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 | Description | |
|---|---|---|
| Buprenorphine |
Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the ÎŒ (mu) and Îș (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the ÎŒ 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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