natgillin/translations-raw huggingface dataset:
The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
kot pri skupini, ki je prejemala placebo, so bili omotica (6,3 % proti 5,6 %), glavobol (5,2 % proti 3,9 %), zaprtje (4,6 % proti 2,6 %), zaspanost (3,4 % proti 2,2 %) in hipertenzija (4,1 % proti 2,8 %).
Furthermore, Memantine LEK has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Prav tako ima zdravilo Memantin LEK majhen do zmerno velik vpliv na sposobnost vožnje in upravljanja s stroji, zato je potrebno bolnike opozoriti na posebno previdnost.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ
Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin-containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Memantin in vitro ni zaviral CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monooksigenaze, ki vsebuje flavin, epoksidne hidroksilaze ali sulfatacije.
Psychotic reactions2
Neznane pogostnosti psihotične reakcije2
Treatment of adult patients with moderate to severe Alzheimer's disease.
Zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
- If you take a large overdose of Memantine LEK, contact your doctor or get medical advice, as you may need medical attention.
- V primeru, da ste zaužili prevelik odmerek zdravila Memantin LEK, obvestite svojega zdravnika, ker boste morda potrebovali zdravniško obravnavo.
Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Linearnost: Študije na zdravih prostovoljcih so pokazale, da ima memantin linearno farmakokinetiko v razponu odmerkov od 10 do 40 mg.
Both active substances are chemically related NMDA-antagonists.
Obe zdravilne učinkovine sta kemijsko sorodna antagonista NMDA.
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
Jetrna okvara: Pri bolnikih z blago ali zmerno jetrno okvaro (Child-Pugh A in Child-Pugh B) prilagoditev odmerka ni potrebna.
If you go into hospital, let your doctor know that you are taking Memantine LEK.
V primeru, da ste sprejeti v bolnišnico, obvestite zdravnika, da jemljete zdravilo Memantin LEK.
Children and adolescents Memantine LEK is not recommended for children and adolescents under the age of 18 years.
Zdravila Mamantin LEK ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
The recommended maintenance dose is 20 mg per day.
Priporočeni vzdrževalni odmerek je 20 mg na dan.
Memantine LEK belongs to a group of medicines known as anti-dementia medicines.
Zdravilo Memantin LEK sodi v skupino zdravil, znanih kot zdravila za zdravljenje demence.
In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
V klinični raziskavi pri mladih zdravih prostovoljcih ni bilo opaziti pomembnega vpliva memantina na farmakokinetiko galantamina.
What is Memantine LEK used for Memantine LEK is used for the treatment of adult patients with moderate to severe Alzheimer's disease.
Za kaj uporabljamo zdravilo Memantin LEK Zdravilo Memantin LEK uporabljamo za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
Somnolence Confusion Hallucinations1
Občasni halucinacije1
Other medicines and Memantine LEK
Druga zdravila in zdravilo Memantin LEK
You may experience increased symptoms as described in section 4 “Possible side effects”.
Morda boste občutili bolj izražene znake, ki so opisani v poglavju 4.
Memantine LEK belongs to a group of medicines called NMDA-receptor antagonists.
Zdravilo Memantin LEK spada v skupino zdravil, ki se imenujejo antagonisti receptorjev NMDA.
The usual starting dose is half a tablet of 10 mg once a day (1x 5 mg) for the first week.
Običajni začetni odmerek je polovica 10 mg tablete enkrat dnevno (1 x 5 mg) v prvem tednu.
Concomitant administration of memantine with the antispasmodic medicinal products, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
Sočasno dajanje memantina in spazmolitikov zdravili, dantrolena ali baklofena lahko spremeni njihove učinke, zato je morda potrebno prilagoditi odmerke.
Sambrook Pharmaceuticals Med SA 800 110 0333 (χωρίς χρέωση) / +30-210
Sambrook Pharmaceuticals Med SA 800 110 0333 (toll free) / +30-210-8194280
• if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
- če ste v preteklosti imeli epileptične napade, - če ste pred kratkim preboleli srčni infarkt (srčna kap), imate kongestivno srčno odpoved ali neurejeno hipertenzijo (visok krvni tlak).
In the event of overdose, treatment should be symptomatic.
Zdravljenje: Pri prevelikem odmerjanju je potrebno simptomatično zdravljenje.
