Active ingredients: Etonogestrel / Ethinylestradiol
NuvaRing, 0.120 mg / 0.015 mg every 24 hours, vaginal device
Why is Nuvaring used? What is it for?
NuvaRing is a contraceptive vaginal ring 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. Because the quantities of hormones released are low, NuvaRing is considered a low-dose hormonal contraceptive. Since NuvaRing releases two different types of hormones, it is a so-called combined hormonal contraceptive.
NuvaRing works just like a combined contraceptive pill (the Pill) but instead of taking one pill every day, the ring is used for three weeks in a row. NuvaRing releases two female sex hormones which prevent the release of an egg cell from the ovaries. there is no release of egg cells, it is not possible to get pregnant.
Contraindications When Nuvaring should not be used
General notes Before you start using NuvaRing you should read the information on blood clots. It is especially important that you read the symptoms of a blood clot
This leaflet describes some situations in which the use of NuvaRing must be discontinued or NuvaRing may be less reliable. In such situations, you should not have sexual intercourse or you should take additional non-hormonal contraceptive precautions, such as using condom or other barrier method. Do not use rhythm and basal temperature methods, which can be unreliable, as NuvaRing alters monthly changes in body temperature and cervical mucus.
NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Do not use NuvaRing if you have any of the conditions listed below. If you have any of the conditions listed below, please contact your doctor. Your doctor will discuss with you other birth control methods that may be more suitable for you.
- if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE) or other organs; 2 54 mm 4 mm
- if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies;
- if you are due to have an "operation or if you are going to lie down for a long time (see section" Blood clots ");
- if you have ever had a heart attack or stroke;
- if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischemic attack (TIA - temporary stroke symptoms);
if you have any of the following diseases, which could increase the risk of blood clots in the arteries:
- severe diabetes with blood vessel injury
- very high blood pressure
- very high level of fat (cholesterol or triglycerides) in the blood
- a disease known as hyperhomocysteinemia
do not use Nuvaring
- if you have (or have ever had) a type of migraine called 'migraine with aura';
- if you have (or have ever had) inflammation of the pancreas (pancreatitis) associated with high levels of fat in the blood.
- if you have (or have ever had) severe liver disease and your liver function has not yet returned to normal.
- if you have (or have ever had) a benign or malignant liver tumor.
- if you have (or have ever had), or may have, breast or genital organ cancer.
- if you have vaginal bleeding of unknown origin.
- if you are allergic to ethinyl estradiol or etonogestrel or any of the other ingredients of this medicine
If any of these conditions appear for the first time while using the NuvaRing, immediately remove the ring and consult your doctor. In the meantime, use non-hormonal methods of contraception.
Precautions for use What you need to know before taking Nuvaring
When should you see a doctor?
Contact a doctor urgently
- if you notice possible signs of a blood clot which may indicate that you are suffering from a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack or a stroke (see section below " Blood clots ").
For a description of the symptoms of these serious side effects go to the section "How to recognize a blood clot".
Tell your doctor if any of the following apply to you. If this condition appears or worsens while you are using NuvaRing you should tell your doctor.
- if a close family member has, or has ever had, breast cancer;
- if you have epilepsy (see section "Interactions");
- 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 the natural defense system);
- if you have haemolytic-uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
- if you have sickle cell anemia (an inherited disease of the red blood cells);
- if you have high levels of fat in the blood (hypertriglyceridaemia) or a "positive family history of this condition." Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
- if you are due to have an "operation or if you are going to lie down for a long time (see section" Blood clots ");
- if you have just given birth, your risk of developing blood clots is higher.Ask your doctor how soon after giving birth you can start using NuvaRing;
- if you have "inflammation of the veins under the skin (superficial thrombophlebitis);
- if you have varicose veins;
- if you have a condition that occurred for the first time, or got worse, during pregnancy or during previous use of sex hormones (eg hearing loss, porphyria [a blood disorder], herpes gestationis [skin rash] with blisters during pregnancy], Sydenham's chorea [a nerve disease in which sudden body movements may occur], hereditary angioedema [you should see your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and / or throat and / or difficulty swallowing or hives associated with breathing difficulties]).
- if you have (or have ever had) chloasma (yellowish-brown pigmentation patches, so-called 'pregnancy patches', especially on the face). If so, avoid prolonged exposure to the sun or ultraviolet rays.
- if you have a medical condition that makes NuvaRing difficult to use, such as constipation, cervical prolapse or pain during sex.
BLOOD CLOTS
Using a combined hormonal contraceptive such as NuvaRing increases your risk of developing a blood clot compared with not using one. In rare cases, a blood clot can block blood vessels and cause serious problems. Blood clots can develop.
in veins (called "venous thrombosis", "venous thromboembolism" or VTE)
in the arteries (referred to as 'arterial thrombosis', 'arterial thromboembolism' or ATE).
Recovery from blood clots is not always complete. Rarely, long-lasting severe effects can occur or, very rarely, they can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with NuvaRing is low.
HOW TO RECOGNIZE A BLOOD CLOT
See a doctor immediately if you notice any of the following signs or symptoms.
- swelling of one leg or along a vein in the leg or foot, especially when accompanied by:
- pain or tenderness in the leg which may only be felt when standing or walking
- increased sensation of heat in the affected leg
- change in color of the skin on the leg, such as turning pale, red or blue
- sudden and unexplained shortness of breath or rapid breathing;
- sudden cough with no obvious cause, possibly causing blood to be emitted;
- sharp chest pain which may increase with deep breathing;
- severe light headedness or dizziness;
- rapid or irregular heartbeat;
- severe pain in the stomach
- immediate loss of vision or
- painless blurring of vision which can progress to loss of vision
- chest pain, discomfort, feeling of pressure or heaviness
- sensation of squeezing or fullness in the chest, arm or below the breastbone;
- feeling of fullness, indigestion or choking;
- upper body discomfort radiating to the back, jaw, throat, arms and stomach;
- sweating, nausea, vomiting or dizziness;
- extreme weakness, anxiety, or shortness of breath;
- rapid or irregular heartbeats
- sudden numbness or weakness of the face, arm or leg, especially on one side of the body;
- sudden confusion, difficulty speaking or understanding;
- sudden difficulty seeing in one or both eyes;
- sudden difficulty walking, dizziness, loss of balance or coordination;
- sudden, severe or prolonged migraine with no known cause;
- loss of consciousness or fainting with or without seizures.
- swelling and pale blue discoloration of one extremity;
- severe stomach pain (acute abdomen).
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
- The use of combined hormonal contraceptives has been linked to an increased risk of blood clots forming in the veins (venous thrombosis). However, these side effects are rare. In most cases they occur in 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."
- Very rarely, a clot can form in another organ such as the eye (retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may be even higher if you restart taking a combined hormonal contraceptive (the same drug or a different drug) after a break of 4 or more weeks.
After the first year, the risk is reduced but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking NuvaRing, your risk of developing a blood clot returns to normal within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with NuvaRing is low.
- Out of 10,000 women who are not using any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive containing norelgestromin or etonorgestrel such as NuvaRing, about 6-12 will develop a blood clot in a year.
- The risk of a blood clot forming depends on your medical history (see under "Factors that increase the risk of a blood clot forming").
Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with NuvaRing is low but some conditions increase the risk. Its risk is greater:
- if you are severely overweight (body mass index or BMI over 30 kg / m2);
- if a member of your immediate family has had a blood clot in the leg, lung or other organ at a young age (less than about 50 years). In this case you could have an inherited blood clotting disorder;
- if you are going to have an operation or if you have to lie down for a long time due to injury or illness or if you have a leg in a cast. You may need to stop taking NuvaRing a few weeks before the surgery or in the period where you are less mobile. If you have to stop taking NuvaRing, ask your doctor when you can start taking it again;
- as you get older (especially over the age of 35);
- if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions you have of this type.
Air travel (lasting> 4 hours) may temporarily increase the risk of a blood clot, especially if you have some of the other risk factors listed
It is important that you tell your doctor if any of these apply to you, even if you are not sure. Your doctor may decide to have you stop taking NuvaRing. If any of the above conditions change while you are using NuvaRing, for example if a close relative has a thrombosis for no known reason or if you gain a lot of weight, contact your doctor .
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an "artery?"
Like blood clots in a vein, clots in an artery can cause serious problems, for example, they can cause a heart attack or stroke.
Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of NuvaRing is very low but can increase:
- with increasing age (over 35 years);
- if you smoke. When using a combined hormonal contraceptive such as NuvaRing you are advised to stop smoking. If you are unable to stop smoking and are over the age of 35, your doctor may advise you to use a different type of contraceptive;
- if you are overweight;
- if you have high blood pressure;
- if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at high risk of having a heart attack or stroke;
- if you or a close relative have a high level of fat in the blood (cholesterol or triglycerides);
- if you suffer from migraines, especially migraines with aura;
- if you have any heart problems (valve defect, a 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, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using NuvaRing, for example if you start smoking, if a close relative has a thrombosis for no known reason, or if you gain a lot of weight, contact your doctor.
Tumors
The information below was obtained in COC studies and can also be applied to the NuvaRing.
There is no information available on the vaginal administration of contraceptive hormones (such as NuvaRing). Breast cancer diagnoses are slightly more common in women using the combined pill, but it is not known whether this is caused by the treatment. For example, it may be that cancers are found more in women taking the combined pill because they are checked more frequently by their doctor. The increase in the occurrence of breast cancer gradually decreases following discontinuation of the combined pill.
It is important to check your breasts regularly and contact your doctor as soon as you feel a lump. You should also tell your doctor if a close relative has or has ever had breast cancer (see section 2.2 "Warnings and Precautions').
Benign liver tumors and in fewer cases still malignant liver tumors have been reported rarely in women taking the Pill. Consult your doctor in case of unusual severe pain in the abdomen.
In women using the combined pill, cancer of the endometrium (the lining of the uterus) and cancer of the ovaries have been reported to occur less frequently. This may also be the case with NuvaRing but has not been confirmed.
Interactions Which drugs or foods may change the effect of Nuvaring
Always tell the doctor who prescribes NuvaRing about any medicines or herbal products you are already taking, and also inform any other doctors or dentists (or dispensing pharmacist) who prescribe other medicines that you are using NuvaRing, so that they can determine whether and for how long it is necessary to use additional contraceptive methods.
Some medicines can cause special problems when using hormonal contraceptives, such as NuvaRing.
There are medicines that can lead to a decrease in the contraceptive efficacy of NuvaRing or cause unexpected bleeding. These include those used to treat:
- l "epilepsy (eg primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
- tuberculosis (eg rifampicin);
- HIV infection (eg ritonavir);
- other infectious diseases (e.g. griseofulvin and antibiotics, except amoxicillin and doxycycline, which have been shown not to affect NuvaRing's release of hormones).
- The herbal product called St. John's wort can also affect the effectiveness of NuvaRing. If you want to use products containing St. John's wort while you are already using NuvaRing, you should consult your doctor first.
- NuvaRing may also interfere with the work of other medicines, such as cyclosporine and the antiepileptic lamotrigine.
Absorbent pads can be used while using the NuvaRing. Insert the NuvaRing before inserting the pad. Special care must be taken when removing the pad to ensure that the ring is not accidentally ejected. Should this occur, simply wash the ring in cold or lukewarm water and reinsert it immediately.
The use of spermicidal or vaginal yeast products does not reduce the contraceptive efficacy of NuvaRing.
Warnings It is important to know that:
Children and adolescents
The safety and efficacy of NuvaRing in adolescents below 18 years of age have not been studied.
Laboratory tests
If you are having blood or urine tests, please inform your healthcare professional that you are using NuvaRing as it may alter the results of some tests.
Pregnancy and breastfeeding
NuvaRing must not be used if you are pregnant or suspected of being pregnant. If you become pregnant while using the NuvaRing, you must remove the ring and contact your doctor.
If you want to stop using NuvaRing because you want to become pregnant, see the section "When you want to stop using NuvaRing".
NuvaRing is not recommended while breastfeeding. If you wish to use NuvaRing while breastfeeding, ask your doctor for advice.
Driving and using machines
NuvaRing is unlikely to affect your ability to drive or use machines.
Dosage and method of use How to use Nuvaring: Dosage
You will insert the NuvaRing into the vagina yourself and remove it yourself. Your doctor will instruct you on when to start using NuvaRing for the first time. The vaginal ring should be inserted on the appropriate day of the menstrual cycle (see section "When to start with the first ring") and left in the vagina for 3 weeks in a row. It is a good practice to check regularly if the ring is still in the vagina. After the third week, take the NuvaRing off and take a week's break. Usually the menstrual cycle will occur during this ring-free interval.
How to insert and remove NuvaRing
- Before inserting the ring, check that it has not expired (see "How to store the NuvaRing").
- Wash your hands before inserting or removing the ring.
- Choose the position that is most comfortable for you, such as standing with one leg raised, squatting or lying down.
- Remove NuvaRing from its sachet.
- Hold the ring between your thumb and forefinger, squeeze it and gently insert it into your vagina. Once NuvaRing has been inserted you shouldn't hear anything. If you feel any discomfort, gently push NuvaRing further into your vagina. The exact position of the ring inside the vagina is not important.
- After 3 weeks, remove NuvaRing from the vagina. The NuvaRing can be removed by hooking the index finger under the front edge of the ring or by grasping the edge of the ring and pulling outward (see Figure 5). If you locate the ring in your vagina but cannot remove it, you must contact your doctor.
- The used ring should be thrown away with normal household waste, preferably inside the resealable bag. Do not throw NuvaRing down the toilet.
Three weeks with the ring inserted, one week without
- Beginning with the day it is inserted, the vaginal ring should be kept in the vagina without interruption for 3 weeks.
- After 3 weeks, remove the ring on the same day of the week it was inserted, at approximately the same time. For example, if the NuvaRing is inserted on a Wednesday around 10pm, the ring should be removed on the Wednesday of the third week following. , at about 10 pm.
- After removal, do not use the ring for 1 week. Vaginal bleeding should occur during this week. It usually starts 2-3 days after NuvaRing is removed.
- Start with a new ring exactly after the 1 week interval (again on the same day of the week and at approximately the same time) even if the vaginal bleeding is not over yet. If the new ring is inserted more than 3 hours later, the protection against pregnancy may be reduced. In this case, follow the instructions provided in the paragraph "What to do if ... You forget to insert a new ring after a ring-free interval ".
If NuvaRing is used as described above, vaginal bleeding will occur every month on approximately the same days.
When to start with the first ring
- If you have not used a hormonal contraceptive in the last month
The first NuvaRing must be inserted on the 1st day of your natural cycle (i.e. the first day of your menstrual cycle). NuvaRing begins to exert its effect immediately. It is not necessary to take other contraceptive measures.
