ETHINYL ESTRADIOL AND ETONOGESTREL (VAGINAL RING)

(ETH in il es tra Paint ole and et oh noe JES trel) Brand: NuvaRing

What is the most significant information I must know about this medication?

• Do not use this medicine if you are pregnant or if you have recently had a baby.

• You must not use this medicine if you have any of the next conditions: uncontrolled tall blood pressure, heart malady, a blood-clotting mess, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver malady or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart onslaught, a stroke, or a blood clot.

• You may need to use back up birth control, such as condoms or a spermicide, when you first start using this medicine or if you miss a doze. Avoid using a diaphragm with the ethinyl estradiol and etonogestrel vaginal ring. Follow your doctor's instructions.

• Smoking can magnify your risk of blood clots, stroke, or heart onslaught caused by this medicine, especially if you are older than 35.

What is ethinyl estradiol and etonogestrel?

• Ethinyl estradiol and etonogestrel contains female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

• Ethinyl estradiol and etonogestrel vaginal ring is used as contraception to prevent pregnancy.

• Ethinyl estradiol and etonogestrel may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till using this medication?

• This medicine can reason birth defects. Do not use if you are pregnant. Speak your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a child, wait at least 4 weeks till using an ethinyl estradiol and etonogestrel vaginal ring.

• You must not use this medicine if you have:

· untreated or uncontrolled tall blood pressure;

· heart malady, circulation problems, history of heart onslaught, stroke, or blood clot;

· a history of hormone-related cancer such as breast or uterine cancer;

· unusual vaginal bleeding that has not been checked by a doctor;

· severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;

· liver malady or liver cancer, a history of jaundice caused by pregnancy or birth control pills; or

· if you smoke and are over 35 years old.

• To create certain you can safely use a vaginal ring speak your doctor if you have any of these another conditions:

· tall blood pressure, varicose veins, tall cholesterol or triglycerides, or if you are overweight;

· a history of depression;

· diabetes, underactive thyroid, gallbladder disease;

· seizures or epilepsy;

· tuberculosis;

· a history of irregular menstrual cycles, toxic shock syndrome, or light vaginal irritation;

· prolapsed (dropped) uterus, bladder, or rectum;

· severe constipation; or

· a history of fibrocystic breast malady, lumps, nodules, or an emergency mammogram.

• The hormones in this medicine can pass into breast milk and may harm a nursing child. Ethinyl estradiol and etonogestrel may also slow breast milk manufacture. Do not use if you are breast feeding a baby.

How must I use this medication?

• Use exactly as predesigned by your doctor. Do not use in larger or less amounts or for longer than recommended. Follow the directions on your prescription label. This medicine comes with patient instructions for safety and effective use. Follow these directions carefully.

• Your doctor will speak which day of your menstrual cycle to insert the first vaginal ring you use. During the first 7 days of using your first vaginal ring, you may need to use back-up birth control, such as condoms or a spermicide. Avoid using a diaphragm. Follow your doctor's instructions.

• The vaginal ring must be left in seat for 3 full weeks. Remove the ring after 3 weeks, on the same day of the week it was inserted at about the same time of day. Let 1 full week to pass till inserting the new ring.

• Your period must start during the week you do not wear a vaginal ring. Insert the new ring on the same day of the week it was inserted in the recent cycle, even if your menstrual period has not ended yet.

• The ethinyl estradiol and etonogestrel vaginal ring will not prevent pregnancy if you wear it only during intercourse. You should wear the ring for 3 full weeks, followed by 1 full week without a ring. The timing of ring insertion and removal is very significant for this medication to be effective as a form of birth control.

• The ring does not need to be removed during sexual intercourse. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse. Do not leave the ring out for longer than 3 hours.

• If you need surgery or medical trials or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you must know that you are using the vaginal ring.

• Store unused vaginal rings at room temperature away from moisture, heat, and easy. To dispose of a used vaginal ring, seat it in the foil pouch it came in and throw it away where children and pets can't get to it. Do not flush the ring down a toilet.

What happens if I miss a dose?

• If the ring ever falls out during the 3-week wearing time, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther. If the ring is lost, a new vaginal ring must be inserted as soon as possible and the schedule continued without change. Do not leave a ring out for longer than 3 hours.

• During week 1 or 2 of wearing time: If a ring has been out of the vagina for more than 3 hours, you may not be protected from pregnancy. You should use a back-up birth control before the new or replaced ring has been in seat for 7 days in a row.

• During week 3 of wearing time: If a ring has been out of the vagina for more than 3 hours, you may either insert a new ring and start a new 3-week cycle, or you may wait 7 days (and have a menstrual period) till you insert a new ring. You should use back-up birth control before the new or replaced ring has been in seat for 7 days in a row.

• Avoid leaving the vaginal ring in seat for longer than 3 weeks. Call your doctor if you get off the proper schedule for use and non-use of the vaginal ring. Do not wear more than one ring at a time.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What must I avoid while using this medication?

• Smoking can magnify your risk of blood clots, stroke, or heart onslaught caused by this medicine, especially if you are older than 35.

• This medicine will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What are the possible side effects of this medication?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Stop using this medicine and call your doctor at once if you have a serious side effect such as:

· sudden numbness or weakness, especially on one side of the body;

· sudden and severe headache, confusion, problems with vision, speech, or balance;

· chest pain or hard feeling, pain spreading to the hand or shoulder, nausea, sweating, common ill feeling;

· sudden cough, wheezing, rapid breathing, coughing up blood;

· pain, swelling, warmth, or redness in one or both legs;

· a change in the pattern or severity of migraine headaches;

· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

· swelling in your hands, ankles, or feet;

· a breast lump; or

· symptoms of depression (sleep problems, weakness, weary feeling, mood changes).

• Smaller serious side effects may include:

· mild nausea, vomiting, bloating, stomach cramps, changes in weight or appetite;

· breast pain, tenderness, or swelling;

· headache, nervousness, dizziness, weary feeling;

· freckles or darkening of facial skin, heighten hair growth, loss of scalp hair;

· problems with contact lenses; or

· vaginal itching or discharge, changes in your menstrual periods, decreased sex drive.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect ethinyl estradiol and etonogestrel?

• Some drugs can create birth control smaller effective, which may result in pregnancy. Till using this medicine, speak your doctor if you are using any of the next drugs:

· bosentan (Tracleer);

· an antibiotic or antifungal medication;

· drugs to treat hepatitis C, HIV, or AIDS;

· phenobarbital (Solfoton) and another barbiturates;

· St. John's wort; or

· seizure medications.

• Speak your doctor about all another medicines you use, especially:

· acetaminophen (Tylenol) or ascorbic acid (vitamin C);

· atorvastatin (Lipitor, Caduet);

· dantrolene (Dantrium);

· vaginal miconazole (Monistat);

· tizanidine (Zanaflex); or

· tranexamic acid (Cyklokapron, Lysteda).

• This list is not complete and another drugs may interact with ethinyl estradiol and etonogestrel. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and etonogestrel.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.