NEMDATINE Film-coated tablets Ref.[6963] Active ingredients: Memantine

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Product name and form

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.

Qualitative and quantitative composition

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

Tablet cores for 5, 10, 15 and 20 mg film-coated tablets:

Microcrystalline cellulose
Crospovidone Type A
Talc
Magnesium stearate

Tablet coat for 5, 10, 15 and 20 mg film-coated tablets:

Hypromellose 6cP
Titanium dioxide (E171)
Lactose monohydrate
Macrogol 3350
Triacetin

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)

Pack sizes and marketing

PVC/PVDC-Aluminium blisters.

Nemdatine 10 mg and 20 mg film-coated tablets: HDPE bottle.

Pack sizes

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.

Marketing authorization holder

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Marketing authorization dates and numbers

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

Drugs

Drug Countries
NEMDATINE Austria, Cyprus, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore

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