Starting NuvaRing between day 2 and day 5 is allowed, but if you have sexual intercourse in the first 7 days of using NuvaRing, make sure you are also using an additional method of contraception (e.g. a condom). This advice should only be followed when using NuvaRing for the first time.
- If you have used a combined oral contraceptive (Pill) in the last month
Start using NuvaRing at the latest the day after the pill-free break of your current pill. If your pack also contains inactive tablets, start using NuvaRing the day after the last inactive tablet at the latest. If you are unsure which it is, consult your doctor or pharmacist. Never extend the hormone-free interval of your current pill pack beyond its recommended length.
If you have used the pill consistently and correctly and if you are sure that you are not pregnant, you can also stop taking the pill on any day of the current pack and start using NuvaRing immediately.
- If you have used a transdermal patch in the last month
Start using NuvaRing the day after your usual patch-free interval at the latest. Never extend the patch-free interval beyond the recommended amount of time
If you have used the patch consistently and correctly and if you are sure that you are not pregnant, you can also stop using the patch on any day and start using NuvaRing immediately.
- If you have used a progestogen-only pill (minipill) in the last month
You can stop the minipill on any day and start using NuvaRing the next day at the same time as you would normally have taken the pill. Be sure to use an additional method of contraception (eg a condom) in the first 7 days of using the ring.
- If you have used a progestogen-releasing injection or implant or IUD in the past month
Start using NuvaRing on the day of the new injection or the day of removal of the implant or progestogen-releasing IUD. ring.
- After giving birth
If you have just had a baby, your doctor will tell you to wait for your first natural cycle before you start using NuvaRing. In some cases it is possible to start earlier. Get advice from your doctor. Even if you want to use NuvaRing while breastfeeding, consult your doctor first.
- After natural or surgical abortion
Consult your doctor.
What to do if ...
The ring is accidentally ejected from the vagina
NuvaRing can accidentally come out of the vagina if, for example, it has not been inserted correctly, during the removal of a tampon, during sexual intercourse, in conjunction with constipation or prolapse of the uterus. Therefore you should regularly check if the ring is still in the vagina.
If the ring is left out of the vagina for less than 3 hours, it will still protect you from pregnancy. Rinse the ring in cold or lukewarm (not hot) water and reinsert it. If the ring is left out of the vagina for more than 3 hours, it may not protect you from pregnancy. See the information under "What to do if ... The ring is temporarily out of the vagina".
The ring temporarily stays outside the vagina
When in the vagina, NuvaRing slowly releases hormones into the body to prevent pregnancy. If the ring remains outside the vagina for more than 3 hours, it may not protect you from pregnancy. Therefore the ring should not remain outside the vagina for more than 3 hours in any 24 hour period.
- If the ring has been out of the vagina for less than 3 hours, it can still protect you from pregnancy. Reinsert the ring as soon as possible, but at the latest within 3 hours
- If the ring remains out of the vagina or you suspect it has been out of the vagina for more than 3 hours during the 1st and 2nd week, it may not protect you from pregnancy. remember to do this and leave the ring in the vagina without interruption for at least 7 days. Use a condom if you have sex during these 7 days. If you are in the 1st week and have had sex in the previous 7 days, there is a possibility that you may be pregnant. If so, contact your doctor.
- If the ring remains outside the vagina or you suspect it has been outside the vagina for more than 3 hours during the 3rd week, it may not protect you from pregnancy. Discard that ring and choose from one of the following two options:
- insert a new ring immediately. This will start the next 3 week use period. The menstrual cycle may not appear, but spotting or breakthrough bleeding may occur.
- Do not insert the ring again. Wait until you have your period first and insert a new ring no later than 7 days after the previous ring was removed or has come out. This option should only be chosen if NuvaRing has been used continuously for the previous 7 days.
The Ring Breaks The NuvaRing can very rarely break.
If you notice that the NuvaRing has broken, discard that ring and start with a new ring as soon as possible. Use additional contraceptive precautions (eg a condom) for the next 7 days. If you have had sex before you noticed the break of the ring, consult your doctor.
More than one ring has been inserted
No serious adverse effects have been reported from an overdose of NuvaRing hormones. If you have accidentally inserted more than one ring, you may have nausea, vomiting or vaginal bleeding. Remove excess rings and consult your doctor if such symptoms persist. You forget to insert a new ring after a ring-free interval If the ring-free interval is more than 7 days, insert a new ring as soon as you remember. Also use another method of contraception (eg condom) , if you have intercourse, for the next 7 days. If you have had intercourse during the gap period, the possibility of pregnancy should be considered. Talk to your doctor immediately. The longer the ring-free interval, the greater the risk of pregnancy.
You forget to remove the ring
- If your ring has been in place for more than 3 but no more than 4 weeks. It can still protect you from pregnancy. Perform the regular one-week ring-free interval and then insert a new ring.
- If your ring has been inserted for more than 4 weeks, there is a possibility of pregnancy. Contact your doctor before inserting a new ring.
There is no menstruation
- NuvaRing was used as directed in the instructions
If you have missed your period, but NuvaRing has been used according to the instructions correctly and you have not taken any other medicines, it is very unlikely that you are pregnant. Continue using NuvaRing as usual. However, if the period does not occur twice in a row, it is possible that you are pregnant. Consult your doctor immediately. Do not start with a new NuvaRing until your doctor has ruled out pregnancy.
- NuvaRing was not used as recommended
If you have missed your period and have not followed the instructions provided and have not had your expected period during the next ring-free interval, you may be pregnant. Contact your doctor before starting to use a new NuvaRing.
You have unexpected bleeding
While using NuvaRing, some women may experience unexpected vaginal bleeding between periods. It may be necessary to use hygienic protection. In any case, leave the ring in the vagina and continue to use it as normal. Consult your doctor if the irregular bleeding persists, becomes intense or recurs.
You want to change the first day of your menstrual cycle
If you use NuvaRing as directed, your menstrual cycle (withdrawal bleeding) will begin during the ring-free interval. If you want to change the start day of your period, you can shorten the ring-free interval (never lengthen this interval!)
For example, if your period usually starts on a Friday, you can change to Tuesday (3 days earlier) starting the following month. Simply insert the next NuvaRing 3 days earlier than usual.
If your ring-free interval is very short (eg 3 days or less), you may not have your usual bleeding, but you may have spotting (drops or flecks of blood) or breakthrough bleeding while using the next ring. .
If you are unsure how to proceed, contact your doctor for clarification.
You want to postpone your period
Although it is not recommended, it is possible to postpone your period (withdrawal bleeding) by inserting a new ring immediately after removing the previous one, without taking any ring-free interval. The new ring can remain inserted for up to 3 weeks. You may experience spotting (drops or flecks of blood) or breakthrough bleeding while using the new ring. Remove the ring when you decide you want to have your period. Respect the regular one-week ring-free interval and then insert a new ring.
You can ask your doctor for advice before deciding to delay your period.
When you want to stop using Nuvaring
You can stop using NuvaRing whenever you want.
If you don't want to get pregnant, see your doctor for other birth control methods.
If you stop using NuvaRing because you want to become pregnant, you must wait for your natural cycle before trying to conceive. This will help you calculate your expected date of birth.
Side Effects What are the side effects of Nuvaring
Like all medicines, NuvaRing can cause side effects, although not everybody gets them.
If you get any side effects, especially if they are severe or persistent, or if there is any change in your health that you think might be due to NuvaRing, please tell your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women taking combined hormonal contraceptives. For more detailed information on the different risks from "taking combined hormonal contraceptives, see section" What you need to know before you use NuvaRing ".
