Adaring

Package leaflet: Information for the user

Adaring, (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 methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet
1. What Adaring is and what it is used for
2. Before using Adaring
2.1 When not to use Adaring
2.2 Warnings and precautions
Blood clots
Tumors
2.3 Children and adolescents
2.4 Adaring with other medicines
Diagnostic tests
2.5 Pregnancy and breastfeeding
2.6 Driving and using machines

3. How to use Adaring

3.1 Insertion and removal of Adaring
3.2 Three weeks of use, one week break
3.3 When to insert the first vaginal therapeutic system Adaring
3.4 What to do if…
Action to take if the system accidentally comes out of the vagina
Action to take if the system has been outside the vagina for some time
Action to take if the vaginal therapeutic system is damaged
Action to take if more than one vaginal therapeutic system has been inserted
Action to take if the patient forgets to insert a new therapeutic system after the
one-week break
Action to take if the patient forgets to remove the vaginal therapeutic system on time
Action to take if there is no bleeding
Action to take if unexpected bleeding occurs
Action to take if the day of bleeding changes
Action to take if the patient wishes to delay the onset of bleeding
3.5 What to do if the patient wishes to stop using Adaring
4. Possible side effects
5. How to store Adaring
6. Contents of the pack and other information
What Adaring contains
What Adaring looks like and contents of the pack
Marketing authorisation holder and manufacturer

1. What is Adaring and what is it used for

Adaring is a contraceptive medicinal product 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 released slowly
from the system into the bloodstream. Due to the low dose of hormones released, Adaring is
classified as a low-dose hormonal contraceptive. Since Adaring releases two different hormones, it is also referred to as a combined contraceptive.
Adaring works in the same way as a tablet containing a combined oral contraceptive (combined pill), but unlike the daily tablet, Adaring is used continuously for 3 weeks.
Adaring releases two female sex hormones which inhibit the release of oocytes from the ovaries. Because oocytes are not released, the user cannot become pregnant.

2. Important information before using Adaring

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

2.1 When not to use Adaring

Adaring must not be used if the patient has any of the conditions listed below.
If any of the following conditions apply to the patient, she must inform her doctor. The doctor will discuss with her which other method of contraception would be more suitable.

• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows she has disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if the patient has had a heart attack or stroke;
• if the patient has (or has previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if the patient has any of the following diseases, which may increase the risk of arterial blood clot:
  • 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 the patient currently has (or has previously had) a type of migraine known as “migraine with aura”;
• if the patient currently has or has previously had pancreatitis associated with high levels of fats in the blood;
• if the patient currently has or has previously had severe liver disease and liver function has not returned to normal;
• if the patient currently has or has previously had a benign or malignant liver tumour;
• if the patient currently has or has previously had breast cancer or genital organ cancer, or if such cancers are suspected;
• if the patient has vaginal bleeding of unknown cause;
• if the patient is 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 during treatment with Adaring, the vaginal ring must be removed immediately and the patient should consult her doctor. During this time, a non-hormonal method of contraception must be used.

Adaring must not be used in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section 2.4 “Adaring with other medicines”).

2.2 Warnings and precautions

When should you contact a doctor?
You should seek medical advice immediately
If the patient notices symptoms suggesting a blood clot, which may indicate that she has a blood clot in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see section below "Blood clots (thrombosis)").
For a description of the symptoms of these serious adverse events, see "How to recognize the formation of blood clots".
You should inform the doctor if the patient has any of the following conditions.
If any of these conditions appear or worsen during treatment with Adaring, you should also inform the doctor.

