Ginoring

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Ginoring, (0.120 mg + 0.015 mg)/24 h, intrauterine therapeutic system
Etonogestrel + Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots").

The leaflet should be read carefully before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for the person it is intended for. It should not be passed on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

The name of this medicine is given above, but in the rest of the leaflet, the name Ginoring will be used.

Table of contents of the leaflet

• 1.

What is Ginoring and what is it used for

• 2.

Important information before using Ginoring

• 2.1 When not to use Ginoring
• 2.2 Warnings and precautions Blood clots Cancer
• 2.3 Children and adolescents
• 2.4 Ginoring and other medicines Diagnostic tests
• 2.5 Pregnancy and breastfeeding
• 2.6 Driving and using machines
• 3.

How to use Ginoring

• 3.1 Insertion and removal of Ginoring
• 3.2 Three weeks of use, one week of break
• 3.3 When to insert the first intrauterine therapeutic system
• 3.4 What to do if… Procedure in case of accidental expulsion of the system from the vaginaProcedure when the system has been out of the vagina for some timeProcedure in case of damage to the intrauterine therapeutic systemUse of more than the recommended number of Ginoring systemsOmission of the application of a new intrauterine therapeutic system after a break in its useProcedure when the patient forgets to remove the intrauterine therapeutic system on time

Procedure in case of absence of bleeding
Procedure in case of unexpected bleeding
Procedure in case of change in the day of bleeding
Procedure in case of desire to delay the onset of bleeding

• 3.5 Discontinuation of Ginoring
• 4.

Possible side effects

• 5.

How to store Ginoring

• 6.

Package contents and other information

What Ginoring contains
What Ginoring looks like and what the package contains
Responsible entity and manufacturer

1. What is Ginoring and what is it used for

Ginoring is a contraceptive in the form of an intrauterine therapeutic system, preventing pregnancy. Each intrauterine 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 small dose of hormones released, Ginoring is classified as a low-hormone contraceptive. Ginoring is called a combined contraceptive because it releases two different hormones.
Ginoring works like a combined oral contraceptive (combined pill), but unlike a pill that needs to be taken every day, the intrauterine therapeutic system is used for 3 weeks in a row.
Ginoring releases two female sex hormones that inhibit the release of egg cells from the ovaries. The patient cannot become pregnant because the egg cells are not released.

2. Important information before using Ginoring

General notes

Before starting to use Ginoring, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots - see section 2 "Blood clots".
This leaflet describes many situations in which Ginoring should be discontinued or its effectiveness may be reduced. In these situations, sexual intercourse should be avoided or an additional non-hormonal contraceptive method should be used, such as a condom or another mechanical method. Do notuse methods based on a calendar or body temperature measurement. They may be ineffective because Ginoring affects changes in body temperature and cervical mucus consistency throughout the month.

Ginoring, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

2.1 When not to use Ginoring

Ginoring should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will 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 they have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobilized for a long time (see section "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if the patient has (or has had) a type of migraine called "migraine with aura";
• if the patient has (or has had) pancreatitis associated with high levels of fats in the blood;
• if the patient has (or has had) severe liver disease ,and liver function has not returned to normal;
• if the patient has (or has had) a benign or malignant liver tumor;
• if the patient has (or has had) breast cancer or genital cancer, or if there is a suspicion of these cancers;
• if the patient has unexplained vaginal bleeding;
• 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 the use of Ginoring, the system should be removed from the vagina immediately and a doctor should be consulted. During this time, a non-hormonal contraceptive method can be used.
The use of the Ginoring intrauterine therapeutic system is contraindicated in the case of concomitant use of medicines containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, and glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir (see section 2.4 "Ginoring and other medicines").

• 2.4 "Ginoring and other medicines").

2.2 Warnings and precautions

When should a doctor be contacted?
A doctor should be contacted immediately

• if the patient notices possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), a blood clot in the lungs (pulmonary embolism), a heart attack, or a stroke (see section "Blood clots").

