Vagiprev - Etonogestrel/Ethinyl estradiol uses, dose and side effects

Vagiprev is a contraceptive in the form of a vaginal 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 your bloodstream. Because of the small amounts of hormone released, Vagiprev is considered a low-dose hormonal contraceptive. Because Vagiprev releases two different types of hormones, it is a so-called combined hormonal contraceptive.

Vagiprev works just like a combined birth control pill, but instead of taking a pill every day, the ring is used for 3 consecutive weeks.

Vagiprev releases two female sex hormones that prevent an egg from being released from the ovaries. If no egg is released, you cannot get pregnant.

The etonogestrel and ethinylestradiol found in Vagiprev may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Vagiprev

General information

Before you start using Vagiprev, 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 Vagiprev, or when Vagiprev may be less reliable. In such situations, you should not have intercourse or you should protect yourself with a non-hormonal contraceptive – such as a condom or some other barrier method. Do not use safe periods or temperature methods. These methods may be unsafe because Vagiprev affects the monthly changes in body temperature and cervical secretions

2.1 Do not use Vagiprev

Do not use Vagiprev 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 what other type of contraception may be more appropriate.

if you have (or have had) a blood clot in a blood vessel in the legs (deep vein thrombosis, DVT), in the lungs ( pulmonary embolism, PE), or any other organ
if you know you have a disease that affects blood clotting – e.g. protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies
if you need to undergo an operation or if you will be bedridden 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 can be the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
if you have any of the following diseases that can increase the risk of a blood clot in the arteries:
- severe diabetes with blood vessel 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 ) combined with high levels of blood fats
if you have (have had) severe liver disease and your liver is not yet working normally
if you have (have had) benign or malignant tumors in the liver
if you have (have had) or if you suspect that you may have breast or abdominal cancer
if you have vaginal bleeding for no known reason
if you are allergic to ethinylestradiol or etonogestrel, or any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions should appear for the first time while using Vagiprev, immediately remove the ring and consult a doctor. In the meantime, use a non-hormonal contraceptive.

Do not use Vagiprev if you have hepatitis C and are using medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section 2.4 “Other medicines and Vagiprev”).

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 could mean you have a blood clot in the leg (so-called deep vein thrombosis ), a blood clot in the lung (so-called pulmonary embolism ), or a heart attack or stroke (see 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 while using Vagiprev, 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 Vagiprev”)
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 that affects your natural immune system)
if you have hemolytic uremic syndrome (HUS – a disease that affects the blood’s ability to clot and leads to kidney failure )
if you have sickle cell anemia (an inherited disease that affects the red blood cells )
if you have elevated levels of blood fats ( hypertriglyceridemia ) or a genetic predisposition to this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis ( inflammation of the pancreas)
if you need to undergo an operation or if you will be bedridden 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 delivery you can start using Vagiprev.
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 disorder], herpes gestationis [redness of the skin with blisters during pregnancy], Sydenham’s chorea [a nervous disorder in which sudden movements of the body occurs]
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 Vagiprev – e.g. if you have constipation, uterine prolapse or pain during intercourse
if you have an urgent, frequent, burning and/or painful urination and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of Vagiprev in the bladder.
if you develop symptoms of angioedema such as the swollen face, tongue, and/or throat and/or difficulty swallowing or hives with possible difficulty breathing, contact a doctor immediately. Products containing estrogen can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

If you use combined hormonal contraceptives such as Vagiprev, the risk of blood clots increases compared to if you do not use these preparations. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form

in veins (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 permanent effects and, in very rare cases, be fatal.

