Package Insert: Information for the User

Ornibel 0.120 mg/0.015 mg every 24 hours, vaginal delivery system EFG

(Etonogestrel/Ethinylestradiol)

Important Information You Should Know About Combined Hormonal Contraceptives (CHCs):

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

Read this package insert carefully before starting to use Ornibel, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

1.What is Ornibel and How is it Used

2. What You Need to Know Before Starting to Use Ornibel

2.1 When Not to Use Ornibel

2.2 Warnings and Precautions

Blood Clots

Cancer

2.3 Children and Adolescents

2.4 Other Medicines and Ornibel

Laboratory Tests

2.5 Pregnancy and Breastfeeding

2.6 Driving and Operating Machines

3. How to Use Ornibel

3.1 How to Put On and Take Off Ornibel

3.2 Three Weeks In, One Week Out

3.3 When to Start with the First Ring

3.4 What to Do If…

Your ring is expelled accidentally from the vagina

Your ring has been temporarily removed from the vagina

The ring is open

More than one ring has been put on

If you forget to put on a new ring after the pause without a ring

If you forget to take off the ring

If your period or menstrual flow does not appear

If you experience unexpected bleeding

If you want to change the day your period or menstrual flow starts

If you want to delay your period or menstrual flow

3.5 If You Want to Stop Using Ornibel

4. Possible Adverse Effects

5. Storage of Ornibel

6. Contents of the Package and Additional Information

Composition of Ornibel

Appearance of Ornibel and Contents of the Package

Marketing Authorization Holder and Responsible Manufacturer

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 releases these hormones slowly into the bloodstream. Given the small amount of hormones released, Ornibel is a low-dose hormonal contraceptive.

Since Ornibel releases two different types of hormones, it is a combined hormonal contraceptive

Ornibel acts like the combined oral contraceptive pill (the “Pill”), but instead of taking a pill every day, the ring is used for 3 consecutive weeks. Ornibel releases two female sex hormones that prevent the ovaries from releasing an egg. If no egg is released, you cannot become pregnant

General Considerations

Before starting to use Ornibel, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

In this leaflet, various situations are described in which you should stop using Ornibel, or in which Ornibel may be less reliable. In these situations, you should not have sexual intercourse, or you should take additional non-hormonal contraceptive measures, such as a condom or another barrier method.Nouse the rhythm or basal body temperature method. These methods may not be reliable since Ornibel alters the monthly body temperature changes and cervical mucus.

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

2.1 When Not to Use Ornibel

You should not use Ornibel if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with vascular damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• 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 fat in your blood.
• If you have or have had a serious liver disease and your liver is not functioning normally.
• If you have or have had a benign or malignant tumor in the liver.
• If you have, have had, or may have breast cancer or cancer of the reproductive organs.
• If you have unexplained vaginal bleeding.
• If you are allergic to ethinylestradiol or etonogestrel, or to any of the other components of this medication (including in section 6).

If any of these circumstances occur for the first time while using Ornibel, remove the ring immediately and consult your doctor. Meanwhile, use non-hormonal contraceptive measures.

You should not use Ornibel if you have hepatitis C or are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section 2.4 “Use of Ornibel with Other Medications”).

2.2 Warnings and Precautions

Inform Your Doctor if You Suffer from Any of the Following Conditions.

If the condition develops or worsens while using Ornibel, you should also inform your doctor.

• If any of your close relatives have had or have cancer of the breast.
• If you suffer from epilepsy (see section 2.4. “Other Medications and Ornibel”).
• If you have a liver disease (for example, jaundice) or a gallbladder disease (for example, gallstones).
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).

• If you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
• If you have sickle cell anemia (a hereditary disorder of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you are at increased risk of blood clots after childbirth. You should ask your doctor when you can start taking Ornibel after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have a disease that appeared for the first time or worsened during pregnancy or previous use of sex hormones (for example, hearing loss, porphyria [a blood disorder], herpes of pregnancy [skin rash with blisters during pregnancy], or Sydenham's chorea [a nervous disorder that causes involuntary movements]).

