0.120 mg / 0.015 mg per 24 hours, vaginal insert
Etonogestrel / Ethinyl Estradiol
What Ornibel Is And What It Is Used For
Ornibel is a contraceptive in the form of a vaginal ring that is used to prevent pregnancy. Each ring contains a small amount of two female sex hormones – etonogestrel and Ethinyl estradiol. The ring slowly releases these hormones into the bloodstream.
Due to the small amounts of hormones that are released, Ornibel is considered a low-dose hormonal contraceptive. Because Ornibel releases two different types of hormones, it is a so-called combined hormonal contraceptive.
Ornibel ring works just like a combined contraceptive pill, but instead of taking one pill every day, the ring is used for 3 weeks in a row.
Ornibel releases two female sex hormones that prevent an egg from detaching from the ovaries. If no egg is released, you can not get pregnant.
What You Need To Know Before Using Ornibel
Before you start Ornibel ring uses, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots – see section 2 “Blood clots”.
This leaflet describes several situations when you should stop using Ornibel or when Ornibel may be less reliable. In such situations, you should not have intercourse or protect yourself with a non-hormonal contraceptive – for example, a condom or some other barrier method. Do not use safe periods or temperature methods. These methods may be unsafe because Ornibel affects the monthly changes in body temperature and secretions in the cervix.
Ornibel, like other hormonal contraceptives, does not protect against HIV infection ( AIDS ) or any other sexually transmitted disease.
2.1 Do Not Use Ornibel
stop Ornibel ring uses
Do not use Ornibe l if you have any of the conditions listed below. If you have any of these conditions, you must inform your doctor/midwife. Your doctor/midwife will discuss which other type of contraception may be more appropriate.
- If you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT),
- In the lungs ( pulmonary embolism, PE) or in any other organ.
- If you know you have a disease that affects blood coagulation – e.g. protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden, or antiphospholipid antibodies.
- If you need to have an operation or if you stay in bed for a long time (see section “Blood clots”).
- If you have (or have had) a heart attack or a stroke.
- If you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms).
- If you have any of the following conditions that may increase the risk of a blood clot in your arteries:
- Severe diabetes with vascular damage
- Very high blood pressure
- Very high levels of blood fats ( cholesterol and triglycerides )
- A condition called hyperhomocysteinemia.
- If you have or have had a type of migraine called “migraine with aura”.
- If you have (have had) inflammation of the pancreas ( pancreatitis ) in combination with high levels of blood fats.
- If you have (have had) severe liver disease and your liver is not yet functioning normally.
- If you have (have had) benign or malignant tumors in your liver.
- If you have (have had) or if you suspect you may have breast or genital cancer.
- If you have genital bleeding for no known reason.
- If you are allergic to Ethinyl estradiol or etonogestrel or any of the other ingredients of this medicine (listed in section 6).
Should any of the above symptoms occur for the first time when using Ornibel, remove the ring immediately and contact your doctor. In the meantime, use a non-hormonal contraceptive.
Do not use Ornibel if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir and dasabuvir or glekaprevir / pibrentasvir
(see also section 2.4 “Other medicines and Ornibel”).
2.2 Warnings And Precautions
|When should you contact a doctor? Seek medical attention immediately if you notice any signs of a blood clot that may mean that you have a blood clot in your leg (so-called deep vein thrombosis ), a blood clot in your lung (so-called pulmonary embolism ), a heart attack or stroke (see the section “Blood clots” below). For a description of the symptoms of these serious side effects, see the section “How to recognize a blood clot”.|
Tell your doctor/midwife if any of the following conditions apply to you.
If the condition occurs or worsens in the case of ornibel ring uses, you should also contact your doctor/midwife.
- 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 (eg jaundice) or gallbladder disease (eg gallstones ).
- If you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease).
- If you have systemic lupus erythematosus ( SLE – a disease that affects your natural immune system).
- If you have hemolytic uremic syndrome (HUS – a disease that affects the blood’s ability to coagulate and leads to kidney failure ).
