Nuvaring

Patient Information Leaflet

Keep this leaflet, information on the outer packaging in a foreign language!
NuvaRing
(0.120 mg + 0.015 mg)/24 h, vaginal ring
Etonogestrel + Ethinylestradiol
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 following a break of 4 weeks or more.
• Be alert and consult your doctor if you suspect symptoms of a blood clot (see section 2 "Blood clots").

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm them.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet 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 medicine in the form of a vaginal ring 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 in the same way as a combined oral contraceptive pill (combined pill). However, unlike a daily pill, NuvaRing is used continuously for 3 weeks.
NuvaRing releases two female sex hormones that inhibit the release of eggs from the ovaries. Because eggs are not released, pregnancy cannot occur.

2. Important information before using NuvaRing

General notes
Before starting NuvaRing, you should read the information about blood clots (thrombosis) in section 2. It is especially 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 may be ineffective because NuvaRing affects changes in body temperature and cervical mucus consistency throughout the month.
NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

2.1 When not to use NuvaRing
Do not use NuvaRing if you have any of the conditions listed below. If you have any of these conditions, 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 veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs,
• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies,
• if you are undergoing 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 conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of blood fats (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 blood fats,
• 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 benign or malignant liver tumours,
• if you currently have or have previously had breast 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 symptoms occur for the first time while using 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 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 you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below “Blood clots”). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

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 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 (a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high blood fat levels (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you are undergoing 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 about how soon you can start using NuvaRing after childbirth;
• if you have phlebitis (inflammation of superficial veins under the skin);
• if you have varicose veins;
• if you have conditions that first appeared 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 nervous system disorder causing involuntary, violent movements]);
• seek immediate medical attention 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 suddenly feel a frequent urge to urinate with a burning sensation and/or pain, and if you cannot locate the NuvaRing vaginal system inside the vagina. These symptoms may indicate accidental placement of the NuvaRing vaginal system 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 such treatment. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (referred to as “venous thrombosis” or “venous thromboembolic disease”);
• in arteries (referred to as “arterial thrombosis” or “arterial thromboembolic disorders”).

Full recovery from a blood clot is not always possible. 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 low.

HOW TO RECOGNIZE A BLOOD CLOT
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 only be felt when standing or walking,
• increased warmth in the affected leg,
• change in skin colour of the leg, e.g. paleness, redness, or blueness.
• sudden onset of unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden coughing without an obvious cause, possibly accompanied by coughing up blood;
• sharp chest pain, which may worsen on 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 breathlessness, may be mistaken for milder conditions such as a respiratory tract infection (e.g. cold).
Symptoms most commonly affect one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless visual disturbances, which may progress to vision loss

chest pain, discomfort, pressure, heaviness; feeling of tightness or fullness in the chest, arm or below the breastbone; feeling of fullness, indigestion or choking; discomfort in the lower part of the body radiating to the back, jaw, throat, arm or stomach; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety or shortness of breath; rapid or irregular heartbeat.	Heart attack
sudden weakness or numbness of the face, arms or legs, especially on one side of the body; sudden confusion, speech or comprehension disturbances; sudden vision disturbances in one or both eyes; sudden disturbances in walking, dizziness, loss of balance or coordination; sudden, severe or prolonged headaches without known cause; loss of consciousness or fainting with or without seizures. In some cases, stroke symptoms may be transient with almost immediate and complete recovery; however, medical attention should be sought immediately, as the patient may be at risk of a subsequent stroke.	Stroke
swelling and slightly bluish discoloration of the skin of the legs or arms; severe abdominal pain (acute abdomen)	Blood clots blocking other blood vessels

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 higher 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 than in women who do not use combined hormonal contraceptives.
If a woman stops using NuvaRing, the risk of developing blood clots returns to normal 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 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 using 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 to 12 out of 10,000 women who use combined hormonal contraceptives containing norelgestromin or etonogestrel, such as the NuvaRing vaginal contraceptive system, will develop blood clots.
• The risk of developing blood clots depends on the individual woman's medical history (see "Factors that increase the risk of blood clots", below).

	Risk of developing blood clots within one year
Women who do not use combined hormonal tablets/patches/vaginal systems and are not pregnant	About 2 per 10,000 women
Women using combined oral contraceptive tablets containing levonorgestrel, norethisterone or norgestimate	About 5-7 per 10,000 women
Women using the NuvaRing vaginal system	About 6-12 per 10,000 women

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

• if the patient is very overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited tendency to clotting;
• if the patient is due to have surgery, is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop using NuvaRing several weeks before surgery or during immobilisation. If the patient has to stop using NuvaRing, she should ask her doctor when she can start using it again;
• 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 blood clots, particularly if the patient has another risk factor listed above.
It is important to tell the doctor if any of the listed risk factors apply to the patient, even if she is unsure. The doctor may decide to discontinue the use of NuvaRing.
The patient should inform her doctor if any of the above conditions change during treatment with NuvaRing, for example, if a close family member is diagnosed with thrombosis without a known 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 note 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. While 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 of age, 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 fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disease, heart rhythm disorder known 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 developing blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with the NuvaRing vaginal ring, for example, if she starts smoking, if a close family member is diagnosed with thrombosis without a known cause, or if she gains significant weight.

