Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**Administration & Dosage:** 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. All indications The recommended dose may be increased or decreased. Doses above 80 mg/day have not been systematically evaluated. Children The use of fluoxetine 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, or in patients where concomitant medication has the potential for interaction with fluoxetine. Withdrawal symptoms seen on discontinuation of fluoxetine Abrupt discontinuation should be avoided. When stopping treatment with Fluxil 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. 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
**Indications:** Adult Depression Fluxil 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 Fluxil is indicated for the reduction of binge-eating and purging activity.
**Contra-indications:** Hypersensitivity to fluoxetine Patients taking monoamine oxidase inhibitor (MAOI) drugs
N06AB03
fluoxetine
Manufacturer Information
ZYFAS PHARMA PTE. LTD.
Delorbis Pharmaceuticals Ltd
Active Ingredients
Documents
Package Inserts
Fluxil Capsule 20mg PI.pdf
Approved: September 19, 2022
