Miraser ^®

Miraser®
Generic Name: Fluoxetine
Dosage Form: 10 mg and 20 mg tablets
Drug Category: Antidepressant

Indications: This drug is used in the treatment of mood disorders.

Miraser®
Miraser® (fluoxetine) is a drug from the selective serotonin reuptake inhibitor (SSRI) class that is primarily used to treat mood disorders.

Indications for Miraser®

Unipolar Major Depressive Disorder (Unipolar 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 Resistant to Treatment

Dosage Form of Miraser®
10 mg and 20 mg oral tablets

How to Use and Dosage of Miraser®
Take Miraser® precisely as directed by your doctor and avoid suddenly stopping it without the physician’s consent.
Take Miraser® exactly as prescribed by your doctor, with or without food.

Forgetting a Dose of Miraser®
If a dose is missed, take it as soon as you remember. If it is near the time of the next dose, do not take the missed dose. Avoid taking two doses at the same time or taking an extra dose.

Overdose of Miraser®
In case of taking more than the recommended dose, inform your doctor immediately or visit a healthcare facility.

Monitoring Needs While Taking Fluoxetine
Before starting and during the use of fluoxetine, the following may be monitored at specific intervals at the physician’s discretion:

Electrolyte levels such as sodium
Kidney and liver function
Blood glucose levels in diabetic patients
Electrocardiogram (ECG)
Changes in disease symptoms
Unusual changes in behavior (such as anxiety, agitation, and irritability)
Suicidal thoughts
Sleep patterns

Contraindications for Fluoxetine Use

History of hypersensitivity to fluoxetine or any of the formulation components
Concurrent use with monoamine oxidase inhibitors (such as moclobemide, selegiline, and tranylcypromine) or within 14 days of stopping monoamine oxidase inhibitors
Concurrent use with linezolid and intravenous methylene blue
Concurrent use with pimozide or thioridazine

Warnings and Precautions for Fluoxetine Use

If you experience symptoms such as fever, abnormal heartbeats, confusion, excessive sweating, irritability, tremor, muscle stiffness, or flushing, consult your doctor immediately.
Fluoxetine use may cause drowsiness or dizziness. If these effects occur, avoid driving or engaging in activities that require high alertness.
If you have symptoms such as changes in vision, eye pain, or swelling and redness inside or around the eye, consult your doctor.
Concurrent use of fluoxetine with antiplatelet drugs, anticoagulant drugs, or nonsteroidal anti-inflammatory drugs may increase the risk of bleeding. Inform your doctor if you are using the mentioned drugs.
In older patients, especially with long-term use of fluoxetine, there is an increased risk of bone fractures. Therefore, during treatment with fluoxetine, take extra precautions regarding bone injuries.
Fluoxetine may lower blood sodium levels, especially in older patients. This condition is reversible by discontinuing the drug. If you experience symptoms such as headache, concentration and memory impairment, confusion, or weakness, consult your doctor.
Fluoxetine use requires more caution in patients with hepatic and renal insufficiency or those with a history of seizures. If you have a history of any of these conditions, inform your doctor.

Use of Fluoxetine During Pregnancy and Breastfeeding
Consult your doctor or pharmacist before using fluoxetine during pregnancy or breastfeeding.
Consult your doctor or pharmacist about using fluoxetine during the last trimester of pregnancy.

Side Effects of Fluoxetine
Alongside its therapeutic effects, every drug may cause some unwanted side effects; however, these side effects do not occur in all individuals. Some potential side effects of this drug include:

Dizziness, headache, weakness, and fatigue
Dry mouth
Frequent urination
Reduced heart rate
Sexual dysfunction
Weight changes
Excessive sweating

Drug Interactions with Fluoxetine
Consult your doctor or pharmacist about using fluoxetine with other drugs or supplements.

Packaging of Miraser®
Each pack contains 100 tablets (10 blisters of 10 tablets each).

Storage Conditions of Miraser®

Store the drug at temperatures below 30 degrees Celsius, away from light and moisture.
The drug is usable until the expiration date mentioned on the packaging. Do not use or store expired drugs.
Keep the drug out of children's reach.
Do not remove the drug from the original packaging until use.

References

Fluoxetine: Drug information, UpToDate 2025
https://www.medicines.org.uk/emc/product/15561/smpc