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 20 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, colourless solution. pH 3.5 to 4.5 |
1 ml oral solution contains 20 mg tapentadol (as hydrochloride).
Excipients with known effect: PALEXIA 20 mg/ml oral solution contains propylene glycol and sodium.
See section 4.4.
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 |
|---|
|
Citric acid monohydrate |
High density polyethylene (HDPE)-bottles sealed with aluminium foil liner and closed with a high density polyethylene (HDPE)/polypropylene (PP) child-resistant cap.
Each bottle of the oral solution is provided with a dosing pipette and an adapter attached to the dosing pipette.
The scale of the 5 ml dosing pipette is subdivided in 0.1 ml intervals. Additionally, the right scale shows the single doses for adults.
100 ml bottles and 200 ml bottles.
Not all pack sizes may be marketed.
Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, United Kingdom
PL 21727/0054
05/12/2012
| Drug | Countries | |
|---|---|---|
| PALEXIA | Austria, Australia, Cyprus, Estonia, Spain, Croatia, Ireland, Lithuania, Malta, Mexico, Netherlands, Poland, United Kingdom, South Africa |
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