GINORING

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Ginoring (Ornique)
(0.120 mg + 0.015 mg)/24 h, vaginal ring
Etonogestrel + Ethinylestradiol
Ginoring and Ornique are different brand names of the same medicine.
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 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 your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots"). Read this leaflet carefully before using the medicine, as it contains important information for you.
• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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

1. What Ginoring is and what it is used for

2. Important information before using Ginoring
       2.1 When not to use Ginoring
       2.2 Warnings and precautions
           Blood clots
           Tumours
       2.3 Children and adolescents
       2.4 Ginoring with other medicines
           Diagnostic tests
       2.5 Pregnancy and breastfeeding
       2.6 Driving and operating machinery

3. How to use Ginoring
       3.1 Insertion and removal of Ginoring
       3.2 Three weeks of use, one week break
       3.3 When to insert the first vaginal ring
       3.4 What to do if…
           What to do if the ring accidentally falls out of the vagina
           What to do if the ring has been outside the vagina for some time
           What to do if the vaginal ring is damaged
           Use of more than the recommended number of Ginoring rings
           What to do if a new vaginal ring is not applied after the break
           What to do if the patient forgets to remove the vaginal ring on time
           What to do if withdrawal bleeding does not occur
           What to do if unexpected bleeding occurs
           What to do if the day of bleeding changes
           What to do if you wish to delay withdrawal bleeding
       3.5 Discontinuation of Ginoring

4. Possible side effects

5. How to store Ginoring

6. Contents of the pack and other information
       What Ginoring contains
       What Ginoring looks like and contents of the pack

1. What Ginoring is and what it is used for

Ginoring is a contraceptive medicine in the form of a vaginal ring, used to prevent pregnancy. Each vaginal ring contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. These hormones are slowly released from the ring into the bloodstream. Due to the low dose of hormones released, Ginoring is classified as a low-dose hormonal contraceptive. Ginoring is referred to as a combined hormonal contraceptive because it releases two different hormones.
Ginoring works in the same way as a combined oral contraceptive pill ("combined pill"), but unlike the pill, which must be taken daily, the vaginal ring is used continuously for 3 weeks.
Ginoring releases two female sex hormones that suppress the release of eggs from the ovaries. Pregnancy cannot occur because eggs are not released.

2. Important information before using Ginoring

General remarks
Before starting to use Ginoring, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots – see section 2, "Blood clots".
This leaflet describes many situations in which you should stop taking Ginoring or in which its effectiveness may be reduced. In such situations, you should abstain from 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 monitoring. These methods may be ineffective because Ginoring affects changes in body temperature and cervical mucus consistency during the menstrual cycle.
Ginoring, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

2.1 When not to use Ginoring

Do not use Ginoring if the patient has any of the conditions listed below. If any of these conditions apply, inform the doctor. The doctor will discuss with the patient which alternative 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 blood clotting disorders—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 currently has (or has had in the past) 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 currently has (or has had in the past) any of the following diseases that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if the patient currently has (or has had in the past) a type of migraine called “migraine with aura”;
• if the patient currently has or has had in the past pancreatitis associated with high fat levels in the blood;
• if the patient currently has or has had in the past severe liver disease and liver function has not returned to normal;
• if the patient currently has or has had in the past a benign or malignant liver tumour;
• if the patient currently has or has had in the past 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 to any of the other ingredients of this medicine (listed in section 6). If any of the above symptoms occur for the first time during use of Ginoring, the vaginal system must be removed immediately and a doctor should be consulted. During this time, a non-hormonal method of contraception may be used.

Use of the Ginoring vaginal therapeutic system is contraindicated when concomitantly using medicinal products containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, as well as glecaprevir/pibrentasvir (see section 2.4 “Ginoring and other medicines”).

2.2 Warnings and precautions

When should you contact a doctor?
You should seek immediate medical advice

• if the patient experiences symptoms suggesting the occurrence of blood clots, which may indicate that the patient has developed blood clots in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or stroke (see section "Blood clots"). For a description of the symptoms of these serious adverse effects, see section "How to recognize the occurrence of blood clots".

