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.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one 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, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").

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

2.1 When not to use NuvaRing

You should not use NuvaRing if you have any of the conditions listed below. If you have any of these conditions, you must inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have 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 you have 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 you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) pancreatitis associated with high levels of fats in the blood;
• if you have (or have had in the past) severe liver disease, and liver function has not returned to normal;
• if you have (or have had in the past) a benign or malignant liver tumor;
• if you have (or have had in the past) breast cancer or genital organ cancer, or if there is a suspicion of these cancers;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions occur for the first time while using NuvaRing, you should immediately remove the system from the vagina and consult a doctor, and in the meantime, use a non-hormonal contraceptive method.

2.2 Warnings and precautions

When should you contact a doctor?

• if you notice possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots").

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

If these symptoms appear or worsen while using NuvaRing, you should also tell your doctor.

• if breast cancer is present or has occurred in close relatives;
• if you have epilepsy (see section 2.4 "NuvaRing and other medicines");
• if you have liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones);
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start using NuvaRing after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have diseases that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [a blistering skin rash during pregnancy], or Sydenham's chorea [a neurological disorder with involuntary, sudden movements of the body]);
• you should consult your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or a rash that may be associated with difficulty breathing. Estrogen-containing medications like NuvaRing may cause or worsen the symptoms of hereditary and acquired angioedema;
• if you have chloasma (yellow-brown spots, so-called "pregnancy spots", especially on the face). If they occur, you should avoid excessive sun exposure and ultraviolet radiation;
• if you have conditions that make it difficult to use NuvaRing, such as frequent constipation, uterine prolapse, or pain during intercourse;
• if you experience sudden, frequent need to urinate with a burning sensation and/or pain, and if you cannot locate the vaginal ring inside the vagina. These symptoms may indicate that the vaginal ring has been accidentally inserted into the bladder.

wewnątrz pochwy. The above symptoms may indicate that the vaginal ring has been accidentally inserted into the bladder.

BLOOD CLOTS

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

How to recognize the occurrence of blood clots

You should immediately consult a doctor if you 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 discoloration.
• sudden onset of unexplained shortness of breath or rapid breathing;
• sudden onset of coughing without an obvious cause, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, you 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 veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of 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 veins highest?

The risk of blood clots in veins 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 medication) 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 NuvaRing is small, but some factors can increase this risk. The risk is higher:

• if you are significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your immediate 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, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness, or have a leg in a cast. It may be necessary to stop using NuvaRing for a few weeks before surgery or immobilization. If you need to stop using NuvaRing, you should ask your doctor when you can resume using it;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in a patient.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?

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 NuvaRing is very small, but it may increase:

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

If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher.

Cancer

The following information is based on studies using combined oral contraceptives and may also apply to NuvaRing. Information on the vaginal use of hormonal contraceptives (as 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 if this is caused by the medication. 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, you should consult a doctor. You should also inform your doctor if someone in your immediate family has had or currently has breast cancer (see section 2.2 "Warnings and precautions").

In rare cases, women using combined contraceptives have developed benign liver tumors, and very rarely, malignant liver tumors. If you experience severe, unexplained abdominal pain, you should consult your doctor.

There are reports that women using combined contraceptives are less likely to develop endometrial cancer (cancer of the lining of the uterus) and ovarian cancer. It is possible that this also applies to NuvaRing, but this has not been confirmed yet.

Mental disorders

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

2.3 Children and adolescents

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

2.4 NuvaRing and other medicines

You should always tell your doctor about any medications or herbal products you are currently taking. You should also inform your doctor of another specialty or dentist prescribing other medications (or pharmacist) about using NuvaRing. They may inform you 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 level 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 blood vessels of the lungs (bosentan);
• depressive moods (St. John's Wort).

If you are taking medications or herbal products that may reduce the effectiveness of NuvaRing, you should also use a mechanical contraceptive method (e.g., a condom for men). 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.

