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

You should not use this medicine if had a hysterectomy, or if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you 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 is estradiol and norgestimate?

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

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

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

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

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease;
• 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.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease;
• liver problems, or jaundice caused by pregnancy or taking hormones;
• 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 norgestimate?

Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended.

Estradiol and norgestimate usually comes in a pack of pills that are different colors. In most cases you will take a pill of one color for 3 days in a row, and then take a pill of the other color for the next 3 days in a row. This cycle is then repeated throughout your treatment.

Each time you start a new pack, start with the first tablet in the first row of pills. Your medicine may come with stickers to mark your weekday schedule on the pack.

Be sure to have a new pack of this medicine ready to start on the day after you have finished an entire pill pack.

If you need major surgery with 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 norgestimate.

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 norgestimate.

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.

If you miss 2 doses in a row, take the next tablet in order and keep taking only one pill per day. Call your doctor if you miss more than 2 doses of this medicine.

What happens if I overdose?

What should I avoid while taking estradiol and norgestimate?

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of estradiol and norgestimate?

• 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 norgestimate?

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 interact with estradiol and norgestimate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. 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 norgestimate.