natgillin/translations-raw huggingface dataset:
By blocking these enzymes, Exelon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’ s dementia and dementia due to Parkinson’ s disease.
Zdravilo Exelon z blokiranjem teh dveh encimov omogoča povečanje ravni acetilholina v možganih, s čimer pomaga zmanjšati simptome Alzheimerjeve demence in demence zaradi Parkinsonove bolezni.
Exelon has been studied in mild to moderately severe Alzheimer’ s disease.
Zdravilo Exelon so preučevali pri blagi do zmerno hudi Alzheimerjevi bolezni.
The capsules have been studied in 2,126 patients in three main studies, and the transdermal patches in one main study involving 1,195 patients.
Kapsule so preučevali pri 2126 bolnikih v treh glavnih študijah, transdermalne obliže pa v eni glavni študiji, ki je vključevala 1195 bolnikov.
Exelon capsules have also been studied in 541 patients with dementia due to Parkinson’ s disease.
Kapsule Exelon so preučevali tudi pri 541 bolnikih z demenco zaradi Parkinsonove bolezni.
The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Glavno merilo učinkovitosti je bila sprememba simptomov na dveh glavnih področjih: kognitivnem (sposobnost mišljenja, učenja in pomnjenja) in globalnem (kombinacija več področij, vključno s splošno funkcijo, kognitivnimi simptomi, vedenjem in zmožnostjo izvajanja vsakodnevnih opravil).
An additional study in 27 patients was used to show that Exelon capsules and oral solution produced similar levels of the active substance in the blood.
Dodatna študija s 27 bolniki je pokazala, da so kapsule in peroralna raztopina Exelon vzpostavile podobno raven zdravilne učinkovine v krvi.
Exelon was more effective than placebo at controlling symptoms.
Zdravilo Exelon je bilo pri nadzorovanju simptomov učinkovitejše od placeba.
In the three studies of Exelon capsules in patients with Alzheimer’ s dementia, patients taking doses of Exelon between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
V treh študijah, izvedenih s kapsulami Exelon pri bolnikih z Alzheimerjevo demenco, je bilo pri bolnikih, ki so jemali zdravilo Exelon v odmerkih med 6 in 9 mg dnevno, povprečno povečanje kognitivnih simptomov za 0, 2 točke glede na izhodiščno vrednost 22, 9 točke na začetku študije, pri čemer označuje nižja vrednost boljši rezultat.
This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
To so primerjali s povečanjem za 2, 6 točke glede na 22, 5 točke pri bolnikih, ki so jemali placebo.
For the global score, patients taking Exelon capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Z vidika globalnega merila je pri bolnikih, ki so jemali kapsule Exelon, prišlo do povečanja simptomov za 4, 1 točke, v primerjavi s 4, 4 točke pri bolnikih, ki so jemali placebo.
The Exelon transdermal patches were also more effective than placebo in preventing dementia from getting worse.
Transdermalni obliži Exelon so bili učinkovitejši od placeba tudi pri preprečevanju poslabšanja demence.
The patients with dementia due to Parkinson’ s disease taking Exelon capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Pri bolnikih z demenco zaradi Parkinsonove bolezni, ki so jemali kapsule Exelon, je prišlo do izboljšanja kognitivnih simptomov za 2, 1 točke, v primerjavi s poslabšanjem za 0, 7 točke pri bolnikih, ki so jemali placebo, glede na izhodiščno vrednost približno 24 točk.
The global symptom score also improved more in the patients taking Exelon.
Tudi rezultat po globalnem merilu se je bolj izboljšal pri bolnikih, ki so jemali zdravilo Exelon.
The types of side effects seen with Exelon depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
Vrste neželenih učinkov, opaženih pri zdravilu Exelon, so odvisne od vrste demence, ki jo zdravimo, in od tega, ali se uporabljajo kapsule, peroralna raztopina ali transdermalni obliži.
Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick) and vomiting, particularly during the phase when the dose of Exelon is being increased.
V splošnem sta najpogostejša neželena učinka (opažena pri več kot 1 bolniku izmed 10) navzeja (slabost) in bruhanje, zlasti med fazo povečevanja odmerka zdravila Exelon.
For the full list of all side effects reported with Exelon, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Exelon, glejte navodilo za uporabo.
Exelon should not be used in people who may be hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Zdravila Exelon ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) rivastigmin, druge derivate karbamata ali katero koli drugo sestavino zdravila.
