Polaring

Leaflet attached to the packaging: information for the user

PolaRing, (0.120 mg + 0.015 mg)/24 h, vaginal therapeutic system
Etonogestrel + Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

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

You should keep this leaflet so that you can read it again if necessary.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1.

What is PolaRing and what is it used for

• 2.

Important information before using PolaRing

• 2.1 When not to use PolaRing
• 2.2 Warnings and precautions Blood clots Cancer
• 2.3 Children and adolescents
• 2.4 PolaRing and other medicines Diagnostic tests
• 2.5 Pregnancy and breastfeeding
• 2.6 Driving and using machines
• 3.

How to use PolaRing

• 3.1 Insertion and removal of PolaRing
• 3.2 Three weeks of use, one week of break
• 3.3 When to insert the first PolaRing vaginal therapeutic system
• 3.4 What to do if… Procedure in case of accidental expulsion of the system from the vagina Procedure when the system has been outside the vagina for some time Procedure in case of damage to the vaginal therapeutic system Procedure in case of insertion of more than one vaginal therapeutic system Procedure when, after a one-week break, the patient forgets to insert a new vaginal therapeutic system Procedure when the patient forgets to remove the vaginal therapeutic system Procedure in case of absence of bleeding Procedure in case of unexpected bleeding Procedure in case of change in the day of bleeding Procedure in case of desire to delay the occurrence of bleeding
• 3.5 Procedure when the patient wants to stop using PolaRing

• 4.

Possible side effects

• 5.

How to store PolaRing

• 6.

Contents of the packaging and other information

What PolaRing contains
How PolaRing looks like and what the packaging contains
Responsible entity and manufacturer

1. What is PolaRing and what is it used for

PolaRing is a contraceptive in the form of a vaginal therapeutic system, preventing pregnancy. Each vaginal therapeutic 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 small dose of hormones released, PolaRing is classified as a low-dose hormonal contraceptive. Since PolaRing releases two different hormones, it is also a combined contraceptive.
PolaRing works like a tablet containing a combined contraceptive (combined tablet), but unlike a tablet that must be taken daily, PolaRing is used for 3 weeks in a row. PolaRing releases two female sex hormones that inhibit the release of egg cells from the ovaries. Since egg cells are not released, the patient cannot become pregnant.

2. Important information before using PolaRing

General notes

Before starting to use PolaRing, you should familiarize yourself with the information about blood clots (thrombosis) in section 2. It is especially important to familiarize yourself with the symptoms of blood clots (see section 2 "Blood clots").
This leaflet describes situations in which you should stop using PolaRing or in which its effectiveness may be reduced. In these situations, you should refrain from sexual intercourse or use an additional contraceptive method, other than hormonal, such as a condom or another mechanical method. You should notuse methods based on a calendar or body temperature measurement. They may be ineffective because PolaRing affects changes in body temperature and cervical mucus consistency throughout the month.

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

2.1 When not to use PolaRing

You should not use PolaRing if you have any of the following conditions. If you have any of the following conditions, you must inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable.
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 blood clotting disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies,
if you need to have surgery or will be immobilized for a long time (see "Blood clots"),
if you have had a heart attack or stroke,
if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (transient stroke symptoms);
if you have any of the following diseases that may increase the risk of a blood clot in an artery:

• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a disease called hyperhomocysteinemia if you have (or have had in the past) a type of migraine called "migraine with aura", if you have (or have had in the past) pancreatitis associated with high levels of fats in the blood, if you have (or have had in the past) severe liver disease, and liver function has not returned to normal, if you have (or have had in the past) a benign or malignant liver tumor, if you have (or have had in the past) breast cancer or genital cancer or if there is a suspicion of these cancers, if you have unexplained vaginal bleeding, if you are allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the above symptoms occur for the first time during the use of PolaRing, you should immediately remove the system from the vagina and consult a doctor, and in the meantime, use a non-hormonal contraceptive method.
You should not use PolaRing 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 2.4 "PolaRing and other medicines").

2.2 Warnings and precautions

When should you contact a doctor?
You should immediately contact a doctor

• -if you notice probable symptoms of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots"). To get a description of the serious side effects listed, see "How to recognize the occurrence of blood clots".

You should tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen during the use of PolaRing, you should also tell your doctor.

