Nuvaring

Leaflet accompanying the packaging: information for the user

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

NuvaRing

(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 this person. It should not be given to others. The medicine may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is NuvaRing and what is it used for
• 2. Important information before using NuvaRing
• 3. How to use NuvaRing
• 4. Possible side effects
• 5. How to store NuvaRing
• 6. Contents of the packaging and other information

1. What is NuvaRing and what is it used for

NuvaRing 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, NuvaRing is classified as a low-hormone contraceptive. Since NuvaRing releases two different hormones, it is also a combined contraceptive.
NuvaRing works like a combined oral contraceptive pill (combined pill), but unlike a pill that must be taken every day, NuvaRing is used for 3 weeks in a row.
NuvaRing 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 NuvaRing

General notes

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

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

2.1 When not to use NuvaRing

You should not use NuvaRing if you have any of the conditions listed below. If you have any of the conditions listed below, 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), lungs (pulmonary embolism), or 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 section "Blood clots"),
• if you have had a heart attack or stroke,
• if you have had angina pectoris (a disease that causes severe chest pain, which can 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)
• hyperhomocysteinemia
• if you have had (or have) a type of migraine called "migraine with aura",
• if you have had (or have) pancreatitis associated with high levels of fats in the blood,
• if you have had (or have) severe liver disease ,and liver function has not returned to normal,
• if you have had (or have) a benign or malignant liver tumor,
• if you have had (or have) breast cancer or genital cancer, or if there is a suspicion of these cancers,
• if you have had (or 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 NuvaRing, the system should be removed from the vagina immediately and a doctor should be consulted, and during this time, a non-hormonal contraceptive method should be used.
If the patient has hepatitis C and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, NuvaRing vaginal therapeutic system should not be used (see also section 2.4 "NuvaRing and other medicines").

2.2 Warnings and precautions

When should you contact your doctor?
You should see your doctor immediately

• if you notice possible 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 (thrombosis)"). To find a description of these serious side effects, see "How to recognize 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 NuvaRing, you should also tell your doctor.

• if breast cancer has occurred or occurred in close relatives;
• if you have epilepsy (see section 2.4 "NuvaRing 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 body's 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);
• 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 section "Blood clots");
• if you have just given birth, as you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start using NuvaRing after giving birth;
• if you have superficial thrombophlebitis (blood clots in 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], pregnancy herpes [a blistering skin rash during pregnancy], or Sydenham's chorea [a nervous system disease in which there are involuntary, violent movements of the body]),
• you should see your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or experiencing hives that may be associated with difficulty breathing. Estrogen-containing medications may cause or worsen symptoms of hereditary and acquired angioedema;
• if you have chloasma (yellow-brown pigmentation 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 NuvaRing, 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 NuvaRing system inside the vagina. These symptoms may indicate that the NuvaRing system has been accidentally inserted into the bladder.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as the NuvaRing 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 thrombosis" or "venous thromboembolism");
• in arteries (hereinafter referred to as "arterial thrombosis" or "arterial thromboembolism").

Not all people recover fully from 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 NuvaRing is small.

HOW TO RECOGNIZE BLOOD CLOTS

You should see your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to suffer
from these symptoms?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, such as pallor, redness, or cyanosis. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain;

If you are unsure, you should see your doctor,
because some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision Retinal vein thrombosis (blood clot in the eye)

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 thrombosis). Although these side effects are rare, they can occur. They most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg 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 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 NuvaRing, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots associated with the use of NuvaRing 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 close family has had blood clots in the 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 NuvaRing for a few weeks before surgery or immobilization. If you need to stop using NuvaRing, 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-distance air travel (>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 risk factors occur in you, even if you are unsure. Your doctor may decide to stop using NuvaRing.
If any of the above conditions change during the use of NuvaRing, e.g., someone in your close family is diagnosed with thrombosis without a known cause, or if you gain significant weight, you should inform your doctor.

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.

What factors 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 NuvaRing is very small, but it may increase:

• with age (over approximately 35 years);
• if you smoke.While using a hormonal contraceptive like NuvaRing, 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 close 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 close 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 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 NuvaRing, e.g., you start smoking, someone in your close family is diagnosed with thrombosis without a known cause, or if you gain significant weight.