How to store Memantine LEK Contents of the pack and other information
Shranjevanje zdravila Memantin LEK Vsebina pakiranja in dodatne informacije
Constipation Vomiting Pancreatitis2
Neznane pogostnosti pankreatitis2
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
amantadin, ketamin, dekstrometorfan dantrolen, baklofen cimetidin, ranitidin, prokainamid, kinidin, kinin, nikotin hidroklorotiazid (ali kombinacije zdravil, ki vsebujejo hidroklorotiazid) antiholinergiki (zdravila, ki se na splošno uporabljajo za zdravljenje motenj gibanja in trebušnih krčev)
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobni podatki o tem izdelku so na voljo na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
In post-marketing experience these reactions have been reported in patients treated with memantine.
Po začetku trženja zdravila so te dogodke navajali pri bolnikih, zdravljenih z memantinom.
What Memantine LEK is and what it is used for What you need to know before you take Memantine LEK How to take Memantine LEK Possible side effects
Kaj je zdravilo Memantin LEK in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Memantin LEK Kako jemati zdravilo Memantin LEK
In particular, Memantine LEK may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Posebno v primeru, da skupaj z zdravilom Memantin LEK jemljete naslednja zdravila, se učinki le teh lahko spremenijo in bo morda vaš zdravnik moral prilagoditi odmerek:
The use of medicinal products called amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Potrebno se je izogibati sočasni uporabi zdravil, kot so amantadin (za zdravljenje Parkinsonove bolezni), ketamin (snov, ki se uprablja kot anestetik), dekstrometorfan (splošna uporaba pri zdravljenju kašlja) in ostali zaviralci receptorjev NMDA.
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 delovanja ledvic (očistek kreatinina 5 - 29 ml/min) naj bo dnevni odmerek 10 mg.
Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4-and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane.
Pri človeku so poglavitni metaboliti N-3,5-dimetil-gludantan, izomerna mešanica 4- in 6-hidroksi-memantina in 1
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Zdravila Memantin LEK 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.
Dose in patients with impaired kidney function
Odmerjanje pri bolnikih z ledvično okvaro
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 spodnji preglednici so navedeni podatki o neželenih učinkih zdravila, zbrani v kliničnih študijah z memantinom in od začetka trženja dalje.
Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/mL (0.5 - 1 μmol) with large interindividual variations.
Porazdelitev: Ob dnevnih odmerkih 20 mg so v stanju dinamičnega ravnovesja dosežene plazemske koncentracije memantina v razponu od 70 do 150 ng/ml (0,5 - 1 µmol) ob veliki variabilnosti med posamezniki.
Memantine LEK acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
NMDA in izboljša prenos živčnih signalov in spomin.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojo zdravnikom ali s farmacevtom.
This is increased to one tablet of 10 mg once a day (1x 10 mg) in the second week and to 1 and a half tablet of 10 mg once a day in the third week.
V drugem tednu povišamo odmerek na eno 10 mg tableto enkrat dnevno (1 x 10 mg) in v tretjem tednu na 1 in ½ 10 mg tablete enkrat dnevno.
Common Common Uncommon Very rare
Občasni neobičajna hoja
None of these metabolites exhibit NMDA-antagonistic activity.
Nobeden od teh metabolitov nima antagonističnega učinka na
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance - active substance interaction of memantine with glyburide/metformin or donepezil was observed.
V raziskavah farmakokinetike (PK) posameznega odmerka pri mladih zdravih osebah ni bilo opaziti součinkovanja memantina z gliburidom/metforminom ali donepezilom.
Memantine LEK 20 mg film-coated tablets are presented as pale red, oval film-coated tablet scored in one side.
Memantin LEK 20 mg filmsko obložene tablete so predstavljene kot bledo rdeče, ovalne, filmsko obložene tablete z razdelilno zarezo na eni strani.
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).
Pri bolnikih, kjer so ocenili hkratno poslabšanje vseh treh domen, 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 domen (21 % proti 11 %,
one and a half 10 mg tablets week 4 and beyond two 10 mg tablets or one 20 mg tablet once a day
4. teden in naprej dve 10 mg tableti ali ena 20 mg tableta enkrat dnevno
Lek S.A.
Polska Lek S.A.
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.
