Sibutramine Hydrochloride Oral capsule

What is this medicine?

SIBUTRAMINE (si BYOO tra meen) is used to promote and maintain weight loss in obese patients. This medicine should be used with a reduced calorie diet and, if appropriate, an exercise program.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have or have had any of these conditions:

• anorexia nervosa, bulimia or other eating disorder
• glaucoma
• heart disease like congestive heart failure or a previous heart attack
• heart rhythm problems or palpitations, chest pain
• high blood pressure
• kidney or liver disease
• stroke or symptoms of a stroke
• thyroid disease
• an unusual or allergic reaction to sibutramine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• medicines for colds, sinus, and breathing difficulties
• other medicines for weight loss including prescription, nonprescription, and herbal products
• procarbazine
• tryptophan

This medicine may also interact with the following medications:

• certain migraine headache medicines like almotriptan, dihydroergotamine, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• dextromethorphan
• erythromycin
• fentanyl
• ketoconazole
• lithium
• medicines for anxiety, depression or other mental problems
• meperidine
• pentazocine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need to have your blood pressure and heart rate checked.

This medicine is intended to be used in addition to a healthy diet and appropriate exercise. The best results are achieved this way. Do not increase or in any way change your dose without consulting your doctor or health care professional.

A weight loss of 4 pounds or more during your first month of treatment is a good indicator of success with this medicine. Most of the weight you will lose will be lost gradually during 6 to 12 months.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• changes in vision
• chest pain
• difficulty breathing
• fever
• heart palpitations
• increased blood pressure
• increased heart rate
• muscle or joint pain
• pain, burning or tingling in the hands or feet
• seizures
• unusual bleeding or bruising
• unusual swelling of the arms or legs
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• dry mouth
• headache
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from heat, light and moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.