Leaflet PROZAC 20mg dispersible tablets

Indicated for: depression

Route of administration: oral

Substance: fluoxetine (selective serotonin reuptake inhibitor)

ATC: N06AB03 (Nervous system | Antidepressants | Selective serotonin reuptake inhibitors)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Suicidal ideation / mental changes
Suicidal ideation / mental changes

Seek medical help if suicidal thoughts or major behavior changes occur.

Withdrawal / do not stop abruptly
Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Fluoxetine is an antidepressant medication from the selective serotonin reuptake inhibitor (SSRI) class, used to treat depression, obsessive-compulsive disorder, anxiety, and bulimia nervosa. It works by increasing serotonin levels in the brain, improving mood and reducing symptoms associated with these conditions.

Fluoxetine is taken orally, usually once a day at the same time, with or without food, as directed by your doctor. The therapeutic effect may appear after several weeks of treatment, and abrupt discontinuation is not recommended without medical advice.

Common side effects include nausea, insomnia, fatigue, dry mouth, or dizziness. Rarely, more serious reactions such as suicidal thoughts, seizures, or severe allergic reactions may occur. If you notice behavioral changes or unusual reactions, contact your doctor immediately.

Fluoxetine is effective in alleviating symptoms of depression and other disorders, but requires careful monitoring and adherence to medical instructions to ensure the safety and effectiveness of the treatment.

General data about PROZAC 20mg

  • Substance: fluoxetine
  • Date of latest medicines list: 01-06-2026
  • Product code: W10228001
  • Concentration: 20mg
  • Pharmaceutical form: dispersible tablets
  • Quantity: 28
  • Product type: Original
  • Price: 92.63 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PATHEON FRANCE - FRANTA
  • Holder: ELI LILLY SA - SPANIA
  • Number: 11794/2019/02
  • Shelf life: 2 years

Pharmaceutical forms available for fluoxetine

Concentrations available for fluoxetine

  • 10mg
  • 20mg

Compensation lists for PROZAC 20mg Eli Lilly

A - Sublist A with 90% discount from the reference price

Price

Copayment

Patient

92.63 RON

13.92 RON

78.71 RON