Nuvaring

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

NuvaRing (Circlet)

(0.120 mg + 0.015 mg)/24 h, vaginal therapeutic system
Etonogestrel + Ethinylestradiol
NuvaRing and Circlet are different trade names for the same drug.

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.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

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

• One should keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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-dose hormonal contraceptive. Since NuvaRing releases two different hormones, it is also a combined hormonal contraceptive. NuvaRing works like a combined oral contraceptive pill, but unlike a pill that must be taken daily, 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, one 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 one should stop using NuvaRing or in which its effectiveness may be reduced. In these situations, one should refrain from sexual intercourse or use an additional non-hormonal contraceptive method, such as a male condom or another mechanical method. One should notuse methods based on calendars or body temperature measurements. They may be ineffective, as 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

NuvaRing should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they must inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs,
• if the patient knows they have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies,
• if the patient needs to undergo surgery or will be immobilized for a long time (see section "Blood clots"),
• if the patient has had a heart attack or stroke,
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain, which can be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms),
• if the patient has any of the following diseases that may increase the risk of arterial thrombosis:
• severe diabetes with vascular damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• hyperhomocysteinemia
• if the patient has (or has had in the past) a type of migraine called "migraine with aura",
• if the patient has (or has had in the past) pancreatitis associated with high levels of fats in the blood,
• if the patient has (or has had in the past) severe liver disease ,and liver function has not returned to normal,
• if the patient has (or has had in the past) a benign or malignant liver tumor,
• if the patient has (or has had in the past) breast cancer or cancer of the genital organs, or if there is a suspicion of these cancers,
• if the patient has unexplained vaginal bleeding,
• if the patient is allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this drug (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 a hepatitis C virus infection and is taking drugs 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 drugs").

2.2 Warnings and precautions

When to contact a doctor? One should immediately consult a doctor

• if the patient notices probable symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots"). To get a description of these serious side effects, see "How to recognize blood clots".

One should tell the doctor if the patient has any of the following conditions.

If these symptoms occur or worsen during the use of NuvaRing, one should also tell the doctor.

• if breast cancer occurs currently or has occurred in close relatives;
• if the patient has epilepsy (see section 2.4 "NuvaRing and other drugs");
• if the patient has liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones);
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has 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 the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has just given birth, as they are at increased risk of blood clots. One should consult a doctor to find out how soon they can start using NuvaRing after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if the patient has 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], or Sydenham's chorea [a neurological disorder with involuntary, sudden movements of the body]),
• one should consult a doctor immediately if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or occurrence of hives, potentially with difficulty breathing. Estrogen-containing drugs may cause or worsen symptoms of hereditary and acquired angioedema;
• if the patient has chloasma (brownish-yellow spots, so-called "pregnancy spots", especially on the face) currently or in the past. If they occur, one should avoid excessive sun exposure and ultraviolet radiation;

one should avoid excessive sun exposure and ultraviolet radiation;

• if the patient has conditions that make it difficult to use NuvaRing, such as frequent constipation, cervical prolapse, or pain during intercourse;
• if the patient has sudden, frequent need to urinate with a burning sensation and/or pain, and if the patient 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 thromboembolism" or "venous thromboembolic disease");
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

Not all patients who have had a blood clot will fully recover. 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

One should immediately consult a doctor if they notice any of the following symptoms. Does the patient experience any of these symptoms? Why is the patient likely to suffer from

• 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 can only be felt when standing or walking;

when standing or walking;

• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or cyanosis.
• 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 the patient is unsure, they should consult a doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold). Pulmonary embolism Symptoms most often occur in one eye:

• sudden loss of vision or

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 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 drug) 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 the patient stops 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 the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have hereditary blood coagulation disorders;
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop using NuvaRing for a few weeks before surgery or immobilization. If the patient needs to stop using NuvaRing, they should ask their doctor when they can resume using the drug;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient. Traveling by plane (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor. It is essential to tell the doctor if any of these risk factors occur in the patient, even if they are unsure. The doctor may decide to stop using NuvaRing. One should inform the doctor if any of the above conditions change during the use of NuvaRing, e.g., if someone in the patient's close family is diagnosed with thrombosis without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similarly to 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 heart attack or stroke associated with the use of NuvaRing is very small, but it may increase:

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

If the patient has more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher. One should inform the doctor if any of the above conditions change during the use of NuvaRing, e.g., if the patient starts smoking, someone in their close family is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