If you are allergic to any of the components of NuvaRing (hypersensitivity) you may have the following symptoms (frequency not known): angioedema [swelling of the face, tongue and / or throat and / or difficulty swallowing] or hives associated with difficulty in breathing. If this occurs, remove the NuvaRing and consult your doctor immediately.
The following side effects have been reported while using NuvaRing:
Common: may affect up to 1 in 10 women
- abdominal pain; feeling sick (nausea)
- vaginal mycosis (eg "Candida"); vaginal discomfort due to the ring; itching in the genital area; vaginal secretions
- headache or migraine; depressed mood; decreased libido
- breast pains; pelvic pain; painful menstruation
- acne
- weight gain
- ejection of the ring
Uncommon: may affect up to 1 in 100 women
- visual disturbances; dizziness
- swollen abdomen; vomiting, diarrhea or constipation
- feeling tired, unwell or irritable; mood changes; mood swings
- excess fluid in the tissues (edema)
- urinary tract or bladder infection
- difficulty or pain in urinating; strong need to urinate; urinating more frequently
- problems during intercourse, including pain, bleeding or a partner's sensation of the ring
- increased blood pressure
- increased appetite
- back pain; muscle spasms; pain in the legs or arms
- reduced skin sensitivity
- sore or enlarged breasts; fibrocystic mastopathy (breast cysts that can swell and cause pain)
- inflammation of the cervix; cervical polyps (growths in the cervix); ejection of the edge of the cervix (ectropion)
- changes in your menstrual cycle (e.g. periods may be heavy, long, irregular or may stop altogether); disorders in the pelvic area; premenstrual syndrome; spasms of the uterus
- vaginal infections (fungal and bacterial); burning, foul odor, pain, discomfort or dryness of the vagina or vulva
- hair loss, eczema, itching, rash or hot flashes
- rupture of the ring
Rare: may affect up to 1 in 1,000 women
- harmful blood clots in a vein or artery, for example: o in a leg or foot (DVT) or lung (PE) or heart attack or stroke or mini-stroke or temporary symptoms similar to those of " stroke, known as a transient ischemic attack (TIA) or blood clots in the liver, stomach / intestines, kidneys or eye. Your chance of developing a blood clot may be higher if you have any other conditions that increase this risk (see section on conditions that increase the risk of blood clots and the symptoms of a blood clot).
- mammary discharge. Not known (frequency cannot be estimated from the available data)
- chloasma (yellowish-brown skin patches, particularly on the face)
- discomfort in your partner's penis (such as irritation, rash, itching). Breast cancer and liver cancer have been reported in association with the use of combined hormonal contraceptives. For further information see section "Cancers".
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine
Expiry and Retention
Store below 30 ° C. Store in the original package to protect the device from light and moisture.
Do not use NuvaRing if it was dispensed to you more than 4 months ago. The dispensing date is stated on the carton and sachet.
Do not use NuvaRing after the expiry date which is stated on the carton and sachet.
Do not use NuvaRing if you notice any changes in the color of the ring or any other visible signs of deterioration.
Dispose of the used ring with your normal household waste, preferably in the resealable sachet. NuvaRing should not be disposed of down the toilet. As with other medicines, do not dispose of unused or expired rings via wastewater or household waste. Ask your pharmacist how to dispose of unused rings that you no longer use. This will help protect the environment.
Contents of the pack and other information
What NuvaRing contains
- The active ingredients are: etonogestrel (11.7 mg) and ethinyl estradiol (2.7 mg)
- The other ingredients are: copolymers of ethylene vinyl acetate (28% and 9% vinyl acetate) (a type of plastic that does not dissolve in the body) and magnesium stearate.
Etonogestrel and ethinylestradiol are released from the ring in daily amounts of 0.120 mg / day and 0.015 mg / day, respectively, for a period of 3 weeks.
What NuvaRing looks like and contents of the pack
NuvaRing is a flexible, clear, colorless or nearly colorless ring with a diameter of 54 mm.
Each ring is contained in a resealable foil pouch and packaged in a cardboard box together with this leaflet. Each box contains 1 or 3 rings. Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
NUVARING 0.120 MG / 0.015 MG EVERY 24 HOURS VAGINAL DEVICE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
NuvaRing contains 11.7 mg of etonogestrel and 2.7 mg of ethinylestradiol. The ring releases etonogestrel and ethinyl estradiol in average amounts of 0.120 mg and 0.015 mg, respectively, every 24 hours, over a period of 3 weeks.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Vaginal device.
NuvaRing is a flexible, clear, colorless or nearly colorless ring with an outer diameter of 54mm and a cross-sectional diameter of 4mm.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Contraception.
NuvaRing is indicated for women of childbearing age. Safety and efficacy have been demonstrated in women aged 18 to 40 years.
The decision to prescribe NuvaRing should take into account the individual woman's current risk factors, particularly those related to venous thromboembolism (VTE) and the comparison between the risk of VTE associated with NuvaRing and that associated with other CHCs (see sections 4.3 and 4.4).
04.2 Posology and method of administration
Dosage
To achieve contraceptive efficacy, NuvaRing must be used as prescribed (see "How to use NuvaRing" and "How to start using NuvaRing").
Pediatric population
The safety and efficacy of NuvaRing in adolescents below 18 years of age have not been studied.
Method of administration
HOW TO USE NUVARING
NuvaRing can be inserted into the vagina directly by the woman. The physician should inform the woman on how to insert and remove the NuvaRing. For insertion, the woman should choose a position that is most comfortable for her, such as standing with one leg raised, squatting or lying down. The NuvaRing should be compressed between two fingers and inserted into the vagina until it reaches a comfortable position. L " NuvaRing's exact position in the vagina does not affect the contraceptive effect of the ring (see Figures 1-4).
Once the NuvaRing has been inserted (see "How to start using NuvaRing"), it is left in the vagina continuously for 3 weeks. The woman should have the good habit of regularly checking for the presence of NuvaRing. In the event that NuvaRing is accidentally expelled the woman should follow the instructions given in section 4.2 "What to do if the" ring is temporarily expelled from the vagina "(for more information see also section 4.4" Expulsion ").
NuvaRing must be removed after 3 weeks of use, on the same day of the week it was inserted. After a ring-free interval of one week, a new ring may be inserted (for example, if the NuvaRing is inserted on a Wednesday around 10 pm, the ring must be removed again on the Wednesday of the third week following, at approximately 10 pm. A new ring must be inserted on the following Wednesday). NuvaRing can be removed by hooking the index finger under the ring or by grasping the ring between the index and middle fingers and pulling outwards (Figure 5). The used ring should be placed in the sachet (keep out of reach of children and pets) and discarded as described in section 6.6. Withdrawal bleeding usually begins 2-3 days after NuvaRing is removed and may not be completely finished when the new ring is to be inserted.
HOW TO START USING NUVARING
No hormonal contraceptive treatment in the previous cycle
NuvaRing must be inserted on the first day of a woman's natural cycle (i.e. the first day of her menstrual bleeding). It is also possible to start on the 2nd to 5th day of the cycle, but during the first cycle, in the first 7 days of using NuvaRing, it is recommended to use a barrier method in addition.
Changing from a combined hormonal contraceptive
The woman should insert NuvaRing at the latest on the day following the usual tablet-free or patch-free interval or following the last placebo tablet of the previous combined hormonal contraceptive.
If the woman has used her previous method consistently and correctly and is reasonably sure that she is not pregnant, she can also switch from her previous combined hormonal contraceptive on any day of the cycle.
The hormone-free interval of the previous method should never be extended beyond its recommended period.
