Nuvaring

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging 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.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2.2 "Warnings and precautions" - BLOOD CLOTS).

One should carefully read the contents of the leaflet before using the medicine, 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 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 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 contraceptive.

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 2.2 "Warnings and precautions" - BLOOD CLOTS).

NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (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), in the lungs (pulmonary embolism), or in other organs,
• if the patient knows they have blood clotting disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies,
• if the patient needs to have surgery or will be immobilized for a long time (see section 2.2 "Warnings and precautions" - 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 a transient ischemic attack (temporary stroke symptoms),
• if the patient has any of the following diseases, which 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 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 genital organ cancer, 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 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 a non-hormonal contraceptive method should be used during this time.

2.2 Warnings and precautions

When should one contact a doctor?

• if the patient notices possible 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), a heart attack, or a stroke (see below "BLOOD CLOTS").

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

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

• if breast cancer occurs in the patient's 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 body's 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 found to have 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 have surgery or will be immobilized for a long time (see section 2.2 "Warnings and precautions" - BLOOD CLOTS);
• if the patient has recently given birth, as they are at increased risk of blood clots. One should consult a doctor for information on how soon they can start using NuvaRing after giving birth;
• if the patient has superficial thrombophlebitis (inflammation of veins under the skin);
• if the patient has varicose veins;
• if the patient has diseases that first occurred 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 characterized by involuntary, abrupt 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 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). 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, uterine 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 vaginal therapeutic system inside the vagina. These symptoms may indicate that the vaginal therapeutic system NuvaRing 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 them. In rare cases, a blood clot can block a blood vessel and cause serious complications.

How to recognize the occurrence of blood clots

One should immediately consult a doctor if they notice any of the following 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 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).

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.
• 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 a 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.

What factors increase the risk of blood clots in veins?

The risk of blood clots associated with the use of the NuvaRing vaginal therapeutic system 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^2);
• 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 clotting disorders;
• if the patient needs to have 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 medicine;
• 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.

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 a heart attack or stroke associated with the use of the NuvaRing vaginal therapeutic system is very small, but may increase:

• with age (over approximately 35 years old);
• if the patient smokes.While using a hormonal contraceptive like the NuvaRing vaginal therapeutic system, 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 found to have 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.

Cancer

The following information is based on studies using combined oral contraceptives and may also apply to NuvaRing. Information on vaginal use of hormonal contraceptives (as with 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 medicines. It is possible that women using combined contraceptives are more likely to have their breasts examined, which may lead to more breast cancers being detected.

The increased incidence of breast cancer disappears 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 their 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 liver tumors. If the patient experiences unusual, severe abdominal pain, they should consult their doctor.

There are reports that women using combined contraceptives are less likely to have 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 18 years old.

2.4 NuvaRing and other medicines

One should always tell their doctor about medicines or herbal products they are currently using. One should also inform other doctors or dentists prescribing other medicines (or pharmacists) about the use of NuvaRing. They may inform about the need to use an additional contraceptive method (e.g., a male condom), and if so, for how long, and whether it is necessary to modify the use of other medicines.

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). 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.

Warning: 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 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, pibrentaswir, they 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 to use these medicines, the doctor will prescribe a different type of contraceptive.

The use of the NuvaRing vaginal therapeutic system 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, one can also use tampons. 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 sufficient to rinse the vaginal therapeutic system with cold or lukewarm water and reinsert it as soon as possible.

Damage to the vaginal therapeutic system has occurred during the use of vaginal products, such as moisturizers or treatments for infections (see section 3.4 "What to do if the vaginal therapeutic 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 vaginal 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 information in 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 use 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 NuvaRing 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. One should regularly check if the vaginal therapeutic system NuvaRing is in place (e.g., before and after 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.

