HYPNODORM Film coated tablet Ref.[9829] Active ingredients: Flunitrazepam

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2019  Publisher: Alphapharm Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.mylan.com.au

Product name and form

Flunitrazepam.

Pharmaceutical Form

Flunitrazepam 1 mg tablets: green, oval, normal convex, scored, film coated tablet debossed “FM |1” on one side and “α” on the other.

Qualitative and quantitative composition

Each Hypnodorm tablet contains 1 mg flunitrazepam.

Molecular formula: C16H12FN3O3
Molecular weight: 313.3

Flunitrazepam is a pale yellow crystalline solid, sparingly soluble in water, slightly soluble in alcohol.

Hypnodorm also contains sugars (as lactose and galactose) and trace amounts of sulfites.

Active Ingredient Description
Flunitrazepam

Flunitrazepam is a member of the benzodiazepine group of drugs and is closely related to nitrazepam, flurazepam and clonazepam. It has marked sedative and hypnotic properties with a rapid onset of action and is used in severe cases of insomnia.

List of Excipients

The tablets also contain the following excipients:

Lactose monohydrate
Maize starch
Pregelatinised maize starch
Magnesium stearate
Indigo carmine CI73015
Opadry Green OY-LS-21051

Pack sizes and marketing

Available in HDPE bottles of 30 tablets.

Marketing authorization holder

Alphapharm Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.mylan.com.au

Marketing authorization dates and numbers

04/10/2001

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.