What YANTIL Retard contains
The active substance is tapentadol.
Each tablet contains 50 mg tapentadol (as hydrochloride).
Each tablet contains 100 mg tapentadol (as hydrochloride).
Each tablet contains 150 mg tapentadol (as hydrochloride).
Each tablet contains 200 mg tapentadol (as hydrochloride).
Each tablet contains 250 mg tapentadol (as hydrochloride).
The other ingredients are:
[50 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171).
[100 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172).
[150 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).
Tapentadol 50 mg, 100 mg 150 mg, 200 mg, 250 mg prolonged-release tablets | Jun 2013 |
EU Master PIL | Version: 11.0 |
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[200 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).
[250 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172), black iron oxide (E 172).
What YANTIL Retard looks like and contents of the pack
[50 mg]: White film-coated oblong shaped prolonged-release 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 prolonged-release 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 prolonged-release 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 prolonged-release 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 prolonged-release tablets (7 mm x 17 mm) marked with
Grünenthal logo on one side and “H5” on the other side.
YANTIL Retard prolonged-release tablets are packed in blisters and are supplied in boxes of 7, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Grünenthal B.V., De Corridor 21K, 3621 ZA Breukelen.
Manufacturer:
Grünenthal GmbH, Zieglerstrasse 6, D-52078 Aachen, Germany.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Germany, Luxembourg, Netherlands, Portugal, Spain: YANTIL retard Denmark, Finland, Norway, Sweden: YANTIL Depot
Ireland, United Kingdom: YANTIL SR
France: YANTIL LP
Italy: YANTIL
This leaflet was last approved in August 2013.