Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH, Hoofddorp, The Netherlands
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. |
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 |
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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 |
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.
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH, Hoofddorp, The Netherlands
PL 31750/0043
30/03/2015
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