirgi according to instructions If withdrawal bleeding does not occur on schedule, but the woman used Mirgi as directed and did not take any other medications during this time, the likelihood of pregnancy is very low. She should continue using Mirgi as before. However, if withdrawal bleeding does not occur for two consecutive cycles, pregnancy is possible. She should contact her doctor as soon as possible. A new Mirgi system should not be inserted until the doctor confirms that she is not pregnant.
• If the woman used Mirgi incorrectly If withdrawal bleeding does not occur during the first break in using Mirgi, and the woman used the vaginal therapeutic system incorrectly, she may be pregnant. She should contact her doctor before using a new Mirgi system.

Action to take if unexpected bleeding occurs
During use of the vaginal therapeutic system, some women may experience unexpected mid-cycle bleeding. Sanitary pads may be needed. The system should remain in the vagina and be used as usual. If irregular bleeding increases or recurs, the woman should contact her doctor.

Action to take if changing the day on which bleeding occurs
If Mirgi is used as directed, menstrual periods (withdrawal bleeds) will begin during the weekly break from using the vaginal therapeutic system. If the woman wishes to shift the day on which withdrawal bleeding begins, she may shorten the break in using the vaginal therapeutic system (but never extend it!).
For example: if withdrawal bleeding usually begins on Friday, and the woman wishes to shift it to Tuesday (3 days earlier) starting next month, she should insert the new vaginal therapeutic system 3 days earlier than usual.
If the break in using the vaginal therapeutic system is significantly shortened (e.g. to 3 days or less), withdrawal bleeding may not occur at all during that time. During use of the next vaginal therapeutic system, spotting (small drops or stains of blood) or mid-cycle bleeding may occur.
If the woman is unsure about what to do, she should consult her doctor.

Action to take if wishing to delay the onset of bleeding
Although not recommended, it is possible to delay the onset of menstruation (withdrawal bleeding) by inserting a new vaginal therapeutic system immediately after removing the previous one, without taking a break. The new vaginal therapeutic system should not be used for longer than 3 weeks. During use of the new vaginal therapeutic system, spotting (small drops or stains of blood) or mid-cycle bleeding may occur. To induce withdrawal bleeding, the vaginal therapeutic system should be removed. A regular weekly break between consecutive systems is recommended.
Before deciding to delay the onset of bleeding, the woman may wish to consult her doctor.

3.5 What to do if the patient wishes to discontinue use of Mirgi

Use of Mirgi may be discontinued at any time.
If the patient does not wish to become pregnant, she should consult her doctor regarding alternative contraceptive methods.
If the patient discontinues use of Mirgi because she wishes to become pregnant, she should wait until her first menstrual period and only after that begin trying to conceive. This will assist in determining the due date.

4. Possible side effects

Like all medicines, this product can cause side effects, although not everyone will experience them.
If any side effects occur, especially severe or persistent ones, or any changes in health status that the patient considers related to the use of Mirgi, medical advice should be sought immediately.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (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 Mirgi".
Seek immediate medical attention if any symptoms of angioedema occur, such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing or urticaria, which may cause breathing difficulties (see also section "Warnings and precautions").

The following side effects have been reported by women using Mirgi:

Common: may affect up to 1 in 10 women

• abdominal pain, nausea
• vaginal fungal infections (such as "thrush"); discomfort due to presence of the system in the vagina; genital itching; vaginal discharge
• headache or migraine headache; depressed mood; decreased libido
• breast pain; pelvic pain; painful menstruation
• acne
• weight gain
• expulsion of the system

Uncommon: may affect up to 1 in 100 women

• visual disturbances; dizziness
• bloating; vomiting, diarrhoea or constipation
• feeling of fatigue, malaise, or restlessness; mood changes; sudden mood swings
• oedema (swelling)
• urinary bladder or urinary tract infections
• problems or pain during urination; urgency or need to urinate; frequent urination
• discomfort during intercourse, including pain, bleeding, or discomfort related to the presence of the system as perceived by the male partner
• increased blood pressure
• increased appetite
• back pain; muscle cramps; pain in lower or upper limbs
• decreased skin sensitivity
• breast tenderness or breast enlargement; fibrocystic breast changes (cysts which may cause breast swelling or pain)
• cervical inflammation; cervical polyps; eversion of the external cervical os
• changes in menstrual bleeding (e.g. heavy, prolonged, irregular or complete absence of menstruation); pelvic discomfort; premenstrual syndrome; uterine cramps
• vaginal infections (fungal or bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
• hair loss, rash, itching, skin rash or hot flushes
• urticaria

