Ornibel

Package leaflet: Information for the user

Ornibel 0.120 mg/0.015 mg every 24 hours, vaginal device

Etonogestrel/Ethinylestradiol
Equivalent medicine

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet
1. What Ornibel is and what it is used for
2. What you need to know before using Ornibel
2.1 When you must not use Ornibel
2.2 Warnings and precautions
Blood clots
Tumours
2.3 Children and adolescents
2.4 Other medicines and Ornibel
Laboratory tests
2.5 Pregnancy and breastfeeding
2.6 Driving and using machines

3. How to use Ornibel

3.1 How to insert and remove Ornibel
3.2 Three weeks with the ring inserted, one week without
3.3 When to start with the first ring
3.4 What to do if…
The ring is accidentally expelled from the vagina
The ring remains temporarily outside the vagina
The ring breaks
You have inserted more than one ring
You forgot to insert a new ring after a ring-free interval
You forgot to remove the ring
You miss your menstrual period
You experience unexpected bleeding
You wish to change the first day of your menstrual cycle
You wish to delay your menstrual cycle
3.5 When you want to stop using Ornibel
4. Possible side effects
5. How to store Ornibel
6. Package contents and other information
What Ornibel contains
Description of the appearance of Ornibel and package contents
Marketing Authorization Holder and Manufacturer

1. What Ornibel is and what it is used for

Ornibel is a vaginal contraceptive ring used to prevent pregnancy. Each ring contains a small amount of two female sex hormones: etonogestrel and ethinylestradiol. The ring slowly releases these hormones into the bloodstream. Because the amounts of hormones released are low, Ornibel is considered a low-dose hormonal contraceptive. Since Ornibel releases two different types of hormones, it is a so-called combined hormonal contraceptive.
Ornibel works in the same way as a combined oral contraceptive pill (the Pill), but instead of taking a pill every day, the ring is used continuously for three weeks.
Ornibel releases two female sex hormones that prevent the release of an egg from the ovaries. If no egg is released, you cannot become pregnant.

2. What you should know before using Ornibel

General notes
Before starting to use Ornibel, you must read the information about blood clots in section

2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”). This patient leaflet describes certain situations in which you should stop using Ornibel or in which Ornibel may be less reliable. In such situations, you should not have sexual intercourse or you must use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use rhythm or basal body temperature methods. These methods may be unreliable because Ornibel alters the monthly fluctuations in body temperature and cervical mucus.

Ornibel, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

2.1 When you must not use Ornibel
Do not use Ornibel if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your case.

• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are scheduled for surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which could increase the risk of forming clots in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have had) pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if you have (or have had) a severe liver disease and liver function has not yet returned to normal;
• if you have (or have had) a benign or malignant liver tumour;
• if you have (or have had), or may have, a tumour of the breast or genital organs;
• if you have vaginal bleeding of unknown origin;
• if you are allergic to ethinylestradiol or etonogestrel or to any of the other ingredients of this medicine (listed in section 6).

If any of these conditions occur for the first time while you are using Ornibel, remove the ring immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.
Do not use Ornibel if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section 2.4 Other medicines and Ornibel).

2.2 Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”).

For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Ornibel, inform your doctor.

• if a close relative has or has ever had breast cancer;
• if you have epilepsy (see section 2.4 “Other medicines and Ornibel”);
• if you have liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defense system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are scheduled for surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start using Ornibel;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a condition that first occurred or worsened during pregnancy or during previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [skin rash with blisters during pregnancy], Sydenham’s chorea [a nerve disorder causing sudden involuntary movements]);
• if you have (or have ever had) chloasma (brownish-yellow patches, so-called “pregnancy spots”, especially on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet rays;
• if you have a medical condition that makes it difficult to use Ornibel, such as constipation, uterine cervical prolapse, or pain during sexual intercourse;
• if you experience urgency to urinate, frequent urination, burning and/or pain, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of Ornibel inside the bladder;
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives potentially with breathing difficulties, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Ornibel increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, and very rarely, these effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Ornibel is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

