ANNOVERA

SEGESTERONE ACETATE; ETHINYL ESTRADIOL (se JES ter one; ETH in il es tra DYE ole) prevents ovulation and pregnancy. It belongs to a group of medications called contraceptives. It is a combination of the hormones estrogen and progestin.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Insert the ring into your vagina as directed. Follow the directions on the prescription label. Leave the ring in place for 3 weeks (21 days). Often check to make sure the ring is still in place. After 3 weeks, remove it for a 1-week break (7 full days). Clean the ring as directed. After the 1-week break is over, reinsert the ring. Follow the same directions each month. The ring is reusable for up to 1 year (13 cycles). Do not use more often than directed.
A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this drug. Read the information carefully. Talk to your pharmacist or care team if you have questions.
Contact your care team regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Do not take this medication with the following:
-Dasabuvir; ombitasvir; paritaprevir; ritonavir
-Ombitasvir; paritaprevir; ritonavir
-Vaginal lubricants or other vaginal products that are oil-based or silicone-based
This medication may also interact with the following:
-Acetaminophen
-Antibiotics or medications for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
-Aprepitant or fosaprepitant
-Armodafinil
-Ascorbic acid (vitamin C)
-Barbiturate medications, such as phenobarbital or primidone
-Bosentan
-Certain antiviral medications for hepatitis, HIV or AIDS
-Certain medications for cancer treatment
-Certain medications for seizures like carbamazepine, clobazam, felbamate, lamotrigine, oxcarbazepine, phenytoin, rufinamide, topiramate
-Certain medications for treating high cholesterol
-Cyclosporine
-Dantrolene
-Elagolix
-Flibanserin
-Grapefruit juice
-Lesinurad
-Medications for diabetes
-Medications to treat fungal infections, such as griseofulvin, miconazole, fluconazole, ketoconazole, itraconazole, posaconazole or voriconazole
-Mifepristone
-Mitotane
-Modafinil
-Morphine
-Mycophenolate
-St. John's wort
-Tamoxifen
-Temazepam
-Theophylline or aminophylline
-Thyroid hormones
-Tizanidine
-Tranexamic acid
-Ulipristal
-Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication.
Check with your care team to see if you need an additional method of contraception during the first cycle that you use this ring. Male condoms (made with natural rubber latex, polyisoprene, and polyurethane) and spermicides may be used. Do not use a diaphragm, cervical cap, or a female condom, as it is unknown if this ring can interfere with these birth control methods and their proper placement.
If you have any reason to think you are pregnant, stop using this medication right away and contact your care team.
If you are taking this medication for hormone related problems, it may take several cycles of use to see improvement in your condition.
Smoking increases the risk of getting a blood clot or having a stroke while you are using hormonal birth control, especially if you are more than 35 years old. You are strongly advised not to smoke.
Some women are prone to getting dark patches on the skin of the face (chloasma). Your risk of getting chloasma with this medication is higher if you had chloasma during a pregnancy. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.
If you are going to have elective surgery, you may need to stop using this medication before the surgery. Consult your care team for advice.
This medication does not protect you against HIV infection (AIDS) or any other sexually transmitted infections.

You will need to use the ring exactly as directed. It is very important to follow the schedule every cycle. If you do not use the ring as directed, you may not be protected from pregnancy. If the ring should slip out, is lost, or if you leave it in longer or shorter than you should, contact your care team for advice.

Side effects that you should report to your care team as soon as possible:
-Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
-Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
-Gallbladder problems—severe stomach pain, nausea, vomiting, fever
-Increase in blood pressure
-Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
-New or worsening migraines or headaches
-Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
-Unusual vaginal discharge, itching, or odor
-Worsening mood, feelings of depression
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
-Breast pain or tenderness
-Dark patches of skin on the face or other sun-exposed areas
-Irregular menstrual cycles or spotting
-Nausea
-Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children and pets.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Between each cycle of use, wash and dry the ring as directed and store in the case. Throw away any unused medication after the expiration date. The ring should be placed in the case after 13 cycles (1 year) of use and discarded via a medication take-back option, if available. If not, then discard in the trash out of reach of children and pets. Do NOT flush down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.