Circlet

Patient Information Leaflet

Circlet, (0.120 mg + 0.015 mg)/24 h, Vaginal Therapeutic System
Etonogestrel + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible forms of contraception available.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 “Blood clots”).

Please read this leaflet carefully before using the medicine, as it contains important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet

1. What Circlet is and what it is used for
2. What you should 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 contraceptive in the form of a vaginal therapeutic system that prevents pregnancy. Each vaginal therapeutic system contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. These hormones are slowly released from the system into the bloodstream. Due to the low dose of hormones released, Circlet is classified as a low-dose hormonal contraceptive. Since Circlet releases two different hormones, it is also known as a combined hormonal contraceptive.
Circlet works similarly to a combined oral contraceptive pill (a "combined pill"). However, unlike a pill that must be taken daily, Circlet is used continuously for 3 weeks. Circlet releases two female sex hormones that suppress the release of eggs from the ovaries. Because eggs are not released, pregnancy cannot occur.

2. Important information before using Circlet

General notes
Before starting to use the medicine Circlet, you should read the information about
blood clots (thrombosis) in section 2. It is particularly important to become familiar with
the symptoms of blood clots (see section 2 "Blood clots").
This leaflet describes situations in which you should stop using Circlet or in which
its effectiveness may be reduced. In these situations, you should avoid sexual intercourse or use an additional method of contraception other than hormonal, such as a male condom or another mechanical method. Do not use methods based on calendar tracking or body temperature measurement. These may be ineffective because Circlet affects body temperature changes and cervical mucus consistency throughout the month.
Circlet, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

2.1 When not to use Circlet
Do not use Circlet if you have any of the conditions listed below.
If you have any of the conditions listed below, you must inform your doctor.
Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs,

• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies,

• if you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots"),

• if you have had a heart attack or stroke,

• if you have (or have previously had) angina pectoris (a condition causing severe chest pain, which may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms),

• if you have any of the following conditions that may increase the risk of arterial blood clots:

  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia

• if you currently have (or have previously had) a type of migraine called "migraine with aura",

• if you currently have or have previously had pancreatitis associated with high levels of fats in the blood,

• if you currently have or have previously had severe liver disease and liver function has not returned to normal,

• if you currently have or have previously had a benign or malignant liver tumour,

• if you currently have or have previously had breast cancer or genital organ cancer, or if such cancers are suspected,

• if you have unexplained vaginal bleeding,

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

If any of the above symptoms occur for the first time while using Circlet, remove the vaginal system immediately and consult your doctor. During this time, use a non-hormonal method of contraception.

If you have hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir, or glecaprevir, pibrentasvir, do not use the vaginal therapeutic system Circlet (see also section 2.4 "Circlet and other medicines").

2.2 Warnings and precautions
When should you contact your doctor?
Seek medical advice immediately if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots (thrombosis)"). For a description of symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
If these symptoms develop or worsen during treatment with Circlet, you should also inform your doctor.

• if breast cancer is currently present or has occurred in close family members;
• if you have epilepsy (see section 2.4 "Circlet and other medicines");
• 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 diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start using Circlet;
• if you have phlebitis (inflammation of superficial veins);
• if you have varicose veins;
• if you have conditions that first occurred or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], or Sydenham's chorea [a nervous system disorder causing involuntary, violent movements]);
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or if you develop hives potentially accompanied by breathing difficulties—seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you currently have or have previously had chloasma (yellowish-brown pigmentation patches, so-called "melasma", especially on the face). If you have such patches, avoid excessive sun exposure and ultraviolet radiation;
• if you have conditions that make using Circlet difficult, such as frequent constipation, uterine prolapse, or pain during intercourse;
• if you experience sudden, frequent need to urinate with a burning sensation and/or pain, and if you cannot locate the vaginal therapeutic system inside the vagina. These symptoms may indicate accidental placement of the Circlet vaginal system into the bladder.