• if breast cancer is currently present or has occurred in close family members;

• if the patient has epilepsy (see section 2.4 "Adaring and other medicines");

• if the patient has liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);

• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);

• if the patient has systemic lupus erythematosus (an autoimmune disease affecting the body's natural defense system);

• if the patient has hemolytic uremic syndrome (a blood clotting disorder leading to kidney failure);

• if the patient has sickle cell anemia (an inherited disorder of red blood cells);

• if the patient or any of her close family members have been diagnosed with high levels of blood fats (hypertriglyceridemia). Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;

• if the patient requires surgery or will be immobile for a prolonged period (see section 2 "Blood clots");

• if the patient has recently given birth, as she is then at increased risk of developing blood clots. Please consult the doctor for advice on how soon after delivery Adaring can be started;

• if the patient has superficial thrombophlebitis (inflammation of veins under the skin);

• if the patient has varicose veins;

• if the patient has conditions that first appeared 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], Sydenham's chorea [a nervous system disorder characterized by involuntary, violent movements]);

• if the patient experiences symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or urticaria with breathing difficulties, she should contact the doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;

• if the patient currently has or has previously had chloasma (yellowish-brown pigmentation patches, so-called "melasma", especially on the face). If such patches occur, excessive exposure to sunlight and ultraviolet radiation should be avoided;

• if the patient has conditions that make the use of Adaring difficult, e.g. frequent constipation, uterine prolapse, pain during intercourse;

• if the patient experiences sudden, frequent urge to urinate with a burning sensation and/or pain, and if she cannot locate the Adaring vaginal ring inside the vagina. These symptoms may indicate accidental placement of the Adaring vaginal ring into the bladder.

BLOOD CLOTS
The use of combined hormonal contraceptives, such as the Adaring vaginal ring, is associated with an increased risk of blood clots compared to not using such treatment. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

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

Complete recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
It should be remembered that the overall risk of harmful blood clots caused by the use of Adaring is small.
HOW TO RECOGNIZE THE FORMATION OF BLOOD CLOTS
Seek medical advice immediately if any of the following symptoms occur.

| Why? | Is the patient experiencing any of these symptoms? | What might the patient have? | |----------|------------------------------------------------------|----------------------------------| | Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by: | | Deep vein thrombosis | | • pain or tenderness in the leg, which may occur only when standing or walking, | | | | • increased warmth in the affected leg, | | | | • change in skin color of the leg, e.g. pallor, redness, or cyanosis. | | | | Sudden onset of unexplained shortness of breath or rapid breathing; | | Pulmonary embolism | | Sudden onset of coughing without obvious cause, possibly associated with coughing up blood; | | | | Sharp chest pain, which may worsen on deep breathing; | | | | Severe dizziness or vertigo; | | | | Rapid or irregular heartbeat; | | | Severe abdominal pain. | | |

If the patient is unsure, she should consult a 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 venous blood clots (venous thromboembolism). 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 venous blood clots the highest?
The risk of developing venous blood clots is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) 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 taking Adaring, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
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 Adaring is low.

• In a one-year period, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a one-year period, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a one-year period, about 6 to 12 out of 10,000 women who use combined hormonal contraceptives containing ethinylestradiol or etonogestrel, such as the Adaring vaginal system, 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 venous blood clots
The risk of blood clots associated with the use of the Adaring vaginal ring is small, but certain factors may increase this risk.
The risk is higher:

• if the patient is very overweight (body mass index (BMI) above 30 kg/m2);
• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In this case, the patient may have an inherited blood clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop using Adaring a few weeks before surgery or immobilization. If the patient must stop using Adaring, ask the doctor when it is safe to resume use;
• with increasing age (especially 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 blood clots, especially if the patient has other risk factors listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Adaring.
Inform the doctor if any of the above conditions change during treatment with Adaring, for example, if a close family member is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

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

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of the Adaring vaginal ring is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as the Adaring vaginal ring, 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 another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member 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 family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorder known 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 developing blood clots may be even greater.
Inform the doctor if any of the above conditions change during treatment with the Adaring vaginal ring, for example, if the patient starts smoking, a close family member is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

