Nuvaring

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
NuvaRing, (0.120 mg + 0.015 mg)/24 h, vaginal ring system
Etonogestrel + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are among the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm other people.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What NuvaRing is and what it is used for

NuvaRing is a contraceptive vaginal ring system that prevents pregnancy. Each vaginal ring contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. These hormones are slowly released from the ring into the bloodstream. Due to the low dose of hormones released, NuvaRing is classified as a low-dose hormonal contraceptive. Since NuvaRing releases two different hormones, it is also known as a combined hormonal contraceptive.
NuvaRing works similarly to a combined oral contraceptive pill (a "combined pill"). However, unlike the daily pill, NuvaRing is used continuously for 3 weeks. NuvaRing releases two female sex hormones that suppress the release of eggs from the ovaries. Since eggs are not released, pregnancy cannot occur.

2. Important information before using NuvaRing

General notes
Before starting NuvaRing, you should read the information regarding blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
This leaflet describes situations in which you should stop using NuvaRing or when its effectiveness may be reduced. In these situations, you should avoid sexual intercourse or use an additional non-hormonal contraceptive method, such as a male condom or another mechanical method. Do not use calendar-based methods or body temperature measurement. These methods may be ineffective because NuvaRing affects monthly changes in body temperature and cervical mucus consistency.
NuvaRing, like other hormonal contraceptives, does not protect against infection with the HIV virus (AIDS) or other sexually transmitted diseases.

2.1 When not to use NuvaRing
Do not use NuvaRing if you have any of the following conditions. If any of the conditions listed below apply to you, you must inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you currently have (or have ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain, which may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following diseases that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you currently have or have previously had pancreatitis associated with high levels of fats in the blood;
• if you currently have or have previously had severe liver disease and liver function has not returned to normal;
• if you currently have or have previously had a benign or malignant liver tumour;
• if you currently have or have previously had breast cancer or genital organ cancer, or if such cancers are suspected;
• 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 during use of NuvaRing, remove the vaginal ring immediately and consult your doctor. In the meantime, use a non-hormonal contraceptive method.
If you have hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir, pibrentasvir, do not use the NuvaRing vaginal ring system (see also section 2.4 "NuvaRing and other medicines").

2.2 Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots"). For a description of symptoms of these serious adverse effects, see "How to recognize blood clots".

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with NuvaRing, you should also inform your doctor.

• if breast cancer is currently present or has occurred in close family members;
• 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 (an autoimmune disease);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to determine how soon after delivery you may start using NuvaRing;
• if you have phlebitis (inflammation of superficial veins under the skin);
• if you have varicose veins;
• if you have conditions that first occurred or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], or Sydenham's chorea [a nervous system disorder causing involuntary, sudden movements]);
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or if you develop hives potentially accompanied by breathing difficulties. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you currently have or have previously had chloasma (yellowish-brown pigmentation patches, so-called "pregnancy mask", especially on the face). If such patches occur, avoid excessive sun exposure and ultraviolet radiation;
• if you have conditions that make using NuvaRing difficult, such as frequent constipation, uterine prolapse, or pain during intercourse;
• if you experience sudden, frequent urge to urinate with a burning sensation and/or pain, and if you cannot locate the vaginal ring inside the vagina. These symptoms may indicate accidental placement of the NuvaRing vaginal ring into the urinary bladder.

BLOOD CLOTS
Using combined hormonal contraceptives such as the NuvaRing vaginal ring is associated with an increased risk of blood clots compared to not using such treatment. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with using NuvaRing is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot – Deep vein thrombosis, especially if accompanied by:
  • pain or tenderness in the leg, which may occur only while standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as pallor, redness, or bluish discolouration.
• sudden onset of unexplained shortness of breath or rapid breathing – Pulmonary embolism;
• sudden cough without an obvious cause, possibly with coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infections (e.g. cold).

Symptoms most commonly occur in one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision, or
• painless visual disturbances, which may progress to vision loss.
• chest pain, discomfort, pressure, or heaviness – Heart attack

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 developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using
combined hormonal contraceptives for the first time. The risk may also be
increased when restarting combined hormonal contraceptives (the same or a different drug)
after a break of 4 weeks or more.
After the first year, the risk decreases, but it remains higher compared to not using
combined hormonal contraceptives at all.
If a woman stops using NuvaRing, the risk of developing blood clots returns to
normal levels within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of developing venous thromboembolic disease and the type of
combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of NuvaRing
is low.

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

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of the NuvaRing vaginal therapeutic system is small, but certain factors may increase this risk.
The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such a case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue use of NuvaRing several weeks before surgery or during immobilization. If the patient must stop using NuvaRing, consult a doctor about when it is safe to resume use;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

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 venous blood clots, particularly if the patient has another risk factor.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue use of NuvaRing.
Inform the doctor if any of the above conditions change during use of NuvaRing, for example, if a close family member is diagnosed with thrombosis of unknown cause or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with use of the NuvaRing vaginal therapeutic system is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as the NuvaRing vaginal therapeutic system, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, a heart rhythm disorder 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 arterial blood clots may be further increased.
Inform the doctor if any of the above conditions change during use of the NuvaRing vaginal therapeutic system, for example, if the patient starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

Tumour diseases
The following information is based on studies using combined oral contraceptives and may also apply to NuvaRing. Data on vaginal use of hormonal contraceptives (as with NuvaRing) are limited.

A slightly higher incidence of breast cancer has been observed among women using combined oral contraceptives, although it is not known whether this is caused by the medication. It is possible that breast cancer is detected more frequently in these women because they undergo more regular medical examinations. The increased risk of breast cancer gradually decreases after stopping combined oral contraceptives.
Regular breast examinations are very important. If any lump is detected, consult a doctor. Also inform the doctor if a close relative has or has had breast cancer (see section 2.2 "Warnings and precautions").

Rarely, benign liver tumours have been reported in women using combined oral contraceptives, and very rarely, malignant liver tumours. If severe or unusual abdominal pain occurs, contact the doctor immediately.

There are reports that women using combined oral contraceptives have a lower incidence of endometrial cancer (cancer of the uterine lining) and ovarian cancer. This may also apply to NuvaRing, but this has not yet been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including NuvaRing, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the 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 of age.

