Nuvaring

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
NuvaRing (Circlet)
(0.120 mg + 0.015 mg)/24 h, vaginal therapeutic system
Etonogestrelum + Ethinylestradiolum
NuvaRing and Circlet are different brand names for the same medicine.
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 developing 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 your 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What NuvaRing is and what it is used for
2. Before you use 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 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 referred to as a combined hormonal contraceptive.
NuvaRing works in the same way as a combined oral contraceptive pill ("combined pill"). However, unlike the pill, which must be taken daily, NuvaRing is used continuously for 3 weeks. NuvaRing releases two female sex hormones that suppress the release of ova from the ovaries. Because ova are not released, pregnancy cannot occur.

2. Important information before using NuvaRing

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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 monthly changes in body temperature and cervical mucus consistency.
NuvaRing, like other hormonal contraceptives, does not protect against infection with HIV (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 any of these conditions apply to you, 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 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 previously had pancreatitis associated with high blood fat levels,
• 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 there is suspicion of such cancers,
• if you have unexplained vaginal bleeding,
• if you are allergic to ethinylestradiol or etonogestrel, or to any of the other ingredients of this medicine (listed in section 6).

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If any of the above symptoms occur for the first time while using NuvaRing, remove the vaginal ring immediately, 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 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 a blood clot, 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 symptoms of these serious side 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 use of NuvaRing, inform your doctor.

• if breast cancer has occurred in your 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 high levels of blood fats (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 when it is safe to start using NuvaRing after childbirth;
• 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], 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

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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 "melasma", especially on the face). If you have this condition, 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 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 contraceptives. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

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

Recovery after 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 A BLOOD CLOT
Seek immediate medical advice 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, 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,
• change in skin colour of 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

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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 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 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 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 use of combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
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After the first year, the risk decreases, although it remains higher compared to when not using combined hormonal contraceptives.
If a patient stops using NuvaRing, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots in veins depend on?
The risk depends on the 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 use of NuvaRing is low.

• In the course of one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and who are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who are using 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 are using 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 patient'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 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 relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have 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 stop using NuvaRing several weeks before surgery or during immobilization. If the patient must stop using NuvaRing, ask the doctor when it is safe to resume use;
• with increasing age (especially over 35 years);
• if the patient has recently 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 inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of NuvaRing.
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Inform the doctor if any of the above conditions change during the use of NuvaRing, for example, if a close relative 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 the use of the NuvaRing vaginal ring is very small, but it 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 another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative 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 relative has high levels of blood lipids (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 blood clots may be further increased.
Inform the doctor if any of the above conditions change during the use of the NuvaRing vaginal ring, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Tumors
The following information is based on studies using combined oral contraceptives and may also apply to NuvaRing. Data on vaginal hormonal contraceptives (such as Nuva游戏副本

3. How to use NuvaRing

The NuvaRing medicine can be inserted and removed by yourself. Your doctor will instruct you when to start using NuvaRing. The vaginal ring system should be inserted on the appropriate day of the cycle (see section 3.3 "When to insert the first NuvaRing vaginal ring system") 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 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 mechanical contraceptive methods should not be used as an additional contraceptive method, as 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 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 the sachet.
5. Holding the ring between your thumb and index finger, squeeze it 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 causes discomfort, gently reposition it (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 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 a sealed pouch such as the original sachet. Do not flush NuvaRing down the toilet.

Figure 1
Remove the ring from the sachet

Figure 2
Squeeze the ring
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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 necessary. Position it inside the vagina so that it does not cause discomfort (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 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 three weeks, starting from the day of insertion.
2. After three weeks, remove the ring 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 at approximately 10:00 PM, it should be removed on a Wednesday three weeks later at approximately 10:00 PM.
3. After removal, take a one-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 this case, follow the instructions in section 3.4 "What to do if after the one-week break the patient forgets to insert a new vaginal ring system".

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

3.3 When to insert the first NuvaRing vaginal ring system

• No hormonal contraceptive was used in the previous cycle
  Insert NuvaRing on the first day of your natural cycle (i.e., the first day of menstruation). NuvaRing is effective immediately upon insertion. There is no need to use any additional contraceptive methods. You may also start using NuvaRing between day 2 and day 5 of menstruation, but in this case, you must use an additional contraceptive method (such as a male condom) during the first 7 days of NuvaRing use. This recommendation applies only when starting NuvaRing for the first time.

• The patient used combined oral contraceptive pills in the previous month
  Begin using NuvaRing no later than the day following the break from your current contraceptive. If your current contraceptive also includes inactive (placebo) tablets, start using 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 at any time and immediately start using NuvaRing.

• The patient used a transdermal system (patch) in the previous month
  Begin using NuvaRing no later than the day following 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 discontinue it at any time and immediately start using NuvaRing.

