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Amitriptyline Tablets BP 10mg (2011)

Product Name and Form

AMITRIPTYLINE TABLETS BP 10mg.

Pharmaceutical form

Blue film-coated tablets.

Qualitative and Quantitative Composition

Each tablet contains 10mg Amitriptyline Hydrochloride.

List of excipients

The tablets also contain:

Lactose monohydrate
Microcrystalline cellulose (E460)
Maize starch
Colloidal anhydrous silica
Magnesium stearate

The coating contains:

Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Macrogol
Indigo carmine (E132)

Pack sizes and Marketing

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.

Container pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Blister pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 98s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Marketing authorization holder
Authorization dates

Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon EX32 8NS
UK

17.4.84

Renewed: 29.10.02

Marketing authorization number:

PL 0142/0176