Norethindrone Acetate; Ethinyl Estradiol Tablets (Estrogen Replacement Therapy)

What is this medication?

NORETHINDRONE ACETATE; ETHINYL ESTRADIOL (nor eth IN drone AS e tate; ETh in il es tra DYE ole) reduces the number and severity of hot flashes due to menopause. It may be used to prevent osteoporosis after menopause. It works by increasing levels of the hormone estrogen in the body, which decreases the symptoms of menopause. It also prevents the lining of the uterus from becoming too thick, which decreases the risk of cancer of the uterus. 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.

COMMON BRAND NAME(S): femhrt 1/5, Fravolv, Fyavolv, Jevantique, Jinteli 1/5

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood vessel disease or blood clots
• Breast, cervical, endometrial, or uterine cancer
• Depression
• Diabetes
• Endometriosis
• Fibroids
• Gallbladder disease
• Heart disease or recent heart attack
• High blood cholesterol
• High blood pressure
• High level of calcium in the blood
• Hysterectomy
• Kidney disease
• Liver disease
• Migraine headaches
• Porphyria
• Systemic lupus erythematosus (SLE)
• Tobacco use
• Stroke
• Vaginal bleeding
• An unusual or allergic reaction to estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a drink of water. You may take this medication with food. Follow the directions on the prescription label. You will take one tablet daily at roughly the same time each day. Do not take your medication more often than directed.

Talk to your care team about the use of this medication in children. Special care may be needed.

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.

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.

What if I miss a dose?

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.

What may interact with this medication?

Do not take this medication with the following:

• Aromatase inhibitors, such as aminoglutethimide, anastrozole, exemestane, letrozole, testolactone
• Dasabuvir, ombitasvir, paritaprevir, ritonavir
• Ombitasvir, paritaprevir, ritonavir

This medication may also interact with the following:

• Barbiturates, such as phenobarbital
• Bexarotene
• Bosentan
• Carbamazepine
• Certain antibiotics, such as erythromycin and clarithromycin
• Certain medications for anxiety or sleep
• Certain medications for fungal infections, such as ketoconazole, itraconazole
• Certain medications for hepatitis, HIV or AIDS
• Cyclosporine
• Dantrolene
• Ethotoin
• Grapefruit juice
• Griseofulvin
• Isoniazid
• Medications for diabetes
• Phenobarbital
• Phenytoin
• Primidone
• Raloxifene
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• St. John's Wort
• Steroid medications, such as prednisone or cortisone
• Tamoxifen
• Thyroid hormones
• Topiramate
• 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.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam. You should also discuss the need for regular mammograms with your care team, and follow their guidelines.

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 have any reason to think you are pregnant, stop taking this medication at once and contact your care team.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. The risk is higher if you are over the age of 35.

This medication may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe.

If you are going to have elective surgery, you may need to stop taking this medication beforehand. Consult your care team for advice prior to scheduling the surgery.

What side effects may I notice from receiving this medication?

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
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• 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
• Vaginal bleeding after menopause, pelvic pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Breast pain or tenderness
• Headache
• Swelling of the ankles, hands, or feet

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.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

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.