NuvaRing 0.120 mg/0.015 mg every 24 hours, vaginal delivery system

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NuvaRing 0.120 mg/0.015 mg per 24 hours, vaginal ring

etonogestrel/ethinylestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read the entire leaflet carefully before you start using NuvaRing, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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. Storage of NuvaRing and the NuvaRing Applicator
6. Contents of the pack and other information

1. What NuvaRing is and what it is used for

NuvaRing is a vaginal contraceptive ring used to prevent pregnancy. Each ring contains a small amount of two female sex hormones, etonogestrel and ethinylestradiol. The ring slowly releases these hormones into the bloodstream. Because of the small amount of hormones released, NuvaRing is a low-dose hormonal contraceptive. As NuvaRing releases two different types of hormones, it is a combined hormonal contraceptive.

NuvaRing works like the combined oral contraceptive pill (the “Pill”), but instead of taking a pill every day, the ring is used continuously for 3 weeks. NuvaRing releases two female sex hormones that prevent the ovaries from releasing an egg. If no egg is released, pregnancy cannot occur.

2. What you need to know before starting to use NuvaRing

General considerations

Before starting to use NuvaRing, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

This leaflet describes various situations in which you should stop using NuvaRing, or when NuvaRing may be less effective. In these situations, you should not have sexual intercourse, or you must use additional non-hormonal contraceptive measures, such as a male condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because NuvaRing alters the monthly changes in body temperature and cervical mucus.

NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

2.1 When not to use NuvaRing

Do not use NuvaRing if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you require surgery or if you are going to be immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or a stroke.

• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of forming a clot in the arteries:

  • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinaemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

• If you have or have had inflammation of the pancreas (pancreatitis), associated with high levels of fats in your blood.

• If you have or have had severe liver disease and your liver is still not functioning normally.

• If you have or have had a benign or malignant liver tumour.

• If you have, have had, or may have breast cancer or cancer of the genital organs.

• If you have vaginal bleeding of unknown origin.

• If you are allergic to ethinylestradiol or etonogestrel, or to any of the other components of this medicine (listed in section 6).

If any of these circumstances occur for the first time while you are using NuvaRing, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.

Do not use NuvaRing if you have hepatitis C and are taking medications containing

ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section 2.4 "Other medicines and NuvaRing").

2.2 Warnings and precautions

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions.

If any of these conditions develop or worsen while using NuvaRing, you must also inform your doctor.

• If any close family member has or has ever had breast cancer.

• If you have epilepsy (see section 2.4 “Other medicines and NuvaRing”).

• 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 disease).

• If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).

• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).

• If you have sickle cell anemia (an inherited red blood cell disorder).

• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).

• If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).

• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you may start using NuvaRing after delivery.

• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).

• If you have varicose veins.

• If you have any condition 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 disorder causing involuntary movements]).

• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives possibly accompanied by breathing difficulties, contact your doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

• If you have or have ever had chloasma (yellowish-brown skin patches, known as “pregnancy mask,” particularly on the face); in such cases, avoid excessive exposure to sunlight or ultraviolet radiation.

• If you have conditions that make using NuvaRing difficult, such as constipation, uterine prolapse (descent of the uterus or cervix), or pain during sexual intercourse.

• If you experience urgent, frequent, burning, and/or painful urination, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of NuvaRing into the urinary bladder.

BLOOD CLOTS

Using a combined hormonal contraceptive like NuvaRing increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot may block blood vessels and cause serious problems.

Blood clots can form:

• In veins (called “venous thrombosis,” “venous thromboembolism,” or VTE).
• In arteries (called “arterial thrombosis,” “arterial thromboembolism,” or TEA).

Recovery from blood clots is not always complete. Rarely, there may be long-lasting serious effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to NuvaRing is low.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen upon deep breathing. Severe dizziness or lightheadedness. Fast or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe weakness, anxiety, or shortness of breath. Fast or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop using NuvaRing, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are using.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with NuvaRing is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will experience a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will experience a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing norelgestromin or etonogestrel, such as NuvaRing, between about 6 and 12 women will experience a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women who use NuvaRing	About 6-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with NuvaRing is small, but certain conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury, illness, or having a leg in a cast. You may need to stop using NuvaRing several weeks before surgery or while you are less mobile. If you need to stop using NuvaRing, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years of age).
• If you have given birth less than a few weeks ago.

