Nuvaring

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
NuvaRing, (0.120 mg + 0.015 mg)/24 h, vaginal contraceptive system
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 developing 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 vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

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

• Keep this leaflet for future reference.
• If you have any questions, 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 the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. 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 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 similarly to a combined oral contraceptive pill (combined pill); however, unlike a pill that must be taken daily, NuvaRing is used continuously for 3 weeks. NuvaRing releases two female sex hormones that suppress the release of eggs from the ovaries. Since eggs are not released, the patient cannot become pregnant.

2. Important information before using NuvaRing

General notes
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Before starting NuvaRing, read the information about blood clots (thrombosis) in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
This leaflet describes situations in which NuvaRing should be discontinued or when its effectiveness may be reduced. In such cases, abstain from sexual intercourse or use an additional non-hormonal contraceptive method, such as a male condom or another mechanical method. Do not use calendar-based methods or body temperature monitoring. These may be ineffective because NuvaRing affects 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 the patient has any of the conditions listed below. If any of these conditions apply, the patient must inform her doctor. The doctor will discuss with the patient which alternative contraceptive method would be more suitable.

• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows she has blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobile for a prolonged period (see section "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has 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 the patient has any of the following conditions, which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• if the patient currently has or has had in the past a type of migraine called "migraine with aura";
• if the patient currently has or has had in the past pancreatitis associated with high levels of fats in the blood;
• if the patient currently has or has had in the past severe liver disease and liver function has not returned to normal;
• if the patient currently has or has had in the past a benign or malignant liver tumour;
• if the patient currently has or has had in the past breast cancer or genital organ cancer, or if such cancers are suspected;
• if the patient has unexplained vaginal bleeding;
• if the patient is allergic to ethinylestradiol or etonogestrel or to any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions occur for the first time during use of NuvaRing, the ring must be removed immediately from the vagina and the doctor consulted, and a non-hormonal contraceptive method should be used in the meantime.
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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 must not be used (see also section 2.4 "NuvaRing and other medicines").

2.2 Warnings and precautions
When to contact a doctor?
Seek immediate medical advice if:

• the patient notices possible symptoms of a blood clot, which may indicate 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 reactions, see "How to recognize blood clots".

Inform the doctor if the patient has any of the following conditions.
If these conditions appear or worsen during use of NuvaRing, inform the doctor as well.

• if breast cancer currently exists or has occurred in close family members;
• if the patient has epilepsy (see section 2.4 "NuvaRing and other medicines");
• if the patient has liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease affecting the body's natural immune system);
• if the patient has haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if the patient has sickle cell anaemia (an inherited red blood cell disorder);
• if the patient has hypertriglyceridaemia (high blood fat levels) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if the patient requires surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if the patient is immediately postpartum, as she is then at increased risk of blood clots. Consult the doctor to determine how soon after delivery NuvaRing can be started;
• if the patient has superficial thrombophlebitis (inflammation of veins under the skin);
• if the patient has varicose veins;
• if the patient has 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 with involuntary, violent movements]);
• seek immediate medical attention if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or if hives appear with potential breathing difficulties. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if the patient currently has or has had chloasma (yellowish-brown pigmentation patches, so-called "pregnancy mask", especially on the face). If present, avoid excessive sunlight and ultraviolet radiation;

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• if the patient has conditions that make using NuvaRing difficult, such as frequent constipation, uterine prolapse, or pain during intercourse;
• if the patient suddenly experiences a frequent urge to urinate with a burning sensation and/or pain, and if the patient cannot locate the vaginal ring inside the vagina. These symptoms may indicate accidental placement of the NuvaRing vaginal ring into the urinary bladder.

BLOOD CLOTS
Using combined hormonal contraceptives, such as the NuvaRing vaginal ring, increases the risk of blood clots compared to not using such therapy. In rare cases, a blood clot can 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 caused by using NuvaRing is small.

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

Does the patient experience any of these symptoms? Likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:

  • pain or tenderness in the leg, felt only when standing or walking,
  • increased warmth in the affected leg,
  • change in skin colour of the leg, e.g. paleness, redness, or blueness.
    → Deep vein thrombosis

• sudden unexplained shortness of breath or rapid breathing;

• sudden coughing without obvious cause, possibly with coughing up blood;

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

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe stomach pain.
  If the patient is unsure, consult a doctor, as some of these symptoms, such as cough or breathlessness, may be mistaken for milder conditions like respiratory tract infections (e.g. cold).
  → Pulmonary embolism

Symptoms occurring in one eye:

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

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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 highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops using NuvaRing, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
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The risk depends on a woman’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 the use of NuvaRing is low.

