Ginoring

Package leaflet: Information for the user

Ginoring, (0.120 mg + 0.015 mg)/24 h, vaginal ring
Etonogestrel + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, 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 clot formation (see section 2 "Blood clots").

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, 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 this 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 using machines

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 out of 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 inserted after the break
       What to do if the vaginal ring is not removed 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 the onset of 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
   Marketing authorisation holder and manufacturer

1. What Ginoring is and what it is used for

Ginoring is a contraceptive in the form of a vaginal ring, which prevents 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 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 in which
its effectiveness may be reduced. In such situations, you should avoid 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 monitoring. These methods may be ineffective because Ginoring affects
changes in body temperature and cervical mucus consistency during the month.
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 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, presence of factor V Leiden or antiphospholipid antibodies;
• if the patient requires surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if the patient has had a heart attack or stroke;
• if the patient has (or has previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if the patient has any of the following diseases, which may increase the risk of arterial blood 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 hyperhomocysteinaemia;
• if the patient currently has (or has previously had) a type of migraine called “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 benign or malignant liver tumours;
• 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 sought. During this time, a non-hormonal method of contraception should be used.
The use of the vaginal therapeutic system Ginoring is contraindicated when simultaneously using medicinal products 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 notices symptoms suggesting the formation of blood clots, which may indicate that the patient has 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 reactions, see section "How to recognize the formation of blood clots".
You should inform the doctor if the patient has any of the following conditions.
If any of these conditions appear or worsen during treatment with 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 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 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. Consult the doctor for advice on how soon after delivery Ginoring can 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 appeared or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], Sydenham's chorea [a nervous system disorder characterized by involuntary, violent movements]);
• if the patient currently has or has previously had chloasma (yellowish-brown pigmented patches, so-called "melasma", especially on the face). If such patches occur, 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 (or) if the patient cannot locate the intravaginal therapeutic system inside the vagina. These symptoms may indicate accidental placement of the Ginoring intravaginal 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 occur, immediate medical attention must be sought. Medicinal products containing estrogens may induce or exacerbate 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 achieved. 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 FORMATION 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 veins?

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

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is greatest during the first year of using
combined hormonal contraceptives for the first time. The risk may also be
increased when restarting combined hormonal contraceptives (the same or a different product)
after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using
combined hormonal contraceptives at all.
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 using 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 to 12 out of 10,000 women who use combined hormonal contraceptives containing ethinylestradiol or etonogestrel, such as Ginoring, will develop blood clots.
• The risk of developing blood clots depends on the individual woman's medical history (see "Factors that increase the risk of 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 had 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 is due to undergo surgery, if she is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Ginoring for several weeks before surgery or immobilisation. If the patient has to stop taking Ginoring, ask the doctor when it is safe to restart;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last 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 tell the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to stop the use of Ginoring.
Inform the doctor if any of the above conditions change during treatment with Ginoring, for example, if a close family member is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with blood clots in veins, blood clots in arteries can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to note 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 cigarettes. 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 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 fats in the blood (cholesterol or triglycerides);
• if the patient has 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 blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Ginoring, for example, if the patient starts smoking, if a close family member is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

Cancer
The following information comes from studies using combined hormonal contraceptives and may also apply to Ginoring. Information on vaginal use of hormonal contraceptives (as is the case with Ginoring) is not yet available.
A slightly higher number of cases of breast cancer have 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 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 examinations are very important. If any lump is detected, consult a doctor. Also inform the doctor if any close relatives have or have 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, contact the treating doctor.
There are reports that women using combined hormonal contraceptives have a lower incidence of endometrial cancer (cancer of the lining of the uterus) and ovarian cancer. This may also apply to Ginoring, but 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, contact the 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 established.

2.4 Ginoring and other medicines

Inform your prescribing doctor if you are taking any other medicines or herbal products.
You should also inform any other doctor, dentist or pharmacist who prescribes you new 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 use of the other medicine 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, Hypericum perforatum).

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 time.
Note: Ginoring should not be used with a diaphragm, cervical cap or female condom.

Ginoring may affect the action of other medicines, such as:

• medicines containing cyclosporine;
• the antiepileptic drug lamotrigine (this may lead to an increased frequency of seizures).

