Ginoring

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-dose hormonal 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 you should stop using Ginoring or in which its effectiveness may be reduced. In these situations, you should refrain from sexual intercourse or use an additional non-hormonal contraceptive method, 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

You should not use Ginoring if you have any of the following conditions. If you have any of the following conditions, you should inform your doctor. The doctor will discuss with you which other contraceptive method will 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 coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you have had a heart attack or stroke;
• if you have angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient symptoms of a stroke);
• if you have 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 you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) pancreatitis associated with high levels of fats in the blood;
• if you have (or have had) severe liver disease, and liver function has not returned to normal;
• if you have (or have had) a benign or malignant liver tumor;
• if you have (or have had) breast cancer or cancer of the genital organs, or if such cancers are suspected;
• if you have bleeding from the genital tract of unknown cause;
• if you are allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this drug (listed in section 6). If any of the above symptoms occur for the first time during the use of Ginoring, you should immediately remove the system from the vagina and consult a doctor. 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 drugs containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, and glecaprevir/pibrentasvir (see section 2.4 "Ginoring and other drugs").

2.2 Warnings and precautions

When should you contact your doctor?
You should see your doctor immediately

• if you notice possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack, or a stroke (see "Blood clots"). To find a description of these serious side effects, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen during the use of Ginoring, you should also tell your doctor.

• if breast cancer is present or has occurred in close relatives;
• if you have epilepsy (see section 2.4 "Ginoring and other drugs");
• 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 that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or if you have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you have recently given birth, in which case you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start using Ginoring after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have diseases that first occurred or worsened during pregnancy or previous use of sex hormones (e.g., loss of hearing, porphyria [a blood disease], herpes gestationis [a blistering skin rash during pregnancy], Sydenham's chorea [a neurological disorder characterized by involuntary, violent movements of the body]),
• if you currently have or have had chloasma (yellow-brown pigmentation spots, so-called "pregnancy spots", especially on the face). If they occur, you should avoid excessive sun exposure and ultraviolet radiation;
• if you have conditions that make it difficult to use Ginoring - e.g., frequent constipation, cervical prolapse, pain during intercourse;
• if you experience sudden, frequent need to urinate with a burning sensation and/or pain, and if you cannot locate the intrauterine therapeutic system in the vagina. These symptoms may indicate that the intrauterine therapeutic system has been accidentally inserted into the bladder;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing, and/or skin rash, and/or breathing difficulties, you should contact your doctor immediately. Drugs 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 when 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 who have a blood clot will recover fully. 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 A BLOOD CLOT

You should see your doctor immediately if you notice any of the following symptoms.

Are you experiencing any of these symptoms? What might be the reason for your condition?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis

BLOOD CLOTS IN VEINS

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause 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 drug) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to when combined hormonal contraceptives are not used.
If you stop using Ginoring, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

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

• if you are significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in your immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, you may have hereditary blood coagulation disorders;
• if you need to have surgery, if you are immobilized for a long time due to injury or illness, or if you have a leg in a cast. It may be necessary to stop using Ginoring for a few weeks before surgery or immobilization. If you need to stop using Ginoring, you should ask your doctor when you can resume using the drug;
• with age (especially over 35 years);
• if you have recently given birth. The risk of blood clots increases with the number of risk factors present. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor. It is essential to tell your doctor if any of the above factors apply to you, even if you are not sure. Your doctor may decide to stop using Ginoring. You should inform your doctor if any of the above conditions change during the use of Ginoring, e.g., if someone in your immediate family is diagnosed with thrombosis without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

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

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

Factors that increase the risk of blood clots in arteries

It is essential to note 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 you smoke.While using a hormonal contraceptive like Ginoring, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change during the use of Ginoring, e.g., if you start smoking, if someone in your immediate family is diagnosed with thrombosis without a known cause, or if you gain significant weight.