The risk of developing a blood clot increases the more conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop using NuvaRing.

If any of the above conditions change while you are using NuvaRing—for example, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke while using NuvaRing is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like NuvaRing, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm disorders such as atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using NuvaRing—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

Cancer

The following information comes from studies on combined oral contraceptives and may be applicable to NuvaRing. There is no available information on the vaginal administration of contraceptive hormones (such as NuvaRing).

A slightly increased frequency of breast tumors has been observed in women using oral contraceptives, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women using oral contraceptives because they attend medical check-ups more frequently. This increased frequency gradually decreases after stopping treatment.

It is important to examine your breasts regularly and inform your doctor if you notice any lumps. Inform your doctor if any close relatives have or have had breast cancer (see section 2.2 “Warnings and precautions”).

Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using oral contraceptives. Contact your doctor if you experience a severe and unusual abdominal pain.

Women using combined oral contraceptives have been found to develop endometrial (lining of the uterus) or ovarian cancer less frequently. This may also be the case for NuvaRing, but it has not been confirmed.

Psychiatric disorders

Some women using hormonal contraceptives such as NuvaRing have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for medical advice as soon as possible.

1. Children and adolescents

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

1. Other medicines and NuvaRing

Always inform your doctor about any medicines or herbal products you are taking. Also inform any doctor or dentist (or pharmacist) who prescribes another medicine that you are using NuvaRing. They can advise you whether you need to take additional contraceptive measures (e.g., use of male condoms), and if so, for how long, or whether you need to adjust the use of the other medicine.

Some medicines:

• may affect the levels of NuvaRing in the blood;
• may make NuvaRing less effective in preventing pregnancy;
• 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);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive mood disorders (the herbal product St. John’s wort).

If you are taking medicines or herbal products that could reduce the effectiveness of NuvaRing, you should also use a barrier contraceptive method (e.g., a male condom). Since the effect of another medicine on NuvaRing may last up to 28 days after stopping the medicine, a barrier contraceptive method must be used during this time. Note: Do not use NuvaRing together with a diaphragm, cervical cap, or female condom.

NuvaRing may influence the effect of other medicines, for example:

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).

Do not use NuvaRing if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as increases in liver function test results (elevated liver enzyme ALT) may occur.

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.

NuvaRing can be used again approximately 2 weeks after completion of this treatment. See section 2.1 “When not to use NuvaRing”.

Consult your doctor or pharmacist before taking any medicine.

Tampons can be used while using NuvaRing. Insert NuvaRing first, then the tampon. Take special care when removing the tampon to avoid accidentally expelling the ring. If the ring is expelled, simply wash it with cool or warm water and reinsert it immediately.

The ring may come open when also using a vaginal product such as a lubricant or treatment for infection (see section 3.4 “What to do if… the ring comes open”). The use of spermicides or vaginal antifungal products does not reduce the contraceptive effectiveness of NuvaRing.

Laboratory tests

If you are having blood or urine tests, inform your doctor that you are using NuvaRing, as it may affect the results of some tests.

1. Pregnancy and breastfeeding

NuvaRing must not be used by women who are pregnant or suspect they may be pregnant. If you become pregnant while using NuvaRing, remove the ring and consult your doctor.

If you wish to stop using NuvaRing because you want to become pregnant, see section 3.5 “If you wish to stop using NuvaRing”.

In general, NuvaRing is not recommended while breastfeeding. If you wish to use NuvaRing while breastfeeding, consult your doctor.

1. Driving and using machines

It is unlikely that NuvaRing will affect your ability to drive or use machines.

3. How to use NuvaRing

You can insert and remove NuvaRing yourself. Your doctor will advise you when to start using it for the first time. The vaginal ring must be inserted on the correct day of your menstrual cycle (see section 3.3 “When to start with the first ring”) and remain in the vagina for three consecutive weeks. You should regularly check that NuvaRing is still in your vagina (for example, before and after sexual intercourse) to ensure you are protected against pregnancy. After the third week, remove NuvaRing and take a one-week break. You will usually have your menstrual period or bleed during this ring-free week.

