Fluoxetine Hydrochloride (floo-OX-e-teen hye-droe-KLOR-ide), Olanzapine (oh-LAN-za-peen)

Treats depression. This medicine contains an SSRI.

Brand Name(s):

Symbyax

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. It is best to take this medicine in the evening.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with pimozide or thioridazine. Do not use this medicine within 14 days of using an MAO inhibitor (MAOI), and do not start an MAOI for at least 5 weeks after you stop using fluoxetine.
• Some medicines can affect how olanzapine/fluoxetine works. Tell your doctor if you are using any of the following:
  • Buspirone, carbamazepine, clozapine, diazepam, digitoxin, dolasetron, fentanyl, fluvoxamine, haloperidol, levodopa, lithium, mefloquine, meperidine, methadone, omeprazole, pentamidine, phenytoin, probucol, rifampin, St John's wort, tacrolimus, tramadol, vinblastine
  • Amphetamine
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • Medicine for heart rhythm problems (including amiodarone, flecainide, procainamide, propafenone, quinidine, sotalol)
  • Medicine to treat mental health problems (including chlorpromazine, droperidol, iloperidone, ziprasidone)
  • Medicine to treat infections (including erythromycin, gatifloxacin, moxifloxacin, sparfloxacin)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Triptan medicine to treat migraine headaches
  • Tryptophan supplements
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have liver disease, bleeding problems, diabetes, high cholesterol, glaucoma, prostate problems, problems with passing urine, breast cancer, mania, seizures, or severe constipation. Tell your doctor if you have had a heart rhythm problem (including QT prolongation), or if you have had a heart attack, heart failure, low blood pressure, or a stroke.
• Do not breastfeed while you are using this medicine.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  • Changes in behavior or mood
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Neuroleptic malignant syndrome (a nerve and muscle problem)
  • High blood sugar, cholesterol, or triglyceride levels
  • Serotonin syndrome (may be life-threatening when used with certain other medicines)
  • Tardive dyskinesia (a muscle problem that may become permanent)
  • Higher risk of bleeding
  • Heart rhythm changes
  • Sexual problems
• This medicine may make you dizzy or drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make it more difficult for your body to cool down. Be careful to not become overheated during exercise or hot weather, because you could have heat stroke.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, sweating, muscle spasms, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Confusion, weakness, and muscle stiffness or twitching
• Eye pain, trouble seeing
• Fast, pounding, or uneven heartbeat
• Feeling very thirsty or hungry, change in how much or how often you urinate
• Fever, chills, cough, sore throat, and body aches
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, fainting
• Loss in sexual ability, desire, drive, or performance, delayed or inability to have an orgasm, inability to have or keep an erection
• Painful, prolonged erection of your penis
• Red, swollen skin, trouble breathing, yellow skin or eyes
• Seizures or tremors
• Unusual behavior, thoughts of hurting yourself or others, trouble sleeping, unusual dreams
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Constipation, increased appetite, weight gain
• Dry mouth
• Sleepiness or unusual drowsiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088