PALEXIA Film-coated tablet Ref.[8093] Active ingredients: Tapentadol

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

Product name and form

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.

Qualitative and quantitative composition

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
Lactose monohydrate
Croscarmellose sodium
Povidone K30
Magnesium stearate

Tablet coat (All doses):

Polyvinylalcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Tablet coat 75mg:

Yellow iron oxide (E172)
Red iron oxide (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, United Kingdom

Marketing authorization dates and numbers

PALEXIA 50 mg film-coated tablets: PL 21727/0032

PALEXIA 75 mg film-coated tablets: PL 21727/0033

04 February 2011

Drugs

Drug Countries
PALEXIA Austria, Australia, Cyprus, Estonia, Spain, Ireland, Lithuania, Malta, Mexico, Netherlands, Poland, United Kingdom, South Africa

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