Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Nemdatine 5 mg film-coated tablets.
Nemdatine 10 mg film-coated tablets.
Nemdatine 15 mg film-coated tablets.
Nemdatine 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Nemdatine 5 mg film-coated tablets: White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side. Nemdatine 10 mg film-coated tablets: White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in size, with score line and the marking “M10” engraved on the scored side. The tablet can be divided into equal doses. Nemdatine 15 mg film-coated tablets: Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side. Nemdatine 20 mg film-coated tablets: Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side. |
Nemdatine 5 mg: Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Nemdatine 10 mg: Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Nemdatine 15 mg: Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Nemdatine 20 mg: Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Excipient(s) with known effect:
Nemdatine 5 mg film-coated tablets: Each film-coated tablet contains 0.47 mg lactose monohydrate.
Nemdatine 10 mg film-coated tablets: Each film-coated tablet contains 0.95 mg lactose monohydrate.
Nemdatine 15 mg film-coated tablets: Each film-coated tablet contains 1.42 mg lactose monohydrate.
Nemdatine 20 mg film-coated tablets: Each film-coated tablet contains 1.89 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Memantine |
Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist. It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction. |
| List of Excipients |
|---|
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Tablet cores for 5, 10, 15 and 20 mg film-coated tablets: Microcrystalline cellulose Tablet coat for 5, 10, 15 and 20 mg film-coated tablets: Hypromellose 6cP Additional for 15 mg film-coated tablets: Iron oxide yellow, red and black (E172) Additional for 20 mg film-coated tablets: Iron oxide red and yellow (E172) |
PVC/PVDC-Aluminium blisters.
Nemdatine 10 mg and 20 mg film-coated tablets: HDPE bottle.
Nemdatine 5 mg film-coated tablets:
Blister packs: 42 and 98 film-coated tablets.
Nemdatine 10 mg film-coated tablets:
Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets.
HDPE bottle: 100 film-coated tablets.
Nemdatine 15 mg film-coated tablets:
Blister packs: 7, 42 and 98 film-coated tablets.
Nemdatine 20 mg film-coated tablets:
Blister packs: 28, 42, 56 and 98 film-coated tablets.
HDPE bottle: 100 film-coated tablets.
Not all pack sizes may be marketed.
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
EU/1/13/824/001
EU/1/13/824/002
EU/1/13/824/003
EU/1/13/824/004
EU/1/13/824/005
EU/1/13/824/006
EU/1/13/824/007
EU/1/13/824/008
EU/1/13/824/009
EU/1/13/824/010
EU/1/13/824/019
EU/1/13/824/011
EU/1/13/824/012
EU/1/13/824/013
EU/1/13/824/014
EU/1/13/824/015
EU/1/13/824/016
EU/1/13/824/017
EU/1/13/824/020
Date of first authorisation: 22 April 2013
| Drug | Countries | |
|---|---|---|
| NEMDATINE | Austria, Cyprus, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore |
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