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

THIS IS HOW YOU RECOGNIZE A BLOOD CLOT

Seek medical attention immediately if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What could you possibly be suffering from?
swelling of a leg or along a blood vessel in the leg or foot, especially if you also get: pain or tenderness in the leg that is felt only when standing or walking increased heat in the affected leg color change of the skin on the leg, e.g. pale, red or blue.	Deep vein thrombosis
sudden unexplained shortness of breath or rapid breathing sudden coughing for no apparent reason which could lead to you coughing up blood severe chest pain that may increase with deep breath severe unsteadiness or dizziness fast or irregular heartbeat severe pain in the stomach. If you are unsure, consult a doctor because some of these symptoms e.g. cough and shortness of breath can be mistaken for a milder condition such as a respiratory infection (eg a common cold).	Pulmonary embolism
Symptoms that usually occur in one eye: immediate vision loss or blurred vision without pain that can progress to vision loss.	Retinal vein 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 of fullness, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm, and stomach sweating, nausea, vomiting or dizziness extreme weakness, anxiety, or shortness of breakfast or irregular heartbeats.	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 sudden difficulty seeing with one or both eyes sudden difficulty walking, dizziness, loss of balance or coordination sudden, severe or prolonged headache with no 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 another 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 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 a vein (venous thrombosis ). However, these side effects are rare. They most often 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 a deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges 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 vein thrombosis ).

When is the risk of developing a blood clot in a vein the greatest?

The risk of developing a blood clot in a vein is greatest during the first year that you first use combined hormonal contraceptives. The risk may also be higher if you start using a combined hormonal contraceptive (the same product or a different product) again 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 Vagiprev, 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 overall risk of a blood clot in the leg or lung with Vagiprev is small.

Out of 10,000 women who are not using a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot within a year.

Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5-7 develop a blood clot during one year.
Out of 10,000 women who use a combined hormonal contraceptive containing norelgestromin or etonogestrel such as Vagiprev, around 6-12 develop a blood clot during one year.
The risk of blood clots varies depending on your medical history (see “Factors that can increase the risk of a blood clot” below).

	Risk of developing a blood clot over a year
Women who are not using a combined hormonal pill/patch/ring and who are not pregnant	About 2 of 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate	About 5-7 out off10,000 women
Women using Vagiprev	About 6-12 off 10,000 women

Factors that can increase the risk of a blood clot in a vein

The risk of a blood clot with Vagiprev is small, but certain conditions increase the risk. The risk is higher:

if you are very overweight (body mass index or BMI over 30 kg/m ² )
if a close relative has had a blood clot in the leg, lung, or other organs at a young age (eg younger than about 50 years). If so, you may have an inherited blood clotting disorder.
if you need to undergo an operation or are bedridden for a long time due to an injury or illness, or if you have a leg cast. The use of Vagiprev may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop using Vagiprev, ask your doctor when you can start using it again.
with increasing age (especially if you are older than about 35)
if you have given birth a few weeks ago.

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

Air travel (over 4 hours) may 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 not sure. Your doctor may decide that you need to stop using Vagiprev.

If any of the above conditions change while you are using Vagiprev, e.g. if a close relative has a blood clot for no known reason or if you gain a lot of weight, talk to your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Similar to 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
You must know that the risk of a heart attack or stroke as a result of using Vagiprev is very small but may increase:

with increasing age (after about age 35)
if you smoke. If you are using a combined hormonal contraceptive such as Vagiprev, you should stop smoking. If you cannot stop smoking and are over 35, your doctor may advise you to use another type of birth control.
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 of 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 problems with your heart (flutter, 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 severe, your risk of developing a blood clot may be even greater.

If any of the above conditions change while you are using Vagiprev, e.g. if you start smoking, a close relative has a blood clot for no known reason or if you gain a lot of weight, talk to your doctor.

Cancer

The information below is taken from studies with combined oral contraceptives and it may also apply to Vagiprev. Information on vaginally administered hormonal contraceptives (such as Vagiprev) is lacking.

Breast cancer has been detected slightly more often in women using combined oral contraceptives, but it is not known whether this is due to the treatment. It can e.g. be that tumors are detected more often in women who use combined oral contraceptives because they go for more check-ups with doctors.

The increased risk of breast cancer gradually decreases when combined oral contraceptives are discontinued.

It is important that you regularly check your breasts and that you contact your doctor/midwife if you feel a lump. 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 oral contraceptives. Contact your doctor/midwife if you experience unusual, severe abdominal pain.

In women using combined oral contraceptives, it has been reported that cancer of the endometrium (the lining of the womb) and cancer of the ovaries are less common. This may also apply to Vagiprev, but this has not been confirmed.

