Sibutramine (By mouth)

Introduction

Sibutramine (si-BUE-tra-meen)

Used as part of a diet plan to help you lose weight.

Brand Name(s)

Meridia

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to sibutramine, or if you have an eating disorder (such as anorexia nervosa or bulimia nervosa) or uncontrolled high blood pressure. You should not use this medicine if you have a history of heart disease, congestive heart failure, heart rhythm problems (such as arrhythmia), or stroke. You should not use sibutramine with other diet pills. You should not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Do not take an MAO inhibitor 2 weeks after stopping this medicine. You should not use this medicine if you are over 65 years of age.

How to Use This Medicine

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may be told to take one capsule every day. Sibutramine can cause trouble sleeping, so your doctor may tell you to use the medicine in the morning.
• You may take this medicine with or without food.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using other medicines to help you lose weight, or medicine to treat colds, cough, or allergies.
• Make sure your doctor knows if you are also using medicine to treat depression (such as fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, Desyrel®, Effexor®, Luvox®, Paxil®, Prozac®, Serzone®, or Zoloft®), dextromethorphan (Benylin®), ketoconazole (Nizoral®), lithium (Eskalith®, Lithobid®), narcotic pain medicine (such as fentanyl, meperidine, pentazocine, Sublimaze®, or Talwin®), tryptophan, medicine for migraine headache (such as sumatriptan, Imitrex®), or dihydroergotamine (DHE 45®).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, or if you have kidney disease, liver disease, or high blood pressure. Tell your doctor if you have bleeding problems, depression, diabetes, glaucoma, underactive thyroid, or a history of gallstones, seizures, or neuroleptic malignant syndrome (NMS). Tell your doctor if you are on dialysis.
• Do not breastfeed while you are using this medicine.
• Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures (convulsions) and may cause serious conditions called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions when it is taken with certain medicines.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may cause a rare and life-threatening condition that affects the blood pressure in the lungs called pulmonary hypertension. Check with your doctor right away if you have new or worsening shortness of breath.
• If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. You will need to have your blood pressure and pulse checked on a regular schedule. Keep all appointments your doctor makes for you.
• Carefully follow your doctor's instructions about a reduced-calorie diet and regular exercise. Talk with your doctor or health caregiver about a healthy and well balanced eating plan that you should follow. Ask your doctor or health caregiver before starting any exercise program.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Fast, pounding, or uneven heartbeat.
• Feeling nervous, anxious, shaky, or unusually happy.
• Fever, chills, cough, sore throat, and body aches.
• Seizures.
• Shortness of breath or troubled breathing.
• Sweating, confusion, or muscle stiffness.
• Swelling in your hands, ankle, or feet.

If you notice these less serious side effects, talk with your doctor:

• Back pain or headache.
• Constipation, nausea, heartburn, indigestion, or loss of appetite.
• Dizziness.
• Dry mouth.
• Joint or muscle pain.
• Stuffy or runny nose.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088