It should not be used in patients with severe liver problems.
Prav tako ga ne smejo uporabljati bolniki s hudimi težavami z jetri.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Exelon has a modest effectiveness in treating the symptoms of Alzheimer’ s dementia, although this does reflect an important benefit in some patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da ima zdravilo Exelon pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta predstavlja pomembno korist pri nekaterih bolnikih.
The Committee initially concluded that for the treatment of dementia due to Parkinson’ s disease, Exelon’ s benefits did not outweigh its risks.
Odbor je sprva sklenil, da koristi zdravila Exelon pri zdravljenju demence zaradi Parkinsonove bolezni ne odtehtajo tveganj.
However, following a re-examination of this opinion, the Committee concluded that the medicine’ s modest effectiveness could also be of benefit to some patients.
Vendar pa je Odbor po ponovni preučitvi tega mnenja sklenil, da je lahko skromen učinek zdravila vseeno koristen za nekatere bolnike.
Therefore, the Committee decided that Exelon’ s benefits are greater than its risks for the treatment of mild to moderately severe Alzheimer’ s dementia and mild to moderately severe dementia in patients with idiopathic Parkinson ’ s disease.
Posledično je Odbor odločil, da so koristi zdravila Exelon pri zdravljenju blage do zmerno hude Alzheimerjeve demence in blage do zmerno težke demence pri bolnikih z idiopatsko Parkinsonovo boleznijo večje od z njim povezanih tveganj.
The Committee recommended that Exelon be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Exelon odobri dovoljenje za promet.
2/ 3 Other information about Exelon:
2/ 3 Druge informacije o zdravilu Exelon:
The European Commission granted a marketing authorisation valid throughout the European Union to Novartis Europharm Limited for Exelon on 12 May 1998.
Evropska komisija je dovoljenje za promet z zdravilom Exelon, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 12. maja 1998.
The marketing authorisation was renewed on 12 May 2003 and on 12 May 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno 12. maja 2003 in 12. maja 2008.
The full EPAR for Exelon can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Exelon je na voljo tukaj.
EU Number EU/ 1/ 98/ 066/ 001 EU/ 1/ 98/ 066/ 002 EU/ 1/ 98/ 066/ 003 EU/ 1/ 98/ 066/ 004 EU/ 1/ 98/ 066/ 005 EU/ 1/ 98/ 066/ 006 EU/ 1/ 98/ 066/ 007 EU/ 1/ 98/ 066/ 008 EU/ 1/ 98/ 066/ 009 EU/ 1/ 98/ 066/ 010 EU/ 1/ 98/ 066/ 011 EU/ 1/ 98/ 066/ 012
Številka EU EU/ 1/ 98/ 066/ 001 EU/ 1/ 98/ 066/ 002 EU/ 1/ 98/ 066/ 003 EU/ 1/ 98/ 066/ 004 EU/ 1/ 98/ 066/ 005 EU/ 1/ 98/ 066/ 006 EU/ 1/ 98/ 066/ 007 EU/ 1/ 98/ 066/ 008 EU/ 1/ 98/ 066/ 009 EU/ 1/ 98/ 066/ 010 EU/ 1/ 98/ 066/ 011 EU/ 1/ 98/ 066/ 012
Invented name Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon
zaščiteno ime Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon
Strength 1.5 mg 1.5 mg 1.5 mg 3 mg 3 mg 3 mg 4.5 mg 4.5 mg 4.5 mg 6 mg 6 mg 6 mg
jakost 1, 5 mg 1, 5 mg 1, 5 mg 3 mg 3 mg 3 mg 4, 5 mg 4, 5 mg 4, 5 mg 6 mg 6 mg 6 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
farmacevtska oblika kapsula, trda kapsula, trda kapsula, trda kapsula, trda kapsula, trda kapsula, trda kapsula, trda kapsula, trda kapsula, trda kapsula, trda kapsula, trda kapsula, trda
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
pot uporabe peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
Packaging blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu)
ovojnina pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij)
Package size 28 56 112 28 56 112 28 56 112 28 56 112
velikost pakiranja 28 56 112 28 56 112 28 56 112 28 56 112
Oral solution Capsule, hard Capsule, hard Capsule, hard Capsule, hard
peroralna raztopina
Oral use Oral use Oral use Oral use Oral use
peroralna uporaba
bottle (amber glass) bottle (HDPE) bottle (HDPE) bottle (HDPE) bottle (HDPE)
steklenica (temno obarvano steklo)
1 bottle 250 250 250 250
250 250 250 250
4.6 mg/ 24 h
4, 6 mg / 24 h
sachet (paper/ polyester/ alu/ polyacrylonitrile)
vrečka (papir/ poliester/ aluminij/ polia krilonitril)
60 sachets (30x2 sachets)
60 vrečk (30x2 vrečki)
90 sachets (30x3 sachets)
90 vrečk (30x3 vrečke)
9.5 mg/ 24 h
9, 5 mg / 24 h
Exelon 1.5 mg hard capsules
Exelon 1, 5 mg trde kapsule
Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg.
