LOPRAZOLAM Tablets Ref.[9823] Active ingredients: Loprazolam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Product name and form

Loprazolam 1mg Tablets.

Dormonoct.

Pharmaceutical Form

Light yellow, biconvex, round tablets, 7mm in diameter marked with an ‘A’ and ‘026’ separated by a score line on one side. The other side is blank.

Qualitative and quantitative composition

Each tablet contains loprazolam mesylate equivalent to 1mg loprazolam.

For the full list of excipients, see section 6.1.

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

Povidone
Lactose
Colloidal silicon dioxide
Maize starch
Microcrystalline cellulose
Magnesium stearate

Pack sizes and marketing

UPVC/aluminium foil blisters, packaged in cartons of 10, 28 or 30 tablets.

Marketing authorization holder

Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Marketing authorization dates and numbers

PL 17780/0306

17 March 2009

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