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, such as standing with one leg raised, squatting, or lying down.
• 4. One should remove the NuvaRing system 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 the NuvaRing vaginal therapeutic system is one in which it is not felt. If the system is uncomfortable, one should gently adjust its position (e.g., push the system 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 index finger around 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. The used system should be disposed of with other household waste, preferably in a sealed pouch in which it was originally packaged. NuvaRing should not be flushed down the toilet.

How to insert the NuvaRing vaginal therapeutic system:

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 place for 3 weeks (Figure 4C).

Figure 5
Remove the system from the vagina, hooking the index finger around 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 3 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 the NuvaRing system was inserted on a Wednesday at around 10:00 PM, it should be removed on a 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, one should insert a new system. If the insertion of a 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 vaginal therapeutic system after the break".

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

3.3 When to insert the first NuvaRing vaginal therapeutic system

• If no hormonal contraceptive was used in the previous cycle, one should insert the NuvaRing system on the first day of the natural cycle (i.e., the first day of menstruation). NuvaRing starts working 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, an additional contraceptive method (such as a male condom) should be used during the first 7 days of using NuvaRing. This recommendation only applies to the first use of NuvaRing.
• If the patient used combined hormonal oral contraceptives in the previous month, one should start using NuvaRing no later than the day after the last active tablet. If the currently used medicine has inactive tablets as well, one should start using NuvaRing no later than the day after the last inactive tablet. If in doubt, which tablet is which, one should ask their doctor or pharmacist. One should not extend the break in using the current tablets beyond the recommended period. If the patient has been taking their tablets regularly and is sure they are not pregnant, they can stop taking the tablets on any day and start using NuvaRing immediately.
• If the patient used a transdermal system (patch) in the previous month, one should start using NuvaRing no later than the day after the patch is removed. 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.
• If the patient used a minipill (progestogen-only pill) in the previous month, one can stop using the minipill on any day and start using NuvaRing the next day at the same time. During the first 7 days of using NuvaRing, an additional contraceptive method (such as a male condom) should be used.
• If the patient used injections 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 scheduled injection or on the day the implant or intrauterine system is removed. During the first 7 days of using NuvaRing, an additional contraceptive method (such as a male condom) should be used.
• 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 vaginal therapeutic system is accidentally expelled from the vagina

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

3.5 Procedure when the 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 her first menstruation and then start trying to conceive. This will help determine the due date.

4. Possible side effects

Like all medicines, the NuvaRing therapeutic vaginal system 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 NuvaRing, the patient should consult her doctor. All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or arteries (arterial thrombosis). To get detailed information on the different risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2. „Important information before using NuvaRing”. If an allergic reaction (hypersensitivity) to any of the components of NuvaRing occurs, 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 urticaria potentially with impaired breathing. In these cases, the patient should remove NuvaRing and contact her doctor immediately (see also section 2.2 „Warnings and precautions”).

Women using NuvaRing have reported the following side effects:

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
• fatigue, malaise, or irritability; mood changes; sudden mood swings
• edema
• urinary tract infections or urinary tract infections
• problems or pain during urination; urgency 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 breast swelling or pain)
• 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 hives
• urticaria

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 ischemic attack or transient stroke-like symptoms, known as a transient ischemic attack liver, stomach, and intestine, kidney, or eye blood clots

The probability of developing blood clots may be higher if the patient has any other risk-increasing factors (see "Section 2" for more information on risk-increasing factors and symptoms of blood clots).

• galactorrhea

Unknown:frequency cannot be determined from available data

• chloasma (yellow-brown 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 adhering 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 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 side effects occur, including any side effects not listed in this leaflet, the patient should tell her doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the use of NuvaRing.

