natgillin/translations-raw huggingface dataset:
In patients with mildly impaired renal function (creatinine clearance 50 − 80 ml/min) no dose adjustment is required. 
Ledvična okvara Pri bolnikih z blago okvaro ledvičnega delovanja (kreatininski očistek 50 − 80 ml/min) prilagoditev odmerka ni potrebna.
Day 15, 16, 17, 18, 19, 20, 21 
Teden 3 Dan 15, 16, 17, 18, 19, 20, 21
What is Nemdatine used for Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer's disease. 
Zdravilo Nemdatine uporabljamo za zdravljenje odraslih bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets. 
Pretisni omoti: 28, 30, 42, 50, 56, 60, 98 in 112 filmsko obloženih tablet.
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p = 0.025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002). 
Po 6-mesečni monoterapiji z memantinom se je pri opazovanih bolnikih pokazalo izboljšanje v primerjavi s placebom (analiza opazovanih primerov po lestvici CIBIC-plus (vtis sprememb na podlagi kliničnega intervjuja, angl. clinician's interview based impression of change), p = 0,025; lestvici ADCS-ADLsev (vprašalnik vsakodnevnih aktivnosti, angl. Alzheimer's disease cooperative study - activities of daily living), p = 0,003; testi po SIB (sklop testov za hudo prizadetost, angl. severe impairment battery), p = 0,002).
The 20 mg tablets furthermore contain iron oxide red and yellow (E172). 
20 mg tablete vsebujejo tudi rdeči in rumeni železov oksid (E172).
Day 22, 23, 24, 25, 26, 27, 28 
Teden 4 Dan 22, 23, 24, 25, 26, 27, 28
There are no or limited amount of data from the use of memantine in pregnant women. 
Nosečnost Podatkov o uporabi memantina pri nosečnicah ni oziroma so omejeni.
Each tablet contains 5, 10, 15 or 20 mg of memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 16.62 mg memantine. 
Ena filmsko obložena tableta vsebuje 5, 10, 15 ali 20 mg memantinijevega klorida, kar ustreza 4,15, 8,31, 12,46 ali 16,62 mg memantina.
Uncommon Confusion Uncommon Hallucinations1 
Občasni halucinacije1
Day 8, 9, 10, 11, 12, 13, 14 
Teden 2 Dan 8, 9, 10, 11, 12, 13, 14
A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients. 
Temeljna študija memantina v monoterapiji pri zdravljenju bolnikov z blago do zmerno Alzheimerjevo boleznijo (skupna ocena pri KPSS ob vključitvi od 10 do 22 točk) je zajela 403 bolnike.
In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg per day. 
Pri bolnikih s hudo okvaro ledvičnega delovanja (kreatininski očistek 5 − 29 ml/min) naj bo dnevni odmerek 10 mg.
Breast-feeding Women taking Nemdatine should not breast-feed. 
Dojenje Ženske, ki jemljejo zdravilo Nemdatine, ne smejo dojiti.
This is increased to 10 mg memantine in the second week and to 15 mg memantine once a day in the third week. 
V drugem tednu povišamo odmerek na 10 mg memantina enkrat dnevno in na 15 mg memantina enkrat dnevno v tretjem tednu.
In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly higher than at human exposure. 
Pri podganah so pri odmerkih, ki so bili primerljivi ali malo večji kot pri ljudeh, ugotovili zmanjšano rast ploda.
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
- The other ingredients for Nemdatine 5, 10, 15 and 20 mg film-coated tablets are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. 
- Druge pomožne snovi za Nemdatine 5, 10, 15 in 20 mg filmsko obložene tablete so: Jedro tablete: mikrokristalna celuloza, krospovidon Tipa A, smukec in magnezijev stearat.
Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate. 
Prav tako Nemdatine lahko vpliva na vašo sposobnost odzivanja, zato se vožnja in upravljanje strojev ne priporoča.
HDPE bottle: 100 film-coated tablets. 
Plastenka HDPE: 100 filmsko obloženih tablet.
28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 98 film-coated tablets 112 film-coated tablets 
28 filmsko obloženih tablet 30 filmsko obloženih tablet 42 filmsko obloženih tablet 50 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 98 filmsko obloženih tablet 112 filmsko obloženih tablet
Paediatric population No data are available. 
Podatkov ni na voljo.
From the fourth week on, the usual dose is 4 tablets once a day (1x 20 mg). 
Od četrtega tedna naprej je običajni odmerek 4 tablete enkrat dnevno (1x20 mg).