In order to obtain a description of the symptoms of these serious side effects, see the section "How to recognize the occurrence of blood clots".

The doctor should be informed if the patient has any of the following conditions.

If these symptoms occur or worsen during the use of Ginoring, the doctor should also be informed.

• if breast cancer has occurred in a close family member;
• if the patient has epilepsy (see section 2.4 "Ginoring 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 (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient requires surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, as they are at increased risk of blood clots. The doctor should be consulted to determine how soon Ginoring can be started after giving birth;
• if the patient has superficial thrombophlebitis (inflammation of the veins under the skin);
• if the patient has varicose veins;
• if the patient has diseases that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disease], pregnancy herpes [a blistering skin rash during pregnancy], Sydenham's chorea [a neurological disorder characterized by involuntary, violent movements of the body],
• if the patient currently has or has had chloasma (brownish-yellow spots, so-called "pregnancy spots", especially on the face). If they occur, excessive sun exposure and ultraviolet radiation should be avoided;
• if the patient has conditions that make it difficult to use Ginoring - e.g., frequent constipation, cervical prolapse, pain during intercourse;
• if the patient experiences sudden, frequent need to urinate with a burning sensation and (or) pain, and if the patient cannot locate the intrauterine therapeutic system in the vagina. These symptoms may indicate that the intrauterine therapeutic system has been accidentally inserted into the urinary bladder;
• if the patient experiences symptoms of angioedema, such as facial swelling, tongue and (or) throat swelling, and (or) difficulty swallowing, as well as skin rash and breathing problems, they should contact their doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Ginoring, is associated with an increased risk of blood clots, compared to a situation where no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

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

Not all patients recover fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the total risk of harmful blood clots caused by Ginoring is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

A doctor should be contacted immediately if any of the following symptoms are noticed.

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur most often in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to a situation where combined hormonal contraceptives are not used.
If the patient stops using Ginoring, the risk of blood clots returns to a normal level within a few weeks.

What factors affect the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The total risk of blood clots in the legs or lungs associated with Ginoring is small.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 6 to 12 out of 10,000 women who use combined hormonal contraceptives containing ethinylestradiol or etonogestrel, such as Ginoring, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Ginoring is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, the patient may have hereditary coagulation disorders;
• if the patient must undergo surgery, is immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Ginoring for a few weeks before surgery or immobilization. If the patient must discontinue Ginoring, they should ask their doctor when they can resume using the medicine;
• with age (especially over 35 years);
• if the patient has recently given birth.

The risk of 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 another risk factor.
It is essential to inform the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to discontinue Ginoring.
The doctor should be informed if any of the above conditions change during the use of Ginoring, e.g., if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similarly, as in the case of blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to emphasize that the risk of a heart attack or stroke associated with Ginoring is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. During the use of a hormonal contraceptive like Ginoring, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50). In this case, the patient may also be at increased risk of a heart attack or stroke;
• if the patient or someone in their close family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia called 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 even higher.
The doctor should be informed if any of the above conditions change during the use of Ginoring, e.g., if the patient starts smoking, someone in the patient's close family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

CANCER

The following information has been obtained from studies using combined contraceptives and may also apply to Ginoring. Information on the intrauterine use of hormonal contraceptives (as in the case of Ginoring) is not yet available.
Among women using combined contraceptives, breast cancer has been found to occur slightly more often, although it is not known whether this is caused by the medicine being used. It is possible that women using combined contraceptives are more likely to have breast cancer detected because they undergo medical examinations more frequently.
The increased incidence of breast cancer decreases gradually after discontinuing combined contraceptives.
Regular breast examination is very important. If a lump is detected, a doctor should be consulted. The doctor should also be informed if someone in the patient's close family has had or has breast cancer (see section 2.2 "Warnings and precautions").
In rare cases, women using combined contraceptives have been found to have benign liver tumors, and very rarely, malignant liver tumors as well. If unusual, severe abdominal pain occurs, a doctor should be consulted.
There have been reports that women using combined contraceptives are less likely to develop endometrial cancer (cancer of the lining of the uterus) and ovarian cancer. It is possible that this also applies to Ginoring, but this has not been confirmed yet.