• if breast cancer is currently present or has occurred in close relatives;
• if you have epilepsy (see section 2.4 "PolaRing 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 (a disease that affects the natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);

and

• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you are immediately postpartum, then you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start using PolaRing after giving birth;
• if you have superficial thrombophlebitis (inflammation of the veins under the skin);
• if you have varicose veins;
• if you have diseases that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disease], herpes gestationis [a blistering skin rash during pregnancy], Sydenham's chorea [a neurological disorder with involuntary, violent body movements]);
• if you currently have or have had chloasma (brownish-yellow spots, so-called "pregnancy spots", especially on the face). If they occur, you should avoid excessive sun exposure and ultraviolet radiation;
• if you have conditions that make it difficult to use PolaRing, such as frequent constipation, cervical prolapse, or pain during intercourse;
• if you experience sudden, frequent need to urinate with a burning sensation and/or pain, and if you cannot locate the vaginal therapeutic system in the vagina. These symptoms may indicate that the vaginal therapeutic system has been accidentally inserted into the bladder;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with breathing difficulties, you should immediately contact a doctor. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as the PolaRing vaginal therapeutic system, is associated with an increased risk of blood clots, compared to not using the therapy. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease")
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

Not all patients recover fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the total risk of harmful blood clots caused by the use of PolaRing is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

You should immediately contact a doctor if you notice any of the following symptoms.
Does the patient experience any of these symptoms?
Why is the patient likely to suffer

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest?

The risk of forming blood clots in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If you stop using PolaRing, 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 total risk of blood clots in the legs or lungs associated with the use of PolaRing is small.

• During the year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During the year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During the year, about 6 to 12 out of 10,000 women who use combined hormonal contraceptives containing ethinylestradiol or etonogestrel, such as the PolaRing vaginal therapeutic system, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with the use of PolaRing is small, but some factors can increase this risk. The risk is higher:

• if you are significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in your immediate family has had blood clots in their legs, lungs, or other organs at a young age (e.g., under 50). In this case, you may have hereditary blood clotting disorders;
• if you need to have surgery or will be immobilized for a long time due to injury or illness, or have a leg in a cast. It may be necessary to stop using PolaRing for a few weeks before surgery or immobilization. If you need to stop using PolaRing, you should ask your doctor when you can resume using it;
• with age (especially over 35 years);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these factors apply to you, even if you are not sure. Your doctor may decide to stop using PolaRing.
You should inform your doctor if any of the above conditions change during the use of PolaRing, e.g., if someone in your immediate family is diagnosed with blood clots without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Like blood clots in veins, blood clots in arteries can have 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 associated with the use of PolaRing is very small, but it may increase:

• with age (over about 35 years);
• if you smoke.While using a hormonal contraceptive like PolaRing, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change during the use of PolaRing, e.g., if you start smoking, if someone in your immediate family is diagnosed with blood clots without a known cause, or if you gain significant weight.

Cancer

The following information was obtained from studies using combined oral contraceptives and may also apply to PolaRing. Information on the vaginal use of hormonal contraceptives (as in the case of PolaRing) is not available.
Among women using combined contraceptives, a slightly higher incidence of breast cancer has been found, although it is not known whether this is caused by the medicines used. It is possible that women using combined contraceptives are more likely to have breast cancer detected, as they undergo more frequent medical examinations. The increased incidence of breast cancer gradually decreases after stopping the use of combined contraceptives.
Regular breast examination is very important. If a lump is detected, you should contact your doctor. You should also inform your doctor if breast cancer has occurred or occurs in close relatives (see section 2.2 "Warnings and precautions").
In rare cases, women using combined contraceptives have developed benign liver tumors, and very rarely, malignant liver tumors. If you experience unusual, severe abdominal pain, you should contact your doctor.
There are reports that women using combined contraceptives less often develop endometrial cancer (cancer of the uterine lining) and ovarian cancer. It is possible that this also applies to PolaRing, but this has not been confirmed yet.

Psychiatric disorders

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

2.3 Children and adolescents

The safety and efficacy of PolaRing have not been studied in adolescents under the age of 18.

2.4 PolaRing and other medicines

You should always tell your doctor about the medicines or herbal products you are currently using. You should also inform your doctor or another doctor prescribing other medicines (or pharmacist) that you are using PolaRing. They may inform you about the need to use an additional contraceptive method (e.g., a condom for men), and if so, for how long, as well as whether it is necessary to modify the use of another medicine.
Some medicines

• may affect the level of PolaRing in the blood
• may reduce its contraceptive effectiveness
• may cause unexpected bleeding.

