Nuvaring

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
NuvaRing, (0.120 mg + 0.015 mg)/24 h, vaginal ring
Etonogestrelum + Ethinylestradiolum
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 a woman suspects 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 in doubt, consult a doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm them.
• If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What NuvaRing is and what it is used for
2. What you need to know 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 in the same way as a combined oral contraceptive pill (a "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. Because eggs are not released, a woman cannot become pregnant.

2. Important information before using NuvaRing

General notes
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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 such situations, you should avoid sexual intercourse or use an additional non-hormonal contraceptive method, such as a male condom or another mechanical method. You should not use calendar-based methods or body temperature monitoring. These may be ineffective because NuvaRing affects body temperature changes and cervical mucus consistency throughout the month.
NuvaRing, like other hormonal contraceptives, does not protect against
HIV (AIDS) infection or other sexually transmitted diseases.

2.1 When not to use NuvaRing
Do not use NuvaRing if you have any of the conditions listed below. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative contraceptive method may be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain, which may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of 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 symptoms listed above occur for the first time during use of NuvaRing, remove the vaginal ring immediately, consult your doctor, and use a non-hormonal contraceptive method in the meantime.
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If you have hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, do not use the NuvaRing vaginal system (see also section 2.4, "NuvaRing and other medicines").

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

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

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

• if breast cancer has occurred in 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 immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if 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;
• if you are undergoing surgery or will be immobile for a prolonged period (see section 2, "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on 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 appeared 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 possibly with breathing difficulties. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you currently have or have previously had chloasma (yellow-brown pigmentation patches, so-called "melasma", especially on the face). If you have chloasma, avoid excessive sun exposure and ultraviolet radiation;

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

BLOOD CLOTS
Using combined hormonal contraceptives, such as the NuvaRing vaginal system, 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 can 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 from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using NuvaRing is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? Possible reason:

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking,
• increased warmth in the affected leg,
• change in skin colour of the leg, such as pallor, redness, or bluish discoloration.
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden coughing without an obvious cause, possibly 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 a respiratory tract infection (e.g. a cold).
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BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• Use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). Although these adverse effects 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 use of combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives at all.
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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 the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive being used.
The overall risk of developing blood clots in the legs or lungs associated with using 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 norgestrel will develop blood clots.
• In the course of one year, about 6 to 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 woman's individual medical history (see "Factors that increase the risk of blood clots", below).

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

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, the patient may have inherited clotting disorders;
• 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, she should consult her doctor about when she can resume use;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past 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 risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue use of NuvaRing.
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The patient should inform her doctor if any of the above conditions change during treatment with NuvaRing, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of the 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 vaginal ring NuvaRing, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (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, particularly migraines with aura;
• if the patient has heart disease (valve disorders, heart rhythm disturbances 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 developing blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with the vaginal contraceptive system NuvaRing, for example, if she starts smoking, if a close family member is diagnosed with unexplained thrombosis, or if she gains significant weight.

Cancer
The following information is based on studies using combined oral contraceptives and may also apply to NuvaRing. Data on the vaginal use of hormonal contraceptives (as with NuvaRing) are limited.
Among women using combined hormonal contraceptives, a slightly higher incidence of breast cancer has been observed, although it is not known whether this is caused by the medication. It is possible that breast cancer is detected more frequently in these women because they undergo more regular medical check-ups. The increased incidence 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 had or currently have breast cancer (see section 2.2 "Warnings and precautions").
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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, but this has not yet been confirmed.

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

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

2.4 NuvaRing and other medicines
The patient should always inform her doctor about any medicines or herbal products she is currently taking. She should also inform any other specialist doctor, dentist, or pharmacist prescribing other medications about the use of NuvaRing. They may advise using additional contraceptive methods (e.g., male condoms), and if so, for how long, and whether any adjustment to other medication is needed.
Some medicines:

• may affect the blood concentration of NuvaRing;
• may reduce its contraceptive effectiveness;
• may cause unexpected bleeding.

These include medications 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 hypertension (bosentan);
• mood disorders (St. John's wort).

If the patient is taking medicines or herbal products 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:

• drugs containing cyclosporine;
• the antiepileptic drug lamotrigine (which may lead to increased frequency of seizures).

