Ringo 0.120 mg/0.015 mg every 24 hours, vaginal ring system EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ringo 0.120 mg/0.015 mg every 24 hours, vaginal delivery system EFG

Etonogestrel/Ethinylestradiol

Important things you need to 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 a blood clot 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 this entire leaflet carefully before you start using Ringo, 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 must not be given 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.

Contents of this leaflet:

1. What Ringo is and what it is used for
2. What you need to know before using Ringo

2.1 When you must not use Ringo

2.2 Warnings and precautions

Blood clots

Cancer

2.3 Children and adolescents

2.4 Other medicines and Ringo

Laboratory tests

2.5 Pregnancy and breastfeeding

2.6 Driving and use of machines

3. How to use Ringo

3.1 How to insert and remove Ringo

3.2 Three weeks in, one week out

3.3 When to start with the first ring

3.4 What to do if

Your ring is accidentally expelled from the vagina

Your ring has been temporarily outside the vagina

The ring opens

More than one ring has been inserted

You forget to insert a new ring after the ring-free interval

You forget to remove the ring

Your period does not appear

You have unexpected bleeding

You wish to change the day your period starts

You wish to delay your period

3.5 If you wish to stop using Ringo

4. Possible side effects
5. How to store Ringo
6. Contents of the pack and other information

Composition of Ringo

Appearance of Ringo and contents of the pack

Marketing Authorization Holder and Manufacturer

1. What Ringo is and what it is used for

Ringo 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. Due to the small amount of hormones released, Ringo is a low-dose hormonal contraceptive. Since Ringo releases two different types of hormones, it is a combined hormonal contraceptive.

Ringo 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. Ringo 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 using Ringo

General considerations

Before starting to use Ringo, 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 Ringo, or in which Ringo may be less effective. In these situations, you should not have sexual intercourse, or you should use additional non-hormonal contraceptive methods, such as male condoms or other barrier methods. Do not use the rhythm method or temperature method. These methods may not be reliable because Ringo alters the monthly changes in body temperature and cervical mucus.

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

2.1 When not to use Ringo

Do not use Ringo 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 the 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 need surgery or if you are immobile for a long time (see section “Blood clots”).

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

  • 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 not functioning normally.
  • If you have or have had a benign or malignant liver tumor.
  • 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 conditions occur for the first time while you are using Ringo, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.

Do not use Ringo if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section 2.4 “Other medicines and Ringo”).

2.2 Warnings and precautions

When should you consult your doctor?

Seek urgent medical help

• 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 the condition develops or worsens while you are using Ringo, you should also inform your doctor.

• If a close relative has or has ever had breast cancer.
• If you have epilepsy (see section 2.4 “Other medicines and Ringo”).
• 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 haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).
• If you have sickle cell anaemia (a hereditary red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or are immobile for a long time (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start using Ringo after childbirth.
• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have a 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], Sydenham’s chorea [a nervous disorder causing involuntary movements]; hereditary angioedema [see your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, or hives with difficulty breathing]).
• If you have or have ever had chloasma (yellow-brown patches on the skin, known as “pregnancy mask,” particularly on the face); if so, avoid excessive exposure to sunlight or ultraviolet radiation.
• If you have conditions that make using Ringo difficult, for example, if you suffer from 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 Ringo into the urinary bladder.

Blood clots

Using a combined hormonal contraceptive such as Ringo increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can 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 ATE).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical help 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 when breathing deeply. Severe dizziness or lightheadedness. Rapid 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 under the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort spreading to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe weakness, anxiety, or shortness of breath. Rapid 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 events are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of 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 (PE).
• 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 increased 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 slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop using Ringo, 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 Ringo is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop 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 develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing norelgestromin or etonogestrel, such as Ringo, between about 6 and 12 women will develop a blood clot in one year.
• Your personal risk of developing a blood clot will depend on your individual 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 contraceptive 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 Ringo	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 Ringo 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 about 50 years). 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 a plaster cast on your leg. You may need to stop using Ringo several weeks before surgery or while you are less mobile. If you need to stop using Ringo, ask your doctor when you can start using it again.
• With increasing age (especially over about 35 years).
• If you have given birth less than a few weeks ago.