5. How to store NuvaRing

The medicine should be stored out of sight and reach of children. The patient should contact her doctor if she discovers that a child has been exposed to the hormones in NuvaRing. Store at a temperature below 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 box and on the sachet. Do not use NuvaRing after the expiry date stated on the packaging. The expiry date refers to the last day of the specified 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 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. Contents of the packaging 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% 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 NuvaRing looks like and what the packaging 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 then reclosed. The sachets are placed in a cardboard box with a leaflet. The packaging contains 1 or 3 systems. For more information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Organon Portugal, Sociedade Unipessoal, Lda. Rua Aleksandre Herculano, 50- Piso 9 1250-011 Lisbon Portugal

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 Portuguese marketing authorization number:3694981 3695087 Parallel import authorization number:333/24

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, 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 (Northern Ireland).

Date of revision of the leaflet:

[Information about the trademark]

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language. NuvaRing, (0.120 mg + 0.015 mg)/24 h, therapeutic vaginal 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 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 her doctor if she suspects that blood clot symptoms have occurred (see section 2.2 „Warnings and precautions” - BLOOD CLOTS). To get a description of the serious side effects listed, see „How to recognize blood clots”.

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

• The patient should keep this leaflet, so that she can read it again if necessary.
• If the patient has any doubts, she should consult her doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. The patient should not pass it on to others. The medicine may harm them.
• 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.

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 and the NuvaRing Applicator
• 6. Contents of the packaging and other information

1. What NuvaRing is and what it is used for

NuvaRing is a contraceptive that prevents pregnancy. Each therapeutic vaginal system contains a small amount of two female sex hormones - etonogestrel and ethinyl estradiol. 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 (COC), 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 eggs from the ovaries. Since eggs are not released, the patient cannot become pregnant.

2. Important information before using NuvaRing

General notes

Before starting to use NuvaRing, the patient 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 2.2 „Warnings and precautions” - BLOOD CLOTS). This leaflet describes situations in which the patient should stop using NuvaRing or in which its effectiveness may be reduced. In these situations, the patient should abstain from intercourse or use an additional non-hormonal contraceptive method, such as a male condom or another mechanical method. The patient should notuse methods based on a calendar or body temperature measurement. 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, she must inform her 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 she has a blood clotting disorder - such as a deficiency of protein C, protein S, antithrombin III, the presence of factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness;
• if the patient has had a heart attack or stroke;
• if the patient has (or has had) angina pectoris (a disease that causes severe chest pain, which can be the first symptom of a heart attack) or a transient ischemic attack (transient stroke-like symptoms);
• if the patient has any of the following diseases, which may increase the risk of developing 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 the patient has (or has ever had) a type of migraine called „migraine with aura”;
• if the patient has (or has ever had) pancreatitis associated with high levels of fats in the blood;
• if the patient has (or has ever had) severe liver disease, and liver function has not returned to normal;
• if the patient has (or has ever had) a benign or malignant liver tumor;
• if the patient has (or has ever had) 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 ethinyl estradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions occur for the first time while using NuvaRing, the patient should remove the system from the vagina and consult her doctor, and use a non-hormonal contraceptive method in the meantime. If the patient has a hepatitis C infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir and pibrentasvir, she should not use the NuvaRing vaginal system (see also section 2.4 „NuvaRing and other medicines”).

2.2 Warnings and precautions

When should the patient contact her doctor? The patient should contact her doctor immediately

• if she notices possible symptoms of a blood clot, which may indicate that she has a blood clot in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see below - BLOOD CLOTS). To get a description of these serious side effects, see „How to recognize blood clots”.

The patient should tell her doctor if she has any of the following conditions.

If these conditions occur or worsen while using NuvaRing, the patient should also tell her doctor.

