LIBRIUM Capsule Ref.[49793] Active ingredients: Chlordiazepoxide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Librium 5mg Capsules.

Pharmaceutical Form

Librium Capsules 5 mg.

Qualitative and quantitative composition

Each 5mg capsule contains 5mg of the active ingredient chlordiazepoxide hydrochloride BP.

Each capsule contains 105.9 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Chlordiazepoxide

Chlordiazepoxide has anxiolytic and central muscle relaxant properties. It has little autonomic activity. Chlordiazepoxide acts as depressant of the central nervous system producing all levels of CNS depression, from mild sedation to hypnosis, to coma depending on the dose.

List of Excipients

5mg capsules contain the following excipients:

Gelatine
Starch maize white
Talc purified
Lactose
Yellow iron oxide E172
Indigo carmine E132
Titanium dioxide E171
Quinoline yellow E104
Erythrosine E127

Pack sizes and marketing

PVDC Blister pack container 10 capsules.

HDPE bottle with jay-cap (snap-fit) closure containing 100 capsules.

Plastic bottle with screw cap containing 100 capsules.

Amber glass bottle with screw cap containing 100 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 46302/0175

1 March 1998 / 18 March 2003

Drugs

Drug Countries
LIBRIUM Germany, Ireland, United Kingdom, South Africa

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