Nuvaring

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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 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 a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains
important information for 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 you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What NuvaRing is and what it is used for
2. Important information before using NuvaRing
3. How to use NuvaRing
4. Possible side effects
5. How to store NuvaRing
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, which 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 daily pill, NuvaRing is used continuously for 3 weeks. NuvaRing releases two female sex hormones that suppress the release of eggs from the ovaries. Because eggs are not released, pregnancy cannot occur.

2. Important information before using NuvaRing

General information
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 method of contraception, 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 infection with HIV (AIDS) or other sexually transmitted infections.

2.1 When not to use NuvaRing
Do not use NuvaRing if you have any of the following conditions. If you have any of the conditions listed below, you must inform your doctor. Your doctor will discuss with you which alternative method of contraception 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 have (or have previously had) angina pectoris (a condition causing severe chest pain, which may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you currently have or have previously had pancreatitis associated with high levels of fats in the blood;
• if you currently have or have previously had severe liver disease and liver function has not returned to normal;
• if you currently have or have previously had a benign or malignant liver tumour;
• if you currently have or have previously had breast cancer or genital organ cancer, or if 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).

If any of the above conditions occurs for the first time during use of NuvaRing, remove the vaginal ring immediately and consult your doctor. During this time, use a non-hormonal method of contraception.
If you have hepatitis C 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 adverse effects, see "How to recognize a blood clot." Tell your doctor if you have any of the following conditions. If these conditions develop or worsen during use of NuvaRing, inform your doctor.
• breast cancer is currently present or has occurred in close family members;
• you have epilepsy (see section 2.4 "NuvaRing and other medicines");
• you have liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);
• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• you have systemic lupus erythematosus (a disease affecting the body's natural defence system);
• you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• you have sickle cell anaemia (an inherited disorder of red blood cells);
• you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• you are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• 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;
• you have superficial thrombophlebitis (inflammation of veins under the skin);
• you have varicose veins;
• 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, jerky movements]);
• 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;
• you currently have or have previously had chloasma (yellowish-brown pigmentation patches, sometimes called "melasma", especially on the face). If you develop chloasma, avoid excessive sun exposure and ultraviolet radiation;
• you have conditions that make using NuvaRing difficult, such as frequent constipation, uterine prolapse, or pain during intercourse;
• you suddenly feel a 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, increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").
  Complete recovery from a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

Remember that the overall risk of harmful blood clots caused by using NuvaRing is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you experience any of the following symptoms.

| Do you experience any of these symptoms? | Possible 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, such as paleness, redness, or blueness. | | | Sudden unexplained shortness of breath or rapid breathing; | Pulmonary embolism | | Sudden cough 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 abdominal pain. | |

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

Symptoms most commonly affecting one eye:
| Sudden loss of vision | Retinal vein thrombosis (blood clot in the eye) |

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 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 when not using combined hormonal contraceptives.
If a woman stops using NuvaRing, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the woman’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 contraceptive system, will develop blood clots.
• The risk of developing blood clots depends on the individual woman’s medical history (see "Factors that increase the risk of blood clots", below).

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

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member 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 blood clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue use of NuvaRing several weeks before surgery or immobilization. If the patient must stop using 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 given birth within the last 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 venous blood clots, especially if the patient has any of the other risk factors listed above.
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 develops thrombosis without a known cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
Similar to 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 vaginal contraceptive system NuvaRing is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as the NuvaRing vaginal system, 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 such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (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 system, for example, if she starts smoking, a close family member develops thrombosis without a known cause, or if she gains significant weight.

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

Psychiatric disorders
Some women using hormonal contraceptives, including NuvaRing, have reported depression or mood changes. 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 that she is using 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. These include medicines used to treat:
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
  • tuberculosis (e.g., rifampicin);
  • HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
  • hepatitis C virus infection (e.g., boceprevir, telaprevir);
  • other infections (e.g., griseofulvin);
  • pulmonary 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 persist for up to 28 days after stopping the medicine, additional mechanical contraception should be used during this period. Note: NuvaRing should not be used with a diaphragm, cervical cap, or female condom.

NuvaRing may affect the action of other medicines, such as:

• medicines containing cyclosporine;
• the antiepileptic medicine lamotrigine (which may lead to increased frequency of seizures). If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, or glecaprevir, pibrentasvir, the NuvaRing vaginal system should not be used, as this may lead to increased liver function test parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).

Before starting these medicines, the doctor will prescribe a different type of contraceptive.
The NuvaRing vaginal system may be restarted approximately 2 weeks after completing this treatment. See section 2.1 "When not to use NuvaRing".
Before taking any medicine, consult a doctor or pharmacist.
During use of NuvaRing, tampons may be used. The NuvaRing should be inserted before inserting a tampon. Care should be taken when removing the tampon to avoid accidentally removing the NuvaRing. If the ring is expelled, it should be rinsed with cool or lukewarm water and reinserted as soon as possible.
Damage to the vaginal system may occur during use of vaginal products such as lubricants or treatments for infections (see section 3.4, "What to do if the vaginal system is damaged"). The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of NuvaRing.

Diagnostic tests
If blood or urine laboratory tests are performed, the patient should inform the healthcare provider that she is using NuvaRing, as the use of the vaginal contraceptive system may affect the results of certain laboratory tests.

2.5 Pregnancy and breastfeeding
NuvaRing must not be used during pregnancy or if pregnancy is suspected. If the patient becomes pregnant while using NuvaRing, the vaginal system 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".
NuvaRing is not recommended during breastfeeding. If the patient wishes to use NuvaRing while breastfeeding, she should consult her doctor first.

