LEXOTAN Tablets (2018)
Product Name and Form
Lexotan 1.5 mg Tablets.
Lexotan 3 mg Tablets.
Lexotan 1.5 mg Tablets
Off-white to slightly yellow, cylindrical, biplane tablets scored on one side and marked Roche 1.5 on reverse.
Lexotan 3 mg Tablets
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.
Lexotan 1.5 mg Tablets:
Lexotan 3 mg Tablets:
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.
Roche Products (Ireland) Limited, 3004 Lake Drive, City West, Naas Road, Dublin 24, Ireland
Date of first authorisation: 31 October 1980
Date of last renewal: 31 October 2010
Lexotan 1.5 mg Tablets: PA 2307/003/001
Lexotan 3 mg Tablets: PA 2307/003/002