• if breast cancer has occurred or occurred in the patient's 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 body's 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;
• if the patient is immediately postpartum, she is at increased risk of developing blood clots. The patient should consult her doctor to find out how soon she can start using NuvaRing after giving birth;
• if the patient has superficial thrombophlebitis (inflammation of the veins just 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., loss of hearing, porphyria [a blood disease], herpes gestationis [a blistering skin rash that occurs during pregnancy], or Sydenham's chorea [a disease of the nervous system, characterized by involuntary, jerky movements of the body];
• the patient should contact her doctor immediately if she experiences symptoms of angioedema, such as swelling of the face, lips, tongue, and/or throat, and/or difficulty swallowing, or if she experiences urticaria with impaired breathing. Estrogen-containing medicines may cause or worsen the symptoms of hereditary and acquired angioedema;
• if the patient has chloasma (melasma) currently or in the past (yellow-brown spots, especially on the face). If this occurs, the patient 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 experiences sudden, frequent need to urinate with a burning sensation and/or pain, and if the patient is unable to locate the therapeutic vaginal system inside the vagina. These symptoms may indicate that the NuvaRing therapeutic vaginal system has been accidentally placed in the urinary bladder.

BLOOD CLOTS

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

Blood clots can occur:

• in the veins (so-called „venous thromboembolism” or „deep vein thrombosis”);
• in the arteries (so-called „arterial thromboembolism” or „arterial thrombosis”).

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

It should be remembered that the overall risk of developing harmful blood clots caused by NuvaRing is small.

HOW TO RECOGNIZE BLOOD CLOTS

The patient should contact her doctor immediately if she notices any of the following symptoms. Is the patient experiencing any of these symptoms? Why is the patient likely to be suffering from

• swelling or a feeling of swelling in the leg or 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 the 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 stomach pain.

If the patient is unsure, she should contact her 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 occur most often 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 a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur.
• 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 a 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 developing blood clots in a vein highest?

The risk of developing 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 developing blood clots returns to normal within a few weeks.

What affects the risk of developing blood clots in a vein?

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

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

Risk of developing blood clots in a year

Women who do not usecombined hormonal tablets/patches/systems and are not pregnant About 2 out of 10,000 women Women using combined hormonal contraceptive tablets containing levonorgestrel, norethisterone, or norgestimateAbout 5-7 out of 10,000 women Women using the NuvaRing vaginal system About 6-12 out of 10,000 women

Factors that increase the risk of developing blood clots in veins

The risk of developing 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/m2);
• 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). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness;
• with age (especially over 35 years);
• if the patient has recently given birth.

The risk of developing blood clots increases with the number of risk factors present in the patient. Air travel (>4 hours) may temporarily increase the risk of developing blood clots, especially if the patient has another risk factor. It is essential to tell the doctor if any of the above factors apply to the patient, even if the patient is not sure. The doctor may decide to stop using NuvaRing. The patient should inform her doctor if any of the above conditions change while using NuvaRing, e.g., if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

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 Medications

A doctor should always be informed about medications or herbal products currently being used by the patient. The doctor of another specialty or the dentist prescribing other medications (or pharmacist) should also be informed about the use of NuvaRing. They may inform about the need to use an additional contraceptive method (e.g., condoms for men), and if so, for how long, as well as whether it is necessary to modify the use of another medication. Some medications

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

This applies to medications 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 pulmonary arteries (bosentan);
• depressive moods (St. John's wort).

If the patient is taking medications or herbal products that may reduce the effectiveness of NuvaRing, an additional mechanical contraceptive method (e.g., condoms for men) should be used. Due to the fact that the effect of another medication on NuvaRing may persist for up to 28 days after stopping the medication, 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 medications such as:

• medications containing cyclosporine
• the antiepileptic medication lamotrigine (which may lead to an increased frequency of seizures).