Do not take Nemdatine - if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine 
Kaj morate vedeti, preden boste vzeli zdravilo Nemdatine Ne jemljite zdravila Nemdatine - če ste alergični na memantinijev klorid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in na ovoju plastenke poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet (20 mg) once a day) as described above. 
Na podlagi kliničnih študij je priporočen odmerek za bolnike starejše od 65 let, 20 mg na dan (štiri 5-miligramske filmsko obložene tablete (20 mg), dve 10-miligramski filmsko obloženi tableti (20 mg) ali ena 20-miligramska filmsko obložena tableta (20 mg) enkrat na dan), kot je opisano zgoraj.
Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers. 
Alkalizacija urina lahko nastopi po izraziti spremembi v prehrani, npr. po prehodu z običajne prehrane na vegetarijansko, ali pri čezmernem zaužitju alkalnih učinkovin za uravnavanje želodčne kisline.
These factors include drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers. 
Med te dejavnike spadajo izrazite spremembe v prehranjevanju, npr. prehod z običajne prehrane na vegetarijansko ali čezmerno zaužitje alkalno delujočih snovi proti želodčni kislini.
The maximum daily dose is 20 mg per day. 
Največji dnevni odmerek je 20 mg na dan.
In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg per day. 
Pri bolnikih z zmerno okvaro ledvičnega delovanja (kreatininski očistek 30 − 49 ml/min) naj bo dnevni odmerek 10 mg.
How to take Nemdatine 
Kako jemati zdravilo Nemdatine
Standard clinical procedures to remove active substance material, e.g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate. 
Pri odstranjevanju učinkovine uporabljamo ustrezne standardne klinične postopke, kot so izpiranje želodca, medicinsko oglje (preprečevanje morebitne enterohepatične recirkulacije), nakisanje urina, prisilna diureza.
In man, about 80 % of the circulating memantine-related material is present as the parent compound. 
Pri človeku je okoli 80 % memantina v obtoku v izvorni (nespremenjeni) obliki.
What you need to know before you take Nemdatine 
Kaj morate vedeti, preden boste vzeli zdravilo Nemdatine Ne jemljite zdravila Nemdatine
Contents of the pack and other information 
Shranjevanje zdravila Nemdatine Vsebina pakiranja in dodatne informacije
Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: Week 1: 7 film-coated tablets of Nemdatine 5 mg 
Vsako pakiranje z 28 filmsko obloženimi tabletami za štiri tedenski program zdravljenja vsebuje: 7 filmsko obloženih tablet Nemdatine 5 mg
The patient should take four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet (20 mg) per day. 
Bolnik mora jemati štiri 5-miligramske filmsko obložene tablete (20 mg), dve 10-miligramski filmsko obloženi tableti (20 mg) ali eno 20-miligramsko filmsko obloženo tableto (20 mg) na dan.
For up-titration other tablet strengths are available. 
Za lažje povečevanje odmerka so na voljo tudi druge jakosti tablete.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) 
Pri odmerku 20 mg memantina na dan so vrednosti v CSL skladne z vrednostjo ki (ki = konstanta inhibicije) memantina, ki je v frontalnem korteksu pri človeku 0,5°µmol.
INFORMATION IN BRAILLE Nemdatine 20 mg 
PODATKI V BRAILLOVI PISAVI Nemdatine 20 mg
Bottle: 100 film-coated tablets. 
Plastenka: 100 filmsko obloženih tablet.
The following Adverse Reactions listed in the table below have been accumulated in clinical studies with memantine and since its introduction in the market. 
V preglednici so navedeni podatki o neželenih učinkih memantina, zbrani v kliničnih študijah in od začetka trženja.
What Nemdatine looks like and contents of the pack 
Izgled zdravila Nemdatine in vsebina pakiranja
The usual starting dose is one tablet once a day (1x 5 mg) for the first week. 
Običajni začetni odmerek je ena tableta enkrat dnevno (1 x 5 mg) v prvem tednu.
Titanium dioxide (E171) 
(E172).
Reykjavikurvegur 78, 200 Hafnarfjörður Iceland 
Reykjavikurvegur 78, 200 Hafnarfjörður Islandija
Week 4 
Teden 4
This is increased to two tablets once a day (1x 10 mg) in the second week and to three tablets once a day (1x 15 mg) in the third week. 
V drugem tednu povišamo odmerek na dve tableti enkrat dnevno (1x10 mg) in v tretjem tednu na tri tablete (1x15 mg) enkrat dnevno.