- If you have sickle cell anemia (a hereditary disease that affects the red blood cells ).
- If you have elevated levels of blood fats ( hypertriglyceridemia ) or heredity for this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis ( inflammation of the pancreas).
- If you need to have an operation or if you stay in bed for a long time (see section 2 “Blood clots”).
- if you have just given birth, you are at increased risk of blood clots. Ask your doctor how soon after giving birth you can start using Ornibel.
- If you have an inflammation of the veins under the skin (superficial thrombophlebitis ).
- If you have varicose veins.
- If you have a condition that first appeared or worsened during pregnancy or previous use of sex hormones (eg hearing loss, porphyria (a blood disease), herpes gestationis (reddening of the skin with fluid blisters during pregnancy), Sydenhams Korea (a nerve disease in which sudden movement disorders in form of involuntary, rapid, jerky movements occur)).
- If you have (or have ever had) chloasma (yellow-brown pigment spots, so-called pregnancy spots, especially on the face). If so, avoid excessive sunlight or ultraviolet rays.
- If you have a medical condition that makes it difficult to use Ornibel – e.g. if you have constipation, uterine prolapse or pain during intercourse.
- If you have frequent urination and it stings and hurts when you urinate and you can not locate the ring in the vagina. These symptoms may indicate that Ornibel has been accidentally placed in the bladder.
- If you experience symptoms of angioedema, such as a swollen face, swollen tongue, and/or swollen throat and/or difficulty swallowing or hives, possibly with difficulty breathing, you should contact a doctor immediately. Estrogen-containing medicines may worsen the symptoms of hereditary or acquired angioedema.
Using combined hormonal contraceptives such as Ornibel increases the risk of blood clots compared to not using these drugs. In rare cases, a blood clot can block the blood vessels and cause serious problems.
Blood clots can form
- In veins (so-called venous thrombosis, venous thromboembolism, or VTE)
- In arteries (so-called arterial thrombosis, arterial thromboembolism, or ATE).
Recovery from blood clots is not always complete. In rare cases, they can cause serious lasting effects and, in very rare cases, be fatal.
It is important to remember that the overall risk of a blood clot due to Ornibel is low.
HOW TO FEEL A BLOOD CLOTH AGAIN
Seek medical attention immediately if you notice any of the following signs or symptoms.
|Do you experience any of these signs?||What can you possibly suffer from?|
|swelling of a bone or along a blood vessel in the bone or foot, especially if you also get: pain or tenderness in the leg that is only felt when you stand or walk increased heat in the affected leg discoloration of the skin on the leg, e.g. pale, red or blue.||Deep vein thrombosis|
|sudden unexplained shortness of breath or rapid breathing sudden cough for no apparent reason that could cause you to cough up blood severe chest pain that may increase with deep breathing severe instability or dizziness fast or irregular heartbeat severe pain in the abdomen. If you are not sure, talk to a doctor because some of these symptoms, e.g. cough and shortness of breath, maybe misinterpreted a milder condition such as respiratory infection(eg a common cold).||Pulmonary embolism|
|Symptoms that usually occur in one eye: immediate loss of vision or blurred vision without pain that can develop into vision loss.||Retinal venous thrombosis(blood clot in the eye)|
|chest pain, discomfort, pressure, heaviness feeling of pressure or fullness in the chest, arm, or below the sternum feeling satiated, indigestion or feeling of suffocation discomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomen sweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breakfast or irregular heartbeat.||Myocardial infarction|
|sudden weakness or numbness in the face, arms, or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding suddenly difficult seeing with one or both eyes sudden difficulty walking, dizziness, loss of balance or coordination sudden, severe or prolonged headache without known cause unconsciousness or fainting with or without seizures. Sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke.||Stroke|
|swelling and slight blue discoloration of an arm or leg severe abdominal pain ( acute abdomen).||Blood clots that block other blood vessels|
BLOOD CLOTS IN A FRIEND
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 blood clots in a vein (venous thrombosis ). However, these ornibel ring side effects are rare. They usually occur during the first year of using a combined hormonal contraceptive.