If the patient has hepatitis C virus infection and is taking medications containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir and pibrentasvir, NuvaRing should not be used, as it may cause an increase in liver function test results (elevation of liver enzyme ALT). Before starting these medications, 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, consult a doctor or pharmacist.
During the use of NuvaRing, tampons can be used at the same time. NuvaRing should be inserted before inserting a tampon. Care should be taken when removing the tampon to avoid accidentally removing NuvaRing as well. If NuvaRing is expelled, it can be rinsed with cold or lukewarm water and reinserted as soon as possible. Damage to the NuvaRing system has occurred during the use of vaginal products, such as lubricants or treatments for infections (see section 3.4 "What to do if the NuvaRing system is damaged"). 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, the persons performing the tests should be informed 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 pregnancy is suspected. If the patient becomes pregnant during the use of NuvaRing, the system should be removed and a doctor consulted. If the patient wants to stop using NuvaRing because she wants to become pregnant, she should refer to the information in section 3.5 "What to do if the patient wants to stop using NuvaRing". It is not recommended to use NuvaRing during breastfeeding. If the patient wants to use NuvaRing during breastfeeding, she should consult a doctor first.

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

3.1 Inserting and Removing NuvaRing

• 1. Before insertion, check the expiration date (see section 5 "How to store NuvaRing and NuvaRing Applicator").
• 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 the NuvaRing system from the pouch.
• 5. Holding the system between the thumb and index finger, squeeze it and insert it into the vagina (see Figures 1-4). Alternatively, the NuvaRing Applicator can be used to help place the system in the vagina (see: User Instructions, below). The correct position of the NuvaRing system is one in which it is not felt. If the system is uncomfortable, it should be gently repositioned (e.g., pushed slightly further into the vagina) until the patient feels comfortable. The position of the system in the vagina does not affect its contraceptive action.
• 6. After 3 weeks, remove the system from the vagina. This can be done by hooking the index finger around the edge of the system or grasping it with the index and middle fingers and pulling it out (Figure 5). If the patient locates the system in the vagina but is unable to remove it, she should contact her doctor.
• 7. Dispose of the used system with household waste, preferably in a sealed pouch in which it was originally contained. Do not flush NuvaRing down the toilet.

Important Information About the NuvaRing Applicator:

• 1. Optional for use during the insertion of the NuvaRing system.
• 2. DO NOT reuse the applicator; it is intended for single use.
• 3. DO NOT lend the applicator to other people.
• 4. If the applicator is accidentally dropped, it should be rinsed with cold or lukewarm (NOT hot) water.
• 5. After use, the applicator should be discarded immediately into a regular household waste container.
• 6. Do not flush the applicator down the toilet.

How to Insert the NuvaRing System Using the Applicator:

1: Preparation

Before opening the packaging, wash your hands. The packaging should be opened ONLY just before using the applicator. DO NOT use the applicator if the packaging or its contents are visibly damaged.

	The applicator is intended for use ONLY with the NuvaRing system. Do not use it with other medicinal products.
	Familiarize yourself with the drawing of the applicator and its parts. A. Plunger B. Handle C. Cylinder D. Opening in the cylinder E. NuvaRing system

2: Setting the Plunger and Assuming the Correct Position

	Gently pull the plunger to the end.
	Squeeze the opposite sides of the NuvaRing system and insert it into the opening in the cylinder.
	Gently push the NuvaRing system into the center of the cylinder. The end of the NuvaRing system should slightly protrude from the opening in the cylinder.

Choose the most comfortable position for inserting the NuvaRing system, such as lying down, squatting, or standing with one leg raised.

3: Inserting the NuvaRing System and Removing the Applicator

	Hold the applicator by the handle with the thumb and middle finger.
	Gently insert the cylinder into the vagina until the fingers (on the handle) touch the body. Then, using the index finger, gently press the plunger to the end. During the use of the applicator, some women have experienced transient, mild pinching sensation.
	The NuvaRing system will be expelled from the applicator. Gently pull out the applicator.
	Make sure the NuvaRing system has not remained in the applicator. The used applicator should be discarded into a regular household waste container. DO NOT flush the applicator down the toilet. DO NOT reuse the applicator.

3.2 Three Weeks of Use, One Week of Break

• 1. The system must remain in the vagina for 3 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, 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.

After removing the system, a 1-week break should be taken. During this time, bleeding may occur. It usually starts 2-3 days after removal. 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, follow the instructions in section 3.4 "What to do if the patient forgets to insert a new NuvaRing system after the break".