Mental disorders

Some women using hormonal contraceptives, including Vagiprev, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact a doctor for advice as soon as possible.

2.3 Children and young people

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

2.4 Other medicines and Vagiprev

Always tell your doctor which medicines or (traditional) herbal medicines you are already using. Also, tell other doctors and dentists who prescribe medicines (and relevant pharmacists) that you are using Vagiprev. They can tell you if you need to use additional protection (eg male condoms) and if so for how long, or if the use of any other medicine you need needs to be changed.

This applies to medicines used in the treatment of:

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 )
mild depression ((traditional) herbal medicines containing St. John’s wort ).

If you are using medicines or (traditional) herbal medicines that can make Vagiprev less effective, a barrier method (eg male condom) should also be used. Since the effect of another drug on Vagiprev can remain for up to 28 days after the end of treatment with the drug, it is necessary to use a barrier method throughout this time. Note: Do not use Vagiprev with pessaries or female condoms.

Vagiprev can affect the effectiveness of other medicines, e.g.

medicines containing ciclosporin
the epilepsy medicine lamotrigine (this may lead to an increased frequency of seizures).

Do not use Vagiprev if you have hepatitis C and are using medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir as this may lead to increased liver function tests in the blood (an increase in the liver enzyme ALT ).

Your doctor/midwife will prescribe another type of birth control before starting treatment with these medicines.

Vagiprev can be started approximately 2 weeks after this treatment has ended. See section 2.1 “Do not use Vagiprev”.

Ask your doctor or pharmacist for advice before taking any medicine.

You can use tampons while using Vagiprev. Insert Vagiprev before inserting the tampon.

Be careful when removing the tampon, so that Vagiprev does not accidentally come out with it. Should this occur, wash the ring in cool or lukewarm water and immediately reinsert it.

It has happened that the ring has broken during the simultaneous use of vaginal products such as lubricants or the treatment of infection (see section 3.4 “What to do if… Your ring breaks”). Concomitant use with spermicides or vaginal antifungals does not affect the effect of Vagiprev.

Laboratory tests

If you are having a blood or urine test, tell the healthcare professional that you are using Vagiprev as it may affect the results of some tests.

2.5 Pregnancy and breastfeeding

Vagiprev should not be used by women who are pregnant or think they may be pregnant. Should you become pregnant while using Vagiprev, remove the ring and contact your doctor/midwife.

If you want to stop using Vagiprev because you want to get pregnant, see section 3.5 “If you stop using Vagiprev”.

Vagiprev is generally not recommended for use during breastfeeding. If you want to use Vagiprev while breastfeeding, contact your doctor for advice.

2.6 Driving ability and use of machines

It is unlikely that Vagiprev would affect the 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 increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

How to use Vagiprev

You can insert and remove Vagiprev yourself. Your doctor/midwife will tell you when to start using Vagiprev for the first time. Vaginal ring one must be inserted on the correct day of your menstrual cycle (see section 3.3: “Inserting the first ring”) and must remain in place for 3 consecutive weeks. Check regularly that Vagiprev remains in the vagina (e.g. before and after intercourse) to ensure you are protected against pregnancy. After the third week, you take out Vagiprev and take a break for one week. Usually, you will get your period during the ring-free interval.

While using Vagiprev, you should not use certain female barrier methods, such as pessaries or female condoms. These contraceptive barrier methods should not be used as supplementary barrier methods because Vagiprev may affect the correct placement and position of pessaries or female condoms. You can, however, use a male condom as an extra barrier method.

3.1 How to insert and remove Vagiprev

Check that the expiry date has not passed (see section 5 “How to store Vagiprev”) before inserting the ring.
Wash your hands before inserting or removing the ring.
Choose the position that feels most comfortable for you, you can e.g. stand with one leg extended, squat, or lie down.
Take Vagiprev out of the sachet. Save the sachet for later use.
Hold the ring between your thumb and forefinger, press the sides together and insert the ring into the vagina (see pictures 1-4). When Vagiprev is in place, you should not feel anything. If it feels uncomfortable, gently push Vagiprev further into the vagina. The exact position of the ring in the vagina is of no importance.
Vagiprev should be removed from the vagina after 3 weeks. You can do this by hooking your index finger on the bottom edge of the ring or by grabbing the edge and pulling it out (see picture 5). If you feel the ring in the vagina but cannot take it out yourself, you should contact your doctor/midwife.
Dispose of the used ring together with your other household waste, preferably in the dosing bag. Do not flush Vagiprev down the toilet.