- If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
- If a blood clot travels from the bone and gets stuck in the lung, it can cause a pulmonary embolism.
- In very rare cases, a blood clot can form in a vein in another organ, such as the eye ( retinal venous thrombosis ).
When is the risk of developing a blood clot in a vein greatest?
The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk may also be higher if you start using a combined hormonal contraceptive again (same product or another product) after a break of 4 weeks or longer.
After the first year, the risk decreases, but it is always slightly higher than if you do not use a combined hormonal contraceptive.
When you stop using Ornibel, the risk of a blood clot returns to normal within a few weeks.
How big 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 using.
The total risk of a blood clot in the leg or lung with Ornibel ring is small.
- Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
- Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone or norgestimate, about 5–7 develop a blood clot in one year.
- Of 10,000 women who use a combined hormonal contraceptive that contains norelgestromin or etonogestrel such as Ornibel develops about 6-12 women a blood clots during a year.
- The risk of a blood clot varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).
|Risk of developing a blood clot during a year|
|Women who do not use a combined hormonal pill/patch/ring and who are not pregnant||About 2 out of 10,000 women|
|Women taking a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate||About 5-7 out of 10,000 women|
|Women using Ornibel||About 6-12 out of 10,000 women|
Factors that may increase the risk of a blood clot in a vein
The risk of a blood clot with Ornibel ring is small but some conditions increase the risk. The risk is higher:
- If you are very overweight (body mass index or BMI over 30 kg / m²).
- If a close relative has had a blood clot in the leg, lung, or other organs at a young age (ie younger than about 50 years). In that case, you may have a hereditary blood clotting disease.
- If you need to have surgery or stay in bed for a long time due to an injury or illness, or if you have a plastered leg. The Ornibel ring uses may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop using Ornibel, ask your doctor when you can start using it again.
- With increasing age (especially if you are older than about 35 years)
- If you gave birth a few weeks ago or less.
The more conditions you have, the greater the risk of developing a blood clot.
Air travel (over 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed.
You must tell your doctor if you have any of these conditions, even if you are unsure. Your doctor may decide that you need to stop using Ornibel.
If any of the above conditions change while you are using Ornibel, e.g. If a close relative suffers from a blood clot for no known reason or if you gain a lot of weight, talk to your doctor.
BLOOD CLOTS IN AN ART
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a blood clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.
Factors that may increase the risk of a blood clot in an artery
It is important to know that the risk of a heart attack or stroke due to the use of Ornibel is very small but may increase:
- With increasing age (after about 35 years of age)
- If you smoke. If you use a combined hormonal contraceptive such as Ornibel, you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another 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 (younger than about 50 years). In that case, you may also be at greater risk for a heart attack or stroke
- If you or a close relative have a high level of blood fats ( cholesterol or triglycerides )
- If you get migraines, especially migraines with aura
- If you have heart problems (flap, heart rhythm disorder called atrial fibrillation )
- If you have diabetes.
If you have more than one of these conditions or if any of them are particularly serious, the risk of developing a blood clot can be even greater.
If any of the above conditions change while you are using Ornibel, e.g. If you start smoking, a close relative suffers from a blood clot for no known reason or if you gain a lot of weight, talk to your doctor.
The information below is taken from studies of combined oral contraceptives and may also apply to Ornibel pregnancy ring. Information on vaginally administered hormonal contraceptives (such as Ornibel) is lacking.
Breast cancer has been detected slightly more often in women using combined contraceptive pills, but it is not known if this is due to the treatment. It can e.g. be that tumors er is more often detected in women who use combined birth control pills because they go to more medical check-ups.
The increased risk of breast cancer gradually decreases when you stop taking combined contraceptive pills.
It is important that you check your breasts regularly and that you contact your doctor/midwife if you feel any lumps. You should also tell your doctor/midwife if a close relative has or has previously had breast cancer (see section 2.2 “Warnings and precautions”).
