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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
ETONOGESTREL/ETHINYL ESTRADIOL RING - VAGINAL
(et-oh-no-GES-trel / ETH-in-il ess-tra-DYE-ole)
COMMON BRAND NAME(S): Nuvaring
WARNING: Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in smokers over 35) and also with frequent smoking (15 or more cigarettes a day).
USES: This medication is a combination of 2 hormones (an estrogen and a progestin) and is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also can work by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and by changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. Using this hormone ring does not protect you or your partner against HIV or other sexually transmitted diseases (STDs).
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. Make sure you understand how to insert a new ring and how to dispose of the used product. If you have any questions, consult your doctor or pharmacist. This product is for vaginal use only. Insert 1 ring and leave in for 3 continuous weeks (21 days), then remove it and discard properly. Do not use a ring for a 1-week period. After the ring-free week, insert a new ring at about the same time of the same day that you removed the previous ring the week before. It may be helpful to mark a calendar to remind you when to remove it and insert a new ring. If any of the information is unclear, consult your doctor or pharmacist. Wash and dry your hands. Open the reclosable foil pouch. Remove the ring, saving the pouch to dispose of the ring after it is used. Fold the ring in half gently and insert into your vagina. When the ring is placed properly, you should not feel it, and it will not interfere with sexual intercourse (though your partner may feel the ring). Unlike a diaphragm, the ring's exact position in the vagina does not matter as long as it stays securely inside. It is very important that you follow the directions carefully for when to insert and remove the ring to prevent pregnancy. If this is the first time you are using the ring, follow the product instructions, unless your doctor has given you other instructions, for when to start using the ring and when you will need to use an additional form of non-hormonal birth control. You may need to use a back-up barrier method (such as male condoms, spermicide) for the first 7 days of your first ring cycle to prevent pregnancy until the ring has enough time to work. Ask your doctor or pharmacist if you have any questions. A diaphragm is not recommended as a back-up method of birth control with the ring because the ring may interfere with the correct placement of a diaphragm. Remove the ring after the 3rd week on the same day of the week and about the same time as you placed it. Put the used ring in the foil pouch and discard in the trash. Do not flush the used ring down a toilet. If you have pain/bleeding when trying to remove the ring, or if you cannot remove it, tell your doctor immediately. Rarely, the ring can become attached to the vagina. If this occurs, your doctor will need to remove the ring. Do not wear a ring for 1 week (7 days). You should get your period within 2 to 3 days after the ring is removed. If your period does not begin during the ring-free week, consult your doctor. Do not go longer than 7 days without a ring. Doing so may increase your risk of pregnancy. After 1 ring-free week, insert a new ring on the same day of the week and about the same time as during the last cycle. You must insert the new ring one week after the last one was removed, even if your period has not stopped. If you need to insert a new ring during your period, you may use tampons at the same time as the ring without affecting how well the ring works. Do not go longer than 7 days without a ring. Doing so may make this product less effective. The vaginal ring may accidentally fall out during intercourse, during a bowel movement, or while removing a tampon. If the ring falls out of the vagina, rinse it with cool to lukewarm (not hot) water and re-insert as soon as possible, within 3 hours maximum. If the ring has been out more than 3 hours, or if you are not sure how long it has been out, you may not be protected from pregnancy. In this case, rinse the ring, re-insert as soon as possible, and use a back-up method of birth control (e.g., male condoms, spermicide) until the ring has been in place for 7 continuous days. If you have left the ring in place for longer than 3 weeks, but less than 4 weeks, remove it, wait 1 week, then insert a new ring. If you have left the ring in place for longer than 4 weeks, your body may not have enough hormones to protect you from pregnancy. Remove the ring and contact your doctor for a pregnancy test. If not pregnant, insert a new ring and use a back-up method of birth control (e.g., condoms, spermicide) until the new ring has been in place for 7 continuous days. If the ring breaks, discard it and replace with a new ring. If you experience urgent/frequent/burning/painful urination and you cannot find the ring in your vagina, tell your doctor immediately. You may have accidentally inserted the ring into your bladder. Ask your doctor or pharmacist or consult the Patient Information Leaflet for information about switching from other forms of birth control to the vaginal ring. If any of this information is unclear, ask your doctor or pharmacist.
SIDE EFFECTS: See also How to Use. Nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal discharge, or breast tenderness/enlargement may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If you miss 2 periods in a row (or 1 period if the ring has not been used properly), contact your doctor for a pregnancy test. If any of these effects persist or worsen, notify your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), problem wearing contact lenses, dark patches on the skin (melasma), swelling of the ankles/feet, weight changes (gain or loss). This medication may rarely cause serious (sometimes fatal) blood clot-related problems (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin. Vaginal rings have rarely caused a very serious (possibly fatal) bacterial infection (toxic shock syndrome-TSS). Remove this product and seek immediate medical attention if you develop symptoms of toxic shock syndrome, including: high fever, severe/sudden dizziness, fainting, unusual muscle pain, sunburn-like rash, diarrhea. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section. Before using this medication ring, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or etonogestrel; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, kidney disease, liver problems (e.g., liver tumor, active liver disease), current or suspected pregnancy, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over). Before using this product, tell your doctor your medical history, especially of: high blood pressure, breathing problems (e.g., asthma), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, fluid retention (edema), gallbladder problems, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems, vaginal conditions (e.g., vaginal stenosis, cervical prolapse). Do not smoke cigarettes or use tobacco. Hormonal birth control (e.g., pills, injections, devices) combined with smoking cigarettes significantly increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist or consult the Patient Information Leaflet that comes with this product. If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted. Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions. The drugs in this ring may cause blotchy, dark areas on your skin (melasma). Sunlight may intensify this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication. The medication from this ring passes into breast milk. This may affect how much milk you make and may also have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: aromatase inhibitors (e.g., anastrozole, exemestane), raloxifene, sodium tetradecyl sulfate, tamoxifen, medication for underactive thyroid (hypothyroidism), drugs that may increase blood levels of this drug such as acetaminophen, ascorbic acid (vitamin C), atorvastatin, azole antifungals such as itraconazole/ketoconazole/vaginal miconazole. Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others. Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include acetaminophen, clofibrate, cyclosporine, morphine, corticosteroids such as prednisolone, certain benzodiazepines such as lorazepam/temazepam, and theophylline, among others. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication. This medication can affect the results of certain lab tests (e.g., blood tests for clotting factors, thyroid). Make sure laboratory personnel and all your doctors know you use this medication. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: This product may be harmful if swallowed. Overdose with this product is highly unlikely. Do not use more than one ring at a time. If overdose or swallowing is suspected, remove the ring if possible and contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
NOTES: Do not share this product with others. Keep all laboratory and medical appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.
MISSED DOSE: If this product is out of the vagina for more than 3 hours, or if you forget to insert or remove this product at the recommended time, read the Patient Information Leaflet or consult your doctor or pharmacist to establish a new dosing schedule. If the hormone ring has been removed for longer than 3 hours, using a back-up method of birth control for 7 days is recommended. See the How to Use section. Consult your doctor or pharmacist for more information. If you have trouble remembering to remove and reinsert the ring as directed, or if it falls out repeatedly, contact your doctor to discuss switching to another form of birth control.
STORAGE: Pharmacist: Prior to dispensing, store in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. Patient: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture for up to 4 months. Brief storage up to 59-86 degrees F (15-30 degrees C) is permitted. Do not use after the expiration date. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed (See How to Use section).
Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.