Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**4.2 Posology and method of Administration** Depression, with or without associated anxiety symptoms Adults and the elderly: A dose of 20 mg/day is recommended Obsessive compulsive disorder Adults and the elderly: 20 mg/day to 60 mg/day. A dose of 20mg/day is recommended as initial dose. Although there may be an increased potential for side effects at higher doses, a dose increase may be considered after several weeks if there is no response. Bulimia Nervosa Adults and the elderly: A dose of 60 mg/day is recommended. Pre-menstrual Dysphoric Disorder (PMDD) A dose of 20mg per day is recommended. Initial treatment should be limited to 6 months, after which patients should be reassessed regarding the benefits of continued therapy. All indications The recommended dose may be increased or decreased. Doses above 80 mg/day have not been systematically evaluated. Children The use of Prozac in children is not recommended, as safety and efficacy have not been established. Hepatic impairment A lower or less frequent dose (e.g. 20mg every second day) should be considered in patients with hepatic impairment (see sections 4.4 and 5.2), or in patients where concomitant medication has the potential for interaction with Prozac (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Withdrawal symptoms seen on discontinuation of Prozac Abrupt discontinuation should be avoided. When stopping treatment with Prozac the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. Method of administration For oral administration, with or without food. When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in mind when starting or stopping treatment.
ORAL
Medical 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.
**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.
N06AB03
fluoxetine
Manufacturer Information
DKSH SINGAPORE PTE. LTD.
Patheon France
Active Ingredients
Documents
Package Inserts
Prozac Capsule PI.pdf
Approved: March 22, 2021