Patient Information: Package Insert

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

etonogestrel/etinilestradiol

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 4-week or longer pause.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

Read this package insert carefully before starting to use this medication, as it contains important information for you.

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

Your medication is referred to by its full name, but throughout this package insert, it will be referred to as Setlona.

1. What is Setlona and how is it used

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

2.1 When not to use Setlona

2.2 Warnings and precautions

Blood Clots

Cancer

2.3 Children and adolescents

2.4 Other medications and Setlona

Laboratory tests

2.5 Pregnancy and breastfeeding

2.6 Driving and operating machinery

3. How to use Setlona

3.1 How to put on and take off Setlona

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 breaks

More than one ring has been put in

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

You forget to take out the ring

You do not get your period or menstruation

You experience unexpected bleeding

You want to change the day your period or menstruation starts

You want to delay your period or menstruation

3.5 If you want to stop using Setlona

4. Possible side effects

5. Storage of Setlona

6. Contents of the package and additional information

Composition of Setlona

Appearance of Setlona and contents of the package

Marketing authorization holder and manufacturer

Setlona 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, Setlona is a low-dose hormonal contraceptive. As Setlona releases two different types of hormones, it is a combined hormonal contraceptive.

Setlona 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. Setlona 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 Setlona, 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”).

In this prospectus, various situations are described in which you should stop using Setlona, or in which Setlona 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 temperature method. These methods may not be reliable since Setlona alters the body's monthly temperature changes and cervical mucus.Nouse the rhythm or temperature method. These methods may not be reliable since Setlona alters the body's monthly temperature changes and cervical mucus.

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

2.1 When Not to Use Setlona

You should not use Setlona 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.

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

• If you know that you have a disorder that affects 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 spend a lot of time without standing up (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 that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).

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

- 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 ever had) pancreatitis (inflammation of the pancreas) associated with high levels of fat in your blood.

• If you have (or have ever had) a severe liver disease and your liver is not functioning normally.

• If you have (or have ever had) a benign or malignant tumor in the liver.

• If you have (or have ever had), or could have, breast cancer or cancer of the reproductive organs.

• If you have any 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 Setlona, remove the ring immediately and consult your doctor. Meanwhile, use non-hormonal contraceptive measures.

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

2.2 Advertencias and Precautions

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

Consult your doctor or pharmacist before using Setlona.

If the condition develops or worsens while using Setlona, you should also inform your doctor.

• If any of your immediate family members have had or have cancer of the breast.

• If you suffer from epilepsy (see section 2.4. “Other Medications and Setlona”).

• If you have a liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones).

• If you have inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis);

• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).

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

• If you have sickle cell anemia (a genetic disorder of red blood cells).

• 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 need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).

• If you recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Setlona after childbirth.

• If you have superficial thrombophlebitis (inflammation of the veins under the skin);

• If you have varicose veins.

• If you have a disease that appeared or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes of pregnancy [skin rash with blisters during pregnancy], or Sydenham's chorea [a nervous disorder with involuntary movements];

• If you experience symptoms of angioedema, such as facial swelling, tongue, or throat swelling, or difficulty swallowing, or urticaria with possible difficulty breathing, see your doctor immediately. The medications containing estrogens in Setlona can cause or worsen symptoms of hereditary or acquired angioedema.

• If you have or have had melasma (brownish-yellow skin patches, particularly on the face); if so, avoid excessive sun exposure or ultraviolet light.

• If you have conditions that make it difficult to use Setlona, for example, if you have constipation, uterine prolapse, or experience pain during sexual intercourse.

• If you have a sudden urge to urinate, frequent urination, burning, or painful urination, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of Setlona in the urinary bladder.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Setlona increases your risk of developing 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 harmful blood clot due to Setlona is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek emergency medical assistance if 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?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of 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 breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.

• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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 taking a combined hormonal contraceptive for the first time. The risk may 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 is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop using Setlona, 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 global risk of a blood clot in the leg or lung (DVT or PE) with Setlona is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 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, 5-7 will develop a blood clot in a year.

