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Lexotan Tablets (2014)

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.

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
Authorization dates

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Date of first authorisation: 31 October 1980

Date of last renewal: 31 October 2010

Marketing authorization number:

Lexotan 1.5 mg Tablets: PA 50/49/1

Lexotan 3 mg Tablets: PA 50/49/2