PSYCHIATRIC DISORDERS:

Some women using hormonal contraceptives, including Ginoring, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, a doctor should be consulted as soon as possible to obtain further medical advice.

2.3 Children and adolescents

The safety and efficacy of Ginoring have not been studied in adolescents under the age of 18.

2.4 Ginoring and other medicines

The doctor prescribing Ginoring should be informed about the use of other medicines and herbal products. The doctor of another specialty or dentist or pharmacist should also be informed about the use of Ginoring when prescribing other medicines. They may inform about the need to use an additional contraceptive method (e.g., condoms for men), and if so, for how long, as well as whether it is necessary to modify the use of another medicine.
Some medicines may

• affect the level of Ginoring in the blood;
• reduce its contraceptive effectiveness;
• cause unexpected bleeding.

This applies to 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 moods (St. John's wort).

If the patient is taking medicines or herbal products that may reduce the effectiveness of Ginoring, they should also use a mechanical contraceptive method (e.g., condoms for men). Since the effect of another medicine on Ginoring may persist for up to 28 days after discontinuing the medicine, it is necessary to use an additional mechanical contraceptive method during this time. Note: Ginoring should not be used with a diaphragm, cervical cap, or female condom.
Ginoring may affect the action of other medicines, such as:

• medicines containing cyclosporine,
• the antiepileptic medicine lamotrigine (which may lead to an increased frequency of seizures).

Ginoring should not be used in patients with hepatitis C virus infection who are using medicines containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, and glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (elevated liver enzyme activity). Before starting these medicines, the doctor will prescribe a different type of contraception.
The use of the Ginoring intrauterine therapeutic system can be resumed after about 2 weeks from the end of the above-mentioned treatment. See section 2.1 "When not to use Ginoring".
Before taking any medicine, a doctor or pharmacist should be consulted.
During the use of Ginoring, tampons can be used at the same time. Ginoring should be inserted before inserting a tampon.
Caution should be exercised when removing a tampon to avoid accidentally removing the Ginoring system as well. If the system is expelled, it can be washed with cold or lukewarm water and reinserted as soon as possible.
Damage to the intrauterine therapeutic system has occurred during the use of vaginal products, such as moisturizers or treatments for infections (see section 3.4 "Procedure in case of damage to the intrauterine therapeutic system"). The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of Ginoring.

Diagnostic tests

If laboratory tests of blood or urine are performed, the person performing the test should be informed about the use of Ginoring, as it may affect the results of some laboratory tests.

2.5 Pregnancy and breastfeeding

Ginoring should not be used during pregnancy or if the patient suspects that they may be pregnant. If the patient becomes pregnant during the use of Ginoring, the intrauterine therapeutic system should be removed and a doctor should be consulted.
If the patient wants to discontinue Ginoring because they want to become pregnant, they should read section 3.5 "Discontinuation of Ginoring".
The use of Ginoring is not recommended during breastfeeding. If the patient wants to use Ginoring during breastfeeding, they should consult their doctor first.

2.6 Driving and using machines

Ginoring does not affect the ability to drive or use machines.

3. How to use Ginoring

This medicine should always be used as directed by a doctor. In case of doubts, a doctor or pharmacist should be consulted.
Ginoring can be inserted and removed by the patient themselves. The doctor will instruct when to start using Ginoring. The intrauterine therapeutic system should be inserted on the appropriate day of the cycle (see section 3.3 "When to insert the first intrauterine therapeutic system") and left in place for 3 weeks in a row. The patient should regularly check that the intrauterine therapeutic system is in place (e.g., before and after sexual intercourse) to ensure that they are protected against pregnancy. After 3 weeks, Ginoring should be removed and a 1-week break should be taken. Usually, withdrawal bleeding occurs during this break.
Certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom, should not be used during the use of Ginoring. These methods should not be used as additional contraceptive methods because Ginoring may make it difficult to properly insert and position the diaphragm, cervical cap, or female condom. However, a condom for men can be used as an additional mechanical contraceptive method.

