Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
IMIPRAMINE TABLETS BP 10mg.
| Pharmaceutical Form |
|---|
|
Sugar-coated tablet. Red, circular, biconvex, sugar-coated tablets, nominal diameter 5.9mm. |
Each tablet contains 10mg Imipramine Hydrochloride PhEur.
For excipients, see 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Imipramine |
Imipramine is a tricyclic antidepressant and has several pharmacological actions including alpha-adrenolytic, antihistamine, anticholinergic and 5HT-receptor blocking properties. However, the main therapeutic activity is believed to be inhibition of the neuronal re-uptake of noradrenaline and 5HT. Imipramine is a so-called “mixed” re-uptake blocker, i.e. it inhibits the reuptake of NA and 5HT to about the same extent. |
| List of Excipients |
|---|
|
Also contains: Carnauba wax |
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.
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 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.
Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 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.
Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
PL 0142/0067 R
13.1.82
(Product Licence of Right issued: 06.02.73)
Renewed: 13.1.87; 17.9.92; 16.9.97
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