CIRCLET 0.120 mg/0.015 mg EVERY 24 HOURS, VAGINAL DELIVERY SYSTEM

Introduction

Package Leaflet: Information for the User

Circlet 0.120 mg/0.015 mg every 24 hours, vaginal release system

etonogestrel/ethinylestradiol

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

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting the 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 the entire package leaflet carefully before starting to use Circlet, as it contains important information for you.

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

Contents of the Package Leaflet

1. What Circlet is and what it is used for
2. What you need to know before you start using Circlet
3. How to use Circlet
4. Possible side effects
5. Storing Circlet
6. Package contents and additional information

1. What Circlet is and what it is used for

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

2. What you need to know before using Circlet

General considerations

Before starting to use Circlet, 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 prospectus describes various situations in which you should stop using Circlet, or in which Circlet 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 notuse the rhythm method or the temperature method. These methods may not be reliable since Circlet alters the monthly temperature changes of the body and cervical mucus.

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

2.1 When you should not use Circlet

You should not use Circlet 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 blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know 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 an operation or if you spend a lot of time without getting 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 stroke symptoms).
• If you have any of the following diseases 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 fat in your blood.
• If you have or have had a severe liver disease and your liver is not functioning normally.
• If you have or have had a benign or malignant tumor in the liver.
• If you have, have had, or could have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding of unknown origin.
• If you are allergic to ethinylestradiol or etonogestrel, or to any of the other components of this medicine (listed in section 6).

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

Do not use Circlet if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section 2.4. "Other medicines and Circlet").

2.2 Warnings and precautions

Tell your doctor if you suffer from any of the following conditions.

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

• If a close relative has or has had breast cancer.
• If you suffer from epilepsy (see section 2.4. "Other medicines and Circlet").
• If you have a 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 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 hereditary disease 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 developing pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of developing blood clots. You should ask your doctor when you can start taking Circlet after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you suffer from any disease that first appeared or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disease], pregnancy herpes [skin rash with blisters during pregnancy], or Sydenham's chorea [a nervous system disease in which involuntary movements are produced]).
• If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or urticaria possibly with difficulty breathing, contact your doctor immediately. Medicines that contain estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.
• If you have or have had chloasma (yellowish-brown spots on the skin, called "pregnancy spots", especially on the face); if this is the case, avoid excessive exposure to the sun or ultraviolet rays.
• If you have disorders that make it difficult to use Circlet, for example, if you suffer from constipation, uterine prolapse (descent of the uterus or cervix) or feel pain during sexual intercourse.
• If you have urgent, frequent, burning, and/or painful urination, and you cannot locate the ring in the vagina. These symptoms may indicate accidental placement of Circlet in the urinary bladder.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Circlet 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 the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention 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 the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can 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 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 also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption 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 Circlet, your risk of a blood clot returns to normal within 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 Circlet is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains norelgestromin or etonogestrel, such as Circlet, 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 a blood clot with Circlet is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 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 (i.e., before the age of 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or spend a lot of time without getting up due to an injury or illness, or if you have your leg in a cast. You may need to stop using Circlet several weeks before surgery or while you have reduced mobility. If you need to stop using Circlet, ask your doctor when you can start using it again.
• As you get older (especially above 35 years).
• If you have recently given birth.

The risk of a blood clot increases with the number of conditions you have.

Long-haul flights (more than 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 above conditions, even if you are not sure. Your doctor may decide that you should stop using Circlet.

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

• With age (above 35 years).
• If you smoke.When using a combined hormonal contraceptive like Circlet, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If 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 suffer from migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using Circlet, 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 has been obtained from studies with combined oral contraceptives and may be applicable to Circlet. There is no information available on the vaginal administration of contraceptive hormones (such as Circlet).

Cases of breast tumors have been observed with a slightly higher frequency in women using oral contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are found in women using oral contraceptives because they undergo 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 close relative has or has 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 have severe and unusual abdominal pain.

In users of combined oral contraceptives, it has been observed that endometrial cancer (the tissue that lines the uterus) or ovarian cancer occurs less frequently. This may also be the case with Circlet, but it has not been confirmed.

Psychiatric disorders

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

2.3 N

3. How to use Circlet

You can put on and remove Circlet yourself. Your doctor will indicate 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. Regularly check that Circlet is in your vagina (for example, before and after sexual intercourse) to ensure that you are protected against pregnancy. After the third week, remove Circlet and take a week off. You will normally have your menstrual period or rule during this ring-free break.