NuvaRing may affect the action of other medications, such as

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

If you have a hepatitis C virus infection and are taking medications containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, you should not use the NuvaRing vaginal ring, as this may cause an increase in liver function test results in the blood (increased activity of the liver enzyme ALT). Before starting these medications, your doctor will prescribe a different type of contraceptive.

You can resume using the NuvaRing vaginal ring about 2 weeks after completing this treatment. See section 2.1 "When not to use NuvaRing".

Before taking any medication, you should consult your doctor or pharmacist.

During the use of NuvaRing, you can also use tampons. You should insert NuvaRing before inserting a tampon. You should be careful when removing a tampon to avoid accidentally removing NuvaRing as well. If NuvaRing is expelled, you can rinse it with cold or lukewarm water and reinsert it as soon as possible.

Damage to the vaginal ring has occurred during the use of vaginal products, such as moisturizing products or products for treating infections (see section 3.4, "What to do if the NuvaRing vaginal ring 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, you should inform the persons performing the tests about the use of NuvaRing, as the use of the vaginal ring 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 while using NuvaRing, the vaginal ring should be removed and a doctor consulted.

If the patient wants to stop using NuvaRing because she wants to become pregnant, she 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, she should consult her doctor first.

2.6 Driving and using machines

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

3. How to use NuvaRing

NuvaRing can be inserted and removed by yourself. Your doctor will instruct you on when to start using NuvaRing. The vaginal ring should be inserted on the appropriate day of the cycle (see section 3.3 "When to insert the first NuvaRing vaginal ring") and left in place for 3 weeks in a row. You should regularly check that the NuvaRing vaginal ring is in place in the vagina (e.g., before and after intercourse) to ensure contraceptive protection. After 3 weeks, you should remove NuvaRing and take a 1-week break. Usually, during this break, withdrawal bleeding occurs.

3.1 Inserting and removing NuvaRing

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

Figure 1
Remove the ring from the pouch

Figure 2
Squeeze the ring

Figure 3
Choose the most comfortable position

Figure 4A
Figure 4B
Figure 4C
Insert the ring 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 ring in place for 3 weeks (Figure 4C).

Figure 5
Remove the ring from the vagina, hooking your index finger around the edge of the ring or grasping it with your index and middle fingers and pulling it out.

3.2 Three weeks of use, one week of break

• 1. The ring must be in the vagina for 3 weeks without interruption, counting from the day of insertion.
• 2. After 3 weeks, you should remove it on the same day of the week that it was inserted, and at approximately the same time. For example, if NuvaRing was inserted on a Wednesday at around 10:00 PM, it should be removed on the following Wednesday, 3 weeks later, at around 10:00 PM.
• 3. After removing the ring, you should take a 1-week break. During this time, you may experience bleeding. It usually starts 2-3 days after removal.

• 4. A new ring 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 ring is delayed by more than 3 hours, its contraceptive effectiveness may be reduced. In such a case, you should follow the instructions in section 3.4 "What to do if, after the 1-week break, the patient forgets to insert a new NuvaRing vaginal ring".