Picture 1

Take Vagiprev out of the sachet.

Picture 2

Press the ring together.

Image 3

Choose a comfortable position to insert the ring

Image 4A Image 4B Image 4C

Insert the ring into the vagina with one hand (picture 4A), if necessary you can separate the labia with the other hand. Push the ring up into the vagina until it feels comfortable (picture 4B). Leave the ring in place for 3 weeks (image 4C).

Picture 5

Vagiprev can be removed by hooking the index finger on the bottom edge of the ring or by grasping the edge with the index and middle fingers and pulling it out.

3 .2 Three weeks deposited, one week withdrawn

From the day the vaginal ring is inserted, it must be in place without interruption for 3 full weeks.
After 3 weeks, the vaginal ring is taken out on the same day of the week and approximately at the same time as it was inserted. For example, if you inserted Vagiprev on a Wednesday around 10 pm, you should take the ring out 3 weeks later on Wednesday around 10 pm.
After you have removed the ring, do not use any ring for 1 week. During this week you should have vaginal bleeding. It usually starts 2-3 days after Vagiprev is taken out.
Insert a new ring exactly one week later (again on the same day of the week and around the same time), even if the bleeding has not stopped.

If the ring is inserted more than 3 hours too late, the pregnancy-protective effect may be reduced. Follow the instructions under section 3.4 “What to do if… You forgot to insert a new ring after the ring-free interval”.

If you use Vagiprev as described above, your vaginal bleeding will come around the same time each month.

3.3 Insertion of the first ring

You have not used any hormonal contraceptive in the last monthInsert your first Vagiprev on the first day of your natural menstrual cycle (ie on the first day of your bleeding). Vagiprev works immediately. You do not need to use any other contraceptive protection. It is also fine to start with Vagiprev on day 2 to day 5 of the menstrual cycle, but then during the first cycle, you must use extra protection, e.g. condom if you have intercourse during the first 7 days of Vagiprev. You only need to follow these instructions the first time you use Vagiprev.

You have used a combined oral contraceptive pill in the last month start Vagiprev no later than the day after the pill-free period for your current pill. If your birth control pill also contains hormone-free tablets, start Vagiprev no later than the day after the last hormone-free tablet. If you are not sure which tablet it is, ask your doctor or pharmacist. Never allow the hormone-free period of your current birth control pills to be longer than the recommended time. If you have been using your birth control pills correctly and without interruption and if you are sure that you are not pregnant, you can stop taking the pills at any time and immediately start Vagiprev.
You have used a contraceptive patch in the last month start using Vagiprev 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 been using the hormonal patch correctly and without interruption and if you are sure that you are not pregnant, you can stop using the hormonal patch at any time and immediately start Vagiprev.
You have used a mini-pill (a pill that only contains progestin ) in the last month you can stop your minipill on any day and start Vagiprev the next day, at the same time you would normally have taken your pill. Be sure to use extra protection (eg condoms) for the first 7 days of Vagiprev.
You have used an injectable preparation or implant or an intrauterine device (IUD) in the last month start using Vagiprev when you should have had your next injection or on the day your implant or hormone-releasing IUD is removed. Be sure to use extra protection (eg condoms) for the first 7 days of Vagiprev.
After you give birth you have just given birth, your doctor/midwife may tell you to wait for your first spontaneous period before starting Vagiprev. Sometimes it is possible to start earlier. Your doctor/midwife will advise you. If you are breastfeeding and want to use Vagiprev, you must first discuss this with your doctor/midwife.
After a miscarriage or abortion your doctor/midwife will advise you.

3.4 What to do if…

Your ring has accidentally been pushed out of the vagina

Vagiprev can be accidentally expelled from the vagina – e.g. if it has not been inserted correctly, when removing a tampon, during intercourse, if you are constipated or if you have a prolapse. It is therefore important that you regularly check that the ring is in place in the vagina (e.g. before and after intercourse).