Tell your doctor if the patient has any of the following conditions.
If any of these conditions develop or worsen during treatment with Ginoring, you should also
inform your doctor.

• if breast cancer is currently present or has occurred in close family members;
• 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 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 has been diagnosed with high levels of fat in the blood (hypertriglyceridemia) or has a family history of this condition. 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. Consult your doctor for advice on how soon after delivery Ginoring may be started;
• if the patient has phlebitis (inflammation of superficial veins under the skin);
• if the patient has varicose veins;
• if the patient has conditions that first occurred or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], Sydenham's chorea [a nervous system disorder characterized by involuntary, violent movements]);
• if the patient currently has or has previously had chloasma (yellowish-brown pigmented patches, commonly known as "melasma", especially on the face). In such cases, excessive sun exposure and ultraviolet radiation should be avoided;
• if the patient has conditions that make the use of Ginoring difficult – e.g. frequent constipation, uterine prolapse, pain during intercourse;
• if the patient experiences sudden, frequent urges to urinate with a burning sensation and/or pain, and if the patient cannot locate the intravaginal therapeutic system inside the vagina. These symptoms may indicate accidental placement of the Ginoring intravaginal therapeutic system into the urinary bladder;
• if the patient develops symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or skin rash, and breathing difficulties – seek immediate medical attention. Medicinal products 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 not using such treatment. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur

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

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 associated with the use of Ginoring is low.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if any of the following symptoms occur.
Is the patient experiencing any of these symptoms? Likely reason
the patient may be
suffering from

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

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

When is the risk of 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 higher 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 woman stops taking Ginoring, 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 being used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Ginoring is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 6–12 out of 10,000 women who use combined hormonal contraceptives containing ethinylestradiol or etonogestrel, such as Ginoring, will develop blood clots.
• The risk of developing blood clots depends on the individual's 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 Ginoring is small, however,
some 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 tendency to form blood clots;
• if the patient needs to undergo surgery, if she is immobilized for a prolonged period due to injury or illness, or if she has her leg in plaster. It may be necessary to stop taking Ginoring for several weeks before surgery or immobilization. If the patient needs to stop taking Ginoring, she should ask her doctor when she can restart taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the last few weeks). 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, particularly if the patient has another risk factor listed above. It is important to inform the doctor if any of the listed factors apply to the patient, even if she is uncertain. The doctor may decide to discontinue the use of Ginoring. The patient should inform her doctor if any of the above conditions change during treatment with Ginoring, for example, if a close family member is diagnosed with thrombosis of unknown cause or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in an artery?
Similarly to 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 Ginoring
is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Ginoring, 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 of age). 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 suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia 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 is particularly severe, the risk of blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with Ginoring, for example, if she starts smoking, if a close family member is diagnosed with thrombosis of unknown cause, or if she gains significant weight.
Tumour diseases
The following information is based on studies of combined hormonal contraceptives and may also apply to Ginoring. Information regarding the vaginal use of hormonal contraceptives (as is the case with Ginoring) is not yet available.
A slightly higher incidence of breast cancer has been observed among women using combined hormonal contraceptives, although it is not known whether this is caused by the medicine. It is possible that breast cancer is detected more frequently in women using combined hormonal contraceptives because these women undergo medical examinations more regularly.
The increased incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Regular breast examination is very important. If any lump is detected, the patient should contact her doctor. She should also inform her doctor if a close relative has or has had 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, the patient should contact her 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 Ginoring, but this has not yet been confirmed.
Psychiatric disorders
Some women using hormonal contraceptives, including Ginoring, 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, the patient should contact her 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 medicines

You should inform the doctor prescribing Ginoring about any other medicines and herbal products you are taking. You should also inform any other doctor, dentist or pharmacist who prescribes other medicines that you are using Ginoring. They may advise you to use an additional method of contraception (e.g. male condoms), and if so, for how long, as well as whether any adjustment in the way another medicine is used is necessary.
Some medicines may:

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

This applies to medicines used in the treatment of:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g. boceprevir, telaprevir);
• other infectious diseases (e.g. griseofulvin);
• pulmonary arterial hypertension (bosentan);
• depressive mood disorders (St. John's wort).