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

3.3 When to insert the first NuvaRing vaginal ring

• If you did not usea hormonal contraceptivein the previous cycleInsert NuvaRing on the first day of your natural cycle (i.e., the first day of your period). NuvaRing is effective from the moment of insertion. There is no need to use any additional contraceptive methods. You can also start using NuvaRing between the 2nd and 5th day of your period, but in this case, you should use an additional contraceptive method (such as a condom for men) during the first 7 days of using NuvaRing. This recommendation only applies to the first use of NuvaRing.
• If you usedcombined hormonal oral contraceptivesin the previous monthYou should start using NuvaRing no later than the day after the break in taking your current medication. If your current medication has tablets that do not contain active substances, you should start using NuvaRing no later than the day after taking the last tablet that does not contain active substances. If you are unsure which tablet this is, you should ask your doctor or pharmacist. You should not extend the break in taking your current tablets beyond the recommended period. If you have been taking your tablets regularly and are sure you are not pregnant, you can stop taking the tablets on any day and start using NuvaRing immediately.
• If you useda transdermal system (patch)in the previous monthYou should start using NuvaRing no later than the day after the break in using the transdermal system. You should not extend the break in using the transdermal system beyond the recommended period. If you have been using the transdermal system regularly and are sure you are not pregnant, you can stop using the transdermal system on any day and start using NuvaRing immediately.
• If you useda minipill (progestogen-only pill)You can stop taking the minipill on any day and start using NuvaRing the next day at the same time you would have taken the minipill. During the first 7 days of using NuvaRing, you should also use an additional contraceptive method (such as a condom for men).
• If you usedinjections or an implant, or an intrauterine system releasing progestogen [IUD]You should start using NuvaRing on the day of the next planned injection or on the day the implant or intrauterine system is removed. During the first 7 days of using NuvaRing, you should use an additional contraceptive method (such as a condom for men).
• After giving birthAfter giving birth, your doctor may recommend using NuvaRing only after your first menstrual period. Sometimes, you can start using NuvaRing earlier; your doctor will advise you when. If you are breastfeeding and want to use NuvaRing, you should discuss this with your doctor first.
• After a miscarriageAccording to your doctor's instructions.

3.4 What to do if…

What to do if the NuvaRing vaginal ring 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 intercourse, due to constipation, or uterine prolapse. Therefore, you should regularly check that the ring is in place in the vagina (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, 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 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 blood clots in the 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. 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 impaired breathing. In these cases, NuvaRing should be removed and the doctor contacted immediately (see also section 2.2 "Warnings and precautions"). Women using NuvaRing have reported the following side effects:

• Frequently: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
• expulsion of the system.

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

• vision disturbances; dizziness
• bloating; vomiting, diarrhea, or constipation
• feeling of fatigue, malaise, or restlessness; 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 swelling or pain in the breast)
• cervicitis; cervical polyps; cervical eversion
• changes in menstrual bleeding (e.g., heavy, prolonged, irregular, or complete absence of menstruation); pelvic discomfort; premenstrual syndrome; uterine contractions
• 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.

Rarely: may occur in up to 1 in 1000 women

• harmful blood clots in a vein or artery, for example: in the leg or foot (e.g., deep vein thrombosis) in the lungs (e.g., pulmonary embolism) heart attack stroke transient ischaemic attack or "mini-stroke" blood clots in the liver, stomach, and intestine, kidneys, or eye The likelihood of developing a blood clot may be higher if the patient has any other risk factors (see section 2 for more information on risk factors and signs of blood clots).
• galactorrhea.

Unknown(frequency cannot be estimated from available data)

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

In women using combined hormonal contraceptives, breast cancer and liver tumors have occurred. 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 the leaflet, the patient should tell her doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, 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 gathered on the safety of the medicine.

5. How to store NuvaRing

The medicine should be stored out of sight and reach of children. The doctor should be contacted in case of exposure of a child to the hormones contained in NuvaRing. Store at a temperature below 30°C. Store in the original packaging to protect from light and moisture. Do not use NuvaRing after 4 months from the date of issue of the medicine in the pharmacy. The date of issue is indicated 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 discarded 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 ethinylestradiol (2.7 mg).
• The other ingredients are: poly(ethylene-vinyl acetate), 28% and 9% vinyl acetate (a type of plastic that does not dissolve in the body) and magnesium stearate.

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

What NuvaRing looks like and what the 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 reopened after opening. 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 Belgium, the country of export:

Organon Belgium Handelsstraat 31 / Rue du Commerce 31 B-1000 Brussels Belgium

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 Belgian marketing authorization number:BE228541

Parallel import authorization number: 163/23

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

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

Date of approval of the leaflet: 18.08.2023

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

Insert Remove NuvaRing NuvaRing [Information about the trademark]

Leaflet included in 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 clots have occurred (see "Blood clots").