• The patient used a progestogen-only pill (minipill) in the previous month
  You may stop taking the minipill at any time and start using NuvaRing the next day at the same time you usually took the minipill. During the first 7 days of NuvaRing use, use an additional contraceptive method (such as a male condom).

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• The patient used progestogen-only injections, an implant, or an intrauterine system releasing progestogen [IUD]
  Begin using NuvaRing on the day of the next scheduled injection or on the day of removal of the implant or intrauterine system releasing progestogen. Use an additional contraceptive method (such as a male condom) during the first 7 days of NuvaRing use.

• After childbirth
  Your doctor may recommend starting NuvaRing only after the first menstruation following childbirth. Sometimes, NuvaRing may be started earlier; your doctor will advise you when. If you are breastfeeding and wish to use NuvaRing, discuss this with your doctor first.

• After an abortion
  As advised by your doctor.

3.4 What to do if…

Management in case 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 (e.g., before and after sexual intercourse).

Management if the ring has been outside the vagina for some time
NuvaRing may still protect against pregnancy, depending 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 system with cold 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 system with cold 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 a male condom as additional protection. If you are in the first week of the 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 system and choose one of the following options:
  1 – Insert a new vaginal ring system as soon as possible. Inserting a new vaginal ring system means starting the next three-week period of use. This may result in the absence of 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 one. This approach may only be used 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.

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Management in case of damage to the vaginal ring system
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 sexual intercourse before noticing the damage, contact your doctor.

Management in case more than one vaginal ring system is 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 genital bleeding may occur. Remove the additional vaginal ring system and contact your doctor if symptoms persist.

Management if after the one-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 sexual intercourse during 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 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 chance of pregnancy.

Management if the patient forgets to remove the vaginal ring system 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 one-week break, then insert a new one.
• If the patient has 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.

Management if withdrawal bleeding does not occur

• If the patient has used NuvaRing according to instructions
  If withdrawal bleeding does not occur on time, but the patient has used NuvaRing as directed and has not taken 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, there may be a possibility of pregnancy. 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 the patient has not used the vaginal ring system as directed, she may be pregnant. Contact your doctor before using a new NuvaRing.

Management in case of unexpected bleeding
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 usual. If irregular bleeding increases or recurs, contact your doctor.

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Management if the day of bleeding changes
If NuvaRing is used as directed, menstruation (withdrawal bleeding) will occur during the weekly break from the vaginal ring system. If the patient wishes withdrawal bleeding to start on a different day, she may shorten the break (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) next month, she should insert the new vaginal ring system 3 days earlier than usual.

If the break from 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 the patient is unsure how to proceed, she should consult her doctor.

Management if the patient wishes to delay the onset of bleeding
Although not recommended, it is possible to delay 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 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
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 menstruation and then start trying to conceive. This will help determine the due date.

4. Possible adverse effects

Like any medicine, NuvaRing may cause adverse effects, although not everyone experiences them. If any adverse effects occur, especially severe and persistent ones, or changes in health status 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 developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). 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".

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If there is hypersensitivity (allergy) 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 development of urticaria potentially accompanied by breathing difficulties. In such cases, NuvaRing should be removed immediately and medical advice should be sought without delay (see also section 2.2 "Warnings and precautions").

Women using NuvaRing have reported the following adverse effects:

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 swings
• Oedema
• 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 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, 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
  • Transient ischaemic attack (mini-stroke) or transient stroke-like symptoms known as transient ischaemic attack
  • 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

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information on risk factors for blood clots and symptoms of blood clots).

• Galactorrhea (discharge of milk from the breast)

Unknown frequency (cannot be estimated from available data)

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

Breast cancer and liver tumours have been reported 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 therapeutic system".

Reporting of adverse effects

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

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, PL-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 gather more information on the safety of the medicine.

5. How to store NuvaRing

The medicine should be stored in a place out of sight and reach of children.
Contact a doctor if exposure to the hormones contained in NuvaRing is suspected in a child.
Do not store above 30°C. Store in the original packaging to protect from light and moisture.
Do not use NuvaRing more than 4 months after the date the medicine was dispensed by the pharmacy. The dispensing date is indicated 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 month indicated.
Do not use NuvaRing if you notice any change in colour or any signs of deterioration.
Used vaginal ring systems should be disposed of in a regular household waste container, preferably in a sealed pouch. NuvaRing must not be flushed down the toilet. As with 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.
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6. Contents of the package 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 which 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, respectively, over a period of 3 weeks.
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 sachet. The sachet can be
resealed after opening. The sachets are contained in a cardboard box together with
a package leaflet and reminder stickers to help remember when to insert and remove the NuvaRing system.
The pack contains 1 or 3 systems.
For more 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German Marketing Authorisation number (country of export): 80333.00.00
Parallel Import Authorisation number: 81/25
This medicinal product is authorised for sale 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).
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