Cancer

The following information is based on studies using combined oral contraceptives and may also apply to NuvaRing. Information on the vaginal use of hormonal contraceptives (as in the case of NuvaRing) is not available.
In 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 medications. It is possible that women using combined contraceptives are more likely to have medical examinations, so breast cancer may be detected more often. The increased incidence of breast cancer decreases gradually after stopping the use of combined contraceptives.
Regular breast examination is very important. If a lump is found, you should contact your doctor. You should also inform your doctor if someone in your close family has had or has breast cancer (see section 2.2 "Warnings and precautions").
In rare cases, women using combined contraceptives have been found to have benign liver tumors, and very rarely, malignant liver tumors as well. 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 lining of the uterus) and ovarian cancer. It is possible that this also applies to NuvaRing, but this has not been confirmed yet.

Mental disorders

Some women using hormonal contraceptives, including NuvaRing, 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 NuvaRing have not been studied in adolescents under the age of 18.

2.4 NuvaRing 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 of another specialty or a prescribing dentist (or pharmacist) that you are using NuvaRing. They may inform you about the need to use an additional contraceptive method (e.g., male condoms), 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 NuvaRing 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 NuvaRing, you should also use a mechanical contraceptive method (such as a male condom). Due to the fact that the effect of another medicine on NuvaRing may persist for up to 28 days after stopping the medicine, it is necessary to use additional mechanical contraception during this time. Note: NuvaRing should not be used with a diaphragm, cervical cap, or female condom.
NuvaRing may affect the action of other medicines, such as

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

If you have hepatitis C and are taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, you should not use the NuvaRing vaginal therapeutic system, as this may cause an increase in liver function test results in the blood (an increase in the activity of the liver enzyme ALT).
Before starting these medicines, your doctor will prescribe a different type of contraceptive.
You can resume using the NuvaRing vaginal therapeutic system about 2 weeks after finishing this treatment. See section 2.1 "When not to use NuvaRing".
Before taking any medicine, you should consult your doctor or pharmacist.
During the use of NuvaRing, you can also use tampons. You should insert NuvaRing before applying a tampon. You should be careful when removing the tampon to avoid accidentally removing NuvaRing as well. If NuvaRing is expelled, it is enough to rinse the therapeutic system with cold or warm water and reinsert it as soon as possible.
Damage to the NuvaRing vaginal therapeutic system has occurred during the use of vaginal products, such as moisturizers or treatments for infections (see section 3.4 "What to do in case of damage to the NuvaRing vaginal therapeutic system"). The use of spermicides or vaginal antifungal medications does not reduce the contraceptive effectiveness of NuvaRing.

Diagnostic tests

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

2.5 Pregnancy and breastfeeding

NuvaRing should not be used during pregnancy or if there is a suspicion that the woman is pregnant. If the patient becomes pregnant during the use of NuvaRing, the vaginal therapeutic system should be removed and a doctor should be consulted.
If the patient wants to stop using NuvaRing because she wants to become pregnant, she should read the contents of section 3.5 "What to do when the patient wants to stop using NuvaRing".
The use of NuvaRing is not recommended during breastfeeding. If the patient wants to use NuvaRing during breastfeeding, she should consult her doctor first.

2.6 Driving and using machines

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

3. How to use NuvaRing

NuvaRing can be inserted and removed by yourself. Your doctor will instruct you on when to start using NuvaRing. The vaginal therapeutic system should be inserted on the appropriate day of the cycle (see section 3.3 "When to insert the first NuvaRing vaginal therapeutic system") and left in place for 3 weeks in a row. You should regularly check if the NuvaRing vaginal therapeutic system is in the vagina (e.g., before and after sexual intercourse) to ensure contraceptive protection.
After 3 weeks, you should remove NuvaRing and take a 1-week break. Usually, withdrawal bleeding occurs during the break.
You should not use certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom, while using NuvaRing. You should not use these mechanical contraceptive methods as an additional method of contraception, as NuvaRing may interfere with the proper insertion and placement of the diaphragm, cervical cap, or female condom. However, you can use a male condom as an additional mechanical contraceptive method.