The patient should carefully read the contents of the leaflet before using the medicine, 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 her doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. 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, 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 applicator
• 6. Contents of the packaging and other information

1. What NuvaRing is and what it is used for

NuvaRing is a contraceptive vaginal system that prevents pregnancy. Each therapeutic vaginal 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 (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 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 signs of blood clots (see "Blood clots"). In this leaflet, situations are described in which the patient should stop using NuvaRing or in which its effectiveness may be reduced. In these situations, the patient should abstain from sexual 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;
• if the patient has had a heart attack or stroke;
• if the patient has angina pectoris (a disease that causes severe chest pain, which can be a sign of a heart attack);
• if the patient has had a transient ischaemic attack or "mini-stroke";
• if the patient has (or has had) a severe liver disease, and liver function has not returned to normal;
• if the patient has (or has had) a benign or malignant liver tumor;
• if the patient has (or has had) 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 conditions occur for the first time while using NuvaRing, the system should be removed and the doctor consulted immediately, and a non-hormonal contraceptive method should be used during this time. If the patient has a hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir and pibrentasvir, NuvaRing should not be used (see also section 2.4 "NuvaRing and other medicines").

2.2 Warnings and precautions

When should the patient contact her doctor?

• The patient should see her doctor immediately if she notices any of the following signs of a blood clot, which may indicate that she has a blood clot in her leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood clots"). To get a description of these serious side effects, see "How to recognize a blood clot".

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 genetic disease of red blood cells);
• if the patient has been diagnosed with high triglycerides (hypertriglyceridemia) or has 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 "Blood clots");
• if the patient is immediately postpartum, she is at increased risk of blood clots. The patient should consult her doctor for information on how soon she can start using NuvaRing after delivery;
• if the patient has superficial thrombophlebitis (inflammation of 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., loss of hearing, porphyria [a blood disease], herpes gestationis [a blistering skin rash during pregnancy], Sydenham's chorea [a neurological disorder characterized by involuntary, sudden movements of the body], hereditary and acquired angioedema [should contact the doctor immediately in case of symptoms of angioedema such as swelling of the face, lips, tongue, and/or throat and/or difficulty swallowing or the occurrence of hives potentially with impaired breathing. Products containing estrogens may cause or worsen symptoms of angioedema]);
• if the patient currently has or has had chloasma (brownish-yellow spots on the skin, especially on the face). If these occur, 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 has sudden, frequent need to urinate with a burning sensation and/or pain, and if the patient cannot locate the therapeutic vaginal system within the vagina. These symptoms may indicate that the therapeutic vaginal system has been accidentally inserted into the urinary bladder.

BLOOD CLOTS

Using combined hormonal contraceptives, such as the NuvaRing vaginal 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.

• Blood clots can occur
• in the veins (called "venous thromboembolism" or "deep vein thrombosis");
• in the arteries (called "arterial thrombosis").

Not all blood clots are life-threatening, but it is essential to recognize the signs and symptoms of blood clots and seek medical attention immediately.

HOW TO RECOGNIZE A BLOOD CLOT

The patient should see her doctor immediately if she notices any of the following signs of a blood clot.

• 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 warmth of the affected leg;
• change in the color of the skin of the leg, such as pale or reddened skin.

Other signs of a blood clot may include:

• sudden unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, 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 see her doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for less severe conditions, such as a respiratory infection (e.g., a cold). A blood clot in the lungs (pulmonary embolism) may cause:

• sudden unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, 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.

A blood clot in the eye (retinal vein thrombosis) may cause:

• sudden loss of vision or
• painless vision disturbances, which may progress to loss of vision.

A heart attack (myocardial infarction) may cause:

• chest pain or discomfort, feeling of pressure or heaviness;
• feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness or indigestion, or choking;
• feeling of discomfort in the upper body, radiating to the back, jaw, throat, arm, or stomach;
• nausea or vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.

