GINORING

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Ginoring (Ornibel)
(0.120 mg + 0.015 mg)/24 h, vaginal therapeutic system
Etonogestrel + Ethinylestradiol
Ginoring and Ornibel are different trade names for 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 developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If the user experiences any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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
Tumour diseases
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 therapeutic system
3.4 What to do if…
Management in case the system accidentally falls out of the vagina
Management if the system has been outside the vagina for some time
Management in case of damage to the vaginal therapeutic system
Use of more than the recommended number of Ginoring systems
Missed application of a new vaginal therapeutic system after the break period
Management if the user forgets to remove the vaginal therapeutic system on time
Management in case of absence of bleeding
Management in case of unexpected bleeding
Management in case of change in the day of bleeding occurrence
Management if wishing to delay bleeding
3.5 Stopping use 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 is Ginoring and what it is used for

Ginoring is a contraceptive medicine in the form of a vaginal therapeutic system that prevents pregnancy. Each vaginal therapeutic system contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. These hormones are released slowly from the system into the bloodstream. Due to the low dose of hormones released, Ginoring is classified as a low-dose hormonal contraceptive. Ginoring is referred to as a combined 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 therapeutic system is used continuously for three 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 notes
Before starting to use Ginoring, you should read the information about blood clots (thrombosis) in section 2. It is especially 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 using Ginoring or when its effectiveness may be reduced. In such situations, you should abstain from sexual intercourse or use an additional contraceptive method other than hormonal, such as a condom or another mechanical method. Do not use calendar-based methods or body temperature measurement. These 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 the following conditions apply to the patient, inform the doctor. The doctor will discuss with the patient which alternative method of contraception may 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 a disorder affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• if the patient requires surgery or will be immobile for a prolonged period (see section "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if the patient has any of the following diseases which may increase the risk of arterial blood 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 previously had) a type of migraine known as "migraine with aura";
• if the patient currently has or has previously had pancreatitis associated with high levels of fats in the blood;
• if the patient currently has or has previously had severe liver disease and liver function has not returned to normal;
• if the patient currently has or has previously had a benign or malignant liver tumour;
• if the patient currently has or has previously had breast cancer or genital organ cancer, or if such cancers are suspected;
• if the patient has vaginal bleeding of unknown cause;
• if the patient is allergic to ethinylestradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the symptoms listed above occur for the first time during use of Ginoring, the vaginal system must be removed immediately and medical advice must be sought. During this time, a non-hormonal method of contraception should be used.
Use of Ginoring is contraindicated when taking medicines containing ombitasvir, paritaprevir, ritonavir, or dasabuvir, as well as glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir (see section 2.4 "Ginoring and other medicines").

2.2 Warnings and Precautions

When should you contact a doctor?
You should immediately consult a doctor

• if the patient experiences symptoms that may indicate blood clots, which could mean she has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see section "Blood clots").

For a description of the symptoms of these serious adverse reactions, see section "How to recognize the occurrence of blood clots".
You should inform the 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 the 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 immune 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 elevated blood lipid levels (hypertriglyceridemia) or 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. Please consult the doctor for advice on how soon after delivery Ginoring can be started;
• if the patient has phlebitis (inflammation of superficial veins);
• 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 [a blistering skin rash during pregnancy], Sydenham's chorea [a nervous system disorder characterized by involuntary, sudden movements]);
• if the patient currently has or has previously had chloasma (yellowish-brown pigmented patches, so-called "melasma" or "pregnancy mask", 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 urge 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 insertion of Ginoring 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 – immediate medical attention must be sought. 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 therapy. 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
You should immediately consult a doctor if you notice any of the following symptoms.

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

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

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

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

Factors increasing the risk of blood clots in veins
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 blood clotting disorder;
• if the patient is due to undergo surgery, if she is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Ginoring several weeks before surgery or immobilization. If the patient must stop taking Ginoring, she should consult her doctor about when it is safe to restart;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of developing blood clots increases with the number of risk factors present in the
patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
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 unexplained thrombosis or if the patient gains significant weight.

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

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with the use of Ginoring
is very small, but it 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 a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of developing blood clots may be 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 unexplained thrombosis, or if she gains significant weight.

