DALMANE Capsule Ref.[9825] Active ingredients: Flurazepam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Dalmane 15 mg Capsules.

Pharmaceutical Form

Dalmane capsules 15 mg.

Qualitative and quantitative composition

Capsules with opaque grey cap and opaque yellow body with “ICN 15” printed in red on both cap and body, containing 16.4 mg flurazepam monohydrochloride (equivalent to 15 mg flurazepam).

Each capsule contains 114.6 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Flurazepam

Flurazepam is a psychotropic substance from the class of 1,4-benzodiazepines. Flurazepam binds to specific benzodiazepine receptors located on GABA-ergic neurones and potentiates the inhibitory actions of GABA-ergic neurones in the nervous system. Flurazepam is used as a short-term treatment of insomnia.

List of Excipients

15 mg capsules contain the following excipients:

Lactose
Talc purified
Magnesium stearate
Black iron oxide E172
Titanium dioxide E171
Yellow iron oxide E172

Pack sizes and marketing

PVDC blister packs, amber glass bottles, polythene bags in tins, plastic adept containers, white securitainers and small HDPE bottles, containing 30 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0125

03/05/1999

Drugs

Drug Countries
DALMANE Ireland, Malta, United Kingdom

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