The risk of developing a blood clot increases the more of these 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 Ringo.

If any of the above conditions change while you are using Ringo—for example, a close relative experiences a thrombosis without a known cause or you gain a lot 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 clot in an artery can cause serious problems. For example, it can lead to 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 Ringo is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Ringo, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend that you 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 Ringo—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight—inform your doctor.

Cancer

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

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 unusual and severe 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 with Ringo, but it has not been confirmed.

Psychiatric disorders

Some women using hormonal contraceptives such as Ringo have reported depression or 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 Ringo in adolescents under 18 years of age has not been established.

1. Other medicines and Ringo

Always inform your doctor about any medicines or herbal remedies you are taking. Also inform any doctor or dentist (or pharmacist) who prescribes another medicine that you are using Ringo. They can advise you whether you need to use additional contraceptive measures (e.g., 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 Ringo in your blood;
• may make Ringo 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 infectious diseases (e.g., griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive mood disorders (the herbal remedy St. John’s wort).

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

Ringo may affect the action of other medicines, for example:

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

Do not use Ringo if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, 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.

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

Consult your doctor or pharmacist before taking any medicine.

Tampons can be used while using Ringo. Insert Ringo 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 cold or lukewarm water and reinsert it immediately.

The ring may 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 opens”). The use of spermicides or vaginal antifungal products does not reduce the contraceptive effectiveness of Ringo.

Laboratory tests

If you undergo blood or urine tests, inform your doctor that you are using Ringo, as it may affect the results of certain tests.

1. Pregnancy and breastfeeding

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

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

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

1. Driving and using machines

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

3. How to use Ringo

You can insert and remove Ringo 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 monthly cycle (see section 3.3 "When to start with the first ring") and must remain in the vagina for three consecutive weeks. You should regularly check that Ringo is in place in your vagina (for example, before and after sexual intercourse) to ensure you are protected against pregnancy. After the third week, remove Ringo and take a one-week break. You will usually have your monthly period or menstruation during this ring-free week.

While using Ringo, you should not use certain female barrier contraceptive methods such as the vaginal diaphragm, cervical cap, or female condom. These barrier contraceptive methods should not be used as a backup method of birth control, as Ringo 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 Ringo

1. Before inserting the ring, check that it is not expired (see section 5 "Storage of Ringo").
2. Wash your hands before inserting or removing the ring.
3. Choose the position that is most comfortable for you when inserting it—for example, standing with one leg raised, squatting, or lying down.
4. Remove Ringo from its foil 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). Once Ringo is in place, you should not feel it. If you feel uncomfortable, gently adjust the position of Ringo (for example, by pushing it slightly further into the vagina) until you feel comfortable. The exact position of the ring within the vagina is not important.
6. After three weeks, remove Ringo from the vagina. You can do this 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 foil pouch. Do not flush Ringo down the toilet.

Figure 1 Remove Ringo from its pouch	Figure 3 Choose a comfortable position to insert the ring
Figure 2 Press the ring
Figure 4A Figure 4B Figure 4C Insert the ring into the vagina with one hand (Figure 4A); if necessary, separate the labia with the other hand. Push the ring into the vagina until it feels comfortable (Figure 4B). Leave the ring in the vagina for 3 weeks (Figure 4C).
	Figure 5 Ringo can be removed by hooking the ring with the index finger or grasping it between the index and middle fingers and pulling outward.

3.2 Three weeks in, one week out

1. The vaginal ring must remain in the vagina from the day you insert it for 3 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 3 weeks later, on a Wednesday, at approximately 10:00 PM.
3. Once you have removed the ring, do not use it for one week. During this week, vaginal bleeding should occur. This usually begins 2–3 days after removing Ringo.
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 you are still bleeding.
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 Ringo 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 Ringo on the first day of your natural cycle (i.e., the first day of your menstruation). Ringo becomes effective immediately. You do not need to use any additional contraceptive measures.

