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 contraceptive 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, particularly during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clot formation (see section 2 "Blood clots").

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

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

Leaflet contents

1. What NuvaRing is and what it is used for
2. 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 contraceptive system that prevents pregnancy. Each vaginal contraceptive 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 hormone dosage 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 (a "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 oocytes from the ovaries. Because oocytes are not released, pregnancy cannot occur.

2. Important information before using NuvaRing

General information
Before starting 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 such cases, you should refrain from sexual intercourse or use an additional contraceptive method other than hormonal, such as a male condom or another mechanical method. Do not use calendar-based methods or body temperature measurement. These methods may be ineffective because NuvaRing affects changes in body temperature and cervical mucus consistency throughout the month.
NuvaRing, like other hormonal contraceptives, does not protect against 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 you have any of these conditions, you must inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs,
• if you know you have disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies,
• if you require 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 such cancers are suspected,
• if you have unexplained vaginal bleeding,
• if you are allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the above symptoms occur for the first time during use of NuvaRing, remove the vaginal ring immediately and consult your doctor. During this time, use a non-hormonal method of contraception.
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 ring (see also section 2.4 "NuvaRing and other medicines").

2.2 Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or stroke (see section below "Blood clots"). For a description of symptoms of these serious adverse reactions, see "How to recognize blood clots".

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during use of NuvaRing, you should also inform your doctor.

• if breast cancer is present or has occurred in close family members;
• if you have epilepsy (see section 2.4 "NuvaRing and other medicines");
• if you have liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require 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 to find out how soon after delivery you can start using NuvaRing;
• if you have phlebitis (inflammation of superficial veins);
• 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 with involuntary, violent movements]);
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or if you develop hives with potential breathing difficulties. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you currently have or have previously had chloasma (yellowish-brown pigmentation, so-called "melasma", especially on the face). If such pigmentation occurs, avoid excessive sun exposure and ultraviolet radiation;
• if you have conditions that make using NuvaRing difficult, such as frequent constipation, uterine prolapse, or pain during intercourse;
• if you suddenly feel a frequent urge to urinate with a burning sensation and/or pain, and if you cannot locate the vaginal ring inside the vagina. These symptoms may indicate accidental insertion of the NuvaRing vaginal ring into the urinary bladder.

BLOOD CLOTS
Using combined hormonal contraceptives such as the NuvaRing vaginal ring is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious health problems.
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").

Complete recovery after 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 BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

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

• pain or tenderness in the leg, which may only be felt when standing or walking;

• increased warmth in the affected leg;

• change in skin colour of the leg, such as pallor, redness, or blueness.

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

• sudden cough without obvious cause, which may be associated with coughing up blood;

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

• severe dizziness or lightheadedness;

• rapid or irregular heartbeat;

• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infections (e.g. cold).
Symptoms most commonly affect one eye:
Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or blurred vision

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 first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (either 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 levels within a few weeks.

What factors influence the risk of blood clots in veins?
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 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 medical history of the woman (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 using the NuvaRing vaginal ring system 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 clotting disorder;
• if the patient requires surgery, will be 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 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 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 to discontinue use of NuvaRing.
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
What can happen if blood clots form in the 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 using the NuvaRing vaginal ring system is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as the NuvaRing vaginal ring system, 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 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 fats (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, arrhythmia 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.
Inform the doctor if any of the above conditions change during use of the NuvaRing vaginal ring system, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Tumors
The following information comes from studies on combined oral contraceptives and may also apply to NuvaRing. Data on vaginal use of hormonal contraceptives (as with NuvaRing) are not available.
Among women using combined hormonal contraceptives, there is a slightly increased incidence of breast cancer, although it is not known whether this is caused by the medication. It is possible that breast cancers are detected more frequently in these women because they undergo more regular medical examinations. The increased incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Regular breast examinations are very important. If any lump is detected, contact the doctor immediately. Also inform the 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, contact the treating 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, but this has not yet been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including NuvaRing, have reported depression or depressed 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 NuvaRing and other medicines
Always inform the doctor about any medicines or herbal products currently used by the patient. Also inform any other specialist doctor, dentist, or pharmacist prescribing other medicines that NuvaRing is being used. They may advise using an additional contraceptive method (e.g., male condoms), and if so, for how long, as well as whether adjustment of the other medicine is needed.
Some medicines:

• may affect the blood concentration 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);
• pulmonary arterial hypertension (bosentan);
• depression (St. John’s wort).

