Nuvaring leaflet – Poland

How to use Nuvaring

Leaflet accompanying the packaging: information for the user

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

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

One should keep this leaflet to be able to read it again if necessary.
In case of any doubts, one should consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. It should not be passed 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 NuvaRing is and what it is 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 NuvaRing is and what it is 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 (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 use 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 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

One should not use NuvaRing if any of the following conditions are present. If any of the following conditions are present, the patient 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 (transient stroke symptoms),
if the patient has 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 the patient has (or has had in the past) a type of migraine called "migraine with aura", if the patient has currently or has had in the past pancreatitis associated with high levels of fats in the blood, if the patient has currently or has had in the past severe liver disease ,and liver function has not returned to normal, if the patient has currently or has had in the past a benign or malignant liver tumor, if the patient has currently or has had in the past breast cancer or genital organ cancer or if there is a suspicion of these cancers, if the patient has bleeding from the genital tract of unknown cause, if the patient is allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the 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 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 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 (thrombosis)"). 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 is present or has occurred in close relatives;
if the patient has epilepsy (see section 2.4 "NuvaRing and other medicines");
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 "Blood clots");
if the patient has just given birth, as she is 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], pregnancy herpes [a blistering skin rash during pregnancy], or Sydenham's chorea [a neurological disease in which there are 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 that may be associated with difficulty breathing. Estrogen-containing medicines may cause or worsen symptoms of hereditary and acquired angioedema;
if the patient has chloasma (yellow-brown pigmentation 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;
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 thrombosis" or "venous thromboembolism");
in arteries (hereinafter referred to as "arterial thrombosis" or "arterial thromboembolism").

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 NuvaRing is small.

HOW TO RECOGNIZE BLOOD CLOTS

One should immediately consult a doctor if any of the following symptoms are noticed.
Is the patient 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 while 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

Pulmonary embolism

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 stomach pain;

If the patient is unsure, they should consult a doctor,
as 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).
Symptoms usually occur in one eye:

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

Heart attack

chest pain, discomfort, pressure, heaviness;
a feeling of squeezing or fullness in the chest, arm, or below the breastbone;

Is the patient experiencing any of these symptoms?
Why is the patient likely to suffer
from these symptoms?

a feeling of fullness, indigestion, or choking;
a feeling of discomfort in the lower body radiating to the back, jaw, throat, arm, and stomach;
sweating, nausea, vomiting, or fainting;
extreme weakness, anxiety, or shortness of breath;
rapid or irregular heartbeat.
sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
sudden confusion, speech disturbances, or difficulty understanding;
sudden vision disturbances in one or both eyes;
sudden walking disturbances, dizziness, loss of balance, or coordination;
sudden, severe, or prolonged headaches without a known cause;
loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be
temporary with almost immediate and complete
recovery, however, one should immediately consult a doctor,
as the patient may be at risk of having another stroke.
Stroke
Blood clots blocking
other blood vessels

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. 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 the patient stops using NuvaRing, the risk of blood clots returns to normal within a few weeks.

swelling and slight blue discoloration of the skin of the legs or arms
severe stomach pain (acute abdomen)

What affects the risk of blood clots?

The risk depends on the natural risk of developing venous thromboembolism and the type of combined hormonal contraceptive used.
The total risk of blood clots in the legs or lungs associated with NuvaRing is small.

During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
During a year, about 6 to 12 out of 10,000 women who use combined hormonal contraceptives containing norelgestromin or etonogestrel, such as NuvaRing, 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).

	Risk of blood clots in a year
Women who do not use combined hormonal pills/patches/systems and are not pregnant	About 2 out of 10,000 women
Women using combined hormonal contraceptive pills containing levonorgestrel, norethisterone, or norgestimate	About 5-7 out of 10,000 women
Women using NuvaRing	About 6-12 out of 10,000 women

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with 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 immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). 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 it;
with age (especially over 35 years);
if the patient has 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 the patient has another risk factor.
It is essential to tell the doctor if any of these factors are present, even if the patient is 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 immediate 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 cause 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 heart attack or stroke associated with NuvaRing is very small, but it may increase:

with age (over about 35 years);
if the patient smokes.During the use of 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 immediate family has had a heart attack or stroke at a young age (under 50). 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 immediate 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 the patient's immediate 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 with NuvaRing) is not available.
In women using combined contraceptives, breast cancer has been found to occur slightly more often, although it is not known if this is caused by the medicines used. It is possible that in women using combined contraceptives, tumors are detected more often because these women are examined by a doctor more frequently. 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 found, one should consult a doctor. One should also inform the doctor if breast cancer has occurred or is occurring in close relatives (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. If unusual, severe stomach pains occur, one should consult a 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, one should consult a 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

One should always tell the doctor about medicines or herbal products currently being used. One should also inform the doctor of another specialty or the dentist prescribing other medicines (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 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 the patient is taking medicines or herbal products that may reduce the effectiveness of NuvaRing, they should also use a mechanical contraceptive method (e.g., a male condom). Since 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

cyclosporine
the antiepileptic medicine lamotrigine (this may lead to an increased frequency of seizures).

If the patient has a hepatitis C virus infection and is taking medicines 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 the blood (increase in liver enzyme ALT activity).
Before starting these medicines, 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 medicine, 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 a 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 system has occurred during the use of vaginal products, such as moisturizers or treatments for infections (see section 3.4 "What to do if the NuvaRing system is damaged"). The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of NuvaRing.

Diagnostic tests

If laboratory tests of blood or urine are 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 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 if 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 consult their doctor first.

2.6 Driving and using machines

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

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 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 make it difficult to properly insert and position 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 between 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 in 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 adjust the position of the NuvaRing system (e.g., push it slightly further into the vagina) until they feel comfortable. The position of the system in the vagina does not affect its contraceptive effectiveness.
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 consult their doctor.
7. One should dispose of the used system with other household waste, preferably in a sealed pouch in which it was originally packaged. One should not flush NuvaRing down the toilet.

