DEMETRIN Tablet Ref.[50581] Active ingredients: Prazepam

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa Tel: +27(0)11 320 6000 / 0860 734 937 (Toll-free South Africa)

Product name and form

DEMETRIN 10 mg Tablet.

Pharmaceutical Form

Tablets.

A white, slightly convex tablet with a bisecting score on one side.

Qualitative and quantitative composition

Each tablet contains 10 mg of prazepam.

Contains sugar (lactose monohydrate).

Excipients with known effect: Each tablet contains 93,73 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Prazepam

Prazepam is a benzodiazepine derivative and has depressant effects on the central nervous system. Benzodiazepines act at the level of the limbic, thalamic, and hypothalamic regions of the CNS and can produce any level of CNS depression required including sedation, hypnosis, skeletal muscle relaxation, and anticonvulsant activity.

List of Excipients

Maize starch
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Silica colloidal anhydrous

Pack sizes and marketing

Clear PVC/Aluminium foil blisters of 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa
Tel: +27(0)11 320 6000 / 0860 734 937 (Toll-free South Africa)

Marketing authorization dates and numbers

G/2.6/188

Date of first autorisation: 12 November 1975

Drugs

Drug Countries
DEMETRIN Germany, South Africa

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