Estradiol and norethindrone

Estradiol is a type of estrogen, which is a female sex hormone that controls various processes in the body.

Norethindrone is a type of progesterone, a female hormone that plays a key role in managing ovulation and menstruation.

Estradiol and norethindrone is a combination medicine used to treat symptoms of menopause like hot flashes and changes in the vagina, and to help prevent osteoporosis (bone loss) in women who are menopausal.

Estradiol and norethindrone may also be used for reasons not mentioned in this medication guide.

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

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor right away if you have any unusual vaginal bleeding while using estradiol and norethindrone.

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 regularly (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps every month and have a mammogram every year while using estradiol and norethindrone.

Store at room temperature away from moisture, heat, and light.

You should not use estradiol and norethindrone 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.

Do not use if you are pregnant.

Estradiol and norethindrone may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol and norethindrone should not be used to prevent heart disease, stroke, or dementia.

You should not use this medicine if you are allergic to estradiol or norethindrone, if you have had a hysterectomy, or if you have:

• 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.

Do not use estradiol and norethindrone if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

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.

Estradiol and norethindrone should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

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.

Using this medicine may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Estradiol and norethindrone can slow breast milk production. Tell your doctor if you are breast-feeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Estradiol and norethindrone may cause serious side effects. Call your doctor right away if you have:

• 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, sharp 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 of estradiol and norethindrone 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.

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

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not smoke. It can greatly increase your risk of blood clots, stroke, or heart attack while using estradiol and norethindrone.

Grapefruit may interact with estradiol and norethindrone and cause unwanted side effects. Avoid using grapefruit products.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of other drugs is in your blood, which may increase side effects or make the medications work less well.

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 the medicines you are currently taking and any that you start or stop using.