This applies to medicines used to treat:

• 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);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (St. John's wort).

If you are taking medicines or herbal products that may reduce the effectiveness of PolaRing, you should use a mechanical contraceptive method (such as a condom for men) as well. Due to the fact that the effect of another medicine on PolaRing may persist for up to 28 days after stopping the medicine, it is necessary to use additional mechanical contraception during this time.
Note: PolaRing should not be used with a diaphragm, cervical cap, or female condom.
PolaRing may affect the action of other medicines, such as:

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

You should not use PolaRing 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, as they may cause abnormal liver function test results, detectable in blood tests (increased ALT activity).
Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
PolaRing can be used again after about 2 weeks after completing treatment with these medicines (see section 2.1 "When not to use PolaRing").
Before taking any medicine, you should consult your doctor or pharmacist.
During the use of PolaRing, you can also use tampons. You should insert PolaRing before inserting a tampon. You should be careful when removing a tampon to avoid accidentally removing PolaRing as well. If it is expelled, it is enough to rinse the vaginal therapeutic system with cold or warm water and reinsert it as soon as possible.
Damage to the vaginal therapeutic system has occurred during the use of vaginal products, such as moisturizers or treatments for infections (see section 3.4 "Procedure in case of damage to the vaginal therapeutic system"). The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of PolaRing.

Diagnostic tests

If laboratory tests of blood or urine are performed, you should inform the persons performing the tests that you are using PolaRing, as the use of the vaginal therapeutic system may affect the results of some laboratory tests.

2.5 Pregnancy and breastfeeding

You should not use PolaRing during pregnancy or if you suspect you are pregnant. If you become pregnant during the use of PolaRing, you should remove the vaginal therapeutic system and contact your doctor.
If you want to stop using PolaRing because you want to become pregnant, you should read the contents of section 3.5 "Procedure when the patient wants to stop using PolaRing".
PolaRing is not recommended during breastfeeding. If you want to use PolaRing during breastfeeding, you should consult your doctor first.

2.6 Driving and using machines

PolaRing does not affect the ability to drive or use machines.

3. How to use PolaRing

This medicine should always be used as directed by your doctor or pharmacist. In case of doubts, you should consult your doctor or pharmacist.
PolaRing can be inserted and removed by yourself. Your doctor will instruct you on when to start using PolaRing for the first time. The vaginal therapeutic system must be inserted on the correct day of the cycle (see section 3.3 "When to insert the first PolaRing vaginal therapeutic system") and left in place for 3 weeks in a row. You should regularly check that the PolaRing vaginal therapeutic system is in the vagina (e.g., before and after sexual intercourse), to ensure that you are protected against pregnancy. After 3 weeks, you should remove the system and take a 1-week break. Usually, during this break, menstrual bleeding occurs. You should not use certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom, while using PolaRing. You should not use these methods as an additional contraceptive method, as PolaRing may make it difficult to properly insert and position the diaphragm, cervical cap, or female condom. However, you can use a condom for men as an additional mechanical contraceptive method.

3.1 Insertion and removal of PolaRing

• 1. Before insertion, check the expiration date (see section 5 "How to store PolaRing").
• 2. Before insertion or removal, wash your hands.
• 3. Choose the most comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
• 4. Remove PolaRing from the pouch. Keep the pouch for later use.
• 5. Holding the system with your thumb and index finger, squeeze it and insert it into the vagina (see Figures 1-4). The correct position of PolaRing is one in which you do not feel it. If the system is uncomfortable, you should gently push it further into the vagina. The position of the system in the vagina does not affect its contraceptive effectiveness.
• 6. After 3 weeks, remove the system from the vagina. You can do this by hooking your index finger under the edge of the system or by grasping it with your index and middle fingers and pulling it out (Figure 5). If you can locate the system in the vagina but are unable to remove it, you should contact your doctor.
• 7. Dispose of the used system with household waste, preferably in the pouch. Do not flush PolaRing down the toilet.

Figure 1
Remove the system from the pouch

Figure 2 Squeeze the system

Figure 3
Choose the most comfortable position for insertion

Figure 4A
Figure 4B
Figure 4C
Insert the system into the vagina with one hand (Figure 4A), if necessary, using the other hand to spread the labia. Place it inside the vagina so that it does not cause discomfort (Figure 4B). Leave the system in the vagina for 3 weeks (Figure 4C).