Farmakokinetično/farmakodinamična povezava: Pri odmerku 20 mg memantina na dan so vrednosti v likvorju skladne s ki vrednostjo (ki = konstanta inhibicije) memantina, ki je 0,5 µmol v frontalnem korteksu pri človeku.
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 delovanja ledvic (očistek kreatinina 50 - 80 ml/min) prilagoditev odmerka ni potrebna.
Memantine LEK should be administered orally once a day.
Zdravilo Memantin LEK jemljite peroralno enkrat dnevno.
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.
Izgled zdravila Memantin LEK in vsebina pakiranja Memantin LEK 10 mg filmsko obložene tablete so predstavljene kot rumene, ovalne, filmsko obložene tablete z razdelilno zarezo na eni strani.
NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pharmathen S.A.
In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20
V študiji peroralnega 14C-memantina se je izločilo 84% odmerka v 20 dneh, več kot 99 % preko ledvic.
The recommended dose of Memantine LEK for adults and elderly patients is 20 mg once a day.
Za odrasle in starejše je priporočeni odmerek zdravila Memantin LEK 20 mg enkrat dnevno.
How to take Memantine LEK
Kako jemati zdravilo Memantin LEK
INFORMATION IN BRAILLE Memantine LEK 20 mg
PODATKI V BRAILLOVI PISAVI Memantin LEK 20 mg
INFORMATION IN BRAILLE Memantine LEK 10 mg
PODATKI V BRAILLOVI PISAVI Memantin LEK 10 mg
Tablet core: croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate
Jedro tablete: mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid in magnezijev stearat.
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).
Te zdravilne učinkovine delujejo na isti receptorski sistem kot memantin, zato so lahko neželeni učinki (zlasti s strani osrednjega živčnega sistema (OŽS))
Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Jedro tablete: mikrokristalna celuloza premrežen natrijev karmelozat brezvoden koloidni silicijev dioksid magnezijev stearat
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.
Starejši: Na podlagi kliničnih študij je priporočen odmerek za bolnike nad 65 let starosti 20 mg na dan
Also, Memantine LEK may change your reactivity, making driving or operating machinery inappropriate.
Prav tako Memantin LEK lahko vpliva na vašo sposobnost odzivanja, zato se vožnja in upravljanje s stroji ne priporoča.
PC:
Izdelovalec:
Pale red, oval film-coated tablet scored in one side.
Bledo rdeče, ovalne filmsko obložene tablete z razdelilno zarezo na eni strani.
In man, about 80% of the circulating memantine-related material is present as the parent compound.
Biotransformacija: Pri človeku je okoli 80 % memantina v obtoku v izvorni obliki.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovaje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Women taking Memantine LEK should not breast-feed.
Ženske, ki jemljejo zdravilo Memantin LEK, ne smejo dojiti.
What you need to know before you take Memantine LEK
Kaj morate vedeti, preden boste vzeli zdravilo Memantin LEK Ne jemljite zdravila Memantin LEK
Marketing Authorisation Holder Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greece
Imetnik dovoljenja za promet z zdravilom Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Grčija
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) per day.
Od 4. tedna dalje Bolnik mora jemati dve 10 mg filmsko obloženi tableti (20 mg) na dan.
Yellow, oval film-coated tablet scored in one side.
Rumene, ovalne filmsko obložene tablete, z razdelilno zarezo na eni strani.
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:
Najvišji dnevni odmerek je 20 mg. Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, dokler ni dosežen vzdrževalni odmerek, in sicer:
• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
• glavobol, zaspanost, zaprtje, zvišani jetrni funkcijski testi, omotica, motnje ravnotežja,
Administration of Memantine LEK is not recommended in patients with severe hepatic impairment.
Dajanje zdravila Memantin LEK bolnikom s hudo jetrno okvaro ni priporočeno.
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).
V temeljni klinični študiji pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3-14 točk na lestvici Kratkega preskusa spoznavnih sposobnosti (KPSS oz. MMSE ali "Mini-mental State Examination")) ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice Vtis sprememb na osnovi kliničnega intervjuja (CIBIC-plus - "Clinician's Interview-Based Impression of Change Plus Caregiver Input"): p=0,025; Vprašalnik vsakodnevnih aktivnosti (ADCS-ADLsev oz. "Alzheimer's Disease Consortium Studies Activities of Daily Living-modified for severe dementia"): p=0,003; Baterije za hudo prizadetost (SIB oz. "Severe Impairment Battery"): p=0,002).
