Uses of Estradiol and Norethindrone Tablets:

• It is used to put off soft, brittle bones (osteoporosis) in women after change of life.
• It is used to prevent or lower the signs of the change of life (menopause).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Estradiol and Norethindrone Tablets?

• If you are allergic to this medicine (estradiol and norethindrone tablets); any part of this medicine (estradiol and norethindrone tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have had any of these health problems: Bleeding disorder, blood clots, a higher risk of having a blood clot, breast cancer, liver problems or liver tumor, heart attack, stroke, or a tumor where estrogen makes it grow.
• If you have had your uterus removed.
• If you have unexplained vaginal bleeding.
• If you are pregnant or may be pregnant. Do not take this medicine (estradiol and norethindrone tablets) if you are pregnant.

This is not a list of all drugs or health problems that interact with this medicine (estradiol and norethindrone tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (estradiol and norethindrone tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Estradiol and Norethindrone Tablets?

• Tell all of your health care providers that you take this medicine (estradiol and norethindrone tablets). This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (estradiol and norethindrone tablets).
• Limit your drinking of alcohol.
• Avoid cigarette smoking. Smoking raises the chance of heart disease. Talk with your doctor.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• High triglyceride levels have happened with this medicine (estradiol and norethindrone tablets). Tell your doctor if you have ever had high triglyceride levels.
• High calcium levels have happened with drugs like this one in some people with cancer. Call your doctor right away if you have signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain.
• If you are 65 or older, use this medicine (estradiol and norethindrone tablets) with care. You could have more side effects.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Soft, brittle bones (osteoporosis):

• This medicine works best when used with calcium/vitamin D and weight-bearing workouts like walking or PT (physical therapy).
• Follow the diet and workout plan that your doctor told you about.

How is this medicine (Estradiol and Norethindrone Tablets) best taken?

Use this medicine (estradiol and norethindrone tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine (estradiol and norethindrone tablets) at the same time of day.
• Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or very upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Vaginal itching or discharge.
• Spotting or vaginal bleeding that is very bad or does not go away.
• Depression or other mood changes.
• Memory problems or loss.
• This medicine may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.

What are some other side effects of Estradiol and Norethindrone Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Back pain.
• Hair loss.
• Upset stomach or throwing up.
• Trouble sleeping.
• Cramps.
• Bloating.
• Tender breasts.
• Enlarged breasts.
• Vaginal bleeding or spotting.
• Signs of a common cold.
• Weight gain.
• This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Estradiol and Norethindrone Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (estradiol and norethindrone tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.