Changing from a progestogen-only method (minipill, implant, or injection) or from a progestogen-releasing intrauterine system (IUS)
The woman can switch from a minipill on any day (from an implant or IUS, on the day of removal, from an injection contraceptive when the new injection is due), but in all cases she must use an additional method of barrier in the first 7 days of use of NuvaRing.
After a first trimester abortion
The woman can start immediately. This way, no additional contraceptive measures are necessary. In case she does not wish to start immediately, the woman should follow the instructions in the section "No hormonal contraceptive treatment in the previous cycle". In the meantime, the use of an alternative method of contraception should be advised.
After a birth or second-trimester abortion
For breastfeeding see section 4.6.
The woman should be advised to start treatment during the fourth week following delivery or second-trimester abortion. If starting later, the woman should be advised to use an additional barrier method for the first 7 days of use of However, if sexual intercourse has already occurred, pregnancy must be excluded or the woman must wait for her first menstrual period before starting treatment with NuvaRing.
DEVIATIONS FROM THE RECOMMENDED DOSAGE
Contraceptive efficacy and cycle control may be compromised if the woman does not comply with the recommended posology. In case of deviation, the following advice should be given to avoid loss of contraceptive efficacy:
• What to do if the ring-free interval is extended
The woman must insert a new ring as soon as she remembers to do so. A barrier method, such as a condom, should also be used for the next 7 days. If intercourse took place during the ring-free period, the possibility of pregnancy should be considered. The longer the ring-free interval, the greater the risk of pregnancy.
• What to do if the ring is temporarily expelled from the vagina
NuvaRing should be left in the vagina for a continuous period of 3 weeks. If the ring is accidentally ejected it can be washed with cold or lukewarm (not hot) water and must be reinserted immediately.
If NuvaRing is left out of the vagina for less than 3 hours, contraceptive efficacy is not reduced. The woman should reinsert the ring as soon as possible, but at the latest within 3 hours.
If NuvaRing remains outside the vagina, or is suspected to have remained outside the vagina for more than 3 hours during the 1st or 2nd week of use, contraceptive efficacy may be reduced. The woman should reinsert the ring as soon as she remembers. to do it. A barrier method, such as a condom, should be used until NuvaRing has been in the vagina continuously for 7 days. The longer the period of time NuvaRing has been out of the vagina and the closer this period is to the ring free interval, the higher the risk of pregnancy.
If NuvaRing has been out of the vagina, or is suspected to have been out of the vagina for more than 3 hours during the 3rd week of the three week use period, contraceptive efficacy may be reduced. The woman should discard that ring and choose one of the following two possibilities:
1. Immediately insert a new ring
Note: Insertion of a new ring will initiate the next three week use period. The woman may not have a withdrawal bleed from her previous cycle. However, spotting or breakthrough bleeding may occur.
2. Have a withdrawal bleed and insert a new ring no later than 7 days (7 x 24 hours) from the time the previous ring was removed or expelled.
Note: This option should only be chosen if the ring has been used continuously for the previous 7 days.
• What to do in case of prolonged use of the ring
Although not the recommended posology, contraceptive efficacy is still satisfactory as long as NuvaRing has been used for up to 4 weeks. The woman can maintain her one-week ring-free interval and then insert a new ring. NuvaRing has been inserted for more than 4 weeks, contraceptive efficacy may be reduced and the possibility of pregnancy must be ruled out before inserting a new NuvaRing.
If the woman has not adhered to the recommended regimen and subsequently no withdrawal bleeding has occurred in the following ring-free interval, the possibility of pregnancy must be ruled out before inserting a new NuvaRing.
HOW TO MOVE OR DELAY A MENSTRUAL CYCLE
If, in exceptional cases, it is necessary to delay a menstrual cycle, the woman can insert a new ring without respecting any ring-free interval. The next ring can be used for up to a further 3 weeks. The woman may experience vaginal bleeding or spotting. Regular use of NuvaRing is then resumed after the usual one week ring free interval.
To shift her period to another day of the week other than that used in her current schedule, the woman may be advised to shorten her next ring-free interval by the number of days she prefers. The shorter the ring-free interval, the greater the risk that the woman will not have any withdrawal bleeding and may have breakthrough bleeding and spotting during the use of the next ring.
04.3 Contraindications
Combined hormonal contraceptives (COCs) should not be used in the following conditions.
If any of these conditions appear for the first time while using the NuvaRing, it should be removed immediately.
• Presence or risk of venous thromboembolism (VTE) or venous thromboembolism - current (with anticoagulant) or previous VTE (eg deep vein thrombosis [DVT] or pulmonary embolism [PE])
• Known hereditary or acquired predisposition to venous thromboembolism, such as resistance to activated protein C (including factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency
• Major surgery with prolonged immobilization (see section 4.4)
• High risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4).
• Presence or risk of arterial thromboembolism (ATE) or Arterial thromboembolism - current or previous arterial thromboembolism (eg myocardial infarction) or prodromal conditions (eg angina pectoris)
• Cerebrovascular disease - current or previous stroke or prodromal conditions (eg transient ischemic attack (transient ischaemic attack, TIA))
• Known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
• History of migraine with focal neurological symptoms
• A high risk of arterial thromboembolism due to the presence of multiple risk factors (see section 4.4) or the presence of a serious risk factor such as:
• diabetes mellitus with vascular symptoms
• severe hypertension
• severe dyslipoproteinemia.
• Pancreatitis or a history of this condition if associated with severe hypertriglyceridaemia.
• Previous or current severe liver disease until liver function values have returned to normal.
• Liver tumors (benign or malignant), current or past.
• Known or suspected malignant diseases of the genital organs or breasts, if hormone-dependent.
• Vaginal bleeding of an unknown nature.
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of NuvaRing.
04.4 Special warnings and appropriate precautions for use
WARNINGS
If any of the conditions or risk factors mentioned below are present, the suitability of NuvaRing should be discussed with the woman.
In the event of worsening or first appearance of any of these risk factors or conditions, the woman should contact her physician to determine whether the use of NuvaRing should be discontinued.
1. Circulatory disorders
Risk of venous thromboembolism (VTE)
The use of any combined hormonal contraceptive (COC) results in an increased risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with a lower risk of VTE. The risk associated with others. products such as NuvaRing can also be twofold. The decision to use a product other than those associated with a lower risk of VTE should only be made after discussions with the woman to ensure that she understands the risk of VTE associated with NuvaRing, the way where your current risk factors influence that risk and the fact that the risk of developing a VTE is highest in the first year of use. There is also some evidence that the risk increases when taking a COC is resumed after a break of 4 or more weeks.
About 2 in 10,000 women who do not use a CHC and who are not pregnant will develop a VTE over a period of one year. In a single woman, however, the risk can be much higher, depending on her underlying risk factors (see below).
It is estimated that out of 10,000 women who use a low-dose CHC that contains levonorgestrel, about 61 will develop a VTE in a year. There were inconsistent results on the risk of VTE associated with NuvaRing compared to COCs containing levonorgestrel (with relative risk estimates ranging from no increase, RR = 0.96 to an almost two-fold increase, RR = 1.90). These values correspond to approximately 6-12 VTE per year for 10,000 women using NuvaRing.
In both cases, the number of VTEs per year is lower than the number expected in pregnant or postpartum women.
VTE can be fatal in 1-2% of cases.
Very rarely, thrombosis has been reported in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries.
Risk factors for VTE
The risk of venous thromboembolic complications in CHC users may increase substantially if additional risk factors are present, especially if there are more than one risk factors (see table).