3.1 Insertion and removal of Ginoring

• 1. Before insertion, the expiration date should be checked (see section 5 "How to store Ginoring").
• 2. Before insertion or removal, the hands should be washed.
• 3. The most comfortable position for insertion should be chosen, e.g., standing with one leg raised, squatting, or lying down.
• 4. Ginoring should be removed from the pouch. The pouch should not be discarded, as it will be used later.
• 5. Holding the system with the thumb and index finger, it should be squeezed and inserted into the vagina (see Figures 1-4). The correct position of Ginoring is one in which it is not felt. If the system is uncomfortable, it should be pushed gently further into the vagina. The position of the system in the vagina does not affect its contraceptive effectiveness.
• 6. After 3 weeks, Ginoring should be removed from the vagina. This can be done by hooking the finger under the edge of the system or by grasping it with the index and middle fingers and pulling it out (see Figure 5). If the patient locates the system in the vagina but is unable to remove it, they should contact their doctor.
• 7. The used system should be discarded with household waste, preferably in the pouch. Ginoring should not be flushed down the toilet.

Figure 1. Remove the system from the pouch

Figure 2. Squeeze the system

Figure 3. Choose the most comfortable position for insertion

Figure 4A
Figure 4B
Figure 4C
Insert the system into the vagina with one hand (Figure 4A), if necessary, using the other hand to spread the labia. Place it inside the vagina so that it does not cause discomfort (Figure 4B). Leave the system in the vagina for 3 weeks (Figure 4C).

Figure 5. Remove Ginoring from the vagina, hooking the finger under the edge of the system or grasping it with the index and middle fingers and pulling it out.

3.2 Three weeks of use, one week of break

• 1. The system should be in the vagina for 3 weeks without interruption, counting from the day of insertion.
• 2. After 3 weeks, it should be removed on the same day of the week it was inserted, at approximately the same time. For example, if Ginoring was inserted on a Wednesday at around 10:00 PM, it should be removed on the same Wednesday 3 weeks later, at around 10:00 PM.
• 3. After removing the system, a 1-week break should be taken. During this time, bleeding may occur. It usually starts 2-3 days after removing Ginoring.
• 4. A new system should be inserted exactly 1 week after the break (on the same day of the week as usual and at approximately the same time), even if bleeding is still present.

In case of a delay in inserting a new system by more than 3 hours, its contraceptive effectiveness may be reduced. In such a case, the instructions in section 3.4 "Procedure when the patient forgets to insert a new intrauterine therapeutic system after a break in its use" should be followed.
If Ginoring is used as directed, subsequent bleeding will occur at approximately the same days of the week.

3.3 When to insert the first intrauterine therapeutic system

• The patient did not use a hormonal contraceptive in the previous cycle. The first Ginoring system should be inserted on the first day of the natural cycle (i.e., the first day of menstruation). Ginoring is effective from the moment of insertion. There is no need to use any additional contraceptive methods. Ginoring can also be started between the 2nd and 5th day of the cycle, but in this case, an additional contraceptive method (such as a condom) should be used during the first 7 days of using Ginoring. This recommendation only applies to the first use of Ginoring.
• The patient used combined hormonal contraceptive pills in the previous month. The use of Ginoring should be started no later than the day following the break in taking the currently used medicine. If the currently used medicine also contains pills that do not contain active substances, the use of Ginoring should be started no later than the day after taking the last pill that does not contain active substances. In case of doubts about which pill is which, the doctor or pharmacist should be consulted. The break in taking the current pills should not be extended beyond the recommended period. If the patient has been taking their pills regularly and is sure they are not pregnant, they can stop taking the pills on any day and start using Ginoring immediately.
• The patient used a transdermal system (patch) in the previous month. The use of Ginoring should be started no later than the day following the break in using the transdermal system. The break in using the transdermal system should not be extended beyond the recommended period. If the patient has been using the transdermal system regularly and is sure they are not pregnant, they can stop using the transdermal system on any day and start using Ginoring immediately.
• The patient used a progestogen-only contraceptive (minipill) in the previous month. The minipill can be stopped on any day, and Ginoring can be started the next day at the same time the minipill was taken. During the first 7 days of using Ginoring, an additional contraceptive method (such as a condom) should be used.
• The patient used an implant, injections, or an intrauterine system releasing progestogen in the previous month. The use of Ginoring should be started on the day of the next planned injection or on the day the implant or intrauterine system is removed. During the first 7 days of using Ginoring, an additional contraceptive method (such as a condom) should be used.
• After giving birth. After giving birth, the doctor may recommend using Ginoring only after the first menstruation. Sometimes, the use of Ginoring can be started earlier. The doctor will recommend when. If the patient is breastfeeding and wants to use Ginoring, they should discuss this with their doctor.
• After a miscarriage. According to the doctor's instructions.

