DORMONOCT Tablet Ref.[50616] Active ingredients: Loprazolam

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2019  Publisher: Sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685, South Africa

Product name and form

DORMONOCT 2 mg Tablets.

Pharmaceutical Form

Tablet.

Light yellow, biconvex round tablets. “B” and “026” are engraved and separated by a score line on one side. The other side is neutral.

Qualitative and quantitative composition

Each tablet contains: 2 mg loprazolam as loprazolam mesylate.

Contains sugar (lactose monohydrate): 83,9 mg per tablet.

Active Ingredient Description
Loprazolam

Benzodiazepines have a widespread action as a result of their enhancing the release of gamma-aminobutyric acid (GABA). They are effective as anti-convulsants, muscle relaxants, anti-anxiety agents, pre-medications and sedative hypnotics. Loprazolam is indicated for the short-term treatment of insomnia including difficulty in falling asleep and/or frequent nocturnal awakenings.

List of Excipients

Colloidal anhydrous silica
Lactose monohydrate
Magnesium stearate
Maize starch
Microcrystalline cellulose
Povidone

Pack sizes and marketing

2 mg tablets packed in blister packs of 30’s and 100’s.

Marketing authorization holder

Sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685, South Africa

Marketing authorization dates and numbers

Q/2.2/355

Date registered: 15.01.1984

Drugs

Drug Countries
DORMONOCT Netherlands, South Africa

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