NuvaRing is contraindicated if a woman has multiple risk factors that increase her risk of venous thrombosis (see section 4.3). If a woman has more than one risk factor, it is possible that the increased risk is greater than the sum of the individual factors; in this case her total risk of VTE should be considered. If the benefit-risk ratio is considered to be negative, a COC should not be prescribed (see section 4.3).
Table: Risk factors for VTE
There is no agreement on the possible role of varicose veins and superficial thrombophlebitis in the onset and progression of venous thrombosis.
The increased risk of thromboembolism in pregnancy, particularly the 6-week period of the puerperium, must be considered (for information on "Pregnancy and lactation" see section 4.6).
Symptoms of VTE (deep vein thrombosis and pulmonary embolism)
If symptoms of this type occur, women should seek immediate medical attention and inform them that they are taking a CHC.
Symptoms of deep vein thrombosis (DVT) can include:
• unilateral swelling of the leg and / or foot or along a vein in the leg;
• pain or tenderness in the leg which may only be felt when standing or walking;
• increased sensation of heat in the affected leg; skin on the leg that is red or discolored.
Symptoms of pulmonary embolism (PE) can include:
• sudden and unexplained onset of shortness of breath and rapid breathing;
• sudden cough which may be associated with hemoptysis;
• sharp pain in the chest;
• severe light headedness or dizziness;
• rapid or irregular heartbeat.
Some of these symptoms (such as "shortness of breath" and "cough") are non-specific and may be misinterpreted as more common or less serious events (eg respiratory tract infections).
Other signs of vascular occlusion may include: sudden pain, swelling or a pale blue discoloration of one "extremity.
If the occlusion takes place in the eye, symptoms can range from painless blurring of vision to loss of vision. Sometimes vision loss occurs almost immediately.
Risk of arterial thromboembolism (ATE)
Epidemiological studies have associated the use of CHCs with an increased risk of arterial thromboembolism (myocardial infarction) or of cerebrovascular accidents (eg transient ischemic attack, stroke). Arterial thromboembolic events can be fatal.
Risk factors of ATE
The risk of arterial thromboembolic complications or a cerebrovascular accident in CHC users increases in the presence of risk factors (see table). NuvaRing is contraindicated if a woman has one serious risk factor or multiple risk factors for ATE that increase her risk of arterial thrombosis (see section 4.3). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors; in this case her total risk should be considered. If the benefit-risk balance is believed to be negative, a CHC should not be prescribed (see section 4.3).
Table: Risk factors of ATE
Symptoms of ATE
If symptoms of this type occur, women must contact a healthcare professional immediately and inform them that they are taking a CHC.
Symptoms of cerebrovascular accident can include:
• sudden numbness or weakness of the face, arm or leg, especially on one side of the body;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden confusion, difficulty speaking or understanding;
• sudden difficulty seeing in one or both eyes;
• sudden, severe or prolonged migraine with no known cause;
• loss of consciousness or fainting with or without convulsions.
Temporary symptoms suggest it is a transient ischemic attack (TIA).
Symptoms of myocardial infarction (MI) can include:
• pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm or below the breastbone;
• discomfort radiating to the back, jaw, throat, arms, stomach;
• feeling of fullness, indigestion or choking;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety or shortness of breath;
• rapid or irregular heartbeats.
In the event of a suspected or confirmed VTE or ATE, the CHC should be suspended. Adequate contraception should be initiated due to the teratogenicity of anticoagulant therapy (coumarins).
2. Tumors
• Epidemiological studies indicate that prolonged use of oral contraceptives is a risk factor for the development of cervical cancer in women with human papillomavirus (HPV). However, there remains uncertainty as to how much this finding is influenced by confounding factors. (eg differences in the number of sexual partners or use of contraceptive barriers.) There are no epidemiological data on the risk of cervical cancer in users of NuvaRing (see "Medical Examinations / Visits").
• A meta-analysis of 54 epidemiological studies found that women currently using CHCs have a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed. The excess risk gradually disappears over the 10 years following discontinuation of treatment. Since breast cancer is rare in women under the age of 40, the number of extra cases of breast cancer diagnosed in women taking or recently taking CHCs is low compared to the overall risk of breast cancer. Breast cancer diagnosed in oral contraceptive users tends to be less clinically advanced than that diagnosed in women who have never used an oral contraceptive. The observations on the increased risk may be due to an early diagnosis of breast cancer in women taking COCs, the biological effects of the same or a combination of both factors.
• Benign liver tumors and, even more rarely, malignant liver tumors have been reported rarely in women taking CHCs. In isolated cases, these tumors have resulted in life-threatening intra-abdominal haemorrhages. Therefore, if a woman using NuvaRing experiences severe upper abdominal pain, liver enlargement, or signs suggestive of intra-abdominal haemorrhage, the possibility of liver cancer should be considered in the differential diagnosis.
3. Other conditions
• Women with hypertriglyceridaemia or a family history of this condition may be at increased risk of pancreatitis when taking hormonal contraceptives.
• Although small increases in blood pressure have been reported in many women taking hormonal contraceptives, clinically relevant increases are rare events. A clear correlation between the use of hormonal contraceptives and clinical hypertension has not been established. However, if prolonged clinically significant hypertension occurs during use of NuvaRing, the physician should, as a precaution, discontinue use of the ring and treat the If appropriate, use of NuvaRing may be resumed if normal blood pressure values have been achieved following antihypertensive therapy.
• The onset or worsening of the conditions listed below has been reported both during pregnancy and while taking hormonal contraceptives, but there is no definite evidence regarding the correlation between these conditions and hormonal contraceptives: jaundice and / or itching due to cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes gestationis, hearing loss from otosclerosis, angioedema (hereditary).
• Acute or chronic disturbances of liver function may require the use of NuvaRing to be discontinued until liver function parameters have returned to normal. Return of cholestatic jaundice and / or cholestatic pruritus, which occurred during pregnancy or during previous treatment with sex steroids, requires discontinuation of the use of the ring.
• Although estrogens and progestogens may affect peripheral insulin resistance and glucose tolerance, there is no evidence for the need for adjustment of the treatment regimen in diabetic patients using hormonal contraceptives. Diabetic patients must be carefully followed especially in the first month of use.
• Worsening of Crohn's disease and ulcerative colitis has been reported in association with the use of hormonal contraceptives.
• Chloasma may occasionally appear, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using NuvaRing.
• If a woman has any of the following conditions, she may not be able to insert the NuvaRing correctly or may lose the ring: prolapse of the uterine cervix, cystocele and / or rectocele, severe or chronic constipation.
Very rarely, there have been reports of NuvaRing being inadvertently inserted into the urethra, possibly ending up in the bladder. Therefore, incorrect placement should be considered in the differential diagnosis if symptoms of cystitis occur.
• Occasionally cases of vaginitis may occur while using NuvaRing. There is no indication that the effectiveness of NuvaRing will be affected by treatment for vaginitis, nor that use of NuvaRing will affect treatment for vaginitis (see section 4.5).
• Very rarely it has been reported that the ring has adhered to vaginal tissue, requiring removal by a trained healthcare professional.
EXAMINATIONS / MEDICAL VISITS
Before initiating or resuming use of NuvaRing, a complete medical history (including family history) should be taken and pregnancy should be ruled out. Blood pressure should be measured and a clinical examination, guided by contraindications, should be performed (see section 4.3 ) and warnings (see section 4.4). It is important to draw a woman's attention to information relating to venous or arterial thrombosis, including the risk associated with NuvaRing compared to other CHCs, symptoms of VTE and ATE, known risk factors and what to do in case of suspected thrombosis.
