Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Nitrazepam 5mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White, circular, flat bevelled-edge uncoated tablets impressed “C” and the identifying letters “NA” on either side of a central division line on one face. |
Each tablet contains 5mg of nitrazepam.
Excipients with known effect: Each tablet contains 504.17mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Nitrazepam |
Nitrazepam is a benzodiazepine compound with sedative properties. It acts in 30 to 60 minutes to produce sleep lasting 6 to 8 hours. |
| List of Excipients |
|---|
|
Lactose |
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad 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:
Pack sizes: 28’s, 30’s, 56’s, 60’s, 84’s, 90’s, 100’s, 112’s, 168’s, 180’s, 250’s, 500’s, 1000’s.
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: 25,000.
Not all pack sizes may be marketed.
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
PL 0142/0086
September 1977
September 1997
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