BLOOD CLOTS
Using combined hormonal contraceptives, such as the vaginal therapeutic system Circlet, increases the risk of blood clots compared to not using such medication. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Circlet is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot—Deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking,
• increased warmth in the affected leg,
• change in skin colour of the leg, such as pallor, redness, or cyanosis.
• sudden unexplained shortness of breath or rapid breathing—Pulmonary embolism
• sudden coughing without obvious cause, possibly accompanied by coughing up blood;
• sharp chest pain, which may worsen on deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, consult your doctor.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different drug) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops using Circlet, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Circlet is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 6 to 12 out of 10,000 women who use combined hormonal contraceptives containing norelgestromin or etonogestrel, such as the vaginal contraceptive system Circlet, will develop blood clots.
• The risk of developing blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of the vaginal therapeutic system
Circlet is small, but certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue use of Circlet for several weeks before surgery or periods of limited mobility. If the patient must stop using Circlet, consult the doctor about when it is safe to resume use;
• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots,
especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of these risk factors apply to the patient,
even if uncertain. The doctor may decide to discontinue use of Circlet.
Inform the doctor if any of the above conditions change during treatment with Circlet,
for example, if a close relative develops thrombosis without a known cause, or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with use of the vaginal therapeutic system Circlet is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as the vaginal therapeutic system Circlet, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with the vaginal therapeutic system Circlet, for example, if the patient starts smoking, a close relative is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

Tumour diseases
The following information is based on studies using combined oral contraceptives and may also apply to Circlet. Data on vaginal hormonal contraceptives (as with Circlet) are limited.
A slightly higher incidence of breast cancer has been observed among women using combined oral contraceptives, although it is not known whether this is caused by the medication. It is possible that breast cancer is detected more frequently in women using combined oral contraceptives because these women undergo medical examinations more regularly. The increased incidence of breast cancer gradually decreases after stopping combined oral contraceptives.
Regular breast examinations are very important. If any lump is detected, consult a doctor. Also inform the doctor if breast cancer has occurred or occurs in close relatives (see section 2.2 "Warnings and precautions").
In rare cases, benign liver tumours have been reported in women using combined oral contraceptives, and very rarely, malignant liver tumours. If unusual, severe abdominal pain occurs, contact the treating doctor.
There are reports that women using combined oral contraceptives have a lower incidence of endometrial cancer (cancer of the uterine lining) and ovarian cancer. This may also apply to Circlet, but has not yet been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including Circlet, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

2.3 Children and adolescents
The safety and efficacy of Circlet have not been studied in adolescents under 18 years of age.

2.4 Circlet and other medicines
Always inform the doctor about any medicines or herbal products currently being used by the patient. Also inform any other specialist doctor or dentist (or pharmacist) prescribing other medicines about the use of Circlet. They may advise on the need for additional contraceptive methods (e.g., male condoms), how long this should be used, and whether adjustment of other medication is required.
Some medicines:

• may affect the blood concentration of Circlet;
• may reduce its contraceptive effectiveness;
• may cause unexpected bleeding.

This applies to medicines used in the treatment of:

• 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);
• pulmonary hypertension (bosentan);
• depressive mood disorders (St. John's wort).

If the patient is taking medicines or herbal remedies that may reduce the effectiveness of Circlet, a mechanical contraceptive method (e.g., male condom) should also be used. Because the effect of another medicine on Circlet may persist for up to 28 days after stopping the medicine, additional mechanical contraception is necessary during this period. Note: Circlet should not be used with a diaphragm, cervical cap, or female condom.
Circlet may affect the action of other medicines, such as:

• medicines containing cyclosporine;
• the anticonvulsant lamotrigine (this may lead to increased frequency of seizures).

If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir or glecaprevir, pibrentasvir, the vaginal therapeutic system Circlet should not be used, as this may lead to increased liver function parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).
Before starting these medicines, the treating doctor will prescribe another type of contraceptive.
Use of the vaginal therapeutic system Circlet may be resumed approximately 2 weeks after completing this treatment. See section 2.1 "When not to use Circlet".
Before taking any medicine, consult a doctor or pharmacist.
Tampons may be used during treatment with Circlet. Insert Circlet before placing the tampon. Be careful when removing the tampon to avoid accidentally removing Circlet as well. If Circlet is expelled, it is sufficient to wash the vaginal therapeutic system with cold or lukewarm water and reinsert it as soon as possible.
Damage to the vaginal therapeutic system has occurred during use of vaginal products such as lubricants or treatments for infections (see section 3.4 “Management in case of damage to the vaginal therapeutic system”). Use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of Circlet.