• If you have or have had melasma (brownish-yellow skin patches, particularly on the face); if this is the case, avoid excessive exposure to the sun or ultraviolet rays.
• If you have conditions that make it difficult to use Ornibel, for example, if you have constipation, uterine prolapse, or experience pain during sexual intercourse.
• If you experience urgent, frequent, painful, or burning urination, and cannot locate the ring in the vagina. These symptoms may indicate that Ornibel has been accidentally placed in the urinary bladder.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Hormonal products can cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Ornibel increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be lasting or, very rarely, fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to Ornibel is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical assistance if you notice any of the following signs or symptoms.

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 blood clots in veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot may form in a vein in another organ, such as the eye (retinal vein thrombosis).

When Is the Risk of a Blood Clot in a Vein Higher?

The risk of a blood clot in a vein is higher during the first year in which you start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop using Ornibel, your risk of a blood clot returns to normal in a few weeks.

What Is the Risk of 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 a blood clot in the leg or lung (DVT or PE) with Ornibel is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing norelgestromin or etonogestrel, such as Ornibel, about 6-12 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors That Increase Your Risk of a Blood Clot” below).

Factors That Increase Your Risk of a Blood Clot in a Vein

Your risk of a blood clot with Ornibel is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop using Ornibel for several weeks before the operation or while you have reduced mobility. If you need to stop using Ornibel, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years).
• If you have given birth recently.

Your risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop using Ornibel.

If any of the conditions listed above change while you are using Ornibel, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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 cause serious problems. For example, it can cause a heart attack or a stroke.

Factors That Increase Your Risk of a Blood Clot in an Artery

It is essential to note that the risk of a heart attack or stroke due to Ornibel is very small, but it may increase:

• With age (over about 35 years).
• If you smoke.When using a combined hormonal contraceptive like Ornibel, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at increased risk of a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, arrhythmia called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

If any of the conditions listed above change while you are using Ornibel, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

CANCER

The following information has been obtained from studies with oral combined contraceptives and may be applicable to Ornibel. There is no information available on the administration of vaginal hormones (such as Ornibel).

Cases of breast cancer have been observed with a slightly higher frequency in women using oral contraceptives, but it is unknown whether this is due to treatment. For example, it may be that more tumors are found in women using oral contraceptives because they attend medical check-ups more frequently. This increased frequency decreases gradually after stopping treatment.

It is essential to examine your breasts regularly and inform your doctor if you notice any lump. Inform your doctor if any of your close relatives have had or have breast cancer (see section 2.2 “Warnings and Precautions”).

Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using oral contraceptives. Contact your doctor if you experience severe and unusual abdominal pain.

In women using oral contraceptives, cancer of the endometrium (the lining of the uterus) or ovaries has been observed to occur less frequently. This may also be the case with Ornibel, but it has not been confirmed.

PSYCHIATRIC DISORDERS:

Some women who use hormonal contraceptives like Ornibel have reported depression or a depressed mood. Depression can be severe and sometimes induces suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

2.3 Children and Adolescents

The safety and efficacy of Ornibel in adolescents under 18 years have not been established.

2.4 Other Medications and Ornibel

Always inform your doctor about any medications or herbal supplements you are taking. Also, inform any doctor, dentist, or pharmacist (or pharmacist) who prescribes another medication that you are using Ornibel. They can advise you on whether you need to take additional contraceptive measures (for example, use of male condoms) and, if necessary, for how long, or whether you need to modify the use of the other medication.

Some medications

• may affect the levels of Ornibel in the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding.

These include medications used to treat:

• epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (for example, rifampicin);
• HIV infection (for example, ritonavir, nelfinavir, nevirapina, efavirenz);
• hepatitis C infection (for example, boceprevir, telaprevir);
• other infectious diseases (for example, griseofulvin);
• high blood pressure in the pulmonary arteries (bosentan);
• mood disorders (the herbal remedy St. John's Wort).

If you are taking medications or herbal supplements that may make Ornibel less effective, you should also use a barrier contraceptive method (e.g., male condom). Since the effect of another medication on Ornibel may last for up to 28 days after stopping the medication, you will need to use a barrier contraceptive method for that time. Note: Do not use Ornibel with a diaphragm, cervical cap, or female condom.

