Label: information for the user

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

etonogestrel/etinilestradiol

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 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 Circlet, because 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 do not appear in this label. See section 4.

Circlet 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. Circlet 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 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”).

In this leaflet, various situations are described 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 not use the rhythm or temperature method. These methods may not be reliable because Circlet alters the monthly body temperature changes and cervical mucus.

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

2.1 When not to 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 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 an operation 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 conditions 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 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 tumor in the liver.
• If you have, have had or may have breast cancer or cancer of the reproductive organs.
• If you have unexplained vaginal bleeding.
• If you are allergic to ethinylestradiol or etonogestrel, or to any of the other components of this medicine (including those 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. Meanwhile, use non-hormonal contraceptive measures.

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

2.2 Warnings and precautions

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

Inform your doctor if the condition develops or worsens while you are using Circlet.

• If any of your close relatives have had or have 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 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 disorder of blood clotting 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 pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you are at increased risk of blood clots after childbirth. Ask your doctor when you can start using Circlet again 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 for the first time 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 disease that causes involuntary movements]).
• 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 containing oestrogens can provoke or worsen the symptoms of hereditary and acquired angioedema.
• If you have or have had melasma (brownish-yellow patches on the skin, called “pregnancy patches”, particularly on the face); if this is the case, avoid excessive exposure to the sun or ultraviolet rays.
• If you have conditions that make it difficult to use Circlet, for example if you have constipation, uterine prolapse (uterine or cervical descent) or experience pain during sexual intercourse.
• If you have a sudden urge to urinate, frequent urination, burning and/or painful urination, and cannot locate the ring in the vagina. These symptoms may indicate that the ring has been accidentally placed in the urinary bladder.

BLOOD CLOTS

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

Blood clots can form:

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

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 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 veins (venous thromboembolism). However, these side 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 may 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 in which you start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medicine or a different medicine) 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 Circlet, 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 Circlet is small.

• Of every 10,000 women who are not using a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women using 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 using a combined hormonal contraceptive containing 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

Your 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 (BMI) of 30 kg/m2 or more).
• 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 about 50 years). In this case, you may have an inherited disorder of blood clotting.
• If you need an operation or spend a lot of time without standing up due to an injury or illness or if you have your leg in a plaster cast. You may need to stop using Circlet for several weeks before the operation or while you have less mobility. If you need to stop using Circlet, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years).
• Ifyou have given birth recently.

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

Long-haul flights (over 4 hours) may temporarily increase your 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 above, even if you are unsure. Your doctor may decide that you should stop using Circlet.

If any of the conditions above change while you are using Circlet, 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 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 (over about 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, 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 about 50 years). In this case, you may also be at increased risk of 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, 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, your risk of a blood clot may be increased even further.

If any of the conditions above change while you are using Circlet, for example, you start smoking, a close relative experiences a blood clot without a 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 administration of vaginal hormones (such as Circlet).

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 lump. Inform your doctor if any of your close relatives have had or have 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 the combined pill. Contact your doctor if you have severe and unusual abdominal pain.

In women using the combined pill, cancer of the endometrium (the lining of the uterus) or ovaries has been observed 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 may induce suicidal thoughts. If you experience mood changes and depressive symptoms, consult your doctor for additional medical advice as soon as possible.

2.3 Children and adolescents

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

2.4 Other medicines and Circlet

Always inform your doctor about any medicines or herbal remedies you are taking. Also inform any doctor, dentist (or pharmacist) who prescribes another medicine that you are using Circlet. They will be able to inform you if you need to take additional contraceptive measures (e.g. use of male condoms) and, if necessary, for how long, or if you need to modify the use of the other medicine.

Some medicines:

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

These include medicines used to treat:

If you are taking medicines or herbal remedies that may make Circlet less effective, you should also use a barrier contraceptive method (e.g. a male condom). Since the effect of another medicine on Circlet may last for up to 28 days after stopping the medicine, you will need to use a barrier contraceptive method for that time. Note: Do not use Circlet with a diaphragm, cervical cap or female condom.

Circlet may affect the effect of other medicines, for example:

-medicines containing ciclosporin

-the antiepileptic lamotrigine (this may lead to an increase in the frequency of seizures).

Do not useCircletif you have hepatitis C and are taking medicines that contain

ombitasvir/paritaprevir/ritonavir and dasabuviror glecaprevir/pibrentasvir, there may be increases in liver test results (elevated ALT levels).

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

medicines.

Circletcan be used again approximately 2 weeks after the end of this treatment. See section2.1“When not to use Circlet”.

Consult your doctor or pharmacist before taking any medicine.

You can use tampons while using Circlet. First, put on Circlet and then the tampon. Be particularly careful when removing the tampon so that the ring is not accidentally expelled. If it is expelled, simply wash the ring with cold or lukewarm water and put it back on immediately.

The ring can open when you are also 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 Circlet as a contraceptive.

Laboratory tests

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

2.5 Pregnancy and breastfeeding

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

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

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

2.6 Driving and operating machinery

Circlet is unlikely to affect your ability to drive or operate machinery.