If the patient has hepatitis C virus infection and is taking medications containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir,
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the vaginal contraceptive system NuvaRing 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 medications, the treating doctor will prescribe another type of contraceptive.
Use of the vaginal contraceptive system NuvaRing 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 falls out, it should be washed with cool or lukewarm water and reinserted 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 medications does not reduce the contraceptive effectiveness of NuvaRing.

Diagnostic tests
If blood or urine laboratory tests are being performed, the patient should inform the healthcare provider about the use of 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, she should 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 operating machinery
NuvaRing does not affect the ability to drive or operate machinery.

3. How to use NuvaRing

The NuvaRing system 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 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. Withdrawal bleeding usually occurs during this break.

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

3.1 Insertion and removal of NuvaRing

1. Before inserting the ring, check the expiry date (see section 5 “How to store NuvaRing”).
2. Wash your hands before inserting or removing the ring.
3. Choose the most comfortable position for insertion, for example standing with one leg raised, sitting in a squatting position, or lying down.
4. Remove the NuvaRing from its pouch.
5. Holding the ring between your thumb and index finger, squeeze it together and insert it into the vagina (see Figures 1–4). The correct position of the NuvaRing is one in which you do not feel it. If the ring causes discomfort, gently adjust its position (e.g., push it slightly deeper 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. This can be done by hooking your index finger under the edge of the ring or grasping it with your index and middle fingers and pulling it out (Figure 5). If you 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 packaging. Do not flush NuvaRing down the toilet.

Figure 1
Remove the ring from the pouch.

Figure 2
Squeeze the ring.
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Figure 3
Choose the most comfortable position.

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

Figure 5
Remove the ring from the vagina by hooking your index finger under its edge 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 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 the NuvaRing was inserted on a Wednesday at around 10:00 PM, it should be removed on a Wednesday three weeks later, around 10:00 PM.
3. After removing the ring, take a one-week break. During this time, withdrawal bleeding may occur. It usually begins 2–3 days after removal.
4. Insert a new ring exactly one week after the break (on the same day of the week and approximately at the same time), even if bleeding is still occurring. 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 the above instructions, subsequent bleedings will occur every month on approximately the same days of the week.

3.3 When to insert the first NuvaRing vaginal ring

• No hormonal contraceptive used in the previous cycle
  Insert the 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, you must use an additional contraceptive method (such as a male condom) for the first 7 days of use. This recommendation applies only when starting NuvaRing for the first time.

• Previously used combined oral contraceptive pills
  Begin using NuvaRing no later than the day after the pill-free interval of your current contraceptive. If your current contraceptive also includes inactive (placebo) pills, start NuvaRing no later than the day after taking the last inactive pill. If you are unsure which pill 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 used a transdermal system (patch)
  Begin using NuvaRing no later than the day after the transdermal system-free interval. Do not extend the break from the transdermal system beyond the recommended period. If you have used the transdermal system regularly and are certain you are not pregnant, you may discontinue it at any time and immediately start using NuvaRing.

• Previously used 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. Use an additional contraceptive method (such as a male condom) for the first 7 days of NuvaRing use.

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

• 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…
Action in case the ring accidentally falls out of the vagina
The 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 ring is in the vagina (for example, before and after sexual intercourse).

Action if the ring has been outside the vagina for some time
The 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, but only if it was outside the vagina for less than 3 hours.
• more than 3 hours during the first or second week of use , contraceptive effectiveness may be reduced. Wash the vaginal ring with cold or lukewarm (not hot) water and reinsert it as soon as possible, and leave it in place continuously for at least 7 days. If you have sexual intercourse during these 7 days, use an additional male condom. If you are in the first week of the cycle and had intercourse in the past 7 days, there is a possibility of pregnancy. In this case, contact your doctor.
• more than 3 hours during the third week of use , contraceptive effectiveness may be reduced. Remove the vaginal ring and choose one of the two 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, although breakthrough bleeding or spotting may occur. 2 - Do not reinsert a vaginal ring. Wait for withdrawal bleeding to occur and insert a new vaginal ring no later than 7 days after removal or expulsion of the previous ring. This approach 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, perform a pregnancy test and consult your doctor.