• Of every 10,000 women who use a combined hormonal contraceptive containing norelgestromina or etonogestrel, like Setlona, 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 Setlona is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).

• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (e.g., before the age of 50). In this case, you may have an inherited blood clotting disorder.

• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop using Setlona for several weeks before surgery or while you have limited mobility. If you need to stop using Setlona, ask your doctor when you can start using it again.

• As you age (especially over 35 years).

• If you have given birth recently.

The risk of a blood clot 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 have any of the conditions above, even if you are unsure. Your doctor may decide to stop using Setlona.

If any of the conditions above change while you are using Setlona, 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, it may cause 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 Setlona is very small, but it may increase:

• With age (over 35 years).

•If you smoke. When using a combined hormonal contraceptive like Setlona, you are advised to quit smoking. If you cannot quit 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 any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.

• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).

• If you have migraines, especially migraines with aura.

• If you have a heart problem (valve disorder, rhythm disorder called atrial fibrillation).

• If you have diabetes.

If you have more than one 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 above change while you are using Setlona, 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 Setlona. There is no information available on the administration of vaginal hormones (like Setlona).

Cases of breast tumors 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 lump. Inform your doctor if any of your close relatives have had or have breast cancer (see section 2.2 “Advertencias and Precautions”).

Rare cases of benign liver tumors and fewer cases of malignant liver tumors have been reported in women using the oral contraceptive. Contact your doctor if you have severe and unusual abdominal pain.

In users of the combined oral contraceptive, cancer of the endometrium (the lining of the uterus) and ovaries has been observed to occur less frequently. This may also be the case with Setlona, but it has not been confirmed.

Mental Health Disorders:

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

2.3 Children and Adolescents

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

2.4 Other Medications and Setlona

Always inform your doctor about any medications or herbal supplements you are taking. Also, inform any doctor, dentist, or pharmacist (or pharmacist) that you are using Setlona. They can advise you if you need to take additional contraceptive measures (e.g., 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 Setlona in the blood.

–may make itless effective in preventing pregnancy.

– may cause unexpected bleeding.

These include medications used to treat:

• Seizures (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate).
• Tuberculosis (e.g., rifampicin).
• HIV infection (e.g., ritonavir, nelfinavir, nevirapina, efavirenz).
• Hepatitis C infection (e.g., boceprevir, telaprevir).
• Other infectious diseases (e.g., griseofulvina).
• Pulmonary hypertension (bosentan).
• Mood disorders (the herbal supplement St. John's Wort (Hypericum perforatum)).

If you are taking medications or herbal supplements that may make Setlona less effective, you should also use a barrier contraceptive method. Since the effect of another medication on Setlona may last up to 28 days after stopping the medication, you will need to use a barrier contraceptive method for that time.

Note: do not use Setlona with a diaphragm, cervical cap, or female condom.

Setlonamay affect the effect of other medications, for example:

-medications containing ciclosporin.

-the antiepileptic lamotrigine (this could lead to an increase in seizure frequency).

You should not use Setlona if you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicationsmay cause increases in liver test results (elevated ALT levels).

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

You can restart using Setlona approximately 2 weeks after completing this treatment. See section 2.1 “When Not to Use Setlona”.

Consult your doctor or pharmacist before taking any medication.

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

The use of spermicides or vaginal yeast products does not reduce the effectiveness of Setlona as a contraceptive.

Laboratory Tests

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

2.5 Pregnancy and Breastfeeding

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

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

Generally, it is not recommended to use Setlona during breastfeeding. If you want to use Setlona while breastfeeding, consult your doctor.

2.6 Driving and Operating Machinery

It is unlikely that Setlona will affect your ability to drive or operate machinery.

You can put and take Setlona 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 remain in the vagina for 3 consecutive weeks. Check regularly if Setlona is still in your vagina (for example, before and after having sex) to ensure you are protected against pregnancy. After the third week, remove Setlona and leave a week of rest. You will usually have your period or menstruation during this pause without a ring.

