natgillin/translations-raw huggingface dataset:
Pri bolnikih, kjer so ocenili hkratno poslabšanje vseh treh področji, so rezultati pokazali statistično značilen učinek memantina pri preprečevanju poslabšanja, saj se je pri dvakrat več bolnikih, ki so prejemali placebo, kot pri bolnikih, zdravljenih z memantinom, pokazalo poslabšanje na področju vseh treh področji (21 
When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%,p<0.0001).
Podatkov o uporabi memantina pri nosečnicah ni oziroma so omejeni. 
There are no or limited amount of data from the use of memantine in pregnant women.
Pri bolnikih z blago okvaro delovanja ledvic (očistek kreatinina 50 - 80 ml/min) prilagoditev odmerka ni potrebna. 
In patients with mildly impaired renal function (creatinine clearance 50 - 80 mL/min) no dose adjustment is required.
s hrano ali brez nje. 
The tablets can be taken with or without food.
smukec rumeni železov oksid (E 172) rdeči železov oksid (E 172) 
Iron oxide yellow (E 172) Iron oxide red (E 172)
Pri glodalcih so opazili fosfolipidozo v makrofagih v pljučih, ker se je memantin kopičil v lizosomih. 
Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was observed in rodents.
Možni neželeni učinki 
Possible side effects
Da bi zmanjšali nevarnost pojava neželenih učinkov, odmerek dosegate postopoma, po priporočilu sledeče 
In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
in upravljanja strojev 
Driving and using machines
Največji dnevni odmerek je 20 mg na dan. 
The maximum daily dose is 20 mg per day.
Infekcijske in parazitske bolezni 
Infections and infestations
Zmerna do huda Alzheimerjeva bolezen je običajno vzrok za nesposobnost vožnje 
Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery.
tedna dalje 
week 1
Noben od teh presnovkov nima antagonističnega učinka na NMDA. 
None of these metabolites exhibit NMDA-antagonistic activity.
Pri bolnikih, zdravljenih z memantinom, so poročali o teh dogodkih. 
These events have been reported in patients treated with memantine.
Sandoz d.d Representative office 
Sandoz d.d Representative office Teл.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. 
- This medicine has been prescribed for you only.
Porazdelitev 
Distribution
Bolezni dihal, prsnega koša in mediastinalnega prostora 
Respiratory, thoracic and mediastinal disorders
se nahajajo tako imenovani receptorji N-metil-D-aspartata (NMDA), ki sodelujejo v prenosu živčnih 
The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali 
- If you have any further questions, ask your doctor or pharmacist.
Jedro tablete: mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid in magnezijev stearat. 
Tablet core: croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate
Srčne bolezni 
Cardiac failure
statistično značilno boljši učinek kot pri bolnikih, ki so prejemali placebo pri primarnih ciljih študije: lestvica za ocenjevanje Alzheimerjeve bolezni (ADAS-cog- Alzheimer's disease assessment scale) (p=0,003) in CIBIC-plus (p=0,004) po 24 tednih (prenos zadnjega opažanja (LOCF-last observation carried forward)). 
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer's disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
Zdravilo Memantine LEK je namenjeno za peroralno uporabo. 
Memantine LEK is for oral use.
Pogostnost 
Frequency
Za odrasle in starejše je priporočeni odmerek zdravila Memantin LEK 20 mg enkrat dnevno. 
The recommended dose of Memantine LEK for adults and elderly patients is 20 mg once a day.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): 
Uncommon (may affect up to 1 in 100 people):
5.2 Farmakokinetične lastnosti 
5.2 Pharmacokinetic properties
Temeljna študija memantina v monoterapiji pri zdravljenju bolnikov z blago do zmerno Alzheimerjevo boleznijo (skupna ocena pri KPSS ob vključitvi 10 do 22 točk) je zajela 403 bolnike. 
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.
ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA 
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Sandoz 
France Sandoz
Izračunali so, da je pri dnevnih odmerkih 5 do 30 mg razmerje med koncentracijo v cerebrospinalnem likvorju (CSL) in serumu 0,52. 
When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): 
Common (may affect up to 1 in 10 people):
Neželeni učinki 
4.8 Undesirable effects
smukec rumen železov oksid (E 172) 
Iron oxide yellow (E 172)
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. 
- If you get any side effects, talk to your doctor or pharmacist.
Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E 171), smukec, rumen železov oksid (E 172) in rdeč železov oksid (E 172). 
Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, iron oxide yellow (E172) and iron oxide red (E-172)
Pri človeku je okoli 80 % memantina v obtoku v nespremenjeni obliki. 
In man, about 80% of the circulating memantine-related material is present as the parent compound.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovaje in izdaja zdravila je le 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Bolezni imunskega sistema 
Immune system disorders
Mednje spadajo izrazite spremembe v prehranjevanju, kot npr. prehod z običajne na vegetarijansko prehrano ali zaužitje večjih količin alkalnodelujočih antacidov. 