While using NuvaRing, you should not use certain female barrier contraceptive methods such as vaginal diaphragm, cervical cap, or female condom. These barrier contraceptive methods should not be used as a backup method of birth control, as NuvaRing may interfere with the correct placement and positioning of the diaphragm, cervical cap, or female condom. However, you may use a male condom as an additional barrier contraceptive method.

3.1 How to insert and remove NuvaRing

1. Before inserting the ring, check that it has not expired (see section 5 “Storage of NuvaRing and NuvaRing Applicator”).
2. Wash your hands before inserting or removing the ring.
3. Choose the most comfortable position for you to insert it, such as standing with one leg raised, squatting, or lying down.
4. Remove NuvaRing from its pouch.
5. Hold the ring between your index finger and thumb, press opposite sides together, and insert the ring into the vagina (see figures 1–4). Alternatively, you may choose to use the NuvaRing Applicator to assist with insertion (see instructions for use below). Once NuvaRing is in place, you should not feel it. If you feel uncomfortable, gently adjust the position of NuvaRing (for example, push the ring slightly further into the vagina) until you feel comfortable. The exact position of the ring inside the vagina is not important.
6. After three weeks, remove NuvaRing from the vagina. This can be done by hooking the ring with your index finger or by grasping it with your fingers and pulling it out (see figure 5). If you are unable to remove the ring despite having located it, contact your doctor.
7. Dispose of the used ring in household waste, preferably placing it back into its pouch. Do not flush NuvaRing down the toilet.

Insertion of NuvaRing using fingers only:

Figure 1 Remove NuvaRing from its pouch Figure 2 Press the ring together

Figure 3 Choose a comfortable position for inserting the ring

Figure 4A Figure 4B Figure 4C

Place the ring into your vagina with one hand (Figure 4A); if necessary, separate the vaginal lips with the other hand. Push the ring further into the vagina until it feels comfortable (Figure 4B). Leave the ring in the vagina for 3 weeks (Figure 4C).

Figure 5 NuvaRing can be removed by hooking the ring with the index finger or grasping it between the index and middle fingers and pulling outward.

Important information about the NuvaRing applicator:

1. Optional use to help insert NuvaRing.
2. Do NOT reuse the applicator; it is designed for single use only.
3. Do NOT share the applicator with other people.
4. If the applicator falls accidentally, wash it with cold or lukewarm water (DO NOT use hot water).
5. Dispose of the applicator in the trash immediately after use.
6. Do not flush the applicator down the toilet.

Inserting NuvaRing with the applicator:

1: Preparation

Wash your hands before opening the container. ALWAYS open immediately before use. DO NOT use if the contents or container are visibly damaged.

The applicator is designed to be used ONLY with the NuvaRing ring, not with other products.

Review the applicator image to become familiar with its parts. Plunger B. Grip area C. Applicator tube D. Tube opening NuvaRing vaginal ring

2: Loading and placement

Pull the plunger gently backward until it stops.

Press the opposite sides of the ring and insert the ring into the opening of the applicator tube.

Gently push the ring into the tube. The end of the ring should protrude slightly from the opening of the applicator tube.

Choose the position that is most comfortable for inserting the ring, such as lying down, squatting, or standing with one leg raised.

3: Insertion and Deletion

Place your thumb and middle finger on the gripping area.

Gently insert the applicator tube into the vagina until your fingers (the gripping area of the applicator) come into contact with your body. Then, use your index finger to gently push the plunger fully into the tube. Some women have noticed a brief, mild pinching sensation when using the applicator.

The ring is pushed out of the applicator. Gently remove the applicator.

Make sure the ring is NO LONGER inside the applicator. Discard the used applicator in the trash. DO NOT flush the applicator down the toilet. DO NOT reuse the applicator.

3.2 Three weeks in, one week out

1. The vaginal ring must remain in the vagina from the day it is inserted for three consecutive weeks uninterrupted.
2. After 3 weeks, remove the ring on the same day of the week and at approximately the same time as when you inserted it. For example, if you inserted it on a Wednesday at approximately 10:00 PM, you should remove it three weeks later, on a Wednesday, at approximately 10:00 PM.
3. Once the ring has been removed, do not use it for one week. During this week, a vaginal bleed should occur. This usually starts 2–3 days after removal of NuvaRing.
4. Insert a new ring exactly after the 1-week interval (again on the same day of the week and at approximately the same time), even if bleeding has not yet stopped.
5. If you insert the new ring more than 3 hours late, contraceptive effectiveness may be reduced. Follow the instructions in section 3.4 “What to do if you forget to insert a new ring after the ring-free interval”.

