Miraser^®

Miraser® (fluoxetine) is a selective serotonin reuptake inhibitor (SSRI) mainly used for the treatment of mood disorders.

• Unipolar major depressive disorder (MDD)
• Social anxiety disorder (SAD)
• Generalized anxiety disorder (GAD)
• Obsessive-compulsive disorder (OCD)
• Bulimia nervosa
• Body dysmorphic disorder (BDD)
• Panic disorder
• Post-traumatic stress disorder (PTSD)
• Premature ejaculation (PE)
• Premenstrual dysphoric disorder (PMDD)
• Fibromyalgia, refractory

Oral tablets: 10 mg and 20 mg

Take Miraser® exactly as prescribed by your physician and avoid stopping it abruptly without medical approval.

Take Miraser® with food or on an empty stomach, as instructed by your doctor.

If you forget a dose, take it as soon as you remember.

If it is close to the next scheduled dose, skip the missed dose.

Do not take two doses together or take an extra dose.

If more than the recommended amount is taken, inform your doctor immediately or go to a medical center.

Before starting and during treatment, your doctor may monitor:

• Electrolytes, including sodium
• Renal and hepatic function
• Blood glucose in diabetic patients
• Electrocardiogram (ECG)
• Progression of disease symptoms
• Unusual changes in behavior (e.g., anxiety, agitation, irritability)
• Suicidal thoughts
• Sleep status

• History of hypersensitivity to fluoxetine or any component of the formulation
• Concomitant use or 14 days before and after discontinuation of monoamine oxidase inhibitor drugs
• Concomitant use with Linezolid or intravenous Methylene blue, Pimozide or Thioridazine

• If you experience symptoms such as fever, abnormal heart rate, confusion, excessive sweating, irritability, tremor, muscle stiffness, or flushing, consult your doctor immediately.
• Fluoxetine may cause drowsiness or dizziness; avoid driving or operating machinery if this occurs.
• If you experience vision changes, eye pain, or swelling/redness in or around the eyes, consult your doctor.
• Concomitant use of fluoxetine with antiplatelet drugs, anticoagulants, or NSAIDs may increase bleeding risk. Inform your physician if you use these medications.
• Long-term use of fluoxetine in older adults may increase the risk of bone fractures. Extra caution is required during treatment.
• Fluoxetine may lower blood sodium levels, especially in the elderly. This is reversible upon stopping the medication. Symptoms may include headache, difficulty concentrating, memory issues, confusion, and weakness.
• Use fluoxetine cautiously in patients with hepatic or renal impairment, or in those with a history of seizures. Inform your doctor if you have any of these conditions.

• Consult your doctor or pharmacist before using fluoxetine during pregnancy or breastfeeding.
• Discuss use of fluoxetine during the third trimester of pregnancy with your healthcare provider.

Not everyone experiences side effects. Possible side effects include:

• Dizziness, headache, weakness, and fatigue
• Dry mouth
• Increased urination
• Slowed heart rate
• Sexual dysfunction
• Weight changes
• Excessive sweating

Consult your doctor or pharmacist before using fluoxetine with other medications or supplements.

Each package contains 100 tablets (10 blister packs of 10 tablets each).

• Store below 30°C, away from moisture and light.
• The medication may be used until the end of the month printed on the package. Avoid using expired medications.
• Keep out of reach of children.
• Do not remove tablets from the original packaging until use.

1. Fluoxetine: Drug Information, UpToDate 2025
2. electronic Medicines Compendium (eMC)