• In 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 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 one year, about 6–12 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’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 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 form blood clots;
• 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 needs to stop using NuvaRing, ask the doctor when it is safe to 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 inform the doctor if any of these factors apply to the patient, even if uncertain. The doctor may decide that NuvaRing should not be used.
Inform the 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
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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. 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 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 blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, 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.
Inform the doctor if any of the above conditions change during treatment with the NuvaRing vaginal ring, for example, if the patient starts smoking, if a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

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

A slightly increased 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 women using combined hormonal contraceptives are diagnosed more frequently with breast cancer because they undergo medical check-ups more regularly. The increased incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Regular breast examinations are very important. If any lump is detected, consult a doctor. Inform the doctor if any close relatives have had or currently have breast cancer (see section 2.2 "Warnings and precautions").

In rare cases, benign liver tumours and very rarely malignant liver tumours have been reported in women using combined hormonal contraceptives. If unusual, severe abdominal pain occurs, consult the 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.

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

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

2.4 Interaction of NuvaRing with other medicines
Always inform the doctor about any medicines or herbal products currently used by the patient. 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 the other medicine 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 blood vessels (bosentan);
• depression (St. John's wort, Hypericum perforatum).

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

If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir, or glecaprevir and pibrentasvir, the NuvaRing vaginal ring should not be used, as this may cause 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.

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The NuvaRing vaginal ring may be used again approximately 2 weeks after completing this treatment. See section 2.1 "When not to use NuvaRing".
Before taking any medicine, consult a doctor or pharmacist.

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

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

Diagnostic tests
If blood or urine laboratory tests are being performed, inform the person conducting the test that NuvaRing is being used, as 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 doctor contacted.
If the patient wishes to stop using NuvaRing because she wants to become pregnant, refer to section 3.5 "What to do when the patient wants to stop using NuvaRing".
Use of Nuva游戏副本

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 NuvaRing vaginal ring system") and left in place continuously for three 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 three 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 because NuvaRing may interfere with the correct placement and positioning of an intrauterine device, cervical cap, or female condom. However, you may use a male condom as an additional mechanical contraceptive method.

3.1 Insertion and removal of NuvaRing

1. Before inserting the system, check the expiry date (see section 5 "How to store NuvaRing").
2. Wash your hands before inserting or removing the system.
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 the NuvaRing from its pouch.
5. Holding the system between your thumb and index finger, squeeze it together and insert it into the vagina (see Figures 1–4). Alternatively, the system may 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 system causes discomfort, gently adjust its position (e.g., push it slightly deeper into the vagina) until you feel comfortable. The exact position of the system within the vagina does not affect its contraceptive effectiveness.
6. After three weeks, remove the system 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 system in the vagina but are unable to remove it, contact your doctor.
7. Dispose of the used system with household waste, preferably in the sealed pouch it originally came in. Do not flush NuvaRing down the toilet.

Figure 1
Remove the system from the pouch

Figure 2
Squeeze the system
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Figure 3
Choose the most comfortable position

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

Figure 5
Remove the system from the vagina by hooking your index finger under the edge of the system or grasping it with your index and middle fingers and pulling it out.
3.2 Three weeks of use, one week break
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1. The system 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 at about 10:00 PM, it should be removed on a Wednesday three weeks later, around 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 system exactly one week after the break (on the same day of the week and approximately at the same time), even if bleeding is still ongoing. If insertion of the new system is delayed by more than 3 hours, contraceptive effectiveness may be reduced. In such a case, follow the instructions in section 3.4 "What to do if 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 each month on approximately the same days of the week.

3.3 When to insert the first NuvaRing vaginal ring system

• 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 day 2 and day 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 NuvaRing use. This recommendation 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) tablets, start using NuvaRing no later than the day after taking the last inactive tablet. If you are unsure which tablet is inactive, 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 the 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 transdermal system break. 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 (minipill) You may stop taking the minipill on any day and start using NuvaRing the next day at the same time you usually take the minipill. Use an additional contraceptive method (such as a male condom) during the first 7 days of NuvaRing use.
• Previously using injections, an implant, or an intrauterine system releasing progestogen [IUD] Start using NuvaRing on the day of your 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 After childbirth, your doctor may recommend waiting until after 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 first with your doctor.
• After miscarriage As advised by your doctor.