These factors include drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers.
Izgled zdravila Memantin LEK in vsebina pakiranja Memantin LEK 10 mg filmsko obložene tablete so rumene, ovalne, filmsko obložene tablete z razdelilno zarezo na eni strani. 
What Memantine LEK looks like and contents of the pack Memantine LEK 10 mg film-coated tablets are presented as yellow, oval film-coated tablet scored in one side.
Neznana pankreatitis2 
Constipation Vomiting Pancreatitis2
PODATKI V BRAILLOVI PISAVI Memantin LEK 10 mg 
INFORMATION IN BRAILLE Memantine LEK 10 mg
PODATKI V BRAILLOVI PISAVI Memantin LEK 20 mg 
INFORMATION IN BRAILLE Memantine LEK 20 mg
tednu ni bilo statistično značilnih razlik pri primarnih ciljih študije. 
In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
Zdravilo Memantine LEK vsebuje učinkovino memantinijev klorid. 
Memantine LEK contains the active substance memantine hydrochloride.
V spodnji preglednici so navedeni podatki o neželenih učinkih zdravila, zbrani v kliničnih študijah z memantinom in od začetka trženja dalje. 
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market.
se memantin izloča v materino mleko, vendar bi iz njegove lipofilnosti lahko sklepali, da se. 
It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs.
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): 
Very Rare (may affect up to 1 in 10,000 people): • Seizures
so na voljo na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Organski sistem 
System organ class
Prav tako Memantin LEK lahko vpliva na vašo sposobnost odzivanja, zato se vožnja in upravljanje strojev ne priporoča. 
Also, Memantine LEK may change your reactivity, making driving or operating machinery inappropriate.
s ki vrednostjo (ki = konstanta inhibicije) memantina, ki je 0,5 µmol v frontalnem korteksu pri človeku. 
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki= inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Na podlagi kliničnih študij je priporočen odmerek za bolnike, starejše od 65 let, 20 mg na dan (dve 
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day as described above.
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA 
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Memantin LEK 20 mg filmsko obložene tablete so bledo rdeče, ovalne, filmsko obložene tablete z razdelilno zarezo na eni strani. 
Memantine LEK 20 mg film-coated tablets are presented as pale red, oval film-coated tablet scored in one side.
Imetnik dovoljenja za promet z zdravilom Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Grčija 
Marketing Authorisation Holder Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greece
FARMAKOLOŠKE LASTNOSTI 
PHARMACEUTICAL PARTICULARS
tega zdravila natančno upoštevajte navodila zdravnika. 
Always take this medicine exactly as your doctor has told you.
Žilne bolezni 
Fungal infections
Bledo rdeče, ovalne filmsko obložene tablete z razdelilno zarezo na eni strani. 
Pale red, oval film-coated tablet scored in one side.
Ženske, ki jemljejo zdravilo Memantin LEK, ne smejo dojiti. 
Women taking Memantine LEK should not breast-feed.
Alkalizacija urina lahko nastopi po izraziti spremembi v prehrani, npr. prehod z običajne na vegetarijansko, ali pri čezmernem zaužitju alkalnih učinkovin za uravnavanje želodčne kisline. 
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.
iz obdobja trženja zdravila so na voljo le omejene izkušnje 
Only limited experience with overdose is available from clinical studies and post-marketing experience.
Ženske, ki prejemajo memantin, naj ne dojijo. 
Women taking memantine should not breast-feed.
In vitro niso zaznali presnove preko citokroma P 450. 
No cytochrome P 450 catalysed metabolism has been detected in vitro.
srčnim popuščanjem (NYHA III-IV) ali neurejeno hipertenzijo izključeni. 
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
4.1 Terapevtske indikacije Zdravljenje odraslih bolnikov z zmerno do hudo Alzheimerjevo boleznijo. 
Treatment of adult patients with moderate to severe Alzheimer's disease.
Če ste vzeli večji odmerek zdravila Memantin LEK, kot bi smeli - Na splošno zaužitje večjega odmerka zdravila Memantin LEK ne bi smelo imeti škodljivih posledic. Morda boste občutili bolj izražene znake, ki so opisani v poglavju 4. 
If you take more Memantine LEK than you should - In general, taking too much Memantine LEK should not result in any harm to you.
Sočasni uporabi antagonistov N-metil-D-aspartata (NMDA), kot so amantadin, ketamin ali dekstrometorfan, se je potrebno izogniti. Te učinkovine delujejo na isti receptorski sistem kot memantin, zato so lahko neželeni učinki (zlasti na centralni živčni sistem (CŽS)) pogostejši in bolj izraženi (glejte tudi poglavje 4.5). 
These active substances act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
V standardnih poskusih niso opazili genotoksičnosti. 
