Sibutramine (Meridia) 98 capsules per package

Sibutramine is used for:

Generic Name: sibutramine (si-BUE-tra-meen)
Brand Name:Meridia

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 brain that reduce 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, or increased blood pressure in the lungs
• you have a history of heart or blood vessel problems (eg, chest pain, fast or irregular heartbeat, heart attack, heart failure, hardening of the arteries or blood vessels, poor circulation in the legs), or stroke or transient ischemic attack (TIA) (mini-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
• you are over 65 years old

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 problems, heart problems, 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, imidazole antifungals (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.

How to use sibutramine:

Use sibutramine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with sibutramine. Talk to your pharmacist if you have questions about this information.
• Take sibutramine by mouth with or without food.
• Unless otherwise directed by your doctor, sibutramine should be taken in the morning to avoid sleeping problems.
• If you miss a dose of sibutramine, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use sibutramine.

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.
• Sibutramine may increase the risk of stroke, heart attack, or similar problems. The risk may be greater if you have a history of heart problems.
• Lab tests, including blood pressure, pulse, 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.
• Do not use sibutramine in ELDERLY patients older than 65 years old; safety and effectiveness in these elderly patients have not been confirmed.
• 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 this medicine 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 the amount of urine; chest, left arm, or jaw 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); numbness of an arm or leg; 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. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; severe or persistent dizziness or headache.

Proper storage of sibutramine:

Store sibutramine at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep sibutramine out of the reach of children and away from pets.

General information:

• If you have any questions about sibutramine, please talk with your doctor, pharmacist, or other health care provider.
• Sibutramine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take sibutramine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sibutramine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sibutramine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sibutramine.