Does it present any of these signs?	What is it probably suffering from?
swelling in one leg or along a vein in the leg or foot, especially if accompanied by: • pain or tenderness in the leg, which may only be felt when standing or walking • increased warmth in the affected leg • change in skin color of the leg, such as paleness, redness, or bluish discoloration	Deep vein thrombosis
sudden, unexplained shortness of breath or rapid breathing; • sudden cough without an obvious cause, possibly accompanied by coughing up blood; • sharp chest pain that may worsen when breathing deeply; • severe dizziness or lightheadedness; • rapid or irregular heartbeat; • severe stomach pain; If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory tract infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: • sudden loss of vision or • painless blurring of vision that may progress to vision loss	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, or heaviness • squeezing sensation or fullness in the chest, in one arm, or under the sternum; • feeling of fullness, indigestion, or suffocation; • discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach; • sweating, nausea, vomiting, or dizziness; • extreme weakness, anxiety, or shortness of breath; • rapid or irregular heartbeat	Heart attack
sudden numbness or weakness in the face, arm, or leg, especially on one side of the body; • sudden confusion, difficulty speaking or understanding speech; • sudden vision problems in one or both eyes; • sudden difficulty walking, dizziness, loss of balance or coordination; • sudden, severe or prolonged headache with no known cause; • loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue discoloration of a limb; • severe stomach (abdominal) pain.	Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Ornibel, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Ornibel is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing norelgestromine or etonogestrel such as Ornibel, about 6–12 will develop a blood clot over one year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

	Chance of developing a blood clot in one year
Women who are not using a combined hormonal pill/patch/ring and who are not pregnant	About 2 women out of 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women out of 10,000
Women who use Ornibel	About 6-12 women out of 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Ornibel is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop using Ornibel several weeks before surgery or during periods of reduced mobility. If you need to stop using Ornibel, ask your doctor when you can start using it again.
• with increasing age (especially over 35 years);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop using Ornibel. If any of the conditions listed above change while you are using Ornibel—for example, if a close relative develops a blood clot without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
As with blood clots in a vein, clots in an artery can cause serious problems, for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Ornibel is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Ornibel, it is advisable to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the conditions listed above change while you are using Ornibel—for example, if you start smoking, if a close relative develops a blood clot without a known cause, or if you gain significant weight—contact your doctor.

Tumors
The information below comes from studies on combined oral contraceptives and may also apply to Ornibel. No specific data are available on the vaginal administration of contraceptive hormones (such as Ornibel).
Diagnoses of breast cancer are slightly more frequent in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, tumors may be detected more often in women taking the combined pill because they undergo more frequent medical check-ups.
The increased occurrence of breast cancer gradually decreases after stopping the combined oral contraceptive.
It is important that you regularly examine your breasts and contact your doctor if you feel a lump. You should also inform your doctor if a close relative has or has had breast cancer (see section 2.2 "Warnings and precautions").
In rare cases, benign liver tumors have been reported in women taking the pill, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusual, severe abdominal pain.
It has been reported that endometrial cancer (cancer of the inner lining of the uterus) and ovarian cancer occur less frequently in women using combined oral contraceptives. This may also be the case with Ornibel, but it has not been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including Ornibel, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

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

2.4 Other medicines and Ornibel
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctor or dentist (or pharmacist) who prescribes other medicines (or dispenses them) that you are using Ornibel. They can advise you whether you need to use additional contraceptive methods (e.g., a male condom) and, if so, for how long, or whether it is necessary to adjust the use of another medicine you are taking.
Some medicines:

• may affect blood levels of Ornibel;
• may cause a decrease in contraceptive effectiveness;
• may cause unexpected bleeding.

These include medicines used to treat:

• Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• Tuberculosis (e.g., rifampicin);
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• Hepatitis C virus infection (e.g., boceprevir, telaprevir);
• Other infectious diseases (e.g., griseofulvin);
• High blood pressure in the pulmonary blood vessels (bosentan);
• Depressed mood (St. John’s wort herbal remedy).