Cancer

The following information was obtained from 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. 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 drugs being used. It is possible that women using combined contraceptives are more likely to have their tumors detected, as they undergo medical examinations more frequently. 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, one should consult a doctor. One should also inform the doctor if someone in their 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 tumors as well. If unusual, severe abdominal pain occurs, one should consult a 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 NuvaRing, but it 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, one should consult a doctor as soon as possible to receive 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 drugs

One should always tell the doctor about the drugs or herbal products being used, and also inform the doctor of another specialty or the dentist prescribing other drugs (or pharmacist) about the use of NuvaRing. They may inform about the need to use an additional contraceptive method (e.g., male condoms), and if so, for how long, and whether it is necessary to modify the use of another drug. Some drugs

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

This applies to drugs 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 the patient is taking drugs or herbal products that may reduce the effectiveness of NuvaRing, they should also use a mechanical contraceptive method (e.g., a male condom). Due to the fact that the effect of another drug on NuvaRing may persist for up to 28 days after stopping the drug, 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 drugs, such as

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

If the patient has a hepatitis C virus infection and is taking drugs containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, NuvaRing vaginal therapeutic system should not be used, as it may cause an increase in liver function test results in blood tests (an increase in the activity of the liver enzyme ALT). Before starting these drugs, the doctor will prescribe a different type of contraceptive. The use of NuvaRing can be resumed about 2 weeks after the end of this treatment. See section 2.1 "When not to use NuvaRing". Before taking any medication, one should consult a doctor or pharmacist.During the use of NuvaRing, tampons can be used at the same time. One should insert NuvaRing before inserting a tampon. One should be careful when removing the tampon to avoid accidentally removing NuvaRing as well. If NuvaRing is expelled, it is enough to wash the therapeutic system with cold or warm water and reinsert it as soon as possible. Damage to the NuvaRing 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 system"). The use of spermicides or vaginal antifungal drugs does not reduce the contraceptive effectiveness of NuvaRing.

Diagnostic tests

If laboratory blood or urine tests are being performed, one should inform the persons performing the tests about the use of 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 therapeutic system should be removed and a doctor should be consulted. If the patient wants to stop using NuvaRing because they want to become pregnant, they 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, they should first consult a doctor.

2.6 Driving and operating machinery

NuvaRing does not affect the ability to drive or operate machinery.

3. How to use NuvaRing

NuvaRing can be inserted and removed by the patient themselves. The doctor will instruct 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 system") and left in place for 3 weeks in a row. One should regularly check if the NuvaRing system is in the vagina (e.g., before and after sexual intercourse) to ensure contraceptive protection. After 3 weeks, the NuvaRing system should be removed and a 1-week break should be taken. Usually, during this break, withdrawal bleeding occurs. One should not use certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom, while using NuvaRing. One 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, a male condom can be used as an additional mechanical contraceptive method.

3.1 Inserting and removing NuvaRing

• 1. Before inserting the system, one should check the expiration date (see section 5 "How to store NuvaRing").
• 2. Before inserting or removing the system, one should wash their hands.
• 3. One should choose the most comfortable position for insertion, e.g., standing with one leg raised, squatting, or lying down.
• 4. One should remove NuvaRing from the pouch.
• 5. Holding the system with the thumb and index finger, one should 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 it is not felt. If the system is uncomfortable, one should gently change the position of the NuvaRing system (e.g., push it slightly deeper into the vagina) until they feel comfortable. The position of the system in the vagina does not matter for its contraceptive effect.
• 6. After 3 weeks, one should remove the system from the vagina. This can be done by hooking the finger under the edge of the system or by grasping it with the index and middle fingers and pulling it out (Figure 5). If the patient is unable to locate the system in the vagina but cannot remove it, they should contact their doctor.
• 7. The used system should be disposed of with other household waste, preferably in a sealed pouch in which it was originally packaged. One should not flush NuvaRing down the toilet.

Figure 1
Remove the system from the pouch

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 the index finger under the edge of the system or grasping it with the 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 three weeks without interruption, counting from the day of insertion.
• 2. After 3 weeks, it should be removed on the same day of the week it was inserted, and at about the same time. For example, if NuvaRing 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, one should take a 1-week break. During this time, bleeding may occur. 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 about 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, one should follow the instructions in section 3.4 "What to do if the patient forgets to insert a new NuvaRing system after the 1-week break".