Tumours
The following information comes from studies on combined oral contraceptives and may also apply to NuvaRing. Information on vaginal hormonal contraceptives (as used in NuvaRing) is limited.

A slightly higher incidence of breast cancer has been observed among women using combined hormonal contraceptives, although it is not known whether this is caused by the medication. It is possible that breast tumours are detected more frequently in these women because they undergo more regular medical check-ups. The increased incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Regular breast examinations are very important. If any lump is detected, the patient should contact her doctor. She should also inform her doctor if any close relatives have had or currently have breast cancer (see section 2.2 “Warnings and precautions”).

Benign liver tumours have rarely occurred in women using combined hormonal contraceptives, and malignant liver tumours have occurred very rarely. If the patient experiences unusual, severe abdominal pain, she should contact her doctor.

There are reports that women using combined hormonal contraceptives have a lower incidence of endometrial cancer (cancer of the lining of the uterus) and ovarian cancer. This may also apply to NuvaRing, although 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, the patient should contact her 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 NuvaRing and other medicines
Always inform the doctor about any medicines or herbal products the patient is currently taking. The patient should also inform any other doctor, dentist or pharmacist prescribing other medicines about the use of NuvaRing. They may advise using an additional method of contraception (e.g. male condoms), and if so, for how long, and whether any adjustment to 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);
• high blood pressure in the pulmonary arteries (bosentan);
• depression (St. John’s wort).

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

NuvaRing may affect the action of other medicines such as:

• medicines containing cyclosporine;
• the anticonvulsant lamotrigine (this 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, 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 another type of contraceptive.
Use of the NuvaRing vaginal ring may be restarted 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. The NuvaRing should be inserted before inserting a tampon. Care should be taken when removing the tampon to avoid accidentally removing the NuvaRing. If the ring falls out, it should be rinsed with cool or lukewarm water and reinserted as soon as possible.
Damage to the vaginal ring has occurred during the 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 to be performed, the patient should inform the person conducting the test that she is using NuvaRing, as the use of the vaginal ring may affect the results of certain laboratory tests.

2.5 Pregnancy and breast-feeding
NuvaRing must not be used during pregnancy or if pregnancy is suspected. If the patient becomes pregnant while using NuvaRing, the vaginal ring should be removed and the patient should contact her doctor.
If the patient wishes to stop using NuvaRing because she wants to become pregnant, she should refer to section 3.5 “What to do if the patient wants to stop using NuvaRing”.
NuvaRing is not recommended during breast-feeding. If the patient wishes to use NuvaRing while breast-feeding, 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

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

Do not use certain mechanical methods of contraception for women, such as a diaphragm, cervical cap, or female condom while using NuvaRing. These mechanical contraceptive 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 Inserting and removing NuvaRing

1. Before inserting the ring, check the expiry date (see section 5 "How to store NuvaRing").
2. Wash your hands before inserting or removing the ring.
3. Choose the most comfortable position for insertion, such as standing with one leg raised, sitting in a squatting position, or lying down.
4. Remove 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 can be inserted using the NuvaRing Applicator (which is not included in the NuvaRing packaging). The NuvaRing Applicator may not be available in all countries. The correct position of NuvaRing is one where you do not feel it. If the ring causes discomfort, gently adjust its position (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 3 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 the most 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 needed. Place it inside the vagina so that it is comfortable (Figure 4B). Leave the ring in the vagina for 3 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 it 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 Wednesday of the third week, also around 10:00 PM.
3. After removal, take a 1-week break. During this time, withdrawal bleeding may occur. It usually starts 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 approximately at 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 such a case, follow the instructions in section 3.4 "What to do if after the 1-week break the patient forgets to insert a new vaginal ring system".

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

3.3 When to insert the first vaginal ring system NuvaRing

• Previously not using hormonal contraception

Insert NuvaRing on the first day of your 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.