• 3. 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 previous cycle did not involvehormonal contraception. Insert the NuvaRing system on the first day of the natural cycle (i.e., the first day of menstruation). NuvaRing starts working immediately. There is no need to use any additional contraceptive methods. Alternatively, NuvaRing can be started between the 2nd and 5th day of menstruation, but in this case, an additional contraceptive method (such as a condom for men) should be used during the first 7 days of NuvaRing use. This recommendation applies only to the first use of NuvaRing.
• The previous month involvedcombined hormonal pills. Start using NuvaRing no later than the day following the pill-free interval of the currently used medication. If the currently used medication also contains inactive pills, start using NuvaRing no later than the day after taking the last inactive pill. In case of doubt about which pill is which, consult a doctor or pharmacist. Do not extend the pill-free interval beyond the recommended period. If the patient has been taking the pills regularly and is certain she is not pregnant, she can stop taking the pills on any day and start using NuvaRing immediately.
• The previous month involveda transdermal patch. Start using NuvaRing no later than the day following the patch-free interval. Do not extend the patch-free interval beyond the recommended period. If the patient has been using the patch regularly and is certain she is not pregnant, she can stop using the patch on any day and start using NuvaRing immediately.
• The previous month involveda minipill (progestogen-only pill). The minipill can be stopped on any day, and NuvaRing can be started the next day at the same time the minipill was taken. During the first 7 days of NuvaRing use, an additional contraceptive method (such as a condom for men) should be used.
• The previous month involvedinjections or an implant, or a progestogen-releasing intrauterine system (IUD). Start using NuvaRing on the day of the next scheduled injection or on the day the implant or IUD is removed. During the first 7 days of NuvaRing use, an additional contraceptive method (such as a condom for men) should be used.

Start using NuvaRing after the first menstruation. Sometimes, NuvaRing can be started earlier; the doctor will advise when. If the patient is breastfeeding and wants to use NuvaRing, she should discuss this with her doctor first.

• After childbirth. The doctor may recommend using NuvaRing only after the first menstruation. Sometimes, NuvaRing can be started earlier; the doctor will advise when. If the patient is breastfeeding and wants to use NuvaRing, she should discuss this with her doctor first.
• After a miscarriage. As advised by the doctor.

3.4 What to Do If...

What to Do If the NuvaRing System Is Accidentally Expelled from the Vagina

The NuvaRing system 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 uterine prolapse. Therefore, the patient should regularly check if the system is in place (e.g., before and after sexual intercourse).

What to Do If the System Has Been Out of the Vagina for a While

NuvaRing may still protect against pregnancy, but this depends on how long it has been out of the vagina.
If the system has been out of the vagina for:

• a period shorter than 3 hours, the patient is still protected against pregnancy. The NuvaRing system should be rinsed with cold or lukewarm (not hot) water and reinserted as soon as possible, but only if it has been out of the vagina for less than 3 hours.
• a period longer than 3 hours during the first or second weekof use, the contraceptive effectiveness may be reduced. The NuvaRing system should be rinsed with cold or lukewarm (not hot) water and reinserted as soon as possible, and it should be left in place without interruption for at least 7 days. If sexual intercourse is planned during these 7 days, a condom for men should be used in addition. If the patient had sexual intercourse before realizing the system was out of place, she should consult a doctor.
• a period longer than 3 hours during the third weekof use, the contraceptive effectiveness may be reduced. The NuvaRing system should be removed, and one of the following options can be chosen:
• 1 – Insert a new NuvaRing system as soon as possible. Inserting a new system means starting the next 3-week period of use. This may result in the absence of expected withdrawal bleeding, although spotting or breakthrough bleeding may occur.
• 2 – Do not insert a new NuvaRing system immediately. Wait for withdrawal bleeding to occur and insert a new system no later than 7 days after the previous system was removed or expelled. This approach can only be taken if the patient has been using NuvaRing continuously for the last 7 days.
• unknown period of time, the woman may not be protected against pregnancy. Before inserting a new NuvaRing system, a pregnancy test should be performed and a doctor consulted.