In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors, have been reported in women using birth control pills. Contact your doctor/midwife if you experience unusual severe abdominal pain.
In women using combined contraceptive pills, it has been reported that cancer of the endometrium (uterine lining) and cancer of the ovaries are less common. This may also apply to Ornibel, but it has not been confirmed.
Some women who use hormonal contraceptives, including Ornibel ring, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.
2.3 Children And Young People
The safety and efficacy of Ornibel in adolescents below 18 years have not been studied.
2.4 Other Medicines And Ornibel
Always tell your doctor/midwife which medicines or (traditional) herbal medicines you are already using. Also, tell other doctors and dentists who prescribe medicines and the relevant pharmacy staff that you are using Ornibel. They can tell you if you need to use supplemental protection (for example, male condoms) and if so, for how long or if the use of any other medicine you need needs to be changed.
- May have an effect on the blood levels of Ornibel
- This may make it less effective in preventing pregnancy
- May cause unexpected bleeding.
This applies to medicines used to treat:
- Epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine, topiramate, felbamate)
- Tuberculosis (eg rifampicin)
- HIV infection (eg ritonavir, nelfinavir , nevirapine, efavirenz)
- Hepatitis C virus infections (eg boceprevir, telaprevir)
- Other infectious diseases (eg griseofulvin)
- High blood pressure in the blood vessels of the lungs ( bosentan )
- Depression ((traditional) herbal medicines containing St. John’s wort ).
If you are taking medicines or (traditional) herbal medicines that may make Ornibel less effective, a barrier method should also be used (eg male condoms). As the effect of another medicine on Ornibel may persist for up to 28 days after stopping treatment with the medicine, it is necessary to use a barrier method throughout this time. Note: Do not use Ornibel ring with diapers or female condoms.
Ornibel can also affect the effectiveness of other drugs e.g.
- Medicines containing ciclosporin
- The epilepsy drug lamotrigine (this may lead to an increased seizure frequency)
Do not use Ornibel if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glekaprevir/pibrentasvir as it may lead to increased liver function levels in the blood (an increase in the liver enzyme ALT ).
Your doctor/midwife will prescribe another type of contraceptive before you start treatment with these medicines.
Ornibel can be used approximately 2 weeks after the end of this treatment. See section 2.1 “When not to use Ornibel”.
Ask your doctor or pharmacist for advice before taking any medicine.
You can use tampons while using Ornibel. Insert Ornibel before inserting the tampon. Be careful when removing the tampon so that the ring does not accidentally come out. Should this occur, wash the ring in cool or lukewarm water and insert it again immediately.
The ring may have ruptured during concomitant use of vaginal products as a lubricant or during the treatment of infection (see section 3.4 “ What to do if… Your ring breaks ”). Concomitant use with spermicides or antifungals given in the vagina does not affect the effect of Ornibel.
If you are taking blood or urine samples, tell your healthcare provider that you are using Ornibel as it may affect the results of some tests.
2.5 Pregnancy And Lactation
Ornibel pregnancy ring should not be used by women who are pregnant or think they may be pregnant. Should you become pregnant while using Ornibel, remove the ring and contact your doctor/midwife.
If you want to stop using Ornibel because you want to get pregnant, see section 3.5 “If you stop using Ornibel”.
Ornibel is generally not recommended for use during breastfeeding. If you want to use Ornibel while breastfeeding, contact your doctor/midwife for advice.
2.6 Driving And Using Machines
There is no reason to believe that Ornibel would affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions ornibel ring side effects and effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How To Use Ornibel Ring?
Ornibel ring uses:
You can insert and remove Ornibel yourself. Your doctor/midwife will tell you when to start using Ornibel for the first time. Vaginal ring one must be inserted on the correct day in your menstrual cycle (see section 3.3 “Inserting the first ring”) and should remain in place for 3 consecutive weeks. Check regularly that Ornibel is still in the vagina (eg before and after intercourse) to ensure that you are protected against pregnancy. After the third week, take out Ornibel and take a break for a week. Usually, you will get your period during the ring-free interval.
