estradiol and norethindrone (oral)

What is the most important information I should know about estradiol and norethindrone?

You should not use this medicine if you have had a hysterectomy, or if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

What are estradiol and norethindrone?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and norethindrone is a combination medicine used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women.

Estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking estradiol and norethindrone?

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease;
• a bleeding disorder;
• a history of heart attack, stroke, or blood clot; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Tell your doctor if you have ever had:

• heart disease;
• liver problems, or jaundice caused by pregnancy or taking hormones;
• hereditary angioedema (an immune system disorder);
• epilepsy or other seizure disorder;
• kidney disease;
• gallbladder disease;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• lupus;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• endometriosis or uterine fibroid tumors;
• a thyroid disorder; or
• high levels of calcium in your blood.

How should I take estradiol and norethindrone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol and norethindrone.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using estradiol and norethindrone.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while using estradiol and norethindrone?

Grapefruit may interact with estradiol and norethindrone and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of estradiol and norethindrone?

• heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot --sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding, pelvic pain;
• a lump in your breast; or
• high levels of calcium in your blood --nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• nausea, vomiting, bloating, stomach cramps;
• fluid retention (swelling, rapid weight gain);
• headache;
• breast pain;
• thinning scalp hair; or
• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect estradiol and norethindrone?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect estradiol and norethindrone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about estradiol and norethindrone.