SEGESTERONE ACETATE; ETHINYL ESTRADIOL (se JES ter one; ETH in il es tra DYE ole) vaginal ring is a flexible, vaginal ring used as a contraceptive (birth control method). This medicine combines 2 types of female hormones, an estrogen and a progestin. This ring is used to prevent ovulation and pregnancy.
Annovera 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). Check often 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 drug 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 health care provider if you have questions.
Contact your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of Annovera contact a poison control center or emergency room at once. NOTE: Annovera is only for you. Do not share Annovera with others.
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
Side effects that you should report to your doctor or health care professional as soon as possible:
-allergic reactions such as skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat
-high blood pressure
-migraines or severe, sudden headaches
-signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg
-signs and symptoms of infection like fever or chills with dizziness and a sunburn-like rash, or pain or trouble passing urine
-symptoms of vaginal infection like itching, irritation or unusual discharge
-yellowing of the eyes or skin
Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):
-breast pain, tenderness
-irregular vaginal bleeding or spotting, particularly during the first month of use
This list may not describe all possible side effects for Annovera. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Source: FDA
Do not take this medicine with the following medication:
-dasabuvir; ombitasvir; paritaprevir; ritonavir
-ombitasvir; paritaprevir; ritonavir
-vaginal lubricants or other vaginal products that are oil-based or silicone-based
This medicine may also interact with the following medications:
-antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
-aprepitant or fosaprepitant
-ascorbic acid (vitamin C)
-barbiturate medicines, such as phenobarbital or primidone
-certain antiviral medicines for hepatitis, HIV or AIDS
-certain medicines for cancer treatment
-certain medicines for seizures like carbamazepine, clobazam, felbamate, lamotrigine, oxcarbazepine, phenytoin, rufinamide, topiramate
-certain medicines for treating high cholesterol
-medicines for diabetes
-medicines to treat fungal infections, such as griseofulvin, miconazole, fluconazole, ketoconazole, itraconazole, posaconazole or voriconazole
-St. John''s wort
-theophylline or aminophylline
They need to know if you have any of these conditions:
-abnormal vaginal bleeding
-blood vessel disease or blood clots
-breast, cervical, endometrial, ovarian, liver, or uterine cancer
-heart disease or recent heart attack
-high blood pressure
-high cholesterol or triglycerides
-history of irregular heartbeat or heart valve problems
-protein C deficiency
-protein S deficiency
-recently had a baby, miscarriage, or abortion
-systemic lupus erythematosus (SLE)
-an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives
-pregnant or trying to get pregnant
Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine.
Check with your doctor or health care professional 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 medicine right away and contact your doctor or health care professional.
If you are taking this medicine 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 medicine 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 medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.
If you are going to have elective surgery, you may need to stop using this medicine before the surgery. Consult your health care professional for advice.
This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.
Keep out of the reach of children.
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 medicine after the expiration date. The ring should be placed in the case after 13 cycles (1 year) of use and discarded via a drug 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.