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine LEK reassessed by your doctor on a regular basis.
Vaš zdravnik naj redno ocenjuje klinično korist zdravila Memantin LEK.
Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Pharmathen S.A , 6, Dervenakion str., 15351 Pallini, Attiki, Grčija ali Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Grčija ali
• The active substance is memantine hydrochloride.
Zdravilna učinkovina je memantinijev klorid.
Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, iron oxide yellow (E172) and iron oxide red (E-172)
Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E 171), smukec, rumen železov oksid (E 172) in rdeč železov oksid (E 172)
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Pri prekomernem odmerjanju do 140 mg ali pri neznanih odmerkih so se pri bolnikih pokazali simptomi povezani s centralnim živčnim sistemom (zmedenost, dremavost, zaspanost,
NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets
IME ZDRAVILA Memantin LEK 10 mg filmsko obložene tablete
week 1
Od 4. tedna dalje
Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Ena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
- If you get any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojo zdravnikom ali farmacevtom.
Memantine LEK 20 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 56, 98 and 100 tablets.
Memantin LEK 20 mg filmsko obložene tablete so na voljo v pretisnih omotih iz PVC / PVDCaluminija s 28, 30, 42, 56, 98 in 100 tablet.
No cytochrome P 450 catalysed metabolism has been detected in vitro.
NMDA. In vitro niso zaznali presnove preko citokroma P 450.
Film-coated tablet.
50 filmsko obloženih tablet.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
10 mg: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E
Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E 171), smukec in rumen železov oksid (E 172)
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.
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.
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
3. teden (15.-21. dan): Bolnik mora sedem dni jemati eno in pol 10 mg filmsko obloženo tableto (15 mg) na dan.
In patients with moderate renal impairment (creatinine clearance 30 - 49 mL/min) daily dose should be 10 mg per day.
30 - 49 ml/min) naj bo dnevni odmerek 10 mg.
Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse events of memantine were noted on fertility.
Memantin ni bil teratogen pri podganah in zajcih,
Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 50, 56, 60, 98, 100 and 112 film-coated tablets.
Al-PVC/PVDC pretisni omoti v kartonskih škatlah, ki vsebujejo 28, 30, 42, 50, 56, 60, 98, 100 in 112 filmsko obloženih tablet.
What Memantine LEK is and what it is used for
Kaj je zdravilo Memantin LEK in za kaj ga uporabljamo Kako deluje zdravilo Memantin LEK
Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 56, 98 and 100 filmcoated tablets.
Al-PVC/PVDC pretisni omoti v kartonskih škatlah, ki vsebujejo 28, 30, 42, 56, 98 in 100 filmsko obloženih tablet.
Each 20 mg tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Ena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina.
The patient should take one 20 mg film-coated tablet (20 mg) per day for 7 days.
Bolnik mora jemati eno 20 mg filmsko obloženo tableto na dan. Vzdrževalni odmerek
The film-coated tablets can be taken with or without food.
Zdravilo Memantin LEK je treba jemati enkrat dnevno in ga je treba vzeti ob istem času vsak dan. Filmsko obložene tablete se lahko jemlje s hrano ali brez nje.
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
2. teden (8.-14. dan): Bolnik mora sedem dni jemati eno 10 mg na dan filmsko obloženo tableto (10 mg) na dan.
Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
1. teden (1.-7. dan): Bolnik mora sedem dni jemati polovico 10 mg filmsko obložene tablete (5 mg) na dan.
Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Neznana pogostnost (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
half 10 mg tablet week 2
1. teden polovico 10 mg tablete
Package leaflet: Information for the user Memantine LEK 10 mg film-coated tablets Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Navodilo za uporabo Memantin LEK 10 mg filmsko obložene tablete Memantin LEK 20 mg filmsko obložene tablete memantinijev klorid
There are no or limited amount of data from the use of memantine in pregnant women.
Za memantin ni na voljo kliničnih podatkov o nosečnicah, ki so bile izpostavljene zdravilu.
How to store Memantine LEK
Shranjevanje zdravila Memantin LEK
NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Memantin LEK 20 mg filmsko obložene tablete memantinijev klorid
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODATKI NA ZUNANJI OVOJNINI ZUNANJI OVOJNINI