If you are taking medicines or herbal remedies that may reduce the effectiveness of Ginoring, you should also use mechanical contraception (e.g. male condoms). Because the effect of another medicine on Ginoring may persist for up to 28 days after discontinuation of the medicine, additional mechanical contraception must be used during this time. Warning: 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 lamotrigine (this may lead to increased frequency of seizures).
  Ginoring must not be used in patients with hepatitis C virus infection who are taking medicines containing ombitasvir, paritaprevir, ritonavir or dasabuvir, or glecaprevir/pibrentasvir, as this may cause abnormalities in liver function tests (increased activity of the liver enzyme AlAT). Your doctor will recommend using another method of contraception before starting treatment with these medicines. The Ginoring vaginal therapeutic system may be reinserted approximately 2 weeks after stopping these medicines. See section 2.1 "When not to use Ginoring".

Before taking any medicine, consult your doctor or pharmacist.
During use of Ginoring, tampons may be used. Ginoring should be inserted before inserting a tampon.
Care should be taken when removing a tampon to avoid accidentally removing the Ginoring system as well. If the system is accidentally expelled, it should be washed with cold or lukewarm water and reinserted as soon as possible.
Damage to the vaginal therapeutic system may occur during use of vaginal products such as lubricants or treatments for infections (see section 3.4 "What to do if the vaginal therapeutic system is damaged"). The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of Ginoring.

Diagnostic tests
If blood or urine laboratory tests are to be performed, inform the person carrying out the test that you are using Ginoring, as it may affect the results of certain laboratory tests.

2.5 Pregnancy and breastfeeding

The medicinal product Ginoring must not be used during pregnancy or if the patient suspects she might be pregnant. If pregnancy occurs while using Ginoring, the intravaginal therapeutic system must be removed and the patient should contact her physician.
If the patient wishes to discontinue using Ginoring because she intends to become pregnant, she should refer to section 3.5 "Discontinuation of Ginoring treatment".
The use of Ginoring during breastfeeding is not recommended. If the patient wishes to use Ginoring while breastfeeding, she should consult her physician first.

2.6 Driving and operating machinery

The Ginoring medication does not affect the ability to drive vehicles or operate machinery.

3. How to use Ginoring

The Ginoring system can be inserted and removed by yourself. Your doctor will instruct you when to start using Ginoring. The vaginal ring should be inserted on the appropriate day of the cycle (see section 3.3 "When to insert the first vaginal ring") and left in place continuously for three weeks. You should regularly check that the vaginal ring is in the correct position (e.g. before and after sexual intercourse) to ensure you are protected against pregnancy. After three weeks, remove the Ginoring ring 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 Ginoring. These mechanical contraceptive methods should not be used as an additional contraceptive method because Ginoring may interfere with the proper placement and positioning of an intrauterine device, cervical cap, or female condom. However, you may use a male condom as an additional mechanical contraceptive method.

3.1 Insertion and removal of Ginoring

1. Before insertion, check the expiry date (see section 5 "How to store Ginoring").
2. Wash your hands before inserting or removing the system.
3. Choose the most comfortable position for insertion, for example standing with one leg raised, squatting, or lying down.
4. Remove Ginoring from the sachet. Do not discard the sachet, as it will be used later.
5. Holding the system between your thumb and index finger, squeeze it and insert into the vagina (see Figures 1–4). Ginoring should be positioned so that it is not felt. If the system causes discomfort, push it further into the vagina. The exact placement within the vagina does not affect its contraceptive efficacy.
6. After three weeks, remove Ginoring from the vagina. This can be done by hooking the index finger under the edge of the system or grasping it between the index and middle fingers and pulling it out (see Figure 5). If the user locates the system in the vagina but is unable to remove it, she should contact her physician.
7. Dispose of the used system with household waste, preferably in the original sachet. Do not flush Ginoring down the toilet.