If you use NuvaRing as described above, your bleeding will occur approximately on the same days each month.

3.3 When to start with the first ring

• If you have not used hormonal contraception in the previous month

Insert NuvaRing on the first day of your natural cycle (i.e., the first day of your menstruation). NuvaRing starts working immediately. You do not need to use any additional contraceptive measures.

You may also start NuvaRing between day 2 and day 5 of your cycle, but if you have sexual intercourse during the first 7 days of using NuvaRing, make sure to use a complementary contraceptive method (such as a male condom). You should only follow this recommendation when using NuvaRing for the first time.

• If you were using a combined oral contraceptive pill in the previous month

Start using NuvaRing no later than the day after the last active tablet of your current pill pack. If your pill pack also contains 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. Never extend the tablet-free interval of your current pill beyond what is recommended.

If you have taken your current pill correctly and continuously and are sure you are not pregnant, you may also stop taking the pill on any day of your current cycle and start using NuvaRing immediately.

• If you were using a transdermal patch in the previous month

Start using NuvaRing no later than the day after the patch-free interval. Do not extend the patch-free interval beyond what is recommended.

If you have used the patch correctly and continuously and are sure you are not pregnant, you may also stop using the patch on any day and start using NuvaRing immediately.

• If you were using a progestogen-only pill in the previous month

You may stop taking your progestogen-only pill on any day and start using NuvaRing the next day at the same time. However, make sure to also use a complementary contraceptive method (such as a male condom) during the first 7 days of ring use.

• If you were using a hormonal injection, implant, or hormonal intrauterine system [IUS (progestogen)] in the previous month

Start using NuvaRing at the time when your next injection is due, or on the day your implant or IUS is removed. However, make sure to use a complementary contraceptive method (such as a male condom) during the first 7 days of ring use.

• After childbirth

If you have recently given birth, your doctor may advise you to wait until your first natural menstrual period occurs before starting NuvaRing. Sometimes it may be possible to start earlier; your doctor will advise you accordingly. If you are breastfeeding and wish to use NuvaRing, you must consult your doctor first.

• After an abortion

Consult your doctor.

3.4 What to do if...

Your ring is accidentally expelled from the vagina

NuvaRing may be accidentally expelled from the vagina, for example if it was not inserted properly, when removing a tampon, during sexual intercourse, if you have constipation, or if you have uterine prolapse (a descent of the uterus). Therefore, you should regularly check whether the ring is still in your vagina (e.g., before and after sexual intercourse).

Your ring has been temporarily removed from the vagina

NuvaRing may still protect you from pregnancy, but this depends on how long it was out of the vagina.

If the ring has been out of the vagina for:

• less than 3 hours, it will still protect you from pregnancy. Wash the ring with cool or lukewarm water (do not use hot water) and reinsert it into the vagina as soon as possible, but only if it has been out for less than 3 hours.
• more than 3 hours during the 1st or 2nd week, it may not protect you from pregnancy. Wash the ring with cool or lukewarm water (do not use hot water) and reinsert it as soon as you remember. Leave it in the vagina for at least 7 consecutive days. Use a male condom if you have sexual intercourse during these 7 days. If you are in the first week and have had sexual intercourse in the previous 7 days, there is a possibility you may be pregnant. In this case, consult your doctor.
• more than 3 hours during the 3rd week, it may not protect you from pregnancy. Remove the ring and choose one of the following two options:

1. Insert a new ring immediately.

By inserting a new ring, you will start a new 3-week cycle and your period may not occur. However, you may experience intermenstrual bleeding or spotting during that cycle.

1. Do not insert a new ring. Allow the intermenstrual bleed to occur and insert a new ring no later than 7 days from the time the previous ring was removed or expelled.

Choose this option only if you have used NuvaRing continuously and correctly for the previous 7 days.

• an unknown period of time, it may not protect you from pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks open

In very rare cases, the NuvaRing may break open. Vaginal injury associated with ring rupture has been reported. If you notice that NuvaRing has broken open, remove the ring and insert a new one as soon as possible. Use additional contraceptive precautions (e.g., a male condom) for the next 7 days. If you had sexual intercourse before noticing the ring had broken open, consult your doctor.