2.4 Interaction of NuvaRing with other medicines
Always inform the doctor about any medicines or herbal products currently being used. Also inform any other doctor, dentist, or pharmacist prescribing other medicines about the use of NuvaRing. They may advise using additional contraceptive methods (e.g., male condoms), how long this should continue, and whether adjustments to other medications are needed.

Some medicines:

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

This applies to medicines used in the treatment of:

• 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 infections (e.g., griseofulvin);
• high blood pressure in the pulmonary blood vessels (bosentan);
• depressive mood disorders (St. John's wort).

If the patient is taking medicines or herbal remedies that may reduce the effectiveness of NuvaRing, additional mechanical contraception (e.g., male condoms) should also be used. Because the effect of another medicine on NuvaRing may persist for up to 28 days after stopping the medicine, additional mechanical contraception should be used during this period.
Note: NuvaRing should not be used with a diaphragm, cervical cap, or female condom.

NuvaRing may affect the action of other medicines such as:

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

If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, the NuvaRing vaginal therapeutic system should not be used, as this may lead to increased liver function parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).
Before starting these medications, the doctor will prescribe another type of contraceptive.
Use of the NuvaRing vaginal therapeutic system may be resumed approximately 2 weeks after completing this treatment. See section 2.1 "When not to use NuvaRing."

Before taking any medicine, consult a doctor or pharmacist.

During use of NuvaRing, tampons may be used. Insert NuvaRing before inserting a tampon. Be careful when removing the tampon to avoid accidentally removing NuvaRing. If NuvaRing is expelled, rinse it with cool or lukewarm water and reinsert it as soon as possible.

Damage to the vaginal therapeutic system has occurred during use of vaginal products such as lubricants or treatments for infections (see section 3.4, "What to do if the vaginal therapeutic system is damaged"). Use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of NuvaRing.

Diagnostic tests
If blood or urine laboratory tests are being performed, inform the person conducting the tests that NuvaRing is being used, as use of the vaginal therapeutic system may affect the results of certain laboratory tests.

2.5 Pregnancy and breastfeeding
NuvaRing must not be used during pregnancy or if pregnancy is suspected. If the patient becomes pregnant while using NuvaRing, remove the vaginal therapeutic system and contact the doctor immediately.

If the patient wishes to stop using NuvaRing because she wants to become pregnant, refer to section 3.5 "What to do if the patient wants to stop using NuvaRing."

Use of NuvaRing is not recommended during breastfeeding. If the patient wishes to use NuvaRing while breastfeeding, consult the doctor first.

2.6 Driving and operating machinery
NuvaRing does not affect the ability to drive or operate machinery.

3. How to use NuvaRing

The NuvaRing vaginal ring can be inserted and removed by yourself. Your doctor will advise you when to start using NuvaRing. The vaginal ring should be inserted on the correct day of your cycle (see section 3.3 "When to insert the first NuvaRing vaginal ring") and left in place continuously for three weeks. You should regularly check that the NuvaRing vaginal ring is still in the vagina (for example, before and after sexual intercourse) to ensure contraceptive protection. After three weeks, remove the NuvaRing and take a one-week break. Withdrawal bleeding usually occurs during this break.

You should not use certain female barrier methods of contraception, such as a diaphragm, cervical cap, or female condom, while using NuvaRing. These barrier methods should not be used as additional contraception because NuvaRing may interfere with the correct placement and positioning of an intrauterine device, cervical cap, or female condom. However, you may use a male condom as an additional mechanical contraceptive method.

3.1 Insertion and removal of NuvaRing

1. Before insertion, check the expiry date (see section 5 "How to store NuvaRing").
2. Wash your hands before inserting or removing the ring.
3. Choose a comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
4. Remove the NuvaRing from its pouch.
5. Holding the ring between your thumb and index finger, squeeze it together and insert it into the vagina (see Figures 1–4). Alternatively, the ring may be inserted using the NuvaRing applicator (not included with the NuvaRing packaging). The NuvaRing applicator may not be available in all countries. The correct position of NuvaRing is one in which you do not feel it. If the ring is uncomfortable, gently reposition it (e.g., push it slightly deeper into the vagina) until you feel comfortable. The exact position of the ring within the vagina does not affect its contraceptive effectiveness.
6. After three weeks, remove the ring from the vagina. This can be done by hooking your index finger under the edge of the ring or grasping it between your index and middle fingers and pulling it out (Figure 5). If you can locate the ring in the vagina but are unable to remove it, contact your doctor.
7. Dispose of the used ring with household waste, preferably in the sealed pouch it originally came in. Do not flush NuvaRing down the toilet.

Figure 1
Remove the ring from the pouch

Figure 2
Squeeze the ring

Figure 3
Choose a comfortable position

Figure 4A Figure 4B Figure 4C
Insert the ring into the vagina with one hand (Figure 4A), spreading the labia with the other hand if necessary. Place it inside the vagina so that it is comfortable (Figure 4B). Leave the ring in place for three weeks (Figure 4C).

Figure 5
Remove the ring from the vagina by hooking your index finger under the edge of the ring or grasping it between your index and middle fingers and pulling it out.

3.2 Three weeks of use, one-week break

1. The ring must remain in the vagina continuously for three weeks, starting from the day of insertion.
2. After three weeks, remove the ring on the same day of the week and at approximately the same time as it was inserted. For example, if NuvaRing was inserted on a Wednesday at around 10:00 PM, it should be removed on a Wednesday three weeks later, also at around 10:00 PM.
3. After removal, take a one-week break. During this time, withdrawal bleeding may occur, usually starting 2–3 days after removal.
4. Insert a new ring exactly one week after the previous removal (on the same day of the week and at approximately the same time), even if bleeding has not stopped. If insertion of the new ring is delayed by more than 3 hours, contraceptive effectiveness may be reduced. In this case, follow the instructions in section 3.4 "What to do if you forget to insert a new vaginal ring after the one-week break".

If NuvaRing is used according to these instructions, withdrawal bleeds will occur approximately on the same days each month.