Diagnostic tests
If blood or urine laboratory tests are performed, inform the testing personnel about the use of Circlet, as use of the vaginal therapeutic system may affect the results of certain laboratory tests.

2.5 Pregnancy and breastfeeding
Circlet must not be used during pregnancy or if pregnancy is suspected. If the patient becomes pregnant while using Circlet, remove the vaginal therapeutic system and contact the doctor.
If the patient wishes to stop using Circlet because she wants to become pregnant, refer to section 3.5 “What to do if the patient wants to stop using Circlet”.
Use of Circlet during breastfeeding is not recommended. If the patient wishes to use Circlet while breastfeeding, consult the doctor first.

2.6 Driving and operating machinery
Circlet does not affect the ability to drive or operate machinery.

3. How to use Circlet

Circlet can be inserted and removed by yourself. Your doctor will advise you when to start using
Circlet. The vaginal ring should be inserted on the correct day of the cycle (see
section 3.3 “When to insert the first Circlet vaginal ring”) and left in place
continuously for 3 weeks. You should regularly check that the Circlet vaginal ring is in place in the vagina (for example, before and after sexual intercourse) to ensure contraceptive protection.
After three weeks, remove Circlet and take a one-week break. During this break, withdrawal bleeding usually occurs.
Do not use certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom while using Circlet. These mechanical contraceptive methods should not be used as an additional contraceptive method, because Circlet may interfere with the correct placement and positioning of an intrauterine device, cervical cap, or female condom. However, you may use a male condom as an additional mechanical contraceptive method.
3.1 Insertion and removal of Circlet

1. Before inserting the ring, check the expiry date (see section 5 “How to store Circlet”).
2. Wash your hands before inserting or removing the ring.
3. Choose the most comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
4. Remove Circlet from its pouch.
5. Holding the ring between your thumb and index finger, squeeze it and insert it into the vagina (see Figures 1–4). Alternatively, the ring may be inserted using the NuvaRing applicator (this is not included with the Circlet packaging). The NuvaRing applicator may not be available in all countries. The correct position of the Circlet ring is one where it is not felt. If the ring causes discomfort, gently adjust its position (e.g., push it slightly deeper into the vagina) until you feel comfortable. The exact position of the ring within the vagina does not affect its contraceptive effectiveness.
6. After three weeks, remove the ring from the vagina. This can be done by hooking your index finger under the edge of the ring or grasping it with your index and middle fingers and pulling it out (Figure 5). If you can locate the ring in the vagina but are unable to remove it, contact your doctor.
7. Dispose of the used ring with household waste, preferably in the sealed pouch it originally came in. Do not dispose of Circlet in the toilet.

Figure 1
Remove the ring from the pouch

Figure 2
Squeeze the ring

Figure 3
Choose the most comfortable position

Figure 4A Figure 4B Figure 4C
Insert the ring into the vagina with one hand (Figure 4A), spreading the labia with the other hand if necessary. Place it inside the vagina so that it is comfortable (Figure 4B). Leave the ring in the vagina for 3 weeks (Figure 4C).

Figure 5
Remove the ring from the vagina by hooking your index finger under the edge of the ring or grasping it with your index and middle fingers and pulling it out.
3.2 Three weeks of use, one-week break

1. The ring must remain in the vagina continuously for three weeks, starting from the day of insertion.
2. After three weeks, remove the ring on the same day of the week and approximately at the same time as it was inserted. For example, if Circlet was inserted on a Wednesday at around 10:00 PM, it should be removed on a Wednesday three weeks later, around 10:00 PM.
3. After removing the ring, take a one-week break. During this time, bleeding may occur. It usually starts 2–3 days after removal.
4. Insert a new ring exactly one week after the break (on the same day of the week and approximately at the same time), even if bleeding is still ongoing. If insertion of the new ring is delayed by more than 3 hours, contraceptive effectiveness may be reduced. In such a case, follow the instructions in section 3.4 “What to do if after the one-week break the patient forgets to insert a new vaginal ring”.

