Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, United Kingdom
PALEXIA SR 50 mg prolonged-release tablets.
PALEXIA SR 100 mg prolonged-release tablets.
PALEXIA SR 150 mg prolonged-release tablets.
PALEXIA SR 200 mg prolonged-release tablets.
PALEXIA SR 250 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. 50 mg: White film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H1” on the other side. 100 mg: Pale yellow film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H2” on the other side. 150 mg: Pale pink film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H3” on the other side. 200 mg: Pale orange film-coated oblong shaped tablets (7 mm x 17 mm) marked with Grünenthal logo on one side and “H4” on the other side. 250 mg: Brownish red film-coated oblong shaped tablets (7 mm x 17 mm) marked with Grünenthal logo on one side and “H5” on the other side. |
Each prolonged-release tablet contains 50 mg tapentadol (as hydrochloride).
Each prolonged-release tablet contains 100 mg tapentadol (as hydrochloride).
Each prolonged-release tablet contains 150 mg tapentadol (as hydrochloride).
Each prolonged-release tablet contains 200 mg tapentadol (as hydrochloride).
Each prolonged-release tablet contains 250 mg tapentadol (as hydrochloride).
Excipient(s) with known effect:
PALEXIA SR 50 mg contains 3.026 mg lactose.
PALEXIA SR 100 mg contains 3.026 mg lactose.
PALEXIA SR 150 mg contains 3.026 mg lactose.
PALEXIA SR 200 mg contains 3.026 mg lactose.
PALEXIA SR 250 mg contains 3.026 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tapentadol |
Tapentadol is a strong analgesic with µ-agonistic opioid and additional noradrenaline reuptake inhibition properties. Tapentadol exerts its analgesic effects directly without a pharmacologically active metabolite. |
| List of Excipients |
|---|
|
Tablet core (all doses): Hypromellose Tablet coat: Hypromellose |
PVC/PVDC-aluminium/paper/PET blisters: Packs with 7, 10, 14, 20, 24, 28, 30, 40, 50, 54, 56, 60, 90, 100 prolonged-release tablets.
PVC/PVDC aluminium/paper/PET perforated unit-dose blisters: Packs with 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, United Kingdom
PALEXIA SR 50 mg prolonged-release tablets: PL 21727/0041
PALEXIA SR 100 mg prolonged-release tablets: PL 21727/0042
PALEXIA SR 150 mg prolonged-release tablets: PL 21727/0043
PALEXIA SR 200 mg prolonged-release tablets: PL 21727/0044
PALEXIA SR 250 mg prolonged-release tablets: PL 21727/0045
04 February 2011
| Drug | Countries | |
|---|---|---|
| PALEXIA | Austria, Australia, Cyprus, Estonia, Spain, Croatia, Ireland, Lithuania, Malta, Mexico, Netherlands, Poland, United Kingdom, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