3.4 What to do if…

3.5 Discontinuation of Ginoring

The use of Ginoring can be discontinued at any time. If the patient does not want to become pregnant, she should ask her doctor about other contraceptive methods. If the patient discontinues the use of Ginoring because she wants to become pregnant, she should wait until the first menstruation and only then start trying to become pregnant. This will help determine the date of birth.

4. Possible adverse reactions

Like any medication, Ginoring can cause adverse reactions, although they do not occur in everyone. If any adverse reactions occur, especially severe and persistent ones or changes in health status that the patient considers related to the use of Ginoring, the patient should consult a doctor. All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). To obtain detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using Ginoring". The patient should contact a doctor immediately if she experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or skin rash, and breathing problems (see section "Warnings and precautions"). Women using Ginoring have reported the following adverse reactions. Frequent: may occur in no more than 1 in 10 women

• abdominal pain, nausea;
• vaginal infections by fungi (fungal changes); discomfort caused by the presence of the system in the vagina; itching of the genital organs; discharge;
• headache or migraine; depressive mood; decreased libido;
• breast pain; pelvic pain; painful menstruation;
• acne;
• weight gain;
• expulsion of the system.

Infrequent: may occur in no more than 1 in 100 women

• vision disturbances; dizziness;
• bloating; vomiting, diarrhea, or constipation;
• feeling of fatigue, malaise, or excitement; mood changes; sudden mood changes;
• fluid retention in the body (edema);
• urinary tract infections;
• problems or pain during urination; urgency to urinate or need to urinate; frequent urination;
• discomfort during intercourse, including pain, bleeding, or inconvenience related to the presence of the system felt by the partner;
• increased blood pressure;
• increased appetite;
• back pain; muscle cramps; pain in the lower or upper limbs;
• decreased skin sensitivity;
• breast tenderness or enlargement; fibrocystic breast disease (cysts that can cause swelling or pain in the breast);
• cervicitis; cervical polyps; cervical erosion;
• changes in menstrual bleeding (e.g., heavy, prolonged, irregular, or complete absence of menstruation); discomfort in the pelvic area; premenstrual syndrome; uterine cramps;
• vaginal infections (fungal or bacterial); feeling of burning, unpleasant odor, pain, discomfort, or dryness of the vagina or vulva;
• hair loss, rash, itching, or flushing;
• hives.

Rare: may occur in no more than 1 in 1000 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; mini-stroke or transient symptoms of stroke, known as a transient ischemic attack; blood clots in the liver, stomach, intestine, kidneys, or eye. The risk of blood clots may be higher if the patient has other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

o
in the lungs (e.g., pulmonary embolism);
o
heart attack;
o
stroke;
o
mini-stroke or transient symptoms of stroke, known as a transient ischemic attack;
o
blood clots in the liver, stomach, intestine, kidneys, or eye.
The risk of blood clots may be higher if the patient has other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

• galactorrhea

Frequency not known (frequency cannot be estimated from the available data)

• chloasma (brownish-yellow spots on the skin, especially on the face);
• discomfort in the partner's penis (symptoms such as irritation, rash, itching);
• inability to remove the vaginal therapeutic system without medical assistance (e.g., due to the vaginal therapeutic system adhering to the vaginal wall)
• vaginal wall damage related to damage to the vaginal therapeutic system

Women using combined hormonal contraceptives have reported breast cancer and liver tumors. For detailed information, refer to section 2.2 "Warnings and precautions", "Tumors". Ginoring may be damaged. For additional information, refer to section 3.4 "Procedure in case of damage to the vaginal therapeutic system".

