Label: Information for the User

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

Etonogestrel/Ethinylestradiol

Important information 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause 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 label carefully before starting to use Ringo, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you should not give it to others, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Ringo and how is it used

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

2.1 When not to 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 operating machinery

3. How to use Ringo

3.1 How to put on and take off 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 expelled accidentally from the vagina

Your ring has been temporarily removed from the vagina

The ring is open

More than one ring has been put on

You forget to put on a new ring after the pause without a ring

You forget to take off the ring

You do not have a period or menstrual bleeding

You have unexpected bleeding

You want to change the day of your period or menstrual bleeding

You want to delay your period or menstrual bleeding

3.5 If you want to stop using Ringo

4. Possible side effects

5. Storage of Ringo

6. Contents of the package and additional information

Composition of Ringo

Appearance of Ringo and contents of the package

Marketing authorization holder and responsible manufacturer

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 releases these hormones slowly into the bloodstream. Given the small amount of hormones released, Ringo is a low-dose hormonal contraceptive. As Ringo releases two different types of hormones, it is a combined hormonal contraceptive.

Ringo acts like the combined oral contraceptive pill (the “Pill”), but instead of taking a pill every day, the ring is used for 3 consecutive weeks. Ringo releases two female sex hormones that prevent the ovaries from releasing an egg. If no egg is released, you cannot become pregnant.

General Considerations

Before starting to use Ringo, you should read the information about blood clots in section 2. It is particularly important that you read 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 reliable. In these situations, you should not have sexual intercourse, or you should take additional non-hormonal contraceptive measures, such as a male condom or another barrier method. Do not use the rhythm or basal body temperature method. These methods may not be reliable because Ringo alters the monthly body temperature changes and cervical mucus.

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

2.1 When Not to Use Ringo

You should 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 what other form of contraception would be more suitable.

• Severe diabetes with vascular 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 pancreatitis (inflammation of the pancreas) associated with high levels of fat in your blood.
  • If you have or have had a serious 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 genital organ cancer.
  • If you have unexplained vaginal bleeding.
  • If you are allergic to ethinylestradiol or etonogestrel, or to any of the other components of this medication (including in section 6).

If any of these circumstances occur for the first time while using Ringo, remove the ring immediately and consult your doctor. Meanwhile, use non-hormonal contraceptive measures.

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

2.2 Warnings and Precautions

When to Consult Your Doctor?

Seek immediate medical attention

• If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack, or a stroke (see section “Blood Clots” below).

For a description of the symptoms of these serious side effects, see “How to Recognize a Blood Clot”.

Inform Your Doctor If You Suffer Any of the Following Conditions.

Inform your doctor if you suffer any of the following conditions, even if they are not severe. Inform your doctor if the condition develops or worsens while you are using Ringo.

Blood Clots

The use of a combined hormonal contraceptive like Ringo increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

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

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

After the first year, the risk decreases, but it is always slightly higher than if you were not using a combined hormonal contraceptive.

When you stop using Ringo, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

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

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing norelgestromin or etonogestrel, such as Ringo, about 6-12 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors that Increase Your Risk of a Blood Clot” below).

Factors that Increase Your Risk of a Blood Clot in a Vein

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

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

Long flights (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop using Ringo.

If any of the conditions listed above change while you are using Ringo, for example, a close relative experiences a blood clot 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 blood clot in an artery can cause serious problems, for example, a heart attack or a stroke.

Factors that Increase Your Risk of a Blood Clot in an Artery

It is essential to note that the risk of a heart attack or stroke due to Ringo is very small, but it may increase:

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

If any of the conditions listed above change while you are using Ringo, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Cancer

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

Cases of breast cancer have been observed with a slightly higher frequency in women using oral contraceptives, but it is unknown whether this is due to treatment. For example, it may be that more tumors are found in women using oral contraceptives because they attend medical check-ups more frequently. This increased frequency decreases gradually after stopping treatment. It is essential to examine your breasts regularly and inform your doctor if you notice any lumps. Inform your doctor if any of your close relatives have had breast cancer (see section 2.2 “Warnings and Precautions”).

