Symbyax contains olanzapine and fluoxetine hydrochloride, combining an atypical antipsychotic and a selective serotonin reuptake inhibitor. It is available as capsules for oral administration in various strength combinations. Some key inactive ingredients are pregelatinized starch, gelatin, dimethicone, and iron oxides.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 10 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Keep container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome
• High prolactin level—unexpected breast tissue growth, discharge from the nipple, change in sex drive or performance, irregular menstrual cycle
• Infection—fever, chills, cough, or sore throat
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Pain or trouble swallowing
• Rash, fever, and swollen lymph nodes
• Seizures
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression
• Trouble passing urine
• Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS)

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Drowsiness
• Dry mouth
• Fatigue
• Increase in appetite
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bipolar disorder
• Bleeding disorders
• Blockage in your bowel
• Cigarette smoker
• Constipation
• Dementia
• Diabetes
• Difficulty swallowing
• Glaucoma
• Have trouble controlling your muscles
• Heart disease
• High cholesterol
• History of breast cancer
• History of irregular heartbeat
• History of stroke
• Liver disease
• Low blood counts, like low white cell, platelet, or red cell counts
• Low blood pressure
• Parkinson's disease
• Prostate disease
• Seizures
• Suicidal thoughts, plans or attempt; a previous suicide attempt by you or a family member
• Take medications that treat or prevent blood clots
• Trouble passing urine
• An unusual or allergic reaction to olanzapine, fluoxetine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Other medications containing fluoxetine or olanzapine, such as Prozac, Sarafem, or Zyprexa
• Cisapride
• Dronedarone
• Linezolid
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)
• Metoclopramide
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Amphetamines
• Aspirin or aspirin-like medications
• Carbamazepine
• Certain medications for depression, anxiety, or psychotic disturbances
• Certain medications for migraine headaches like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Digoxin
• Diuretics
• Fentanyl
• Flecainide
• Furazolidone
• Isoniazid
• Lithium
• Medications for high blood pressure
• Medications for Parkinson's disease
• Medications for sleep
• Medications that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Omeprazole
• Other medications that prolong the QT interval (cause an abnormal heart rhythm)
• Phenytoin
• Procarbazine
• Propafenone
• Rifampin
• Ritonavir
• Supplements like St. John's Wort, kava kava, valerian
• Tramadol
• Tryptophan
• Vinblastine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if symptoms do not start to get better or if they get worse. Do not stop taking except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your care team.

This medication may increase blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

This medication can cause problems with controlling your body temperature. It can lower the response of your body to cold temperatures. If possible, stay indoors during cold weather. If you must go outdoors, wear warm clothes. It can also lower the response of your body to heat. Do not overheat. Do not over-exercise. Stay out of the sun when possible. If you must be in the sun, wear cool clothing. Drink plenty of water. If you have trouble controlling your body temperature, call your care team right away.

What are the most serious risks of this medication?

This medication should not be used to treat mood and behavior changes caused by dementia. It may increase the risk of death in older adults with dementia.

This medication may increase thoughts of suicide. This may be more common in children, teenagers, and young adults. The risk may increase after first starting the medication and after dose changes. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide.