Symbyax ®  is a combination of two medicines in one capsule. One of the medicines is a common medication used to treat depression. The other belongs to a group of medicines called "psychotropics", and is approved for the treatment of the manic and maintenance phases of bipolar disorder. The two medicines in Symbyax ®  work together to help treat a specific kind of illness known as bipolar depression.

It is the first medication approved by the U.S. Food and Drug Administration for the treatment of bipolar depression.


Symbyax
fluoxetine and olanzapine (flew OX eh teen and oh LAN za peen)
 

What is the most important information I should know about Symbyax?
¢  Do not take Symbyax if you are taking or have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) during the last 2 weeks. Serious, and sometimes fatal, reactions have occurred when these medicines have been used together. Also, do not take Symbyax if you are taking thioridazine (Mellaril). Dangerous, even fatal irregular heartbeats may occur if these medicines are taken together. You must wait 5 weeks after stopping Symbyax before taking thioridazine (Mellaril).
¢  Do not stop taking Symbyax without first talking to your doctor. It may take several weeks before you start to feel better.
¢  Contact your doctor immediately if you experience fever, sweating, severe muscle stiffness (rigidity), confusion, or fast or irregular heart beats. These could be symptoms of a potentially fatal side effect called Neuroleptic Malignant Syndrome (NMS).
¢  Contact your doctor immediately if you experience uncontrollable movements of the mouth, tongue, cheeks, jaw, arms, or legs.
¢  Use caution when driving, operating machinery, or performing other hazardous activities. Symbyax may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
¢  Dizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
¢  Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Symbyax.
¢  There is an increased chance of becoming overheated while taking Symbyax. Drink plenty of fluid and use caution in hot weather and during exercise.




What are fluoxetine and olanzapine?
¢  Fluoxetine is in a class of drugs called selective serotonin reuptake inhibitors. Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, mood disturbances, or other psychological symptoms.
¢  Olanzapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
¢  Together, fluoxetine and olanzapine are used to treat depression associated with bipolar disorder.
¢  Symbyax may also be used for purposes other than those listed in this medication guide.




What should I discuss with my healthcare provider before taking Symbyax?
¢  Do not take Symbyax if you are taking or have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) during the last 2 weeks. Serious, and sometimes fatal, reactions have occurred when these medicines have been used together. Also, do not take Symbyax if you are taking thioridazine (Mellaril). Dangerous, even fatal irregular heartbeats may occur if these medicines are taken together. You must wait 5 weeks after stopping Symbyax before taking thioridazine (Mellaril).
¢  Before taking Symbyax, tell your doctor if you
     · are taking another form of fluoxetine such as Prozac, Prozac Weekly, or Sarafem;
     · are taking another form of olanzapine such as Zyprexa or Zyprexa Zydis;
     · have liver disease;
     · have kidney disease;
     · have heart disease or other heart problems such as high blood pressure, a previous heart attack, or irregular heartbeats;
     · have diabetes;
     · suffer from seizures;
     · have an enlarged prostate or difficulty urinating; or
     · have glaucoma.
¢  You may not be able to take Symbyax, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
¢  Symbyax is in the FDA pregnancy category C. This means that it is not known whether Symbyax will be harmful to an unborn baby. Do not take Symbyax without first talking to your doctor if you are pregnant or could become pregnant during treatment.
¢  Symbyax passes into breast milk and may affect a nursing infant. Do not take Symbyax without first talking to your doctor if you are breast-feeding a baby.




How should I take Symbyax?
¢  Take Symbyax exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
¢  Take each dose with a full glass of water.
¢  Symbyax can be taken with or without food.
¢  Try to take Symbyax at the same time each day.
¢  Do not stop taking Symbyax without first talking to your doctor. It may take several weeks before you start to feel better.
¢  It is important to take Symbyax regularly to get the most benefit.
¢  Your doctor may want to perform tests or schedule appointments to monitor your treatment with Symbyax.
¢  Store Symbyax at room temperature away from moisture and heat.




What happens if I miss a dose?
¢  Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.




What happens if I overdose?
¢  Seek emergency medical attention if an overdose is suspected.
¢  Symptoms of a Symbyax overdose may include nausea, vomiting, tremor, drowsiness, slurred speech, agitation, seizures, hyperactivity, enlarged pupils, and coma.




What should I avoid while taking Symbyax?
¢  Use caution when driving, operating machinery, or performing other hazardous activities. Symbyax may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
¢  Dizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
¢  Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Symbyax.
¢  There is an increased chance of becoming overheated while taking Symbyax. Drink plenty of fluid and use caution in hot weather and during exercise.




What are the possible side effects of Symbyax?
¢  Contact your doctor immediately if you experience fever, sweating, severe muscle stiffness (rigidity), confusion, or fast or irregular heart beats. These could be symptoms of a potentially fatal side effect called Neuroleptic Malignant Syndrome (NMS).
¢  Contact your doctor immediately if you experience uncontrollable movements of the mouth, tongue, cheeks, jaw, arms, or legs.
¢  If you experience any of the following serious side effects, stop taking Symbyax and contact your doctor immediately or seek emergency medical treatment:
     · an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
     · an irregular heartbeat or pulse;
     · low blood pressure (dizziness, weakness);
     · high blood pressure (severe headache, blurred vision);
     · chills or fever;
     · unusual bleeding or bruising;
     · a rash or hives.
¢  If you experience any of the following less serious side effects, continue taking Symbyax and talk to your doctor:
     · headache, tremor, nervousness, or anxiety;
     · difficulty concentrating;
     · nausea, diarrhea, dry mouth, or changes in appetite or weight;
     · weakness;
     · increased sweating;
     · sleepiness or insomnia; or
     · decreased sex drive, impotence, or difficulty having an orgasm.
¢  Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.




What other drugs will affect Symbyax?
¢  Do not take Symbyax if you are taking or have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) during the last 2 weeks. Serious, and sometimes fatal, reactions have occurred when these medicines have been used together. Also, do not take Symbyax if you are taking thioridazine (Mellaril). Dangerous, even fatal irregular heartbeats may occur if these medicines are taken together. You must wait 5 weeks after stopping Symbyax before taking thioridazine (Mellaril).
¢  Before taking Symbyax, tell your doctor if you are taking any of the following medicines:
     · another form of fluoxetine such as Prozac, Prozac Weekly, or Sarafem;
     · another form of olanzapine such as Zyprexa or Zyprexa Zydis;
     · another medicine for a psychiatric condition such as depression, anxiety, bipolar disorder, schizophrenia, and others;
     · St. John's wort;
     · a headache or migraine medicine such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);
     · a medication to control blood pressure or to treat a heart condition;
     · aspirin or a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, others), naproxen (Aleve, Anaprox, Naprosyn, others), diclofenac (Voltaren, Cataflam), indomethacin (Indocin), and others;
     · carbamazepine (Tegretol) or phenytoin (Dilantin);  
     · levodopa (Sinemet, Larodopa, Dopar); or
     · warfarin (Coumadin).
¢  You may not be able to take Symbyax, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
¢  Symbyax may increase the effects of drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (medicines that treat insomnia), pain relievers, anxiety medicines, muscle relaxants, and any other drug that makes you feel sleepy or relaxed. Tell your doctor about all medicines that you are taking and do not take any medicine without first talking to your doctor.
¢  Drugs other than those listed here may also interact with Symbyax. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.




Where can I get more information?
¢  Your pharmacist has additional information about Symbyax written for health professionals that you may read.