If you are taking medicines or herbal products that may reduce the effectiveness of Ornibel, you should also use a barrier contraceptive method (e.g., a male condom). Because the effect of other medicines on Ornibel may last up to 28 days after stopping them, you must use an additional barrier contraceptive method throughout this period. Note: Do not use Ornibel in combination with a diaphragm, cervical cap, or female condom.
Ornibel may affect the effect of other medicines, for example:

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

Do not use Ornibel if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these may cause increases in liver function blood test results (increase in liver enzyme transaminase (ALT)).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Use of Ornibel may be resumed 2 weeks after completion of this treatment. See section 2.1 “When you must not use Ornibel”.
Ask your doctor or pharmacist for advice before taking any medicine.
Sanitary tampons may be used during use of Ornibel. Insert Ornibel before inserting the tampon.
Take particular care when removing the tampon to ensure that the ring is not accidentally expelled. If this occurs, simply wash the ring with cold or lukewarm water and reinsert it immediately.
Ring breakage has occurred when also using a vaginal product such as a lubricant or treatment for infection (see section 3.4 "What to do if... the ring breaks"). The use of spermicidal products or vaginal yeast-based treatments does not reduce the contraceptive effectiveness of Ornibel.

Laboratory tests
If you need to have blood or urine tests, inform the healthcare professional that you are using Ornibel, as it may alter the results of certain tests.

2.5 Pregnancy and breastfeeding
Ornibel must not be used by women who are pregnant or think they might be pregnant. If you become pregnant while using Ornibel, you must remove the ring and contact your doctor.
If you wish to stop using Ornibel because you want to start a pregnancy, see section 3.5 "When you want to stop using Ornibel".
Ornibel is generally not recommended during breastfeeding. If you wish to use Ornibel while breastfeeding, consult your doctor.

2.6 Driving and use of machines
It is unlikely that Ornibel will affect your ability to drive or use machines.

3. How to use Ornibel

Take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
You can insert and remove Ornibel yourself. Your doctor will tell you when to start using Ornibel
for the first time. The vaginal ring must be inserted on the appropriate day of the menstrual cycle
(see section 3.3 'When to start with the first ring') and left in the vagina for 3 consecutive weeks.
Check regularly whether Ornibel is still in the vagina (e.g. before and after sexual intercourse) to ensure
protection against pregnancy. After the third week, remove Ornibel and have a one-week break.
Your menstrual period will usually occur during this ring-free interval.
While using Ornibel, you must not use certain female barrier contraceptive methods, such as
a vaginal diaphragm, cervical cap, or female condom. These barrier methods should not be used as an additional method of birth control, as Ornibel may interfere with the correct placement and position of the diaphragm, cervical cap, or female condom. However, you may still use a male condom as an additional barrier contraceptive method.

3.1 How to insert and remove Ornibel

1. Before inserting the ring, check that it is not expired (see section 5 'How to store Ornibel').
2. Wash your hands before inserting or removing the ring.
3. Choose the most comfortable position for inserting the ring, for example, standing with one leg raised, squatting, or lying down.
4. Remove Ornibel from its pouch. Keep the pouch for future use.
5. Hold the ring between your thumb and index finger, compress it on opposite sides, and gently insert it into the vagina (see Figures 1–4). When Ornibel is correctly placed, you should not feel any discomfort. If you do feel discomfort, gently push Ornibel further into the vagina. The exact position of the ring within the vagina is not important.
6. After 3 weeks, remove Ornibel from the vagina. You can do this by hooking your index finger under the front edge of the ring or by grasping the edge and pulling outward (see Figure 5). If you locate the ring in the vagina but cannot remove it, contact your doctor.
7. The used ring should be disposed of with household waste, preferably inside the pouch. Do not flush Ornibel down the toilet.

Figure 1
Remove Ornibel from the pouch

Figure 2
Compress the ring

Figure 3
Choose a comfortable position for inserting the ring

Figure 4A Figure 4B Figure 4C
Insert the ring into the vagina with one hand (Figure 4A); if necessary, the labia may be parted with the other hand. Push the ring into the vagina until you feel it is comfortably in place (Figure 4B). Leave the ring in place for 3 weeks (Figure 4C).

Figure 5:
Ornibel can be removed by hooking your index finger under the ring or by grasping the edge between your index and middle fingers and pulling outward.

3.2 Three weeks with the ring inserted, one week without

1. Starting from the day you inserted it, the vaginal ring must remain in the vagina continuously for 3 weeks.
2. After 3 weeks, remove the ring on the same day of the week and approximately at the same time as when you inserted it. For example, if you inserted Ornibel on Wednesday around 10 p.m., you should remove the ring 3 weeks later, on Wednesday at approximately 10 p.m.
3. After removing the ring, do not use a ring for 1 week. During this week, vaginal bleeding should occur. It usually starts 2–3 days after removal of Ornibel.
4. Start a new ring exactly after the 1-week break (again on the same day of the week and approximately at the same time), even if vaginal bleeding has not yet stopped.