You may also start using NuvaRing between Day 2 and Day 5 of your menstrual cycle, but in this case, you must use an additional contraceptive method (such as a male condom) for the first 7 days of NuvaRing 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 pill-free interval of your current contraceptive. If your current pills include inactive (placebo) tablets, start NuvaRing no later than the day after taking the last inactive tablet. If you are unsure which tablet this is, consult your doctor or pharmacist. Do not extend the break from your current pills beyond the recommended period. If you have taken your pills regularly and are certain you are not pregnant, you may stop taking them on any day and immediately start using NuvaRing.

• Previously using a transdermal patch

Begin using NuvaRing no later than the day after the patch-free interval. Do not extend the patch-free interval beyond the recommended period. If you have used the patch regularly and are certain you are not pregnant, you may stop using the patch on any day and immediately start using NuvaRing.

• Previously using progestogen-only pills (mini-pills)

You may stop taking the mini-pill on any day and start using NuvaRing the next day at the same time you usually took the mini-pill. For the first 7 days of NuvaRing use, 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 NuvaRing use, use an additional contraceptive method (such as a male condom).

• After childbirth

After childbirth, your doctor may advise you to wait until after your first menstrual period before starting NuvaRing. Sometimes, earlier use may be possible; your doctor will advise you when. If you are breastfeeding and wish to use NuvaRing, discuss this with your doctor first.

• After a miscarriage

As advised by your doctor.

3.4 What to do if…

What to do if the ring 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 intercourse, in case of constipation, or due to uterine prolapse. Therefore, you should regularly check that the ring is in the vagina (e.g., before and after sexual intercourse).

What to do if the ring has been out of the vagina for some time

NuvaRing may still protect 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 system with cool or lukewarm (not hot) water and reinsert it as soon as possible—but only if it was out 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 ring system with cool or lukewarm (not hot) water and reinsert it as soon as possible, leaving it in place continuously for at least 7 days. If you have intercourse during these 7 days, use an additional male condom. If you are in the first week of the cycle and have had intercourse in the past 7 days, there is a possibility you may be pregnant. 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 system and choose one of the following two options:
  1 – Insert a new vaginal ring system as soon as possible. Inserting a new vaginal ring system means starting the next 3-week cycle of use. This may prevent the expected withdrawal bleeding, although breakthrough bleeding or spotting may occur.
  2 – Do not reinsert a vaginal ring system. Wait for withdrawal bleeding to occur and insert a new vaginal ring system no later than 7 days after removal or expulsion of the previous ring. This approach is only acceptable if you have used NuvaRing continuously for the past 7 days.
• unknown duration , you may not be protected against pregnancy. Before inserting a new vaginal ring system, perform a pregnancy test and consult your doctor.

What to do if the vaginal ring system is damaged

Very rarely, NuvaRing may become damaged. Vaginal wall injury has been reported in association with damage to the vaginal ring system. 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., a male condom) for the next 7 days. If you had intercourse before noticing the damage, contact your doctor.

What to do if more than one vaginal ring system has been inserted

There have been no reports of serious harmful effects related to overdose of the hormones in NuvaRing. If more than one vaginal ring system is accidentally inserted, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Remove the additional vaginal ring system and contact your doctor if symptoms do not resolve.

What to do if after the 1-week break the patient forgets to insert a new vaginal ring system

If the break in using the vaginal ring system was longer than 7 days , insert a new ring as soon as possible. If you have intercourse within the next 7 days, use an additional contraceptive method (e.g., a male condom). If intercourse occurred during the break in using the vaginal ring system, there is a possibility of pregnancy. In this case, contact your doctor as soon as possible. The longer the break in using the vaginal ring system, the greater the likelihood of pregnancy.

What to do if the patient forgets to remove the vaginal ring on time

• If the ring has remained in the vagina for longer than 3 weeks but not longer than 4 weeks , you are still protected against pregnancy. Remove the vaginal ring system and take a 1-week break, then insert a new one.
• If you have used the vaginal ring system for longer than 4 weeks , there is a possibility of pregnancy. Contact your doctor before inserting a new vaginal ring system.

What to do if withdrawal bleeding does not occur

• If the patient has used NuvaRing according to instructions
  If withdrawal bleeding does not occur on time, but you have used NuvaRing as directed and have not taken other medications, the likelihood of pregnancy is very low. Continue using NuvaRing as before. However, if withdrawal bleeding does not occur for two consecutive cycles, pregnancy is possible. Contact your doctor as soon as possible. Do not insert a new NuvaRing until your doctor confirms you are not pregnant.

• If the patient has not used NuvaRing according to instructions
  If withdrawal bleeding does not occur during the first break in using NuvaRing and you have not used the vaginal ring system as directed, you may be pregnant. Contact your doctor before using a new NuvaRing.

