TEMAZEPAM Uncoated tablet Ref.[7938] Active ingredients: Temazepam

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

Temazepam Tablets 10mg.

Pharmaceutical Form
White to off-white uncoated tablets.

Qualitative and quantitative composition

Each tablet contains 10mg Temazepam PhEur.

Excipient with known effect: Each 10mg tablet contains 141.10mg lactose PhEur.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Temazepam	Temazepam is a benzodiazepine with hypnotic and sedative effects as well as anxiolytic activity. Temazepam effects are likely to be due to potentiation of gamma-aminobutyric acid (GABA), although other neurotransmitters may also be affected.

List of Excipients
Lactose Magnesium stearate Maize starch Povidone Colloidal silica

Pack sizes and marketing

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

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

Carton: Printed carton manufactured from white folding box board.
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 or:
Blister pack: 250µm white PVC/60g/m² PVdC with 20µm aluminium foil

Pack sizes: 7s, 21s, 28s, 30s, 50s, 56s, 60s, 84s, 100s, 112s, 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.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 00142/0363

Date of first authorization: 3^rd January 1995

Date of latest renewal: 5^th October 2005

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