Ornibel may affect the effect of other medications, for example:

• medications containing ciclosporin
• the antiepileptic lamotrigine (this may increase the frequency of seizures)

You should not use Ornibel if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Ornibel can be restarted approximately 2 weeks after completing this treatment. See section 2.1 “When Not to Use Ornibel”.

Consult your doctor or pharmacist before taking any medication.

You can use tampons while using Ornibel. First, put on Ornibel, and then the tampon. Be especially careful when removing the tampon to avoid accidentally expelling the ring. If it is expelled, simply wash the ring with cold or lukewarm water and put it back on immediately.

The ring can open when using a vaginal product, such as a lubricant or a treatment for an infection (see section 3.4 “What to Do If....the Ring Opens”).

The use of spermicides or vaginal antifungal products does not reduce the effectiveness of Ornibel as a contraceptive.

Laboratory Tests

If you have blood or urine tests, inform your doctor that you are using Ornibel, as it may affect the results of some tests.

2.5 Pregnancy and Breastfeeding

Women who are pregnant or suspect they may be pregnant should not use Ornibel. If you become pregnant while using Ornibel, remove the ring and consult your doctor.

If you want to stop using Ornibel because you want to become pregnant, see section 3.5 “If You Want to Stop Using Ornibel”.

In general, it is not recommended to use Ornibel while breastfeeding. If you want to use Ornibel while breastfeeding, consult your doctor.

2.6 Driving and Operating Machinery

Ornibel is unlikely to affect your ability to drive or operate machinery

You can put and take out Ornibel yourself. Your doctor will tell you when to start using it for the first time. The vaginal ring must be inserted on the correct day of your menstrual cycle (see section 3.3 "When to start with the first ring") and stay in the vagina for 3 consecutive weeks. Check regularly if the ring is still in your vagina (for example, before and after sexual intercourse) to make sure you are protected against pregnancy. After the third week, remove Ornibel and leave a week of rest. You will normally have your period or menstruation during this pause without a ring.Menstrual period or menstruation

While using Ornibel, you should not use some barrier female contraceptives, such as the vaginal diaphragm, cervical cap, or female condom. These barrier contraceptives should not be used as a backup method of birth control since Ornibel may interfere with the correct placement and position of the diaphragm, cervical cap, or female condom. However, you can use a male condom as an additional barrier contraceptive method.

3.1 How to put on and take off Ornibel

1. Before putting on the ring, check that it is not expired (see section 5 "Storage of Ornibel").
2. Wash your hands before putting on or taking off the ring.
3. Choose a comfortable position for you to insert it, for example, standing with one leg raised, squatting, or lying down.
4. Remove Ornibel from its package. Save the package for later use.
5. Hold the ring between your index and middle fingers, press the opposite sides, and insert the ring into the vagina (see figures 1-4).

When Ornibel is in place, you should not feel anything. If you feel uncomfortable, gently push Ornibel into the vagina. The exact position of the ring inside the vagina is not important.

1. After 3 weeks, remove Ornibel from the vagina. You can do this by hooking the ring with your index finger or holding it with your fingers and stretching it out (see figure 5). If you cannot remove the ring despite having located it, contact your doctor.
2. Dispose of the used ring in the regular household trash, preferably in its package. Do not flush Ornibel down the toilet.

Figure 1

Remove Ornibel from its package

Figure 2

Press the ring

Figure 3

Choose a comfortable position to put on the ring

Figure 4AFigure 4BFigure 4C

Put the ring in the vagina with one hand (Figure 4A), if necessary, separate the vaginal lips with the other hand. Push the ring into the vagina until you feel comfortable (Figure 4B). Leave the ring in the vagina for 3 weeks (Figure 4C).

Figure 5:

Ornibel can be removed by hooking the ring with the index finger or holding it with the index and middle fingers and stretching it out.