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

In women using combined oral contraceptives, there has been a decrease in the frequency of endometrial cancer (the tissue that covers the uterus) or ovarian cancer. This may also be the case with Ringo, but it has not been confirmed.

Mental Health Disorders

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

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

Always inform your doctor about any medications or herbal supplements you are taking. Also, inform any doctor, dentist, or pharmacist (or pharmacist) who prescribes another medication that you are using Ringo. They can inform you if you need to take additional contraceptive measures (for example, use a male condom) and, if necessary, for how long, or if you need to modify the use of the other medication.

Some medications

• may affect the levels of Ringo in the blood;
• may make itless effective in preventing pregnancy;;
• may cause unexpected bleeding.

These include medications used to treat:

• epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (for example, rifampicin);
• HIV infection (for example, ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C infection (for example, boceprevir, telaprevir);
• other infectious diseases (for example, griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• mood disorders (the herbal remedy St. John's Wort).

If you are taking medications or herbal supplements that may make Ringo less effective, you should also use a barrier method (for example, a male condom). Since the effect of another medication on Ringo may last for up to 28 days after stopping the medication, you will need to use an additional barrier method during that time. Note: Do not use Ringo with a diaphragm, cervical cap, or female condom.

Ringo may affect the effect of other medications, for example:

• medications containing cyclosporin.
• the antiepileptic lamotrigine (this may lead to an increase in seizure frequency).

You should not use Ringo if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir. This may cause an increase in liver enzyme levels (ALT).

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

You can start using Ringo again about 2 weeks after completing this treatment. See section 2.1 “When Not to Use Ringo”.

Consult your doctor or pharmacist before taking any medication.

You can use tampons while using Ringo. First, put on Ringo, and then the tampon. Be especially careful when removing the tampon to avoid accidentally expelling the ring. If the ring is expelled, simply wash it with cold or lukewarm water and put it back on immediately.

The ring may open when using a vaginal product, such as a lubricant or a treatment for an infection (see section 3.4 “What to Do If… the Ring Opens”). The use of spermicides or vaginal antifungal products does not reduce the effectiveness of Ringo as a contraceptive.

Laboratory Tests

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

Women who are pregnant or suspect they may be pregnant should not use Ringo. If you become pregnant while using Ringo, remove the ring and consult your doctor.

If you want to stop using Ringo because you want to become pregnant, see section 3.5 “If You Want to Stop Using Ringo”.

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

Ringo is unlikely to affect your ability to drive or operate machines.

You can put in and take out Ringo yourself. Your doctor will tell 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 stay in the vagina for 3 consecutive weeks. Check regularly that Ringo is in your vagina (for example, before and after sexual intercourse) to ensure that you are protected against pregnancy. After the third week, remove Ringo and leave a 1-week break. Normally, you will have your menstrual period or period during this pause without a ring.

While using Ringo, you should not use some barrier female contraceptives, such as the vaginal diaphragm, cervical cap, or female condom. These barrier contraceptives should not be used as a backup method of birth control since Ringo may interfere with the correct placement and position of the diaphragm, cervical cap, or female condom. However, you can use a male condom as an additional barrier contraceptive method.

3.1 How to put in and take out Ringo

1. Before putting in the ring, check that it is not expired (see section 5 "Storage of Ringo").
2. Wash your hands before putting in or taking out the ring.
3. Choose a comfortable position for you to insert it, for example, standing with one leg raised, squatting, or lying down.
4. Remove Ringo from its package.
5. Hold the ring between your index and middle fingers, press the opposite sides, and insert the ring into the vagina (see figures 1-4).If Ringo is in place, you should not feel anything. If you feel uncomfortable, gently change the position of Ringo (for example, push the ring a little deeper into the vagina) until you feel comfortable. The exact position of the ring inside the vagina is not important.
6. After 3 weeks, remove the Ringo from the vagina. You can do this by hooking the ring with your index finger or holding it with your fingers and pulling it out (see figure 5). If you cannot remove the ring despite having located it, contact your doctor.
7. Dispose of the used ring in the regular household trash, preferably in its package. Do not flush Ringo down the toilet.