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

3. How to use NuvaRing

The NuvaRing vaginal ring can be inserted and removed by the woman herself. 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 three 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 three weeks, remove the NuvaRing and take a one-week break. During this break, withdrawal bleeding usually occurs.

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, male condoms may be used 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, for example, standing with one leg raised, squatting, or lying down.
4. Remove the NuvaRing from its pouch.
5. With your thumb and index finger, squeeze the ring and insert it into the vagina (see Figures 1–4). Alternatively, the ring 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 ring is uncomfortable, gently push it further into the vagina until you feel comfortable. The exact position of the ring within the vagina does not affect its contraceptive effectiveness.
6. After three weeks, remove the ring from the vagina 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 feel the ring in the vagina but cannot remove it, contact your doctor.
7. Dispose of the used ring with household waste, preferably in the sealed pouch it originally came in. Do not flush NuvaRing down the toilet.

Figure 1
Remove the ring from the pouch

Figure 2
Squeeze the ring

Figure 3
Choose the most comfortable position

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

Figure 5
Remove the ring from the vagina by hooking your index finger under the edge of the ring or grasping it 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 about 10:00 PM, it should be removed on a Wednesday, three weeks later, at about 10:00 PM.
3. After removing the ring, take a one-week break. During this time, withdrawal bleeding may occur, usually starting 2–3 days after removal.
4. Insert a new ring exactly one week after the previous one was removed (on the same day of the week and approximately at the same time), even if bleeding is still occurring. If insertion of the new ring is delayed by more than 3 hours, contraceptive effectiveness may be reduced. In such a case, follow the instructions in section 3.4 “What to do if after the one-week break the patient forgets to insert a new vaginal ring”.

If NuvaRing is used according to these instructions, withdrawal bleeding will typically occur each month around the same days of the week.

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 menstruation).
NuvaRing is effective immediately upon insertion. There is no need to use any additional contraceptive method.
You may also start using NuvaRing between days 2 and 5 of your period, but in this case, you must use an additional contraceptive method (such as a male condom) for the first 7 days of NuvaRing use. This recommendation applies only when starting NuvaRing for the first time.

• Previously using combined oral contraceptives

Begin using NuvaRing no later than the day after the break from your current contraceptive. If your current contraceptive includes inactive (placebo) tablets, start 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 them at any time and immediately start using NuvaRing.

• Previously using a transdermal patch

Begin using NuvaRing no later than the day after the transdermal patch is removed. Do not extend the break from the transdermal patch beyond the recommended period. If you have used the patch regularly and are certain you are not pregnant, you may stop using the patch at any time and immediately start using NuvaRing.

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

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

• Previously using injections, an implant, or a progestogen-releasing intrauterine system (IUS)

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

• After childbirth

After childbirth, your doctor may advise you to wait until your first period before starting NuvaRing. 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 miscarriage

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

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

Management in case more than one vaginal ring is inserted
There have been no reports of serious adverse 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.

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

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

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

Management if withdrawal bleeding does not occur

• If NuvaRing has been used correctly
  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 until your doctor confirms you are not pregnant.

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

Management of unexpected bleeding
During use of the vaginal ring, some women may experience unexpected mid-cycle bleeding. Sanitary pads may be needed. Leave the ring in place and continue using it as usual. If irregular bleeding increases or persists, contact your doctor.

Management if the day of withdrawal bleeding changes
If NuvaRing is used as directed, menstruation (withdrawal bleeding) will occur during the one-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 shift it to Tuesday (3 days earlier), insert the new vaginal ring 3 days earlier than usual.

If the break is significantly shortened (e.g., to 3 days or less), withdrawal bleeding may not occur at all. During use of the next vaginal ring, spotting (small drops or stains of blood) or breakthrough bleeding may occur.

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

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

Before deciding to delay menstruation, 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 alternative 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 any medicine, NuvaRing may cause adverse effects, although not everyone will experience them. If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of NuvaRing, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using NuvaRing".

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

Women using NuvaRing have reported the following adverse effects:

Common: may affect up to 1 in 10 women

• Abdominal pain, nausea
• Vaginal yeast infections (such as "thrush"); discomfort due to the presence of the system in the vagina; genital itching; vaginal discharge
• Headache or migraine headache; depressed mood; decreased libido
• Breast pain; pelvic pain; painful menstruation
• Acne
• Weight gain
• Expulsion of the system

Uncommon: may affect up to 1 in 100 women

• Vision disturbances; dizziness
• Bloating; vomiting, diarrhoea or constipation
• Feeling of fatigue, malaise or restlessness; mood changes; sudden mood swings
• Swelling (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 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 cramps
• Vaginal infections (fungal or bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
• Hair loss, rash, itching, skin eruptions or hot flushes
• Urticaria

Rare: may affect up to 1 in 1,000 women

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

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

• Galactorrhoea (discharge of fluid from the breast)

Frequency not known (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 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

In women using combined hormonal contraceptives, cases of breast cancer and liver tumours have occurred. 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 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, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Adverse effects can also be reported to the marketing authorisation holder or parallel importer.

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

5. How to store NuvaRing

Keep the medicine out of the sight and reach of children.
Contact a doctor if a child is 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 from the date of dispensing. The date of dispensing 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 stated month.
Do not use NuvaRing if you notice any change in colour or any signs of deterioration.
Used vaginal contraceptive 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 bins. Ask your pharmacist how to dispose of medicines no longer in use. 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).
• The other ingredients 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 therapeutic system at a rate of 0.120 mg/day and 0.015 mg/day 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 therapeutic system is individually packed in a 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 which may help you remember when to insert and remove NuvaRing.
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:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
German marketing authorisation number, country of export: 80333.00.00
Parallel import authorisation number: 96/25
This medicinal product is authorised for sale in the European Economic Area countries 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).