Ginoring must not be used in patients with hepatitis C who are being treated with 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, e.g. AlAT). Before starting these medicines, your doctor will prescribe a different type of contraception.
Use of the Ginoring vaginal ring may be resumed 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 the Ginoring vaginal ring, tampons may be used. Insert Ginoring before inserting a tampon.
Be careful when removing the tampon to avoid accidentally removing the Ginoring ring as well.
If the ring is expelled, simply wash it with cool or lukewarm water and reinsert it as soon as possible.
Damage to the vaginal ring may occur during use of vaginal products such as moisturizers or treatments for infections (see section 3.4 "What to do if the vaginal ring is damaged").
The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of Ginoring.

Diagnostic tests
If laboratory blood or urine tests are to be performed, 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

Do not use Ginoring during pregnancy or if the patient suspects she may be pregnant. If pregnancy occurs while using Ginoring, remove the intravaginal therapeutic system and consult a physician.
If the patient wishes to discontinue using Ginoring because she intends to become pregnant, refer to 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 first consult her doctor.

2.6 Driving and operating machinery

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

3. How to use Ginoring

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Ginoring 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 correct 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 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 (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 together and insert into the vagina (see Figures 1–4). Ginoring is correctly positioned when you do not feel it. If the system causes discomfort, push it slightly deeper into the vagina. The exact position within the vagina does not affect its contraceptive efficacy.
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 grasping it between your index and middle fingers and 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 doctor.
7. Dispose of the used system with household waste, preferably inside the 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 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 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 your index finger under the edge of the system or grasping it between your index and middle fingers and pulling it out.

3.2 Three weeks of use, one week break

1. The system should remain in the vagina continuously for three weeks, starting from the day of insertion.
2. After three weeks, the system must be removed on the same weekday and approximately at the same time as it was inserted. For example, if Ginoring 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 removal of the system, a one-week break from using the system should be observed. During this time, bleeding may occur. It usually begins 2–3 days after removal of Ginoring.
4. A new system must be inserted exactly one week after the previous removal (on the same weekday and approximately at the same time), even if bleeding is still ongoing.

If insertion of the new system is delayed by more than 3 hours, contraceptive efficacy may be reduced. In such a case, follow the instructions provided in section 3.4 "Instructions if, after the weekly break, the patient forgot to insert a new vaginal therapeutic system".
If Ginoring is used according to the above instructions, subsequent bleedings will usually occur on approximately the same days of the week.

3.3 When to apply the first vaginal contraceptive system

• No previous use of a hormonal contraceptive in the preceding cycle
  Apply the first Ginoring on the first day of the natural cycle (i.e. the first day of menstruation). Ginoring is effective from the moment of application. 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 using Ginoring. This recommendation applies only when starting Ginoring for the first time.

• Previously used combined oral contraceptive tablets
  Begin using Ginoring no later than the day following the break from the currently used contraceptive. If the current preparation includes placebo tablets (without active ingredients), start using Ginoring no later than the day after taking the last placebo tablet. In case of doubt about which tablet is which, consult a doctor 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 patch-free interval. Do not extend the patch-free interval beyond the recommended period. If the patient has used the transdermal system regularly and is certain she is not pregnant, she may discontinue the patch on any day and immediately start using Ginoring.

• Previously used a progestogen-only contraceptive (mini-pill)
  The mini-pill may be discontinued on any day. Begin using Ginoring the following day at the same time the mini-pill was usually taken. An additional contraceptive method (such as a condom) must be used during the first 7 days of using Ginoring.

• Previously used an implant, injectable contraceptive, or intrauterine device (IUD) 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. An additional contraceptive method (such as a condom) must be used during the first 7 days of using Ginoring.

• After childbirth
  After childbirth, the doctor may recommend starting Ginoring only after the first menstrual period. Sometimes it may be possible to start earlier, as advised by the doctor. If breastfeeding and wishing to use Ginoring, this should be discussed with the doctor.

• After miscarriage
  As directed by the doctor.

3.4 What to do if…

Management in case the system accidentally falls out of the vagina
Ginoring 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 important to regularly check whether the system is still in place in the vagina (e.g. before and after sexual intercourse).
If the system has been outside the vagina for 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.
If the system has been outside the vagina for more than 3 hours, contraceptive protection may be reduced: in this case, refer to the recommendations in section 3.4 “Management if the system has been outside the vagina for some time”.