Cancer
The following information comes from studies on combined hormonal contraceptives and may also apply to Adaring. Data specifically on vaginal hormonal contraceptives (as used in Adaring) are not yet available.
Women using combined hormonal contraceptives have shown a slightly increased incidence of breast cancer, although it is not known whether this is caused by the medication. It is possible that breast cancer is detected more frequently in these women because they undergo medical examinations more regularly. The increased incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Regular breast examinations are very important. If any lump is detected, contact the doctor immediately. Also inform the doctor if any close relatives have had or currently have breast cancer (see section 2.2 “Warnings and precautions”).
In rare cases, benign liver tumours have been reported in women using combined hormonal contraceptives, and very rarely, malignant liver tumours. If unusual, severe abdominal pain occurs, contact the treating doctor.
There are reports that women using combined hormonal contraceptives have a lower incidence of endometrial cancer (cancer of the uterine lining) and ovarian cancer. This may also apply to Adaring, but this has not yet been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including Adaring, have reported depression or low mood. Depression can be severe and may 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 Adaring in adolescents below the age of 18 have not been established.

2.4 Adaring and other medicines

Always inform your doctor if you are taking other medicines or herbal products.
You should also inform a specialist doctor or dentist (or pharmacist) about using Adaring
when being prescribed other medicines (or when a pharmacist dispenses medicines).
They may advise you to use an additional contraceptive method (e.g. male condoms),
how long to use it, or whether a change in your current medication is necessary.

Some medicines:

• may affect the blood concentration of Adaring
• may reduce the effectiveness of Adaring in preventing pregnancy
• may cause unexpected bleeding. This applies, among others, 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 (HCV) (e.g. boceprevir, telaprevir);
  • other infectious diseases (e.g. griseofulvin);
  • pulmonary arterial hypertension (bosentan);
  • depressive disorders (herbal products containing St. John's wort, Hypericum perforatum).

If you are taking medicines or herbal products that may reduce the effectiveness of Adaring,
you should additionally use a barrier contraceptive method (e.g. male condom).
Since the effect of another medicine on Adaring may persist for up to 28 days after stopping it,
a barrier contraceptive method must be used for this entire period.
Note: Do not use Adaring with a diaphragm, cervical cap, or female condom.

Adaring may affect the action of other medicines, for example:

• medicines containing cyclosporine;
• the antiepileptic drug lamotrigine (which may result in increased frequency of seizures).

Do not use Adaring in patients with hepatitis C who are taking medicinal products containing
ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir
with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results
(increased activity of liver enzymes ALT).

Before starting these medicines, your doctor will prescribe another type of contraception.
Adaring may be restarted approximately 2 weeks after completing the above-mentioned treatment.
See section 2.1 "When not to use Adaring".

Before taking any medicine, consult your doctor or pharmacist.

During use of Adaring, tampons may be used. Insert Adaring before inserting a tampon.
Be careful when removing the tam游戏副本

2.5 Pregnancy and breastfeeding

Adaring must not be used during pregnancy or if there is suspicion that a woman may be pregnant. If
a patient becomes pregnant while using Adaring, the intravaginal therapeutic system should be removed
and a doctor should be consulted immediately.
If a patient wishes to discontinue using Adaring because she intends to become pregnant, she should refer to section 3.5 "Instructions when a patient wishes to discontinue using Adaring".
Adaring is not recommended during breastfeeding. If a patient wishes to use Adaring while breastfeeding, she should consult her doctor beforehand.

2.6 Driving and operating machinery

Adaring has no influence on the ability to drive vehicles or operate machinery.

3. How to use Adaring

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Adaring can be inserted and removed by yourself. Your doctor will advise you when to start using
Adaring. The vaginal ring should be inserted on the correct day of the cycle (see section 3.3 "When to insert the first Adaring vaginal ring") and left in place continuously for 3 weeks. It is advisable to regularly check that the vaginal ring is still in place. After 3 weeks, remove Adaring and take a one-week break. During this break, withdrawal bleeding usually occurs.
You should not use certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom, while using Adaring. These mechanical contraceptive methods should not be used as additional contraception, because Adaring may interfere with the correct placement and positioning of a diaphragm, cervical cap, or female condom. However, a male condom may be used as an additional mechanical contraceptive method.

