BARACLUDE Film-coated tablets

Active ingredients: Entecavir

Product name and form

Baraclude 0.5 mg film-coated tablets.

Baraclude 1 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Baraclude 0.5 mg film-coated tablets: White to off-white and triangular-shaped tablet with “BMS” debossed on one side and “1611” on the other.

Baraclude 1 mg film-coated tablets: Pink and triangular-shaped tablet with “BMS” debossed on one side and “1612” on the other.

Qualitative and quantitative composition

Baraclude 0.5 mg film-coated tablets: Each tablet contains 0.5 mg entecavir (as monohydrate).

Baraclude 1 mg film-coated tablets: Each tablet contains 1 mg entecavir (as monohydrate).

Excipients with known effect:

Each 0.5 mg film-coated tablet contains 120.5 mg lactose.

Each 1 mg film-coated tablet contains 241 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

╬Ľntecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.

List of Excipients

Baraclude 0.5 mg film-coated tablets:

Tablet core:

Crospovidone
Lactose monohydrate
Magnesium stearate
Cellulose, microcrystalline
Povidone

Tablet coating:

Titanium dioxide
Hypromellose
Macrogol 400
Polysorbate 80 (E433)

Baraclude 1 mg film-coated tablets:

Tablet core:

Crospovidone
Lactose monohydrate
Magnesium stearate
Cellulose, microcrystalline
Povidone

Tablet coating:

Titanium dioxide
Hypromellose
Macrogol 400
Iron oxide red

Pack sizes and marketing

Each carton contains either:

  • 30 × 1 film-coated tablet; 3 blister cards of 10 × 1 film-coated tablet each in Alu/Alu perforated unit dose blisters, or
  • 90 × 1 film-coated tablet; 9 blister cards of 10 × 1 film-coated tablet each in Alu/Alu perforated unit dose blisters.

High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets. Each carton contains one bottle.

Not all pack sizes and container types may be marketed.

Marketing authorization holder

BRISTOL-MYERS SQUIBB PHARMA EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

Marketing authorization dates and numbers

Baraclude 0.5 mg film-coated tablets:

Blister packs:

EU/1/06/343/003
EU/1/06/343/006

Bottle packs:

EU/1/06/343/001

Baraclude 1 mg film-coated tablets:

Blister packs:

EU/1/06/343/004
EU/1/06/343/007

Bottle packs:

EU/1/06/343/002

Date of first authorisation: 26 June 2006
Date of latest renewal: 26 June 2011

Drugs

Drug
Countries
Austria, Brazil, Canada, Cyprus, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, United States