3.3 When to insert the first NuvaRing vaginal ring

• Previously not using hormonal contraception Insert NuvaRing on the first day of your natural cycle (i.e., the first day of your period). NuvaRing is effective immediately upon insertion. There is no need to use any additional contraceptive methods. You may also start using NuvaRing between days 2 and 5 of your period, but in this case, you must use an additional contraceptive method (such as a male condom) for the first 7 days of use. This recommendation applies only when starting NuvaRing for the first time.
• Previously using combined oral contraceptive pills Begin using NuvaRing no later than the day after the last active pill of your current contraceptive. If your current contraceptive includes inactive (placebo) pills, start using NuvaRing no later than the day after taking the last inactive pill. If you are unsure which pill is the last, consult your doctor or pharmacist. Do not extend the pill-free interval beyond the recommended duration. If you have taken your pills regularly and are certain you are not pregnant, you may stop taking your pills at any time and immediately start using NuvaRing.
• Previously using a transdermal patch Begin using NuvaRing no later than the day after removing the transdermal patch. Do not extend the patch-free interval beyond the recommended duration. If you have used the patch regularly and are certain you are not pregnant, you may stop using the patch at any time and immediately start using NuvaRing.
• Previously using a progestogen-only pill (mini-pill) You may stop taking the mini-pill at any time and start using NuvaRing the next day at the same time you usually took the mini-pill. For the first 7 days of using NuvaRing, use an additional contraceptive method (such as a male condom).
• Previously using injections, an implant, or a progestogen-releasing intrauterine system (IUD) Begin using NuvaRing on the day of your next scheduled injection or on the day of removal of the implant or progestogen-releasing intrauterine system. For the first 7 days of using NuvaRing, use an additional contraceptive method (such as a male condom).
• After childbirth After childbirth, your doctor may recommend waiting until after your first period before starting NuvaRing. Sometimes you may be able to start earlier; your doctor will advise you when. If you are breastfeeding and wish to use NuvaRing, discuss this with your doctor first.
• After miscarriage As advised by your doctor.

3.4 What to do if…

Management of accidental ring expulsion from the vagina
NuvaRing may accidentally fall out of the vagina, for example, if inserted incorrectly, during tampon removal, during sexual intercourse, in cases of constipation, or due to uterine prolapse. Therefore, you should regularly check that the ring is still in the vagina (e.g., before and after sexual intercourse).

Management if the ring has been out of the vagina for some time
NuvaRing may still provide protection against pregnancy, depending on how long it was out of the vagina.

If the ring was out of the vagina for:

• less than 3 hours , you are still protected against pregnancy. Wash the vaginal ring with cool or lukewarm (not hot) water and reinsert it as soon as possible.
• more than 3 hours during the first or second week of use , contraceptive effectiveness may be reduced. Wash the vaginal ring with cool or lukewarm (not hot) water and reinsert it as soon as possible. Leave it in place continuously for at least 7 days. If you have sexual intercourse during these 7 days, use an additional male condom. If you are in the first week of your cycle and had intercourse in the past 7 days, there is a possibility of pregnancy. In this case, contact your doctor.
• more than 3 hours during the third week of use , contraceptive effectiveness may be reduced. Remove the vaginal ring and choose one of the following two options:
  1 – Insert a new vaginal ring as soon as possible. Starting a new ring means beginning the next three-week cycle. This may prevent the expected withdrawal bleed, but breakthrough bleeding or spotting may occur.
  2 – Do not insert a new vaginal ring. Wait for withdrawal bleeding to occur and insert a new vaginal ring no later than 7 days after removal or expulsion of the previous ring. This option is only acceptable if you have used NuvaRing continuously for the past 7 days.
• unknown duration , you may not be protected against pregnancy. Perform a pregnancy test and consult your doctor before inserting a new vaginal ring.

Management if the vaginal ring is damaged
Very rarely, NuvaRing may become damaged. Vaginal wall injury has been reported in association with damage to the vaginal ring. If you notice that NuvaRing is damaged, remove it and insert a new one as soon as possible. Use an additional contraceptive method (e.g., male condom) for the next 7 days. If you had sexual intercourse before noticing the damage, contact your doctor.

Management if more than one vaginal ring is inserted accidentally
There have been no reports of serious harmful effects related to overdose of the hormones in NuvaRing. If more than one vaginal ring is inserted by accident, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Remove the extra ring and contact your doctor if symptoms persist.

Management if you forget to insert a new vaginal ring after the one-week break
If the break in using the vaginal ring was longer than 7 days , insert a new ring as soon as possible. If you have sexual intercourse in the next 7 days, use an additional contraceptive method (e.g., male condom). If sexual intercourse occurred during the break in using the vaginal ring, there is a risk of pregnancy. In this case, contact your doctor as soon as possible. The longer the break, the higher the risk of pregnancy.

Management if you forget to remove the vaginal ring on time

• If the ring has remained in the vagina for longer than 3 weeks but not more than 4 weeks , you are still protected against pregnancy. Remove the vaginal ring and take a one-week break, then insert a new ring.
• If you have used the vaginal ring for longer than 4 weeks , there is a risk of pregnancy. Contact your doctor before inserting a new vaginal ring.

Management if withdrawal bleeding does not occur

• If you used NuvaRing correctly If withdrawal bleeding does not occur on time, but you used NuvaRing as directed and did not take other medications, the chance of pregnancy is very low. Continue using NuvaRing as usual. However, if withdrawal bleeding does not occur twice in a row, pregnancy is possible. Contact your doctor immediately. Do not insert a new NuvaRing until your doctor confirms you are not pregnant.
• If you used NuvaRing incorrectly If withdrawal bleeding does not occur during the first break and you did not use the vaginal ring as directed, you may be pregnant. Contact your doctor before using a new NuvaRing.

Management of unexpected bleeding
Some women may experience unexpected mid-cycle bleeding while using the vaginal ring. You may need to use sanitary pads. Leave the ring in place and continue using it as usual. If irregular bleeding increases or persists, contact your doctor.

Management if you wish to change the day of withdrawal bleeding
If you use NuvaRing as directed, withdrawal bleeds (periods) will occur during the one-week break. If you wish to shift the day of bleeding, you may shorten the break (but never extend it!).

For example: if withdrawal bleeding usually starts on Friday, and you wish to shift it to Tuesday (3 days earlier), insert the new vaginal ring 3 days earlier than usual.

If the break is significantly shortened (e.g., to 3 days or less), withdrawal bleeding may not occur at all. During the next ring cycle, spotting or breakthrough bleeding may occur.

If you are unsure how to proceed, consult your doctor.

Management if you wish to delay withdrawal bleeding
Although not recommended, you may delay the onset of menstruation (withdrawal bleeding) by inserting a new vaginal ring immediately after removing the previous one, without taking a break. The new vaginal ring should not be used for longer than 3 weeks. During this time, spotting or breakthrough bleeding may occur. To induce withdrawal bleeding, remove the vaginal ring. A regular one-week break between rings is recommended.

