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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

etonogestrel/ethinylestradiol

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

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read all of this leaflet carefully before you start using Circlet, because it contains important information for you.

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

Leaflet contents

1. What Circlet is and what it is used for
2. What you need to know before using Circlet
3. How to use Circlet
4. Possible side effects
5. How to store Circlet
6. Contents of the pack and other information

1. What Circlet is and what it is used for

Circlet is a vaginal contraceptive ring used to prevent pregnancy. Each ring contains a small amount of two female sex hormones, etonogestrel and ethinyl estradiol. The ring slowly releases these hormones into the bloodstream. Because of the small amount of hormones released, Circlet is a low-dose hormonal contraceptive. Since Circlet releases two different types of hormones, it is a combined hormonal contraceptive.

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

2. What you need to know before you start using Circlet

General considerations

Before you start using Circlet, you must read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood clots”).

This leaflet describes various situations in which you should stop using Circlet, or in which Circlet may be less effective. In these situations, you should not have sexual intercourse, or you must use additional non-hormonal contraceptive methods, such as a male condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because Circlet alters the monthly changes in body temperature and cervical mucus.

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

2.1 When not to use Circlet

Do 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 which other form of contraception would be most suitable.

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

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you need surgery or if you are going to be immobile for a long time (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 causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of forming a blood clot in the arteries: − Severe diabetes with blood vessel damage.

  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

• If you have or have had inflammation of the pancreas (pancreatitis), associated with high levels of fats in your blood.

• If you have or have had a serious liver disease and your liver is not functioning normally.

• If you have or have had a benign or malignant tumour of the liver.

• If you have, have had, or may have breast cancer or cancer of the genital organs.

• If you have vaginal bleeding of unknown origin.

• If you are allergic to ethinylestradiol or etonogestrel, or to any of the other ingredients of this medicine (listed in section 6).

If any of these conditions occurs for the first time while you are using Circlet, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.

Do not use Circlet if you have hepatitis C and are taking medications containing

ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section 2.4 “Other medicines and Circlet”).

2.2 Warnings and precautions

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot, which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions.

If any of these conditions develop or worsen while you are using Circlet, you must also inform your doctor.

• If any close relative has or has ever had breast cancer.
• If you have epilepsy (see section 2.4. "Other medicines and Circlet").
• If you have liver disease (e.g., jaundice) or gallbladder disease (e.g., gallstones).
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
• If you have sickle cell anemia (an inherited red blood cell disorder).
• 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 require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”).
• If you have recently given birth, you are at 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 beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have any condition that first appeared or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [a blistering skin rash during pregnancy], or Sydenham's chorea [a neurological disorder causing involuntary movements]).
• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives possibly accompanied by difficulty breathing, contact your doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• If you have or have ever had chloasma (yellowish-brown patches on the skin, known as “pregnancy mask,” particularly on the face); in such cases, avoid excessive exposure to sunlight or ultraviolet radiation.
• If you have disorders that make the use of Circlet difficult, for example, if you suffer from constipation, uterine prolapse (descent of the uterus or cervix), or pain during sexual intercourse.
• If you experience urgent, frequent, burning, and/or painful urination, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of Circlet into the urinary bladder.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Circlet increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot may block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (known as “venous thrombosis,” “venous thromboembolism,” or VTE).
• In the arteries (known as “arterial thrombosis,” “arterial thromboembolism,” or ATE).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when taking a deep breath. Severe dizziness or lightheadedness. Fast or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort spreading to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe weakness, anxiety, or shortness of breath. Fast or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently during the first year of using 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 travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

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

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

When you stop using Circlet, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

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

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

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing norelgestromin or etonogestrel, such as Circlet, between about 6 and 12 women will develop a blood clot in one year.
• Your personal risk of developing a blood clot will depend on your individual risk factors (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/vaginal ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women who use Circlet	About 6-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you remain immobile for long periods due to injury, illness, or having a leg in a cast. You may need to stop using Circlet several weeks before surgery or during periods of reduced 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 of age).
• If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other listed risk factors.

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop using 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 significant weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can lead to a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of heart attack or stroke while using Circlet is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm 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 developing a blood clot may be further increased.

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 significant weight—inform your doctor.

Cancer

The following information comes 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).