While using Circlet, 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 reinforcement of birth control, as Circlet may interfere with the correct placement and positioning 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 on and remove the Circlet

1. Before putting on the ring, check that it is not expired (see section 5 "Storage of Circlet").
2. Wash your hands before putting on or removing the ring.
3. Choose the position that is most comfortable for you to insert it, for example standing with one leg raised, squatting, or lying down.

1. Remove Circlet from its packaging.

1. Hold the ring between your index and thumb fingers, press the opposite sides, and insert the ring into the vagina (see figures 1-4). Alternatively, you can choose to use the NuvaRing Aplicator (not included with the Circlet packaging) to help you insert the ring. The NuvaRing Aplicator may not be available in all countries. When Circlet is in place, you should not feel anything. If you feel uncomfortable, gently change the position of Circlet (for example, push the ring a little further into the vagina) until you feel comfortable. The exact position of the ring inside the vagina is not important.
2. After 3 weeks, remove Circlet 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 are unable to remove the ring despite having located it, contact your doctor.
3. Dispose of the used ring with normal household waste, preferably in its packaging. Do not flush Circlet down the toilet.

3.2 Three weeks in, one week out

1. The vaginal ring must remain in the vagina from the day it is put on for 3 consecutive weeks, without interruption.
2. After 3 weeks, remove the ring on the same day of the week that it was put on and at approximately the same time. For example, if you put it on a Wednesday at approximately 10:00 PM, you should remove it 3 weeks later, on Wednesday, at approximately 10:00 PM.

1. Once you have removed the ring, do not use it for a week. During this week, you should have vaginal bleeding. It usually starts 2-3 days after removing Circlet.
2. Put on a new ring exactly after the 1-week break (again on the same day of the week and at approximately the same time), even if you have not stopped bleeding.

If you put on the new ring more than 3 hours late, the contraceptive efficacy may be reduced. Follow the instructions in section 3.4 "What to do if you forget to put on a new ring after the ring-free break".

If you use Circlet as described above, your bleeding will take place approximately on the same days each month.

3.3 When to start with the first ring

• If you have not usedhormonal contraceptionin the previous month

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

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

• If you were using acombined pillin the previous month

Start using Circlet as soon as the day after the break with your current pill. If the packaging of your pill also contains inactive tablets, start Circlet as soon as the day after the last inactive tablet. If you are not sure which tablet is which, consult your doctor or pharmacist. Never extend the break days of your current pill beyond what is recommended.

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

• If you were using atransdermal patchin the previous month

Start using Circlet as soon as the day after the patch-free break. Never extend the patch-free break days beyond what is recommended.

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

• If you were using aprogestogen-only pillin the previous month

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

• If you were using aninjectable, an implant, or an Intrauterine System (IUS) with hormonal load (progestogen)in the previous month

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

• After childbirth

If you have just given birth, your doctor may advise you to wait until your first normal period appears before starting with Circlet. 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 Circlet, you should consult your doctor first.

• After an abortion

Consult your doctor.

3.4 What to do if...

The ring is accidentally expelled from the vagina

Circlet can be accidentally expelled from the vagina, for example, if it is 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 regularly check if the ring is in your vagina (for example, before and after sexual intercourse).

The ring has been out of the vagina temporarily

Circlet 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. You should wash the ring with cold or warm 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. You should wash the ring with cold or warm 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 previous 7 days, there is a possibility that you may be pregnant. In this case, consult your doctor.
• more than 3 hours in the 3rd week, it may not protect you from pregnancy. You should remove the ring and choose one of the following two options:

1. Put on a new ring immediately.

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

1. Do not put on a new ring. Wait for the intermenstrual bleeding and put on 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 Circlet continuously for the previous 7 days.

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

The ring opens

In rare cases, the Circlet ring can open. Vaginal injury associated with ring breakage has been reported. If you notice that Circlet has opened, remove the ring and put on a new one as soon as possible. Take complementary contraceptive precautions (for example, a male condom) for the following 7 days. If you have had sexual intercourse before noticing that the ring had opened, consult your doctor.

More than one ring is inserted

There are no reports of serious harm due to overdose of Circlet hormones. If you accidentally insert 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 disappear.

