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NUVARING
ETONOGESTREL/ETHINYL ESTRADIOL - VAGINAL RING

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ETONOGESTREL/ETHINYL ESTRADIOL - VAGINAL RING

(et-oh-no-GES-trel / ETH-in-il ess-tra-DYE-ole)

COMMON BRAND NAME(S): Nuvaring

WARNING: Smoking cigarettes while using this vaginal ring increases your chance of having heart problems. Do not smoke while using this product. The risk of heart problems increases with age (women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).

Uses

This combination hormone ring is used to prevent pregnancy. It contains hormones similar to those in birth control pills. The hormones release from the ring slowly over time. Using this hormone ring does not protect you or your partner against HIV or other sexually transmitted diseases (STDs).

How To Use

Review the Patient Information Leaflet. Follow all instructions on how to use this hormone ring and also the best time (during your menstrual cycle) to start using it. Wear each ring for 3 continuous weeks, then remove it for a 1 week period. A new ring is inserted one week after the last ring is removed and a new cycle begins again. If any of the information is unclear, consult your doctor or pharmacist. Wash and dry your hands. Open the reclosable foil pouch container. Remove the ring from the container and save the pouch for disposal of the ring after it is used. Insert the ring into your vagina. Keep the ring in place for 3 continuous weeks (21 days). When placed properly, you should not feel the ring and it will not interfere with sexual intercourse. Remove the ring on the 4th week on the same day of the week and about the same time as you placed it. This will be the start of a one week (7 day) ring-free break. Put the used ring in the foil pouch and discard in the trash container. Do not flush the used ring down a toilet. Your menstrual cycle (period) should usually start within 2 to 3 days after the ring is removed. If your period does not begin during the ring-free week, consult your doctor. After the 4th 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 menstrual bleeding has not stopped. Do not go longer than 7 days without a ring. Doing so may make this product less effective. 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, 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., 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 check to make sure you are not pregnant. If pregnant, contact your physician. 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. Depending on your situation, you may need to use an additional method of birth control (e.g., condoms, spermicide) for the first 7 days during your first ring cycle. A diaphragm is not recommended as a back-up method of birth control with this ring because this device may interfere with the correct placement of a diaphragm. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

Side Effects

Nausea, vomiting, headache, stomach cramps and bloating, dizziness, vaginal discomfort/irritation, increased vaginal discharge, or breast tenderness may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: dark patches on the skin or face (melasma), weight changes (gain or loss), problem wearing contact lenses, changes in vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged bleeding or complete stoppage of bleeding), unusual vaginal discharge/itching/odor, swelling, severe headache, mental/mood changes. Tell your doctor immediately if any of these unlikely but serious side effects occur: pain in the groin or lower legs, trouble breathing, chest pain, coughing up of blood, severe stomach pain, vision or eye problems, yellowing eyes or skin, dark urine, one-sided weakness, tingling/weakness/numbness in the arms/legs, sudden speech problems, lumps in the breast. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of blood clots (e.g., in the legs, groin, lungs), history of heart disease or stroke, heart valve disease, severe high blood pressure, diabetes (especially affecting the circulation), severe headaches, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), liver problems, history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, cancer (especially endometrial or breast cancer), undiagnosed abnormal vaginal bleeding, currently pregnant, heavy tobacco use (if 35 years old or greater). Before using this product, tell your doctor your medical history, especially of: high cholesterol or triglyceride (fat) levels, recent pregnancy, depression, high blood pressure, gallbladder problems, kidney problems, thyroid problems, severe constipation, obesity, vaginal conditions (e.g. vaginal stenosis, cervical prolapse), any allergies (especially to hormones used in birth control pills, such as estrogen or progestins). Do not smoke cigarettes. Hormonal birth control products (e.g., pills, injections, devices) combined with smoking cigarettes significantly increase your risk for strokes, blood clots, high blood pressure, and heart attacks; especially in women older than 35 years of age. Ask your doctor or pharmacist or consult the patient information leaflet that comes with this product for more details. It may take a long time for you to become pregnant after you stop using the ring. Consult your doctor. Before having surgery, including dental surgery, tell your doctor(s) that you are using this product. The drugs in this ring may cause blotchy, dark areas on your skin (melasma) and sunlight may intensify this effect. If this occurs, avoid prolonged sun exposure, sunlamps, or tanning booths. Use a sunscreen, and wear protective clothing when outdoors. If you are near-sighted or wear contact lenses, you may develop vision problems or may have problems wearing your contact lenses. Contact your eye doctor if these problems occur. If you miss a menstrual period and/or interrupt the dosing schedule, check to be sure that you are not pregnant. This product must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. The medication from this ring passes into breast milk. This may affect milk production and may have undesirable effects on the nursing infant. Breast-feeding is not recommended while using this product.

Drug Interactions

Certain drugs can decrease the effectiveness of this product by decreasing the amount of birth control hormones in your system. This can result in pregnancy. Consult your doctor or pharmacist for details. Drugs that may cause this effect include: griseofulvin, many antibiotics (e.g., penicillins, macrolides, tetracyclines, sulfas, cephalosporins, chloramphenicol), many seizure medications (e.g., phenytoin, barbiturates, primidone, carbamazepine), dapsone, rifamycins (e.g., rifampin), modafinil, nevirapine, St. John's wort, bosentan, certain HIV protease inhibitors (e.g., amprenavir, nelfinavir, ritonavir). Ask your doctor if you should use additional reliable birth control methods while taking any of the drugs mentioned above while also using the ring. Do not use this hormone ring if you are also taking troleandomycin. Before using this product, tell your doctor of all prescription and nonprescription medication you may use, especially of: atorvastatin, ascorbic acid (vitamin C), acetaminophen, azole antifungals (e.g., itraconazole, ketoconazole), cyclosporine, corticosteroids (e.g., prednisolone), theophylline, temazepam, aspirin, morphine, clofibric acid, thyroid hormones, antidepressants (e.g., tricyclics), warfarin, insulin. This birth control device may interfere with the correct placement of a diaphragm. The use of a diaphragm as a back-up method of birth control is not recommended. Consult your doctor or pharmacist for more information. This product can affect the results of certain lab tests (e.g., blood tests such as glucose, clotting factors, triglycerides (fat), folic acid, or thyroid). Make sure laboratory personnel and your doctors know you use this product. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

Overdose with this product is highly unlikely. Do not use more than one ring at a time. If overdose is suspected, remove the ring and contact your local poison control center or emergency room immediately. This product may be harmful if swallowed. Symptoms of overdose may include: severe nausea, vomiting, unusual vaginal bleeding or irregular menstrual periods.

Notes

Do not share this product with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. A manufacturer's Patient Information Leaflet about this product should be dispensed with each prescription. Read the information carefully. Ask your doctor or pharmacist any questions you may have.

Missed Dose

If the use of this product is interrupted (removed or falls out) or if you forget to insert or remove this product at the recommended time, consult the Patient Information Leaflet or your doctor or pharmacist to establish a new dosing schedule. If the hormone ring has been removed for longer than 3 hours, the use of 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.

Storage

Pharmacist: Prior to dispensing, store in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Patient: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage up to 59 to 86 degrees F (15 to 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.