Cancer
The following information comes from studies on combined hormonal contraceptives and may also apply to Ginoring. Data regarding the vaginal use of hormonal contraceptives (as with Ginoring) are not yet available.
Among women using combined hormonal contraceptives, a slightly higher incidence of breast cancer has been observed, although it is not known whether this is caused by the medication. It is possible that breast cancers are detected more frequently in these women because they undergo medical examinations more regularly.
The increased incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Regular breast self-examination is very important. If any lump is detected, the patient should contact her doctor. She should also inform her doctor if any close relatives have or have had breast cancer (see section 2.2 "Warnings and precautions").
Rarely, benign liver tumors have been reported in women using combined hormonal contraceptives, and very rarely, malignant liver tumors. 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 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 specialist 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 disorders (St. John's wort).

If you are taking medicines or herbal products that may reduce the effectiveness of Ginoring, you should also use a mechanical contraceptive method (e.g. male condoms). Because the effect of another medicine on Ginoring may persist for up to 28 days after stopping the medicine, additional mechanical contraception must be used during this period. 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 who are taking medicines containing ombitasvir, paritaprevir, ritonavir or dasabuvir, or glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may cause abnormal liver function test results (increased activity of liver enzymes AlAT). Before starting these medicines, your doctor will prescribe another type of contraception.
Ginoring may be restarted approximately 2 weeks after completion of the above-mentioned treatment. 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 Ginoring as well. If expulsion occurs, the vaginal delivery system may be washed with cold or lukewarm water and reinserted as soon as possible.
Damage to the vaginal delivery system has occurred during use of vaginal products such as lubricants or treatments for infections (see section 3.4 "What to do if the vaginal delivery 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, you should inform the person conducting the tests that you are using Ginoring, as it may affect the results of certain laboratory tests.

2.5 Pregnancy and breastfeeding

Ginoring must not be used during pregnancy or if the patient suspects she might be pregnant. If pregnancy occurs while using Ginoring, the vaginal delivery system should be removed and the patient should contact her doctor.
If the patient wishes to discontinue using Ginoring because she wants to become pregnant, she should read section 3.5 "Discontinuation of Ginoring treatment".
The use of Ginoring is not recommended during breastfeeding. If the patient wishes to use Ginoring while breastfeeding, she should consult her doctor 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

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
Ginoring can be inserted and removed by yourself. Your doctor will advise when you may start using Ginoring. The vaginal ring must be inserted on the correct day of the cycle (see section 3.3 "When to insert the first vaginal ring") and left in place continuously for 3 weeks. You should regularly check that the vaginal ring is in place (e.g. before and after sexual intercourse) to ensure you are protected against pregnancy. After three weeks, remove Ginoring 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 additional contraception, because Ginoring may interfere with the correct placement and positioning of an intrauterine device, cervical cap, or female condom. However, a male condom may be used as an additional mechanical contraceptive method.

3.1 Insertion and removal of Ginoring

1. Before insertion, check the expiry date of the medicinal product (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 the Ginoring from its pouch. Do not discard the pouch, as it will be used later.
5. Holding the system between your thumb and index finger, compress it and insert into the vagina (see Figures 1–4). The correct position of Ginoring is one in which it is not felt. If the system causes discomfort, push it slightly deeper into the vagina. The exact placement within the vagina does not affect its contraceptive effectiveness.
6. After three weeks, remove Ginoring from the vagina. This can be done by hooking your index finger under the edge of the system or by grasping it between your index and middle fingers and gently pulling it out (see Figure 5). If the user can locate 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 placing it back into the pouch. Do not flush Ginoring down the toilet.