Rare: may affect up to 1 in 1,000 women

• 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 transient ischaemic attack
  • blood clots in the liver, stomach and intestine, kidneys or eye
    The likelihood of developing 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).
• galactorrhea (discharge of milk from the breast)

Unknown frequency (cannot be estimated from available data)

• chloasma (pigmented yellowish-brown patches on the skin, especially on the face)
• partner discomfort during intercourse (such as irritation, rash, itching)
• inability to remove the vaginal therapeutic system without medical assistance (e.g. due to adhesion to the vaginal wall)
• vaginal wall injury related to damage of the vaginal therapeutic system

Breast cancer and liver tumours have been reported in women using combined hormonal contraceptives. For detailed information, see section 2.2 "Warnings and precautions", "Neoplastic diseases".
Very rarely, Mirgi may become damaged. For additional information, see section 3.4 "What to do... Procedure in case more than one vaginal therapeutic system has been inserted".

Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland.
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Mirgi

Keep this medicine out of sight and reach of children.
Contact a doctor if a child is exposed to the hormones contained in Mirgi.
This medicinal product does not require special temperature conditions during storage. Store in the original packaging to protect from light.
Do not use Mirgi after the expiry date stated on the box and on the sachet.
Do not use Mirgi if you notice any change in colour or any signs of deterioration.
Used rings should be disposed of with ordinary household waste, preferably in the original sachet. Do not dispose of Mirgi in the toilet. As with other medicines, unused or expired systems should not be disposed of via sewage systems or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Mirgi contains

• The active substances are etonogestrel and ethinylestradiol. Each ring contains 11.7 mg of etonogestrel and 2.7 mg of ethinylestradiol.
• Other components are: ethylene-vinyl acetate copolymer (vinyl acetate 28%), ethylene-vinyl acetate copolymer (vinyl acetate 9%) (a type of plastic that does not dissolve in the body), and magnesium stearate.

Every day, over a period of 3 weeks, the ring releases 0.12 mg of etonogestrel and 0.015 mg of ethinylestradiol.

What Mirgi looks like and contents of the pack
Mirgi is a flexible, transparent, colourless ring with an outer diameter of 54 mm and a cross-section diameter of 4 mm. Each ring is packed in a foil sachet, either with or without a resealable closure, depending on the country. The sachet is enclosed in a cardboard box. Each box contains 1, 3, or 6 rings.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
Dolni Mĕcholupy
102 37 Prague 10
Czech Republic

Manufacturer:
Mithra Pharmaceuticals CDMO S.A.
Rue de l’Expansion 57
4400 Flemalle
Belgium

This medicinal product is authorised in the European Economic Area countries under the following names:
Croatia Etonogestrel/Etinilestradiol Mithra 0.120 mg/0.015 mg tijekom 24 sata, sustav za isporuku u rodnicu
Poland Mirgi
Austria MyRing 0.120 mg/0.015 mg pro 24 Stunden vaginales Wirkstofffreisetzungssystem
Belgium Myloop 0.120 mg/0.015 mg per 24 uur, hulpmiddel voor vaginaal gebruik
Germany MYCIRQ 0.120 mg/0.015 mg pro 24 Stunden vaginales Wirkstofffreisetzungssystem
Spain Mithraring 0.120 mg/0.015 mg cada 24 horas, sistema de liberación vaginal
France ETHINYLESTRADIOL/ETONOGESTREL ZENTIVA 15 microgrammes /120 microgrammes /24 heures, système de diffusion vaginale
Italy KIRKOS
Luxembourg Myloop 0.120 mg/0.015 mg par 24 heures, système de diffusion vaginale
Netherlands Etonogestrel/Ethinylestradiol Abbott 0.120 mg/0.015 mg per 24 uur, hulpmiddel voor vaginaal gebruik