Before deciding to delay your period, you may wish to consult your doctor.

3.5 What to do if you wish to stop using NuvaRing
You may stop using NuvaRing at any time.
If you do not wish to become pregnant, ask your doctor about alternative contraceptive methods.
If you stop using NuvaRing because you wish to become pregnant, wait until after your first natural period before trying to conceive. This will help determine your due date.

4. Possible adverse effects

Like all medicines, NuvaRing may cause adverse effects, although not everyone experiences them. If any adverse effects occur, especially severe and persistent ones, or any changes in health that the patient considers related to the use of NuvaRing, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of venous thromboembolism (blood clots in the veins) or arterial thromboembolism (blood clots in the arteries). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, see section 2, "Important information before using NuvaRing".

If hypersensitivity (allergy) to any of the components of NuvaRing occurs, it may manifest as (frequency unknown): angioedema and (or) anaphylactic reaction [swelling of the face, lips, tongue, and (or) throat and (or) difficulty swallowing] or urticaria potentially associated with breathing difficulties. In such cases, NuvaRing should be removed and medical advice should be sought immediately (see also section 2.2, "Warnings and precautions").

Women using NuvaRing have reported the following adverse effects:

Common: may affect up to 1 in 10 women

• abdominal pain, nausea
• vaginal fungal infections (such as "thrush"); discomfort due to the presence of the system in the vagina; genital itching; vaginal discharge
• headache or migraine headache; depressed mood; decreased libido
• breast pain; pelvic pain; painful menstruation
• acne
• weight gain
• expulsion of the system.

Uncommon: may affect up to 1 in 100 women

• visual disturbances; dizziness
• bloating; vomiting, diarrhoea or constipation
• feeling of fatigue, malaise or irritability; mood changes; sudden mood swings
• oedema (swelling)
• urinary tract or bladder infections
• problems or pain during urination; urgency or need to urinate; frequent urination
• discomfort during intercourse, including pain, bleeding, discomfort due to the presence of the system, or discomfort experienced 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 changes (cysts which may cause swelling or breast 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); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
• hair loss, rash, itching, skin rash or hot flushes
• urticaria.

Rare: may affect up to 1 in 1,000 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 temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach and intestines, kidneys or eye The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of clot formation).
• galactorrhoea (discharge from the breast).

Unknown frequency (frequency cannot be estimated from available data)

• chloasma (pigmented patches of yellowish-brown colour on the skin, especially on the face)
• partner's intercourse discomfort (such as irritation, rash, itching)
• inability to remove the vaginal contraceptive system without medical assistance (e.g. due to adhesion of the vaginal contraceptive system to the vaginal wall)
• vaginal wall injury related to damage of the vaginal contraceptive system.

Breast cancer and liver tumours have occurred in women using combined hormonal contraceptives. For detailed information, see section 2.2, "Warnings and precautions", "Tumours".

Very rarely, NuvaRing may become damaged. For additional information, see section 3.4, "What to do if the vaginal contraceptive system is damaged".

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist.

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store NuvaRing

Keep this medicine out of sight and reach of children.
If you suspect that a child has been exposed to the hormones in NuvaRing, contact a doctor immediately.
Store below 30°C. Keep 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 sachet.
Do not use NuvaRing after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use NuvaRing if you notice any change in colour or any signs of deterioration.
Used vaginal rings should be disposed of in a regular household waste container, preferably in a sealed pouch. Do not flush NuvaRing down the toilet. As with other medicines, unused or expired vaginal rings must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What NuvaRing contains

• The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• Other ingredients: 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 vaginal ring system at a rate of
0.120 mg/day and 0.015 mg/day over a 3-week period.
What NuvaRing looks like and contents of the pack
NuvaRing is a flexible, transparent, colourless or almost colourless ring
with an outer diameter of 54 mm.
Each vaginal ring system is individually packed in a sealed foil pouch. The pouch
can be resealed after opening. The pouches are contained in a cardboard box together
with the package leaflet. The pack contains 1 or 3 systems.
For further information, please contact the responsible entity or parallel importer.
Responsible entity in Belgium, country of export:
Organon Belgium
Handelsstraat 31 / Rue du Commerce 31
B-1000 Brussels
Belgium
Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Belgium, country of export: BE228541
Parallel import authorisation number: 163/23
This medicine is authorised for marketing in 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 ring
Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Romania, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland).
These stickers, placed on the appropriate day of the calendar, may help remember when to insert and remove NuvaRing.

Insert Remove
NuvaRing NuvaRing

Package leaflet: information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
NuvaRing, (0.120 mg + 0.015 mg)/24 h, vaginal ring
Etonogestrelum + Ethinylestradiolum
Important information about combined hormonal contraceptives

• When 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 during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains
important information for you.

• Keep this leaflet, so you can read it again if necessary.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not give it to others. It may harm someone else.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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 package and other information

1. What NuvaRing is and what it is used for

NuvaRing is a contraceptive in the form of a vaginal ring system
that prevents pregnancy. Each vaginal ring 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 low dose of hormones released, NuvaRing is
classified as a low-dose hormonal contraceptive. Because NuvaRing releases
two different hormones, it is also known as a combined hormonal contraceptive.
NuvaRing works similarly to a combined oral contraceptive pill (combined pill),
but unlike a pill that must be taken daily, NuvaRing is used
continuously for 3 weeks. NuvaRing releases two female sex hormones that inhibit the release
of eggs from the ovaries. Since eggs are not released, you cannot become pregnant.

2. Important information before using NuvaRing

General notes
Before starting NuvaRing, read the information about
blood clots (thrombosis) in section 2. It is especially important to understand the symptoms
of blood clots (see section 2 "Blood clots").
This leaflet describes situations in which you should stop using NuvaRing or when its effectiveness may be reduced. In such situations, you should avoid sexual intercourse or use an additional non-hormonal contraceptive method, such as
a male condom or another mechanical method. Do not use calendar-based methods or body temperature monitoring. These may be ineffective because NuvaRing
affects body temperature changes and cervical mucus consistency throughout the month.
NuvaRing, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

2.1 When not to use NuvaRing

Do not use NuvaRing if you have any of the following conditions. If you have any of the conditions listed below, you must inform your doctor. Your doctor will discuss with you which alternative contraceptive method may be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs,
• if you have known disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies,
• if you are undergoing surgery or will be immobile 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 condition causing severe chest pain, which may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms),
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a condition called hyperhomocysteinemia
• if you currently have or have had in the past a type of migraine called "migraine with aura",
• if you currently have or have had in the past pancreatitis associated with high levels of fats in the blood,
• if you currently have or have had in the past severe liver disease and liver function has not returned to normal,
• if you currently have or have had in the past benign or malignant liver tumours,
• if you currently have or have had breast cancer or genital organ cancer, or if there is suspicion of such 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 symptoms occur for the first time during use of NuvaRing, remove the system from the vagina immediately and consult your doctor, and use a non-hormonal contraceptive method in the meantime.
If you have hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir or glecaprevir, pibrentasvir, do not use the NuvaRing vaginal ring system (see also section 2.4 "NuvaRing with other medicines").

