Basic Information
PROZAC CAPSULE 20 mg
CAPSULE
Regulatory Information
SIN03027P
June 7, 1989
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 4, 2025
XN06AB03
Company Information
Active Ingredients
Strength: 20 mg
Detailed Information
Contraindications
**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information._ _Monoamine Oxidase Inhibitors:_ Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued an SSRI and have been started on a MAOI. Treatment of fluoxetine should only be started 2 weeks after discontinuation of a MAOI. Some cases presented with features resembling serotonin syndrome (which may resemble and be diagnosed as neuroleptic malignant syndrome). Cyproheptadine may benefit patients experiencing such reactions. Symptoms of a drug interaction with a MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma. Therefore, fluoxetine is contraindicated in combination with a MAOI or RIMA or within 14 days of discontinuing treatment with a MAOI or RIMA. Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI or RIMA. If fluoxetine has been prescribed chronically and/or at a high dose, a longer interval should be considered.
Indication Information
**4.1 Therapeutic indications** Depression Prozac is indicated for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms, especially where sedation is not required. Obsessive-compulsive disorder Bulimia nervosa Prozac is indicated for the reduction of binge-eating and purging activity. Pre-menstrual Dysphoric Disorder (PMDD) Prozac is indicated for the treatment of pre-menstrual dysphoric disorder. Diagnosis of PMDD: The essential diagnostic features of PMDD are clear and established cyclicity (occurring during the last week of the luteal phase in most menstrual cycles) of symptoms such as depressed mood, anxiety, affective lability, accompanied by impairment in social and/or occupational function and physical symptoms (such as breast tenderness or swelling, headaches, joint or muscle pain, a sensation of bloating, weight gain) - all of which must be severe. This syndrome should be distinguished from the commoner “pre-menstrual tension (distinguished from PMDD by milder symptoms and less impact on normal activities)” and from any co-existing psychiatric disorder.