Cancer

The following information was obtained from studies using combined hormonal 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 hormonal contraceptives, breast cancer has been found to occur slightly more often, although it is not known whether this is caused by the drug being used. It is possible that women using combined hormonal contraceptives are more likely to have breast cancer detected because they are more likely to have medical examinations.
The increased frequency of breast cancer in women using combined hormonal contraceptives gradually decreases after stopping the use of combined hormonal contraceptives.
Regular breast examination is very important. If a lump is found, you should contact your doctor. You should also inform your doctor if breast cancer has occurred or occurs in close relatives (see section 2.2 "Warnings and precautions").
In rare cases, women using combined hormonal contraceptives have been found to have benign liver tumors, and very rarely, malignant liver tumors as well. If you experience unusual, severe abdominal pain, you should contact your doctor.
There are reports that women using combined hormonal contraceptives are less likely to have endometrial cancer (cancer of the lining of the uterus) and ovarian cancer. It is possible that this also applies to Ginoring, but it 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, you should contact your doctor as soon as possible for further medical advice.

2.3 Children and adolescents

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

2.4 Ginoring and other drugs

You should inform your doctor about the use of other drugs and herbal products. You should also inform your doctor of another specialty or dentist or pharmacist if other drugs are prescribed. They may inform you about the need to use an additional contraceptive method (e.g., a condom for men), and if so, for how long, as well as whether it is necessary to modify the use of another drug.
Some drugs may

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

This applies to drugs 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 you are taking drugs or herbal products that may reduce the effectiveness of Ginoring, you should use a mechanical contraceptive method (e.g., a condom for men) as well. Due to the fact that the effect of another drug on Ginoring may persist for up to 28 days after stopping the drug, it is necessary to use additional mechanical contraception during this time. Note: Ginoring should not be used with a diaphragm, cervical cap, or female condom. Ginoring may affect the action of other drugs, such as:

• drugs containing cyclosporine,
• the antiepileptic drug lamotrigine (this may lead to an increased frequency of seizures). You should not use Ginoring if you have viral hepatitis C and are taking drugs containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, and glecaprevir/pibrentasvir, as this may cause liver function test abnormalities (elevated liver enzyme ALT). Your doctor will recommend using a different contraceptive method before starting these drugs. The Ginoring intrauterine therapeutic system can be reinserted about 2 weeks after stopping these drugs. See section 2.1 "When not to use Ginoring".

Before taking any medication, you should consult your doctor or pharmacist.
During the use of Ginoring, you can also use tampons. You should insert Ginoring before inserting a tampon.
You should be careful when removing a tampon to avoid accidentally removing the Ginoring system as well. If the system is expelled, you can rinse it with cold or warm water and reinsert it as soon as possible.
Damage to the intrauterine therapeutic system has occurred during the use of vaginal products, such as lubricants or treatments for infections (see section 3.4 "What to do if..."). The use of spermicides or vaginal antifungal drugs does not reduce the contraceptive effectiveness of Ginoring.

Diagnostic tests

If laboratory tests of blood or urine are performed, you should inform the persons performing the tests about the use of Ginoring, as it may affect the results of some laboratory tests.

2.5 Pregnancy and breastfeeding

You should not use Ginoring if you are pregnant or think you may be pregnant. If you become pregnant during the use of Ginoring, you should remove the intrauterine therapeutic system and contact your doctor.
If you want to stop using Ginoring because you want to become pregnant, you should read section 3.5 "Discontinuation of Ginoring".
Ginoring is not recommended during breastfeeding. If you want to use Ginoring during breastfeeding, you should consult your doctor first.

2.6 Driving and using machines

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

3. How to use Ginoring

Ginoring can be inserted and removed by yourself. Your doctor will instruct you on 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. You should regularly check that the intrauterine therapeutic system is in place (e.g., before and after sexual intercourse) to ensure that you are protected against pregnancy. After 3 weeks, you should remove Ginoring and take a 1-week break. Usually, withdrawal bleeding occurs during the break.
You should not use certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom, while using Ginoring. You should not use these mechanical contraceptive methods as an additional contraceptive method because Ginoring may make it difficult to properly insert and position the diaphragm, cervical cap, or female condom. However, you can use a condom for men as an additional mechanical contraceptive method.