3.2 Three weeks in, one week out

1. The vaginal ring must remain in the vagina from the day you put it in for 3 consecutive weeks, uninterrupted.
2. After 3 weeks, remove the ring on the same day of the week that you put it in and at approximately the same time. For example, if you put it in on a Wednesday at approximately 22:00, remove it 3 weeks later on a Wednesday at approximately 22:00.
3. Once you have removed the ring, do not use it for 1 week. During this week, you should have a menstrual period. Normally, it starts 2-3 days after removing Ringo.
4. Put in a new ring exactly 1 week after the break (again on the same day of the week and approximately at the same time), even if you have not stopped bleeding yet.
5. If you put in a new ring more than 3 hours late, the contraceptive effectiveness may be reduced. Follow the instructions in section 3.4 "What to do if you forget to put in a new ring after the break without a ring."

If you use Ringo as described above, your menstrual period will occur approximately on the same days each month.

3.3 When to start with the first ring

Put in Ringo on the first day of your natural cycle (i.e., the first day of your menstruation). Ringo starts working immediately. You do not need to take any other contraceptive measures.

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

Start using Ringo as late as the day after the break with your current pill. If the package of your pill also contains inactive pills, start Ringo as late as the day after the last inactive pill. If you are unsure which pill is which, consult your doctor or pharmacist. Do not extend the break days 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 can also stop taking the pill on any day of your cycle and start with Ringo immediately.

Start using Ringo as late as the day after the break without a patch. Do not extend the break days without a patch beyond what is recommended.

If you have used the patch correctly and continuously and are sure you are not pregnant, you can also stop the patch on any day and start with Ringo immediately.

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

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

If you have just given birth, your doctor may advise you to wait until your first normal menstrual period before starting with Ringo. Sometimes it is possible to start earlier, your doctor will advise you how to do it. If you are breastfeeding and want to use Ringo, consult your doctor first.

Consult your doctor.

3.4 What to do if...

Your ring is expelled accidentally from the vagina

Ringo can be expelled accidentally from the vagina, for example, if it was not inserted correctly, when removing a tampon, during sexual intercourse, if you have constipation, or if you have uterine prolapse (uterine descent). Therefore, you should check regularly if the ring is in your vagina (for example, before and after sexual intercourse).

Your ring has been out of the vagina temporarily

Ringo may still protect you from pregnancy, but this will depend on how long it has been out of your 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 cold or lukewarm water (do not use hot water) and put the ring back in the vagina as soon as possible but only if the ring has been out of the vagina for less than 3 hours.
• more than 3 hours in 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 put the ring back in the vagina 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 those 7 days. If you are in the first week and have had sexual intercourse in the 7 days prior, there is a possibility that you may be pregnant. In that case, consult your doctor.
• more than 3 hours in the 3rd week, it may not protect you from pregnancy. Remove the ring and choose one of the two options below:

1. Put in a new ring immediately.

By putting in a new ring, you will start a new 3-week cycle of use. You may not have a period. However, you may experience intermenstrual bleeding or spotting during that cycle.

2. Do not put in a new ring. Let the intermenstrual bleeding pass and put in 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 consecutively for the 7 days prior.

• for an unknown period, it may not protect you from pregnancy. Perform a pregnancy test and consult your doctor before putting in a new ring.

The ring has opened

In rare cases, the Ringo ring may open. Vaginal injury associated with ring rupture has been reported. If you notice that Ringo has opened, remove the ring and put in a new one as soon as possible. Take additional contraceptive precautions (such as a male condom) for the next 7 days. If you had sexual intercourse before noticing that the ring had opened, consult your doctor.