Hand holding the flexible NuvaRing ring removed from the pouch

Figure 1
Remove the system from the pouch

Hand squeezing the flexible NuvaRing ring before insertion

Figure 2
Squeeze the system

Woman in three positions for inserting NuvaRing: standing with one leg raised, squatting, and lying down with legs raised

Figure 3
Choose the most comfortable position

Schematic representation of the vagina with NuvaRing inserted in three stages: insertion, correct positioning, and leaving for 3 weeks

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. Position it inside the vagina so that it does not cause discomfort (Figure 4B). Leave the system in the vagina for 3 weeks (Figure 4C).

Hand removing the flexible NuvaRing ring from the vagina, hooked under the edge with the index finger

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 three 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 three 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 approximately every month on the same days of the week.

3.3 When to insert the first NuvaRing system

The patient did not usea hormonal contraceptive in the previous cycle

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.
One can also start using NuvaRing 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 applies only to the first use of NuvaRing.

The patient usedcombined hormonal contraceptive pills in the previous month

One should start using NuvaRing no later than the day following the end of the use of the currently used medicine. If the currently used medicine 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 patient useda transdermal system (patch) in the previous month

One should start using NuvaRing no later than the day following the end of the use of 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 patient useda minipill (progestogen-only contraceptive) in the previous month

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

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. Sometimes, one can start using NuvaRing 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 if the NuvaRing system is accidentally expelled from the vagina

NuvaRing may be accidentally expelled from the vagina, e.g., if it was not inserted correctly, during tampon removal, during sexual intercourse, due to constipation, or due to cervical prolapse. Therefore, one should regularly check if the system is in the vagina (e.g., before and after sexual intercourse).

3.5 Procedure when the patient wants to stop using the NuvaRing medication

The patient can stop using the NuvaRing medication 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 the NuvaRing medication because she wants to become pregnant, she should wait until her first menstruation and then start trying to conceive. This will help determine the due date.

4. Possible side effects

Like all medications, NuvaRing can cause side effects, although not everybody gets them. If side effects occur, especially serious and persistent ones or changes in health that the patient considers related to the use of the NuvaRing medication, the patient should consult a doctor.
All women using combined hormonal contraceptives are at an increased risk of developing blood clots in the veins (venous thromboembolism) or arteries (arterial thromboembolism). To obtain detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2.

Frequent: may occur in up to 1 in 10 women

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

Uncommon: may occur in up to 1 in 100 women

vision disturbances; dizziness
bloating; vomiting, diarrhea, or constipation
feeling tired, unwell, or restless; mood changes; sudden mood swings
edema
urinary tract infections or bladder infections
problems or pain during urination; urge to urinate or frequent urination
discomfort during intercourse, including pain, bleeding, or discomfort associated with the presence of the system, felt by the male 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 eversion
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

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

harmful blood clots in a vein or artery, such as:
in the leg or foot (e.g., deep vein thrombosis)
in the lungs (e.g., pulmonary embolism)
heart attack
stroke
blood clots in the liver, stomach, and intestine, kidneys, or eye

o stroke
o mini-stroke or transient symptoms of a stroke, known as a transient ischemic attack
o blood clots in the liver, stomach, and intestine, kidneys, or eye
The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for developing blood clots and symptoms of blood clots).

galactorrhea (spontaneous flow of milk from the breast, not associated with childbirth or nursing)

Unknown(frequency cannot be estimated from the available data)

chloasma (yellowish-brown spots on the skin, especially on the face)
partner's penis 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 detailed information, see section 2.2 "Warnings and precautions", "Tumors".
Very rarely, NuvaRing may be damaged. For additional 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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 the NuvaRing medication

The medication should be stored out of sight and reach of children.
The patient should contact a doctor if she discovers that a child has been exposed to the hormones in the NuvaRing medication.
Store at a temperature below 30°C. Store in the original packaging to protect from light and moisture.
Do not use the NuvaRing medication after 4 months from the date of dispensing the medication from the pharmacy. The dispensing date is indicated on the box and on the sachet.
Do not use the NuvaRing medication after the expiration date indicated on the box and on the sachet.
Do not use the NuvaRing medication if it has changed color or if there are any signs of deterioration.
The used therapeutic vaginal system should be discarded in a regular household waste bin, preferably in a sealed sachet. The NuvaRing medication 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 bins. The patient should ask her pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does the NuvaRing medication contain?

The active substances of the medication are: etonogestrel (11.7 mg) and ethinyl estradiol (2.7 mg)
The other ingredients are: ethylene and vinyl acetate copolymers (28% and 9% vinyl acetate) (a type of plastic that does not dissolve in the body) 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 does the NuvaRing medication look like and what does the packaging contain?

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. The packaging contains 1 or 3 systems.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
organonpolska@organon.com

Manufacturer:

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands.

This medication is authorized for marketing in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following name:

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 last revision of the leaflet: 06/2024

Leaflet included in the packaging: information for the user of NuvaRing, (0.120 mg + 0.015 mg)/24 h, Therapeutic Vaginal System

Etonogestrel + Ethinyl Estradiol

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 developing blood clots in the veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
The patient should be cautious and consult a doctor if she suspects that blood clots have occurred (see section 2 "Blood clots").

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

The patient should keep this leaflet, so that she can read it again if necessary.
In case of any doubts, the patient should consult a doctor or pharmacist.
This medication has been prescribed to a specific person. It should not be passed on to others. The medication may harm another person.
If the patient experiences any side effects, including any side effects not listed in this leaflet, she should tell her doctor or pharmacist. See section 4.