Figure 1. Remove Ginoring from the pouch

Figure 2. Compress the system

Figure 3. Choose the most comfortable position for inserting the system

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

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

3.2 Three weeks of use, one week break

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

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

3.3 When to insert the first vaginal ring

• No previous use of a hormonal contraceptive in the preceding cycle Insert the Ginoring ring for the first time on the first day of the natural cycle (i.e. the first day of menstruation). The Ginoring ring is effective immediately from the moment of insertion. There is no need to use any additional contraceptive methods. It is also possible to start using the Ginoring ring between days 2 and 5 of the cycle; however, in this case, an additional contraceptive method (such as condoms) must be used during the first 7 days of using Ginoring. This recommendation applies only when starting Ginoring for the first time.
• Previously used combined oral hormonal contraceptives Begin using the Ginoring ring no later than the day following the tablet-free interval of the currently used contraceptive. If the current contraceptive also includes placebo tablets (without active ingredients), start using the Ginoring ring 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 pills regularly and is certain she is not pregnant, she may stop taking the pills at any time and immediately start using the Ginoring ring.
• Previously used a transdermal patch system Begin using the Ginoring ring no later than the day following the patch-free interval. 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 the Ginoring ring.
• Previously used a progestogen-only contraceptive (mini-pill) The mini-pill may be discontinued at any time. The Ginoring ring should be inserted the following day at the same time the mini-pill was usually taken. An additional contraceptive method (such as condoms) must be used during the first 7 days of using Ginoring.
• Previously used an implant, injectable contraception, or an intrauterine device (IUD) releasing progestogen Begin using the Ginoring ring on the day of the next scheduled injection or on the day of removal of the implant or progestogen-releasing intrauterine system. An additional contraceptive method (such as condoms) must be used during the first 7 days of using Ginoring.
• After childbirth After childbirth, the physician may recommend starting the Ginoring ring only after the first menstrual period. Sometimes it may be possible to start earlier; the physician will advise when. If breastfeeding and considering use of Ginoring, this should be discussed with a physician.
• After miscarriage As advised by the physician.

3.4 What to do if…

Management in case the system accidentally falls out of the vagina
The Ginoring medicinal product may accidentally fall out of the vagina, for example if it was incorrectly inserted, during tampon removal, during sexual intercourse, in case of constipation or uterine prolapse. Therefore, it is necessary to regularly check whether the system is in the vagina (e.g. before and after sexual intercourse).
If the system has been outside the vagina for less than 3 hours, the patient is still protected against pregnancy. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted. If the system has been outside the vagina for longer than 3 hours, the patient may not be protected against pregnancy: in this case, see 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 medicinal product may still provide protection against pregnancy, but this depends on how long it has been outside the vagina.

• Less than 3 hours: the patient is still protected against pregnancy. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted as soon as possible, but only if the system has been outside the vagina for less than 3 hours.
• More than 3 hours during the first or second week of use: contraceptive efficacy may have decreased. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted as soon as possible, and left in place continuously for at least 7 days. If the patient has sexual intercourse during these 7 days, a male condom should also be used. If the patient was in the first week of the cycle and had sexual intercourse during the previous 7 days, there is a possibility of pregnancy. In such a case, the patient should contact her doctor.
• More than 3 hours during the third week of use: contraceptive efficacy 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 vaginal therapeutic system means starting the next three-week treatment period. This may result in the absence of expected withdrawal bleeding, although mid-cycle 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 followed if the patient has used Ginoring continuously for the last 7 days.
• If Ginoring has been outside the vagina for an unspecified duration, contraceptive efficacy may be reduced. A pregnancy test should be performed and the patient should contact her doctor before inserting a new vaginal therapeutic system.

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

Use of more than the recommended number of Ginoring systems
There are 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 patient 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 sexual intercourse occurs during the next 7 days, an additional contraceptive method (e.g. male condom) should be used.
If sexual intercourse occurred during the break in use of the vaginal therapeutic system, there is a possibility of pregnancy. In such a case, the patient should contact her doctor as soon as possible. The longer the break in use of the vaginal therapeutic system, the higher the probability of pregnancy.

Management if the patient forgets to remove the vaginal system on time

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

Management in case of absence of bleeding

• If the patient used Ginoring as directed

If withdrawal bleeding does not occur at the expected time, but the patient used Ginoring as directed and did not take other medications during this time, the likelihood of pregnancy is very low. The patient should continue using Ginoring as before. However, if withdrawal bleeding does not occur for two consecutive cycles, there is a possibility of pregnancy. The patient should contact her doctor as soon as possible. A new Ginoring system should not be inserted until the doctor confirms that the patient is not pregnant.

• If the patient used Ginoring incorrectly

If withdrawal bleeding does not occur during the first break in using Ginoring, and the patient used the vaginal therapeutic system incorrectly, she may be pregnant. The patient 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 mid-cycle bleeding. The patient may need sanitary pads. The system should remain in the vagina and be used as before. If irregular bleeding increases or recurs, the patient should contact her doctor.

Management in case of changing the day of bleeding occurrence
If Ginoring is used as directed, menstruation (withdrawal bleeding) will begin during the weekly break in use of the vaginal therapeutic system. If the patient wishes withdrawal bleeding to start on a different day, she may shorten the break in use of the vaginal therapeutic system (but never extend it!).
For example: if withdrawal bleeding usually starts on Friday, and the patient wishes to change this to Tuesday (3 days earlier) starting next month, she should insert a 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 spots of blood) or mid-cycle bleeding may occur.
If the patient is unsure how to proceed, she should consult her doctor.

