Sibutramine (patient information)

# Why is this medication prescribed?
Sibutramine is used in combination with a reduced calorie diet and exercise to help people who are overweight lose weight and maintain their weight loss. Sibutramine is in a class of medications called appetite suppressants. It works by acting on appetite control centers in the brain to decrease appetite.

# How should this medicine be used?
Sibutramine comes as a capsule to take by mouth. It is usually taken with or without food once a day. To help you remember to take sibutramine, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sibutramine exactly as directed. Sibutramine can be habit forming. Do not take more or less of it or take it more often or for a longer time than prescribed by your doctor.
Your doctor may start you on a low dose of sibutramine and increase your dose, after you have been taking sibutramine for at least 4 weeks. Your doctor may decrease your dose if you experience certain side effects while you are taking your starting dose.
You will probably lose weight soon after you begin taking sibutramine and following your diet and exercise program. Be sure to monitor your weight, and call your doctor if you do not lose at least 4 pounds during your first 4 weeks of therapy. Your doctor may wish to change your dose of sibutramine.
You may not continue to lose weight after your first 6 months of treatment. However, you should continue to take sibutramine even if you have stopped losing weight. If you stop taking sibutramine, you may gain weight. Do not stop taking sibutramine without talking to your doctor.

# Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

# What special precautions should I follow?
Before taking sibutramine:
- tell your doctor and pharmacist if you are allergic to sibutramine or any other medications.
- do not take sibutramine if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate), or have stopped taking them within the past 2 weeks. Do not start taking these drugs for at least 2 weeks after you stop taking sibutramine.
- do not take other prescription or non-prescription medications, herbal products or nutritional supplements to help you lose weight such as benzphetamine (Didrex), methamphetamine (Desoxyn), phendimetrazine (Adipost, Bontril, others), and phentermine (Adipex-P, Phentride, others) while you are taking sibutramine.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amiodarone (Cordarone); anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); caffeine-containing products including NoDoz, and Vivarin; cancer chemotherapy medications; clarithromycin (Biaxin, Prevpac); clopidogrel (Plavix) ; cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); fentanyl (Actiq, Duragesic); gold salts such as auranofin (Ridaura) and aurothioglucose (Solganal); heparin; HIV protease inhibitors such as indinavir (Crixivin), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Fortovase, Invirase); isoniazid (INH, Nydrazid); lithium (Eskalith, Lithobid); medications for allergies, coughs, and colds; medications for depression; medications for high blood pressure; medications for migraine headaches such as dihydroergotamine mesylate (Migranal), ergoloid mesylates (Gerimal, Hydergine), ergonovine (Ergotrate, Methergine); ergotamine (Bellamine, Cafergot, others), frovatriptan (Frova), methysergide (Sansert), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); medications for nausea such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran) and palonosetron (Aloxi); medications for anxiety, mental illness, seizures, and pain; meperidine (Demerol, Mepergan); metronidazole (Flagyl); muscle relaxants; pentazocine (Talcen, Talwin); quinine; quinidine (Quinidex); salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sedatives; sleeping pills; sulfa antibiotics such as sulfadiazine, sulfamethizole (Urobiotic), sulfamethoxazole and trimethoprim (Bactrim, Septra), sulfasalazine (Azulfidine), sulfisoxazole (Gatrisin, Pediazole); ticlopidine (Ticlid); tranquilizers; troleandomycin (TAO); tryptophan; verapamil (Calan, Covera, Isoptin, Verelan); or zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had an eating disorder such as anorexia nervosa (abnormal focus on being thin that causes patient to eat very little and exercise excessively) or bulimia nervosa (eating large amounts of food and then removing the food from the body using diuretics (water pills), laxatives, or vomiting); cancer; chest pain; congestive heart failure (heart is unable to pump blood well enough); depression; gallstones (clumps of hardened material that can block the passages from the liver to intestine); glaucoma (an eye disease); a heart attack; hemophilia or other bleeding problems; high blood pressure; irregular heart beat; migraine headaches; osteoporosis (thinning and weakening of the bones); Parkinson's disease (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); seizures; a stroke or mini-stroke; pulmonary hypertension (high pressure in the vessel that moves blood from the heart to the lungs); or kidney, liver, or thyroid disease. Also tell your doctor if you have ever used street drugs or overused prescription medications.
- tell your doctor if you are pregnant or are breast-feeding. You should use effective birth control to be sure you do not become pregnant while you are taking sibutramine. Ask your doctor if you need help choosing a method of birth control.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sibutramine.
- you should know that sibutramine may make you drowsy and may affect your judgment, your ability to think, and your coordination. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication. Ask your doctor about the safe use of alcoholic beverages while you are taking sibutramine.
- ask your doctor about drinking coffee, tea, or caffeinated beverages while taking sibutramine. Caffeine may make the side effects from sibutramine worse.

# What special dietary instructions should I follow?
Follow the diet and exercise program your doctor has given you.
Talk to your doctor about drinking grapefruit juice while taking this medicine.

# What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

# Side effects

## Mild side effects
Sibutramine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- change in appetite
- constipation
- heartburn
- dry mouth
- weakness
- back pain
- nervousness
- difficulty falling asleep or staying asleep
- runny nose
- flu-like symptoms
- flushing
- painful menstrual periods

## Severe side effects
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- fast or pounding heart beat
- chest pain
- shortness of breath
- upset stomach
- stomach pain
- vomiting
- extreme excitement
- restlessness
- anxiety
- depression
- dizziness
- lightheadedness
- fainting
- confusion
- uncoordinated or abnormal movement
- muscle stiffness
- shaking hands that you cannot control
- seizures
- shivering
- excessive sweating
- fever
- sore throat
- large pupils (black area in center of eyes)
- change in vision
- eye pain
- hives
- skin rash
- itching
- difficulty speaking, breathing, or swallowing
- hoarseness
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- unusual bleeding or bruising
Sibutramine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online  or by phone .

# What storage conditions are needed for this medicine
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom) and light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

# In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- fast heart beat

# What other information should I know?
Keep all appointments with your doctor. Your doctor will monitor your blood pressure and heart rate (pulse) frequently while you are taking sibutramine.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

# Brand names
- Meridia