Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
ISOSORBIDE DINITRATE TABLETS BP 10mg.
| Pharmaceutical Form |
|---|
|
White to off-white uncoated tablets. White to off-white, circular, flat bevelled-edge uncoated tablets impressed “C” on one face and the identifying code “IT” and “10” on either side of a central division line on the reverse. |
Each tablet contains 10mg Isosorbide Dinitrate PhEur.
| Active Ingredient | Description | |
|---|---|---|
| Isosorbide dinitrate |
Isosorbide dinitrate is an organic nitrate, which in common with other cardioactive nitrates, is a vasodilator. |
| List of Excipients |
|---|
|
Also contains: magnesium stearate, maize starch, lactose, polyvidone. |
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers 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, 56s, 60s, 84s, 90s, 100s, 112s, 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.
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
PL 0142/0321
April 1993
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