Precautions and Warnings With Olanzapine and Fluoxetine (Cont.)

• Antidepressants, including fluoxetine (Prozac^®) -- one of the components of olanzapine and fluoxetine -- may increase the risk of suicidal thoughts or behavior in (see Depression and Suicide). Therefore, if you notice any changes in symptoms or develop new symptoms, talk to your healthcare provider immediately. Some of these symptoms can include:

• Anxiety
• Hostility
• Agitation
• Panic
• Restlessness
• Hallucinations
• Extreme hyperactivity
• Suicidal thoughts or behavior (see Prozac and Suicide).

• The U.S. Food and Drug Administration (FDA) has issued a special warning (a "black box warning") about the use of olanzapine and fluoxetine in elderly people with dementia (a condition involving confusion; disorientation; and a loss of memory, intellect, and judgment) or psychosis.

Elderly people with dementia (Alzheimer's disease is the most common form) who are treated with antipsychotics -- including olanzapine and fluoxetine -- are more likely to die of various causes than those who were not treated with those medications. Olanzapine and fluoxetine is not approved to treat dementia or dementia-related psychosis, and caution should be used before prescribing the medication to elderly people with dementia.

• Olanzapine and fluoxetine can cause a life-threatening condition called neuroleptic malignant syndrome (NMS). Some symptoms of NMS include:

o A high fever

o Stiff muscles

o Confusion

o An irregular pulse or blood pressure

o A fast heart rate (tachycardia)

o Sweating

o An irregular heart rhythm (arrhythmia).

Tell your healthcare provider right away if think you might have NMS.

• Olanzapine and fluoxetine can cause tardive dyskinesia, a condition involving unusual and uncontrollable body or facial movements. The condition can become permanent even if the medication is stopped. The best way to prevent it from becoming permanent is to tell your healthcare provider right away if you notice any abnormal movements (including abnormal movements of the tongue) while taking olanzapine and fluoxetine.
   
• There is an increased risk of strokes in elderly people who take olanzapine and fluoxetine for dementia. The medication is not approved for the treatment of dementia in the elderly.
   
• Olanzapine and fluoxetine can cause an increase in blood sugar levels and can increase the risk of developing diabetes. Tell your healthcare provider if you develop signs of diabetes while taking the medication. Possible signs can include increases in thirst, urination, or hunger. If you have diabetes, your blood sugar should be monitored carefully and regularly during treatment with olanzapine and fluoxetine to make sure that your diabetes is not becoming more severe (see Symbyax and Diabetes).
   
• The medication can cause a drop in blood pressure when going from a sitting or lying-down position to standing (known medically as orthostatic hypotension). This can cause a person to have lightheadedness, dizziness, or fainting spells. Tell your healthcare provider if you have any of these symptoms when standing.
   
• Taking olanzapine and fluoxetine with other medications that affect serotonin can increase your risk of a dangerous group of symptoms called serotonin syndrome. These other medications include other antidepressants, triptans (migraine medications), and several other medications (see Drug Interactions With Olanzapine and Fluoxetine). Contact your healthcare provider immediately if you have any possible symptoms of serotonin syndrome, including:

o Confusion

o Seeing or hearing things that are not really there (hallucinations)

o A fast heartbeat (tachycardia)

o Feeling faint

o Fever

o Sweating

o Muscle spasms

o Difficulty walking

o Diarrhea.

• Olanzapine and fluoxetine may increase the risk of seizures. Before starting the medication, tell your healthcare provider if you have epilepsy or a history of seizures.
   
• The medication can cause difficulty swallowing, which can lead to inhalation of food and possibly pneumonia. Tell your healthcare provider if you notice any problems swallowing during treatment.
   
• Olanzapine and fluoxetine can increase the level of a certain hormone (prolactin) in the blood. Increased prolactin can cause breast enlargement in men and women, impotence (erectile dysfunction or ED) in men, unusual breast discharge in women, and menstrual changes in women. Tell your healthcare provider if you have any of these side effects.
   
• Olanzapine and fluoxetine can cause an increase in liver enzymes. Usually, this increase is harmless, although liver damage could occur. Talk with your healthcare provider before taking the medication if you have liver problems.
   
• Olanzapine and fluoxetine may cause bleeding in the stomach or intestines. This risk is increased in those taking aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen. Symptoms of gastrointestinal bleeding may include:

• Bright red blood coating the stool
• Dark blood mixed with the stool
• Black or tarry stool
• Bright red blood in vomit
• Vomit that has the appearance of coffee grounds.

If you experience any of these symptoms, call your healthcare provider right away.

• If you are elderly or taking a diuretic, olanzapine and fluoxetine could cause low salt levels in the blood (hyponatremia). This generally returns to "normal" levels when the medication is discontinued.
   
• Olanzapine and fluoxetine may affect your ability to perform complex tasks requiring mental and motor skills. Therefore, it is recommended that you become accustomed to its effects on you before becoming involved in activities requiring mental or motor concentration (such as driving a car or operating machinery).
   
• Olanzapine and fluoxetine is considered a pregnancy Category C medication. This means that it may not be safe to take during pregnancy. Be sure to talk with your healthcare provider about the risks and benefits of using the medication while pregnant (see Symbyax and Pregnancy).
   
• The medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, talk with your healthcare provider about using olanzapine and fluoxetine during this time (see Symbyax and Breastfeeding).
   
• Olanzapine and fluoxetine can make certain medical conditions worse, including glaucoma (a condition of the eye), bowel blockages or bowel obstruction, and an enlarged prostate (benign prostatic hyperplasia or BPH). Talk with your healthcare provider if you have any of these conditions.
   
• The medication has not been fully studied in people with liver, kidney, or heart problems. Talk with your healthcare provider if you have any of these conditions.
   
• In general, alcohol should be avoided while taking olanzapine and fluoxetine (see Alcohol and Symbyax).
   
• Olanzapine and fluoxetine can interact with certain other medications (see Drug Interactions With Olanzapine and Fluoxetine).