While using Ornibel, do not use certain female barrier methods, such as pessaries or female condoms. These barrier methods should not be used as complementary contraceptives as Ornibel may impede the correct placement and position of the diaphragm or female condom. However, male condoms can be used as an extra barrier method.
3.1 How To Insert And Remove Ornibel
1. Check that the expiry date has not passed (see section 5 “How to store Ornibel”) before inserting the ring.
2. Wash your hands before inserting or removing the ring.
3. Choose the position that feels most comfortable for you, you can e.g. stand with one leg up, squat, or lie down.
4. Remove Ornibel from the sachet. Save the sachet for later use.
5. Hold the ring between your thumb and forefinger, press the sides together, and insert the ring into the vagina (see pictures 1-4).
When Ornibel is in place, you should not feel anything. If it feels uncomfortable, gently push Ornibel a little further into the vagina. The exact position of the ring in the vagina does not matter.
6. Ornibel should be removed after 3 weeks. You do this by hooking your index finger to the bottom edge of the ring or by grasping the edge and pulling it out (see picture 5). If you feel Ornibel in your vagina but cannot remove it yourself, contact your doctor/midwife.
7. Dispose of the used ring together with other household waste, preferably in the sachet. Do not flush Ornibel down the toilet.
Take Ornibel pregnancy ring out of the sachet
Squeeze the ring
Choose a comfortable position to insert the ring
|Figure 4A||Figure 4B||Figure 4C|
Insert the ring into the vagina with one hand (Fig. 4A), if necessary you can separate the labia with the other hand. Push the ring up into the vagina until it feels comfortable (Fig. 4B). Leave the ring in place for 3 weeks (Fig. 4C).
Ornibel can be removed by hooking the index finger to the lower edge of the ring or by grasping the edge with the index and middle fingers and pulling it out.
3.2 Three weeks inserted, one week removed
- From the day when the vaginal ring is inserted, it must be in place without interruption for 3 whole weeks.
- After 3 weeks, the Ornibel pregnancy ring is removed on the same day of the week and at approximately the same time as it was inserted. For example, if you have inserted Ornibel around 10 pm on a Wednesday, you should remove the ring 3 weeks later, around 10 pm on Wednesday.
- After removing the ring, do not use the ring for 1 week. During this week, you should have genital bleeding. It usually starts 2-3 days after Ornibel is taken out.
- Insert a new Ornibel pregnancy ring after exactly one week (again on the same day of the week and at about the same time), even if the bleeding has not stopped.
If the ring is inserted more than 3 hours late, the contraceptive effect may be reduced. Follow the instructions in section 3.4 “What to do again… You forgot to insert a new ring after the ring-free interval”.
If your Ornibel ring uses as described above, your vaginal bleeding will occur every month at about the same time.
3.3 Inserting The First Ring
- You have not used a hormonal contraceptive in the last monthInsert your first Ornibel on the first day of your natural menstrual cycle (ie on your first day of bleeding). Ornibel works immediately. You do not need to use any other contraceptive. It is also possible to start with Ornibel on day 2 to day 5 of the menstrual cycle, but then you must use extra protection (for example a condom) during the first cycle if you have intercourse during the first 7 days with Ornibel. You only need to follow these instructions the first time you use Ornibel.
- You have been using a combined pill for the past month Start with Ornibel no later than the day after the tablet-free period for your current birth control pill. If your birth control pill also contains hormone-free tablets, start with Ornibel no later than the day after the last hormone-free tablet. If you are not sure which tablet it is, ask your doctor/midwife or pharmacist. Never allow the hormone-free period for your current birth control pills to be longer than the recommended time. If you have used your birth control pills correctly and without interruption and if you are sure that you are not pregnant, you can stop taking the tablets at any time and start using Ornibel immediately.
