Use

SYNTHROID^® (levothyroxine sodium tablets, USP) is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism, except in cases of temporary hypothyroidism, which is usually associated with an inflammation of the thyroid gland (thyroiditis). It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life.

Important Safety Information

• Thyroid hormones, including SYNTHROID, should not be used either alone or in combination with other drugs for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of SYNTHROID used daily for hormone replacement are not helpful for weight loss. Larger doses may result in serious or even life-threatening events, especially when used in combination with certain other drugs used to reduce appetite.

• Do not use SYNTHROID if you have hyperthyroidism or over-active thyroid, uncorrected adrenal problems, are having symptoms of a heart attack, or are allergic to any of its ingredients.

• In women, long-term treatment with SYNTHROID has been associated with increased bone loss, especially in women who are on high doses or those who are on high doses after menopause.

• Tell your doctor if you are allergic to any foods or drugs, are pregnant or plan to become pregnant, are breast-feeding or are taking any other drugs, as well as prescription and over-the-counter products.

• Tell your doctor about any other medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking SYNTHROID. If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor and immediately tell your doctor if there are any changes. If you are taking blood thinners, your blood clotting status should be checked often.

• Use SYNTHROID only as ordered by your doctor. Do not stop or change the amount you take, or how often you take it, unless told to do so by your doctor.

• Products such as iron and calcium supplements and antacids can lower your body’s ability to absorb SYNTHROID, so SYNTHROID should be taken 4 hours before or after taking these products.

• Take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast. Your body’s ability to absorb SYNTHROID is improved when you take it on an empty stomach.

• Tell your doctor if you develop any of the following symptoms: rapid or abnormal heartbeat, chest pain, difficulty catching breath, leg cramps, headache, feeling nervous, irritability, sleeplessness, shaking, change in appetite, weight gain or loss, throwing up, diarrhea, increased sweating, unable to tolerate heat, fever, changes in menstrual periods, swollen red bumps on the skin or skin rash, or any other unusual medical event.

• Tell your doctor or dentist that you are taking SYNTHROID before any surgery.

• Once your body’s response to SYNTHROID has stabilized, it is important to have lab tests done, as ordered by your doctor, at least once a year.

This is the most important safety information you should know about SYNTHROID. For more information, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact www.pparx.org for assistance.