The woman should also be advised of the need to read the package leaflet carefully and to follow its advice. The frequency and type of examinations should be based on established guidelines and should be adapted to the individual woman.
Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
REDUCTION OF EFFECTIVENESS
The effectiveness of NuvaRing may be reduced if the information provided is not adhered to (section 4.2) or when other medicinal products are taken at the same time (section 4.5).
DECREASE IN CYCLE CONTROL
Irregular bleeding (spotting or breakthrough bleeding) may occur during use of NuvaRing. If irregular bleeding occurs after previously regular cycles while NuvaRing is used at the recommended posology, a non-hormonal cause should be considered and, to exclude malignant tumors or pregnancy, appropriate diagnostic measures must be implemented, which may include curettage.
In some women, withdrawal bleeding may not occur during the ring-free interval. If NuvaRing has been used according to the instructions described in section 4.2, it is unlikely that she is pregnant. has been used correctly or if two withdrawal bleeds are missing, pregnancy must be ruled out before continuing to use NuvaRing.
EXPOSURE OF "MAN ALL" ETINILESTRADIOLO AND ALL "ETONOGESTREL
The degree and possible pharmacological role of the male sexual partner's exposure to ethinylestradiol and etonogestrel via absorption from the penis has not been examined.
BREAKING OF THE RING
It has been reported that on very rare occasions the NuvaRing ring has opened during use (see section 4.5). The woman should be advised to remove the broken ring and reinsert a new ring as soon as possible, and to additionally use a barrier method, such as a condom, for the next 7 days. The possibility of pregnancy should be considered and the woman should contact the doctor.
EXPULSION
It has been reported that the NuvaRing may be expelled, for example if the ring has not been inserted properly, during the removal of a tampon, during intercourse, or in the case of severe or chronic constipation. Prolonged expulsion can lead to contraceptive failure and / or breakthrough bleeding.
Therefore, to ensure efficacy, the woman should be advised to regularly check for the presence of NuvaRing.
If NuvaRing is accidentally expelled and left out of the vagina for less than 3 hours, contraceptive efficacy is not reduced. The woman should wash the ring with cold or warm (not hot) water and reinsert it as soon as possible, but at the latest by 3 hours.
If NuvaRing has been out of the vagina, or is suspected to have been out of the vagina for more than 3 hours, contraceptive efficacy may be reduced. In that case, the advice given in section 4.2 "What to do if the ring is is temporarily expelled from the vagina ".
04.5 Interactions with other medicinal products and other forms of interaction
INTERACTIONS WITH OTHER MEDICINES
Interactions between hormonal contraceptives and other medicinal products can lead to breakthrough bleeding and / or contraceptive failure. The following interactions have been reported in the literature.
Hepatic metabolism: Interactions may occur with medicinal products that induce microsomal enzymes, resulting in increased clearance of sex hormones (e.g. phenytoin, phenobarbital, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and products containing St. John's wort).
Women being treated with any of these medicines should temporarily use a barrier method in addition to NuvaRing or choose another method of contraception. With hepatic microsomal enzyme inducing medicinal products, the barrier method should be used throughout the concomitant drug administration period and for 28 days following discontinuation.
If concomitant drug administration continues beyond the 3-week cycle of a ring, the next ring should be inserted immediately without observing the usual ring-free interval.
Loss of contraceptive efficacy has also been reported with antibiotics, such as penicillins and tetracyclines. The mechanism of this effect has not been well understood. In an interaction pharmacokinetic study, oral administration of amoxicillin (875 mg, twice daily) or doxycycline (200 mg on day 1, followed by 100 mg daily) for 10 days while using NuvaRing, did not affect significantly the pharmacokinetics of etonogestrel and EE. Women being treated with antibiotics (except amoxicillin and doxycycline) should use a barrier method for up to 7 days after discontinuation. If concomitant drug administration continues beyond 3 weeks of cycle of a ring, the next ring should be inserted immediately without observing the usual ring-free interval.
Based on pharmacokinetic data, vaginal antifungals and spermicides are not expected to affect the contraceptive efficacy and safety of NuvaRing. During concomitant use of antifungal pessaries, the chance of ring rupture may be slightly higher (see paragraph 4.4 "Rupture of the" ring ").
Hormonal contraceptives can interfere with the metabolism of other medicines. Consequently, plasma and tissue concentrations may either increase (e.g. cyclosporine) or decrease (e.g. lamotrigine).
The prescribing information for concomitant medications should be consulted to identify potential interactions.
LABORATORY EXAMS
The use of contraceptive steroids can affect the results of some laboratory tests including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of transport proteins (for example of corticosteroid-binding globulin and hormone-binding globulin sexual), of lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis.The variations are generally within the limits of normal laboratory values.
INTERACTIONS WITH ABSORBENT PADS
Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of hormones released by NuvaRing. On rare occasions, the NuvaRing may be expelled during the removal of a tampon (see tips under "What to do if the" ring is temporarily expelled from the vagina ").
04.6 Pregnancy and lactation
Fertility
NuvaRing is indicated for the prevention of pregnancy. If the woman wants to stop using NuvaRing because she wants to get pregnant, it is recommended to wait until she has a natural period before trying to conceive as this will help her calculate when the baby is due.
Pregnancy
NuvaRing is not indicated during pregnancy. If you become pregnant with NuvaRing in situ, the ring must be removed. Extensive epidemiological studies have not revealed any increased risk of congenital defects in children born to women who used COCs prior to pregnancy, nor has there been any teratogenic effects in cases where a COC is been used inadvertently during early pregnancy.
A clinical study in a small number of women has shown that, despite intravaginal administration, intrauterine concentrations of contraceptive steroids with NuvaRing are similar to levels observed in COC users (see section 5.2).
No clinical experience has been reported with the outcomes of pregnancies exposed to NuvaRing.
The increased risk of thromboembolism in the postpartum period should be taken into account when NuvaRing is restarted (see sections 4.2 and 4.4).
Feeding time
Breastfeeding can be influenced by estrogen, as it can reduce the amount and change the composition of breast milk. The use of NuvaRing should therefore be discouraged until the mother has completed weaning. Small amounts of the contraceptive steroids and / or their metabolites may be excreted in the milk but there is no evidence that this adversely affects the baby's health.
04.7 Effects on ability to drive and use machines
Based on the pharmacodynamic profile, NuvaRing has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects
The most frequently reported side effects in clinical trials with NuvaRing were headache, vaginal infections and vaginal discharge, each reported by 5-6% of the women.
Description of some adverse reactions
An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in CHC users, and this risk is discussed in more detail in section 4.4.
Other undesirable effects have also been reported in CHC users: these effects are discussed in more detail in section 4.4.
The table below lists adverse drug reactions reported in clinical trials, observational studies, or post-marketing use with NuvaRing. The most appropriate MedDRA term is listed to describe a certain adverse event.
All adverse reactions are listed by system organ class and frequency; common (≥ 1/100,
1) List of adverse events based on spontaneous reports.
Hormone-dependent tumors (eg liver tumors, breast cancer) have been reported in association with COC use. For further information see section 4.4.
In rare cases, partners of women using NuvaRing have reported penile disease during post-marketing surveillance.
In women using combined hormonal contraceptives, a number of undesirable effects have been reported in more detail in section 4.4. These effects include:
- venous thromboembolic disorders;
- arterial thromboembolic disorders;
- hypertension;
- hormone-dependent tumors (eg liver tumors, breast cancer);
- chloasma
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address:" www.agenziafarmaco.gov.it/it/responsabili ".