What to do if unexpected bleeding occurs

During use of the vaginal ring system, some women may experience unexpected mid-cycle bleeding. You may need sanitary pads. Leave the ring in the vagina and continue using it as before. If irregular bleeding increases or recurs, contact your doctor.

What to do if the day of bleeding changes

If you use NuvaRing as directed, menstrual periods (withdrawal bleeds) will begin during the 1-week break from the vaginal ring system. If you wish withdrawal bleeding to start on a different day, you may shorten the break in using the vaginal ring system (but never extend it!).

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

If the break in using the vaginal ring system is significantly shortened (e.g., to 3 days or less), withdrawal bleeding may not occur at all during that time. During use of the next vaginal ring system, spotting (single drops or stains of blood) or mid-cycle bleeding may occur.

If you are unsure what to do, consult your doctor.

What to do if you wish to delay the onset of bleeding

Although not recommended, you may delay the onset of menstruation (withdrawal bleeding) by inserting a new vaginal ring system immediately after removing the previous one, without taking a break. The new vaginal ring system should not be used for longer than 3 weeks. During use of the new vaginal ring system, spotting (single drops or stains of blood) or mid-cycle bleeding may occur. To induce withdrawal bleeding, remove the vaginal ring system. A regular weekly break between consecutive rings is recommended.

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

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

You may stop using NuvaRing at any time.

If you do not wish to become pregnant, ask your doctor about other contraceptive methods.

If you stop using NuvaRing because you wish to become pregnant, wait until your first menstrual period and then begin trying to conceive. This will help determine the 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 or persistent ones, or any changes in health that the patient considers related to the use of NuvaRing, medical advice should be sought from a doctor.

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, please refer to section 2, "Important information before using NuvaRing".

If a patient is allergic (hypersensitive) to any of the components of NuvaRing, this 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 immediately and medical advice sought without delay (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

• Vision disturbances; dizziness
• Bloating; vomiting, diarrhoea or constipation
• Feeling tired, malaise or restlessness; mood changes; sudden mood swings
• Oedema (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 related to the presence of the system, as experienced by the male partner
• 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 which may cause breast swelling or pain)
• Cervicitis; cervical polyps; cervical ectropion
• Changes in menstrual bleeding (e.g. heavy, prolonged, irregular or complete absence of menstruation); pelvic discomfort; premenstrual syndrome; uterine cramps
• Vaginal infections (fungal or bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
• Hair loss, rash, itching, 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
  • Mini-stroke or transient ischaemic attack (TIA)
  • Blood clots in the liver, stomach and intestine, kidneys or eye

The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

• Galactorrhoea (discharge of milk from the breast)

Frequency not known (cannot be estimated from the available data)

• Chloasma (yellowish-brown pigmentation patches on the skin, especially on the face)
• Partner's intercourse discomfort (such as irritation, rash, itching)
• Inability to remove the vaginal ring without medical assistance (e.g. due to adhesion of the vaginal ring to the vaginal wall)
• Vaginal wall injury related to damage of the vaginal ring

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

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

Reporting of adverse effects

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

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

5. How to store NuvaRing

Keep this medicine out of sight and reach of children.
Contact a doctor if a child is suspected to have been exposed to the hormones contained in NuvaRing.
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 dispensing date is indicated on the box and on the sachet.
Do not use NuvaRing after the expiry date stated on the box and on the sachet.
Do not use NuvaRing if you notice any change in colour or any signs of deterioration.
Dispose of used vaginal contraceptive rings in a regular household waste container, preferably in a sealed pouch. Do not flush NuvaRing down the toilet. Like other medicines, unused or expired systems must not be disposed of via sewage systems or household waste bins. Ask your pharmacist how to properly 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 components are: poly(ethylene vinyl acetate), 28% vinyl acetate (EVA 28), poly(ethylene vinyl acetate), 9% vinyl acetate (EVA 9), 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, respectively, 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 packaged in a sealed foil pouch. The pouch can be resealed after opening. The pouches are contained in a cardboard box together with a patient leaflet and reminder stickers to help remember when to insert and remove the NuvaRing.
The pack contains 1 or 3 vaginal ring systems.

For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Romania, country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popişteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 şi Birou 307, Etaj 3, Sectorul 1,
Bucharest,
Romania

Manufacturer:
N.V. Organon
Kloosterstraat 6, 5349 AB Oss
The Netherlands
Organon Ireland Ltd.
Drynam Road, Swords, Co. Dublin, Ireland

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation numbers in Romania, country of export:
4823/2012/01
4823/2012/02
Parallel Import Authorisation number: 121/21

This medicinal product is authorised for marketing in the European Economic Area under the following name:
NuvaRing
0.120 mg/0.015 mg/24 h, vaginal ring
Austria, Belgium, Bulgaria, 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.