TRIMIPRAMINE Film-coated tablet Ref.[9774] Active ingredients:

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Product name and form

Trimipramine 10mg Tablets.

Pharmaceutical Form

Film-coated tablet.

White to pale yellow, circular, biconvex, film coated tablet, embossed ‘TM’ above ‘10’ on one side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide the dose.

Qualitative and quantitative composition

Each tablet contains 14mg of trimipramine maleate equivalent to 10mg of trimipramine.

For a full list of excipients, see section 6.1.

List of Excipients

Tablet Core:

Calcium hydrogen phosphate
Starch potato
Magnesium stearate
Talc

Tablet Coat (Opadry OY-L-28900):

Lactose monohydrate
Hypromellose
Titanium dioxide
Macrogol 4000

Pack sizes and marketing

HDPE bottles or Securitainers of 50 tablets and cartons containing PVDC/coated UPVC/aluminium foil blister packs of 56, 84 or 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 17780/0636

Date of first authorisation: 6 April 1973
Date of latest renewal: 3 May 2002

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