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 time.
Warning: 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 lamotrigine (this may lead to increased frequency of seizures).

If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, the NuvaRing vaginal ring system should not be used, as this may lead to increased liver function parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).
Before starting these medicines, the treating doctor will prescribe another type of contraceptive.
Use of the NuvaRing vaginal ring system may be resumed 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. If the ring falls out, rinse the vaginal ring system with cool or lukewarm water and reinsert it as soon as possible.
Damage to the vaginal ring system has occurred during use of vaginal products such as moisturizers or treatments for infections (see section 3.4, "What to do if the vaginal ring 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, inform the testing personnel that NuvaRing is being used, as use of the vaginal ring 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, remove the vaginal ring system and contact the doctor.
If the patient wishes to stop using NuvaRing because she wants to become pregnant, refer to section 3.5 "What to do if the patient wants to stop using NuvaRing".
Use of NuvaRing is not recommended during breastfeeding. If the patient wishes to use NuvaRing while breastfeeding, she should consult her doctor first.

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

3. How to use NuvaRing

NuvaRing can be inserted and removed by yourself. Your doctor will advise you when to start using NuvaRing. The vaginal ring should be inserted on the correct day of your 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 NuvaRing and take a one-week break. Withdrawal bleeding usually occurs during this break.

Do not use certain mechanical methods of contraception for women, such as a diaphragm, cervical cap, or female condom while using NuvaRing. These mechanical contraceptive methods should not be used as additional contraception, because NuvaRing may interfere with the correct placement and positioning of an intrauterine device, cervical cap, or female condom. However, you may use a male condom as an additional mechanical contraceptive method.

3.1 Inserting and removing NuvaRing

1. Before inserting the ring, check the expiry date (see section 5 “How to store NuvaRing”).
2. Wash your hands before inserting or removing the ring.
3. Choose the most comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
4. Remove NuvaRing from its foil pouch.
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 where you do not feel it. If the ring is uncomfortable, gently adjust its position (e.g., push it slightly deeper into the vagina) until you feel comfortable. The exact position 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 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 foil pouch. Do not flush NuvaRing down the toilet.

Figure 1
Remove the ring from the pouch

Figure 2
Squeeze the ring

Figure 3
Choose the most comfortable position

Figure 4A Figure 4B Figure 4C
Insert the ring into the vagina with one hand (Figure 4A), spreading the labia with the other hand if needed. Place it inside the vagina so that it is comfortable (Figure 4B). Leave the ring in the vagina for 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 when 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 removing the ring, 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 previous removal (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”.

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

• 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 methods. You may also start using NuvaRing between days 2 and 5 of your period, but in this case, an additional contraceptive method (such as a male condom) must be used during the first 7 days of 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 following the end of the pill-free interval of your current contraceptive. If your current pill pack 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 beyond the recommended period. If you have taken your pills regularly and are certain you are not pregnant, you may stop taking the pills at any time and immediately start using NuvaRing.
• Previously using a transdermal patch Begin using NuvaRing no later than the day after removal of the transdermal patch. Do not extend the patch-free interval beyond the recommended period. If you have used the patch regularly and are certain you are not pregnant, you may stop using the patch at any time and immediately start using NuvaRing.
• Previously using a progestogen-only pill (minipill) You may stop taking the minipill at any time and start using NuvaRing the next day at the same time you usually take the minipill. During the first 7 days of using NuvaRing, use an additional contraceptive method (such as a male condom).
• Previously using 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. During the first 7 days of using NuvaRing, use an additional contraceptive method (such as a male condom).
• After childbirth After childbirth, your doctor may recommend waiting until after the first menstrual 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 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 out of the vagina for some time
NuvaRing may still protect against pregnancy, depending on how long it has been outside the vagina.

If the ring has been 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—but only if it has been out for less than 3 hours.
• more than 3 hours during the first or second week of use , contraceptive effectiveness may be reduced. Wash the vaginal ring 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 intercourse during these 7 days, use an additional male condom. If you are in the first week of your cycle and have had intercourse in the past 7 days, there is a possibility you may be pregnant. In this case, contact your doctor.
• more than 3 hours during the third week of use , contraceptive effectiveness may be reduced. Remove the vaginal ring and choose one of the following options:
  1 – Insert a new vaginal ring as soon as possible. Inserting a new vaginal ring starts the next three-week cycle. This may prevent the expected withdrawal bleeding, but breakthrough bleeding or spotting may occur.
  2 – Do not reinsert a vaginal ring. Wait for withdrawal bleeding to occur and insert a new vaginal ring no later than 7 days after removal or expulsion of the previous ring. This 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. For the next 7 days, use an additional contraceptive method (e.g., a male condom). If you had intercourse before noticing the damage, contact your doctor.