A slightly increased frequency of breast tumors has been observed in women using contraceptive pills, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women using contraceptive pills because they visit their doctor more frequently. This increased frequency gradually decreases after stopping treatment.

It is important to examine your breasts regularly and inform your doctor if you notice any lumps. Inform your doctor if any close relatives have or have had breast cancer (see section 2.2 "Warnings and precautions").

Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women using the contraceptive pill. Contact your doctor if you experience strong and unusual abdominal pain.

Women using combined oral contraceptives have been found to develop endometrial (lining of the uterus) or ovarian cancer less frequently. This may also be the case with Circlet, but it has not been confirmed.

Psychiatric disorders

Some women using hormonal contraceptives such as Circlet have reported depression or a depressed mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor for further medical advice as soon as possible.

2.3 Children and adolescents

The safety and efficacy of Circlet in adolescents under 18 years of age has 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 or dentist (or pharmacist) who prescribes another medicine that you are using Circlet. They can advise you whether you need to take additional contraceptive measures (e.g., use of male condoms), and if so, for how long, or whether you need to adjust the use of the other medicine.

Some medicines:

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

These include medicines used to treat:

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

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

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

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

Do not use Circlet if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as increases in liver function test results (elevated liver enzyme ALT) may occur.

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

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

Consult your doctor or pharmacist before taking any medicine.

Tampons can be used while using Circlet. Insert Circlet first, then the tampon. Take special care when removing the tampon to avoid accidentally expelling the ring. If the ring is expelled, simply wash it with cool or lukewarm water and reinsert it immediately.

The ring may open when also using a vaginal product such as a lubricant or treatment for infection (see section 3.4 "What to do if… The ring opens"). The use of spermicides or products for vaginal fungal infections does not reduce the contraceptive effectiveness of Circlet.

Laboratory tests

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

2.5 Pregnancy and breastfeeding

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

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

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

2.6 Driving and use of machines

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

3. How to use Circlet

You can insert and remove Circlet yourself. Your doctor will advise you when to start using it for the first time. The vaginal ring must be inserted on the correct day of your monthly cycle (see section 3.3 "When to start with the first ring") and remain in the vagina for 3 consecutive weeks. Check regularly that Circlet is in your vagina (for example, before and after sexual intercourse) to ensure you are protected against pregnancy. After the third week, remove Circlet and take a one-week break. You will usually have your monthly period or menstruation during this ring-free week.

While using Circlet, you should not use certain female barrier contraceptive methods, such as a vaginal diaphragm, cervical cap, or female condom. These barrier methods should not be used as a backup method of birth control, as Circlet may interfere with the correct placement and positioning of the diaphragm, cervical cap, or female condom. However, you may use a male condom as an additional barrier contraceptive method.

3.1 How to insert and remove Circlet

1. Before inserting the ring, check that it is not expired (see section 5 “Storage of Circlet”).

2. Wash your hands before inserting or removing the ring.

3. Choose the position that is most comfortable for you when inserting it, for example standing with one leg raised, squatting, or lying down.

4. Remove Circlet from its pouch.

5. Hold the ring between your index finger and thumb, press opposite sides together, and insert the ring into the vagina (see figures 1–4). Alternatively, you may choose to use the NuvaRing Applicator (not included with the Circlet packaging) to assist with insertion. The NuvaRing Applicator may not be available in all countries. When Circlet is correctly placed, you should not feel it. If you feel discomfort, gently adjust the position of Circlet (for example, push the ring slightly further into the vagina) until you feel comfortable. The exact position of the ring inside the vagina is not important.

6. After 3 weeks, remove Circlet from the vagina. You can do this by hooking your index finger under the ring or by grasping it with your fingers and pulling it out (see figure 5). If you are unable to remove the ring despite locating it, contact your doctor.

7. Dispose of the used ring in household waste, preferably in its original pouch. Do not flush Circlet down the toilet.

3.2 Three weeks in, one week out

1. The vaginal ring must remain in the vagina continuously from the day of insertion for 3 consecutive weeks, without interruption.

2. After 3 weeks, remove the ring on the same day of the week and at approximately the same time as when you inserted it. For example, if you inserted it on a Wednesday at approximately 10:00 PM, you should remove it 3 weeks later on a Wednesday at approximately 10:00 PM.

