Important Safety Information about SYMBYAX^® (olanzapine and fluoxetine HCl)

Please read the Medication Guide that comes with SYMBYAX before you start taking it and each time you get a refill.

What is the most important information I should know about SYMBYAX?

Who should not take SYMBYAX?

• Do not take SYMBYAX if you already take a Monoamine Oxidase Inhibitor (MAOI) or if you stopped taking an MAOI in the last 2 weeks. Do not take an MAOI within 5 weeks of stopping SYMBYAX. People who take SYMBYAX close in time to an MAOI can have serious and life-threatening side effects, with symptoms including: high fever, continued muscle spasms that you cannot control, rigid muscles, changes in heart rate and blood pressure that happen fast, confusion, unconsciousness. Ask your doctor or pharmacist if you are not sure if your medicine is an MAOI.
• Do not take SYMBYAX if you already take Mellaril (thioridazine). Do not take Mellaril within 5 weeks of stopping SYMBYAX. Mellaril can cause serious heart rhythm problems and you could die suddenly.
• Do not take SYMBYAX if you take the antipsychotic medicine pimozide (Orap).

What other important safety information should I know about SYMBYAX?

• Suicidal thoughts or actions. Persons taking SYMBYAX may be more likely to think about killing themselves or actually try to do so, especially when treatment is first started or the dose is changed. People close to patients taking SYMBYAX can help by paying attention to changes in patients’ moods or actions. Contact the doctor right away if someone using SYMBYAX talks about or shows signs of killing him or herself or has sudden changes in mood, behaviors, thoughts, or feelings. If you are taking SYMBYAX yourself and you start having any of these symptoms, tell your doctor about this right away.
• High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to a build up of acid in your blood due to ketones (ketoacidosis), coma, or death. Your doctor should do tests to check your blood sugar before you start taking SYMBYAX and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when SYMBYAX is stopped. People with diabetes and some people who did not have diabetes before taking SYMBYAX need to take medicine for high blood sugar even after they stop taking SYMBYAX. If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking SYMBYAX.
  
  Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking SYMBYAX:
• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused, or your breath smells fruity
• High fat levels in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with SYMBYAX, especially in teenagers (13 to 17 years old) who received olanzapine, one of the drugs in SYMBYAX. SYMBYAX is not approved for use in patients less than 18 years old. You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking SYMBYAX and during treatment.
• Increase in weight (weight gain). Weight gain is common in people who take SYMBYAX. Teenagers (13 to 17 years old) who received olanzapine, one of the drugs in SYMBYAX, were more likely to gain weight and to gain more weight than adults. SYMBYAX is not approved for use in people less than 18 years. Some people may gain a lot of weight while taking SYMBYAX, so your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet and exercising.
• Strokes and “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). SYMBYAX is not approved for these patients.
• Severe allergic reactions. Tell your doctor right away if you get red itchy welts (hives) or a rash, alone or with fever and joint pain, while taking SYMBYAX. Call your doctor right away if you become severely ill and have swelling of your face, eyes or mouth, and/or trouble breathing.
• Neuroleptic malignant syndrome (NMS). NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including SYMBYAX. NMS can cause death and must be treated in a hospital. The symptoms include high fever; excessive sweating; rigid muscles; confusion; and changes in breathing, heartbeat, and blood pressure. Call your doctor right away if you become severely ill and have any of these symptoms.
• Tardive dyskinesia. This condition causes body movements that keep happening and that you cannot control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking SYMBYAX. It may also start after you stop taking SYMBYAX. Tell your doctor if you get any body movements that you cannot control.
• Serotonin syndrome. This is a condition that can be life threatening. Call your doctor right away if you become severely ill and have some or all of these symptoms: agitation; hallucinations; problems with coordination; racing heart beat; over-active reflexes; fever; nausea, vomiting, and diarrhea.
• Abnormal bleeding. Tell your doctor if you notice any increased or unusual bruising or bleeding while taking SYMBYAX, especially if you take one of these medications: the blood thinner warfarin (Coumadin, Jantoven), a nonsteroidal anti-inflammatory drug (NSAID), or aspirin.
• Low salt (sodium) levels in the blood (hyponatremia). Call your doctor right away if you become severely ill and have some or all of these symptoms: headache, feel weak, confusion, problems concentrating, memory problems, feel unsteady.
• Decreased blood pressure when you change position, with symptoms of dizziness, fast or slow heart beat, or fainting.
• Decreases in white blood cells (infection-fighting cells) have been reported in some patients taking antipsychotic agents, including SYMBYAX. Patients with a history of a significant decrease in white blood cell (WBC) count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy.
• Trouble swallowing, that can cause food or liquid to get into your lungs.
• Seizures. Tell your doctor if you have a seizure during treatment with SYMBYAX.
• Problems with control of body temperature. You could become very hot; for instance, when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine.
• Increases in prolactin (a naturally occurring hormone in the body) have been reported in some patients taking SYMBYAX and other medications like it, and these increases can continue while taking the medication. Some patients who have taken medications that increase prolactin have reported milk production from the breasts, stopping of menstrual periods, enlargement of the breasts in men, and impotence.
• SYMBYAX can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how SYMBYAX affects you.