Management if more than one vaginal ring 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 is accidentally inserted, nausea, vomiting, or genital bleeding may occur. Remove the extra vaginal ring and contact your doctor if symptoms do not resolve.

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

Management if withdrawal bleeding does not occur

• If the patient has used NuvaRing correctly If withdrawal bleeding does not occur on time, but NuvaRing has been used correctly and no other medications have been taken, 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 the patient has not used NuvaRing correctly If withdrawal bleeding does not occur during the first break and NuvaRing has not been used correctly, pregnancy is possible. 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. You may need sanitary pads. Leave the ring in place and continue using it as usual. If irregular bleeding increases or recurs, contact your doctor.

Management if the day of withdrawal bleeding changes
If NuvaRing is used correctly, withdrawal bleeding (periods) will begin 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 mid-cycle 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 ring, spotting or mid-cycle bleeding may occur. To induce withdrawal bleeding, remove the vaginal ring. A regular one-week break between rings is recommended.

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

3.5 What to do if the patient wishes to stop using NuvaRing
You may stop using NuvaRing at any time.
If you do not wish to become pregnant, ask your doctor about other contraceptive methods.
If you stop using NuvaRing because you wish to become pregnant, wait until your first menstrual period and then begin trying to conceive. This will help determine the due date.

4. Possible adverse effects

Like all medicines, NuvaRing may cause adverse effects, although not everyone will experience 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 venous thromboembolism (blood clots in the veins) or arterial thromboembolism (blood clots in the arteries). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before using NuvaRing".

If a patient is allergic (hypersensitive) to any component of NuvaRing, this may manifest as (frequency unknown): angioedema and (or) anaphylactic reaction [swelling of the face, lips, tongue, and (or) throat and (or) difficulty swallowing] or urticaria potentially associated with breathing difficulties. In such cases, NuvaRing should be removed immediately and medical advice 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 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 tired, 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 experienced by the male partner
• Increased blood pressure
• Increased appetite
• Back pain; muscle cramps; pain in lower or upper limbs
• Decreased skin sensitivity
• Breast tenderness or enlargement; fibrocystic breast changes (cysts which may cause breast swelling or pain)
• Cervicitis; cervical polyps; cervical ectropion
• Changes in menstrual bleeding (e.g. heavy, prolonged, irregular or complete absence of menstruation); pelvic discomfort; premenstrual syndrome; uterine cramps
• Vaginal infections (fungal or bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
• Hair loss, rash, itching, skin rash or hot flushes
• Urticaria

Rare: may occur in up to 1 in 1000 women

• Harmful blood clots in a vein or artery, for example:
  • In the leg or foot (e.g. deep vein thrombosis)
  • In the lungs (e.g. pulmonary embolism)
  • Heart attack
  • Stroke
  • Mini-stroke or transient ischaemic attack (TIA)
  • Blood clots in the liver, stomach and intestines, kidneys or eye The likelihood of blood clots may be higher if the patient has other risk factors (see section 2 for further 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 pigmented 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 "What to do if the vaginal therapeutic system is damaged".

Reporting of adverse effects

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

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

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

5. How to store NuvaRing

Keep this medicine out of sight and reach of children.
Contact a doctor if a child is suspected to have been exposed to the hormones contained in NuvaRing.
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 it was dispensed by the pharmacy. The dispensing date is indicated on the packaging.
Do not use NuvaRing after the expiry date stated on the packaging. The expiry date refers to the last day of the indicated 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, do not dispose of unused or expired vaginal rings via sewage systems or in household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What NuvaRing contains

• The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• The 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 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 packaged in a foil sachet. The sachet can be resealed after opening. The sachets are contained in a cardboard box together with a leaflet. The pack contains 1 or 3 systems.

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

Marketing Authorisation Holder in Germany, the country of export:
Organon Healthcare GmbH
Neuturmstr. 5
80331 Munich
Germany

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

German Marketing Authorisation Number (country of export): 80333.00.00
Parallel Import Authorisation Number: 173/24

This medicinal product is authorised in the European Economic Area (EEA) and 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).

These stickers, when attached to the appropriate day on a calendar, may help you remember when to insert and remove NuvaRing.

Insert NuvaRing Remove NuvaRing