olanzapine/fluoxetine - oral, Symbyax (cont.)
USES: This medication is a combination of 2 drugs, olanzapine (an antipsychotic drug) and fluoxetine (a selective serotonin reuptake inhibitor-SSRI). It is used to treat a certain type of mental/mood disorder (depression associated with bipolar disorder). It is also used to treat depression that has not responded to other medications. This medication may help you sleep, improve your mood, improve your concentration, and decrease nervousness. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).Talk to the doctor about the risks and benefits of treatment (especially when used in teenagers). See also Precautions section.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using olanzapine/fluoxetine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth, with or without food, usually once daily in the evening or as directed by your doctor.The dosage is based on your medical condition and response to treatment.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.It may take up to several weeks before the full benefit of this drug takes effect. It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.If your condition persists or worsens, contact your doctor or pharmacist.
SIDE EFFECTS: See also the Warning section.Dizziness, drowsiness, diarrhea, dry mouth, constipation, increased appetite, weight gain, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, unusual or severe mental/mood changes (e.g., nervousness, trouble concentrating, rare thoughts of suicide), swelling hands/ankles/feet, restlessness, shaking (tremor), inability to keep still, decreased interest in sex, changes in sexual ability, large pupils.Tell your doctor immediately if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds, easy bruising/bleeding, muscle spasm, change in the amount of urine, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, slow/irregular/fast heartbeat, signs of infection (such as fever, persistent sore throat).Seek immediate medical attention if any of these rare but very serious side effects occur: severe headache, seizures.This drug may infrequently make your blood sugar level rise, an effect that may cause or worsen diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst/urination or unexplained weakness. If you already have diabetes, be sure to check your blood sugars regularly and share the results with your doctor. Your doctor may need to adjust your medication, diet, and exercise program when you start or stop this medication.This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels, especially in teenagers. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs such as "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including other SSRIs (e.g., citalopram, paroxetine) and SNRIs (e.g., duloxetine, venlafaxine), lithium, tramadol, tryptophan, or a certain drug to treat obesity (sibutramine). See also Drug Interactions section. Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop any of the following symptoms: hallucinations, unusual restlessness, severe dizziness, unexplained fever, loss of coordination, severe nausea/vomiting/diarrhea, twitchy muscles.This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: confusion, high fever, muscle stiffness, severe sweating, fast or irregular heartbeat.Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face/lips/tongue).In rare cases, this medication may increase your blood level of a certain hormone (prolactin). For females, this rare increase in prolactin levels may result in unwanted breast milk, irregular/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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