Management if 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 it has been 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. It should then be left in place continuously for at least 7 days. During these 7 days, if the woman has sexual intercourse, she should additionally use a male condom. If the woman is in the first week of her cycle and has had intercourse during the previous 7 days, there is a possibility she may be pregnant. In such a 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 should be chosen:
  1. Insert a new vaginal therapeutic system as soon as possible. Inserting a new system means starting the next three-week cycle of use. 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 is only acceptable if the woman has used Ginoring continuously for the last 7 days.
• If Ginoring 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
Ginoring 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 sexual intercourse occurred before the woman noticed the damage, she should contact her doctor.

Use of more Ginoring systems than recommended
There have been no reports of serious harmful effects related to overdose of the hormones contained in Ginoring. If more than one vaginal therapeutic system is accidentally inserted, symptoms such as 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 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 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 forgot to remove the vaginal therapeutic system on time

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

Management in case of absence of bleeding

• If Ginoring was used correctly: If withdrawal bleeding does not occur on time, but Ginoring was used correctly and no other medications were taken, 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 she is not pregnant.

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

Management in case of unexpected bleeding
During use of Ginoring, some women may experience unexpected mid-cycle bleeding. Sanitary pads may be needed. 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 changing the day of bleeding onset
If Ginoring is used correctly, menstruation (withdrawal bleeding) will start during the weekly break from using the vaginal therapeutic system. If the woman 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 woman wishes to shift it to Tuesday (3 days earlier) from 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 that time. During use of the next vaginal therapeutic system, spotting (small drops or stains of blood) or mid-cycle bleeding may occur.
If the woman is unsure how to proceed, she should consult her doctor.

Management if wishing to delay the onset of bleeding
Although not recommended, it is possible to delay menstruation (withdrawal bleeding) by inserting a new vaginal therapeutic system immediately after removing the previous one, without a break.
The new vaginal therapeutic system should not be used for longer than 3 weeks. During this time, spotting (small drops or stains of blood) or mid-cycle bleeding may occur. To induce withdrawal bleeding, the vaginal therapeutic system should be removed. A regular weekly break between consecutive systems is recommended.
Before deciding to delay 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 consult her doctor about alternative contraceptive methods.
If the woman stops using Ginoring because she wishes to become pregnant, she should wait until her first natural menstrual period before trying to conceive. This helps in determining the due date.

4. Possible side effects
Like all medicines, this product may cause side effects, although not everyone experiences them.
If any side effects occur, especially severe or persistent ones, or any changes in health that the woman considers related to the use of Ginoring, she should consult her doctor.
All women using combined hormonal contraceptives have an increased risk of venous thrombosis (venous thromboembolic disease) or arterial thrombosis (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 “Important information before using Ginoring”.

Seek immediate medical attention if the woman 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”).

Women using Ginoring have reported the following side 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

• Vision 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; urgency or need to urinate; frequent urination;
• Discomfort during intercourse, including pain, bleeding, or discomfort felt by the male partner due to the 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 changes (cysts that may cause swelling or breast 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 their occurrence).

• Galactorrhoea (milk discharge from the breast)

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

• Chloasma (yellowish-brown pigmentation 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”, “Neoplastic diseases”.

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

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can 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, PL-02 222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps to provide more information on the safety of the medicine.
Side effects can also be reported to the Marketing Authorisation Holder.

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 in Ginoring.
This medicine has no special storage temperature requirements. Store in the original packaging to protect from light.
Ginoring may be used if at least one month remains until the expiry date printed on the box and sachet after the abbreviation “EXP”. The expiry date refers to the last day of the stated month. The batch number is indicated on the packaging after the abbreviation “Lot”.
Do not use this medicine if you notice any change in the colour of the system or if there are any visible signs of damage.
This medicine may be harmful to the environment. After removing Ginoring, place it in the sachet and close it securely. The sealed sachet 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 medicines, including this one, should not be disposed of via sewage systems or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

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

• The active substances are: etonogestrel and ethinylestradiol. Ginoring contains 8.25 mg etonogestrel and 2.60 mg ethinylestradiol. The vaginal therapeutic system releases etonogestrel and ethinylestradiol at average rates of 0.120 mg and 0.015 mg respectively per 24 hours over a 3-week period.
• Other ingredients: ethylene and vinyl acetate copolymer, 28% vinyl acetate, polyurethane (a type of plastic that 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 packed in an aluminium sachet. The sachet is packed in a cardboard box together with this leaflet and calendar stickers to help remember when to insert and remove the vaginal therapeutic system.
Each pack contains:
1 system;
3 systems;
6 systems.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw, Poland

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

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