3.1 Insertion and removal of Adaring

1. Before insertion, check the expiry date (see section 5 "How to store Adaring").
2. Wash your hands before inserting or removing the system.
3. Choose the most comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
4. Remove Adaring from the pouch. Keep the pouch for later use.
5. Holding the system between your thumb and index finger, compress it and insert into the vagina (see Figures 1–4). The correct position is when you do not feel the system. If the system causes discomfort, push it slightly deeper into the vagina. The exact placement within the vagina is not important for contraceptive effectiveness.
6. After 3 weeks, remove the system from the vagina. This can be done by hooking your index finger under the edge of the system or grasping it between your index and middle fingers and pulling it out (Fig. 5). If the patient can locate the system in the vagina but is unable to remove it, she should contact her healthcare provider.
7. Dispose of the used system with household waste, preferably in the sealed pouch it originally came in. Do not flush Adaring down the toilet.

Figure 1
Remove system from pouch

Figure 2
Compress the system

Figure 3
Choose the most comfortable position

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

Figure 5
Remove the system from the vagina by hooking your index finger under the edge of the system or grasping it between your index and middle fingers and pulling it out.

3.2 Three weeks of use, one week off

1. The system should remain in the vagina for three consecutive weeks starting from the day of insertion.
2. After three weeks, it must be removed on the same day of the week and approximately at the same time as when it was inserted. For example, if Adaring was inserted on a Wednesday at about 10:00 PM, it should be removed also on a Wednesday, three weeks later, at about 10:00 PM.
3. After removal of the system, a one-week break should be taken. During this time, bleeding may occur, usually starting 2–3 days after removal.
4. A new system should be inserted exactly one week after the previous removal (on the same day of the week and approximately at the same time), even if bleeding is still ongoing.

If insertion of the new system is delayed by more than 3 hours, contraceptive effectiveness may be reduced. In such a case, follow the instructions provided in section 3.4 "What to do if, after the weekly break, the patient has forgotten to insert a new therapeutic vaginal system".
If Adaring is used according to the above recommendations, subsequent bleedings will typically occur on approximately the same days of the week.

3.3 When to insert the first Adaring vaginal ring

• No hormonal contraceptive was used in the previous cycle Insert Adaring on the first day of the natural cycle (i.e. the first day of menstruation). Adaring is effective from the moment of insertion. There is no need to use any additional contraceptive methods. It is also possible to start using Adaring between day 2 and day 5 of menstruation; however, in this case, an additional contraceptive method (such as a condom) must be used during the first 7 days of using Adaring. This recommendation applies only when starting Adaring for the first time.

• The patient used combined oral contraceptive tablets in the previous month Begin using Adaring no later than the day following the end of the active tablet-taking period of the currently used contraceptive. If the current preparation includes placebo tablets (without active ingredients), start using Adaring no later than the day after taking the last placebo tablet. In case of doubt about which tablet is the last, consult a doctor or pharmacist. Do not extend the tablet-free interval beyond the recommended duration. If the patient has taken her tablets regularly and is certain she is not pregnant, she may stop taking the tablets at any time and immediately start using Adaring.

• The patient used a transdermal patch (contraceptive patch) in the previous month Begin using Adaring no later than the day following the end of the transdermal patch application cycle. Do not extend the patch-free interval beyond the recommended duration. If the patient has used the transdermal patch regularly and is certain she is not pregnant, she may discontinue the patch at any time and immediately start using Adaring.

• The patient used a progestogen-only contraceptive (mini-pill) in the previous month The mini-pill may be discontinued at any time, and Adaring should be inserted the following day at the same time the mini-pill was usually taken. An additional contraceptive method (such as a condom) must be used during the first 7 days of using Adaring.