Figure 5
Remove PolaRing from the vagina by hooking your index finger under the edge of the system or by grasping it with your index and middle fingers and pulling it out.

3.2 Three weeks of use, one week of break

• 1. The system must be in the vagina for 3 weeks without interruption, counting from the day of insertion.
• 2. After 3 weeks, you should remove it on the same day of the week that it was inserted, and at about the same time. For example, if PolaRing was inserted on a Wednesday at around 10:00 PM, it should be removed on the Wednesday 3 weeks later, at around 10:00 PM.
• 3. After removing the system, you should take a 1-week break. During this time, you may experience bleeding. It usually starts 2-3 days after removing PolaRing.
• 4. A new system should be inserted exactly 1 week after the break (on the same day of the week as usual, and at about the same time), even if bleeding is still present.

If the insertion of a new system is delayed by more than 3 hours, its contraceptive effectiveness may be reduced. In this case, you should follow the instructions in section 3.4 "Procedure when, after a one-week break, the patient forgets to insert a new vaginal therapeutic system".
If you use PolaRing according to the above instructions, subsequent bleedings will occur approximately every month on the same days of the week.

3.3 When to insert the first PolaRing vaginal therapeutic system

• In the previous month, you did not use a hormonal contraceptive

Insert the first PolaRing on the first day of your natural cycle (i.e., the first day of your period). PolaRing is effective from the moment of insertion. There is no need to use any additional contraceptive methods.
You can also start using PolaRing between the 2nd and 5th day of your period, but in this case, you should use an additional contraceptive method (such as a condom for men) during the first 7 days of using PolaRing. This recommendation applies only to the first use of PolaRing.

• In the previous month, you used combined hormonal contraceptive pills

You should start using PolaRing no later than the day after the break in taking your current medicine. If your current medicine also has pills that do not contain active substances, you should start using PolaRing no later than the day after taking the last pill that does not contain active substances.
In case of doubts, which pill is which, you should ask your doctor or pharmacist. You should never extend the break in taking your current pills beyond the recommended period.
If you have been taking your pills regularly and are sure you are not pregnant, you can stop taking the pills on any day and start using PolaRing immediately.

• In the previous month, you used a transdermal system (patch)

You should start using PolaRing no later than the day after the break in using the transdermal system. You should never extend the break in using the transdermal system beyond the recommended period. If you have been using the transdermal system regularly and are sure you are not pregnant, you can stop using the transdermal system on any day and start using PolaRing immediately.

• In the previous month, you used a progestogen-only contraceptive (minipill)

You can stop taking the minipill on any day and start using PolaRing the next day, at the same time you would have taken the minipill. During the first 7 days of using PolaRing, you should also use an additional contraceptive method (such as a condom for men).

• In the previous month, you used injections or an implant, or an intrauterine system releasing progestogen [IUD]

You should start using PolaRing on the day of the next planned injection or on the day the implant or intrauterine system releasing progestogen is removed.
During the first 7 days of using PolaRing, you should use an additional contraceptive method (such as a condom for men).

• After giving birth

After giving birth, your doctor may recommend using PolaRing only after your first period. Sometimes, you can start using PolaRing earlier; your doctor will advise you when. If you are breastfeeding and want to use PolaRing, you should discuss this with your doctor first.

• After a miscarriage

According to your doctor's instructions.

3.4 What to do if…

Procedure in case of accidental expulsion of the system from the vagina

PolaRing may be accidentally expelled from the vagina, e.g., if it was not inserted correctly, during tampon removal, during sexual intercourse, in case of constipation, or uterine prolapse. Therefore, you should regularly check that the system is in the vagina (e.g., before and after sexual intercourse).

3.5 Procedure when a patient wants to stop using PolaRing

The use of PolaRing can be stopped at any time.
If the patient does not want to become pregnant, she should ask her doctor about other contraceptive methods.
If the patient stops using PolaRing because she wants to become pregnant, she should wait until the first menstruation and then start trying to conceive. This will help determine the date of birth.