Common possible side effects of SYMBYAX include:

• Tiredness
• Feeling weak
• Increased appetite
• Sleeping for long periods of time
• Blurred vision
• Tremors (shakes)
• Dry mouth
• Swelling of your hands and feet

This is not a complete list of possible side effects. If you have questions or if you have any side effects that concern you, talk with your doctor and/or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What should I tell my doctor before taking SYMBYAX?

Tell your doctor if you are taking, or plan to take, any prescription or over-the-counter drugs including vitamins and herbal supplements. SYMBYAX and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Do not start or stop any medicine while taking SYMBYAX without talking to your doctor first.

SYMBYAX may not be right for you. Before starting SYMBYAX, tell your doctor if you have or had: heart problems, seizures, diabetes or high blood sugar levels (hyperglycemia), high cholesterol or triglyceride levels in your blood, liver problems, low or high blood pressure, strokes or “mini-strokes” (also called transient ischemic attacks [TIAs]), bleeding problems, Alzheimer’s disease, narrow-angle glaucoma, enlarged prostate in men, bowel obstruction, breast cancer, thoughts of suicide or hurting yourself, or any other medical condition. Also tell your doctor if you are pregnant or plan to become pregnant (it is not known if SYMBYAX will harm your unborn baby), or if you are breast-feeding or plan to breast-feed. SYMBYAX can pass into your breast milk and may harm your baby. You should not breast-feed while taking SYMBYAX. Talk to your doctor about the best way to feed your baby if you take SYMBYAX.

What other important information should I know about SYMBYAX?

If you take SYMBYAX, you should not take any other medicines that contain olanzapine (Zyprexa, Zyprexa Relprevv, or Zyprexa Zydis) or fluoxetine hydrochloride (Prozac, Prozac Weekly, or Sarafem). You could take too much medicine.

Take SYMBYAX exactly as prescribed. To prevent serious side effects, do not stop taking SYMBYAX suddenly. If you need to stop taking SYMBYAX, your doctor can tell you how to safely stop taking it.

Avoid the use of alcohol while taking SYMBYAX.

It is not known if SYMBYAX is safe and effective in children under the age of 18.

If you have any questions or concerns, or if you want to report any problems with the use of SYMBYAX, contact your doctor, pharmacist, or other healthcare provider. For more information, talk with your doctor, visit www.SYMBYAX.com, or call 1-800-LillyRx.

SYMBYAX is available by prescription only

See accompanying Full Prescribing Information and Medication Guide including boxed warnings regarding suicidality and antidepressant drugs and increased risk of death in elderly people with dementia-related psychosis.

OF Con ISI 25Aug2011