Nuvaring

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
NuvaRing (Circlet)
(0.120 mg + 0.015 mg)/24 h, vaginal therapeutic system
Etonogestrel + Ethinylestradiol
NuvaRing and Circlet are different brand names of the same medicine.
Important information regarding 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, particularly during the first year of use or after restarting 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, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What NuvaRing is and what it is used for

NuvaRing is a contraceptive medicine in the form of a vaginal therapeutic system that prevents pregnancy. Each vaginal therapeutic system contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. These hormones are slowly released from the system into the bloodstream. Due to the 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 the daily pill, NuvaRing is used continuously for 3 weeks. NuvaRing releases two female sex hormones which suppress the release of eggs from the ovaries. As eggs are not released, pregnancy cannot occur.

2. Important information before using NuvaRing

General notes
Before starting to use NuvaRing, you should read the information about blood clots (thrombosis) in section 2. It is 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 monitoring. These methods 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 infections.

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 currently 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 blood fats (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 blood fats,
• 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 in the past breast cancer or genital organ cancers, 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 during use of NuvaRing, remove the vaginal ring immediately and consult your doctor. During this time, 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 a doctor?
You should contact a doctor immediately:

• 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 a blood clot".

Tell your doctor if you have any of the following conditions.
If any of these conditions 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 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 causing kidney failure),
• if you have sickle cell anaemia (an inherited disorder of red blood cells),
• if you have been diagnosed with high blood fat levels (hypertriglyceridaemia) or have 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 for advice on when it is safe to 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 occurred 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]),
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives potentially with breathing difficulties. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema,
• if you currently have or have had chloasma (yellowish-brown pigmentation patches, so-called "melasma", especially on the face). If these occur, avoid excessive sun exposure and ultraviolet radiation,
• if you have conditions that make using NuvaRing difficult, e.g. frequent constipation, uterine prolapse, or pain during intercourse,
• if you experience sudden, frequent urge to urinate with a burning sensation and/or pain, or if you cannot locate the vaginal ring 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 therapy. In rare cases, a blood clot can block a blood vessel and cause serious health problems.
Blood clots may occur:

• in veins (called "venous thrombosis" or "venous thromboembolic disease"),
• in arteries (called "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 low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact your doctor immediately if you notice 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, especially if accompanied by:
  Deep vein thrombosis

• pain or tenderness in the leg, which may occur only when standing or walking,

• increased warmth in the affected leg,

• change in skin colour of the leg, e.g. paleness, redness, or blueness.

• sudden unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• sudden cough without an obvious cause, which may be accompanied by coughing up blood;

• sharp chest pain, which may worsen with deep breathing;

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe stomach pain.

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

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

• The use of combined hormonal contraceptives is associated with an increased risk of 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 compared to not using combined hormonal contraceptives at all.
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 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 delivery system, will develop blood clots.
• The risk of developing blood clots depends on the woman's individual 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 ring 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 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 clotting disorder;
• if the patient needs to undergo surgery, if she 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 resume use;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of venous 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 present.
It is important to inform the doctor if any of these risk factors apply to the patient, even if uncertain. 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 unexplained thrombosis 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 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, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years of age, 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 (before age 50). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a 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 disorder, 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 arterial 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 unexplained thrombosis, or if she 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 breast cancer is detected more frequently in these women because they undergo medical examinations more regularly. The increased risk of breast cancer gradually decreases after stopping combined oral 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 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 unusual, severe abdominal pain occurs, the patient should contact her doctor.
There are reports that women using combined oral contraceptives have a lower incidence of endometrial cancer (cancer of the lining of the uterus) 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, 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 Interaction of NuvaRing with other medicines
Always inform the doctor about any medicines or herbal products currently being used. 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 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 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);
• pulmonary arterial hypertension (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 a mechanical contraceptive method (e.g. male condom). 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 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 ring should not be used, as this may cause increased liver function test parameters in blood laboratory tests (increased liver enzyme AlAT activity).
Before starting these medications, the doctor will prescribe a different type of contraceptive.
Use of the NuvaRing vaginal ring may be resumed approximately 2 weeks after completion of 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 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"). 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, the patient should inform the laboratory staff that she is using NuvaRing, 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, 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, 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, she should consult her 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 medicine 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 appropriate day of the cycle (see section 3.3 "When to insert the first NuvaRing vaginal ring") and left in place continuously for 3 weeks. You should regularly check that the NuvaRing vaginal ring 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 contraceptive methods 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, squatting, 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 in which you do not feel it. If the ring is uncomfortable, gently adjust its position (e.g., push it slightly deeper into the vagina) until you feel comfortable. The exact position of the ring in 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 by grasping it with 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), separating the labia with the other hand if necessary. 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 by grasping it with 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 3 weeks, starting from the day of insertion.
2. After 3 weeks, remove the ring on the same day of the week and approximately at the same time as when it was inserted. For example, if NuvaRing was inserted on a Wednesday at around 10:00 PM, it should be removed on a Wednesday 3 weeks later, around 10:00 PM.
3. After removing the ring, 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 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 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 you forgot to insert a new vaginal ring after the 1-week break."
   If NuvaRing is used according to these instructions, withdrawal bleeding 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 from the moment of 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) during the first 7 days of using NuvaRing. This applies only when starting NuvaRing for the first time.

