BUPRENORPHINE Sublingual tablet

Active ingredients: Buprenorphine

Product name and form

Buprenorphine 2 mg sublingual tablets.

Pharmaceutical Form

Sublingual tablet.

2 mg tablet: White to off-white, round, biconvex uncoated sublingual tablet debossed with “2” on one side and plain on the other side.

Qualitative and quantitative composition

Buprenorphine 2mg: each tablet contains 2.16mg buprenorphine hydrochloride equivalent to 2mg buprenorphine.

Excipients with known effect: Each tablet contains 29.85mg of lactose monohydrate and 0.25mg of butylhydroxyanisole (E320).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the μ (mu) and κ (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the μ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence.

List of Excipients

Lactose monohydrate
Mannitol
Citric acid anhydrous
Sodium citrate dihydrate
Povidone K30
Butylhydroxyanisole (E320)
Maize starch
Maize starch pregelatinised
Magnesium stearate

Pack sizes and marketing

Blister consists of PVC, PVDC, aluminium and heat seal lacquer lidding foil.

Pack size: 7 and 28 sublingual tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH, Hoofddorp, The Netherlands

Marketing authorization dates and numbers

PL 31750/0043

30/03/2015