28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 
28 filmsko obloženih tablet 42 filmsko obloženih tablet 56 filmsko obloženih tablet 98 filmsko obloženih tablet
Hepatic impairment 
Neznani hepatitis
INFORMATION IN BRAILLE Nemdatine 15 mg 
PODATKI V BRAILLOVI PISAVI Nemdatine 15 mg
Tablet cores for 5, 10, 15 and 20 mg film-coated tablets Microcrystalline cellulose 
Jedro tablete za 5, 10, 15 in 20 mg filmsko obložene tablete mikrokristalna celuloza krospovidon (Tip A) smukec magnezijev stearat
- There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. 
- Ob sočasni uporabi memantina in hidroklorotiazida (HCT) oziroma zdravil, ki vsebujejo HCT, lahko pride do zmanjšane serumske koncentracije HCT.
In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows. 
Največji dnevni odmerek je 20 mg. Da bi zmanjšali pojavnost neželenih učinkov, je v prvih treh tednih zdravljenja potrebno postopno povečevanje odmerka po 5 mg na teden, dokler ni dosežen vzdrževalni odmerek.
There was no evidence of any carcinogenicity in life long studies in mice and rats. 
V študijah na miših in podganah, ki so potekale vso življenjsko dobo, niso opazili karcinogenosti.
Nemdatine contains the active substance memantine hydrochloride. 
Zdravilo Nemdatine vsebuje učinkovino memantinijev klorid.
The recommended dose of Nemdatine for adults and older people is 20 mg once a day. 
Odmerjanje Za odrasle in starejše ljudi je priporočeni odmerek zdravila Nemdatine 20 mg enkrat dnevno.
Week 2 
Teden 2
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR BOTTLE 
PODATKI, KI MORAJO BITI NAVEDENI NA PRIMARNEM PAKIRANJU NALEPKA ZA PLASTENKE
Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory. 
Nemdatine spada v skupino zdravil, ki se imenujejo antagonisti receptorjev NMDA. Nemdatine deluje na receptorje NMDA in izboljša prenos živčnih signalov in spomin.
Week 1 (day 1-7): Take one 5 mg tablet once a day (white, oval-shaped) for 7 days. 
1. teden (1.-7. dan): Vzemite po eno 5 mg tableto enkrat dnevno (bela, ovalne oblike), jemljite 7 dni.
Week 3 
Teden 3
Nemdatine should be administered orally once a day. 
Zdravilo Nemdatine jemljite peroralno enkrat dnevno.
Week 2 (day 8-14): Take one 10 mg tablet once a day (white, capsule shaped) for 7 days. 
2. teden (8.-14. dan): Vzemite po eno 10 mg tableto enkrat dnevno (bela, v obliki kapsule), jemljite 7 dni.
Week 4 (day 22-28): Take one 20 mg tablet per day (dark pink, oval shaped) for 7 days. 
4. teden (22.-28. dan): Vzemite po eno 20 mg tableto enkrat dnevno (temno rožnata, ovalne oblike), jemljite 7 dni.
Date of latest renewal: 
DATUM ZADNJE REVIZIJE BESEDILA1.
What Nemdatine is and what it is used for 
Kaj je zdravilo Nemdatine in za kaj ga uporabljamo Kako deluje zdravilo Nemdatine
Half a 10 mg tablet 
Ena in pol 10 mg tableta
This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablets once a day (1x 15 mg) in the third week. 
drugem tednu povišamo odmerek na eno tableto enkrat dnevno (1x10 mg) in v tretjem tednu na 1 tableto in pol (1x15 mg) enkrat dnevno.
The patient should take one 10 mg film-coated tablet per day (white, capsule shaped) for 7 days. 
Bolnik mora sedem dni jemati eno 10-miligramsko filmsko obloženo tableto (belo, v obliki kapsule) na dan.
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) 
Dodatno za 15 mg filmsko obložene tablete rumeni, rdeči in črni železov oksid (E172)
Nemdatine belongs to a group of medicines known as anti-dementia medicines. 
znanih kot zdravila za zdravljenje demence.
Week 3 (day 15-21): Take one 15 mg tablet once a day (orange, oval shaped) for 7 days. 
3. teden (15.-21. dan): Vzemite po eno 15 mg tableto enkrat dnevno (oranžna, ovalne oblike), jemljite 7 dni.
Common (affects 1 to 10 users in 100) - Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, 
Pogosti (pojavijo se pri 1 do 10 bolnikov od 100 bolnikov): - glavobol, zaspanost, zaprtje, zvišane vrednosti testov jetrne funkcije, omotica, motnje ravnotežja, zasoplost, visok krvni tlak in preobčutljivost za zdravilo
The patient should take one 20 mg film-coated tablet per day (dark pink, oval shaped) for 7 days. 
