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
- High density polystyrene container with polythene lid and polyurethene/polythene insert. Pack size 100 and 500 Tablets.
- Polypropylene container with polypropylene or polythene lids and polyurethene/polythene insert. Pack size 100 and 500 Tablets.
- 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
PL 20075/0035