Your ring has temporarily been out of the vagina

Vagiprev can still protect you against 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 cool to lukewarm water (do not use hot water) and reinsert 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, protection against pregnancy may have been affected. Rinse the ring with cool to lukewarm water (do not use hot water) and replace the ring as soon as you remember and leave the ring in place without removal for at least 7 days. Use a male condom if you have intercourse in the next 7 days. If it happens during the first week of use and you have had intercourse in 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, protection against pregnancy may have been affected. Discard the ring and then choose one of the following options:

1. Insert a new ring immediately. By inserting a new ring, the next 3-week period begins. It is possible that you will not have a period, but breakthrough bleeding or spotting may occur.
2. Do not reinsert the ring. Wait for your period and then insert a new ring no later than 7 days after the previous ring was removed or expelled. You should only select this option if you have used the ring continuously during the previous 7 days.
If you do not know how long Vagiprev has been removed from the vagina, you may not be protected against pregnancy. Take a pregnancy test and consult your doctor/midwife before inserting a new ring.

Your ring is broken

Vagiprev can rupture. Vaginal injuries have been reported in connection with ring rupture. If you discover that your ring has broken, remove the ring and insert a new ring as soon as possible. Use additional protection, e.g. 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 harmful effects following an overdose of the hormones included in Vagiprev. If you have accidentally inserted more than one ring, you may feel nauseous, vomit, or experience vaginal bleeding.

You forgot to insert a new ring after the ring-free interval

If your ring-free interval was longer than 7 days, insert a new ring as soon as you remember. Use extra protection (eg a male condom) if you have intercourse in 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 lasted, the greater the risk that you became pregnant.

You forgot to take out the ring

If your ring has been in 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 in 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 missed

You have used Vagiprev according to the instructions. If you have missed your period but you have used Vagiprev as directed and if you have not used other medicines, it is very unlikely that you are pregnant. Continue with Vagiprev as usual. However, if you miss your period twice in a row, you may be pregnant. Contact your doctor/midwife immediately. Do not start the next Vagiprev until your doctor/midwife has checked that you are not pregnant.
If you have deviated from the instructions for Vagiprev.If you have missed your period and you have deviated from the instructions for Vagiprev and you do not have your expected withdrawal bleeding in the ring-free period, you may be pregnant. Contact your doctor/midwife before inserting a new Vagiprev.

You have unexpected bleeding

While using Vagiprev, some women may experience unexpected vaginal bleeding between periods. You may need to use menstrual protection. 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 returns, contact a doctor/midwife.

Do you want to change the first day of your period

If you use Vagiprev as directed, you will have your period (withdrawal bleeding) during the ring-free interval. If you want to change the day the bleeding starts, you can shorten (but never lengthen!) the ring-free interval.

For example, if your period usually starts on a Friday, you can change it to a Tuesday (3 days earlier) from the 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 have your normal bleeding. You may have spotting (drops or spots of blood) or breakthrough bleeding while using the next ring.

If you are unsure about what to do, contact your doctor/midwife for advice.

Do you want to postpone your period?

Although it is not the recommended regimen, it is possible to delay the period (withdrawal bleeding) by inserting a new ring immediately after the current one, thus without a ring-free interval between rings.

You can leave the new ring in for up to 3 weeks. While using the new ring, you may have spotting (drops or spots of blood) or breakthrough bleeding. When you want your period to come, just take out the ring. Have your usual 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 When you want to stop using Vagiprev

You can stop using Vagiprev whenever you want.

If you do not want to get pregnant, contact your doctor/midwife about other contraceptives.

If you stop taking Vagiprev because you want to get pregnant, it is generally recommended that you wait until you have had a natural period. This will help you calculate the time of delivery.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, especially if they are severe or persistent, or if your health changes and you think it may be due to Vagiprev, 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)) exists in all women using combined hormonal contraceptives. For more detailed information about the different risks of using combined hormonal contraceptives, see section 2, “What you need to know before using Vagiprev”.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue, and/or throat and/or difficulty swallowing or hives with possible difficulty breathing (see also section 2.2 “Warnings and precautions”).