3.2 Three weeks in, one week out

1. The vaginal ring must remain in the vagina from the day you put it in for 3 consecutive weeks, uninterrupted.
2. After 3 weeks, remove the ring on the same day of the week and at the same time as when you put it in. For example, if you put it in on a Wednesday around 22:00, remove it 3 weeks later on a Wednesday around 22:00.
3. Once you have removed the ring, do not use it for a week. During this week, you should experience a vaginal bleeding. Normally, it starts 2-3 days after removing Ornibel.
4. Put a new ring exactly 1 week after the pause without a ring (again on the same day of the week and approximately at the same time), even if you have not stopped bleeding yet.

If you put a new ring more than 3 hours late, the contraceptive effectiveness may be reduced. Follow the instructions in section 3.4 "What to do if you forget to put a new ring after the pause without a ring."

If you use Ornibel as described above, your menstrual period will occur approximately on the same days each month.

3.3 When to start with the first ring

• If you have not used hormonal contraception in the previous month

Put Ornibel on the first day of your natural cycle (i.e., the first day of your menstruation). Ornibel starts working immediately. You do not need to take any other contraceptive measures.

You can also start with Ornibel between days 2 and 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 (male condom). You should only follow this recommendation when using Ornibel for the first time.

• If you were using a combined pill in the previous month

Start using Ornibel as late as the day after your current pill pause. If your pill package also contains inactive pills, start Ornibel as late as the day after the last inactive pill. If you are unsure which pill is which, consult your doctor or pharmacist. Do not extend your pill pause beyond what is recommended.

If you have taken your current pill correctly and continuously and are sure you are not pregnant, you can stop taking the pill on any day of your cycle and start with Ornibel immediately.

• If you were using a transdermal patch in the previous month

Start using Ornibel as late as the day after your patch-free pause. Do not extend your patch-free pause beyond what is recommended.

If you have used the patch correctly and continuously and are sure you are not pregnant, you can stop using the patch on any day and start with Ornibel immediately.

• If you were using a progestin-only pill in the previous month

You can stop taking your progestin-only pill on any day and start Ornibel the next day at the same time. However, make sure to use an additional contraceptive method (male condom) during the first 7 days of using the ring.

• If you were using an injectable, an implant, or an Intrauterine System (IUS) with hormonal load (progestin) in the previous month

Start using Ornibel at the time you should receive the next injection or the day the implant or IUS is removed. However, make sure to use an additional contraceptive method (male condom) during the first 7 days of using the ring.

• After childbirth

If you have just given birth, your doctor may advise you to wait until your first normal menstrual period before starting with Ornibel. Sometimes it is possible to start earlier, your doctor will advise you on how to do it. If you are breastfeeding and want to use Ornibel, consult your doctor first.

• After an abortion

Consult your doctor.

3.4 What to do if...

Your ring is accidentally expelled from the vagina

Ornibel can be accidentally expelled from the vagina, for example, if it was not inserted correctly, when removing a tampon, during sexual intercourse, if you have constipation, or if you have uterine prolapse (uterine descent). Therefore, you should regularly check if the ring is in your vagina. (For example, before and after sexual intercourse).

Your ring has been out of the vagina temporarily

Ornibel may still protect you from pregnancy, but this will depend on how long it has been out of your vagina.

If the ring has been out of the vagina for:

• Less than 3 hours, it will still protect you from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and put the ring back in the vagina as soon as possible, but only if the ring has been out of the vagina for less than 3 hours.
• More than 3 hours in the 1st or 2nd week, it may not protect you from pregnancy. Wash the ring with cold or lukewarm water (do not use hot water) and put the ring back in the vagina as soon as you remember and leave it in the vagina for at least 7 consecutive days. Use a male condom if you have sexual intercourse during those 7 days. If you are in the first week and had sexual intercourse in the 7 days prior, there is a possibility that you may be pregnant. In that case, consult your doctor.
• More than 3 hours in the 3rd week, it may not protect you from pregnancy. Remove the ring and choose one of the two options below:

1. Put a new ring immediately.

By putting a new ring, you will start a new 3-week cycle of use, and you may not experience your period. However, you may experience intermenstrual bleeding or spotting during that cycle.

1. Do not put a new ring. Let the intermenstrual bleeding pass and put a new ring no later than 7 days from the time the previous ring was removed or expelled.

Choose this option only if you have used Ornibel consecutively for the 7 days prior.