- You have used a contraceptive patch in the last month start using Ornibel no later than the day after the patch-free period. Never allow the patch-free period to last longer than the recommended time. If you have used the hormone patch correctly and without interruption and if you are sure that you are not pregnant, you can stop using the hormone patch at any time and start using Ornibel immediately.
- You have been using a mini-pill (containing only progestin ) for the past month You can stop taking your mini-pill any day and start taking Ornibel the next day, at the same time as you would normally take your pill. Be sure to use extra protection (eg condoms) for the first 7 days with Ornibel.
- You have used an injection or implant or an IUD during the last month Start using Ornibel when you should have your next injection or the day your implant or hormone-releasing IUD is removed. Be sure to use extra protection (eg condoms) for the first 7 days with Ornibel.
- After you have given birth if you have just given birth, your doctor/midwife may tell you to wait for your first spontaneous period before starting Ornibel. Sometimes it is possible to start earlier. Your doctor/midwife will give you advice. If you are breastfeeding and want to use Ornibel, you should first discuss this with your doctor/midwife.
- After miscarriage or abortion, Your doctor/midwife will give you advice.
3.4 What To Do About…
Your ring has been accidentally pushed out of the vagina
Ornibel can be accidentally ejected from the vagina – e.g. if it has not been inserted correctly, when taking out a tampon, during intercourse, during constipation or if you have a prolapse. It is therefore important that you regularly check that the ring is in place in the vagina (eg before and after intercourse).
Your ring has temporarily been out of the vagina
Ornibel can still protect you from pregnancy, but it depends on how long it has been out of the vagina.
If the ring has been out of the vagina
- Less than 3 hours you are still protected against pregnancy. Rinse the ring with cold to lukewarm water (do not use hot water) and replace the ring as soon as possible but only if the ring has been out of the vagina for less than 3 hours.
- More than 3 hours during the 1st or 2nd week of use, the protection against pregnancy may have been affected. Rinse the ring with cold to lukewarm water (do not use hot water) and replace the ring as soon as you remember and leave the ring in place without a socket for at least 7 days. Use a male condom if you have intercourse for the next 7 days. If it occurs during the first week of use and you have had intercourse during the last 7 days, there is a risk that you are pregnant. In such cases, contact your doctor/midwife.
- More than 3 hours during the 3rd week, the protection against pregnancy may have been affected. Discard the ring and then select one of the following options:
- Insert a new ring immediately By inserting a new ring, the next 3-week period begins. It is possible that you do not get a period, however, breakthrough bleeding or splashing bleeding may occur.
- Do not insert the ornibel ring again. Wait for your period and then insert a new ring no later than 7 days after the previous ring was removed or pushed out. You should only choose this option if you have used Ornibel continuously for the previous 7 days.
- If you do not know how long Ornibel has been removed from your vagina, you may not be protected against pregnancy. Take a pregnancy test and talk to your doctor/midwife before inserting a new ring.
Your Ornibel ring is breaking
Ornibel can burst. Vaginal injuries have been reported in connection with the ring breaking. If you discover that Ornibel has broken, remove the ring and insert a new ring as soon as possible. Use extra protection (eg male condom) for the next 7 days. Contact your doctor/midwife if you had intercourse before you discovered that the ring had broken.
You have inserted more than one ring
There are no reports of serious adverse effects following an overdose of the hormones included in Ornibel. If you have accidentally inserted more than one ring, you may feel nauseous, vomit or have genital bleeding. Remove the extra ring and contact your doctor or hospital if symptoms persist.
You forgot to insert a new ring after the ringless interval
If your ring-free interval was longer than 7 days, insert a new ring as soon as you remember. Use extra protection (eg male condom) if you have intercourse for the next 7 days. If you have had intercourse during the ring-free interval, there is a risk that you have become pregnant. In such cases, contact your doctor/midwife immediately. The longer the ring-free interval lasts, the greater the risk that you will become pregnant.