The following side effects have been reported by users of rings containing etonogestrel/ethinylestradiol.

Common (may affect up to 1 in 10 women)

abdominal pain, nausea
vaginal yeast infection (such as “cod”), ring-related vaginal discomfort, vaginal itching, vaginal discharge
headache or migraine, low mood, decreased sex drive
sore breasts, pelvic pain, painful periods
acne
weight gain
ring ejection.

Uncommon ( may affect up to 1 in 100 users ):

visual disturbance, dizziness
swollen abdomen, vomiting, diarrhea, or constipation
fatigue, malaise or irritation, mood changes, mood swings
fluid accumulation in the body ( edema )
cystitis (urinary tract infection)
difficulty or pain when 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
elevated blood pressure
increased appetite
back pain, muscle cramps, pain in legs and arms
reduced skin sensitivity
tender or enlarged breasts, fibrocystic breast disease (cysts in the breasts that may swell or become painful)
inflammation of the cervix, cervical polyp (growth in the cervix), growth on the border of the cervix (ectopy)
changes in bleeding pattern (e.g., bleeding may become heavier, longer, irregular, or absent), pelvic discomfort, premenstrual syndrome (PMS), uterine spasm
vaginal infection (fungal and bacterial); burning sensation, smelly discharge, pain, discomfort, or dryness in the vagina or vulva
hair loss, eczema, itching, rashes, or hot flashes
Hives.

Rare ( may affect up to 1 in 1,000 users ):

harmful blood clots in a vein or artery, eg:
- in a leg or foot (so-called DVT)
- in a lung (so-called PE)
- myocardial infarction
- stroke
- mini-stroke or transient stroke-like symptoms called the 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 about the conditions that increase the risk of blood clots and symptoms of a blood clot.)

secretion from the breasts.

Has been reported ( occurring in an unknown number of users ):

chloasma (yellow-brown spots on the skin, especially on the face)
complaints from the partner’s penis (such as irritation, rash, itching )
inability to remove the ring without medical help (e.g. because it is stuck to the vaginal wall)
vaginal damage 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”.

Vagiprev can rupture. For more information, see section 3.4 “What to do if… Your ring breaks”.

How to store Vagiprev

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

If you discover that a child has been exposed to hormones from Vagiprev, contact a doctor or hospital for advice.

No special temperature instructions.

Store in the original packaging. Light sensitive.

Vagiprev must be inserted no later than one month before the expiry date stated on the carton and sachet. The expiration date is the last day of the specified month.

Do not use Vagiprev if you see any discoloration of the ring or signs of deterioration.

This medicine may pose a risk to the environment. After removal, the Vagiprev ring must be put back into the dosage bag, which is sealed properly. The sealed dose bag can then be thrown away with normal household waste or handed into the pharmacy to be disposed of according to current instructions.

Do not flush Vagiprev down the toilet. As with other medicines, do not throw unused vaginal rings down the drain or with household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

The active substances are etonogestrel and ethinylestradiol.
Vagiprev contains 11.0 mg etonogestrel and 3.474 mg ethinylestradiol. The ring releases etonogestrel and ethinylestradiol with a release of 0.120 mg and 0.015 mg respectively per 24 hours over 3 weeks.
Other ingredients are ethylene vinyl acetate copolymer (28% vinyl acetate) and polyurethane (a type of plastic that does not dissolve inside the body).

Appearance and package sizes of the medicine

Vaginal insert.

Vagiprev is a flexible, transparent, colorless to almost colorless ring with an outer diameter of 54 mm and a thickness of 4 mm.

Each ring is packed in an aluminum foil sachet. The sachet is packed in a cardboard box along with this leaflet and stickers that you can put on your calendar to help you remember when to insert and remove the ring.

Each box contains:

1 ring, 3 rings, or 6 rings

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Orion Corporation

Orion Indie 1

FI-02200 Espoo

Finland

Manufacturer

Laboratorios León Farma, SA

Calle La Vallina s/n, Polígono Industrial Navatejera

24008- Navatejera, León

Spain

Orion Corporation Orion Pharma