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

3.5 Discontinuation of Ginoring

Ginoring may be discontinued at any time.
If the patient does not wish to become pregnant, she should consult her doctor regarding alternative contraceptive methods.
If the patient stops taking Ginoring because she wants to become pregnant, she should wait until the first menstrual period after discontinuation and only then attempt conception. This will help establish the due date.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the user considers related to the use of Ginoring, medical advice should be sought.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Ginoring".
Immediate medical attention should be sought if the user experiences symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or skin rash, and breathing difficulties (see section "Warnings and precautions").
The following adverse reactions have been reported by women using Ginoring.

Common: may affect up to 1 in 10 women

• abdominal pain, nausea;
• vaginal fungal infections (fungal changes); discomfort due to the presence of the system in the vagina; genital itching; vaginal discharge;
• headache or migraine-type headaches; 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 bladder or urinary tract infections;
• problems or pain during urination; urgency or need to urinate; frequent urination;
• discomfort during intercourse, including pain, bleeding, or discomfort related to the presence of the system felt by the male partner;
• increased blood pressure;
• increased appetite;
• back pain; muscle cramps; pain in lower or upper limbs;
• decreased skin sensitivity;
• breast tenderness or enlargement; fibrocystic breast disease (cysts which may cause swelling or breast pain);
• cervicitis; cervical polyps; cervical ectropion;
• changes in menstrual bleeding (e.g. heavy, prolonged, irregular or complete absence of menstruation); pelvic discomfort; premenstrual syndrome; uterine contractions;
• vaginal infections (fungal or bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva;
• hair loss, rash, itching, skin eruption or hot flushes;
• urticaria.

Rare: may affect up to 1 in 1000 women

• harmful blood clots in a vein or artery, for example:
  o in the leg or foot (e.g. deep vein thrombosis);
  o in the lungs (e.g. pulmonary embolism);
  o heart attack;
  o stroke;
  o mini-stroke or transient ischaemic attack (TIA);
  o blood clots in the liver, stomach, intestine, kidneys or eye.

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

• milk discharge from the breast.

Frequency unknown (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 vaginal therapeutic system to the vaginal wall);
• vaginal wall injury related to damage of 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", "Neoplastic diseases".
Ginoring may become damaged. For additional information, see section 3.4 "Instructions in case of damage to the vaginal therapeutic system".
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Ginoring

The medicine should be stored in a place inaccessible and out of sight of children.
Contact a doctor if a child has been exposed to the hormones contained in Ginoring.
No special storage temperature requirements apply. Store in the original packaging to protect from light.
Ginoring may be used only if at least one month remains until the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Do not use this medicine if you notice any colour changes in the system or if there are any visible signs of damage.
This medicine may pose a risk to the environment. After removing Ginoring, it should be placed in a pouch and securely closed. The sealed pouch should then be disposed of with regular household waste or returned to a pharmacy for disposal in special collection containers, in accordance with local regulations. Do not flush the Ginoring medicinal product down the toilet. As with other medicines, unused or expired systems must not be disposed of via sewage systems or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. Such procedures will help protect the environment.

6. Contents of the packaging and other information

What Ginoring contains

• The active substances are: etonogestrel and ethinylestradiol. Ginoring contains 8.25 mg of etonogestrel and 2.60 mg of ethinylestradiol. The vaginal drug delivery system releases etonogestrel and ethinylestradiol at average rates of 0.120 mg and 0.015 mg respectively per 24 hours over a period of 3 weeks.
• Other components are: ethylene vinyl acetate copolymer, 28% vinyl acetate, and polyurethane (a type of synthetic polymer which does not dissolve in the human body).

What Ginoring looks like and contents of the pack
Vaginal drug delivery system.
Ginoring is a flexible, transparent and colourless or almost colourless ring (system) with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm.
Each ring is packed in a pouch made of PET/Aluminium/LDPE.
The pouch is packed in a cardboard box together with the package leaflet and calendar stickers, which help you remember when to insert and remove the vaginal drug delivery system.
Each pack contains:
1 system;
3 systems;
6 systems.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer:
Laboratorios León Farma S.A
C/ La Vallina s/n, Pol. Ind. Navatejera
24008- Leon
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 Number in the Netherlands, country of export: RVG 118994
Parallel Import Licence Number: 50/26

This medicinal product is authorised in the European Economic Area (EEA) Member States 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 hours, 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