3.1 Insertion and removal of Ginoring

• 1. Before insertion, you should check the expiration date (see section 5 "How to store Ginoring").
• 2. Before inserting or removing the system, you should wash your hands.
• 3. You should choose the most comfortable position for insertion, e.g., standing with one leg raised, squatting, or lying down.
• 4. Remove Ginoring from the pouch. Do not throw away the pouch, as it will be used later.
• 5. Holding the system with your thumb and index finger, you should squeeze it and insert it into the vagina (see Figures 1-4). The correct position of Ginoring is one in which you do not feel it. If the system is uncomfortable, you should gently push it further into the vagina. The position of the system in the vagina does not affect its contraceptive effectiveness.
• 6. After 3 weeks, you should remove Ginoring from the vagina. You can do this by hooking your index finger under the edge of the system or by grasping it with your index and middle fingers and pulling it out (see Figure 5). If you locate the system in the vagina but are unable to remove it, you should contact your doctor.
• 7. Dispose of the used system with other household waste, preferably in the pouch. Do not flush Ginoring 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 your index finger under the edge of the system or grasping it with your 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, you should remove it on the same day of the week that it was inserted, and at about the same time. For example, if Ginoring was inserted on a Wednesday at around 10:00 PM, it should be removed on the following Wednesday, 3 weeks later, at around 10:00 PM.
• 3. After removing the system, you should take a 1-week break in using the system. During this time, you may experience bleeding. 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 about the same time), even if bleeding is still present. If the insertion of the new system is delayed by more than 3 hours, its contraceptive effectiveness may be reduced. In such a case, you should follow the instructions in section 3.4 "What to do if...". If you use Ginoring according to the above instructions, subsequent bleeding will occur at approximately the same days of the week.

3.3 When to insert the first intrauterine therapeutic system

• The previous cycle did not involve the use of a hormonal contraceptiveInsert Ginoring for the first time on the first day of your natural cycle (i.e., the first day of your period). Ginoring is effective from the moment of insertion. There is no need to use any additional contraceptive methods. You can also start using Ginoring between the 2nd and 5th day of your cycle, but in this case, you should use an additional contraceptive method (such as a condom) during the first 7 days of using Ginoring. This recommendation only applies to the first use of Ginoring.
• Last month you used combined hormonal contraceptive pillsYou should start using Ginoring no later than the day following the end of the use of your current contraceptive. If your current contraceptive has pills that do not contain active substances, you should start using Ginoring no later than the day after taking the last pill that does not contain active substances. If you are unsure which pill is which, you should ask your doctor or pharmacist. Do not extend the break in using your current pills beyond the recommended period. If you have been taking your pills regularly and are sure you are not pregnant, you can stop taking the pills on any day and start using Ginoring immediately.

If you have been using your pills regularly and are sure you are not pregnant, you can stop taking the pills on any day and start using Ginoring immediately.

• Last month you used a transdermal system (patch)You should start using Ginoring no later than the day following the end of the use of the transdermal system. Do not extend the break in using the transdermal system beyond the recommended period. If you have been using the transdermal system regularly and are sure you are not pregnant, you can stop using the transdermal system on any day and start using Ginoring immediately.
• Last month you used a progestogen-only contraceptive (minipill)You can stop using the minipill on any day and start using Ginoring the next day at the same time you would have taken the minipill. During the first 7 days of using Ginoring, you should also use an additional contraceptive method (such as a condom).
• Last month you used an implant, injections, or an intrauterine system releasing progestogen [IUD]You should start using Ginoring on the day of the next scheduled injection or on the day the implant or intrauterine system releasing progestogen is removed. During the first 7 days of using Ginoring, you should also use an additional contraceptive method (such as a condom).
• After giving birthAfter giving birth, your doctor may recommend using Ginoring only after your first menstrual period. Sometimes, you can start using Ginoring earlier. Your doctor will advise you when. If you are breastfeeding and want to use Ginoring, you should discuss this with your doctor.
• After a miscarriageAccording to your doctor's instructions.