If Circlet is used according to the above recommendations, subsequent bleeds will occur
each month on approximately the same days of the week.
3.3 When to insert the first Circlet vaginal ring

• Previously not using hormonal contraception

Insert Circlet on the first day of your natural cycle (i.e., the first day of your period). Circlet is effective
from the moment of insertion. There is no need to use any additional contraceptive methods.
You may also start using Circlet between days 2 and 5 of your period, but
in this case, you must use an additional contraceptive method (such as a male condom) for the first 7 days of use. This recommendation applies only when starting Circlet for the first time.

• Previously using combined oral contraceptive pills

Start using Circlet no later than the day after the break from your current pill. If your current pill pack includes inactive (placebo) tablets, start using Circlet no later than the day after taking the last inactive tablet. If you are unsure which tablet is which, consult your doctor or pharmacist. Do not extend the break from your current pills beyond the recommended period.
If you have taken your pills regularly and are certain you are not pregnant, you may stop taking them on any day and immediately start using Circlet.

• Previously using a contraceptive transdermal patch

Start using Circlet no later than the day after stopping the transdermal patch. Do not extend the break from the transdermal patch beyond the recommended period. If you have used the transdermal patch regularly and are certain you are not pregnant, you may stop using it on any day and immediately start using Circlet.

• Previously using a progestogen-only pill (minipill)

You may stop taking the minipill on any day and start using Circlet the next day at the same time you usually took the minipill. For the first 7 days of using Circlet, use an additional contraceptive method (such as a male condom).

• Previously using injections, an implant, or a progestogen-releasing intrauterine system [IUD]

Start using Circlet on the day of your next scheduled injection or on the day of removal of the implant or progestogen-releasing intrauterine system. For the first 7 days of using Circlet, use an additional contraceptive method (such as a male condom).

• After childbirth

After childbirth, your doctor may recommend starting Circlet only after your first period. Sometimes you may start earlier; your doctor will advise you when. If you are breastfeeding and wish to use Circlet, discuss this with your doctor first.

• After miscarriage

As advised by your doctor.
3.4 What to do if…
What to do if the ring accidentally falls out of the vagina
Circlet may accidentally fall out of the vagina, for example, if it was inserted incorrectly, during tampon removal, during intercourse, in case of constipation, or uterine prolapse. Therefore, you should regularly check that the ring is in place in the vagina (for example, before and after sexual intercourse).
What to do if the ring has been outside the vagina for some time
Circlet may still protect against pregnancy, but this depends on how long it was outside the vagina.
If the ring was outside the vagina for:

• less than 3 hours , you are still protected against pregnancy. Wash the vaginal ring with cold or lukewarm (not hot) water and reinsert it as soon as possible, but only if it was outside the vagina for less than 3 hours.
• more than 3 hours in the first or second week of use, contraceptive effectiveness may have decreased. Wash the vaginal ring with cold or lukewarm (not hot) water and reinsert it as soon as possible and leave it in place continuously for at least 7 days. If you have intercourse during these 7 days, use an additional male condom. If you are in the first week of your cycle and have had intercourse in the past 7 days, there is a possibility you may be pregnant. In this case, contact your doctor.
• more than 3 hours in the third week of use, contraceptive effectiveness may have decreased. Remove the vaginal ring and choose one of the following options: 1 - Insert a new vaginal ring as soon as possible. Inserting a new vaginal ring means starting the next three-week cycle of use. This may result in the absence of expected withdrawal bleeding, although breakthrough bleeding or spotting may occur. 2 - Do not reinsert a vaginal ring. Wait for withdrawal bleeding to occur and insert a new vaginal ring no later than 7 days after removal or expulsion of the previous ring. This approach may only be used if you have used Circlet continuously for the past 7 days.
• unknown duration , you may not be protected against pregnancy. Before inserting a new vaginal ring, perform a pregnancy test and consult your doctor.