Vsaka kapsula vsebuje rivastigminijev hidrogentartrat, ki ustreza 1, 5 mg rivastigmina.
Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ EXELON 1,5 mg ” on body.
Belkast do rahlo rumen prašek v kapsuli z rumenim pokrovčkom in rumenim telesom kapsule z rdečim napisom “ EXELON 1, 5 mg ”.
Symptomatic treatment of mild to moderately severe Alzheimer’ s dementia.
Simptomatsko zdravljenje blage do zmerno težke Alzheimerjeve demence.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’ s disease.
Simptomatsko zdravljenje blage do zmerno težke demence pri bolnikih z idiopatsko Parkinsonovo boleznijo.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’ s dementia or dementia associated with Parkinson’ s disease.
Zdravljenje mora uvesti in nadzorovati zdravnik, ki je izkušen v diagnostiki in zdravljenju Alzheimerjeve demence ali demence, povezane s Parkinsonovo boleznijo.
Initial dose 1.5 mg twice a day.
Začetni odmerek 1, 5 mg dvakrat na dan.
Dose titration The starting dose is 1.5 mg twice a day.
Titriranje odmerka Začetni odmerek je 1, 5 mg dvakrat na dan.
Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
Tudi poznejše povečanje odmerka na 4, 5 mg in nato na 6 mg dvakrat na dan mora temeljiti na dobrem prenašanju trenutnega odmerka in lahko pride v poštev po najmanj dveh tednih zdravljenja s tem odmerkom.
If adverse reactions (e. g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e. g. tremor) in patients with dementia associated with Parkinson’ s disease are observed during treatment, these may respond to omitting one or more doses.
Če med zdravljenjem opazimo neželene učinke (npr. navzeo, bruhanje, bolečine v trebuhu ali izgubo teka), hujšanje ali poslabšanje ekstrapiramidnih simptomov (npr. tremorja) pri bolnikih z demenco v povezavi s Parkinsonovo boleznijo, se utegnejo le- ti odzvati na opustitev enega ali več odmerkov.
Maintenance dose The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose.
Za dosego največjega zdravilnega učinka moramo bolnike vzdrževati na največjem odmerku, ki ga še dobro prenašajo.
2 Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
2 Vzdrževalno zdravljenje lahko nadaljujemo, dokler ima bolnik od njega terapevtske koristi.
If after 3 months of maintenance dose treatment the patient’ s rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued.
Če se po treh mesecih vzdrževalnega odmerka slabšanje simptomov demence ne spremeni v bolnikovo korist, je treba zdravljenje prekiniti.
However, a greater treatment effect was seen in Parkinson’ s disease patients with moderate dementia.
Vendar pa so boljši terapevtski učinek opazili pri tistih bolnikih s Parkinsonovo boleznijo, ki so imeli zmerno demenco.
Similarly a larger effect was observed in Parkinson’ s disease patients with visual hallucinations (see section 5.1).
Prav tako so boljši učinek opazili pri tistih bolnikih s Parkinsonovo boleznijo, ki so imeli vidne halucinacije (glejte poglavje 5. 1).
Re-initiation of therapy If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily.
Ponoven začetek zdravljenja Če je zdravljenje prekinenjeno za več kot nekaj dni, ga moramo spet začeti z odmerkom 1, 5 mg dvakrat na dan.
Renal and hepatic impairment Due to increased exposure in moderate renal and mild to moderate hepatic impairment, dosing recommendations to titrate according to individual tolerability should be closely followed (see section 5.2).
Okvare ledvic in jeter Zaradi povečane izpostavljenosti zdravilu pri zmernih ledvičnih in blagih do zmernih jetrnih okvarah se moramo natančno ravnati po priporočilih, naj se odmerjanje titrira glede na individualno prenašanje (glejte poglavje 5. 2).