A stroke (cerebrovascular accident) may cause:

• sudden weakness or numbness of the face, arm, or leg, especially on one side of the body;
• sudden confusion, difficulty speaking, or understanding;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden severe headache with no known cause;
• loss of consciousness or fainting, with or without seizures.

In some cases, the symptoms of a stroke may be transient, with almost immediate and complete recovery, but the patient should see her doctor immediately, as she may be at risk of having another stroke.

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives, such as the NuvaRing vaginal system, is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can be serious and potentially life-threatening.

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in the veins (venous thromboembolism).
• If blood clots form in the veins of the leg or foot, it can lead to 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 veins highest?

The risk of developing a blood clot 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 product) after a break of 4 weeks or more. After the first year, the risk decreases, but it is always higher than when not using combined hormonal contraceptives. If the patient stops using NuvaRing, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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

• if the patient is 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 years). 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 (see "Blood clots");
• with increasing 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. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor. It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop the use of NuvaRing. The patient should inform her doctor if any of these conditions change while using NuvaRing, e.g., if someone in her 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?

Similar 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 the NuvaRing medication have not been studied in adolescents under the age of 18.

2.4 NuvaRing and Other Medications

The 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 the NuvaRing medication. 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 the NuvaRing medication 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 blood vessels of the lungs (bosentan);
• depressive moods (St. John's wort).

If the patient is taking medications or herbal products that may reduce the effectiveness of the NuvaRing medication, an additional mechanical contraceptive method (e.g., a condom 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: The NuvaRing medication should not be used with a diaphragm, cervical cap, or female condom. NuvaRing may affect the action of other medications, such as

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

If the patient has a hepatitis C virus infection and is taking medications containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir and pibrentasvir, the NuvaRing therapeutic system should not be used, as it may cause an increase in liver function test parameters in blood laboratory tests (increase in liver enzyme ALT activity). Before starting these medications, the attending physician will prescribe other types of contraceptives. The use of the NuvaRing therapeutic system can be resumed about 2 weeks after the end of this treatment. See section 2.1 "When not to use the NuvaRing medication". Before taking any medication, consult a doctor or pharmacist.
During the use of the NuvaRing medication, tampons can be used at the same time. The NuvaRing should be inserted before inserting the tampon. Care should be taken when removing the tampon to avoid accidentally removing the NuvaRing medication as well. If it is dislodged, it is sufficient to rinse the therapeutic system with cold or warm water and reinsert it as soon as possible. Damage to the NuvaRing therapeutic system has occurred during the use of vaginal products, such as moisturizers or treatments for infections (see section 3.4, "Procedure in case of damage to the NuvaRing therapeutic system"). The use of spermicides or vaginal antifungal medications does not reduce the contraceptive effectiveness of the NuvaRing medication.

Diagnostic Tests

In the event of blood or urine laboratory tests, the persons performing the tests should be informed about the use of the NuvaRing medication, as the use of the vaginal therapeutic system may affect the results of some laboratory tests.

2.5 Pregnancy and Breastfeeding

The NuvaRing medication 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 the NuvaRing medication, the therapeutic system should be removed and the doctor should be consulted. If the patient wants to stop using the NuvaRing medication because she wants to become pregnant, she should refer to the content in section 3.5 "Procedure when the patient wants to stop using the NuvaRing medication". The use of the NuvaRing medication is not recommended during breastfeeding. If the patient wants to use the NuvaRing medication during breastfeeding, she should consult her doctor first.

2.6 Driving and Operating Machines

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

3. How to Use the NuvaRing Medication

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

3.1 Inserting and Removing the NuvaRing Medication

• 1. Before inserting the system, check the expiration date (see section 5 "How to store the NuvaRing medication and the NuvaRing Applicator").
• 2. Before inserting or removing the system, wash your hands.
• 3. Choose the most comfortable position for insertion, for example, standing with one leg raised, squatting, or lying down.
• 4. Remove the NuvaRing 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 is one in which it is not felt. If the system is uncomfortable, gently adjust its position (e.g., push it 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 under 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 other household waste, preferably in a sealed pouch in which it was originally contained. Do not flush the NuvaRing medication down the toilet.

