LEXOTAN Tablet

Active ingredients: Bromazepam

Product name and form

Lexotan 1.5 mg Tablets.
Lexotan 3 mg Tablets.

Pharmaceutical Form

Lexotan 1.5 mg Tablets

Tablet.

Off-white to slightly yellow, cylindrical, biplane tablets scored on one side and marked Roche 1.5 on reverse.

Lexotan 3 mg Tablets

Tablet.

Pale red, slightly speckled, cylindrical, biplane tablets scored on one side and marked Roche 3 on reverse.

The tablets can be divided into equal doses.

Qualitative and quantitative composition

Lexotan 1.5 mg Tablets

Each tablet contains 1.5 mg bromazepam.

Excipients: Also contains 96.1 mg lactose monohydrate.

Lexotan 3 mg Tablets

Each tablet contains 3 mg bromazepam.

Excipients: Also contains 94.4 mg lactose monohydrate.

Excipient(s) with known effect: For the full list of excipients, see section 6.1.

Active Ingredient
Description

Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties.

List of Excipients

Lexotan 1.5 mg Tablets:

Microcrystalline cellulose
Lactose monohydrate
Magnesium stearate
Talc

Lexotan 3 mg Tablets:

Microcrystalline cellulose
Lactose monohydrate
Magnesium stearate
Talc
Iron oxide red (E172)

Pack sizes and marketing

PVDC blister packs of 4, 10, 20, 60 or 100 tablets.
HDPE bottles of 100 tablets.
PVC blister packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Roche Products (Ireland) Limited, 3004 Lake Drive, City West, Naas Road, Dublin 24, Ireland

Marketing authorization dates and numbers

Lexotan 1.5 mg Tablets: PA 2307/003/001
Lexotan 3 mg Tablets: PA 2307/003/002

Date of first authorisation: 31 October 1980
Date of last renewal: 31 October 2010

Drugs

Drug
Countries
Australia, Brazil, Hong Kong, Ireland, Singapore