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SYNTHROID®


(sin-throyd)


(levothyroxine sodium) tablets, USP Patient Information


What is the most important information I should know about SYNTHROID?


• 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 uncorrected adrenal problems.


• Taking too much levothyroxine has been associated with increased bone loss, especially in women after menopause.


• Once your doctor has found your specific SYNTHROID dose, it is important to have lab tests done, as ordered by your doctor, at least once a year.


• Foods like soybean flour, cottonseed meal, walnuts, and dietary fiber may cause your body to absorb less SYNTHROID from the gastrointestinal tract. Grapefruit juice may cause your body to absorb less levothyroxine and may reduce its effect. Let your doctor know if you eat these foods, as your dose of SYNTHROID may need to be adjusted.


• Use SYNTHROID only as ordered by your doctor. Take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.


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


• Tell your doctor if you are pregnant or breastfeeding or are thinking of becoming pregnant while taking SYNTHROID. Your dose of SYNTHROID may need to be increased during your pregnancy.


• It may take several weeks before you notice an improvement in your symptoms.


• Tell your doctor if you are taking any other drugs, including 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.


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


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


• Partial hair loss may occur during the first few months you are taking SYNTHROID.


What is SYNTHROID?


• SYNTHROID is a prescription man-made thyroid hormone medication that is used to treat a condition called hypothyroidism (under active thyroid).


• SYNTHROID is meant to replace a hormone that is usually made by your thyroid gland.


• Generally, thyroid replacement treatment is to be taken for life.


• SYNTHROID should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis).


Who should not take SYNTHROID?


• Do not take SYNTHROID if you have uncorrected adrenal gland problems.


What should I tell my doctor before taking SYNTHROID?


• Tell your doctor if you are taking any other drugs, including 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.


How should I take Synthroid?


• Use SYNTHROID only as ordered by your doctor. Take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.


• Once your doctor has found your specific SYNTHROID dose, it is important to have lab tests done, as ordered by your doctor, at least once a year.


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


• Foods like soybean flour, cottonseed meal, walnuts, and dietary fiber may cause your body to absorb less SYNTHROID from the gastrointestinal tract. Grapefruit juice may cause your body to absorb less levothyroxine and may reduce its effect. Let your doctor know if you eat these foods, as your dose of SYNTHROID may need to be adjusted.


What are the possible side effects of SYNTHROID?


• You may develop side effects from SYNTHROID if your dose of SYNTHROID is too high. These side effects could include, tiredness, increased appetite, weight loss, inability to tolerate heat, fever, increased sweating, headache, hyperactivity, feeling nervous, anxiety, irritability, extreme changes in mood, sleeplessness, shaking, muscle weakness, muscle spasm, rapid or abnormal heart beat, increased pulse and blood pressure, heart failure, chest pain, heart attack, difficulty catching breath, diarrhea, vomiting, stomach cramps, changes in liver function tests, hair loss, flushing, rash, decreased bone strength, changes in menstrual periods, decreased fertility.


• Partial hair loss may occur rarely during the first few months of SYNTHROID therapy, but this is usually temporary.


Tell your doctor if you have any side effect that bothers you or does not go away.


These are not all of the possible side effects of SYNTHROID. For more information, ask your doctor of pharmacist.


CONSUMER BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION


Read this Brief Summary before you start taking SYNTHROID and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. You and your doctor should talk about your treatment with SYNTHROID before you start taking it and at regular check-ups. You should stay under your doctor’s care when taking SYNTHROID.


Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Keep SYNTHROID and all medicines out of the reach of children.


General information about SYNTHROID


Medicines are sometimes prescribed for purposes other than those listed in a Brief Summary. Do not use SYNTHROID for a condition for which it was not prescribed. Do not give SYNTHROID to other people, even if they have the same condition you have.


This Brief Summary summarizes the most important information about SYNTHROID. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for more information about SYNTHROID that is written for health care professionals. For more information or a copy of full Prescribing Information call AbbVie Inc. at 1-800-241-1643 or visit www.synthroid.com.


Synthroid is a registered trademark of AbbVie Inc. AbbVie Inc.


North Chicago, IL 60064, U. S. A. Ref: 03-A648 Revised February 2017 605-1912102 MASTER


605-1923226


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