Patients with severe liver impairment have not been studied (see section 4.3).
Uporabe zdravila pri bolnikih s težko jetrno okvaro niso proučili (glejte poglavje 4. 3).
Children Rivastigmine is not recommended for use in children.
Otroci Uporaba rivastigmina pri otrocih ni priporočljiva.
The use of this medicinal product is contraindicated in patients with
Uporaba tega zdravila je kontraindicirana pri bolnikih, ki imajo
- hypersensitivity to the active substance, other carbamate derivatives or to any of the excipients
- preobčutljivost za zdravilno učinkovino, druge derivate karbamata ali katerokoli pomožno snov,
used in the formulation,
uporabljeno v pripravku,
- severe liver impairment, as it has not been studied in this population.
- težko jetrno okvaro, ker zdravila pri tej skupini niso proučili.
If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily to reduce the possibility of adverse reactions (e. g. vomiting).
Če zdravljenje prekinemo za več kot nekaj dni, ga moramo spet začeti z odmerkom 1, 5 mg dvakrat na dan, da zmanjšamo možnost neželenih učinkov (na primer bruhanja).
Dose titration:
Titriranje odmerka:
Adverse reactions (e. g. hypertension and hallucinations in patients with Alzheimer’ s dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson’ s disease) have been observed shortly after dose increase.
V kratkem času po povečanju odmerka so opazili neželene učinke (npr. hipertenzijo in halucinacije pri bolnikih z Alzheimerjevo demenco in poslabšanje ekstrapiramidnih simptomov pri bolnikih z demenco v povezavi s Parkinsonovo boleznijo).
They may respond to a dose reduction.
Le- ti se utegnejo odzvati na zmanjšanje odmerka.
In other cases, Exelon has been discontinued (see section 4.8).
V drugih primerih so Exelon ukinili (glejte poglavje 4. 8).
Gastrointestinal disorders such as nausea and vomiting may occur particularly when initiating treatment and/ or increasing the dose.
Prebavne motnje, na primer navzea in bruhanje, se lahko pojavijo predvsem na začetku zdravljenja in/ ali ob povečanju odmerka.
Patients with Alzheimer’ s disease may lose weight.
Bolniki z Alzheimerjevo boleznijo včasih hujšajo.
During therapy patient’ s weight should be monitored.
Med zdravljenjem moramo spremljati bolnikovo telesno maso.
In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
V primeru hudega bruhanja v povezavi z zdravljenjem z rivastigminom je treba ustrezno prilagoditi odmerek, kot je priporočeno v poglavju 4. 2.
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
V nekaterih primerih je bilo hudo bruhanje povezano z rupturo požiralnika (glejte poglavje 4. 8).
3 Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
3 Previdnost je potrebna pri uporabi rivastigmina pri bolnikih s sindromom bolnega sinusnega vozla ali prevodnimi motnjami (sinuatrialni blok, atrioventrikularni blok) (glejte poglavje 4. 8).
The use of rivastigmine in patients with severe dementia of Alzheimer’ s disease or associated with Parkinson’ s disease, other types of dementia or other types of memory impairment (e. g. age-related cognitive decline) has not been investigated and therefore use in these patient populations is not recommended.
Uporabe rivastigmina pri bolnikih s težko demenco pri Alzheimerjevi bolezni ali demenco, povezano s Parkinsonovo boleznijo, z drugimi vrstami demence ali drugimi vrstami spominskih okvar (na primer starostnega kognitivnega upada) niso raziskali, zato uporaba pri teh skupinah bolnikov ni priporočena.
Worsening (including bradykinesia, dyskinesia, gait abnormality) and an increased incidence or severity of tremor have been observed in patients with dementia associated with Parkinson’ s disease (see section 4.8).
Pri bolnikih z demenco v povezavi s Parkinsonovo boleznijo so opazili poslabšanje (ki vključuje bradikinezijo, diskinezijo in motnje drže) in povečano pojavnost in intenzivnost tremorja (glejte poglavje 4. 8).
These events led to the discontinuation of rivastigmine in some cases (e. g. discontinuations due to tremor 1.7% on rivastigmine vs 0% on placebo).
Zaradi teh težav so v nekaterih primerih prekinili zdravljenje z rivastigminom (npr. z rivastigminom 1, 7% prekinitev zaradi tremorja v primerjavi z 0% pri placebu).
In view of its pharmacodynamic effects, rivastigmine should not be given concomitantly with other cholinomimetic substances and might interfere with the activity of anticholinergic medicinal products.
