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This drug safety and warning guide provides crucial information on the potential risks and precautions associated with the use of Symbyax (olanzapine/fluoxetine). It is important to review these details carefully and consult your healthcare provider with any concerns or questions.

• Worsening Depression and Suicidal Thoughts: There is a risk of increased depression and suicidal behavior, particularly in individuals under 25 or those with a history of mental health conditions. Immediate medical attention is necessary if you or someone else notices suicidal thoughts or unusual behaviors, such as anxiety, panic attacks, irritability, restlessness, or difficulty sleeping.

• Increased Mortality in Older Adults with Dementia-Related Psychosis: Older adults over 65 with dementia-related psychosis should not use Symbyax due to the elevated risk of death. Ensure your prescriber is aware of any dementia diagnosis before starting this medication.

• Neuroleptic Malignant Syndrome: This rare but life-threatening condition may occur with antipsychotics like olanzapine. Symptoms include high fever, muscle stiffness, confusion, and irregular heartbeat. Seek immediate medical care if these symptoms arise.

• Sedation and Cognitive Impairment: Symbyax can cause extreme drowsiness and affect concentration, especially when combined with other sedative medications or alcohol. Avoid driving or operating heavy machinery until you know how the medication affects you. Report excessive drowsiness to your healthcare provider.

• Serious Allergic Reactions: Although rare, severe skin reactions, including rash, swelling, or breathing difficulties, may occur. Discontinue use and seek emergency medical help if these symptoms develop.

• Metabolic Changes: Olanzapine may lead to weight gain, increased blood sugar, and cholesterol levels. Regular monitoring through blood tests and maintaining a balanced diet and exercise routine is recommended.

• Serotonin Syndrome Risk: This potentially fatal condition can occur if combined with other serotonin-elevating drugs. Symptoms include rapid heartbeat, fever, and confusion. Ensure your healthcare provider knows all medications you are taking.

• Glaucoma Concerns: Symbyax may worsen angle-closure glaucoma. Regular eye exams are advised, and any changes in vision should be reported immediately.

• Involuntary Movements: Long-term use may result in uncontrolled movements, which can become permanent if untreated. Contact your healthcare professional promptly if these occur.

• Risk of Bleeding: The fluoxetine component increases bleeding risk, particularly with blood-thinning medications. Seek medical attention for unexplained bruising or bleeding.

• Reduced White Blood Cell Count: Olanzapine can lower WBC counts, increasing infection risk. Regular blood tests are necessary, especially if you have a history of low WBCs.

• Low Sodium Levels: Rare cases of low blood sodium have been reported, particularly in older adults or those on diuretics. Symptoms like confusion and weakness require immediate medical evaluation.

• Heart Rhythm Issues (QT Prolongation): Fluoxetine may cause potentially serious heart rhythm disturbances. Your heart function may be monitored via EKGs, and any symptoms like fainting or chest pain warrant emergency care.

• Anticholinergic Effects: Symptoms such as urinary retention and constipation may occur, especially with concurrent anticholinergic medications.

• Elevated Prolactin Levels: Regular monitoring is advised as high levels can cause reproductive issues and require medical evaluation.

Contraindications:

• Do not use Symbyax if taking or have recently taken MAOIs, linezolid, methylene blue, pimozide, or thioridazine. Consult your healthcare provider for guidance on timing and alternative treatments.

If you experience overdose symptoms or any severe side effects, seek emergency medical attention immediately. Always discuss any concerns with your healthcare provider to ensure safe and effective use of Symbyax.

Common side effects:

• Sleepiness
• Weight gain
• Increased appetite
• Dry mouth
• Fluid-related swelling
• Tiredness
• Shakiness
• Dizziness
• Lightheadedness
• Trouble sleeping

Less common but important to monitor:

• Blurry vision
• Weakness
• Pain
• Difficulty concentrating
• Restlessness
• Nervousness
• Runny nose
• Fever
• Sexual dysfunction

Serious side effects:

• Suicidal thoughts or actions
• Serious allergic reactions
• Neuroleptic malignant syndrome
• Serotonin syndrome
• Seizures
• Difficulty swallowing
• Abnormal heart rhythms
• Increased blood sugar levels
• Low sodium levels
• Increased prolactin levels
• Unwanted breast milk production
• Menstrual irregularities
• Prolonged or painful erections

Interactions with high risk of serious adverse effects and should be avoided:

• MAO inhibitors (isocarboxazid, Linezolid, Metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, Rasagiline, safinamide, Selegiline, Tranylcypromine)

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• fosamprenavir/ritonavir
• metoprolol
• diuretics (such as Furosemide)
• antiplatelet drugs (such as Clopidogrel)
• NSAIDs (such as Ibuprofen, Naproxen)
• anticoagulants (such as Dabigatran, Warfarin)
• drugs for high blood pressure
• medicines for Parkinson's disease (such as cabergoline)
• Cimetidine
• Phenytoin
• Pimozide
• vinblastine
• antipsychotics (such as Aripiprazole, Clozapine, Haloperidol, Perphenazine, Thioridazine)
• antiarrhythmics (such as Propafenone, Flecainide)
• tricyclic antidepressants (such as Desipramine, imipramine)
• Aspirin
• street drugs (such as MDMA/'ecstasy')
• St. John's wort
• certain antidepressants (such as SSRIs like Citalopram, paroxetine, SNRIs like Duloxetine, Venlafaxine)
• Tryptophan

Interactions with low risk that usually do not require a change in therapy:

• opioid pain or cough relievers (such as codeine, hydrocodone)
• alcohol
• marijuana (cannabis)
• drugs for sleep or anxiety (such as Alprazolam, Lorazepam, Zolpidem)
• muscle relaxants (such as Carisoprodol, Cyclobenzaprine)
• antihistamines (such as Cetirizine, diphenhydramine)