3. Once you have removed the ring, do not use it for one week. During this week, vaginal bleeding should occur. It usually begins 2–3 days after removing Circlet.

4. Insert a new ring exactly after the 1-week interval (again on the same day of the week and at approximately the same time), even if you are still bleeding.

If you insert the new ring more than 3 hours late, contraceptive effectiveness may be reduced. Follow the instructions in section 3.4 “What to do if you forget to insert a new ring after the ring-free pause”.

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

3.3 When to start with the first ring

• If you have not usedhormonal contraception**in the previous month

Insert 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 use any other contraceptive measures.

You may also start Circlet between day 2 and day 5 of your cycle, but if you have sexual intercourse during the first 7 days of using Circlet, make sure to use an additional contraceptive method (such as a male condom). This recommendation applies only when using Circlet for the first time.

• If you were using acombined oral contraceptive pill**in the previous month

Start using Circlet no later than the day after the last active tablet of your current pill pack. If your pill pack also contains inactive tablets, start Circlet no later than the day after the last inactive tablet. If you are unsure which tablet is inactive, consult your doctor or pharmacist. Do not extend the pill-free interval beyond what is recommended.

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

• If you were using atransdermal patch**in the previous month

Start using Circlet no later than the day after the patch-free interval. Do not extend the patch-free break beyond what is recommended.

If you have used the patch correctly and continuously and are sure you are not pregnant, you may stop using the patch on any day and start Circlet immediately.

• If you were using aprogestogen-only pill**in the previous month

You may 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 an additional contraceptive method (such as a male condom) during the first 7 days of ring use.

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

Start using Circlet on the day you are due for your next injection or on 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 ring use.

• After childbirth

If you have recently given birth, your doctor may advise you to wait until your first natural period occurs before starting Circlet. Sometimes it is possible to start earlier; your doctor will advise you accordingly. If you are breastfeeding and wish 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 may be accidentally expelled from the vagina, for example if it was not inserted properly, when removing a tampon, during sexual intercourse, if you have constipation, or if you have uterine prolapse. Therefore, you should regularly check whether the ring is in your vagina (for example, before and after sexual intercourse).

Your ring has been temporarily outside the vagina

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

If the ring has been outside the vagina for:

• less than 3 hours, it will still protect you from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and reinsert it into the vagina as soon as possible, but only if it has been out for less than 3 hours.
• more than 3 hours during the 1st or 2nd week, it may not protect you from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and reinsert it as soon as you remember. Leave it in the vagina for at least 7 consecutive days. Use a male condom if you have sexual intercourse during these 7 days. If you are in the first week and have had sexual intercourse in the previous 7 days, there is a possibility you could be pregnant. In this case, consult your doctor.
• more than 3 hours during the 3rd week, it may not protect you from pregnancy. Remove the ring and choose one of the following two options:

1. Insert a new ring immediately.

By inserting a new ring, you will start a new 3-week cycle, and your period may not occur. However, you may experience intermenstrual bleeding or spotting during this cycle.

1. Do not insert a new ring. Allow the intermenstrual bleeding to occur and insert a new ring no later than 7 days from when the previous ring was removed or expelled.

Choose this option only if you have used Circlet correctly and continuously for the 7 days prior.

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

The ring breaks open

Very rarely, the Circlet ring may break open. Vaginal injury associated with ring breakage has been reported. If you notice that Circlet has broken open, remove it and insert a new ring as soon as possible. Use additional contraceptive precautions (for example, a male condom) for the next 7 days. If you had sexual intercourse before noticing the ring had broken, consult your doctor.

You have inserted more than one ring

There are no reports of serious harm due to overdose of the hormones in Circlet. If you have accidentally inserted more than one ring, you may feel unwell (nausea), vomit, or have vaginal bleeding. Remove the extra ring and contact your doctor if these symptoms do not resolve.

You may also call the Toxicology Information Service at phone number: 91 562 04 20, indicating the medication and amount used.

If you forget to insert a new ring after the ring-free pause

Your ring-free pause has lasted more than 7 days. Insert a new ring into the vagina as soon as you remember. Use additional contraceptive measures (such as a male condom) if you have sexual intercourse during the next 7 days. If you had sexual intercourse during this ring-free pause, you may have become pregnant. In this case, inform your doctor immediately. The longer the ring-free pause, the higher the risk of pregnancy.