Figure 1. Remove Ginoring from the sachet

Figure 2. Squeeze the system

Figure 3. Choose the most comfortable position for insertion

Figures 4A, 4B, 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 three weeks (Fig. 4C).

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

3.2 Three weeks of use, one week break

1. The system should remain in the vagina continuously for three weeks, starting from the day of insertion.
2. After three weeks, remove the system on the same day of the week and approximately at the same time as it was inserted. For example, if Ginoring was inserted on Wednesday around 10:00 p.m., it should be removed also on Wednesday three weeks later around 10:00 p.m.
3. After removal of the system, take a one-week break from using the system. During this time, bleeding may occur. It usually starts 2–3 days after removal of Ginoring.
4. A new system must be inserted exactly one week after the break (on the same day of the week and approximately at the same time as usual), even if bleeding is still ongoing. If insertion of the new system is delayed by more than 3 hours, contraceptive efficacy may be reduced. In such a case, follow the instructions provided in section 3.4 "Instructions if the patient forgets to insert a new vaginal therapeutic system after the weekly break". If Ginoring is used according to the above recommendations, subsequent bleedings will generally occur on approximately the same days of the week.

3.3 When to insert the first vaginal contraceptive system

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

• Previously used combined oral hormonal contraceptives Begin using Ginoring no later than the day following the end of the current contraceptive cycle. If the currently used preparation includes inactive (placebo) tablets, start using Ginoring no later than the day after taking the last inactive tablet. In case of uncertainty about which tablet is inactive, consult a physician or pharmacist. Do not extend the tablet-free interval beyond the recommended period. If the patient has taken her tablets regularly and is certain she is not pregnant, she may stop taking the tablets on any day and immediately start using Ginoring.

• Previously used a transdermal contraceptive patch Begin using Ginoring no later than the day following the end of the transdermal patch cycle. Do not extend the patch-free interval beyond the recommended period. 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 Ginoring.

• Previously used a progestogen-only contraceptive (mini-pill) Discontinue the mini-pill at any time and start using Ginoring the next day at the same time of day as the mini-pill was previously taken. An additional contraceptive method (such as a condom) must be used during the first 7 days of Ginoring use.

• Previously used an implant, injectable contraceptive, or intrauterine system (IUS) releasing progestogen Begin using Ginoring on the day of the next scheduled injection or on the day of removal of the implant or progestogen-releasing intrauterine system (IUS). An additional contraceptive method (such as a condom) must be used during the first 7 days of Ginoring use.

• After childbirth After childbirth, the physician may recommend starting Ginoring only after the first menstrual period. Sometimes it may be possible to start Ginoring earlier—the physician will advise when. If breastfeeding and considering use of Ginoring, discuss this with a physician.

• After miscarriage As directed by the physician.

3.4 What to do if…

Management in case the system accidentally falls out of the vagina
The Ginoring product may accidentally fall out of the vagina, for example if it was incorrectly inserted, during tampon removal, during intercourse, in case of constipation or uterine prolapse. Therefore, it is recommended to regularly check whether the system is still in place in the vagina (e.g. before and after intercourse).
If the system has been outside the vagina for less than 3 hours, the woman 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.
If the system has been outside the vagina for more than 3 hours, contraceptive protection may no longer be ensured: in this case, refer to the recommendations in section 3.4 “Management when the system has been outside the vagina for some time”.

Management when the system has been outside the vagina for some time
The Ginoring system may still provide protection against pregnancy, but this depends on how long it has been outside the vagina.

• Less than 3 hours: the woman remains 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 the system was outside the vagina for less than 3 hours.
• More than 3 hours during the first or second week of use: contraceptive effectiveness may be reduced. 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 intercourse occurs during these 7 days, a male condom should also be used. If the woman is in the first week of her cycle and has had intercourse during the past 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 be reduced. The vaginal therapeutic system should be removed and one of the following two options chosen:
  1. Insert a new vaginal therapeutic system as soon as possible. Inserting a new system starts the next three-week treatment period. This may result in the absence of expected withdrawal bleeding, although intermenstrual 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 woman has used Ginoring continuously for the past 7 days.
• If the Ginoring product has been outside the vagina for an unspecified duration, contraceptive effectiveness may be reduced. A pregnancy test should be performed and the woman should contact her doctor before inserting a new vaginal therapeutic system.

