Sibutramine is used for:

Treating obesity. It should be used with a reduced calorie diet.

Sibutramine is a diet aid. It appears to work by regulating chemicals in the appetite center in the brain to cause a temporary reduction in hunger or craving for food.

Do NOT use Sibutramine if:

• you are allergic to any ingredient in Sibutramine
• you have an eating disorder (eg, anorexia, bulimia), uncontrolled or severe high blood pressure, hardening of the arteries, fast or irregular heartbeat, heart failure, or increased blood pressure in the lungs, or you have had a stroke
• you have severe liver or kidney problems or you are on dialysis for severe kidney problems
• you are taking a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine), another appetite suppressant, or you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sibutramine :

Some medical conditions may interact with Sibutramine . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney or liver disease, heart disease, high blood pressure, bleeding problems, narrow-angle glaucoma, gallbladder problems (eg, gallstones), underactive thyroid, or seizures
• if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Sibutramine . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Dextromethorphan, dihydroergotamine, imidazoles (eg, itraconazole, ketoconazole), lithium, MAOIs (eg, phenelzine), narcotic analgesics (eg, codeine, fentanyl, meperidine), pentazocine, serotonin 5-HT₁ receptor agonists (eg, sumatriptan), SSRIs (eg, fluoxetine), or tryptophan because they may increase the risk of Sibutramine 's side effects, including increased risk of restlessness, fever, excessive sweating, twitching, and seizures that can, rarely, be life-threatening
• Ephedrine or pseudoephedrine because they may increase the risk of Sibutramine 's side effects, including increased blood pressure and fast or irregular heartbeat
• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
• Cyclosporine because the risk of its side effects may be increased by Sibutramine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sibutramine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Sibutramine may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Sibutramine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Sibutramine ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Changes in dietary habits and increased exercise are important parts of a successful weight loss program. To maintain your ideal weight, these changes should be continued for life. Follow the guidelines given to you by your doctor or diet counselor.
• Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions are possibly fatal syndromes that can be caused by Sibutramine . Your risk may be greater if you take Sibutramine with certain other medicines (eg, "triptans," MAOIs, antipsychotics [eg, aripiprazole, risperidone]). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; incoordination; rigid muscles; blood pressure changes; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
• Lab tests, including blood pressure, pulse monitoring, and weight monitoring, may be performed while you use Sibutramine . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use an effective method of birth control while you are taking Sibutramine .
• Use Sibutramine with caution in the ELDERLY; they may be more sensitive to its effects.
• Sibutramine should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sibutramine while pregnant. It is not known if Sibutramine is found in breast milk. Do not breast-feed while taking Sibutramine .

When used for long periods of time or at high doses, some people develop a need to continue taking Sibutramine . This is known as DEPENDENCE or addiction.

Possible side effects of Sibutramine :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; dizziness; dry mouth; flu-like symptoms; headache; increased or decreased appetite; joint pain; nausea; nervousness; painful menstruation; runny nose; sleeplessness; sore throat; upset stomach; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; anxiety; blurred vision or other vision changes; change in amount of urine; chest pain; clumsiness; confusion; difficulty breathing; disorientation; excitement; eye pain; fainting; fast or irregular heartbeat; high fever; increased sweating; large, unchanging pupils; loss of consciousness; mood or mental changes (eg, depression, mania, psychosis, thoughts of suicide or suicide attempt); one-sided weakness; restlessness; seizures; severe or persistent dizziness, headache, or weakness; shivering; shortness of breath; stomach pain; swelling of the feet, ankles, or legs; tremors; unusual bruising or bleeding; vomiting.

This is not a complete list of all side effects that may occur.