If Ornibel has been out of the vagina for an unknown period, you may not be protected against pregnancy. You should undergo a pregnancy test and consult your doctor before inserting a new ring.

The ring has opened

Ornibel may open. Vaginal injury associated with ring rupture has been reported. If you notice that Ornibel has opened, remove the ring and put a new one as soon as possible. Take additional contraceptive precautions (e.g., male condom) for the next 7 days. If you had sexual intercourse before noticing that the ring had opened, consult your doctor.

More than one ring has been put on

No severe side effects have been reported due to Ornibel overdose. If you accidentally put more than one ring, you may feel unwell (nausea), vomit, or experience vaginal bleeding. Remove the extra ring and contact your doctor if these symptoms do not subside. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to put a new ring after the pause without a ring

Your pause without a ring has lasted more than 7 days. Put a new ring in the vagina as soon as you remember. Take additional contraceptive measures (e.g., male condom) if you have sexual intercourse during the next 7 days.If you had sexual intercourse during this pause without a ring, there is a possibility that you may be pregnant.In that case, inform your doctor immediately. The longer the pause without a ring, the higher the risk of pregnancy.

If you have forgotten to remove the ring

• If the ring has been in the vagina for 3 to 4 weeks, it will still protect you from pregnancy. Let the week without a ring pass and then put a new ring.
• If the ring has been in the vagina for more than 4 weeks, there is a possibility that you may be pregnant. Contact your doctor before starting with a new ring.

If your period or menstruation does not appear

• You have used Ornibel as instructed.

If your period does not appear, but you have used Ornibel as instructed and have not taken any other medications, it is very unlikely that you are pregnant. Continue using Ornibel as usual. However, if you have two consecutive missed periods, you may be pregnant, so inform your doctor immediately. Do not put the next Ornibel until your doctor has confirmed that you are not pregnant.

• If you have deviated from the recommended use of Ornibel.

If your menstrual period does not appear during the pause without a ring and you have deviated from the recommended regimen, there is a possibility that you may be pregnant, so you should contact your doctor before putting a new ring.

If you experience unexpected bleeding

During the use of Ornibel, some women may experience unexpected vaginal bleeding between their menstrual periods. You may need sanitary protection. However, continue using the ring as usual, do not remove it. If the bleeding continues, becomes heavier, or starts again, consult your doctor.

If you want to change the day your period or menstruation starts

If you use Ornibel as instructed, your menstrual period will start during the pause without a ring. If you want to change the day it starts, you must shorten (never extend!) the pause without a ring.

For example, if your period usually starts on a Friday, you can change it to a Tuesday, i.e., 3 days earlier from the next month. Simply put the next ring 3 days earlier than usual.

If the pause is made very short (e.g., 3 days or less), you may not have your usual menstrual period. You may experience spotting (drops or spots of blood) or intermenstrual bleeding during the use of the next ring.

If you are unsure how to do it, consult your doctor.

If you want to delay your period or menstruation

Although this is not the recommended regimen, you can delay your menstrual period (menstrual deprivation) by putting a new ring immediately after removing the current ring, without leaving the pause between rings. You can keep the new ring in place for a maximum of 3 weeks. During the use of the new ring, you may experience spotting (drops or spots of blood) or irregular bleeding. When you want your period to start, simply remove the ring. Leave the usual pause without a ring and put a new ring afterwards.

You can consult your doctor before deciding to delay your menstrual period.

3.5 If you want to stop using Ornibel

You can stop using Ornibel at any time you want. If you do not want to become pregnant, consult your doctor about other contraceptive methods.

If you stop using Ornibel because you want to become pregnant, it is recommended to wait until you have had your first natural menstrual period before trying to conceive. This will help you calculate the due date.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be due to Ornibel, consult your doctor.

All women taking combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Ornibel”.

Contact a doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing (also see section “Warnings and precautions”).

Users of the ring containing Etonogestrel / Etinilestradiol have reported the following side effects:

Frequent:can affect up to 1 in 10 women.