Reporting adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should tell her doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting adverse reactions, more information can be collected on the safety of the medication. Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Ginoring

The medication should be stored out of sight and reach of children. A doctor should be consulted in case of suspected exposure of a child to the hormones contained in Ginoring. This medication has no special storage temperature requirements. Store in the original packaging to protect from light. The Ginoring system can be used if there is at least one month left until the expiration date, which is indicated on the box and sachet after the abbreviation "EXP". The expiration date indicates the last day of the specified month. The batch number is indicated on the packaging after the abbreviation "Lot". Do not use this medication if a change in the color of the system or any signs of damage are noticed. This medication may pose a risk to the environment. After removing Ginoring, it should be placed in the sachet and closed tightly. The closed sachet should then be disposed of with normal waste or returned to a pharmacy for disposal in special containers in accordance with local regulations. Ginoring should not be flushed down the toilet. As with other medications, unused or expired systems should not be disposed of in the sewage system or household waste containers. The patient should ask her pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ginoring contains

• The active substances of Ginoring are etonogestrel and ethinylestradiol. Ginoring contains 8.25 mg of etonogestrel and 2.60 mg of ethinylestradiol. The vaginal therapeutic system releases etonogestrel and ethinylestradiol in an average amount of 0.120 mg and 0.015 mg, respectively, over 24 hours, for a period of 3 weeks.
• Other ingredients are: ethylene and vinyl acetate copolymer, 28% vinyl acetate, and polyurethane (a type of plastic that is not soluble in the human body).

What Ginoring looks like and what the packaging contains

Vaginal therapeutic system. Ginoring is a flexible, transparent, and colorless or almost colorless ring (system), with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. Each ring is packaged in an aluminum sachet. The sachet is packaged in a carton with this leaflet and calendar stickers to help remember when to insert and remove the vaginal therapeutic system. Each package contains: 1 system; 3 systems; 6 systems.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o. Szamocka 8, 01-748 Warsaw

Manufacturer

Laboratorios León Farma, S.A. c/La Vallina s/n, Polígono Industrial Navatejera; 24193 Villaquilambre, León, Spain

This medication is authorized for distribution in the member states of the European Economic Area under the following names:

Austria: GinoRing Vaginalring 0.120 mg/0.015 mg pro 24 Stunden vaginales Wirkstofffreisetzungssystem; Czech Republic: Ornibel; Denmark: Ornibel; Estonia: Ornique; Finland: Ornibel 0.120 mg / 0.015 mg per 24 tuntia, depotlääkevalmiste, emättimeen; Netherlands: Etonogestrel/ethinylestradiol Exeltis 0,120/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik; Iceland: Ornibel; Lithuania: Ornique 120/15 mikrogramų/24 valandas vartojimo į makštį sistema; Latvia: Ornique 120/15 mikrogrami vaginālās ievadīšanas sistēma; Germany: GinoRing 0.120/0.015 mg pro 24 Studen vaginales Wirkstofffreisetzungssystem; Norway: Ornibel; Poland: Ginoring; Slovakia: Ornibel 0.120/0.015 mg za 24 hodín vaginálny inzert; Sweden: Ornibel 0,120 mg/0,015 mg per 24 timmar vaginalinlägg; Hungary: Ladeering 0.120/0.015 mg 24 óra hüvelyben alkalmazott gyógyszerleadó rendszer; Date of last update of the leaflet:28.11.2024