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MERIDIA is available by prescription only.

Use and Important Safety Information You Should Know About
MERIDIA^® (sibutramine HCl monohydrate) Capsules C-IV

USE

• MERIDIA^® (sibutramine hydrochloride monohydrate) is used for people who need to lose 30 pounds or more, depending on height, and should be used with a reduced-calorie diet.

Important Safety Information You Should Know

MERIDIA is not for everyone. Do not take MERIDIA if you:

• Have, or ever have had, a heart problem, including
  • Heart attack
  • Chest pain or heart disease caused by poor blood flow in the heart (e.g., angina)
  • Heart failure
  • A fast heart rate or uneven heartbeat
  • Hardening of the arteries or other blood vessels; poor circulation in the legs
• Have or ever had a stroke or stroke symptoms
• Have high blood pressure over 145/90 mmHg and it is not controlled by medication or you are not on medication
• Are over 65 years of age
• Are taking monoamine oxidase inhibitors (MAOIs)
• Have an eating disorder called anorexia nervosa or bulimia nervosa
• Are taking weight-loss medications to control your appetite
• Are allergic to any of the ingredients of MERIDIA

MERIDIA can cause a large increase in blood pressure or heart rate (pulse) in some people. Your doctor should check your blood pressure and heart rate before you start MERIDIA and continue checking it regularly while you are taking it. It is important to have regular check-ups with your doctor while you are taking MERIDIA.

You should not take MERIDIA if you have severe liver or kidney disease, if you are pregnant or planning to get pregnant, or if you are nursing.

A rare but life-threatening problem called “serotonin syndrome” may occur when people take drugs that affect a brain chemical called serotonin along with MERIDIA. Do not take other medicines with MERIDIA unless your doctor has told you it is okay to do so. Get medical help right away if you have any of the following symptoms, especially if you take other medicines with MERIDIA: feeling weak, restless, confused, or anxious; loss of consciousness; fever, vomiting, sweating, shivering or shaking; muscle stiffness or spasms; or fast heartbeat.

Talk to your doctor about all medications (including prescriptions for depression and those which may increase risk of bleeding), over-the-counter medicines such as cough and cold, and herbal products that you are currently taking or have recently taken.

Tell your doctor if you have or ever have had glaucoma, thyroid problems, seizures, bleeding problems, gallstones, or depression.

Certain weight-loss medicines have been associated with a rare but life-threatening condition that affects the blood pressure in the lungs (pulmonary hypertension). Because the condition is rare, it is not known if MERIDIA may cause this disease. If you experience new or worsening shortness of breath, notify your doctor immediately.

The most common side effects include headache, dry mouth, anorexia, constipation, and insomnia.

MERIDIA is a controlled substance (CIV). Keep your MERIDIA in a safe place.

This is the most important information to know about MERIDIA. For more information, talk with your health care provider.

Reference: MERIDIA [package insert]. North Chicago, IL: Abbott Laboratories.

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: http://www.pparx.org/ or call the toll-free phone number (1-888-4PPA-NOW) for assistance.

600-384615