4. Possible side effects

Like any medication, this medication can cause side effects, although not everyone will experience them.
If any side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of PolaRing, a doctor should be consulted.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more information on the various risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important information before using PolaRing".
A doctor should be consulted 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 hives potentially with difficulty breathing (see also section "Warnings and precautions").
Women using the therapeutic vaginal system containing etonogestrel and ethinyl estradiol have reported the following side effects:
Frequently: may occur in up to 1 in 10 women

• abdominal pain, nausea
• vaginal infections caused by fungi (such as "thrush"); discomfort caused by the presence of the system in the vagina; itching of the genitals; discharge
• headache or migraine; depressive mood; decreased libido
• breast pain; pelvic pain; painful menstruation
• acne
• weight gain
• expulsion of the system

Less frequently: may occur in up to 1 in 100 women

• vision disorders; dizziness
• bloating; vomiting, diarrhea, or constipation
• feeling of fatigue, malaise, or irritability; mood changes; sudden mood changes
• edema
• urinary tract infections or kidney infections
• problems or pain during urination; urge to urinate or need to urinate frequently
• discomfort during intercourse, including pain, bleeding, or inconvenience related to the presence of the system, felt by the partner
• increased blood pressure
• increased appetite
• back pain; muscle cramps; pain in the lower or upper limbs
• decreased skin sensitivity
• breast tenderness or enlargement; fibrocystic breast disease (cysts that can cause swelling or pain in the breast)
• cervicitis; 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); feeling of burning, unpleasant odor, pain, discomfort, or dryness of the vagina or vulva
• hair loss, rash, itching, or flushing
• hives

Rarely: may occur in up to 1 in 1000 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 a transient ischemic attack blood clots in the liver, stomach, intestine, kidneys, or eye The risk of developing blood clots may be higher if the patient has other risk factors (see section 2 for more information on risk factors and symptoms of blood clots).
• galactorrhea

Unknown(frequency cannot be determined from available data)

• chloasma (brownish-yellow spots on the skin, especially on the face)
• partner's genital discomfort (such as irritation, rash, itching)
• inability to remove the therapeutic vaginal system without medical assistance (e.g., due to the therapeutic vaginal system adhering to the vaginal wall)
• vaginal wall damage associated with damage to the therapeutic vaginal system

Women using combined hormonal contraceptives have experienced breast cancer and liver tumors. For more information, see section 2.2 "Warnings and precautions", "Tumors".
PolaRing may be damaged. For more information, see section 3.4 "Procedure in case of damage to the therapeutic vaginal system".
Before the patient decides to delay the occurrence of menstruation, she may consult her doctor.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, a doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store PolaRing

The medication should be stored out of sight and reach of children.
A doctor should be consulted if a child is exposed to the hormones contained in PolaRing.
There are no special storage temperature recommendations for the medication. Store in the original packaging to protect from light.
PolaRing should be inserted at least one month before the expiration date stated on the box and on the sachet after EXP. The expiration date indicates the last day of the given month.
The inscription on the packaging after the abbreviation "EXP" indicates the expiration date, and after the abbreviation "Lot" indicates the batch number.
PolaRing should not be used if it has changed color or if there are any signs of damage.
This medication may pose a risk to the environment. After removal, PolaRing should be placed in the sachet and carefully closed. The closed sachet should be thrown away with other household waste or taken back to a pharmacy for proper disposal in accordance with local regulations.
PolaRing should not be flushed down the toilet. Like other medications, unused or expired systems should not be disposed of in the sewage system or household waste containers. A pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What PolaRing contains

• The active substances of PolaRing are: etonogestrel (8.25 mg) and ethinyl estradiol (2.60 mg). The therapeutic vaginal system releases etonogestrel and ethinyl estradiol in amounts of 0.120 mg per day and 0.015 mg per day, respectively, for a period of 3 weeks.
• Other ingredients: ethylene and vinyl acetate copolymer (28% vinyl acetate), polyurethane (a type of plastic that does not dissolve in the body).

What PolaRing looks like and what the packaging contains

Therapeutic vaginal system.
PolaRing is a flexible, transparent, colorless or almost colorless ring with an outer diameter of 54 mm. The ring's cross-section diameter is 4 mm.
Each therapeutic vaginal system is packaged in an aluminum sachet. The sachets are placed in a cardboard box with a leaflet.
Stickers are attached to the packaging, which, when stuck to the corresponding day in the calendar, help remember when to insert and remove the PolaRing system.
The packaging contains 1, 3, or 6 systems.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

Laboratorios León Farma, S.A.
Calle La Vallina s/n, Poligono Industrial Navatejera

• 24193- Villaquilambre, León, Spain

Date of last update of the leaflet:December 2024