How to insert the NuvaRing therapeutic system using only the fingers:

Figure 1
Remove the NuvaRing from the pouch

Figure 2
Squeeze the system

Figure 3
Choose the most comfortable position for insertion

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

Figure 5
Remove the system from the vagina, hooking the index finger under the edge of the system or grasping it with the index and middle fingers and pulling it out.
Important information about the NuvaRing Applicator:

• 1. Optional for use when inserting the NuvaRing therapeutic 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, rinse it with cold or warm (NOT hot) water.
• 5. After use, the applicator should be disposed of immediately in a regular household waste container.
• 6. Do not flush the applicator down the toilet.

How to insert the NuvaRing therapeutic system using the applicator:

1: Preparation

	Before opening the packaging, wash your hands. The packaging should be opened ONLY immediately 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 therapeutic system. Do not use it with other medicinal products.
	Familiarize yourself with the drawing of the applicator and its individual parts. A. Plunger B. Handle C. Cylinder D. Hole in the cylinder E. NuvaRing therapeutic system

2: Setting the plunger and assuming the correct position

Gently pull the plunger back to the end.

	Squeeze the opposite sides of the NuvaRing therapeutic system and insert it into the hole in the cylinder.
	Gently push the NuvaRing therapeutic system into the center of the cylinder. The end of the NuvaRing therapeutic system should protrude slightly from the hole in the cylinder.
	Choose the most comfortable position for inserting the NuvaRing therapeutic system, for example, lying down, squatting, or standing with one leg raised.

3: Inserting the NuvaRing therapeutic 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.

	The NuvaRing therapeutic system will be pushed out of the applicator. Gently pull out the applicator.
	Make sure the NuvaRing therapeutic system has not remained in the applicator. The used applicator should be disposed of in 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 be in the vagina for 3 consecutive weeks, 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 the NuvaRing was inserted on a Wednesday at around 10:00 PM, it should be removed on the following Wednesday, 3 weeks later, at around 10:00 PM.
• 3. After removing the system, 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, 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 "Procedure if the patient forgets to insert a new NuvaRing therapeutic system after the break".

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

3.3 When to Insert the First NuvaRing Therapeutic System

• If no hormonal contraceptive was used in the previous cycle, insert the NuvaRing on the first day of the natural cycle (i.e., the first day of menstruation). The NuvaRing starts working immediately. There is no need to use any additional contraceptive methods. The NuvaRing can also 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 the NuvaRing.
• If the patient used combined hormonal oral contraceptives in the previous month, start using the NuvaRing no later than the day following the break in taking the current medication. If the current medication has tablets that do not contain active substances, start using the NuvaRing no later than the day after taking the last tablet that does not contain active substances. In case of doubt about which tablet is which, consult a doctor or pharmacist. Do not extend the break in taking the current tablets beyond the recommended period. If the patient has been taking the tablets regularly and is sure she is not pregnant, she can stop taking the tablets and start using the NuvaRing immediately.

If the patient has been using the tablets regularly and is sure she is not pregnant, she can stop taking the tablets and start using the NuvaRing immediately.

• If the patient used a transdermal system (patch) in the previous month, start using the NuvaRing no later than the day following the break in using the transdermal system. Do 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 she is not pregnant, she can stop using the transdermal system and start using the NuvaRing immediately.
• If the patient used a minipill (progestogen-only contraceptive) in the previous month, the minipill can be stopped at any time, and the 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.
• If the patient used injections or an implant, or an intrauterine system releasing progestogen (IUD) in the previous month, start using the NuvaRing on the day of the next planned injection or on the day the implant or intrauterine system is removed. During the first 7 days of NuvaRing use, an additional contraceptive method (such as a condom for men) should be used.
• After childbirth, the doctor may recommend using the NuvaRing only after the first menstruation. Sometimes, the doctor may recommend starting the NuvaRing earlier; the doctor will advise when. If the patient is breastfeeding and wants to use the NuvaRing, she should discuss this with her doctor first.
• After a miscarriage, follow the doctor's instructions.