What to Do If the NuvaRing System Is Damaged

Very rarely, the NuvaRing system may be damaged. There have been reports of vaginal wall damage associated with the damage of the NuvaRing system. If the patient notices that the NuvaRing system is damaged, she should remove it and insert a new one as soon as possible. For the next 7 days, an additional contraceptive method (e.g., a condom for men) should be used. If sexual intercourse occurred before the patient noticed the damage, she should consult a doctor.

What to Do If More Than One NuvaRing System Is Inserted

So far, there have been no reports of serious harmful effects associated with an overdose of the hormones contained in NuvaRing. If more than one NuvaRing system is inserted accidentally, nausea, vomiting, or bleeding from the genital tract may occur. The additional NuvaRing system should be removed, and a doctor consulted if the symptoms do not resolve.

What to Do If a New NuvaRing System Is Forgotten After the Break

If the break in useof the NuvaRing system is longer than 7 days, a new system should be inserted as soon as possible. If sexual intercourse occurs during the next 7 days, an additional contraceptive method (e.g., a condom for men) should be used. If sexual intercourseoccurred during the break in useof the NuvaRing system, there is a possibility of pregnancy. In such a case, a doctor should be consulted as soon as possible. The longer the break in use of the NuvaRing system, the higher the probability of pregnancy.

What to Do If the NuvaRing System Is Not Removed on Time

• If the system has been in the vagina for longer than 3 weeks but no longer than 4 weeks, the patient is still protected against pregnancy. The NuvaRing system should be removed, and a 1-week break taken before inserting a new system.
• If the patient has used the NuvaRing system for more than 4 weeks, there is a possibility of pregnancy. Before inserting a new NuvaRing system, a doctor should be consulted.

What to Do If Withdrawal Bleeding Does Not Occur

If the Patient Has Used NuvaRing According to the Instructions

If withdrawal bleeding does not occur on time, but the patient has used NuvaRing according to the instructions and has not used other medications during this time, the probability of pregnancy is very low. The patient should continue using NuvaRing as before. However, if withdrawal bleeding does not occur twice in a row, there is a possibility of pregnancy. A doctor should be consulted as soon as possible. A new NuvaRing system should not be inserted until the doctor has confirmed that the patient is not pregnant.

If the Patient Has Not Used NuvaRing According to the Instructions

If withdrawal bleeding does not occur during the first break in NuvaRing use, and the patient has not used the system according to the instructions, she may be pregnant. Before using a new NuvaRing, a doctor should be consulted.

What to Do If Unexpected Bleeding Occurs

During the use of the NuvaRing system, some women may experience unexpected breakthrough bleeding. The patient may need to use sanitary pads. The NuvaRing system should be left in place and used as before. If irregular bleeding becomes heavier or recurs, a doctor should be consulted.

What to Do If the Day of Withdrawal Bleeding Needs to Be Changed

If NuvaRing is used according to the instructions, menstruation (withdrawal bleeding) will start during the break in NuvaRing use. If the patient wants the withdrawal bleeding to start on a different day, she can shorten the break in NuvaRing use (but never extend it!). For example: if withdrawal bleeding usually starts on a Friday, and the patient wants to change this day to Tuesday (3 days earlier), she should insert a new NuvaRing system 3 days earlier than usual. If the break in NuvaRing use is significantly shortened (e.g., to 3 days or less), withdrawal bleeding may not occur at all during this time. During the use of the next NuvaRing system, spotting or breakthrough bleeding may occur.