If insertion of the new ring is delayed by more than 3 hours, protection against
pregnancy may be reduced. In this case, follow the instructions provided in section 3.4 “What
to do if you forgot to insert a new ring after a ring-free interval”.
If you use Ornibel as described above, vaginal bleeding will occur every month approximately
on the same days.

3.3 When to start with the first ring

• If you have not used a hormonal contraceptive during the last month Insert the first Ornibel on day 1 of your natural cycle (i.e. the first day of your menstrual period). Ornibel will start working immediately. You do not need to take any additional contraceptive precautions. You may also start Ornibel between day 2 and day 5 of your cycle, but if you have sexual intercourse during the first 7 days of using Ornibel, make sure to use an additional contraceptive method (e.g. a condom). You need to follow this advice only when using Ornibel for the first time.
• If you have used a combined oral contraceptive pill during the last month Start using Ornibel no later than the day after the pill-free interval of your current pill pack. If your pill pack also contains inactive tablets, start using Ornibel no later than the day after the last inactive tablet. If you are unsure which tablet is inactive, consult your doctor or pharmacist. Never extend the hormone-free interval of your current pill pack beyond the recommended period. If you have taken the pill consistently and correctly and are sure you are not pregnant, you may also stop taking the pill on any day of the current pack and start using Ornibel immediately.
• If you have used a transdermal patch during the last month Start using Ornibel no later than the day after your usual patch-free interval. Never extend the patch-free interval beyond the recommended period. If you have used the patch consistently and correctly and are sure you are not pregnant, you may also stop using the patch on any day and start using Ornibel immediately.
• If you have used a progestogen-only pill (mini-pill) during the last month You may stop taking the mini-pill on any day and start using Ornibel the next day at the same time you would normally have taken the pill. However, make sure to use an additional contraceptive method (e.g. a condom) during the first 7 days of ring use.
• If you have used a progestogen-releasing injection, implant, or intrauterine device (IUD) during the last month Start using Ornibel on the day the next injection is due, or on the day of removal of the implant or progestogen-releasing IUD. However, make sure to use

an additional contraceptive method (e.g. a condom) during the first 7 days of ring use.

• After childbirth If you have recently given birth, your doctor may advise you to wait until your first natural menstrual cycle before starting to use Ornibel. In some cases, earlier initiation may be possible. Consult your doctor. If you are breastfeeding and wish to use Ornibel, you must consult your doctor first.
• After spontaneous or surgical abortion Consult your doctor.

3.4 What to do if...
The ring is accidentally expelled from the vagina
Ornibel may accidentally come out of the vagina, for example, if it was not inserted correctly, during tampon removal, during sexual intercourse, in case of constipation, or if you have uterine prolapse. Therefore, you should regularly check whether the ring is still in the vagina (e.g. before and after sexual intercourse).

The ring remains outside the vagina temporarily
Ornibel may still protect you from pregnancy, but this depends on how long it has been outside your vagina.
If the ring remains outside the vagina for:

• less than 3 hours, it may still protect you from pregnancy. Rinse the ring with cool to lukewarm water (do not use hot water) and reinsert it as soon as possible, but only if it has been outside the vagina for less than 3 hours.
• more than 3 hours, during week 1 or 2, it may not protect you from pregnancy. Rinse the ring with cool to lukewarm water (do not use hot water) and reinsert it as soon as you remember, and leave the ring in the vagina continuously for at least 7 days. Use a male condom if you have sexual intercourse during these 7 days. If you are in your first week and have had sexual intercourse in the previous 7 days, there is a possibility you could be pregnant. In this case, contact your doctor.
• more than 3 hours, during week 3, it may not protect you from pregnancy. Discard that ring and choose one of the following two options: 1 - Insert a new ring immediately. This will start the next 3-week treatment period. You may not have a menstrual period, but breakthrough spotting or bleeding may occur. 2 - Do not insert a new ring. Wait until you have your menstrual period and insert a new ring no later than 7 days after the previous ring was removed or expelled. You should choose this option only if you have used Ornibel continuously during the previous 7 days.
• If Ornibel has been outside the vagina for an unknown length of time, you may not be protected from pregnancy. Perform a pregnancy test and consult your doctor before inserting a new ring.