You have inserted more than one ring

There are no reports of serious harm due to overdose of the hormones in NuvaRing. If you have accidentally inserted more than one ring, you may feel unwell (nausea), vomit, or have vaginal bleeding. Remove the extra ring and contact your doctor if these symptoms do not go away. You may also call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and amount used.

If you forget to insert a new ring after the ring-free interval

Your ring-free interval has lasted more than 7 days. Insert a new ring into the vagina as soon as you remember. Use additional contraceptive measures (such as a male condom) if you have sexual intercourse during the next 7 days. If you had sexual intercourse during this ring-free interval, there is a possibility you may have become pregnant. In this case, inform your doctor immediately. The longer the ring-free interval, the higher the risk of pregnancy.

If you forget to remove the ring

• If the ring has been in the vagina between 3 and 4 weeks, it will still protect you from pregnancy. Allow the one-week ring-free interval and then insert a new ring.
• If the ring has been in the vagina for more than 4 weeks, there is a possibility of pregnancy. Contact your doctor before starting a new ring.

If your period or menstrual bleed does not occur

• You have used NuvaRing according to the instructions.

If your period does not occur, but you have used NuvaRing as directed and have not taken other medications, it is very unlikely that you are pregnant. Continue using NuvaRing as usual. However, if you miss two consecutive periods, you may be pregnant and should inform your doctor immediately. Do not insert the next NuvaRing until your doctor has confirmed you are not pregnant.

• If you have deviated from the recommended use of NuvaRing.

If your usual bleed does not occur during the one-week ring-free interval and you have deviated from the recommended regimen, there is a possibility you may be pregnant, so you should contact your doctor before inserting a new ring.

If you have unexpected bleeding

In some women, unexpected vaginal bleeding may occur between menstrual periods while using NuvaRing. You may need to use sanitary protection. Nevertheless, continue using the ring as usual—do not remove it. If the bleeding continues, becomes heavier, or starts again, consult your doctor.

If you wish to change the day your period or menstrual bleed starts

If you use NuvaRing as directed, your menstrual period (withdrawal bleed) will begin during the ring-free week. If you wish to change the day it starts, you must shorten (but never lengthen) the ring-free interval.

For example, if your period usually starts on Friday, you can change it to Tuesday—3 days earlier starting the following month. Simply insert the next ring 3 days earlier than usual.

If the ring-free interval is very short (e.g., 3 days or less), you may not have your usual bleed. You may experience spotting (drops or stains of blood) or intermenstrual bleeding during use of the next ring.

If you are unsure how to do this, consult your doctor.

If you wish to delay your period or menstrual bleed

Although not the recommended regimen, you may delay your period (withdrawal bleed) by inserting a new ring immediately after removing the current ring, without taking a ring-free interval. You may keep the new ring in place for up to 3 weeks maximum. During use of the new ring, you may experience spotting (drops or stains of blood) or irregular bleeding. When you wish your period to start, simply remove the ring. Then observe the normal one-week ring-free interval before inserting a new ring.

You may consult your doctor before deciding to delay your menstrual period.

3.5 If you wish to stop using NuvaRing

You may stop using NuvaRing at any time. If you do not wish to become pregnant, consult your doctor about other contraceptive methods.

If you stop using NuvaRing because you wish to become pregnant, it is recommended to wait until you have had your first natural menstrual period before trying to conceive. This will help you calculate your due date.

4. Possible adverse effects

Like all medicines, NuvaRing can cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to NuvaRing, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2, “What you need to know before starting to use NuvaRing”.

If you are allergic to any of the components of NuvaRing (hypersensitivity), you may experience the following symptoms (frequency not known): angioedema and/or anaphylaxis [swelling of the face, lips, tongue and/or throat and/or difficulty swallowing] or urticaria, possibly with difficulty breathing. If this occurs, remove NuvaRing immediately and contact your doctor without delay (see also section 2.2 “Warnings and precautions”).

Users of NuvaRing have reported the following adverse effects:

Common: may affect up to 1 in 10 women.