2.2 Warnings and precautions

When to contact your doctor?
Seek immediate medical advice

• if you notice possible symptoms of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack or stroke (see section below "Blood clots"). For a description of symptoms of these serious side effects, see "How to recognise blood clots".

Tell your doctor if you have any of the following conditions.
If these symptoms appear or worsen during use of NuvaRing, you should also inform your doctor.

• if breast cancer is currently present or has occurred in close family members;

• if you have epilepsy (see section 2.4 "NuvaRing with 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 affecting the body's natural defence system);

• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);

• if you have sickle cell anaemia (an inherited red blood cell disorder);

• if you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;

• if you require surgery or will be immobile for a long time (see section 2 "Blood clots");

• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after childbirth you can start using NuvaRing;

• if you have superficial thrombophlebitis (inflammation of veins under the skin);

• if you have varicose veins;

• if you have conditions that first occurred or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], Sydenham's chorea [a nervous system disorder with involuntary, sudden movements], hereditary or acquired angioedema [seek immediate medical attention if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives potentially with breathing difficulties. Products containing oestrogens may cause or worsen angioedema symptoms]);

• if you currently have or have had chloasma (yellowish-brown pigmentation spots, so-called "pregnancy mask", especially on the face). If they occur, avoid excessive sun exposure and ultraviolet radiation;

• if you have conditions that make using NuvaRing difficult, such as frequent constipation, uterine prolapse, or pain during intercourse;

• if you experience sudden, frequent urge to urinate with a burning sensation and/or pain, and if you cannot locate the vaginal ring system
  inside the vagina.
  These symptoms may indicate accidental placement of the NuvaRing vaginal ring system in the bladder.
  BLOOD CLOTS
  Using combined hormonal contraceptives, such as the NuvaRing vaginal ring system, is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.
  Blood clots may occur

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");

• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using NuvaRing is small.
HOW TO RECOGNISE BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
• pain or tenderness in the leg, which may occur
  only when standing or walking;
• increased warmth in the affected leg;
• skin colour changes in the leg, such as pallor, redness, or blueness.
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden cough without an obvious cause, possibly accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, consult your doctor,
as some of these symptoms, such as cough or
shortness of breath, may be mistaken for milder
conditions such as respiratory tract infection (e.g.
common cold).
Symptoms most commonly occur in one eye: Retinal vein thrombosis

• sudden vision loss or (blood clot in the eye)
• painless visual disturbances, which may progress to vision loss.
• chest pain, discomfort, pressure, heaviness; Heart attack

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• Use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives.
If a woman stops using NuvaRing, the risk of developing blood clots returns to normal within a few weeks.

What does the risk of developing blood clots in veins depend on?
The risk depends on the natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of NuvaRing is low.

• In the course of one year, blood clots will occur in about 2 out of 10,000 women who do not use combined hormonal contraceptives and who are not pregnant.
• In the course of one year, blood clots will occur in about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate.
• In the course of one year, blood clots will occur in about 6–12 out of 10,000 women who use combined hormonal contraceptives containing norelgestromin or etonogestrel, such as the NuvaRing vaginal contraceptive system.
• The risk of developing blood clots depends on an individual woman’s medical history (see "Factors that increase the risk of developing blood clots", below).

Factors increasing the risk of venous blood clots
The risk of developing blood clots associated with the use of the NuvaRing vaginal ring is low, but certain factors may increase this risk.
The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In such cases, the patient may have an inherited blood clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to stop using NuvaRing several weeks before surgery or during immobilization. If the patient must discontinue NuvaRing, she should consult her doctor about when it is safe to restart;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

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 blood clots, particularly if the patient has another risk factor.
It is important to inform the doctor if any of these risk factors apply, even if uncertain. The doctor may decide to discontinue NuvaRing.
Inform the doctor if any of the above conditions change during NuvaRing use, for example, if a close family member develops unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial clots can lead to serious complications such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of the NuvaRing vaginal ring is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as the NuvaRing vaginal ring, it is recommended to stop smoking. If the patient is unable to stop 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 a close family member has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, heart rhythm disorder such as 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 further increased.
Inform the doctor if any of the above conditions change during use of the NuvaRing vaginal ring, for example, if the patient starts smoking, a close family member develops unexplained thrombosis, or if the patient gains significant weight.

Cancer
The following information is based on studies using combined oral contraceptives and may also apply to NuvaRing. Data on vaginal hormonal contraceptives (such as NuvaRing) are limited.
A slightly increased incidence of breast cancer has been observed among women using combined oral contraceptives, although it is not known whether this is caused by the medication. It is possible that tumors are detected more frequently in these women because they undergo more regular medical check-ups. The increased risk of breast cancer gradually decreases after stopping combined oral contraceptives.
Regular breast self-examination is very important. If any lump is detected, consult a doctor. Also inform the doctor if a close relative has or has had breast cancer (see section 2.2 "Warnings and precautions").
In rare cases, benign liver tumors have been reported in women using combined oral contraceptives, and very rarely malignant liver tumors. If unusual, severe abdominal pain occurs, contact the doctor.
There are reports that women using combined oral contraceptives have a lower incidence of endometrial cancer (cancer of the uterine lining) and ovarian cancer. This may also apply to NuvaRing, but has not yet been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including NuvaRing, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact 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 women under 18 years of age.

2.4 NuvaRing and other medicines

Always inform the doctor about any medicines or herbal products currently being used. Also inform any other doctor, dentist, or pharmacist prescribing other medicines about the use of NuvaRing. They may advise using an additional contraceptive method (e.g. male condoms), and if so, for how long, and whether any adjustment of other medication is needed.
Some medicines:

• may affect the blood levels of NuvaRing;
• 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 infections (e.g. griseofulvin);
• pulmonary hypertension (bosentan);
• depression (St. John's wort).