The ring breaks
Ornibel may break. Vaginal injuries associated with ring breakage have been reported. If you notice that Ornibel has broken, discard that ring and start with a new one as soon as possible. Use additional contraceptive precautions (e.g. a male condom) for the next 7 days. If you had sexual intercourse before noticing the breakage, consult your doctor.

You inserted more than one ring
No serious harmful effects due to overdose of Ornibel's hormones have been reported. If you accidentally inserted more than one ring, you may feel unwell (nausea), or experience vomiting or vaginal bleeding. Remove the extra rings and consult your doctor if symptoms persist.

You forgot to insert a new ring after a ring-free interval
If your ring-free interval is longer than 7 days, insert a new ring as soon as you remember. Also use an additional contraceptive method (such as a male condom) if you have sexual intercourse during the next 7 days. If you had sexual intercourse during the interval period, there is a possibility you could be pregnant. In this case, contact your doctor immediately. The longer the ring-free interval, the greater the risk of pregnancy.

You forgot to remove the ring

• If your ring has remained inserted for a period between 3 and 4 weeks, it will still protect you from pregnancy. Take your regular one-week ring-free break and then insert a new ring.
• If your ring has remained inserted for more than 4 weeks, there is a possibility of pregnancy. Contact your doctor before inserting a new ring.

You miss your period

• You followed the instructions for Ornibel If you miss a period but have followed the instructions for Ornibel and have not used other medicines, it is very unlikely that you are pregnant. Continue using Ornibel as usual. However, if you miss two periods in a row, you may be pregnant. Contact your doctor immediately. Do not start the next Ornibel until your doctor has confirmed you are not pregnant.
• If you did not follow the instructions for Ornibel If you miss a period and did not follow the instructions for Ornibel and did not have your expected period during the first ring-free interval, you may be pregnant. Contact your doctor before starting a new Ornibel.

You have unexpected bleeding
While using Ornibel, some women may experience unexpected vaginal bleeding between periods. You may need to use sanitary protection. In any case, leave the ring in the vagina and continue using it normally. If irregular bleeding persists, becomes heavy, or recurs, contact your doctor.

You want to change the first day of your menstrual cycle
If you have followed the instructions for Ornibel, your menstrual period (withdrawal bleeding) will begin during the ring-free interval. If you wish to change the starting day of your period, you may shorten the ring-free interval (but never extend it!).
For example, if your period usually starts on Friday, you can change it to Tuesday (3 days earlier) starting next month. Simply insert the next ring 3 days earlier than usual.
If you make your ring-free interval very short (e.g. 3 days or less), you may not have your usual bleeding. You may experience spotting (drops or small stains of blood) or breakthrough bleeding during use of the next ring.
If you are unsure how to proceed, contact your doctor for clarification.

You want to delay your menstrual period
Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by inserting a new ring immediately after removing the previous one, without taking a ring-free interval.
You may leave the new ring in place for a maximum of 3 weeks. During use of the new ring, you may experience spotting (drops or small stains of blood) or breakthrough bleeding. When you wish your period to start, simply remove the ring. Observe the regular one-week ring-free interval and then insert a new ring.
You may consult your doctor before deciding to delay your menstrual period.

3.5 When you want to stop using Ornibel
You may stop using Ornibel at any time.
If you do not wish to become pregnant, ask your doctor about other methods of birth control.
If you stop using Ornibel because you wish to become pregnant, wait until you have had a natural menstrual period before trying to conceive. This will help you calculate your expected due date.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Ornibel, tell your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before using Ornibel”.
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives potentially with breathing difficulties (see also section “Warnings and precautions”).
The following adverse reactions have been reported by users of rings containing etonogestrel/ethinylestradiol.