While using Setlona, 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, as Setlona 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 and take Setlona

1. Before putting on the ring, check that it is not expired (see section 5 "Storage of Setlona").

2. Wash your hands before putting on or taking off 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 Setlona from its package. Save the package for later use.

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).

When Setlona is in place, you should not feel anything. If you feel uncomfortable, gently push Setlona into the vagina. The exact position of the ring inside the vagina is not important.

6. After 3 weeks, remove Setlona from the vagina. You can do this by hooking the ring with your index finger or holding it with your fingers and stretching it out (see figure 5). If you cannot remove the ring despite locating it, contact your doctor.

7. Dispose of the used ring in the household trash, preferably in its package. Do not flush Setlona down the toilet.

Figure 1

Remove Setlona from its package.

Figure 2

Press the ring.

Figure 3

Choose a comfortable position to put on the ring.

Figure 4AFigure 4BFigure 4C

Put the ring in the vagina with one hand (Figure 4A), if necessary, separate the vaginal lips with the other hand. Push the ring into the vagina until you feel comfortable (Figure 4B). Leave the ring in the vagina for 3 weeks (Figure 4C).

Figure 5:

Setlona can be removed by hooking the ring with your index finger or holding it with your index and middle fingers and stretching it out.

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 and at the same time as you put it in. For example, if you put Setlona on a Wednesday around 22:00, remove it 3 weeks later on a Wednesday around 22:00.

3. Once you have removed the ring, do not use it for a week. During this week, you should experience vaginal bleeding. You will usually start bleeding 2-3 days after removing Setlona.

4. Put a new ring exactly 1 week after the pause (again on the same day of the week and approximately at the same time), even if you have not stopped bleeding yet.

If you put the 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 a new ring after the pause without a ring."

If you use Setlona as described above, your vaginal 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

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

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

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

Start using Setlona as late as the day after your current pill pause. If your pill package also contains placebo pills, start Setlona as late as the day after the last placebo pill. If you are unsure which pill is which, consult your doctor or pharmacist. Do not extend your pill pause 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 Setlona immediately.

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

Start using Setlona as late as the day after your patch-free pause. Do not extend your patch-free pause beyond what is recommended. If you have used the patch correctly and continuously, and are sure you are not pregnant, you can also stop using the patch on any day and start with Setlona immediately.

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

You can stop taking your progestin-only pill on any day and start Setlona the next day at the same time you normally would have taken your pill. 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 were using an injectable, an implant, or an Intrauterine System (IUS) with hormonal load (progestin) in the previous month

Start using Setlona at the time you would normally receive your next injection or the day your 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.

• After childbirth

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

• After an abortion

Consult your doctor.

3.4 What to do if...

Your ring is expelled accidentally from the vagina

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

If the ring has been expelled and more than 3 hours have passed, it may not protect you against pregnancy. See the recommendation in section 3.4 "What to do if... your ring has been temporarily outside the vagina."

Your ring has been temporarily outside the vagina

In the vagina, Setlona releases hormones slowly into the body to prevent pregnancy. If the ring has been outside the vagina for more than 3 hours, it may not protect you against pregnancy. Therefore, the ring cannot be outside the vagina for more than 3 hours in a 24-hour period.

• If the ring has been outside the vagina and less than 3 hours have passed, you are still protected against pregnancy. You should put the ring back in as soon as possible, always within 3 hours.

• If the ring has been outside the vagina or you suspect it has been outside the vagina for more than 3 hours in the 1st or 2nd week, you may not be protected against pregnancy. Put the ring back in as soon as you remember and leave it in the vagina for at least 7 consecutive days. Use a male condom if you have sex during those 7 days. If you are in the first week and had sex in the 7 days prior, there is a possibility you may be pregnant. In that case, consult your doctor.