If the patient is taking medicines or herbal products that may reduce the effectiveness of NuvaRing, a mechanical contraceptive method (e.g. male condom) should also be used. Because the effect of another medicine on NuvaRing may last up to 28 days after stopping the medicine, additional mechanical contraception is necessary 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 cyclosporine;
• the antiepileptic drug lamotrigine (which may lead to increased frequency of seizures).

If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir and pibrentasvir, the NuvaRing vaginal ring should not be used, as this may lead to increased liver function test parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).
Before starting these medicines, the doctor will prescribe a different type of contraceptive.
Use of the NuvaRing vaginal ring may be resumed approximately 2 weeks after completing this treatment. See section 2.1 "When not to use NuvaRing".
Before taking any medicine, consult a doctor or pharmacist.
During use of NuvaRing, tampons may be used. Insert NuvaRing before inserting a tampon. Be careful when removing the tampon to avoid accidentally removing NuvaRing as well. If NuvaRing falls out, simply rinse the vaginal ring with cool or lukewarm water and reinsert it as soon as possible.
Damage to the vaginal ring may occur during use of vaginal products such as lubricants or treatments for infections (see section 3.4, "What to do if the vaginal ring is damaged"). The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of NuvaRing.

Diagnostic tests
If blood or urine laboratory tests are performed, inform the laboratory staff that NuvaRing is being used, as the use of the vaginal ring may affect the results of certain laboratory tests.

2.5 Pregnancy and breastfeeding

NuvaRing must not be used during pregnancy or if pregnancy is suspected. If the patient becomes pregnant while using NuvaRing, remove the vaginal ring and contact a doctor.
If the patient wishes to stop using NuvaRing because she wants to become pregnant, refer to section 3.5 "What to do if the patient wishes to stop using NuvaRing".
NuvaRing is not recommended during breastfeeding. If the patient wishes to use NuvaRing while breastfeeding, she should consult her doctor first.

2.6 Driving and using machines

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 advise when to start using NuvaRing. The vaginal ring should be inserted on the correct day of the cycle (see section 3.3 "When to insert the first NuvaRing vaginal ring") and left in place for three consecutive weeks. Regularly check that the NuvaRing vaginal ring is in the vagina (e.g. before and after sexual intercourse) to ensure contraceptive protection. After three weeks, remove NuvaRing and take a one-week break. Withdrawal bleeding usually occurs during this break.
Do not use certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom, while using NuvaRing. These methods should not be used as additional contraception because NuvaRing may interfere with the correct placement and positioning of an intrauterine device, cervical cap, or female condom. However, male condoms may be used as an additional mechanical contraceptive method.

3.1 Inserting and removing NuvaRing

1. Before insertion, check the expiry date (see section 5 "How to store NuvaRing and the NuvaRing applicator").
2. Wash hands before inserting or removing the ring.
3. Choose the most comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
4. Remove NuvaRing from the pouch.
5. Holding the ring between the thumb and index finger, compress it and insert into the vagina (see Figures 1–4). Alternatively, the NuvaRing applicator may be used to help place the ring in the vagina (see Patient Instructions below). The correct position is one where the ring is not felt. If the ring causes discomfort, gently adjust its position (e.g. push it slightly deeper into the vagina) until the patient feels comfortable. The exact position within the vagina does not affect its contraceptive effectiveness.
6. After three weeks, remove the ring from the vagina by hooking a finger under its edge or grasping it with the index and middle fingers and pulling it out (Figure 5). If the patient locates the ring in the vagina but cannot remove it, she should contact her doctor.
7. Dispose of the used ring with household waste, preferably in the sealed pouch it came in. Do not flush NuvaRing down the toilet.

How to insert the NuvaRing vaginal ring using fingers only:

Figure 1
Remove NuvaRing from the pouch

Figure 2
Compress the ring

Figure 3
Choose the most comfortable position for insertion

Figure 4A Figure 4B Figure 4C
Insert the ring into the vagina with one hand (Figure 4A), spreading the labia with the other hand if needed. Place it inside the vagina so it is comfortable (Figure 4B). Leave the ring in the vagina for 3 weeks (Figure 4C).

Figure 5
Remove the ring by hooking a finger under its edge 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 vaginal ring.
2. DO NOT reuse the applicator; it is for single use only.
3. DO NOT share the applicator with others.
4. If the applicator is accidentally dropped, wash it with cool or lukewarm (NOT hot) water.
5. After use, immediately dispose of the applicator in a regular household waste container.
6. Do not flush the applicator down the toilet.

How to insert the NuvaRing vaginal ring using the applicator:
1: Preparation

2: Positioning the plunger and assuming the correct position

3: Insertion of the vaginal ring and removal of the applicator

3.2 Three weeks of use, one week off

1. The system must remain in the vagina for three weeks without interruption, starting from the day of insertion.
2. After three weeks, the system should be removed on the same day of the week and approximately at the same time as it was inserted. For example, if NuvaRing was inserted on a Wednesday around 10:00 PM, it should be removed on the following Wednesday three weeks later, around 10:00 PM.
3. After removal of the system, a one-week break should be taken. During this time, bleeding may occur. It usually begins 2–3 days after removal.
4. A new system should be inserted exactly one week after the break (on the same day of the week and approximately at the same time), even if bleeding is still ongoing. If insertion of the new system is delayed by more than 3 hours, 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 vaginal therapeutic system after the weekly break."

If NuvaRing is used according to the above recommendations, withdrawal bleeding will typically occur each month on approximately the same days of the week.