What to Do If Withdrawal Bleeding Needs to Be Delayed

Although not recommended, withdrawal bleeding can be delayed by inserting a new NuvaRing system immediately after removing the previous one, without a break. The new NuvaRing system can be used for no longer than 3 weeks. During the use of the new NuvaRing system, spotting or breakthrough bleeding may occur. To induce withdrawal bleeding, the NuvaRing system should be removed. It is recommended to take regular weekly breaks between NuvaRing systems. Before deciding to delay withdrawal bleeding, the patient may want to consult her doctor.

3.5 What to Do If the Patient Wants to Stop Using NuvaRing

The patient can stop using NuvaRing 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 after the first menstruation and then try to conceive. This will help determine the due date.

4. Possible Side Effects

Like all medications, the NuvaRing system can cause side effects, although not everybody gets them. If any side effects occur, especially severe or persistent ones, or changes in health that the patient thinks may be due to NuvaRing, a doctor should be consulted. All women using combined hormonal contraceptives are at an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). To obtain detailed information about the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using NuvaRing". If an allergic reaction (hypersensitivity) to any of the components of NuvaRing occurs, 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 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
• headaches or migraines; 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
• feeling tired, unwell, or restless; mood changes; sudden mood swings
• edema
• urinary tract infections or bladder 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 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 breast swelling or pain)
• cervicitis; cervical polyps; cervical ectropion
• 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 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 ischemic attack or "mini-stroke" blood clots in the liver, stomach, intestine, kidneys, or eye

The probability of developing blood clots may be higher if the patient has other risk factors (see section 2 for more information about risk factors for 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 determined from available data

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

Women using combined hormonal contraceptives have developed breast cancer and liver tumors. For detailed information, see section 2.2 "Warnings and precautions" - Cancer. Very rarely, the NuvaRing system may be damaged. For additional information, see section 3.4 "What to do if the NuvaRing system is damaged".

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medication.

5. How to Store NuvaRing and NuvaRing Applicator

The medication should be stored out of sight and reach of children. A doctor should be consulted if a child is exposed to the hormones in NuvaRing. Store at a temperature below 30°C. Store in the original packaging to protect from light and moisture. Do not use NuvaRing after 4 months from the date of dispensing. The date of dispensing is indicated on the box and on the pouch of the NuvaRing system. Do not use NuvaRing after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Do not use NuvaRing if it has changed color or if there are any visible signs of deterioration. The used NuvaRing system should be disposed of in a regular household waste container, preferably in a sealed pouch in which it was originally contained. The used applicator should be discarded in a regular household waste container. NuvaRing or the NuvaRing Applicator should not be flushed down the toilet. As with other medications, unused or expired systems should not be disposed of in the sewage system or household waste. A pharmacist should be asked 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 NuvaRing contains

• The active substances of the medicinal product are: etonogestrel (11.7 mg) and ethinyl estradiol (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 ethinyl estradiol are released from the vaginal therapeutic 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 packaging contains

NuvaRing is a flexible, transparent, colorless or almost colorless ring
with an outer diameter of 54 mm.
Each vaginal therapeutic system is packaged in a separate foil sachet. The sachet
can be reopened after opening.
The applicator is a plastic, non-sterile medical device made of PP, intended for
single use (i.e. single-use). Each applicator is packaged separately. The applicator
bears the CE marking, which is embossed on the medical device.
The sachet with the vaginal therapeutic system (and) the applicator(s) are placed
in a cardboard box with the leaflet.
Each package contains 1 or 3 systems and applicators.
To obtain more detailed information, please contact the marketing authorization holder
or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Organon Portugal, Sociedade Unipessoal, Lda.
Aleksandre Herculano Street, 50 - 9th floor
1250-011 Lisbon
Portugal

Manufacturer:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska Street 249
04-458 Warsaw
Authorization number in Portugal, the country of export:5717756
5717764
Parallel import authorization number:333/24

This medicinal product is authorized for sale 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, vaginal therapeutic 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 (Northern Ireland).

Date of approval of the leaflet: 30.12.2024

[Information about the trademark]