You forgot to take out the ring
- If your ring has been inserted between 3 and 4 weeks, it still protects against pregnancy. Start with your ring-free interval for a week and then insert a new ring.
- If your ring has been inserted for more than 4 weeks, there is a risk that you have become pregnant. Contact your doctor/midwife before inserting a new ring.
Your period has not been missed
- You have used Ornibel according to the instructions. If you have not had your period but once ornibel ring uses according to the instructions and if you have not used other medicines, it is very unlikely that you are pregnant. Continue with Ornibel as usual. However, if you miss your period twice in a row, you may be pregnant. Contact your doctor/midwife immediately. Do not start with the next Ornibel until your doctor/midwife has checked that you are not pregnant.
- If you have deviated from the instructions for OrnibelIf you have not had your period and you have deviated from the instructions for Ornibel and you do not get your expected period during the ring-free period, you may be pregnant. Contact your doctor/midwife before inserting a new Ornibel.
You get an unexpected bleeding
While using Ornibel, some women may experience unexpected genital bleeding between menstrual periods. You may need to use menstrual pads. You should always leave the ring in the vagina and continue to use the ring as usual. If the irregular bleeding continues, becomes heavier, or recurs, contact a doctor/midwife.
You want to change the first day of your period
If you use Ornibel according to the instructions, you will have your period (dropout bleeding) during the ring-free interval. If you want to change the day when the bleeding starts, you can shorten (but never extend!) The ring-free interval.
For example, if your period usually starts on a Friday, you can change this to a Tuesday (3 days earlier) from next month onwards. Just insert your next ring 3 days earlier than usual.
If you make the ring-free interval very short (eg 3 days or less) you may not get your usual bleeding. You may have spotting (drops or stains of blood) or breakthrough bleeding while using the next ring.
If you have any further questions on the ornibel ring uses, ask your doctor/midwife for advice.
Do you want to postpone your period
Even if it is not the recommended regimen, it is possible to postpone the period (dropout bleeding) by inserting a new ring directly after the current one, ie without a ring-free interval between the rings.
You can leave the new ring for a maximum of 3 weeks. While using the new ring, you may experience spotting (drops or stains of blood) or breakthrough bleeding. When you want your period to come, just take out the ring. Have your regular ring-free interval of one week and then insert a new ring.
You can ask your doctor/midwife for advice before you decide to postpone your period.
3.5 If You Stop Using Ornibel Pregnancy Ring
You can stop using ornibel pregnancy ring whenever you want.
If you do not want to get pregnant, contact your doctor/midwife regarding other contraceptives.
If you stop taking ornibel pregnancy ring because you want to get pregnant, it is generally recommended that you wait until you have had a natural menstrual period. This will help you calculate the time of delivery.
Possible Ornibel Ring Side Effects
Like all medicines, ornibel ring side effects, although not everybody gets them. If you get any side effects, especially if they are serious or persistent, or if your health changes and you think it may be due to Ornibel, talk to your doctor.
An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries ( arterial thromboembolism (ATE)) is present in all women who use combined hormonal contraceptives. For more detailed information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before you use Ornibel”.
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, swollen tongue and/or swollen throat and/or difficulty swallowing and/or hives, possibly with difficulty breathing (see also section “Warnings and precautions”).
The following Ornibel ring side effects have been reported by users of rings containing etonogestrel / Ethinyl estradiol.
Common ornibel ring side effects: may affect up to 1 in 10 women
- Abdominal pain, nausea
- Vaginal fungal infection (eg “cod”)
- Ring-related vaginal discomfort
- Genital itching
- Vaginal Discharge
- Headache or migraine
- Decreased sex drive
- Sore breasts
- Pelvic pain
- Painful menstruation
- Weight gain
- Ring ejection.