• abdominal pain, discomfort (nausea)
• infection of the vagina by yeast (similar to oral candidiasis), vaginal discomfort due to the ring, genital itching, vaginal discharge
• headache or migraine, depressive mood, decreased libido
• breast pain, pelvic pain, painful menstruation
• acne
• weight gain
• expulsion of the ring

Infrequent:can affect up to 1 in 100 women.

• vision changes, dizziness
• swollen abdomen, vomiting, diarrhea, or constipation
• • fatigue, discomfort, or irritability, mood changes, changes in mood
• fluid retention in the body (edema)
• urinary tract infection or bladder infection
• difficulty, pain, or urgency while urinating; frequent need to urinate
• problems with sexual relations such as pain, bleeding, or the partner noticing the ring
• increased blood pressure
• increased appetite

• back pain, muscle cramps, leg or arm pain
• reduced skin sensitivity
• breast tension or pain, or breast enlargement; fibrocystic breast disease (quists in the breasts that can become swollen or painful)
• inflammation of the cervix, polyps that grow on the cervix, displacement of tissue from the inside of the cervix to the outside (ectropion)
• • changes in menstrual period (more intense, longer, irregular, or absent), pelvic discomfort, premenstrual syndrome, uterine cramps
• infection of the vagina (by fungi or bacteria), burning, odor, pain, discomfort, or dryness of the vagina or vulva
• hair loss, eczema, itching, rash, or hot flashes
• Urticaria

Rare:can affect up to 1 in 1,000 women.

• harmful blood clots in a vein or artery, for example:

• in a leg or foot (i.e., DVT)
• in a lung (i.e., PE)
• heart attack
• stroke
• transient ischemic attack (TIA) or mild stroke symptoms
• blood clots in the liver, stomach/intestine, kidneys, or eye

The chances of having 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 secretion

Unknown frequency:(cannot be estimated from available data).

• melasma (yellow-brown skin patches, particularly on the face)
• partner's genital discomfort (irritation, rash, itching).
• inability to remove the ring without medical assistance (e.g., due to its adherence to the vaginal wall).
• vaginal injury associated with ring rupture.

Cases of breast cancer and liver tumors have been reported in women using combined hormonal contraceptives. For more information, see section 2.2 “Warnings and precautions, Cancer”.

Ornibel may open. For more information, see section 3.4 “What to do if… the ring opens.”

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es

Keep this medication out of the sight and reach of children.

If you discover that a child has been exposed to Ornibel hormones, consult your doctor.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Ornibel must be inserted at least one month before the expiration date appears on the box and on each package after CAD. The expiration date is the last day of the month indicated.

Do not use Ornibel if you observe changes in the color of the ring or any visible sign of deterioration.

This medication may pose a risk to the environment. Once removed, Ornibel must be returned to its package and closed properly. The closed package must be disposed of with household waste or returned to the pharmacy for proper destruction in accordance with local regulations.

Do not dispose of it through the toilet. Like other medications, do not dispose of unused or expired rings through the drains or trash.

Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Ornibel

• The active principles are etonogestrel and ethinylestradiol.

Ornibel contains 8.25 mg of etonogestrel and 2.60 mg of ethinylestradiol. The ring releases etonogestrel and ethinylestradiol in an amount of 0.120 mg and 0.015 mg, respectively, over 24 hours, for a period of 3 weeks.

• The other components are: copolymer of vinyl acetate and ethylene 28% vinyl acetate and polyurethane (a type of plastic that does not dissolve in the body).

Appearance of Ornibel and contents of the packaging

Vaginal delivery system.

Ornibel is a flexible, transparent, colorless or almost colorless ring, measuring 54 mm in diameter and 4 mm in thickness.

Each ring is packaged in an aluminum pouch. The pouch is presented in a cardboard box along with this leaflet and stickers for your calendar to help you remember when to insert or remove the ring.

Each box contains 1, 3 or 6 rings.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Exeltis Healthcare, S.L.

Avda. De Miralcampo 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares.Guadalajara.

Spain

Responsible for manufacturing:

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera.

La Vallina s/n.

24193 Villaquilambre, León.

Spain.

This medication is authorized in the member states of the European Economic Area with the following name:

Last review date of this leaflet:November 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)