3.1 Inserting and removing NuvaRing

• 1. Before inserting the system, check the expiration date (see section 5 "How to store NuvaRing").
• 2. Before inserting or removing the system, wash your hands.
• 3. Choose the most comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
• 4. Remove NuvaRing from the sachet.
• 5. Holding the system between your thumb and index finger, squeeze it and insert it into the vagina (see Figures 1-4). Alternatively, the system can be inserted using the NuvaRing Applicator (not included with the NuvaRing packaging). The NuvaRing Applicator may not be available in all countries. The correct position of NuvaRing is one in which you do not feel it. If the system is uncomfortable, you should gently change the position of the NuvaRing system (e.g., push it slightly further into the vagina) until you feel comfortable. The position of the system in the vagina does not matter for its contraceptive effect.
• 6. After 3 weeks, remove the system from the vagina. You can do this by hooking your index finger around the edge of the system or by grasping it with your index and middle fingers and pulling it out (Figure 5). If you are unable to locate the system in the vagina but cannot remove it, you should contact your doctor.
• 7. Dispose of the used system with household waste, preferably in a sealed sachet, in which it was originally packaged. Do not flush NuvaRing down the toilet.

Figure 1
Remove the system from the sachet

Figure 2
Squeeze the system

Figure 3
Choose the most comfortable position

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 the system from the vagina, hooking your index finger around the edge of the system or 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 approximately the same time. For example, if NuvaRing was inserted on a Wednesday at around 10:00 PM, it should be removed on the following 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 removal.
• 4. A new system should be inserted exactly 1 week after the break (on the same day of the week as usual and at approximately the same time), even if bleeding is still present. If the insertion of the new system is delayed by more than 3 hours, its contraceptive effectiveness may be reduced. In such a case, you should follow the instructions in section 3.4 "What to do if, after the 1-week break, the patient forgets to insert a new NuvaRing vaginal therapeutic system".

If you use NuvaRing according to the above instructions, subsequent bleedings will occur every month, approximately on the same days of the week.

3.3 When to insert the first NuvaRing vaginal therapeutic system

• In the previous cycle, no hormonal contraceptive was used

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

• In the previous month, the patient usedcombined hormonal oral contraceptives

You should start using NuvaRing no later than the day after stopping the current contraceptive. If the current contraceptive has tablets that do not contain active substances, you should start using NuvaRing no later than the day after taking the last tablet that does not contain active substances.
In case of doubt about which tablet it is, you should ask your doctor or pharmacist. You should not extend the break in using the current tablets beyond the recommended period.
If you have been taking your tablets regularly and are sure you are not pregnant, you can stop taking the tablets on any day and start using NuvaRing immediately.

• In the previous month, the patient useda transdermal system (patch)

You should start using NuvaRing no later than the day after the break in using the transdermal system. You should not 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 NuvaRing immediately.

• In the previous month, the patient useda minipill (progestogen-only contraceptive)

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

• In the previous month, the patient usedinjections or an implant, or an intrauterine system releasing progestogen [IUD]

You should start using NuvaRing 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 NuvaRing, you should use an additional contraceptive method (such as a male condom).

• After childbirth

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

• After a miscarriage

According to your doctor's instructions.

3.4 What to do if…

What to do in case of accidental expulsion of the system from the vagina

NuvaRing may be accidentally expelled from the vagina, e.g., if it is inserted incorrectly, during tampon removal, during sexual intercourse, due to constipation, or due to cervical prolapse. Therefore, you should regularly check if the system is in the vagina (e.g., before and after sexual intercourse) to ensure contraceptive protection.

What to do if the NuvaRing vaginal therapeutic system is damaged

Damage to the NuvaRing vaginal therapeutic system has occurred during the use of vaginal products, such as moisturizers or treatments for infections (see section 3.4 "What to do in case of damage to the NuvaRing vaginal therapeutic system"). The use of spermicides or vaginal antifungal medications does not reduce the contraceptive effectiveness of NuvaRing.

3.5 Procedure when a patient wants to stop using NuvaRing

NuvaRing 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 NuvaRing because she wants to become pregnant, she should wait until the first menstruation and only then start trying to become pregnant. This will help determine the date of birth.

