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AMITRIPTYLINE Film-coated tablets (2018)

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.

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
Authorization Dates

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

26th April 2005

Marketing authorization number:

PL 20075/0035