Ethinyl Estradiol/Segesterone Vaginal System (SEGESTERONE/ETHINYL ESTRADIOL RING - VAGINAL)

Instructions

This medicine needs to be placed into the vagina. Please ask your doctor or pharmacist to show you how to use this medicine correctly.

This vaginal ring is reusable for up to 1 full year (13 cycles).

Wash the vaginal ring with mild soap and water, then rinse and pat dry with a clean cloth or paper towel before each insertion and after each removal.

Wear the vaginal ring continuously for 3 weeks and then remove it for 1 week. Store the cleaned ring inside the original case. After 1 week, reinsert the ring into the vagina. Repeat this cycle every month.

Your menstrual period should occur 2-3 days after removing the vaginal ring. If your period does not start, contact your doctor.

Do not wait more than 7 days before reinserting the vaginal ring even if your menstrual periods has not stopped by then.

The first time you use this medicine, you may need extra birth control protection for the first week while your body adjusts to this new medicine.

Do not use the same vaginal ring for more than 1 year. After a year of use, place the ring inside the original case and throw it away - out of reach of children and pets. Do not flush the ring down the toilet.

Keep the medicine at room temperature. Avoid heat and direct light.

Wash your hands before and after using this medicine.

This medicine may cause dark patches to appear on your face. Avoid sunlight and use sunscreen lotion to minimize further darkening of these skin patches.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Speak with your doctor about using additional forms of birth control if you forget to insert your vaginal ring on time or if the ring has been out of the vagina for more than 2 hours.

This medicine may affect your blood sugar levels. If you have diabetes, talk to your doctor before changing the dose of your diabetes medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Cautions

This medicine may increase the risk of some types of cancer in women. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine is associated with an increased risk of blood clots, heart attack, and stroke. Contact your doctor immediately if you experience leg pain or swelling, difficulty breathing, chest or jaw pain, severe headache, one-sided weakness or slurred speech.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Avoid smoking while on this medicine. Smoking may increase your risk for stroke, heart attack, blood clots, high blood pressure, and other diseases of the heart and blood vessels.

Ask your doctor how to do a breast self-exam. Check monthly. Report any changes to your doctor.

Talk to your doctor about getting a complete physical exam every year while on this medicine.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• bloating
• breast pain or swelling
• headaches
• nausea and vomiting
• vaginal itching or discharge
• weight gain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• severe or persistent abdominal pain
• breast lumps
• chest or jaw pain
• depression or feeling sad
• severe, watery or bloody diarrhea
• dizziness
• swelling of the legs, feet, and hands
• fainting
• fever
• severe or persistent headache
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• muscle pain
• shortness of breath
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• persistent or unusual thirst
• increased urinary frequency
• cramping of the uterus or bleeding from the vagina
• vaginal itching or yeast infection
• sudden change or loss of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.