TRAZODONE Film-coated tablet Ref.[7367] Active ingredients: Trazodone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Flamingo Pharma UK Ltd., I<sup>st</sup> floor, Kirkland House, 11-15 Peterborough Road, Harrow, Middlesex, HA12AX, United Kingdom

Product name and form

Trazodone Hydrochloride 150 mg Film-coated Tablets.

Pharmaceutical Form

Film-coated Tablet.

Pink, approx 10 mm round, biconvex film coated tablet debossed with “T” on upper side of breakline and plain on other side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 150mg of Trazodone Hydrochloride.

Excipient(s) with known effect: Each film-coated tablet contains 82.00 mg lactose monohydrate.

For full list of excipients, see section 6.1.

Active Ingredient Description
Trazodone

Trazodone is a potent antidepressant. It also has anxiety reducing activity. Trazodone is a triazolopyridine derivative chemically unrelated to known tricyclic, tetracyclic and other antidepressant agents. It has negligible effect on noradrenaline re-uptake mechanisms.

List of Excipients

Tablet Core:

Lactose Monohydrate
Microcrystalline Cellulose
Calcium Hydrogen Phosphate Dihydrate (E341)
Sodium Starch Glycolate Type A
Povidone (PVP-K30)
Purified Water
Colloidal Anhydrous Silica
Magnesium Stearate

Film-coating:

Instacoat Sol IC-S-5585 Peach which contains:

Hypromellose
Polyethylene glycol
Talc
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide yellow (E172)

Pack sizes and marketing

Trazodone Hydrochloride Tablets are available in blisters of Aluminium-PVC/PVDC White Opaque Film containing packs of 20’s, 28’s, 30’s, 56’s, 84’s and 100’s along with leaflet inside.

Not all pack sizes may be marketed.

Trazodone Hydrochloride Tablets are available in white opaque HDPE bottle with white polypropylene child resistant cap containing packs of 100, 250 and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Flamingo Pharma UK Ltd., Ist floor, Kirkland House, 11-15 Peterborough Road, Harrow, Middlesex, HA12AX, United Kingdom

Marketing authorization dates and numbers

PL 43461/0033

26/06/2018

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