MOLIPAXIN Capsule Ref.[49991] Active ingredients: Trazodone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Trading as: Zentiva, 12 New Fetter Lane, London EC4A 1JP, United Kingdom

Product name and form

Molipaxin 50 mg Capsules/Trazodone hydrochloride 50 mg Capsules.

Pharmaceutical Form

Capsules.

Qualitative and quantitative composition

Trazodone hydrochloride 50 mg per capsule.

Excipients with known effect: Each tablet contains 78.3 mg lactose.

For a full list of excipients, see 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

Lactose
Magnesium stearate
Gelatin
Titanium dioxide E171
Erythrosine E127
Indigo carmine E132
Yellow iron oxide E172
Ink (black iron oxide E172, shellac, propylene glycol and ammonium hydroxide (pH adjustment) or black iron oxide E172, shellac, propylene glycol, strong ammonia solution (pH adjustment) and potassium hydroxide (pH adjustment))

Pack sizes and marketing

  • Amber glass bottles with jay-cap closures: contents 100 capsules.
  • PVdC coated 250μm PVC blisters sealed with 20μm aluminium foil: contents 84 and 100 capsules.
  • Securitainers: contents 1000 capsules.

Marketing authorization holder

Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Trading as: Zentiva, 12 New Fetter Lane, London EC4A 1JP, United Kingdom

Marketing authorization dates and numbers

PL 17780/0617

13/05/1999

Drugs

Drug Countries
MOLIPAXIN Ireland, Malta, United Kingdom, South Africa
 
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