FLUVOXAMINE Film-coated tablets Ref.[7257] Active ingredients: Fluvoxamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K.

Product name and form

Fluvoxamine 50mg Film-Coated Tablets.

Pharmaceutical Form

Tablet.

White to off-white, film coated circular tablets. Upper face FX/50, lower face CP.

Qualitative and quantitative composition

Fluvoxamine Maleate 50mg.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Fluvoxamine

The mechanism of action of fluvoxamine is thought to be related to selective serotonin re-uptake inhibition in brain neurones. There is minimum interference with noradrenergic processes. Receptor binding studies have demonstrated that fluvoxamine has negligible binding capacity to alpha adrenergic, beta adrenergic, histaminergic, muscarine cholinergic, dopaminergic or serotonergic receptors.

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)

Pack sizes and marketing

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.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K.

Marketing authorization dates and numbers

PL 29831/0096

Date of first authorisation: 18 September 2000
Date of latest renewal: 03 March 2008

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