3.4 What to do if…
Management in case the system accidentally falls out of the vagina
NuvaRing may accidentally fall out of the vagina, for example, if inserted incorrectly, during tampon removal, during sexual intercourse, in case of constipation, or uterine prolapse. Therefore, you should regularly check that the system is in the vagina (for example, before and after sexual intercourse).

Management if the system 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 system was outside the vagina for:

• less than 3 hours , you are still protected against pregnancy. Wash the vaginal ring system in 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 have decreased. Wash the vaginal ring system in cold or lukewarm (not hot) water and reinsert it as soon as possible, leaving it in place continuously for at least 7 days. If you have sexual intercourse during these 7 days, use an additional male condom. If you are in the first week of your cycle and had intercourse in the past 7 days, there is a possibility you may be pregnant. In this case, contact your doctor.
• more than 3 hours during the third week of use , contraceptive effectiveness may have decreased. 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 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 is acceptable only 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., male condom) for the next 7 days. If you had sexual intercourse before noticing the damage, contact your doctor.

Management if more than one vaginal ring 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 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 system as soon as possible. If you have sexual intercourse during the next 7 days, use an additional contraceptive method (e.g., male condom). If sexual intercourse occurred during the break in using the vaginal ring system, pregnancy may have occurred. In this case, contact your doctor as soon as possible. The longer the break in using the vaginal ring system, the higher the likelihood of pregnancy.

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

• If the system 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 vaginal ring system has been used 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 schedule, but you have used NuvaRing as directed and have 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, pregnancy is possible. Contact your doctor as soon as possible. Do not insert a new NuvaRing system 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.

Management of unexpected bleeding
During use of the vaginal ring system, some women may experience unexpected mid-cycle bleeding. You may need to use sanitary pads. Leave the system in the vagina and continue using it as before. If irregular bleeding increases or recurs, contact your doctor.
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Management if the day of bleeding changes
If NuvaRing is used according to instructions, periods (withdrawal bleedings) will begin during the one-week break from using the vaginal ring system. If you wish for 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 shift it 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 (light drops or stains of blood) or mid-cycle bleeding may occur.

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

Management 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 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 (light 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 your period, you may 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 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 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 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, see 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 hives, potentially with breathing difficulties. In such cases, NuvaRing should be removed and medical advice sought immediately (see also section 2.2 "Warnings and precautions").

Women using NuvaRing have reported the following adverse effects:

Common: may affect up to 1 in 10 women

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

Uncommon: may affect up to 1 in 100 women

• visual disturbances; dizziness
• bloating; vomiting, diarrhoea or constipation
• feeling tired, malaise or restlessness; mood changes; sudden mood swings
• oedema (swelling)
• urinary tract or bladder infections
• problems or pain when urinating; urgency or need to urinate; frequent urination
• discomfort during intercourse, including pain, bleeding, discomfort due 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
• reduced 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 periods); 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 (hives)

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 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 factors increasing the risk of blood clots and symptoms of blood clots).

• galactorrhea (discharge of fluid from the breast)

Unknown frequency (cannot be estimated from available data)

• chloasma (yellowish-brown pigmented patches on the skin, especially on the face)
• partner discomfort during intercourse (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)
• injury to the vaginal wall associated with damage to the vaginal ring.

In women using combined hormonal contraceptives, cases of breast cancer and liver tumours have been reported. For detailed information, see section 2.2 "Warnings and precautions", "Tumours".

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

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform a 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 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 physician if a child is 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 more than 4 months after the date it 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 stated month.
Do not use NuvaRing if you notice any change in colour or any signs of deterioration.
Used vaginal rings should be disposed of in a regular household waste container, preferably in a sealed pouch. Do not flush NuvaRing down the toilet. As with other medicines, unused or expired systems must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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% vinyl acetate, poly(ethylene-vinyl acetate), 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 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 therapeutic 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 the package leaflet and reminder stickers to help remember when to insert and remove the NuvaRing system.
The pack contains 1 or 3 systems.
Other information
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, country of export:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
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
Marketing authorisation number in Greece, country of export: 57201/1-9-2015
Parallel import authorisation number: 69/23
This medicinal product is authorised for supply 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 therapeutic system
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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