Rivastigmin lahko moti delovanje antiholinergičnih zdravil.
For rivastigmine no clinical data on exposed pregnancies are available.
Za rivastigmin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
In peri/ postnatal studies in rats, an increased gestation time was observed.
V perinatalnih in postnatalnih študijah pri podganah so opazili podaljšano obdobje brejosti.
Alzheimer’ s disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
Alzheimerjeva bolezen lahko povzroči postopno zmanjšanje sposobnosti upravljanja motornih vozil ali zmanjša sposobnost uporabe strojev.
Therefore, the ability of patients with dementia on rivastigmine to
Zato mora lečeči zdravnik pri
4 continue driving or operating complex machines should be routinely evaluated by the treating physician.
4 bolnikih z demenco, ki jemljejo rivastigmin, redno ocenjevati sposobnost za upravljanje motornih vozil ali zapletenih strojev.
The most commonly reported adverse reactions are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Najpogosteje so poročali o gastrointestinalnih neželenih učinkih, med drugim o navzei (38%) in bruhanju (23%), posebno med titriranjem odmerka.
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’ s dementia treated with Exelon.
Neželene učinke, navedene v spodnji preglednici 1, so zbrali pri bolnikih z Alzheimerjevo demenco, zdravljenih z Exelonom.
Very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000) and not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni po skupinah glede na pogostnost, najpogostejši najprej, po naslednjem dogovoru: zelo pogosti (≥1/ 10); pogosti (≥1/ 100 do < 1/ 10); občasni (≥1/ 1. 000 do < 1/ 100); zelo redki (< 1/ 10. 000) in pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very rare
zelo redko
Psychiatric disorders Nervous
Psihiatrične motnje
Common Common Uncommon Uncommon Very rare system disorders Very common Common Common Common Uncommon Rare Very rare
pogosto pogosto občasno občasno zelo redko
Agitation Confusion Insomnia Depression Hallucinations Dizziness Headache Somnolence Tremor Syncope Seizures Extrapyramidal symptoms (including worsening of Parkinson’ s disease)
agitiranost zmedenost nespečnost depresija halucinacije
Cardiac
Bolezni živčevja
disorders Rare Very rare
zelo redko pogosto pogosto pogosto občasno redko zelo redko
Angina pectoris Cardiac arrhythmia (e. g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
vrtoglavost glavobol somnolenca tremor sinkopa epileptični napadi ekstrapiramidni simptomi (vključno s poslabšanjem Parkinsonove bolezni)
Very rare
redko zelo redko
Hypertension
angina pektoris srčne aritmije (npr. bradikardija, atrioventrikularni blok, atrijska fibrilacija in tahikardija)
Gastrointestinal disorders
Žilne bolezni Bolezni
Very common Very common Very common Common Rare Very rare Very rare Not known
zelo redko prebavil zelo pogosto zelo pogosto zelo pogosto pogosto redko zelo redko zelo redko
Nausea Vomiting Diarrhoea Abdominal pain and dyspepsia Gastric and duodenal ulcers Gastrointestinal haemorrhage Pancreatitis Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
hipertenzija navzea bruhanje driska bolečine v trebuhu in dispepsija razjede želodca in dvanajstnika krvavitev v prebavila pankreatitis
Metabolism and nutritional disorders
pogostnost neznana
Very common
v nekaterih primerih je bilo hudo bruhanje povezano z rupturo požiralnika (glejte poglavje 4. 4)
Anorexia
Presnovne in prehranske motnje Bolezni
Hepatobiliary disorders
zelo pogosto jeter, žolčnika in žolčevodov občasno
Elevated liver function tests
anoreksija zvišani jetrni funkcijski testi
5 Skin and subcutaneous tissue disorders General
5 Bolezni kože in podkožja povečano potenje pogosto izpuščaji redko Splošne težave in spremembe na mestu aplikacije
Common Common Uncommon
pogosto pogosto občasno
Fatigue and asthenia Malaise Accidental fall
utrujenost in astenija splošno slabo počutje nezgodni padec
Common
pogosto
Weight loss
shujšanje
The following additional adverse reactions have been observed with Exelon transdermal patches: anxiety, delirium, pyrexia (common).
Pri uporabi transdermalnih obližev Exelon so dodatno opažali še naslednje neželene učinke: tesnobo, delirij, zvišano telesno temperaturo (pogosto).