You can put and take Circlet 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 Circlet is in your vagina (for example, before and after sexual intercourse) to make sure you are protected against pregnancy. After the third week, remove Circlet and let a week of rest pass. You will usually have your menstrual period or period during this pause without a ring.After the third week, remove Circlet and let a week of rest pass. You will usually have your menstrual period or period during this pause without a ring.

While using Circlet, do 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 Circlet 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 on and take off 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 taking off 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 package.

1. Hold the ring between your index and middle fingers, press the opposite sides, and insert the ring into the vagina (see figures 1-4).Alternatively, you can use the NuvaRing Applicator (not included with the Circlet package) to help you insert the ring. The NuvaRing Applicator 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 the 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 cannot remove the ring despite having located it, contact your doctor.
3. Dispose of the used ring in the regular household trash, preferably in its package. 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 you put it on for 3 consecutive weeks, uninterrupted.
2. After 3 weeks, remove the ring on the same day of the week that you put it 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 experience a vaginal bleeding. Normally, it starts 2-3 days after removing the Circlet.
2. Put 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 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 break without a ring."

If you use Circlet as described above, your menstrual period 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 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 any other contraceptive measures.

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

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

Start using Circlet as late as the day after the break with your current pill. If the package of your pill also contains inactive pills, start Circlet 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 stop taking the pill on any day of your cycle and start with Circlet immediately.

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

Start using Circlet 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 stop using the patch on any day and start with Circlet 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 Circlet the next day at the same time. However, make sure to use a complementary 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 Circlet at the time 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 menstrual period 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, consult your doctor first.

• After an abortion

Consult your doctor.

3.4 What to do if...

Your ring is accidentally expelled from the vagina

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

Your ring has been out of the vagina temporarily

Circlet may still protect you against 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 against 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 against 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 against pregnancy. Remove the ring and choose one of the two options below:

1. Put a new ring immediately.

When you put a new ring, you will start a new 3-week cycle of use. You may not experience your period. However, you may experience intermenstrual bleeding or spotting during that cycle.

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

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

The ring has opened

In very rare cases, the Circlet ring may open. Uterine injury associated with ring rupture has been reported. If you notice that Circlet has opened, remove the ring and put a new one as soon as possible. Take complementary 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.

You have put more than one ring

No serious damage has been reported due to Circlet hormone overdose. If you have accidentally put more than one ring, you may feel unwell (nausea), vomit, or experience vaginal bleeding. Remove the extra ring and contact your doctor if these symptoms do not subside.

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 a new ring after the break without a ring

Yourbreak without a ringhas lastedmore than 7 days. Put 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 against pregnancy. Let the week without a ring pass and then put a new one.
• If the ring has been in the vagina formore than 4 weeks, there is a possibility of pregnancy. Contact your doctor before starting with a new ring.

If your period or menstrual period does not appear

• You have used Circlet as instructed.

If your period does not appear, but you have used Circlet as instructed and have not taken any 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 the next Circlet until your doctor has confirmed that you are not pregnant.

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

If your menstrual period does not appear during the week 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 a new ring.

If you experience unexpected vaginal bleeding

During the use of Circlet, 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 when your period or menstrual period starts

If you use Circlet as instructed, your menstrual period (withdrawal bleeding) will start during the week without a ring. If you want to change the day when your period starts, you must 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 the next ring 3 days earlier than usual.

If the break is made very short (for example, 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 menstrual period

Although this is not the recommended regimen, you can delay your period (withdrawal bleeding) by putting a new ring immediately after removing the current ring, without leaving the break 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. Let the usual break of 1 week without a ring pass and then put 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 normal menstrual period before trying to conceive. This will help you calculate the due date.

Like all medicines, Circlet may 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 Circlet, 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 Circlet”.

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

Users of Circlet 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

Infrequent:may affect up to 1 in 100 women.

• vision changes, 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, pain, or urgency while urinating; frequent need to urinate
• sexual problems such as pain, bleeding, or the partner noticing the ring
• increased blood pressure
• increased appetite
• back pain, muscle cramps, leg or arm pain
• reduced 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 (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

Rare:may affect up to 1 in 1,000 women.

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

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)
• discomfort in the penis of the partner (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 rupture.

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

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

Reporting of 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 medication.

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

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

Store below 86°F. 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 dispensation date is shown on the box and on each packet.

Do not use Circlet after the expiration date that appears on the box and on each packet.

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

Dispose of the used ring with household waste, preferably in its sealed packet. Circlet should not be flushed down the toilet. Like other medications, do not dispose of unused or expired rings through the drains or trash.

Medications should not be disposed of through the drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Circlet

• The active principles are etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• The other components are: a copolymer of vinyl acetate and ethylene (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 proportion of 0.120 mg/day and 0.015 mg/day respectively, over three weeks.

Appearance of the product and contents of the packaging

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

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible manufacturer:

N.V. Organon

Kloosterstraat 6,

5349 AB Oss

Netherlands

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

Circlet

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

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

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

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