Bolnik mora sedem dni jemati eno 20-miligramsko filmsko obloženo tableto (temno rožnato, ovalno) na dan.
One treatment initiation pack contains 28 tablets in 4 blisters in a wallet pack or a multipack of 4 blisters in 4 separate immediate cartons and one outer carton with 7 tablets of Nemdatine 5 mg, 7 tablets of Nemdatine 10 mg, 7 tablets of Nemdatine 15 mg and 7 tablets of Nemdatine 20 mg. 
Eno pakiranje za začetno zdravljenje vsebuje 28 tablet v 4 pretisnih omotih v zgibanki ali v skupnem pakiranju 4 blistrov v 4 ločenih notranjih škatlah in eni zunanji škatli s 7 tabletami Nemdatine 5 mg, 7
Uncommon (affects 1 to 10 users in 1,000) - Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) 
Občasni (pojavijo se pri 1 do 10 bolnikov od 1.000 bolnikov): - utrujenost, glivična okužba, zmedenost, halucinacije, bruhanje, neobičajna hoja, odpoved srca in krvni strdki v venah (tromboza/tromboembolija) Zelo redki (pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov):
Reykjavíkurvegi 78 220 Hafnarfjörður Iceland 
Reykjavíkurvegi 78 220 Hafnarfjörður Islandija
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/011 7 film-coated tablets EU/1/13/824/012 42 film-coated tablets EU/1/13/824/013 98 film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/824/011 7 film-coated tablets EU/1/13/824/012 42 film-coated tablets EU/1/13/824/013 98 film-coated tablets
7 film-coated tablets of Nemdatine 20 mg 
7 filmsko obloženih tablet Nemdatine 20 mg
PHARMACEUTICAL FORM AND CONTENTS 7 film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg film-coated tablets memantine hydrochloride 
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg filmsko obložene tablete memantinijev klorid
Uncommon Fungal infections 
Občasni glivična okužba
Each pack contains 28 film-coated tablets (7 film-coated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film-coated tablets of 20 mg) in a wallet pack or as a pack of 4 blisters in 4 separate immediate cartons and one outer carton. 
Eno pakiranje vsebuje 28 filmsko obloženih tablet (7 filmsko obloženih tablet po 5 mg, 7 filmsko obloženih tablet po 10 mg, 7 filmsko obloženih tablet po 15 mg, 7 filmsko obloženih tablet po 20 mg)
EU/1/13/824/003 28 film-coated tablets EU/1/13/824/004 30 film-coated tablets EU/1/13/824/005 42 film-coated tablets EU/1/13/824/006 50 film-coated tablets EU/1/13/824/007 56 film-coated tablets EU/1/13/824/008 60 film-coated tablets EU/1/13/824/009 98 film-coated tablets EU/1/13/824/010 112 film-coated tablets 
EU/1/13/824/003 28 filmsko obloženih tablet EU/1/13/824/004 30 filmsko obloženih tablet EU/1/13/824/005 42 filmsko obloženih tablet EU/1/13/824/006 50 filmsko obloženih tablet EU/1/13/824/007 56 filmsko obloženih tablet EU/1/13/824/008 60 filmsko obloženih tablet EU/1/13/824/009 98 filmsko obloženih tablet EU/1/13/824/010 112 filmsko obloženih tablet
< 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
- epileptični napadi Neznana pogostnost (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11 − 23) were randomised. 
V drugi študiji zdravljenja z monoterapijo pri blagi do zmerni Alzheimerjevi bolezni (skupna ocena pri KPSS ob vključitvi od 11 do 23 točk), je bilo zajetih in randomiziranih 470 bolnikov.
Two 5 mg tablets 
Dve 5 mg tableti
Each film-coated tablet contains 1.42 mg lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 1,42 mg laktoze monohidrata.
Blister packs: 28, 42, 56 and 98 film-coated tablets. 
Pretisni omoti: 28, 42, 56 in 98 filmsko obloženih tablet.
In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis. 
Zdravnik naj redno ocenjuje klinično korist zdravila Nemdatine.
7 film-coated tablets of Nemdatine 15 mg 
7 filmsko obloženih tablet Nemdatine 15 mg
Each film-coated tablet contains 1.89 mg lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 1,89 mg laktoze monohidrata.
Each film-coated tablet contains 0.95 mg lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 0,95 mg laktoze monohidrata.
