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 50 mg film-coated tablets.
PALEXIA 75 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). 50mg: White round shaped film-coated tablets of 7 mm diameter, marked with Grünenthal logo on one side and “H6” on the other side. 75mg: Pale yellow round shaped film-coated tablets of 8 mm diameter, marked with Grünenthal logo on one side and “H7” on the other side. |
Each film-coated tablet contains 50 mg tapentadol (as hydrochloride).
Each film-coated tablet contains 75 mg tapentadol (as hydrochloride).
Excipient(s) with known effect:
PALEXIA 50 mg contains 24.74 mg lactose.
PALEXIA 75 mg contains 37.11 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): Microcrystalline cellulose Tablet coat (All doses): Polyvinylalcohol Tablet coat 75mg: Yellow iron oxide (E172) |
PVC/PVDC aluminium blisters: Packs with 5, 10, 14, 20, 24, 28, 30, 40, 50, 54, 56, 60, 90, 100 film-coated tablets.
PVC/PVDC aluminium perforated unit-dose blisters: Packs with 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 100x1 film-coated 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 50 mg film-coated tablets: PL 21727/0032
PALEXIA 75 mg film-coated tablets: PL 21727/0033
04 February 2011
| Drug | Countries | |
|---|---|---|
| PALEXIA | Austria, Australia, Cyprus, Estonia, Spain, Croatia, Ireland, Lithuania, Malta, Mexico, Netherlands, Poland, United Kingdom, South Africa |
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