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

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

Start using Ringo no later than the day after the end of the pill-free interval of your current pill. If your pill pack also contains inactive tablets, start Ringo no later than the day after the last inactive tablet. If you are unsure which tablet is inactive, consult your doctor or pharmacist. Never extend the pill-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 cycle and start using Ringo immediately.

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

Start using Ringo 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 remove the patch on any day and start using Ringo 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 Ringo the following day at the same time. However, make sure you also use a complementary contraceptive method (such as the male condom) during the first 7 days of using the ring.

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

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

• After childbirth

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

• After an abortion

Consult your doctor.

3.4 What to do if...

Your ring is accidentally expelled from the vagina

Ringo 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 (uterine descent). 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 outside the vagina

Ringo may still protect you from pregnancy, but this depends on how long it has been outside your vagina.

If the ring has been outside the vagina for:

• less than 3 hours, you will still be protected from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and reinsert it into the vagina as soon as possible, but only if it has been outside the vagina 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 cold 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. You should 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 of use, 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 bleeding 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 Ringo continuously 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 opens

In very rare cases, the Ringo ring may open. Vaginal injury associated with ring breakage has been reported. If you notice that Ringo has opened, 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 opened, consult your doctor.

You have inserted more than one ring

There are no reports of serious harm due to overdose of the hormones in Ringo. 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 resolve. 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 be pregnant. In such a 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, you will still be protected 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 does not occur

• You have used Ringo according to instructions.

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

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

If your usual bleeding 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 Ringo. You may need sanitary protection. Nevertheless, continue using the ring as normal; 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 starts

If you use Ringo according to instructions, your menstrual period (withdrawal bleeding) will begin during the ring-free week. If you wish to change the day it starts, you must shorten (never lengthen) the ring-free interval.

For example, if your period usually starts on a Friday, you can change it to a Tuesday, i.e., 3 days earlier starting next 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 bleeding. 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

Although this is not the recommended regimen, you may delay your period (withdrawal bleeding) by inserting a new ring immediately after removing the current one, without taking a ring-free interval. You may keep the new ring in place for up to 3 weeks. 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. Take the normal one-week ring-free interval and then insert a new ring.

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

3.5 If you wish to stop using Ringo

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

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

4. Possible adverse effects

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

If you are allergic to any of the components of Ringo (hypersensitivity), you may experience the following symptoms (frequency not known): angioedema [swelling of the face, tongue or throat, difficulty swallowing] or urticaria, together with breathing difficulties. If this occurs, remove Ringo immediately and contact your doctor without delay.

Users of Ringo have reported the following adverse effects:

Frequent: 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 emotional state

• 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, pain or enlargement; fibrocystic breast disease (breast cysts that may become swollen or painful)

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

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

• vaginal infection (fungal or bacterial), burning sensation, 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/intestines, 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 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.

Very rarely, the Ringo ring 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 via 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 Ringo

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

If you discover that a child has been exposed to Ringo hormones, consult your doctor.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the pack and on each sachet after “EXP”. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any changes in the ring's colour or any visible signs of deterioration.

Dispose of used rings with household waste, preferably placed inside its sealed sachet. This medicine must not be disposed of via the toilet. Likewise, as with other medicines, unused or expired rings must not be flushed down drains or thrown into household waste.

Medicines must not be disposed of via drains or household waste. Dispose of packaging and unused medicines at the SIGRE collection 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 Ringo

• The active substances are etonogestrel and ethinylestradiol. Each ring contains 11.7 mg of etonogestrel and 2.7 mg of ethinylestradiol.
• 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.

What Ringo looks like and contents of the pack

Ringo is a flexible, transparent, and almost colourless ring, approximately 54 mm in diameter.

Each ring is packaged in a laminated aluminium pouch with a resealable closure. The pouch is supplied in a cardboard box together with this leaflet. Each box contains 1 or 3 rings.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: November 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/)