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

3.3 When to insert the first NuvaRing system

• The previous cycle did not involvehormonal contraception. Insert NuvaRing on the first day of the natural cycle (i.e., the first day of menstruation). NuvaRing is effective from the moment of insertion. There is no need to use any additional contraceptive methods. NuvaRing can also be started between the 2nd and 5th day of menstruation, but in this case, during the first 7 days of using NuvaRing, an additional contraceptive method should be used (such as a male condom). This recommendation only applies to the first use of NuvaRing.
• The previous month the patient usedcombined hormonal contraceptive pills. One should start using NuvaRing no later than the day following the break in taking the currently used drug. If the currently used drug also has pills that do not contain active substances, one should start using NuvaRing no later than the day after taking the last pill that does not contain active substances. In case of doubt about which pill is which, one should ask their doctor or pharmacist. One should not extend the break in using the current pills beyond the recommended period. If the patient has been taking their pills regularly and is sure they are not pregnant, they can stop taking the pills on any day and start using NuvaRing immediately.
• The previous month the patient useda transdermal system(patch). One should start using NuvaRing no later than the day following the break in using the transdermal system. One should not extend the break in using the transdermal system beyond the recommended period. If the patient has been using the transdermal system regularly and is sure they are not pregnant, they can stop using the transdermal system on any day and start using NuvaRing immediately.
• The previous month the patient useda minipill(progestogen-only contraception). One can stop using the minipill on any day and start using NuvaRing the next day at the same time they would have taken the minipill. During the first 7 days of using NuvaRing, an additional contraceptive method should be used (such as a male condom).
• The previous month the patient usedinjections or an implant, or an intrauterine systemreleasing progestogen [IUD]. One 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, an additional contraceptive method should be used (such as a male condom).
• After childbirth. After giving birth, the doctor may recommend using NuvaRing only after the first menstruation has occurred. Sometimes, NuvaRing can be started earlier; the doctor will advise when. If the patient is breastfeeding and wants to use NuvaRing, they should discuss this with their doctor first.
• After a miscarriage. According to the 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 was inserted incorrectly, during tampon removal, during sexual intercourse, due to constipation, or uterine prolapse. Therefore, one should regularly check if the system is in the vagina (e.g., before and after sexual intercourse).

3.5 What to do when the patient wants to stop using NuvaRing

If the patient wants to stop using NuvaRing because they want to become pregnant, they should consult their doctor. The doctor will advise them on how to proceed.

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 severe and persistent ones or changes in health that the patient considers related to the use of NuvaRing, the patient should consult a doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before using NuvaRing".
If there is an allergy (hypersensitivity) to any of the ingredients 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:
Common:may occur in up to 1 in 10 women

• abdominal pain, nausea
• vaginal infections by yeast (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.

Uncommon: may occur in up to 1 in 100 women

• vision disturbances; dizziness
• bloating; vomiting, diarrhea, or constipation
• fatigue, malaise, or restlessness; mood changes; sudden mood swings
• edema
• urinary tract infections
• problems or pain during urination; urgency to urinate or need to urinate frequently
• 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 breasts)
• cervicitis; cervical polyps; cervical ectropion
• changes in menstrual bleeding (e.g. heavy, prolonged, irregular, or complete lack 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 hives.

Rare: 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 transient ischaemic attack or "mini-stroke" blood clots in the liver, stomach, and intestine, kidneys, or eye The risk 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.

Not known(frequency cannot be estimated from the 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 related to damage to the therapeutic vaginal system.

In women using combined hormonal contraceptives, breast cancer and liver tumors have occurred. For more detailed information, see section 2.2 "Warnings and precautions", "Tumors".
NuvaRing may rarely 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 Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. 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 will help to gather more information on the safety of the drug.

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 suspected exposure of a child to the hormones contained in NuvaRing.
Do not store above 30°C. Store in the original packaging to protect from light and moisture.
Do not use NuvaRing after 4 months from the date of issue of the medicine in the pharmacy. The date of issue is stated on the packaging.
Do not use NuvaRing after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Do not use NuvaRing 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 bag. 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 ethinylestradiol (2.7 mg).
• The other ingredients are: poly(ethylene-vinyl acetate), 28% and 9% vinyl acetate (a type of plastic that does not dissolve in the body) and magnesium stearate.

Etonogestrel and ethinylestradiol 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 opened and re-closed. The sachets are placed in a cardboard box with a leaflet. The packaging contains 1 or 3 systems.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Organon Healthcare GmbH
Neuturmstr. 5
80331 Munich
Germany

Manufacturer:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:80333.00.00

Parallel import authorization number: 173/24

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

NuvaRing
0.120 mg/ 0.015 mg/ 24 h, therapeutic vaginal system
Austria, Belgium, 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 (Northern Ireland).

Date of revision of the leaflet: 25.04.2024

These stickers, stuck on the corresponding day in the calendar, can help remember when to insert and remove NuvaRing.

Insert Remove
NuvaRing NuvaRing
[Information about trademark]