What to do if the vaginal ring is damaged
Very rarely, Circlet may become damaged. Vaginal wall injury has been reported in association with damage to the vaginal ring. If you notice that Circlet is damaged, remove it and insert a new one as soon as possible. Use an additional contraceptive method (e.g., a male condom) for the next 7 days. If you had intercourse before noticing the damage, contact your doctor.
What to do if more than one vaginal ring has been inserted
There have been no reports of serious harmful effects related to overdose of the hormones in Circlet. If more than one vaginal ring is accidentally inserted, nausea, vomiting, or genital bleeding may occur. Remove the additional vaginal ring and contact your doctor if symptoms do not resolve.
What to do if after the one-week break the patient forgets to insert a new vaginal ring
If the break in using the vaginal ring was longer than 7 days, insert a new ring as soon as possible. If you have intercourse in the next 7 days, use an additional contraceptive method (e.g., a male condom). If intercourse occurred during the break in using the vaginal ring, there is a possibility of pregnancy. In this case, contact your doctor as soon as possible. The longer the break in using the vaginal ring, the greater the likelihood of pregnancy.
What to do if the patient forgets to remove the vaginal ring on time

• If the ring has been in the vagina for longer than 3 weeks but not longer than 4 weeks, you are still protected against pregnancy. Remove the vaginal ring for one week, then insert a new one.
• If you have used the vaginal ring for longer than 4 weeks, there is a possibility of pregnancy. Before inserting a new vaginal ring, contact your doctor.

What to do if there is no bleeding

• If the patient has used Circlet according to instructions If withdrawal bleeding does not occur on time, but you have used Circlet as directed and have not taken other medications, the likelihood of pregnancy is very low. Continue using Circlet as before. However, if withdrawal bleeding does not occur twice in a row, there is a possibility of pregnancy. Contact your doctor as soon as possible. Do not insert a new Circlet ring until your doctor confirms you are not pregnant.
• If the patient has not used Circlet according to instructions If withdrawal bleeding does not occur during the first break from using Circlet and you have not used the vaginal ring as directed, you may be pregnant. Contact your doctor before using a new Circlet.

What to do if unexpected bleeding occurs
During use of the Circlet vaginal ring, some women may experience unexpected mid-cycle bleeding. You may need sanitary pads. Leave the ring in place and continue using it as before. If irregular bleeding increases or recurs, contact your doctor.
What to do if the day of bleeding changes
If Circlet is used as directed, periods (withdrawal bleeds) will start during the one-week break from using the vaginal ring. If you wish withdrawal bleeding to start on a different day, you may shorten the break in using the vaginal ring (but never extend it!).
For example: if withdrawal bleeding usually starts on Friday, and you wish to change it to Tuesday (3 days earlier) next month, insert the new vaginal ring 3 days earlier than usual.
If the break in using the vaginal ring is significantly shortened (e.g., to 3 days or less), withdrawal bleeding may not occur at all during that time. During use of the next vaginal ring, spotting (drops or stains of blood) or mid-cycle bleeding may occur.
If you are unsure what to do, consult your doctor.
What to do if you wish to delay the onset of bleeding
Although not recommended, you may delay the onset of menstruation (withdrawal bleeding) by inserting a new vaginal ring immediately after removing the previous one, without taking a break. The new vaginal ring may be used for no longer than 3 weeks. During use of the new vaginal ring, spotting (drops or stains of blood) or mid-cycle bleeding may occur. To induce withdrawal bleeding, remove the vaginal ring. A regular weekly break between consecutive rings is recommended.
Before deciding to delay your period, you may consult your doctor.
3.5 What to do if the patient wishes to stop using Circlet
You may stop using Circlet at any time.
If you do not wish to become pregnant, ask your doctor about other contraceptive methods.
If you stop using Circlet because you wish to become pregnant, wait until your first period and then start trying to conceive. This will help determine the due date.

4. Possible adverse reactions

Like any medicinal product, Circlet may cause adverse reactions, although not everyone experiences them. If any adverse reactions occur, particularly severe or persistent ones, or changes in health that the patient considers related to the use of Circlet, medical advice should be sought from a physician.

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before taking Circlet".

If hypersensitivity (allergy) to any component of Circlet occurs, it may manifest as (frequency unknown): angioedema and/or anaphylactic reaction [swelling of the face, lips, tongue, and/or throat and/or difficulty swallowing], or urticaria potentially accompanied by breathing difficulties. In such cases, Circlet should be removed immediately and medical advice sought without delay (see also section 2.2 "Warnings and precautions").