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 on a new ring after the ring-free break

Your ring-free breakhas lasted more than 7 days. Put on 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 following 7 days. If you have had sexual intercourse during this ring-free break, there is a possibility that you may have become pregnant. In this case, inform your doctor immediately. The longer the ring-free break, the higher the risk of pregnancy.

If you forget to remove the ring

• If the ring has been in the vagina for 3 to 4 weeks, it will still protect you from pregnancy. Wait for the week without the ring and then put on a new one.
• If the ring has been in the vagina for more than 4 weeks, there is a possibility of pregnancy. Contact your doctor before starting with a new ring.

If your period or rule does not appear

• You have used Circlet according to the instructions.

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

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

If your usual bleeding does not occur during the 1-week break without the 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 on a new ring.

If you have unexpected bleeding

In some women, during the use of Circlet, unexpected vaginal bleeding may appear between menstrual periods. You may need hygienic protection. However, continue to use 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 rule starts

If you use Circlet according to the instructions, your menstrual period (withdrawal bleeding) will start during the week without the ring. If you want to change the day it starts, you must shorten (never lengthen!) the ring-free break.

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

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

If you are not sure how to do it, consult your doctor.

If you want to delay your period or rule

Although it is not the recommended regimen, you can delay your period (withdrawal bleeding) by putting on a new ring immediately after removing the current ring, without taking the break between rings. You can leave the new ring in place 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. Take the normal 1-week break without the ring and then put on a new ring.

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

3.5 If you want to stop using Circlet

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

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

4. Possible Adverse Effects

Like all medicines, Circlet can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Circlet, consult your doctor.

All women who take 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 you start using Circlet".

If you are allergic to any of the components of Circlet (hypersensitivity), you may have the following symptoms (frequency not known): angioedema and/or anaphylaxis [swelling of the face, lips, tongue, and/or throat and/or difficulty swallowing] or urticaria, possibly with difficulty breathing. If this occurs, remove Circlet and contact your doctor immediately (see also section 2.2 "Warnings and precautions").

Users of Circlet 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 candidiasis), vaginal discomfort due to the ring, genital itching, vaginal discharge
• headache or migraine, depressive mood, decreased sexual desire
• breast pain, pelvic pain, painful menstruation
• acne
• weight gain
• expulsion of the ring

Infrequent:may affect up to 1 in 100 women.

• vision changes, dizziness
• bloating, vomiting, diarrhea, or constipation
• feeling tired, irritable, or moody, mood changes, changes in mood
• fluid retention in the body (edema)
• urinary tract infection or bladder infection
• difficulty, pain when urinating; urgency to urinate. Need to urinate more frequently
• sexual intercourse problems such as pain, bleeding, or 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 (breast lumps that can become swollen or painful)
• cervical inflammation, polyps growing on the cervix, displacement of tissue from the inside of the cervix to the outside (ectropion)
• changes in menstrual period (heavier, 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 flushing
• 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
• mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys, or eye

The chances 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 the available data).

• chloasma (yellowish-brown spots on the skin, particularly on the face)
• discomfort in the partner's penis (irritation, rash, itching)
• inability to remove the ring without medical assistance (e.g., due to its adherence to the vaginal wall)
• vaginal injury associated with ring breakage.

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

In very rare cases, the Circlet 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Circlet

Keep this medicine out of sight and reach of children.

If you discover that a child has been exposed to the hormones of Circlet, ask your doctor for advice.

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

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

Do not use Circlet after the expiration date shown on the box and on each pouch.

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

Dispose of the used ring with household waste, preferably inside its pouch with a closure. Circlet should not be flushed down the toilet. Like other medicines, do not throw unused or expired rings down the drain or in the trash.

Medicines should not be thrown down the drain or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Circlet

• The active ingredients are etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• The other components are: vinyl acetate and 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 in a ratio of 0.120 mg/day and 0.015 mg/day, respectively, for three weeks.

Appearance of the Product and Package Contents

Circlet is a flexible, transparent, and almost colorless ring, measuring 54 mm in width.

Each ring is packaged in a laminated aluminum pouch that can be reclosed. The pouch is presented in a cardboard box along with this leaflet. Each box contains 1 or 3 rings.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

N.V. Organon

Kloosterstraat 6,

5349 AB Oss

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following name:

Circlet

0.120 mg/0.015 mg every 24 hours, vaginal release system

Germany, Belgium, Spain, Slovakia, Hungary, Luxembourg, Netherlands, Poland, Portugal.

Date of the last revision of this leaflet:September 2022.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)