3.4 What to do if…

3.5 Discontinuation of the Ginoring medicine

You can discontinue the use of the Ginoring medicine 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 the Ginoring medicine 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 medicine, the Ginoring medicine can cause adverse reactions, although not everybody gets them. If any adverse reactions occur, especially severe and persistent ones or changes in health that the patient considers related to the use of the Ginoring medicine, you should consult a doctor. In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). To obtain detailed information about the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using the Ginoring medicine". You should contact a doctor immediately if the patient 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 the Ginoring medicine 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 infections); discomfort caused by the presence of the system in the vagina; itching of the genitals; 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 disorders; dizziness;
• bloating; vomiting, diarrhea, or constipation;
• fatigue, malaise, or excitement; mood changes; sudden mood changes;
• fluid retention in the body (edema);
• urinary tract infections or kidney infections;
• problems or pain during urination; urgency or need to urinate; frequent urination;
• discomfort during intercourse, including pain, bleeding, or inconvenience caused by the presence of the system felt by the male 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 hives;
• urticaria.

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 probability of blood clots may be higher if the patient has any other risk factors (see section 2 for further information about risk factors for blood clots and symptoms of blood clots). You should contact a doctor immediately if the patient experiences any of these symptoms.

• galactorrhea (spontaneous flow of milk from the breast, not associated with childbirth or nursing).

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

• chloasma (brownish-yellow pigmentation 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 associated with damage to the vaginal therapeutic system. In women using combined hormonal contraceptives, breast cancer and liver tumors have occurred. For more information, see section 2.2 "Warnings and precautions", "Tumors".

The Ginoring medicine may be damaged. For more information, see 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 mentioned in the leaflet, you should tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting adverse reactions, you can help provide more information on the safety of the medicine.

5. How to store the Ginoring medicine

The medicine should be stored out of sight and reach of children. You should contact a doctor in case of suspected exposure of a child to the hormones contained in the Ginoring medicine. There are no special recommendations for storage temperature. 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 packaging. The expiration date means the last day of the specified month. Do not use this medicine if you notice any changes in the color of the system or if there are any visible signs of damage. This medicinal product may pose a risk to the environment. After removing the Ginoring medicine, you should put it in a sachet and close it tightly. Then, the closed sachet should be thrown away with normal waste or disposed of in a pharmacy in special containers in accordance with local regulations. Do not throw the Ginoring medicine down the toilet. Like other medicines, unused or expired systems should not be disposed of in the sewage system or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What the Ginoring medicine contains

• The active substances of the medicine are etonogestrel and ethinylestradiol. The Ginoring medicine contains 11.0 mg of etonogestrel and 3.474 mg of ethinylestradiol. The vaginal therapeutic system releases etonogestrel and ethinylestradiol in an average amount of 0.120 mg (120 micrograms) and 0.015 mg (15 micrograms), respectively, over 24 hours, for a period of 3 weeks.
• The 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 the Ginoring medicine looks like and what the packaging contains

Vaginal therapeutic system. The Ginoring medicine is a flexible, transparent, and colorless or almost colorless ring (system) with an outer diameter of 54 mm and a cross-section diameter of 4 mm. Each ring is packaged in a sachet made of PET/Aluminum/LDPE. The sachet is packaged in a carton with a 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. For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

UAB "Exeltis Baltics" Islandijos pl. 209A Kowno, LT-49163 Lithuania

Manufacturer:

Laboratorios León Farma, S.A. Calle La Vallina s/n. Polígono Industrial Navatejera 24008-Villaquilambre, León Spain

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Marketing authorization number in Lithuania, the country of export:LT/1/17/4101/001 LT/1/17/4101/002 LT/1/17/4101/003 Parallel import authorization number:398/21

This medicinal product is authorized for sale 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 Exelring 0,120 mg/0,015 mg za 24 hodin Denmark Exelring Finland Exelring 0,120 mg / 0,015 mg per 24 hours, depotlääkevalmiste, emättimeen Netherlands Ornibel 0,120/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik Ireland Ornique 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 Exelring Poland Ginoring Slovakia Exelring 0.120/0.015 mg za 24 hodín vaginálny inzert Sweden Exelring Hungary Exelring 0.120/0.015 mg 24 óra hüvelyben alkalmazott gyógyszerleadó rendszer Date of approval of the leaflet: 11.04.2022[Information about the trademark]