4. Possible side effects

Like all medicines, NuvaRing can cause side effects, although not everybody gets them. If any side effects occur, especially serious and persistent ones or changes in health that the patient considers related to the use of NuvaRing, the patient should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before using NuvaRing".
If there is an allergy (hypersensitivity) to any of the components of NuvaRing, it may manifest as (frequency not known): angioedema and (or) anaphylactic reaction [swelling of the face, lips, tongue, and (or) throat and (or) difficulty swallowing] or the occurrence of hives potentially with difficulty breathing. In these cases, NuvaRing should be removed and a doctor consulted immediately (see also section 2.2 "Warnings and precautions").
Women using NuvaRing have reported the following side effects:
Frequent:may occur in no more than 1 in 10 women

• abdominal pain, nausea (nausea)
• vaginal infections 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
• system expulsion

Uncommon: may occur in no more than 1 in 100 women

• vision disturbances; dizziness
• bloating; vomiting, diarrhea or constipation
• fatigue, malaise or irritability; mood changes; sudden mood changes
• edema
• urinary tract infections or urinary tract infections
• problems or pain during urination; urgency to urinate or need to urinate; frequent urination
• discomfort during intercourse, including pain, bleeding, 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, rash or hot flashes
• hives

Rare: may occur in no more than 1 in 1000 women

• harmful blood clots in a vein or artery, for example: o in the leg or foot (e.g. deep vein thrombosis) o in the lungs (e.g. pulmonary embolism) o heart attack o stroke o mini-stroke or transient stroke-like symptoms, known as transient ischemic attack o blood clots in the liver, stomach and intestine, kidneys or eye

The probability of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots 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 penis disorders (such as irritation, rash, itching)
• inability to remove the therapeutic vaginal system without medical assistance (e.g. due to the therapeutic vaginal system sticking to the vaginal wall)
• vaginal wall damage related to damage to the therapeutic vaginal system

Women using combined hormonal contraceptives have reported breast cancer and liver tumors. For more detailed information, see section 2.2 "Warnings and precautions", "Tumors".
Very rarely, NuvaRing may be damaged. For more information, see section 3.4 "Procedure in case of damage to the therapeutic vaginal system".

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell her doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store NuvaRing

The medicine should be stored out of sight and reach of children.
A doctor should be consulted in case of exposure of a child to the hormones contained in NuvaRing.
Store at a temperature below 30°C. Store in the original packaging to protect from light and moisture.
NuvaRing should not be used after 4 months from the date of issue of the medicine in the pharmacy. The date of issue is stated on the box and on the sachet.
NuvaRing should not be used after the expiry date stated on the box and on the sachet.
NuvaRing should not be used if it has changed color or if there are any signs of deterioration.
The used therapeutic vaginal system should be disposed of in a regular household waste bin, preferably in a sealed sachet. NuvaRing should not be flushed down the toilet. Like other medicines, unused or expired systems should not be disposed of in the sewage system or household waste bins. The patient should ask her pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What NuvaRing contains

• The active substances of NuvaRing are: etonogestrel (11.7 mg) and ethinyl estradiol (2.7 mg)
• The other ingredients are: poly(ethylene-vinyl acetate), 28% vinyl acetate (EVA 28), poly(ethylene-vinyl acetate), 9% vinyl acetate (EVA 9), and magnesium stearate.

Etonogestrel and ethinyl estradiol are released from the therapeutic vaginal system in amounts of 0.120 mg/day and 0.015 mg/day over a period of 3 weeks.

What NuvaRing looks like and what the package contains

NuvaRing is a flexible, transparent, colorless or almost colorless ring with an outer diameter of 54 mm.
Each therapeutic vaginal system is packaged in a separate foil sachet. The sachet can be reopened after opening. The sachets are placed in a cardboard box with a leaflet and stickers to help remember when to insert and remove NuvaRing.
The package contains 1 or 3 systems.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

ORGANON BIOSCIENCES S.R.L.
Avenue Popişteanu, No. 54A, Expo Business Park, Building 2
Office 306 and Office 307, 3rd floor, Sector 1,
Bucharest,
Romania

Manufacturer:

N.V. Organon
Kloosterstraat 6, 5349 AB Oss
Netherlands
Organon Ireland Ltd.
Drynam Road, Swords, Co. Dublin, Ireland

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
IVA Pharm Sp. z o.o.
Drawska 14/1 Street
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Marketing authorization number in Romania, the country of export:
4823/2012/01
4823/2012/02
Parallel import authorization number: 121/21

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

NuvaRing
0.120 mg/ 0.015 mg/ 24 h, therapeutic vaginal system
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Romania, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

Date of approval of the leaflet: 21.09.2023

[Information about the trademark]