NITREDON Tablet Ref.[28291] Active ingredients: Nitrazepam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Nitredon 5 mg tablets.

Pharmaceutical Form

Tablet.

White, round, flat scored tablets.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 5 mg nitrazepam.

Excipient(s) with known effect: This product contains 69 mg lactose.

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

Microcrystalline cellulose
Lactose monohydrate
Pregelatinized starch
Magnesium stearate
Colloidal silicon dioxide
Talc
Maize starch
Povidone

Pack sizes and marketing

PVC/Aluminium blisters. Pack-sizes of 10, 40, 1000 tablets.

PP containers with PE closure. Pack-sizes of 30, 500, 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

19885

Date of first authorisation: 13 December 2005
Date of latest renewal: 06 July 2012

Drugs

Drug Countries
NITREDON Cyprus, Hong Kong, Malta

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