• The patient used an implant, injections, or an intrauterine system (IUS) releasing progestogen in the previous month Begin using Adaring on the day of the next scheduled injection or on the day of removal of the implant or intrauterine system releasing progestogen. An additional contraceptive method (such as a condom) must be used during the first 7 days of using Adaring.

• After childbirth After delivery, the doctor may recommend starting Adaring only after the first menstrual period. Sometimes it may be possible to start Adaring earlier, depending on the doctor's advice. If breastfeeding and wishing to use Adaring, discuss this with the doctor.

• After miscarriage As directed by the doctor.

3.4 What to do if…

Action to take if the system accidentally falls out of the vagina
Adaring may accidentally fall out of the vagina, for example, if it was inserted incorrectly, during tampon removal, during sexual intercourse, in case of constipation, or due to uterine prolapse. Therefore, it is important to regularly check whether the system is still in place inside the vagina (e.g. before and after intercourse).

Action to take if the system has been outside the vagina for some time
The vaginal therapeutic system Adaring may still provide protection against pregnancy, but this depends on how long it was outside the vagina.
If the system was outside the vagina for:

• less than 3 hours, the patient is still protected against pregnancy. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted as soon as possible, but only if it was outside the vagina for less than 3 hours.
• more than 3 hours during the first or second week of use, contraceptive effectiveness may have decreased. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted as soon as possible, and left in place continuously for at least 7 days. If the patient has sexual intercourse during these 7 days, a male condom should also be used. If the patient is in the first week of her cycle and had intercourse during the previous 7 days, there is a possibility she may be pregnant. In this case, she should contact her doctor.
• more than 3 hours during the third week of use, contraceptive effectiveness may have decreased. The vaginal therapeutic system should be removed, and one of the following two options should be chosen:

1. Insert a new vaginal therapeutic system as soon as possible. Inserting a new system means starting the next three-week treatment period. This may prevent the expected withdrawal bleeding, although breakthrough bleeding or spotting may occur.
2. Do not reinsert a vaginal therapeutic system. Wait for withdrawal bleeding to occur, and insert a new vaginal therapeutic system no later than 7 days after removal or expulsion of the previous one. This approach may only be used if the patient has used Adaring continuously for the last 7 days.

If the patient does not know how long Adaring was outside the vagina, she may not be protected against pregnancy. A pregnancy test should be performed and medical advice sought before inserting a new system.

Action to take if the vaginal therapeutic system is damaged
Adaring may become damaged. There have been reports of vaginal wall injury associated with damage to the vaginal therapeutic system. If the patient notices that Adaring is damaged, she should remove it and insert a new one as soon as possible. For the next 7 days, an additional contraceptive method (e.g. male condom) should be used. If sexual intercourse occurred before the damage was noticed, the patient should contact her doctor.

Action to take if more than one vaginal therapeutic system is inserted by mistake
There have been no reports of serious adverse effects related to overdose of the hormones contained in Adaring. If more than one vaginal therapeutic system is accidentally inserted, nausea, vomiting, or vaginal bleeding may occur. The additional vaginal therapeutic system should be removed, and the patient should contact her doctor if symptoms persist.

Action to take if the patient forgets to insert a new vaginal therapeutic system after the 7-day break
If the break in using the vaginal therapeutic system was longer than 7 days, a new system should be inserted as soon as possible. If sexual intercourse occurs within the next 7 days, an additional contraceptive method (e.g. male condom) should be used.
If sexual intercourse occurred during the break in using the vaginal therapeutic system, there is a risk of pregnancy. In this case, the patient should contact her doctor as soon as possible. The longer the break in using the vaginal therapeutic system, the higher the risk of pregnancy.