• Previously using combined oral contraceptive pills

Start using NuvaRing no later than the day after the break from your current pill. If your current pill pack includes inactive (placebo) pills, start using NuvaRing no later than the day after taking the last inactive pill. If you are unsure which pill 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 your pills on any day and immediately start using NuvaRing.

• Previously using a transdermal system (patch)

Start using NuvaRing no later than the day after the break from the transdermal system. Do not extend the break from the transdermal system beyond the recommended period. If you have used the transdermal system regularly and are certain you are not pregnant, you may stop using it on any day and immediately start using NuvaRing.

• Previously using a progestogen-only pill (mini-pill)

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. Use an additional contraceptive method (such as a male condom) during the first 7 days of using NuvaRing.

• Previously using injections, an implant, or a progestogen-releasing intrauterine system [IUD]

Start using NuvaRing on the day of your next scheduled injection or on the day of removal of the implant or progestogen-releasing intrauterine system. Use an additional contraceptive method (such as a male condom) during the first 7 days of using NuvaRing.

• After childbirth

After childbirth, your doctor may advise you to wait until your first period before starting NuvaRing. Sometimes you may start earlier; 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 sexual intercourse, in case of constipation, or uterine prolapse. Therefore, you should regularly check that the ring is in the vagina (for example, before and after sexual intercourse).

What to do if the ring has been outside the vagina for some time
NuvaRing may still protect against pregnancy, but this depends on how long it was outside the vagina.

If the ring was outside 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, 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 ring with cool or lukewarm (not hot) water and reinsert it as soon as possible, and 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 the cycle and had sexual intercourse in the last 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 and choose one of the following two options:
  1 – Insert a new vaginal ring as soon as possible. Inserting a new vaginal ring means starting the next 3-week cycle. This may prevent the expected withdrawal bleeding, but breakthrough bleeding or spotting may occur.
  2 – Do not reinsert a 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 approach may only be used if you have used NuvaRing continuously for the last 7 days.
• unknown duration , you may not be protected against pregnancy. Before inserting a new vaginal ring, perform a pregnancy test and consult your doctor.

What to do 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., a male condom) for the next 7 days. If you had sexual intercourse before noticing the damage, contact your doctor.

What to do if more than one vaginal ring 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 is accidentally inserted, symptoms such as nausea, vomiting, or genital bleeding may occur. Remove the additional vaginal ring and contact your doctor if symptoms persist.

What to do if you forgot to insert a new vaginal ring after the 1-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., a male condom). If sexual intercourse occurred during the break in using the vaginal ring, pregnancy is possible. In this case, contact your doctor as soon as possible. The longer the break in using the vaginal ring, the greater the chance of pregnancy.

What to do if you forgot 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 and take a 1-week break, then insert a new ring.
• If you have used the vaginal ring for longer than 4 weeks , there is a possibility of pregnancy. Contact your doctor before inserting a new vaginal ring.