3.4 What to Do If…

Procedure in Case of Accidental Expulsion of the System from the Vagina

The NuvaRing may accidentally come out of 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 in the vagina (e.g., before and after sexual intercourse).

Procedure if the System Was Outside the Vagina for Some Time

The NuvaRing therapeutic system may still provide protection against pregnancy, but this depends on how long it was outside the vagina.
If the system was outside the vagina for:

• a time shorter than 3 hours, the patient is still protected against pregnancy. The therapeutic system should be rinsed with cold or warm (not hot) water and reinserted as soon as possible, but only if it was outside the vagina for less than 3 hours.
• a time longer than 3 hours in the first or second week of use, the contraceptive effectiveness may be reduced. The therapeutic system should be rinsed with cold or warm water and reinserted, and it should be left in place without interruption for at least 7 days. If sexual intercourse occurs during these 7 days, an additional contraceptive method (such as a condom for men) should be used. If sexual intercourse occurred before the patient noticed the system was dislodged, she should consult her doctor.

If the patient is in the first week of the cycle and had sexual intercourse during the last 7 days, there is a possibility that she is pregnant. In such a case, the patient should consult her doctor.

• a time longer than 3 hours in the third week of use, the contraceptive effectiveness may be reduced. The therapeutic system should be removed, and one of the following two solutions should be chosen:
• 1 – Insert a new therapeutic system as soon as possible. Inserting a new therapeutic system means starting the next 3-week period of its use. This may cause the absence of expected withdrawal bleeding, although spotting or breakthrough bleeding may occur.
• 2 – Do not insert the therapeutic system again. Wait for withdrawal bleeding to occur and insert a new therapeutic system no later than 7 days after the removal or expulsion of the previous one. This approach can only be taken if the patient has been using the NuvaRing without interruption for the last 7 days.
• unknown period of time, the woman may not be protected against pregnancy. Before inserting a new therapeutic system, a pregnancy test should be performed, and the doctor should be consulted.

Procedure in Case of Damage to the NuvaRing Therapeutic System

Very rarely, the NuvaRing may be damaged. Damage to the vaginal wall has been reported in association with damage to the NuvaRing therapeutic system. If the patient notices that the NuvaRing 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 her doctor.

Procedure in Case of Insertion of More Than One NuvaRing Therapeutic System

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

Procedure if the Patient Forgets to Insert a New NuvaRing Therapeutic System After the Break

If the break in useof the therapeutic 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 intercourse occurred during the break in useof the therapeutic system, there is a possibility of pregnancy. In such a case, the doctor should be consulted as soon as possible. The longer the break in use of the therapeutic system, the higher the probability of pregnancy.

Procedure if the Patient Forgets to Remove the NuvaRing Therapeutic System on Time

• If the system has been in the vagina for longer than 3 weeks but not longer than 4 weeks, the patient is still protected against pregnancy. The therapeutic system should be removed, and a 1-week break should be taken before inserting a new system.
• If the patient has been using the therapeutic system for more than 4 weeks, there is a possibility of pregnancy. Before inserting a new therapeutic system, the doctor should be consulted.

Procedure in Case of Absence of Bleeding

If the Patient Has Been Using the NuvaRing According to the Instructions

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

If the Patient Has Not Been Using the NuvaRing According to the Instructions

If withdrawal bleeding does not occur during the first break in use of the NuvaRing, and the patient has not been using the therapeutic system according to the instructions, she may be pregnant. Before using the NuvaRing again, the patient should consult her doctor.