No genotoxicity has been observed following testing of memantine in standard assays.
Tel.: +30 210 66 65 067 E-pošta: 
Tel.: +30 210 66 65 067 Email: info@pharmathen.com
Na podlagi mehanizma delovanja se pričakuje, da se ob sočasnem zdravljenju z antagonisti NMDA kot je memantin, učinki L-dope, dopaminergičnih agonistov in antiholinergikov, lahko okrepijo. 
• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
Memantin LEK 10 mg filmsko obložene tablete so na voljo v pretisnih omotih iz PVC / PVDCaluminija s 28, 30, 42, 50, 56, 60, 98, 100 in 112 tablet. 
Memantine LEK 10 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 50, 56, 60, 98, 100 and 112 tablets.
Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30 - 49 ml/min) naj bo dnevni odmerek 10 mg. 
In patients with moderate renal impairment (creatinine clearance 30 - 49 mL/min) daily dose should be 10 mg per day.
Neznana hepatitis 
Hepatic impairment
Izdelovalec: 
PC:
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI 
UNIQUE IDENTIFIER - HUMAN READABLE DATA
Od 4. 
See section 4.
Občasni nenormalna hoja 
Common Common Uncommon Very rare
Kaj morate vedeti, preden boste vzeli zdravilo Memantin LEK Ne jemljite zdravila Memantin LEK 
What you need to know before you take Memantine LEK
Slovenská republika Sandoz d.d. organizacna zlozka Tel: + 421-2/48 200 600 
organizacna zlozka Tel: + 421-2/48 200 600
Kako jemati zdravilo Memantin LEK 
How to take Memantine LEK
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako 
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Potem je treba ocenjevati klinično korist in prenašanje zdravljenja z memantinom skladno 
Thereafter, the clinical benefit of memantine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines.
5.1 Farmakodinamične lastnosti 
5.1 Pharmacodynamic properties
, 6, Dervenakion str., 15351 Pallini, Attiki, Grčija Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, 
Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Rumene, ovalne filmsko obložene tablete, z razdelilno zarezo na eni strani. 
Yellow, oval film-coated tablet scored in one side.
Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E 171), smukec in rumen železov oksid (E 172). 
10 mg: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E
Al-PVC/PVDC pretisni omoti v kartonskih škatlah, ki vsebujejo 28, 30, 42, 56, 98 in 100 filmsko obloženih tablet. 
Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 56, 98 and 100 filmcoated tablets.
s peroralnim memantinom 14C se je v 20 dneh izločilo povprečno 84% odmerka, od tega več kot 99 % preko ledvic. 
In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20
Zdravilo Memantin LEK ni priporočljivo uporabljati pri otrocih in mladostnikih mlajših od 18 let, 
Memantine LEK is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Možna je povezava med tem kopičenjem 
There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
s hudo okvaro delovanja ledvic (očistek kreatinina 5 - 29 ml/min) naj bo dnevni odmerek 10 mg. 
In patients with severe renal impairment (creatinine clearance 5 - 29 mL/min) daily dose should be 10 mg per day.
Al-PVC/PVDC pretisni omoti v kartonskih škatlah, ki vsebujejo 28, 30, 42, 50, 56, 60, 98, 100 in 112 filmsko obloženih tablet. 
Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 50, 56, 60, 98, 100 and 112 film-coated tablets.
IMETNIK DOVOLJENJA 
MARKETING AUTHORISATION HOLDER
Vaš zdravnik naj redno ocenjuje klinično korist zdravila Memantin LEK. 
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine LEK reassessed by your doctor on a regular basis.
IME ZDRAVILA Memantin LEK 10 mg filmsko obložene tablete 
NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets
Jedro tablete mikrokristalna celuloza premrežen natrijev karmelozat brezvoden koloidni 
Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
teh lahko spremenijo in bo morda vaš zdravnik moral prilagoditi odmerek: 
In particular, Memantine LEK may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Poročanje o neželenih učinkih 
Reporting of side effects
cimetidin, ranitidin, prokainamid, kinidin, kinin, nikotin hidroklorotiazid (ali kombinacije zdravil, ki vsebujejo hidroklorotiazid) 
amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (or any combination with hydrochlorothiazide) anticholinergics (substances generally used to treat movement disorders or intestinal cramps) anticonvulsants (substances used to prevent and relieve seizures) barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine) neuroleptics (substances used in the treatment of mental disorders) oral anticoagulants
Filmsko obložene tablete se lahko jemlje 
The film-coated tablets can be taken with or without food.
Antidota za zastrupitev ali preveliko odmerjanje ni. Pri odstranjevanju učinkovine uporabljamo ustrezne standardne klinične postopke, kot so izpiranje želodca, medicinsko oglje (preprečevanje možne enterohepatične recirkulacije), nakisanje urina, prisilna diureza. 