Management in case of damage to the vaginal therapeutic system
The Ginoring product may become damaged. Vaginal wall injury has been reported in association with damage to the vaginal therapeutic system. If the woman notices that Ginoring 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 intercourse occurred before the woman noticed the damage, she should contact her doctor.

Use of more than the recommended number of Ginoring systems
There have been no reports of serious harmful effects associated with overdose of the hormones contained in Ginoring. 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 woman should contact her doctor if symptoms persist.

Omission of inserting a new vaginal therapeutic system after a break in use
If the break in use of the vaginal therapeutic system was longer than 7 days, a new system should be inserted as soon as possible. If intercourse occurs during the following 7 days, an additional contraceptive method (e.g. male condom) should be used.
If intercourse occurred during the break in use of the vaginal therapeutic system, pregnancy may have occurred. In this case, the woman should contact her doctor as soon as possible. The longer the break in use of the vaginal therapeutic system, the higher the likelihood of pregnancy.

Management if the woman forgets to remove the vaginal therapeutic system on time

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

Management in case of absence of bleeding

• If the woman used Ginoring as directed: If withdrawal bleeding does not occur on schedule, but the woman used Ginoring according to instructions and did not take other medications during this time, the likelihood of pregnancy is very low. The woman should continue using Ginoring as before. However, if withdrawal bleeding does not occur for two consecutive cycles, pregnancy is possible. The woman should contact her doctor as soon as possible. A new Ginoring system should not be inserted until the doctor confirms that the woman is not pregnant.

• If the woman used Ginoring incorrectly: If withdrawal bleeding does not occur during the first break in use of Ginoring and the woman used the vaginal therapeutic system incorrectly, she may be pregnant. The woman should contact her doctor before using a new Ginoring product.

Management in case of unexpected bleeding
During use of Ginoring, some women may experience unexpected intermenstrual bleeding. The woman may need sanitary pads. The system should remain in the vagina and be used as before. If irregular bleeding increases or recurs, the woman should contact her doctor.

Management in case of change in the day of bleeding occurrence
If Ginoring is used as directed, menstrual periods (withdrawal bleeding) will begin during the weekly break from the vaginal therapeutic system. If the woman 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 woman wishes to change this to Tuesday (3 days earlier) next month, she should insert the new vaginal therapeutic system 3 days earlier than usual.
If the break in use of the vaginal therapeutic system is significantly shortened (e.g. to 3 days or less), withdrawal bleeding may not occur at all during this time. During use of the next vaginal therapeutic system, spotting (single drops or blood stains) or intermenstrual bleeding may occur.
If the woman is unsure how to proceed, she should consult her doctor.

Management if delaying the onset of bleeding is desired
Although not recommended, withdrawal bleeding (menstruation) may be delayed by inserting a new vaginal therapeutic system immediately after removing the previous one, without a break.
The new vaginal therapeutic system should not be used for longer than 3 weeks. During use of the new system, spotting (single drops or blood stains) or intermenstrual bleeding may occur. To induce withdrawal bleeding, the vaginal therapeutic system should be removed. A regular weekly break between systems is recommended.
Before deciding to delay bleeding, the woman may consult her doctor.

3.5 Discontinuation of Ginoring
Ginoring may be discontinued at any time.
If the woman does not wish to become pregnant, she should ask her doctor about alternative contraceptive methods.
If the woman stops using Ginoring because she wishes to become pregnant, she should wait until after her first natural menstrual period before trying to conceive. This will help determine the expected date of delivery.

4. Possible adverse effects
Like all medicines, this product may cause adverse effects, although not everyone experiences them.
If any adverse effects occur, especially severe or persistent ones, or any changes in health the woman considers related to use of Ginoring, she should consult her doctor.
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with use of combined hormonal contraceptives, refer to section 2 “Important information before using Ginoring”.
The woman should contact her doctor immediately if she experiences symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, skin rash, or breathing difficulties (see section “Warnings and precautions”).

