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What is the most important information I should know about MERIDIA?
Some people taking MERIDIA can have a large increase in blood pressure or heart rate (pulse). Do not take MERIDIA if your blood pressure is not well controlled. Contact your doctor if you experience an increase in blood pressure while taking MERIDIA. Your doctor should check your blood pressure and heart rate before you start MERIDIA and continue checking it regularly while you are using MERIDIA. It is important to have regular check-ups while tak- ing MERIDIA.
What is MERIDIA?
MERIDIA is a medicine that may help obese people, as determined by their doctor, lose weight and keep weight off. MERIDIA may help with weight loss because it affects areas of the brain that control hunger. You should use MERIDIA with a low calorie diet. The use of MERIDIA for more than 2 years has not been studied. MERIDIA has not been studied in children under 16 years of age.
Who should not take MERIDIA?
Do not take MERIDIA if you:
What should I avoid while taking MERIDIA?
MERIDIA may not be the right medicine for you if you have certain medical conditions. Tell your doctor about all of your medical conditions, especially if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking MERIDIA and certain other medicines may affect each other and may cause serious and in some cases life-threatening side effects. Make sure you tell your doctor if you take:
What are the possible side effects of MERIDIA?
Common side effects of MERIDIA include: dry mouth, headache, loss of appetite, trouble sleeping, and constipation. The following serious side effects have been reported with MERIDIA: Certain weight loss medicines have been associated with a rare, but life-threatening condition that affects the blood pressure in lungs (pulmonary hypertension). Because the condition is so rare it is not known if MERIDIA may cause this disease. If you experience new or worsening shortness of breath notify your doctor immediately. Tell your doctor if you get a rash or hives while taking MERIDIA. You may be having an allergic reaction. Tell your doctor if you get effects that bother you or that do not go away. These are not all the side effects of MERIDIA. For more information, ask your doctor or pharmacist. MERIDIA is a controlled substance (CIV). This means that MERIDIA can be a target for people who abuse prescription medicines. Keep your MERIDIA in a safe place. Selling or giving away MERIDIA is against the law.
How should I store MERIDIA?

What are the ingredients in MERIDIA?
Active Ingredient: sibutramine hydrochloride monohydrate Inactive Ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide, NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP; gel- atin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15-mg capsules only), and other inactive ingredients].
Dosage and Administration
The recommended starting dose of MERIDIA is 10 mg administered once daily with or without food. If there is inadequate weight loss, the dose may be titrated after four weeks to a total of 15 mg once daily. The 5 mg dose should be reserved for patients who do not tolerate the 10 mg dose. Blood pressure and heart rate changes should be taken into account when making decisions regarding dose titration Doses above 15 mg daily are not recommended. In most of the clinical trials, MERIDIA was given in the morning. Analysis of numerous variables has indicated that approximately 60% of patients who lose at least 4 pounds in the first 4 weeks of treatment with a given dose of MERIDIA in combination with a reduced-calorie diet lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose of MERIDIA. Conversely, approximately 80% of patients who do not lose at least 4 pounds in the first 4 weeks of treatment with a given dose of MERIDIA do not lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose. If a patient has not lost at least 4 pounds in the first 4 weeks of treatment, the physician should consider reevaluation of therapy which may include increasing the dose or discontinuation of MERIDIA. The safety and effectiveness of MERIDIA, as demonstrated in double-blind, placebo-controlled trials, have not been determined beyond 2 years at this time.

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