Procedure in Case of Unexpected Bleeding

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

Procedure in Case of Change in the Day of Bleeding

If the NuvaRing is used according to the instructions, menstruation (withdrawal bleeding) will start during the break in use of the therapeutic system. If the patient wants the withdrawal bleeding to start on a different day, she can shorten the break in use of the therapeutic system (but never extend it!). For example: if the 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 therapeutic system 3 days earlier than usual. If the break in use of the therapeutic system 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 therapeutic system, spotting or breakthrough bleeding may occur.

Procedure in Case of Desire to Delay the Onset of Bleeding

Although it is not recommended, the onset of menstruation (withdrawal bleeding) can be delayed by inserting a new therapeutic system without a break in use. The new therapeutic system can be used for no longer than 3 weeks. During the use of the new therapeutic system, spotting or breakthrough bleeding may occur. To induce withdrawal bleeding, the therapeutic system should be removed. It is recommended to take regular weekly breaks between systems. Before the patient decides to delay the onset of menstruation, she may consult her doctor.

3.5 Procedure When the Patient Wants to Stop Using the NuvaRing Medication

The use of the NuvaRing medication 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 the NuvaRing because she wants to become pregnant, she should wait until the first menstruation and then try to conceive. This will help determine the due date.

4. Possible Side Effects

Like all medications, the NuvaRing can cause side effects, although not everyone will experience them. If any side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of the NuvaRing, the 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. If an allergic reaction (hypersensitivity) to any component of the 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, the NuvaRing should be removed, and the doctor should be consulted immediately (see also section 2.2 "Warnings and precautions"). Women using the NuvaRing have reported the following side effects: Frequent:may occur in no more than 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 no more than 1 in 100 women

• vision disturbances; dizziness
• bloating; vomiting, diarrhea, or constipation
• fatigue, malaise, or restlessness; mood changes; sudden mood swings
• edema
• urinary tract infections or kidney infections
• problems or pain during urination; urgency to urinate or need to urinate frequently
• discomfort during intercourse, including pain, bleeding, or discomfort 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 (lumps 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

Rare: may occur in no more than 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 temporary stroke symptoms, known as a transient ischemic attack blood clots in the liver, stomach, and intestine, kidneys, or eye The probability of developing blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors 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-yellow skin discoloration, especially on the face)
• partner's penis problems (such as irritation, rash, itching)
• inability to remove the therapeutic system without medical assistance (e.g., due to the therapeutic system adhering to the vaginal wall)
• damage to the vaginal wall associated with damage to the therapeutic system.

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

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, 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 the NuvaRing Medication and the NuvaRing Applicator

The medication should be stored out of sight and reach of children. The doctor should be consulted in case of suspected exposure of a child to the hormones contained in the NuvaRing. 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 date of dispensing is indicated on the box and on the pouch. Do not use the NuvaRing medication after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month. Do not use the NuvaRing medication if it has changed color or if there are any visible signs of deterioration. The used NuvaRing therapeutic 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 disposed of in a regular household waste container. The NuvaRing medication or applicator should not be flushed down the toilet. Like other medications, unused or expired systems should not be disposed of in the sewage system or household waste containers. The 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 the NuvaRing Medication Contains

• The active substances of the medication are: etonogestrel (11.7 mg) and ethinyl estradiol (2.7 mg).
• 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 system in amounts of 0.120 mg/day and 0.015 mg/day, respectively, over a period of 3 weeks.

How the NuvaRing medicine and Applicator look 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 (i) 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 Belgium, the country of export:

Organon Belgium
Handelsstraat 31 /Rue du Commerce 31
B-1000 Brussels
Belgium

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
Authorization number in Belgium, the country of export:BE228541

Parallel import authorization number: 163/23

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, 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 leaflet approval: 18.08.2023

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

Insert Remove
NuvaRing NuvaRing
[Information about the registered trademark]