Uncommon ornibel ring side effects: may affect up to 1 in 100 women
- Visual disturbance, dizziness
- Swollen abdomen, vomiting, diarrhea, or constipation
- Fatigue, malaise or irritation, mood swings
- Fluid retention in the body ( edema )
- Cystitis (urinary tract infection)
- Difficulty or pain in emptying the bladder, strong desire and need to empty the bladder, frequent urges
- Problems during intercourse such as pain, bleeding, or the partner feeling the ring
- High blood pressure
- Increased appetite
- Back pain, muscle cramps, pain in legs and arms
- Decreased skin sensitivity
- Tender or enlarged breasts, fibrocystic breast disease (cysts in the breasts that may swell or become painful)
- Inflammation of the cervix, cervical polyps (growths on the cervix), growth on the border of the cervix (ectopy)
- Changes in the bleeding pattern (eg bleeding may be heavier, longer, irregular, or completely absent), pelvic discomfort, premenstrual tension syndrome (PMS), uterine spasm
- Vaginal infection (fungal and bacterial), burning sensation, foul-smelling discharge, pain, discomfort, or dryness in the vagina or vulva
- Hair loss, eczema, itching, rash, or hot flashes
Rare ornibel ring side effects: may affect up to 1 in 1,000 women
- Harmful blood clots in a vein or artery, for example:
- In one leg or foot (so-called DVT)
- In a lung (so-called PE)
- Myocardial infarction
- Mini-stroke or transient stroke-like symptoms called transient ischemic attack ( TIA )
- Blood clots in the liver, stomach/intestines, kidneys, or eyes.
The risk of developing a blood clot may be higher if you have any other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and symptoms of a blood clot).
- Secretion from the breasts
Has been reported (occurs in an unknown number of users):
- Chloasma (yellow-brown spots on the skin, especially on the face)
- Partner’s penis problems (such as irritation, rash, itching )
- Inability to remove the ring without medical help (eg due to sticking to the vaginal wall)
- Vaginal injury in connection with the rupture of the ring.
Breast cancer and liver tumors have been reported in users of combined hormonal contraceptives. For more information, see section 2.2 “Warnings and Precautions, Cancer”.
Ornibel can burst. For more information, see section 3.4 What to do about… Your ring is missing.
How To Store Ornibel Ring:
- Keep this medicine out of sight and reach of children.
- If you find that a child has been exposed to hormones from Ornibel, contact a doctor, hospital, or the Poison Information Center (tel. 112) for advice.
- No special temperature instructions.
- Store in the original package. Sensitive to light.
- Ornibel must be inserted at least one month before the expiry date which is stated on the carton and sachet (after EXP). The expiration date is the last day of the specified month.
- Do not use Ornibel if you notice any color change on the ring or other signs of poor quality.
- This medicine may pose a risk to the environment. After removal, the Ornibel ring should be placed in the sachet, which should be closed properly. The sealed sachet can then be disposed of with normal household waste or handed in at a pharmacy for disposal according to current instructions.
- Do not flush Ornibel down the toilet. As with other medicines, do not dispose of unused rings in drains or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
- The active substances are etonogestrel and Ethinyl estradiol. Ornibel contains 11.0 mg etonogestrel and 3.474 mg Ethinyl estradiol. The ring releases etonogestrel and Ethinyl estradiol with a release of 0.120 mg and 0.015 mg, respectively, per 24 hours over a period of 3 weeks.
- The other ingredients are ethylene vinyl acetate copolymer ( 28% vinyl acetate) and polyurethane (a type of plastic that cannot be dissolved in the body).
What The Medicine Looks Like And Contents Of The Pack
- Ornibel is a flexible, transparent, colorless almost colorless ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm.
- Each ring is packed in a sachet of aluminum foil. The sachet is packed in a cardboard box together with this leaflet and stickers for your calendar to remind you of the days when the ring is to be inserted and removed.
- Each carton contains 1 ring, 3 rings, or 6 rings.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Exeltis Healthcare SL
Of. Miralcampo 7-Poligono Ind. Miralcampo
19200 Azuqueca de Henares, Guadalajara
Laboratorios León Farma, SA
Calle La Vallina s / n. Poligono Industrial Navatejera Villaquilambre