DIAZEPAM Rectal solution

Active ingredients: Diazepam

Product name and form

Diazepam RecTubes 10mg Rectal Solution.

Pharmaceutical Form

Rectal solution.

A clear, colourless or almost yellow solution.

Qualitative and quantitative composition

Diazepam Ph Eur 10mg in 2.5ml (4mg/ml).

Excipients: each 2.5ml dose contains Benzoic acid (E210) 2.5mg, Sodium benzoate (E211) 122.5mg and Propylene glycol 1000mg.

For the full list of excipients, see section 6.1.

Active Ingredient

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

Benzyl alcohol
Ethanol 96%
Propylene glycol
Benzoic acid
Sodium benzoate
Purified Water

Pack sizes and marketing

Packs of 2 or 5 rectal tubes each containing 2.5ml of solution

The tubes are made of low-density polyethylene. The tubes have a nozzle attached for application. Each tube is individually presented in a foil wrap and placed in an outer carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Marketing authorization dates and numbers

PL 29831/0066