• If the ring has been outside the vagina or you suspect it has been outside the vagina for more than 3 hours in the 3rd week, you may not be protected against pregnancy. You should remove the ring and choose one of the two options below:

1 - Put a new ring in immediately.

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

2 - Do not put a new ring in. Let your menstrual period pass and put a new ring in no later than 7 days from the time the previous ring was removed or expelled.

Choose this option only if you have used Setlona consecutively for the past 7 days.

• If Setlona has been outside the vagina for an unknown period, you may not be protected against pregnancy. Take a pregnancy test and consult your doctor before putting a new ring in.

The ring has broken

It is rare for the Setlona ring to break. Vaginal injury related to ring breakage has been reported. If you notice that Setlona has broken, remove the ring and put a new one in as soon as possible. Take additional contraceptive precautions (such as a male condom) for the next 7 days. If you had sex before noticing the ring had broken, consult your doctor.

More than one ring has been put in

No serious injuries have been reported due to Setlona overdose. If you accidentally put more than one ring in, you may feel unwell (nausea), vomit, or experience 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: 915 620 420, indicating the medication and the amount used.

If you forget to put a new ring after the pause without a ring

If your pause without a ring has lasted more than 7 days, put a new ring in the vagina as soon as you remember. Take additional contraceptive precautions (such as a male condom) if you have sex during the next 7 days.If you had sex during this pause without a ring, there is a possibility you may be pregnant.In that case, inform your doctor immediately. The longer the pause 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, you are still protected against pregnancy. Let your menstrual period pass and then put a new ring in.

• If the ring has been in the vagina for more than 4 weeks, there is a possibility you may be pregnant. Contact your doctor before starting a new ring.

If your period or menstruation does not appear

•You have used Setlona as instructed

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

•You have deviated from the recommended use of Setlona

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

If you experience unexpected bleeding

In some women, during the use of Setlona, unexpected vaginal bleeding may occur between 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 menstruation starts

If you use Setlona as instructed, your menstrual period (withdrawal bleeding) will start during the pause without a ring. If you want to change the day your period starts, you need to shorten (never extend!) the pause 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 the next ring 3 days earlier than usual.

If the pause is made very short (e.g., 3 days or less), you may not experience your usual menstrual 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 menstruation

Although this is not the recommended regimen, you can delay your menstrual period (withdrawal bleeding) by putting a new ring in immediately after removing the current ring, without leaving the pause between rings. You can leave the new ring in for a maximum of 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 pause without a ring and put a new ring in.

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

3.5 If you want to stop using Setlona

You can stop using Setlona at any time you want.

If you do not want to become pregnant, consult your doctor about other contraceptive methods.

If you stop using Setlona because you want 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 the due date.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe or persistent, or if you have any health changes that you think may be related to Setlona, 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 Setlona”.

If you notice any of the following side effects, you may need urgent medical attention. Stop using Setlona and contact your doctor immediately.

Contact your doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section “Warnings and precautions”)

Users of the ring containing etonogestrel/ethinylestradiol have reported the following side effects:

Frequent: may affect up to 1 in 10 women

• abdominal pain, discomfort (nausea)

• vaginal yeast infection (similar to oral candidiasis), vaginal discomfort due to the ring, genital itching, vaginal discharge

• headache or migraine, depressive mood, decreased libido

• breast pain, pelvic pain, painful menstruation

• acne

• weight gain

• expulsion of the ring

Rare: may affect up to 1 in 100 women

• vision disturbances, dizziness

• swollen abdomen, vomiting, diarrhea, or constipation

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

• fluid retention in the body (edema)

• urinary tract infection or bladder infection

• difficulty or pain urinating; urgency to urinate; need to urinate more frequently

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

• increased blood pressure

• increased appetite

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

• decreased skin sensitivity

• breast tension or pain, or increased size; fibrocystic breast disease (cysts in the breasts that may become swollen or painful)

• inflammation of the cervix, polyps that grow on the cervix, displacement of tissue from the inside of the cervix to the outside (ectropion)

• changes in menstrual period (e.g., heavier, longer, irregular, or disappearance of period), pelvic pain, 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.