Women using Ginoring have reported the following adverse effects.

Common: may affect up to 1 in 10 women

• abdominal pain, nausea;
• vaginal yeast infections (fungal changes); 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 affect up to 1 in 100 women

• visual disturbances; dizziness;
• bloating; vomiting, diarrhoea or constipation;
• feeling of fatigue, malaise or restlessness; mood changes; sudden mood swings;
• fluid retention (oedema);
• urinary tract or bladder infections;
• problems or pain during urination; urinary urgency or need to urinate; frequent urination;
• discomfort during intercourse, including pain, bleeding, or discomfort felt by the male partner due to presence of the system;
• increased blood pressure;
• increased appetite;
• back pain; muscle cramps; pain in lower or upper limbs;
• decreased skin sensitivity;
• breast tenderness or enlargement; fibrocystic breast disease (cysts which may cause breast swelling or pain);
• cervicitis; cervical polyps; cervical erosion;
• changes in menstrual bleeding (e.g. heavy, prolonged, irregular or complete absence of menstruation); pelvic discomfort; premenstrual syndrome; uterine cramps;
• vaginal infections (fungal or bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva;
• hair loss, rash, itching, skin rash or hot flushes;
• urticaria.

Rare: may affect up to 1 in 1000 women

• harmful blood clots in veins or arteries, 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 ischaemic attack (TIA);
  • blood clots in the liver, stomach, intestine, kidneys or eye.

The risk of blood clots may be higher if the woman has other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

• galactorrhoea (milky discharge from the breast).

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

• chloasma (yellowish-brown pigmented patches 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 adhesion of the system to the vaginal wall);
• vaginal wall injury associated with damage to the vaginal therapeutic system.

Breast cancer and liver tumours have occurred in women using combined hormonal contraceptives. For detailed information, see section 2.2 “Warnings and precautions”, “Malignant diseases”.

Ginoring 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, the woman should inform her doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Ginoring
Keep the medicine out of sight and reach of children.
Contact a doctor if a child is exposed to the hormones contained in Ginoring.
No special temperature storage conditions are required. Store in the original packaging to protect from light.
Ginoring may be used if at least one month remains until the expiry date indicated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if a change in colour of the system is observed or if any signs of damage are visible.
This medicinal product may be harmful to the environment. After removal, Ginoring should be placed in a pouch and securely closed. The sealed pouch should then be disposed of with household waste or returned to a pharmacy for disposal in special containers according to local regulations. Do not flush Ginoring down the toilet. Unused or expired systems should not be disposed of via sewers or household waste bins. Ask a pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information
What Ginoring contains

• The active substances are: etonogestrel and ethinylestradiol. Ginoring contains 11.0 mg etonogestrel and 3.474 mg ethinylestradiol. The vaginal therapeutic system releases etonogestrel and ethinylestradiol at average rates of 0.120 mg (120 micrograms) and 0.015 mg (15 micrograms), respectively, per 24 hours over a 3-week period.
• Other ingredients: ethylene vinyl acetate copolymer, 28% vinyl acetate, polyurethane (a type of synthetic polymer which does not dissolve in the human body).

What Ginoring looks like and contents of the pack
Vaginal therapeutic system. Ginoring is a flexible, transparent, colourless or almost colourless ring (system) with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. Each ring is packaged in a PET/Aluminium/LDPE pouch. The pouch is placed in a cardboard box together with the package leaflet and calendar stickers to help remember when to insert and remove the vaginal therapeutic system.

Pack sizes contain:
1 system;
3 systems;
6 systems.
For more detailed information, contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Lithuania, country of export:
UAB „Exeltis Baltics“
Islandijos pl. 209A
Kaunas, 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
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Numbers in Lithuania, country of export:
LT/1/17/4101/001
LT/1/17/4101/002
LT/1/17/4101/003

Parallel Import Number: 398/21

This medicinal product is authorised for marketing in 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 Stunden 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