Olanzapine/fluoxetine (By mouth)

Introduction

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

Treats depression that is a part of bipolar disorder or that does not respond to other antidepressants. This medicine contains a selective serotonin reuptake inhibitor (SSRI) antidepressant.

Brand Name(s)

Symbyax

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to olanzapine (Zyprexa®) or fluoxetine (Prozac®, Sarafem®). Do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Do not use thioridazine (Mellaril®) or an MAOI for at least 5 weeks after you stop using Symbyax®. You should not use this medicine if you are using pimozide (Orap®).

How to Use This Medicine

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• You may take this medicine with or without food.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are using digitoxin, linezolid (Zyvox®), omeprazole (Prilosec®), rifampin (Rifadin®), St. John's wort, sumatriptan (Imitrex®), tramadol (Ultram®), tryptophan, or vinblastine. Tell your doctor if you are using a blood thinner (such as warfarin or Coumadin®), other medicine for mental illness (such as clozapine, fluvoxamine, haloperidol, lithium, tryptophan, Clozaril®, Haldol®, or Luvox®), medicine for Parkinson's disease (such as levodopa, Sinemet®, or Stalevo®), phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®), or medicine for heart rhythm problems (such as flecainide, propafenone, Rythmol®, or Tambocor®).
• Make sure your doctor knows if you are also using a pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Feldene®, Daypro®, Motrin®, Orudis®, Relafen®, or Voltaren®), medicine for seizures (such as carbamazepine, phenytoin, Dilantin®, or Tegretol®), medicine to treat depression (such as amitriptyline, desipramine, imipramine, nortriptyline, Aventyl®, Elavil®, Norpramin®, Pamelor®, or Tofranil®), medicine for anxiety (such as alprazolam, diazepam, Librium®, Valium®, or Xanax®), or blood pressure medicine (such as atenolol, hydrochlorothiazide [HCTZ], lisinopril, metoprolol, Cozaar®, Diovan®, Lotrel®, Norvasc®, Prinivil®, Toprol®, or Zestril®).
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Tell your doctor if you are also using any other medicine that contains olanzapine or fluoxetine. Some other brand names are Zyprexa®, Zyprexa Zydis®, Prozac®, Prozac Weekly?, or Sarafem®.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, or if you have diabetes, seizures, bleeding problems, liver disease, prostate problems, narrow-angle glaucoma, trouble swallowing, or a history of neuroleptic malignant syndrome (NMS), breast cancer, or severe constipation. Your doctor needs to know if you have any kind of heart or circulation problems, including heart disease, low blood pressure, high blood pressure, heart failure, heart rhythm problems, or a history of heart attack or stroke.
• Do not breastfeed while you are using this medicine.
• For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
• This medicine may raise or lower your blood sugar, or it may cover up symptoms of very low blood sugar (hypoglycemia).
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.
• This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.
• If you develop new hives or a skin rash, even a mild one, stop using this medicine and call your doctor right away.
• This medicine may cause a serious condition called serotonin syndrome when it is taken with certain medicines. Check with your doctor first before taking any other medicines.
• Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
• You might get overheated while using this medicine. Drink plenty of water during hot weather, while exercising, or while using a hot tub or sauna. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.
• Some side effects are more likely to happen in elderly people who have memory problems or other reduced mental skills. Make sure the doctor knows if the person who will be using this medicine has forgetfulness or confusion related to aging (such as Alzheimer's disease or other kind of dementia).
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so stand up slowly.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• If your symptoms do not improve or if they get worse, call your doctor.

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
• Bloody or black, tarry stools.
• Change in how much or how often you urinate.
• Changes in behavior, or thoughts of hurting yourself or others.
• Chest pain, shortness of breath, or coughing up blood.
• Confusion, weakness, and muscle twitching.
• Fast, slow, uneven, or pounding heartbeat.
• Feeling very thirsty or hungry.
• Fever, unusual sweating, or feeling too hot.
• Lightheadedness or fainting.
• Muscle pain, tenderness, or weakness.
• Muscle stiffness, spasms, or other muscle movements you cannot control (especially in your face or mouth).
• Pain in your lower leg (calf).
• Seizures or tremors.
• Severe stomach pain, or vomiting of blood or material that looks like coffee grounds.
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Trouble breathing or swallowing.
• Trouble sleeping, racing thoughts, feeling very nervous, energetic, or restless.
• Unusual bleeding or bruising.
• Yellowing of your skin or the whites of your eyes.

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

• Blurred vision.
• Diarrhea.
• Dry mouth, sore throat, or hoarseness.
• Increase in appetite.
• Joint pain or swelling.
• Sleepiness or unusual drowsiness.
• Tiredness.
• Trouble concentrating.
• Trouble having sex.
• Weight gain.

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