DIAZEPAM Uncoated tablets

Active ingredients: Diazepam

Product name and form

DIAZEPAM TABLETS BP 10mg.

Pharmaceutical Form

Blue uncoated tablets.

Qualitative and quantitative composition

Each tablet contains 10mg Diazepam Ph.Eur.

Excipient with known effect: Each tablet contains 147.00mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Diazepam is a psychotropic substance from the class of 1,4-benzodiazepines with marked properties of suppression of tension, agitation and anxiety as well as sedative and hypnotic effects. In addition, diazepam demonstrates muscle relaxant and anticonvulsive properties. It is used in the short-term treatment of anxiety and tension states, as a sedative and premedicant, in the control of muscle spasm and in the management of alcohol withdrawal symptoms.

List of Excipients

Also contains:

Lactose
Magnesium stearate
Maize starch
Stearic acid
E132

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and press fit 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 in 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 5-8g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack size: 7, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500, 1000.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00142/0089

Date of first authorization: 15 July 1977
Date of latest renewal: 06 September 2004