What to do if there is no withdrawal bleeding

• If you used NuvaRing according to instructions
  If withdrawal bleeding does not occur on time, but you used NuvaRing as directed and did not take other medicines during this time, the chance of pregnancy is very low. Continue using NuvaRing as before. However, if withdrawal bleeding does not occur twice in a row, 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 you used NuvaRing incorrectly
  If withdrawal bleeding does not occur during the first break in using NuvaRing and you used the vaginal ring incorrectly, 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, some women may experience unexpected mid-cycle bleeding. You may need sanitary pads. Leave the ring in place and continue using it as before. If irregular bleeding increases or recurs, contact your doctor.

What to do if the day of withdrawal bleeding changes
If you use NuvaRing as directed, periods (withdrawal bleeding) will begin during the 1-week break. If you wish withdrawal bleeding to start on a different day, you may shorten the break (but never extend it!).
For example: if withdrawal bleeding usually starts on Friday, and you wish to change 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 use of the next vaginal ring, spotting (small 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 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 a break. The new vaginal ring should not be used for longer than 3 weeks. During use of the new vaginal ring, spotting or mid-cycle bleeding may occur. To induce withdrawal bleeding, remove the vaginal ring. A regular 1-week break between rings is recommended.
Before deciding to delay your period, you may 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 other contraceptive methods.
If you stop using NuvaRing because you wish to become pregnant, wait until your first period and then start trying to conceive. This will help determine your due date.

4. Possible adverse reactions

Like all medicines, NuvaRing may cause adverse reactions, although not everyone experiences them. If any adverse reactions 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 thromboembolic disorders (blood clots in the veins) or arterial thromboembolic disorders (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 there is hypersensitivity (allergy) to any component 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 reactions:

Common: may occur in 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 occur in up to 1 in 100 women

• visual disturbances; dizziness
• bloating; vomiting, diarrhoea or constipation
• feeling of fatigue, malaise or restlessness; mood changes; sudden mood changes
• 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 perceived 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 disease (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 spasm
• 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 occur in up to 1 in 1000 women

• harmful blood clots in a vein or artery, for example:
  • in the leg or foot (e.g. deep vein thrombosis)
  • in the lungs (e.g. pulmonary embolism)
  • heart attack
  • stroke
  • mini-stroke or transient ischaemic attack (TIA)
  • blood clots in the liver, stomach and intestines, kidneys or eye

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

• galactorrhoea (discharge of milk from the breast)

Frequency not known (cannot be estimated from available data)

• chloasma (yellowish-brown pigmentation spots 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 occurred in women using combined hormonal contraceptives. For detailed information, see section 2.2 "Warnings and precautions", "Neoplastic diseases".

Very rarely, NuvaRing may become damaged. For additional information, see section 3.4 "Management in case of damage to the vaginal ring".

Reporting of adverse reactions

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

Adverse reactions 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 reactions helps provide more information on the safety of this medicine.

5. How to store NuvaRing

Keep this medicine out of the sight and reach of children.
Contact a doctor if a child is suspected to have been exposed to the hormones contained in NuvaRing.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Do not use NuvaRing after 4 months have passed from the date it was dispensed by the pharmacy. The dispensing date is indicated on the packaging.
Do not use NuvaRing after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Do not use NuvaRing if you notice any change in colour or if there are any signs of deterioration.
Used vaginal contraceptive systems 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 systems must not be disposed of via sewage systems or household waste. Ask your pharmacist how to properly dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What NuvaRing contains

• The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• Other components are: poly(ethylene-vinyl acetate), 28% and 9% vinyl acetate (a type of plastic that does not dissolve in the body), and magnesium stearate.

Etonogestrel and ethinylestradiol are released from the vaginal therapeutic system at a rate of 0.120 mg/day and 0.015 mg/day, respectively, over a period of 3 weeks.

What NuvaRing looks like and contents of the packaging
NuvaRing is a flexible, transparent, colourless or almost colourless ring with an outer diameter of 54 mm.
Each vaginal therapeutic system is individually packaged in a sealed foil pouch made of LDPE/Aluminium/PET. The pouch can be resealed after opening. The pouches are contained in a cardboard box together with the package leaflet and reminder stickers, which may help you remember when to insert and remove the NuvaRing. The packaging contains 1 or 3 systems.

For further detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Organon Healthcare GmbH
Pestalozzistr. 31
80469 Munich
Germany

Manufacturer:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

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

Repackaging performed by:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

German Marketing Authorisation Number (country of export): 80333.00.00
Parallel Import Authorisation Number: 380/25