3.3 When to insert the first NuvaRing vaginal therapeutic system

• Previously not using hormonal contraception Insert NuvaRing on the first day of the natural cycle (i.e., the first day of menstruation). NuvaRing is effective from the moment of insertion. There is no need to use any additional contraceptive methods. Alternatively, NuvaRing may be started between days 2 and 5 of menstruation; however, in this case, an additional contraceptive method (such as a male condom) must be used during the first 7 days of NuvaRing use. This recommendation applies only when starting NuvaRing for the first time.
• Previously using combined oral contraceptives Begin NuvaRing no later than the day after the break from the current oral contraceptive. If the current oral contraceptive includes placebo tablets (without active ingredients), start NuvaRing no later than the day after the last placebo tablet is taken. If there is any uncertainty about which tablet is the last, consult a doctor or pharmacist. Do not extend the break from the current oral contraceptive beyond the recommended period. If the patient has taken her pills regularly and is certain she is not pregnant, she may stop taking the pills at any time and immediately start using NuvaRing.
• Previously using a transdermal system (patch) Begin NuvaRing no later than the day after the transdermal system is removed. Do not extend the break from the transdermal system beyond the recommended period. If the patient has used the transdermal system regularly and is certain she is not pregnant, she may discontinue use at any time and immediately start using NuvaRing.
• Previously using progestin-only pills (mini-pills) The patient may discontinue the mini-pill at any time and start NuvaRing the next day at the same time she usually took the mini-pill. An additional contraceptive method (such as a male condom) must be used during the first 7 days of NuvaRing use.
• Previously using injections, an implant, or a progestin-releasing intrauterine system [IUD] Begin NuvaRing on the day the next injection is due, or on the day the implant or progestin-releasing intrauterine system is removed. An additional contraceptive method (such as a male condom) must be used during the first 7 days of NuvaRing use.
• After childbirth After childbirth, the doctor may recommend waiting until the first menstrual period before starting NuvaRing. Sometimes NuvaRing may be started earlier; the doctor will advise when. If breastfeeding and wishing to use NuvaRing, discuss this first with a doctor.
• After miscarriage As directed by the doctor.

3.4 What to do if…

Management in case the system accidentally falls out of the vagina
NuvaRing may accidentally fall out of the vagina, for example, if it was inserted incorrectly, during tampon removal, during sexual intercourse, in case of constipation, or uterine prolapse. Therefore, it is recommended to regularly check whether the system is still in the vagina (e.g., before and after sexual intercourse).

Management if the system has been outside the vagina for some time
The NuvaRing system may still provide protection against pregnancy, depending on how long it was outside the vagina.

If the system was outside the vagina for:

• less than 3 hours, the patient remains protected against pregnancy. The vaginal therapeutic system should be washed in cold or lukewarm (not hot) water and reinserted as soon as possible, but only if it was outside the vagina for less than 3 hours.
• more than 3 hours during the first or second week of use, contraceptive effectiveness may be reduced. Wash the vaginal therapeutic system in cold or lukewarm (not hot) water and reinsert it as soon as possible, leaving it in place continuously for at least 7 days. If sexual intercourse occurs during these 7 days, a male condom should also be used. If the patient is in the first week of the cycle and had sexual intercourse in the past 7 days, there is a possibility of pregnancy. In this case, contact a doctor.
• more than 3 hours during the third week of use, contraceptive effectiveness may be reduced. Remove the vaginal therapeutic system and choose one of the following two options:
  1. Insert a new vaginal therapeutic system as soon as possible. Inserting a new system marks the beginning of the next three-week cycle of use. This may result in the absence of expected withdrawal bleeding, although intermenstrual bleeding or spotting may occur.
  2. Do not reinsert a vaginal therapeutic system. Wait for withdrawal bleeding to occur and insert a new vaginal therapeutic system no later than 7 days after removal or expulsion of the previous one. This approach may only be used if the patient has used NuvaRing continuously for the past 7 days.
• unknown duration, the woman may not be protected against pregnancy. Before inserting a new vaginal therapeutic system, a pregnancy test should be performed and a doctor consulted.

Management in case of damage to the vaginal therapeutic system
NuvaRing may very rarely become damaged. Vaginal wall injury has been reported in association with damage to the vaginal therapeutic system. If the patient notices that NuvaRing is damaged, she should remove it and insert a new one as soon as possible. An additional contraceptive method (e.g., a male condom) should be used for the next 7 days. If sexual intercourse occurred before the damage was noticed, contact a doctor.

Management if more than one vaginal therapeutic system is inserted
There have been no reports of serious harmful effects related to overdose of hormones contained in NuvaRing. If more than one vaginal therapeutic system is accidentally inserted, symptoms such as nausea, vomiting, or genital bleeding may occur. The additional system should be removed, and a doctor should be contacted if symptoms persist.

Management if the patient forgets to insert a new vaginal therapeutic system after the weekly break
If the break in use of the vaginal therapeutic system was longer than 7 days, insert a new system as soon as possible. If sexual intercourse occurs during the next 7 days, an additional contraceptive method (e.g., a male condom) should be used. If sexual intercourse occurred during the break in use of the vaginal therapeutic system, pregnancy is possible. In this case, contact a doctor as soon as possible. The longer the break in use, the higher the likelihood of pregnancy.

Management if the patient forgets to remove the vaginal therapeutic system on time

• If the system remained in the vagina longer than 3 weeks but not longer than 4 weeks, the patient remains protected against pregnancy. The system should be removed for one week, then a new one inserted.
• If the patient used the vaginal therapeutic system longer than 4 weeks, pregnancy is possible. Contact a doctor before inserting a new system.

Management if withdrawal bleeding does not occur

• If the patient used NuvaRing according to instructions If withdrawal bleeding does not occur on schedule, but the patient used NuvaRing as directed and did not take other medications, the likelihood of pregnancy is very low. Continue using NuvaRing as usual. However, if withdrawal bleeding does not occur for two consecutive cycles, pregnancy is possible. Contact a doctor as soon as possible. Do not insert a new NuvaRing system until a doctor confirms the patient is not pregnant.
• If the patient used NuvaRing incorrectly If withdrawal bleeding does not occur during the first break and the patient used the vaginal therapeutic system incorrectly, she may be pregnant. Contact a doctor before using a new NuvaRing.

Management of unexpected bleeding
During use of the vaginal therapeutic system, some women may experience unexpected intermenstrual bleeding. Sanitary pads may be needed. Leave the system in place and continue using it as usual. If irregular bleeding increases or recurs, contact a doctor.

Management if the day of bleeding changes
If NuvaRing is used as directed, menstrual periods (withdrawal bleeding) will occur during the weekly break. If the patient wishes withdrawal bleeding to start on a different day, she may shorten the break in use (but never extend it!).
For example: if withdrawal bleeding usually starts on Friday, and the patient wishes to shift it to Tuesday (3 days earlier) starting next month, she should insert the new vaginal therapeutic system 3 days earlier than usual.
If the break is significantly shortened (e.g., to 3 days or less), withdrawal bleeding may not occur at all. During use of the next system, spotting (small drops or blood stains) or intermenstrual bleeding may occur.
If the patient is unsure how to proceed, she should consult a doctor.