Action in case of damage to the vaginal ring
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Very rarely, the NuvaRing may become damaged. Vaginal wall injury has been reported in association with damage to the vaginal ring. If you notice that the 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.

Action if more than one vaginal ring is inserted
There have been no reports of serious harmful effects related to overdose of 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.

Action 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 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, there is a possibility of pregnancy. In this case, contact your doctor as soon as possible. The longer the break in using the vaginal ring, the higher the risk of pregnancy.

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

• If the ring has remained in the vagina 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 longer than 4 weeks , there is a risk of pregnancy. Contact your doctor before inserting a new vaginal ring.

Action 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 correctly 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 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 correctly, you may be pregnant. Contact your doctor before using a new NuvaRing.

Action in case 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.

Action if the day of bleeding changes
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If NuvaRing is used according to instructions, menstrual periods (withdrawal bleeding) will occur during the weekly break from the vaginal ring. If you wish withdrawal bleeding to start on a different day, you may shorten the break in using the vaginal ring (but never extend it!).

For example: if withdrawal bleeding usually starts on Friday, and you wish to change it to Tuesday (3 days earlier) next month, insert the new vaginal ring 3 days earlier than usual.

If the break in using the vaginal ring 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, spotting (single drops or spots of blood) or mid-cycle bleeding may occur.

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

Action 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 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 (single drops or spots of blood) or mid-cycle bleeding may occur. To induce withdrawal bleeding, remove the vaginal ring. A regular weekly break between consecutive rings 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 alternative contraceptive methods.
If you stop using NuvaRing because you wish to become pregnant, wait until after your first menstrual period before trying to conceive. This will help determine the due date.

4. Possible adverse effects

Like any medicine, the NuvaRing system may cause adverse effects, although not everyone experiences them. If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of NuvaRing, consult a doctor.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (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 hypersensitivity (allergy) to any of the components of NuvaRing occurs, it may manifest as (frequency unknown): angioedema and (or) anaphylactic reaction [swelling of the face, lips, tongue, and (or) throat and (or) difficulty swallowing] or development of urticaria potentially accompanied by breathing difficulties. In such cases, remove the NuvaRing and contact a doctor immediately (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 yeast 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

• Vision disturbances; dizziness
• Bloating; vomiting, diarrhoea or constipation
• Feeling of fatigue, malaise or restlessness; mood changes; sudden mood swings
• Oedema
• Urinary bladder or urinary tract infections
• Problems or pain during urination; urgency or need to urinate; frequent urination
• Discomfort during intercourse, including pain, bleeding, or discomfort related to the presence of the system, as felt 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 swelling or breast 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, 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 eyes The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).
• Galactorrhea (discharge of fluid from the breast)

Unknown frequency (cannot be estimated from available data)

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

Breast cancer and liver tumours have occurred in women using combined hormonal contraceptives. For detailed information, see section 2.2 "Warnings and precautions", "Neoplastic diseases".

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

Reporting of adverse effects

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

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 collect 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.
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.
Do not use NuvaRing if you notice any change in colour or if there are any signs of deterioration.
Used vaginal ring systems should be disposed of in a regular household waste container, preferably in a sealed pouch. Do not flush NuvaRing down the toilet. As with any other medicines, do not dispose of unused or expired systems via sewage systems or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What NuvaRing contains

• The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg)

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• Other components: poly(ethylene - vinyl acetate), 28% vinyl acetate (EVA 28), poly(ethylene - vinyl acetate), 9% vinyl acetate (EVA 9), magnesium stearate.

Etonogestrel and ethinylestradiol are released from the vaginal therapeutic system at doses 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 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.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, the country of export:
ORGANON BIOSCIENCES S.R.L., Strada Av. Popișteanu, Nr. 54A
Expo Business Park, Clădirea 2, Birou 306 și Birou 307, Etaj 3, Sectorul 1
Bucharest, Romania
Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, 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 Romania, the country of export: 4823/2012/01
4823/2012/02
Parallel Import Authorisation Number: 17/21
This medicinal product is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following name:
NuvaRing
0.120 mg/0.015 mg/24 h, vaginal therapeutic system
Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Romania, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland).
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