• abdominal pain, discomfort (nausea)
• vaginal yeast infection (similar to oral thrush), vaginal discomfort due to the ring, genital itching, vaginal discharge
• headache or migraine, depressed mood, decreased sexual desire
• breast pain, pelvic pain, painful menstruation
• acne
• weight gain
• expulsion of the ring

Uncommon: may affect up to 1 in 100 women.

• visual disturbances, dizziness

• bloated abdomen, vomiting, diarrhoea or constipation

• feeling tired, unwell or irritable, mood changes, changes in mood

• fluid retention in the body (oedema)

• urinary tract or bladder infection

• difficulty or pain when urinating; urgency to urinate. Need to urinate more frequently

• problems during sexual intercourse such as pain, bleeding or partner noticing the ring

• increased blood pressure

• increased appetite

• back pain, muscle cramps, pain in the legs or arms

• reduced skin sensitivity

• breast tenderness or pain or increased breast size; fibrocystic breast disease (breast cysts that may become swollen or painful)

• cervical inflammation, cervical polyps, displacement of inner cervical tissue to the outer part (ectropion)

• changes in menstrual periods (heavier, longer, irregular or absent), pelvic discomfort, premenstrual syndrome, uterine cramps

• vaginal infection (fungal or bacterial), burning, odour, pain, discomfort or dryness of the vagina or vulva

• hair loss, eczema, itching, rash 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 a leg or foot (i.e., DVT)

• in a lung (i.e., PE)

• heart attack

• stroke

• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)

• blood clots in the liver, stomach/intestine, kidneys or eye

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

• breast discharge

Frequency not known (cannot be estimated from available data).

• chloasma (yellowish-brown patches on the skin, particularly on the face)
• penile discomfort in the partner (irritation, rash, itching)
• inability to remove the ring without medical assistance (e.g., due to adhesion to the vaginal wall)
• vaginal injury associated with ring rupture.

Cases of breast cancer and liver tumours have been reported in women using combined hormonal contraceptives. For more information, see section 2.2 Warnings and precautions, Cancer.

In very rare cases, the NuvaRing may open. For more information, see section 3.4 What to do if... The ring opens.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NuvaRing and the NuvaRing Applicator

Keep this medicine out of the sight and reach of children.

If you find that a child has been exposed to the hormones in NuvaRing, consult your doctor.

Store below 30°C. Keep in the original packaging to protect from light and moisture.

Do not use NuvaRing if it was dispensed more than 4 months ago. The dispensing date is shown on the box and on each individual ring pouch.

Do not use NuvaRing after the expiry date stated on the box and on each individual pouch.

Do not use NuvaRing if you notice any changes in the colour of the ring or any visible signs of deterioration.

Dispose of used rings with household waste, preferably within their sealed pouch. Dispose of the used applicator with normal household waste. Neither NuvaRing nor the applicator should be flushed down the toilet.

As with other medicines, do not dispose of unused or expired rings via drains or household waste.

Medicines should not be disposed of via drains or in household waste. Return unused packaging and medicines to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of NuvaRing

• The active substances are etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• The other components are: vinyl acetate-ethylene copolymer (28% and 9% vinyl acetate) (a type of plastic that does not dissolve in the body) and magnesium stearate.

Etonogestrel and ethinylestradiol are released from the ring at a rate of 0.120 mg/day and 0.015 mg/day, respectively, over three weeks.

Appearance of NuvaRing and the NuvaRing Applicator and contents of the pack

NuvaRing is a flexible, transparent, and nearly colourless ring measuring 54 mm in diameter.

Each ring is packaged in a laminated aluminium foil pouch with a resealable closure.

The applicator is a non-sterile plastic device designed for single use (i.e., disposable). Each applicator is individually packaged. The applicator bears the engraved CE mark.

The pouches containing the ring(s) and applicator(s) are supplied in a cardboard box together with this leaflet. Each box contains 1 or 3 rings and the corresponding number of applicators.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

N.V. Organon

Kloosterstraat 6,

5349 AB Oss

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following name:

NuvaRing

0.120 mg/0.015 mg per 24 hours, vaginal delivery system

Germany, Austria, Belgium, Czech Republic, Denmark, Spain, Slovakia, Slovenia, Estonia, Finland, France, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, The Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Romania, Sweden.

Date of the most recent revision of this leaflet: 09/2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)