Action to take if the patient forgets to remove the vaginal therapeutic system on time

• If the system remained in the vagina longer than 3 weeks, but not longer than 4 weeks, the patient is still protected against pregnancy. The vaginal therapeutic system should be removed for one week, and then a new one inserted.
• If the patient used the vaginal therapeutic system for longer than 4 weeks, there is a risk of pregnancy. The patient should contact her doctor before inserting a new vaginal therapeutic system.

Action to take if withdrawal bleeding does not occur

• If the patient used Adaring correctly
  If withdrawal bleeding does not occur on schedule, but the patient used Adaring correctly and did not take any other medications during this time, the likelihood of pregnancy is very low. The patient should continue using Adaring as before. However, if withdrawal bleeding does not occur for two consecutive cycles, pregnancy is possible. The patient should contact her doctor as soon as possible. A new Adaring system should not be inserted until the doctor confirms the patient is not pregnant.
• If the patient used Adaring incorrectly
  If withdrawal bleeding does not occur during the first break in using Adaring, and the patient used the vaginal therapeutic system incorrectly, she may be pregnant. The patient should contact her doctor before using a new Adaring system.

Action to take if unexpected bleeding occurs
During use of the vaginal therapeutic system, some women may experience unexpected mid-cycle bleeding. The patient may need to use sanitary pads. The system should remain in the vagina and be used as usual. If irregular bleeding increases or recurs, the patient should contact her doctor.

Action to take if the patient wishes to change the day on which withdrawal bleeding starts
If Adaring is used correctly, menstrual periods (withdrawal bleeds) will occur during the weekly break from using the vaginal therapeutic system. If the patient wishes withdrawal bleeding to start on a different day, she may shorten the break (but never extend it!).
For example: if withdrawal bleeding usually starts on Friday, and the patient wishes to shift it to Tuesday (3 days earlier) next month, she should insert the new vaginal therapeutic system 3 days earlier than usual.
If the break in using the vaginal therapeutic system 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 therapeutic system, spotting (small drops or stains of blood) or mid-cycle bleeding may occur.
If the patient is unsure about what to do, she should consult her doctor.

Action to take if the patient wishes to delay withdrawal bleeding
Although not recommended, it is possible to delay menstruation (withdrawal bleeding) by inserting a new vaginal therapeutic system immediately after removing the previous one, without taking a break. The new vaginal therapeutic system may be used for no longer than 3 weeks. During this time, spotting (small drops or stains of blood) or mid-cycle bleeding may occur. To induce withdrawal bleeding, the vaginal therapeutic system should be removed.
A regular weekly break between consecutive systems is recommended.
Before deciding to delay menstruation, the patient may wish to consult her doctor.

3.5 What to do if a patient wishes to discontinue using Adaring

Adaring may be discontinued at any time.
If the patient does not wish to become pregnant, she should consult her doctor about alternative contraceptive methods.
If she stops taking Adaring because she wants to become pregnant, she should wait until her first menstrual period and only then start trying to conceive. This will help establish the due date.

4. Possible adverse effects

Like all medicines, Adaring may cause adverse effects, although not everyone experiences them. If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Adaring, medical advice should be sought from a doctor.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, see section 2, "Important information before using Adaring".

Immediate medical attention is required if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially accompanied by breathing difficulties (see also section "Warnings and precautions").

The following adverse effects have been reported in women using Adaring:

Common: may occur in up to 1 in 10 women

• Abdominal pain, nausea
• Vaginal fungal infections (such as "thrush"); discomfort due to 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 occur in up to 1 in 100 women

• Visual disturbances; dizziness
• Bloating; vomiting, diarrhoea or constipation
• Feeling tired, malaise or restlessness; mood changes; sudden mood swings
• Fluid retention (oedema)
• 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, as experienced 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 breast swelling or pain)
• 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 eruptions or hot flushes
• Urticaria

Rare: may occur in up to 1 in 1,000 women

• Harmful blood clots in veins or arteries, for example:
  o in the leg or foot (e.g. deep vein thrombosis);
  o in the lungs (e.g. pulmonary embolism);
  o heart attack;
  o stroke;
  o mini-stroke or transient ischaemic attack (TIA);
  o blood clots in the liver, stomach, 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 factors increasing the risk of blood clots and symptoms of clot formation).

