Brand Names: Symbyax

Generic Name: fluoxetine and olanzapine (Pronunciation: floo OX eh teen and oh LAN za peen)

• What is fluoxetine and olanzapine (Symbyax)?
• What are the possible side effects of fluoxetine and olanzapine (Symbyax)?
• What is the most important information I should know about fluoxetine and olanzapine (Symbyax)?
• What should I discuss with my healthcare provider before taking fluoxetine and olanzapine (Symbyax)?
• How should I take fluoxetine and olanzapine (Symbyax)?
• What happens if I miss a dose (Symbyax)?
• What happens if I overdose (Symbyax)?
• What should I avoid while taking fluoxetine and olanzapine (Symbyax)?
• What other drugs will affect fluoxetine and olanzapine (Symbyax)?
• Where can I get more information?

What is fluoxetine and olanzapine (Symbyax)?

Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

Olanzapine is an antipsychotic medication. These drugs affect chemicals in the brain.

The combination of fluoxetine and olanzapine is used to treat depression caused by bipolar disorder (manic depression). Fluoxetine and olanzapine is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Fluoxetine and olanzapine may also be used for other purposes not listed in this medication guide.

Symbyax 25 mg-6 mg

brown/yellow, imprinted with Lilly 3231, 6/25

Symbyax 3 mg-25 mg

peach/yellow, imprinted with Lilly 3230, 3/25

Symbyax 50 mg-12 mg

gray/red, imprinted with Lilly 3234, 12/50

Symbyax 50 mg-6 mg

gray/yellow, imprinted with Lilly 3233, 6/50

What are the possible side effects of fluoxetine and olanzapine (Symbyax)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• sudden and severe headache, blurred vision, confusion, chest pain, numbness, and problems with vision, speech, or balance;
• increased thirst, frequent urination, excessive hunger, or weakness;
• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, trouble breathing;
• jerky muscle movements you cannot control;
• seizure (convulsions);
• feeling like you might pass out;
• easy bruising or bleeding; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• trouble swallowing, runny nose, sore throat;
• weight gain, swelling in your hands of feet;
• drowsiness, trouble concentrating, sleep problems (insomnia);
• dry mouth, diarrhea, changes in appetite; or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluoxetine and olanzapine (Symbyax)?

This medication is not for use in psychotic conditions related to dementia. Olanzapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not take fluoxetine and olanzapine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), rasagiline (Azilect), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Olanzapine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking olanzapine.

SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine and olanzapine, do not stop taking the medication without first talking to your doctor.