If you forget to remove the ring

• If the ring has been in the vagina between 3 and 4 weeks, it will still protect you from pregnancy. Take the usual one-week break and then insert a new ring.
• If the ring has been in the vagina for more than 4 weeks, there is a possibility of pregnancy. Contact your doctor before starting a new ring.

If your period or menstruation does not occur

• You have used Circlet according to the instructions.

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

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

If your usual withdrawal bleeding does not occur during the one-week ring-free pause and you have not followed the recommended regimen, you may be pregnant, so you should contact your doctor before inserting a new ring.

If you have unexpected bleeding

Some women may experience unexpected vaginal bleeding between menstrual periods while using Circlet. You may need sanitary protection. However, continue using the ring as usual—do not remove it. If the bleeding continues, becomes heavier, or recurs, consult your doctor.

If you wish to change the day your period or menstruation starts

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

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

If the ring-free interval is very short (e.g., 3 days or less), you may not have your usual bleeding. You may experience spotting (drops or stains of blood) or intermenstrual bleeding during use of the next ring.

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

If you wish to delay your period or menstruation

Although not the recommended regimen, you can delay your period (withdrawal bleeding) by inserting a new ring immediately after removing the current one, without taking a ring-free break. The new ring may be worn for up to a maximum of 3 weeks. During use of the new ring, you may experience spotting (drops or stains of blood) or irregular bleeding. When you wish your period to start, simply remove the ring. Take the usual one-week break without a ring and then insert a new ring.

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

3.5 If you wish to stop using Circlet

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

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

4. Possible adverse effects

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

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use 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 adverse effects:

Common: 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, depressed mood, decreased sexual desire
• breast pain, pelvic pain, painful menstruation
• acne
• weight gain
• expulsion of the ring

Uncommon: may affect up to 1 in 100 women.

• visual disturbances, dizziness
• bloated abdomen, vomiting, diarrhoea or constipation
• feeling tired, uncomfortable or irritable, mood changes, changes in mood
• fluid retention in the body (edema)
• urinary tract or bladder infection
• difficulty or pain when urinating; urgency to urinate; need to urinate more frequently
• problems during sexual intercourse such as pain, bleeding, or partner noticing the ring
• increased blood pressure
• increased appetite
• back pain, muscle cramps, pain in the legs or arms
• reduced skin sensitivity
• breast tenderness or pain, or increased breast size; fibrocystic breast disease (breast cysts that may become swollen or painful)
• cervical inflammation, polyps growing on the cervix, displacement outward of tissue from inside the cervix (ectropion)
• changes in menstrual periods (heavier, longer, irregular, or absent), pelvic discomfort, premenstrual syndrome, uterine cramps
• vaginal infection (fungal or bacterial), burning, odor, pain, discomfort or dryness of the vagina or vulva
• hair loss, eczema, itching, rash or hot flushes
• urticaria

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

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

• in a leg or foot (i.e., DVT)

• in a lung (i.e., PE)

• heart attack

• stroke

• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)

• blood clots in the liver, stomach/intestines, kidneys or eye

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

• milk-like discharge from the breasts

Frequency not known (cannot be estimated from available data).

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

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.

Very rarely, 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Circlet

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

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

Store below 30°C. Keep in the original packaging to protect 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 individual pouch.

Do not use Circlet after the expiry date stated on the box and on each pouch.

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

Dispose of used rings with household waste, preferably sealed inside their pouch. Circlet must not be flushed down the toilet. As with other medicines, unused or expired rings must not be disposed of via toilets or household waste.

Medicines must not be disposed of via sewage systems or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Circlet

• The active substances are etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• The other components are: 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 at a rate of 0.120 mg/day and 0.015 mg/day, respectively, over three weeks.

Appearance of the product and contents of the pack

Circlet is a flexible, transparent, and nearly colourless ring measuring 54 mm in diameter.

Each ring is packed in a laminated aluminium foil pouch which can be resealed. The pouch is presented in a cardboard box together with this leaflet. Each box contains 1 or 3 rings.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

N.V. Organon

Kloosterstraat 6,

5349 AB Oss

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following name:

Circlet

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

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

Date of the most recent review of this leaflet: September 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)