04.9 Overdose
No serious adverse effects from hormonal contraceptive overdose have been reported. Symptoms such as nausea, vomiting and, in girls, mild vaginal bleeding may occur in this circumstance. There are no antidotes and any treatment must be symptomatic.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other gynecologicals, Intravaginal contraceptives, vaginal ring with progestogen and estrogen, ATC code: G02BB01.
Mechanism of action
NuvaRing contains etonogestrel and ethinyl estradiol. Etonogestrel is a 19-nortestosterone derivative progestin and binds with high affinity to progesterone receptors in target organs. Ethinylestradiol is an estrogen widely used in contraceptives. The contraceptive effect of NuvaRing is based on various mechanisms, the most important of which is the inhibition of ovulation.
Clinical efficacy and safety
Clinical studies have been carried out worldwide (USA, Europe and Brazil) on women between 18 and 40 years of age. The contraceptive efficacy appeared to be at least comparable to that known for combined oral contraceptives. The following table shows the Pearl Indices (number of pregnancies per years of use by 100 women) found in clinical studies with NuvaRing.
With the use of higher-dose COCs (0.05 mg ethinylestradiol) the risk of endometrial and ovarian cancer is reduced. It remains to be determined whether this also applies to lower-dose contraceptives such as NuvaRing.
BLOOD PROFILE
A large comparative study versus a levonorgestrel / ethinyl estradiol 150/30? G oral contraceptive (n = 512 vs n = 518), which evaluated vaginal bleeding characteristics over 13 cycles, showed a low incidence of spotting or bleeding intermenstruals in the NuvaRing group (2.0-6.4%). Furthermore, vaginal bleeding was limited exclusively to the ring-free interval in most subjects (58.8-72.8%).
EFFECTS ON DENSITY BONE MINERAL
The effects of NuvaRing (n = 76) on bone mineral density were studied in comparison to a non-hormonal intrauterine device (IUD) (n = 31) over a two-year period. No adverse effects on bone mass were observed.
Pediatric population
The safety and efficacy of NuvaRing in adolescents below 18 years of age have not been studied.
05.2 Pharmacokinetic properties
Etonogestrel
Absorption
The etonogestrel released by NuvaRing is rapidly absorbed by the vaginal mucosa. Maximum serum concentrations of etonogestrel, approximately 1,700 pg / mL, are reached approximately one week after insertion. Serum concentrations show slight fluctuations and slowly decline to approximately 1,600 pg / mL after 1 week, 1,500 pg / mL after 2 weeks and 1,400 pg / mL after 3 weeks of use. Absolute bioavailability is approximately 100%, which is greater than that obtained after oral administration. Cervical and intrauterine etonogestrel levels were measured in a small number of women using NuvaRing or an oral contraceptive containing 0.150 mg desogestrel and 0.020 mg ethinyl estradiol. The observed levels were comparable.
Distribution
Etonogestrel is bound to serum albumin and sex hormone binding globulin (SHBG). The apparent volume of distribution of etonogestrel is 2.3 L / kg.
Biotransformation
Etonogestrel is metabolised via known pathways of steroid metabolism. Apparent serum clearance is approximately 3.5 L / h. No direct interaction was found with co-administered ethinylestradiol.
Elimination
Serum levels of etonogestrel decrease in a biphasic manner. The terminal elimination phase is characterized by a half-life of approximately 29 hours. Etonogestrel and its metabolites are excreted in a urine / bile ratio of approximately 1.7: 1. The half-life of the excretion metabolite is approximately 6 days.
Ethinylestradiol
Absorption
The ethinylestradiol released by NuvaRing is rapidly absorbed by the vaginal mucosa. Maximum serum concentrations, approximately 35 pg / mL, are reached 3 days after insertion and decrease to 19 pg / mL after 1 week, 18 pg / mL after 2 weeks and 18 pg / mL after 3 weeks of use. The monthly systemic exposure to ethinylestradiol (AUC0-∞) with NuvaRing is 10.9 ng • h / mL. The absolute bioavailability is approximately 56%, comparable to the oral intake of ethinylestradiol. Cervical and intrauterine ethinylestradiol levels were measured in a small number of women using NuvaRing or an oral contraceptive containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol. The observed levels were comparable.
Distribution
Ethinylestradiol is largely, but not specifically, bound to serum albumin. An apparent volume of distribution of approximately 15 L / kg was determined.
Biotransformation
The main metabolic pathway of ethinylestradiol is aromatic hydroxylation but a wide variety of hydroxylated and methylated metabolites are also formed, present as free metabolites and as sulfate and glucuronate conjugates. The apparent clearance is approximately 35 L / h.
Elimination
Serum levels of ethinylestradiol decrease in a biphasic manner. The terminal elimination phase is characterized by a large individual variation in half-life resulting in a median half-life of approximately 34 hours. Unchanged ethinylestradiol is not excreted; the metabolites of ethinylestradiol are excreted in a urine / bile ratio of 1.3: 1. The half-life of metabolite excretion is approximately 1.5 days.
Special populations
Pediatric population
The pharmacokinetics of NuvaRing have not been studied in healthy female post-menarche adolescents less than 18 years of age.
Effect of kidney damage
No studies have been performed to evaluate the effect of kidney disease on NuvaRing pharmacokinetics.
Effect of hepatic impairment
No studies have been conducted to evaluate the effect of liver disease on NuvaRing pharmacokinetics. However, steroid hormones may be poorly metabolised in women with impaired liver function.
Ethnic groups
No formal studies have been performed to evaluate pharmacokinetics in ethnic groups.
05.3 Preclinical safety data
Non-clinical data with ethinylestradiol and etonogestrel reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity, in addition to those already known for humans.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Copolymer of ethylene vinyl acetate, 28% vinyl acetate;
ethylene vinyl acetate copolymer, 9% vinyl acetate;
magnesium stearate.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
40 months.
06.4 Special precautions for storage
Before dispensing:
3 years, store in the refrigerator (2 ° C - 8 ° C).
At the time of dispensation:
The pharmacist writes the date of sale on the package. The product must be inserted no later than 4 months from the date of sale, but in any case before the expiry date in case this falls before.
After dispensing:
4 months, store below 30 ° C.
Store in the original package to protect the device from light and moisture.
06.5 Nature of the immediate packaging and contents of the package
Sachet containing a single NuvaRing. The sachet is made of an aluminum foil whose inner layer is low density polyethylene, while the outer layer is polyethylene terephthalate (PET). The sachet is resealable and waterproof and is packaged in a cardboard box printed together with the package leaflet. Each box contains 1 or 3 rings.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
See section 4.2. The pharmacist must indicate the date of sale on the package. For the pack of 3 rings it is recommended to indicate this date on the outer case and on the sachets. NuvaRing must be inserted no later than 4 months from the date of sale, but in any case before the expiry date in case this is earlier. removed, NuvaRing must be returned to the resealable sachet and disposed of with normal household waste to avoid accidental contact. NuvaRing must not be disposed of in the toilet. Any unused (expired) ring must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
N.V. Organon
Kloosterstraat 6
5349 AB Obs
Netherlands
08.0 MARKETING AUTHORIZATION NUMBER
1 sachet containing 1 vaginal device
AIC N. 035584010
3 sachets each containing 1 vaginal device
AIC N. 035584022
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 28, 2002 / March 1, 2012
10.0 DATE OF REVISION OF THE TEXT
July 2014
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