MOGADON Tablet Ref.[27521] Active ingredients: Nitrazepam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Mogadon 5 mg Tablets.

Pharmaceutical Form

Tablets.

Round, white tablets with " "

imprinted on one face with a single break bar on the other.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 5 mg of nitrazepam.

There is 301 mg lactose per tablet.

For the full list of excipients, See section 6.1.

Active Ingredient Description
Nitrazepam

Nitrazepam is a benzodiazepine compound with sedative properties. It acts in 30 to 60 minutes to produce sleep lasting 6 to 8 hours.

List of Excipients

Each 5 mg tablet contains the following excipients:

Lactose
Starch maize white
Magnesium stearate

Pack sizes and marketing

HDPE or glass bottles, in packs of 30 or 100.

PVC/Aluminium blister packs, containing 30 or 50 tablets.

Clic-loc containers, in a pack of 10.

Polypropylene mini-kegs, containing 5000 tablets.

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 46302/0135

3 May 1999

Drugs

Drug Countries
MOGADON Austria, Australia, Canada, France, Ireland, Malta, United Kingdom

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