AMITRIPTYLINE Film-coated tablet Ref.[6172] Active ingredients: Amitriptyline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: ACCORD HEALTHCARE LIMITED, SAGE HOUSE, 319 PINNER ROAD, HARROW, MIDDLESEX, HA1 4HG, UNITED KINGDOM

Product name and form

Amitriptyline 25mg Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow coloured, round, biconvex, film-coated tablet plain on both sides.

Qualitative and quantitative composition

Each tablet contains Amitriptyline HCl 25.00mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Amitriptyline

Amitriptyline is a tricyclic antidepressant and an analgesic. It prevents the re-uptake, and hence the inactivation of noradrenaline and serotonin at nerve terminals. Reuptake prevention of these monoamine neurotransmitters potentiate their action in the brain. This appears to be associated with the antidepressant activity.
List of Excipients

Core Tablet:

Lactose Monohydrate
Microcrystalline Cellulose (PH 102)
Maize Starch
Magnesium Stearate
Colloidal Anhydrous silica

Film Coat:

Hydroxy Propyl Methylcellulose
Ethyl Cellulose
Diethyl pthalate
Titanium Dioxide ( E171 )
Lake of Sunset yellow (E 110)
Lake of Quinoline yellow (E 104)
Purified Talc

Pack sizes and marketing

  1. High density polystyrene container with polythene lid and polyurethene/polythene insert. Pack size 100 and 500 Tablets.
  2. Polypropylene container with polypropylene or polythene lids and polyurethene/polythene insert. Pack size 100 and 500 Tablets.
  3. Blister pack of PVC/PVdC – Aluminium, containing 28 tablets.

Not all the pack sizes may be marketed.

Marketing authorization holder

ACCORD HEALTHCARE LIMITED, SAGE HOUSE, 319 PINNER ROAD, HARROW, MIDDLESEX, HA1 4HG, UNITED KINGDOM

Marketing authorization dates and numbers

PL 20075/0035

26th April 2005

 
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