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.
se je pojavila ataksija in drugi predklinični znaki. 
Ataxia and other preclinical signs have preceded the vacuolisation and necrosis.
s placebom (analiza opazovanih primerov po lestvici CIBIC-plus (vtis sprememb na podlagi kliničnega intervjuja (CIBIC- clinician's interview based impression of change)), p=0,025; po lestvici ADCS-ADLsev (vprašalnik vsakodnevnih aktivnosti (ADCS-ADLsev-Alzheimer's disease cooperative study - activities of daily living)), p=0,003; testi po SIB (sklop 
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).
teden polovica 10 mg tablete 
half 10 mg tablet week 2
Zdravilo Memantin LEK je treba jemati enkrat dnevno 
Memantine LEK should be administered orally once a day.
- Če ste zaužili prevelik odmerek zdravila Memantin LEK, obvestite 
- If you take a large overdose of Memantine LEK, contact your doctor or get medical advice, as you may need medical attention.
6.1 Seznam pomožnih snovi 
6.1 List of excipients
Navedba smiselno ni potrebna. 
Not applicable.
teden ena 10 mg tableta 
one 10 mg tablet week 3
Bolnik mora jemati dve 10 mg filmsko obloženi tableti (20 mg) na dan. 
The patient should take one 20 mg film-coated tablet (20 mg) per day for 7 days.
Ena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina. 
Each 20 mg tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Ena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina. 
Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
s študijami zdravljenja v monoterapiji ter študijami bolnikov, ki so prejemali stabilni odmerek zaviralcev acetilholinesteraze), je pokazala statistično značilen učinek v korist zdravljenja z memantinom pri spoznavnih funkcijah ter globalnih in funkcionalnih področjih. 
A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Splošne težave in spremembe na mestu aplikacije 
General disorders and administration site conditions
Eesti Sandoz d.d. Estonia Tel: + 372 6652405 
Estonia Tel: + 372 6652405
50 filmsko obloženih tablet. 
Film-coated tablet.
Memantin ni bil teratogen pri podganah in zajcih, 
Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse events of memantine were noted on fertility.
NMDA in tako izboljša prenos živčnih 
Memantine LEK acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
EU/1/13/826 /007 28 filmsko obloženih tablet EU/1/13/826 /008 30 filmsko obloženih tablet EU/1/13/826 /009 42 filmsko obloženih tablet EU/1/13/826 /010 56 filmsko obloženih tablet EU/1/13/826 /011 98 filmsko obloženih tablet EU/1/13/826 /015 100 filmsko obloženih tablet 
EU/1/13/826 /007 28 film-coated tablets EU/1/13/826 /008 30 film-coated tablets EU/1/13/826 /009 42 film-coated tablets EU/1/13/826 /010 56 film-coated tablets EU/1/13/826 /011 98 film-coated tablets EU/1/13/826 /015 100 film-coated tablets
izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom. 
If you get any side effects, talk to your doctor or pharmacist.
OZNAČEVANJE IN NAVODILO ZA UPORABO 
ANNEX III LABELLING AND PACKAGE LEAFLET
Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve za predložitev rednih posodobljenih poročil o varnosti zdravila za to zdravilo 
• Periodic safety update reports
Sorazmerno veliki čezmerni odmerki (200 mg dnevno oziroma 105 mg dnevno, tri dni) 
Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms.
6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev. 
6.6 Special precautions for disposal
Ni znano, ali 
Common Not known
Bolnik je okreval brez 
The patient recovered without permanent sequelae.
Čeprav vzročna povezanost ni bila dokazana, je pri bolnikih, ki se sočasno zdravijo 
Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.
Neznana pogostnost (pogostosti ni mogoče oceniti iz razpoložljivih podatkov): 
Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
POSEBNI VARNOSTNI UKREPI 
SPECIAL STORAGE CONDITIONS
Pred začetkom jemanja zdravila Memantine LEK se posvetujte z zdravnikom ali 
Talk to your doctor or pharmacist before taking Memantine LEK
PRETISNI OMOT 
Dose titration
Lek Pharmaceuticals d.d. Tel: + 386 1 580 3327 
Tel: + 386 1 580 3327
Obloga tablete polivinilalkohol makrogol 3350 titanov dioksid (E 171) 
Polyvinyl alcohol Macrogol 3350
Pri drugi študiji zdravljenja v monoterapiji pri blagi do zmerni Alzheimerjevi bolezni (skupna ocena KPSS ob vključitvi 11 do 23 točk), v katero je bilo zajetih in naključno razdeljenih 470 bolnikov. 
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.
Kako deluje zdravilo Memantin LEK 
How does Memantine LEK work
KLINIČNI PODATKI 
CLINICAL PARTICULARS
Vrsta ovojnine in vsebina 
6.5 Nature and contents of container
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU 
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