Management if delaying the onset of bleeding is desired
Although not recommended, menstruation (withdrawal bleeding) may be delayed by inserting a new vaginal therapeutic system immediately after removing the previous one, without a break. The new vaginal therapeutic system should not be used for longer than 3 weeks. During this time, spotting (small drops or blood stains) or intermenstrual bleeding may occur. To induce withdrawal bleeding, remove the vaginal therapeutic system. A regular weekly break between systems is recommended.
Before deciding to delay menstruation, the patient may consult her doctor.

3.5 What to do if the patient wishes to stop using NuvaRing

NuvaRing may be discontinued at any time.
If the patient does not wish to become pregnant, consult a doctor about alternative contraceptive methods.
If the patient stops using NuvaRing because she wishes to become pregnant, she should wait until her first menstrual period and then begin trying to conceive. This helps determine the expected date of delivery.

4. Possible side effects

Like all medicines, NuvaRing can cause side effects, although not everyone will experience them. If any side effects occur, especially severe or persistent ones, or any changes in health that the patient believes are related to NuvaRing use, consult a doctor.
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with combined hormonal contraceptives, refer to section 2, "Important information before using NuvaRing."
If the patient is allergic (hypersensitive) to any component of NuvaRing, this may manifest as (frequency unknown): angioedema and (or) anaphylactic reaction [facial, lip, tongue, and (or) throat swelling and (or) difficulty swallowing] or hives, potentially with breathing difficulties. In such cases, remove NuvaRing and contact a doctor immediately (see also section 2.2, "Warnings and precautions").
Women using NuvaRing have reported the following side effects:
Common: may affect up to 1 in 10 women

• abdominal pain, nausea
• vaginal yeast infections (e.g., "thrush"); discomfort due to presence of the system in the vagina; genital itching; vaginal discharge
• headache or migraine headache; depressed mood; decreased libido
• breast pain; pelvic pain; painful menstruation
• acne
• weight gain
• expulsion of the system.

Uncommon: may affect up to 1 in 100 women

• vision disturbances; dizziness
• bloating; vomiting, diarrhea, or constipation
• fatigue, malaise, or restlessness; mood changes; sudden mood swings
• swelling
• urinary bladder or urinary tract infections
• problems or pain during urination; urgency or need to urinate; frequent urination
• discomfort during intercourse, including pain, bleeding, or discomfort felt by the male partner due to the presence of the system
• increased blood pressure
• increased appetite
• back pain; muscle cramps; pain in lower or upper limbs
• decreased skin sensitivity
• breast tenderness or enlargement; fibrocystic breast changes (cysts that may cause swelling or pain)
• cervical inflammation; cervical polyps; cervical ectropion
• changes in menstrual bleeding (e.g., heavy, prolonged, irregular, or complete absence of periods); pelvic discomfort; premenstrual syndrome; uterine cramps
• vaginal infections (fungal or bacterial); burning sensation, unpleasant odor, pain, discomfort, or dryness of the vagina or vulva
• hair loss, rash, itching, hives, or hot flushes
• hives.

Rare: may affect up to 1 in 1000 women

• harmful blood clots in a vein or artery, for example:
  o in the leg or foot (e.g., deep vein thrombosis)
  o in the lungs (e.g., pulmonary embolism)
  o heart attack
  o stroke
  o mini-stroke or transient ischemic attack
  o blood clots in the liver, stomach, intestines, kidneys, or eye
  The risk of blood clots may be higher if the patient has other risk factors (see section 2 for further information on risk factors and symptoms of blood clots).
• milk-like discharge from the breasts.

Unknown frequency (cannot be estimated from available data)

• chloasma (yellowish-brown pigmentation on the skin, especially on the face)
• partner discomfort (e.g., irritation, rash, itching)
• inability to remove the vaginal therapeutic system without medical assistance (e.g., due to adhesion of the system to the vaginal wall)
• vaginal wall injury related to damage of the vaginal therapeutic system.

Breast cancer and liver tumors have occurred in women using combined hormonal contraceptives. For detailed information, see section 2.2, "Warnings and precautions," "Tumors."
NuvaRing may very rarely become damaged. For additional information, see section 3.4, "Management in case of damage to the vaginal therapeutic system."

Reporting of side effects
If any side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting side effects helps increase knowledge about the safety of the medicine.

5. How to store NuvaRing and the NuvaRing applicator

Keep the medicine out of sight and reach of children.
Contact a doctor if a child is exposed to the hormones in NuvaRing.
Store below 30°C. Keep in the original packaging to protect from light and moisture.
Do not use NuvaRing more than 4 months after the date it was dispensed from the pharmacy. This date is printed on the box and on the pouch.
Do not use NuvaRing after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use NuvaRing if a change in color is noticed or if there are any visible signs of deterioration.
Used vaginal therapeutic systems should be disposed of in a regular household waste container, preferably in a sealed pouch. Used applicators should be disposed of in a regular household waste container. Do not flush NuvaRing or the applicator down the toilet. Unused or expired medicines, like other pharmaceuticals, should not be disposed of via sewage or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What NuvaRing contains

• Active substances: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• Other ingredients: 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 vaginal therapeutic system at a rate of 0.120 mg/day and 0.015 mg/day over a 3-week period.

What NuvaRing and the applicator look like and contents of the pack
NuvaRing is a flexible, transparent, colorless or almost colorless ring with an outer diameter of 54 mm.
Each vaginal therapeutic system is individually packaged in a foil pouch. The pouch can be resealed after opening.
The applicator is a non-sterile, single-use medical device made of PP plastic. Each applicator is individually packaged. The applicator bears a CE mark, embossed on the device.
The pouch containing the vaginal therapeutic system(s) and applicator(s) is placed in a cardboard box with the package leaflet.
Each pack contains 1 or 3 systems and applicators.
For more detailed information, contact the responsible entity or parallel importer.
Responsible entity in Belgium, country of export:
Organon Belgium
Handelsstraat 31 / Rue du Commerce 31
B-1000 Brussels
Belgium
Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization number in Belgium, country of export: BE228541
Parallel import authorization number: 163/23
This medicine is authorized for sale in the European Economic Area and 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).
These stickers, placed on the appropriate day in the calendar, may help remember when to insert and remove NuvaRing.

Insert Remove
NuvaRing NuvaRing