MAGRILAN CAPSULE 20 MG

MEDOCHEMIE LTD (CENTRAL FACTORY) (CYPRUS)🇸🇬 Health Sciences Authority

Approval Date: Apr 16, 1991
Approval ID: 287a347b8abb98c7
Company: MEDOCHEMIE LTD (CENTRAL FACTORY) (CYPRUS)
Type: Therapeutic

Approval Details

Approval Id: 287a347b8abb98c7
Drug Name: MAGRILAN CAPSULE 20 MG
Product Name: MAGRILAN CAPSULE 20 MG
Approval Number: SIN05766P
Approval Date: 1991-04-16
Registrant: MEDOCHEMIE SINGAPORE PTE. LTD.
Licence Holder: MEDOCHEMIE SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: CAPSULE
Dosage: 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 Magrilan 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), or in patients where concomitant medication has the potential for interaction with Magrilan (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 Magrilan Abrupt discontinuation should be avoided. When stopping treatment with Magrilan 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.
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Depression Magrilan 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 Magrilan is indicated for the reduction of binge-eating and purging activity. Pre-menstrual Dysphoric Disorder (PMDD) Magrilan 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.
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.
Atc Code: N06AB03
Atc Item Name: fluoxetine
Pharma Manufacturer Name: MEDOCHEMIE SINGAPORE PTE. LTD.
Company Detail Path: /organization/medochemie-singapore-pte-ltd

Active Ingredients

FLUOXETINE HCl 22.4MG EQV FLUOXETINE

20 mg

FLUOXETINE HCl 22.4MG EQV FLUOXETINE

20 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 16, 1991

Approval ID

287a347b8abb98c7

Type

Therapeutic

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