Three 5 mg tablets Week 4 and beyond Four 5 mg tablets once a day 
Štiri 5 mg tablete enkrat dnevno
The patient should take three 5 mg film-coated tablets (15 mg) or one 15 mg film-coated tablet (15 mg) per day for 7 days. 
Bolnik mora sedem dni jemati tri 5-miligramske filmsko obložene tablete (15 mg) ali eno 15-miligramsko filmsko obloženo tableto (15 mg) na dan.
28 film-coated tablets 
7 filmsko obloženih tablet
Administration of Nemdatine is not recommended in patients with severe hepatic impairment. 
Dajanje zdravila Nemdatine bolnikom s hudo jetrno okvaro ni priporočljivo.
Nemdatine 20 mg film-coated tablets: 
Nemdatine 20 mg filmsko obložene tablete:
In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation). 
Pojavili so se učinki na centralni živčni sistem (desetdnevna koma, kasneje diplopija in vznemirjenost).
7 film-coated tablets of Nemdatine 10 mg 
7 filmsko obloženih tablet Nemdatine 10 mg
Each film-coated tablet contains 0.47 mg lactose monohydrate. 
Ena filmsko obložena tableta vsebuje 0,47 mg laktoze monohidrata.
Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side. 
Nemdatine 5 mg filmsko obložene tablete so bele, ovalne, bikonveksne, velikosti 8 mm x 4,5 mm z vtisnjeno oznako “M5” na eni strani.
Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg 
Pakiranje z 28 (4x7) filmsko obloženimi tabletami za štiri tedenski začetni program zdravljenja:
Pack sizes Blister packs: 7, 42 and 98 film-coated tablets. 
Velikosti pakiranj Pretisni omoti: 7, 42 in 98 filmsko obloženih tablet.
One 10 mg tablet 
Ena 10 mg tableta
Pack sizes Blister packs: 42 and 98 film-coated tablets. 
Velikosti pakiranj Pretisni omoti: 42 in 98 filmsko obloženih tablet.
Nemdatine 20 mg film-coated tablets 
Nemdatine 20 mg filmsko obložene tablete
The patient should take two 5 mg film-coated tablets (10 mg) or one 10 mg film-coated tablet (10 mg) per day for 7 days. 
Bolnik mora sedem dni jemati dve 5-miligramski filmsko obloženi tableti (10 mg) ali eno 10-miligramsko filmsko obloženo tableto (10 mg) na dan.
Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin. 
Obloga tablete: (Opadry II belo 33G28435): hipromeloza 6cP, titanov dioksid (E171), laktoza monohidrat, makrogol 3350 in triacetin.
PHARMACEUTICAL FORM AND CONTENTS 42 film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 42 filmsko obložene tablete 98 filmsko obloženih tablet.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE 
PRETISNI OMOT ZA TABLETE- PAKIRANJE ZA ZAČETNO ZDRAVLJENJE - ŠTIRI TEDENSKI PROGRAM ZDRAVLJENJA
Nemdatine 10 mg film-coated tablets: 
Nemdatine 10 mg filmsko obložene tablete:
The patient should take one 5 mg film-coated tablet (5 mg) or half a 10 mg film-coated tablet (5 mg) per day for 7 days. 
Bolnik mora sedem dni jemati eno 5-miligramsko filmsko obloženo tableto (5 mg) ali polovico 10-miligramske filmsko obložene tablete (5 mg) na dan.
What Nemdatine looks like and contents of the pack Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side. 
Izgled zdravila Nemdatine in vsebina pakiranja Nemdatine 20 mg filmsko obložene tablete so temno rožnate, ovalne, bikonveksne, velikosti 12,6 mm x 7 mm, z vtisnjeno oznako “M20” na eni strani.
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 − 14) included a total of 252 outpatients. 
V temeljno klinično študijo je bilo vključenih 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo, ki so ob vključitvi pri kratkem preizkusu spoznavnih sposobnosti (KPSS, angl. Mini mental state examination, MMSE) dosegli 3-14 točk.
Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side. 
Nemdatine 15 mg filmsko obložene tablet so oranžne, ovalne, bikonveksne, velikosti 11,4 mm x 6,4 mm z vtisnjeno oznako “M15” na eni strani.
The film-coated tablets can be taken with or without food. 
Zdravilo Nemdatine je treba jemati peroralno enkrat dnevno in ob istem času vsak dan. Filmsko obloženo tableto lahko bolnik zaužije s hrano ali brez.
EU/1/13/824/002 98 film-coated tablets 
EU/1/13/824/001 42 filmsko obloženih tablet EU/1/13/824/002 98 filmsko obloženih tablet