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
• transient ischemic attack (TIA) or temporary symptoms similar to a stroke
• blood clots in the liver, stomach/intestine, kidneys, or eyes

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

• breast secretion

Frequency not known (cannot be estimated from available data)

• melasma (yellow-brown patches on the skin, particularly on the face)

• penile discomfort (irritation, rash, itching)

• inability to remove the ring without medical assistance (e.g., due to its adherence to the vaginal wall)

• vaginal injury related to the ring rupture.

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

In very rare cases, the ring may break. For more information, see section 3.4What to do if…The ring breaks.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

This medication should be used at least one month before the expiration date that appears

in the box and on each pack after CAD or EXP. The expiration date refers to the last day of the month indicated.

Do not use Setlona if you observe changes in the ring color or any visible sign of deterioration.

This medication may pose a risk to the environment. After removing it, you must place Setlona in the pack and close it properly..The disposal of the pack must be carried out with household waste or returned to the pharmacy for correct destruction in accordance with local regulations.

This medication should not be flushed down the toilet. Like other medications, do not dispose of unused or expired rings through the drain or trash.

Deposit the packaging and medications you no longer need at the SIGRE pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Setlona

• The active principles are etonogestrel and ethinylestradiol.

Setlona contains 11.0 mg of etonogestrel and 3.474 mg of ethinylestradiol. The ring releases etonogestrel and ethinylestradiol in a proportion of 0.120 mg and 0.015 mg, respectively, every 24 hours for three weeks.

• The other components are: vinyl acetate copolymer, 28% vinyl acetate, and polyurethane (a type of plastic that does not dissolve in the body).

Appearance of Setlona and contents of the package

Vaginal delivery system.

Setlona is a flexible, transparent, colorless to almost colorless ring with an outer diameter of 54 mm and a section diameter of 4 mm.

Each ring is packaged in an aluminum foil. The foil is presented in a cardboard box along with this leaflet and adhesive stickers to help you remember when to put on and take off the ring.

Each box contains:

1 ring.

3 rings.

6 rings.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 – Barcelona

Spain

Manufacturer responsible

Laboratorios León Farma S.A.

Navatejera Industrial Estate

C/La Vallina, s/n

24193 - Villaquilambre, León

Spain

This medicine is authorized in the member states of the European Economic Area with the following name:

Germany:SetLona 0.120 / 0.015 mg per 24 hours, vaginal delivery system

Austria:SetLona 0,120 mg/0,015 mg per 24 hours vaginal delivery system

Belgium:Ringafema 0,120 mg / 0,015 mg per 24 hours, vaginal delivery system

0,120 mg / 0,015 mg per 24 hours, vaginal delivery system

0,120 mg / 0,015 mg per 24 hours, vaginal delivery system

Slovenia:Setlona 0,120 mg / 0,015 mg per 24 hours, vaginal delivery system

Spain:Setlona 0,120 mg/0,015 mg per 24 hours, vaginal delivery system EFG

Estonia:Setlona

Finland:Vonamyl 0,120 mg / 0,015 mg per 24 hours, vaginal delivery system

France:ETONOGESTREL / ETHINYLESTRADIOL VIATRIS120 micrograms / 15 micrograms / 24 hours, vaginal delivery system

Island:Vonamyl 0,120 mg/0,015 mg/24 hours, vaginal delivery system

Italy:MYPRIMOSE

Lithuania:Ringafema 120 / 15 micrograms / 24 hours, vaginal delivery system

Luxembourg:Ringafema 0,120 mg / 0,015 mg per 24 hours, vaginal delivery system

Netherlands:Etonogestrel/Ethinylestradiol Viatris 0,120 mg/ 0,015 mg per 24 hours, vaginal delivery system

Portugal:Mystrelle

Sweden:Vonamyl 0,120 mg/0,015 mg per 24 hours, vaginal delivery system

Last review date of this leaflet:October 2022.

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/