• Galactorrhea (discharge of milk from the breast)

Unknown frequency (cannot be estimated from available data)

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

Breast cancer and liver tumours have been reported in women using combined hormonal contraceptives. For detailed information, see section 2.2 "Warnings and precautions", "Tumours".

Adaring may become damaged. For additional information, see section 3.4 "Management in case of damage to the vaginal therapeutic system".

Reporting of adverse effects

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

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL: 02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl.

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

Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Adaring

Keep this medicine out of the sight and reach of children.
Contact a doctor if a child is exposed to the hormones contained in Adaring.
There are no special storage temperature requirements for this medicine. Store in the original packaging to protect from light.
Adaring should be used (inserted) no later than one month before the expiry date stated on the box and sachet, following "EXP". The expiry date refers to the last day of the stated month. The batch number is indicated on the packaging after the abbreviation "Lot". After opening, the sachet should be kept for later use, e.g. for temporary storage of the Adaring vaginal ring when removed from the vagina, and for its disposal.
Do not use Adaring if you notice any change in colour or any signs of deterioration.
This medicinal product may pose a risk to the environment. After removal of the Adaring vaginal ring from the vagina, it should be placed into the sachet and the sachet securely closed. The closed sachet should then be carefully disposed of according to local requirements (i.e. with household waste or returned to a pharmacy for proper disposal) in such a way as to avoid exposure of other people. Do not flush the Adaring vaginal ring down the toilet or into the sewage system. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Adaring contains

• The active substances are: etonogestrel and ethinylestradiol.
  Adaring contains 8.25 mg of etonogestrel and 2.60 mg of ethinylestradiol.
  Etonogestrel and ethinylestradiol are released from the vaginal therapeutic system at a rate of 0.120 mg and 0.015 mg per day over a 3-week period.
• Other components are: ethylene vinyl acetate copolymer (28% vinyl acetate) and polyurethane (a type of synthetic polymer that does not dissolve in the body).

What Adaring looks like and contents of the pack
Vaginal therapeutic system.
Adaring is a soft, flexible, transparent, colourless or almost colourless ring with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm.
Each vaginal therapeutic system is individually packed in an aluminium foil sachet. The sachet is placed in a cardboard box together with the package leaflet and calendar stickers to help you remember when to insert and remove the vaginal therapeutic system.
Pack sizes:
1 vaginal therapeutic system
3 vaginal therapeutic systems
6 vaginal therapeutic systems
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Laboratorios León Farma, S.A.
c/La Vallina s/n, Poligono Industrial Navatejera
24193 - Villaquilambre, León
Spain
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

This medicinal product is authorised in the European Economic Area under the following names:
Netherlands: Nilho 0.120 mg / 0.015 mg per 24 hours, vaginal ring
Czech Republic: Teyla
Finland: Vagiprev 0.120 mg / 0.015 mg per 24 tuntia, depotlääkevalmiste, emättimeen
Denmark: Vagiprev 0.120 / 0.015 mg microg./24 timer
Ireland: Etonogestrel/Ethinylestradiol 0.120 / 0.015 mg per 24 hours, vaginal delivery system
United Kingdom: SyreniRing 0.120 mg / 0.015 mg per 24 hours
Hungary: Ringinel 0.120 mg/0.015 mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer
Norway: Etonogestrel/Ethinylestradiol Chemo 0.120 mg/0.015 mg per 24 timer, vaginalinnlegg
Slovakia: Teyla 0.120 mg/0.015 mg za 24 hodín vaginálny inzert
Romania: Teyla 0.120 mg/0.015 mg / 24 de ore sistem cu cedare vaginală
Poland: Adaring