Common: may affect up to 1 in 10 women

• abdominal pain; feeling unwell (nausea)
• vaginal fungal infection (e.g. “Candida”); vaginal discomfort due to the ring; genital itching; vaginal discharge
• headache or migraine; depressed mood; decreased libido
• breast pain; pelvic pain; painful menstruation
• acne
• weight gain
• expulsion of the ring

Uncommon: may affect up to 1 in 100 women

• visual disturbances; dizziness
• bloated abdomen; vomiting, diarrhoea or constipation
• feeling tired, unwell or irritable; mood changes; mood swings
• fluid retention in tissues (oedema)
• bladder or urinary tract infection
• difficulty or pain when urinating; strong urge or need to urinate; increased frequency of urination
• problems during sexual intercourse, including pain, bleeding or partner sensation of the ring
• increased blood pressure
• increased appetite
• back pain; muscle spasms; leg or arm pain
• reduced skin sensitivity
• sore or enlarged breasts; fibrocystic mastopathy (breast cysts that may swell and cause pain)
• inflammation of the cervix; cervical polyps (growths in the cervix); eversion of the cervical margin (ectropion)
• menstrual cycle changes (e.g. periods may be heavy, prolonged, irregular or may stop completely); pelvic discomfort; premenstrual syndrome; uterine spasms
• vaginal infections (fungal and bacterial); burning sensation, odour, pain, discomfort or dryness of the vagina or vulva
• hair loss, eczema, itching, rash or hot flushes
• urticaria

Rare: may affect up to 1 in 1,000 women

• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT) or in a lung (PE) or heart attack or stroke or mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA) or blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• breast discharge

Not known (frequency cannot be estimated from the available data)

• chloasma (yellowish-brown pigmented skin patches, particularly on the face)
• penile discomfort in the partner (such as irritation, rash, itching)
• inability to remove the ring without medical assistance (e.g. due to adhesion to the vaginal wall)
• vaginal lesion associated with ring breakage

Breast cancer and liver tumours have been reported with the use of combined hormonal contraceptives. For further information, see section 2.2 Warnings and precautions, Tumours.
Ornibel may break. For further information, see section 3.4 "What to do if... The ring breaks".
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ornibel

Keep this medicine out of the sight and reach of children.
If you find that a child has been exposed to the hormones in Ornibel, consult your doctor.
This medicine does not require any special storage temperature. Store in the original packaging to protect from light.
Ornibel must be removed at least one month before the expiry date, which is indicated on the box and on the sachet after EXP. The expiry date refers to the last day of that month.
Do not use Ornibel if you notice any change in the colour of the ring or any visible signs of deterioration.
This medicine may pose a risk to the environment. After removal, Ornibel must be placed back into the sachet and sealed properly. The sealed sachet should be disposed of with household waste or returned to a pharmacy for proper disposal according to local regulations.
Do not flush Ornibel down the toilet. As with other medicines, do not dispose of unused or expired rings via wastewater or household waste. Ask your pharmacist how to dispose of rings that are no longer needed or have expired. This will help protect the environment.

6. Package contents and other information

What Ornibel contains

• The active substances are: etonogestrel and ethinylestradiol. Ornibel contains 8.25 mg of etonogestrel and 2.60 mg of ethinylestradiol. The ring releases etonogestrel and ethinylestradiol at average rates of 0.120 mg and 0.015 mg per 24 hours, respectively, over a period of 3 weeks.
• The other components are: ethylene vinyl acetate copolymer, 28% vinyl acetate, and polyurethane (a type of plastic that does not dissolve in the body).

Description of the appearance of Ornibel and contents of the pack
Vaginal device.
Ornibel is a flexible, transparent, colourless or almost colourless ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm.
Each ring is contained in an aluminium pouch. The pouch is packaged in a cardboard box together with this leaflet and calendar stickers to help you remember when to insert and remove the ring.
Each box contains:
1 ring
3 rings
6 rings
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Exeltis Italia S.r.l.
Via San Bovio 3
20054 Segrate (MI)
Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Ornibel 0.120/0.015 mg per 24 hours, vaginal use aid
Belgium: IzzyRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system
IzzyRing 0.120 mg/0.015 mg per 24 hours, vaginal use aid
IzzyRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system
Luxembourg: IzzyRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system
France: Maival 15 micrograms/120 micrograms/24 hours, vaginal delivery system
Italy: Ornibel
Spain: Ornibel 0.120 mg/0.015 mg every 24 hours, vaginal release system EFG
Portugal: Ornibel 0.120 mg + 0.015 mg per 24 hours, vaginal release system
Romania: Ornibel 0.120 mg/0.015 mg/24 hours vaginal delivery system
Bulgaria: Ornibel 0.120/0.015 mg per 24 hours, vaginal delivery system