More than one ring has been put in

No serious injuries have been reported due to Ringo hormone overdose. If you accidentally put in 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 can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to put in a new ring after the break without a ring

Your break without a ring has lastedmore than 7 days. Put in a new ring in the vagina as soon as you remember. Take additional contraceptive measures (such as a male condom) if you have sexual intercourse during the next 7 days.If you have had sexual intercourse during this break without a ring, there is a possibility that you may be pregnant. In that case, inform your doctor immediately.The longer the break without a ring, the higher the risk of pregnancy.

If you have forgotten to remove the ring

• If the ring has been in the vagina for 3-4 weeks, it will still protect you from pregnancy. Leave the break without a ring and then put in a new ring.
• If the ring has been in the vagina formore than 4 weeks, there is a possibility that you may be pregnant. Contact your doctor before starting with a new ring.

If your period or menstrual period does not appear

If your period does not appear, but you have used Ringo as instructed and have not taken any other medications, it is very unlikely that you are pregnant. Continue using Ringo as usual. However, if you have two consecutive missed periods, you may be pregnant, so inform your doctor immediately. Do not put in the next Ringo until your doctor has confirmed that you are not pregnant.

If your menstrual period does not appear during the break without a ring and you have deviated from the recommended regimen, there is a possibility that you may be pregnant, so you should contact your doctor before putting in a new ring.

If you have unexpected vaginal bleeding

During the use of Ringo, some women may experience unexpected vaginal bleeding between their menstrual periods. You may need sanitary protection. However, continue using the ring as usual, do not remove it. If the bleeding continues, becomes heavier, or starts again, consult your doctor.

If you want to change the day your period or menstrual period starts

If you use Ringo as instructed, your menstrual period will start during the break without a ring. If you want to change the day it starts, you need to shorten (never extend!) the break without a ring.

For example, if your period usually starts on a Friday, you can change it to a Tuesday, i.e., 3 days earlier from the next month. Simply put in the next ring 3 days earlier than usual.

If the break is made very short (for example, 3 days or less), you may not have your usual period. You may experience spotting (drops or spots of blood) or intermenstrual bleeding during the use of the next ring.

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

If you want to delay your period or menstrual period

Although this is not the recommended regimen, you can delay your period (menstrual bleeding) by putting in a new ring immediately after removing the current ring, without leaving the break between rings. You can leave the new ring in for up to 3 weeks. During the use of the new ring, you may experience spotting (drops or spots of blood) or irregular bleeding. When you want your period to start, simply remove the ring. Leave the usual break without a ring and put in a new ring.

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

3.5 If you want to stop using Ringo

You can stop using Ringo at any time you want. If you do not want to get pregnant, consult your doctor about other contraceptive methods.

If you stop using Ringo because you want to get pregnant, it is recommended to wait until you have had your first normal menstrual period before trying to conceive. This will help you calculate the due date.

Like all medicines, Ringo can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Ringo, consult your doctor.

All women taking combined hormonal contraceptives are at a higher 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 of 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, along with difficulty breathing. If this occurs, remove Ringo and contact your doctor immediately.

Users of Ringo have reported the following side effects:

Frequent:can affect up to 1 in 10 women.

Infrequent:can affect up to 1 in 100 women.

• changes in menstrual period (more intense, longer, irregular, or absent), pelvic discomfort, premenstrual syndrome, uterine cramps
• vaginal infection (by fungi or bacteria), burning, odor, pain, discomfort, or dryness of the vagina or vulva
• hair loss, eczema, itching, rash, or hot flashes
• urticaria

• harmful blood clots in a vein or artery, for example:

• melasma (yellow-brown patches on the skin, particularly on the face)
• discomfort in the penis of the partner (irritation, rash, itching)
• inability to remove the ring without medical assistance (e.g., due to itsadherenceto the vaginal wall)
• vaginal injury associated with ring rupture.