Women using Circlet have reported the following adverse reactions:

Common: may affect up to 1 in 10 women

• Abdominal pain, nausea
• Vaginal fungal infections (such as "thrush"); discomfort due to the presence of the system in the vagina; genital itching; vaginal discharge
• Headache or migraine headache; depressed mood; decreased libido
• Breast pain; pelvic pain; painful menstruation
• Acne
• Weight gain
• Expulsion of the system

Uncommon: may affect up to 1 in 100 women

• Visual disturbances; dizziness
• Bloating; vomiting; diarrhoea or constipation
• Feeling of fatigue, malaise, or restlessness; mood changes; sudden mood swings
• Oedema (swelling)
• Urinary bladder or urinary tract infections
• Problems or pain during urination; urgency or need to urinate; frequent urination
• Discomfort during intercourse, including pain, bleeding, or discomfort related to the presence of the system felt by the male partner
• Increased blood pressure
• Increased appetite
• Back pain; muscle cramps; pain in lower or upper limbs
• Decreased skin sensitivity
• Breast tenderness or enlargement; fibrocystic breast changes (cysts which may cause swelling or pain in the breasts)
• Cervicitis; cervical polyps; cervical ectropion
• Changes in menstrual bleeding (e.g. heavy, prolonged, irregular or complete absence of menstruation); pelvic discomfort; premenstrual syndrome; uterine cramps
• Vaginal infections (fungal or bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
• Hair loss, rash, itching, skin 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 the leg or foot (e.g. deep vein thrombosis)
  • In the lungs (e.g. pulmonary embolism)
  • Heart attack
  • Stroke
  • Transient ischaemic attack (mini-stroke) or transient stroke-like symptoms
  • Blood clots in the liver, stomach and intestines, kidneys or eye. The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of their occurrence).
• Milky discharge from the breast

Unknown frequency (cannot be estimated from available data)

• Chloasma (yellowish-brown patches on the skin, especially on the face)
• Partner discomfort during intercourse (such as irritation, rash, itching)
• Inability to remove the intravaginal therapeutic system without medical assistance (e.g. due to adhesion of the intravaginal therapeutic system to the vaginal wall)
• Vaginal wall injury related to damage of the intravaginal therapeutic system

In women using combined hormonal contraceptives, cases of breast cancer and liver tumours have been observed. For detailed information, see section 2.2 "Warnings and precautions", "Neoplastic diseases".

Very rarely, Circlet may become damaged. For additional information, see section 3.4 "Management in case of damage to the intravaginal therapeutic system".

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of this medicinal product.

5. How to store Circlet

Keep the medicine out of the sight and reach of children.
Contact a doctor if a child is suspected of having been exposed to the hormones contained in Circlet.
Store below 30 °C. Keep in the original packaging to protect from light and moisture.
Do not use Circlet after 4 months from the date it was dispensed by the pharmacy. The dispensing date is indicated on the box and on the sachet.
Do not use Circlet after the expiry date stated on the box and on the sachet.
Do not use Circlet if you notice any change in colour or any signs of deterioration.
Used vaginal therapeutic systems should be disposed of in a regular household waste container, preferably in a sealed sachet. Do not flush Circlet down the toilet. As with other medicines, do not dispose of unused or expired systems via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Circlet contains

• The active substances are: etonogestrel (11.7 mg) and ethinylestradiol (2.7 mg).
• The other components are: ethylene vinyl acetate copolymers (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 vaginal therapeutic system at a rate of
0.120 mg/day and 0.015 mg/day over a 3-week period.

What Circlet looks like and contents of the pack
Circlet is a soft, transparent, colourless or almost colourless ring with an outer diameter of
54 mm.
Each vaginal therapeutic system is individually packaged in a sealed foil pouch. The pouch can be resealed after opening. The pouches are contained in a cardboard box together with the package leaflet.
The pack contains 1 or 3 systems.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warszawa
Tel.: +48 22 105 50 01
[email protected]

Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands.

This medicinal product is authorised in the European Economic Area countries under the following name:
Circlet
0.120 mg/0.015 mg/24 h, Vaginal Therapeutic System
Belgium, Germany, Hungary, Luxembourg, The Netherlands, Poland, Portugal, Slovakia, Spain.

These stickers, when attached to the corresponding day on the calendar, may help you remember when to insert and remove the vaginal therapeutic system Circlet.

Insert vaginal therapeutic system Circlet
Remove vaginal therapeutic system Circlet