FLUVOXAMINE Film-coated tablets (2018)
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Περιεχόμενα
Name of the medicinal product
Fluvoxamine 50mg Film-Coated Tablets.
Qualitative and quantitative composition
Fluvoxamine Maleate 50mg. For a full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white, film coated circular tablets. Upper face FX/50, lower face CP.
Therapeutic indications
Major depressive episode. Obsessive Compulsive Disorder (OCD).
Posology and method of administration
Depression Adults The recommended dose is 100mg daily. Patients should start on 50 or 100mg, given as a single dose in the evening. Dosage should be reviewed and adjusted if necessary within three to four ...
Contraindications
Fluvoxamine tablets are contraindicated in combination with tizanidine and monoamine oxidase inhibitors (MAOIs) (see sections 4.4 and 4.5). Treatment with fluvoxamine can be initiated: two weeks after ...
Special warnings and precautions for use
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents (including tramadol, triptans, linezolid, SSRIs and St. John´s ...
Pregnancy and lactation
Pregnancy Epidemiological data have suggested that the use of Selective Serotonin Reuptake Inhibitors (SSRIs)in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary ...
Effects on ability to drive and use machines
Fluvoxamine up to 150 mg has no or negligible influence on the ability to drive and use machines. It showed no effect on psychomotor skills associated with driving and operating machinery in healthy volunteers. ...
Undesirable effects
Adverse events, observed in clinical studies at frequencies listed below, are often associated with the illness and are not necessarily related to treatment. Frequency estimate: Very common (≥1/10), common ...
Overdose
Symptoms Symptoms include gastro-intestinal complaints (nausea, vomiting and diarrhoea), somnolence and dizziness. Cardiac events (tachycardia, bradycardia, hypotension), liver function disturbances, convulsions, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antidepressants, Selective serotonin reuptake inhibitors ATC code: N06AB08 The mechanism of action of fluvoxamine is thought to be related to selective serotonin re-uptake inhibition ...
Pharmacokinetic properties
Absorption Fluvoxamine is completely absorbed following oral administration. Maximum plasma concentrations occur within 3-8 hours of dosing. The mean absolute bioavailability is 53%, due to first-pass ...
Preclinical safety data
Carcinogenesis and mutagenesis There is no evidence of carcinogenicity or mutagenicity with fluvoxamine. Fertility and reproductive toxicity Animal studies on male and female fertility revealed reduction ...
List of excipients
Mannitol Pregelatinised starch Maize starch Sodium stearyl fumarate Opadry White Y-1-7000 (containing hydroxypropyl methyl cellulose [HPMC], polyethylene glycol [PEG] and E171, titanium oxide)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Do not store above 25°C. Store in the original container.
Nature and contents of container
Blister strip consisting of hard tempered aluminium foil (20 micron) and PVC film (250 micron) containing 30, 60 and 90 tablets in cartons. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K.
Marketing authorization number(s)
PL 29831/0096
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 September 2000 Date of latest renewal: 03 March 2008
Date of revision of the text
30 October 2018
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