natgillin/translations-raw huggingface dataset:
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).
V nekaterih primerih so zaradi teh dogodkov zdravljenje z rivastigminom prekinili (npr. pri zdravljenju z rivastigminom so zaradi tremorja prekinili 1,7 % zdravljenj, pri placebu pa 0 %).
In other cases, rivastigmine has been discontinued (see section 4.8).
V drugih primerih so zdravljenje z rivastigminom prekinili (glejte poglavje 4.8).
When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals.
Če so izpostavljenost rivastigminu in njegovim presnovkom normalizirali glede na telesno površino, je bila izpostavljenost približno enakovredna največjem priporočenem odmerku pri človeku, 12 mg/dan; vendar so v primerjavi z največjim odmerkom pri človeku, pri živalih dosegli 6-krat večji odmerek.
In animals, rivastigmine crosses the placenta and is excreted into milk.
Pri živalih rivastigmin prehaja skozi placento in se izloča v mleko.
The secondary definition of response required a 4-point or greater improvement on the ADAS-Cog, no worsening on the CIBIC-Plus, and no worsening on the PDS.
Za sekundarno opredelitev odziva je bilo potrebno izboljšanje rezultata ADAS-Cog za 4 točke ali več, odsotnost poslabšanja rezultata CIBIC-Plus, in odsotnost poslabšanja rezultata PDS.
However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more adverse reactions (see sections 4.4 and 5.2).
Vendar se je treba zaradi povečane izpostavljenosti pri bolnikih pri teh populacijah natančno ravnati po priporočilih, naj se odmerjanje titrira glede na posameznikovo prenašanje, saj je pri bolnikih s klinično pomembno okvaro ledvic ali jeter lahko število neželenih učinkov večje (glejte poglavji 4.4 in 5.2).
This medicinal product does not require any special storage instructions.
Za shranjevanje zdravila niso potrebna posebna navodila.
Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.
Aktivnost encima se vrne na izhodiščno raven približno po 9 urah po doseženem največjem zaviralnem učinku.
However a greater treatment effect was seen in Parkinson's disease patients with moderate dementia.
Vendar so večji učinek zdravljenja opazili pri bolnikih s Parkinsonovo boleznijo z zmerno demenco.
Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Peroralne študije pri brejih podganah niso pokazale nikakršnega teratogenega potenciala rivastigmina.
Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10 - 24.
Bolniki, ki so sodelovali v študiji so imeli rezultat MMSE (kratek preizkus spoznavnih sposobnosti - MiniMental State Examination) 10 - 24.
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Simptomatsko zdravljenje blage do zmerne Alzheimerjeve demence.
Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Podobno so večji učinek opazili pri bolnikih s Parkinsonovo boleznijo z vidnimi halucinacijami (glejte poglavje 5.1).
• Aggression , feeling restless
• agresivnost, občutek nemira
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.
4.2 Odmerjanje in način uporabe Zdravljenje mora začeti in nadzirati zdravnik z izkušnjami v diagnosticiranju in zdravljenju Alzheimerjeve demence ali demence, povezane s Parkinsonovo boleznijo.
Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Rivastigmin je zaviralec acetil- in butirilholinesteraze karbamatnega tipa, za katerega menijo, da pomaga pri holinergični nevrotransmisiji tako, da upočasni razgradnjo acetilholina, ki ga sproščajo funkcionalno intaktni holinergični nevroni.
Patients with mild dementia (MMSE 18-24)
Bolniki z blago demenco (MMSE
Children Rivastigmine is not recommended for use in children.
Uporaba rivastigmina pri otrocih ni priporočljiva.
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).
Pri uporabi rivastigmina pri bolnikih s sindromom bolnega sinusnega vozla ali motnjami prevodnosti (sinuatrialni blok, atrioventrikularni blok) je potrebna previdnost (glejte poglavje 4.8).
Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
V preskušanjih, nadzorovanih s placebom učinka zdravljenja niso raziskovali dlje kot 6 mesecev.
Other side effects seen with Rivastigmine transdermal patches and which may occur with hard capsules:
Drugi neželeni učinki, ki so jih opažali pri uporabi transdermalnih obližev in bi se lahko pojavili tudi pri uporabi trdih kapsul: Pogosti
No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Neugodnih učinkov na srčno prevodnost po sočasni uporabi digoksina in rivastigmina niso opazili.
If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily.
Če se zdravljenje prekine za več kot nekaj dni, ga je treba začeti znova pri odmerku 1,5 mg dvakrat na dan.
4.9 Overdose Symptoms
4.9 Preveliko odmerjanje Simptomi
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
During therapy patient's weight should be monitored.
Med zdravljenjem je treba spremljati telesno maso bolnikov.
In this leaflet: What Rivastigmine Teva is and what it is used for
KAJ JE ZDRAVILO RIVASTIGMINE TEVA IN ZA KAJ GA UPORABLJAMO
The recommended maximum daily dose is 6 mg twice a day.
Priporočen največji dnevni odmerek je 6 mg dvakrat na dan.
What Rivastigmine Teva looks like and contents of the pack
Izgled zdravila Rivastigmine Teva in vsebina pakiranja
INFORMATION IN BRAILLE Rivastigmine Teva 1.5 mg
PODATKI V BRAILLOVI PISAVI Rivastigmine Teva 1,5 mg
Patients with severe hepatic impairment have not been studied (see section 4.4).
Bolnikov s hudo jetrno okvaro niso raziskovali (glejte poglavje 4.4).
Take special care with Rivastigmine Teva
Bodite posebno pozorni pri jemanju zdravila Rivastigmine Teva
The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine.
Uporaba rivastigmina ne vpliva na povečanje protrombinskega časa, ki ga povzroči varfarin.
You should not breast-feed during treatment with Rivastigmine Teva.
Med zdravljenjem z zdravilom Rivastigmine Teva ne smete dojiti.
According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Na podlagi presnove je videti, da presnovne interakcije z drugimi zdravili niso verjetne, vendar lahko rivastigmin zavira presnovo drugih snovi, ki jo uravnava butirilholinesteraza.
If you take more Rivastigmine Teva than you should If you accidentally take more Rivastigmine Teva than you should, inform your doctor.
Če nehote vzamete več zdravila Rivastigmine Teva, kot bi smeli, obvestite svojega zdravnika.
Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Klinične študije pri demenci, povezani s Parkinsonovo boleznijo Učinkovitost rivastigmina pri demenci, povezani s Parkinsonovo boleznijo so pokazali v 24-tedenski multicentrični, dvojno slepi, s placebom nadzorovani osrednji študiji in naknadni 24-tedenski odprti fazi.
Caution is recomemended when selecting anaesthetic agents.
Pri izbiri anestetika je priporočena previdnost.
Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease and Parkinson's disease.
Zato rivastigmin zmanjša holinergični primanjkljaj pri demenci, povezani z Alzheimerjevo in Parkinsonovo boleznijo.
Do not use Rivastigmine Teva after the expiry date that is stated on the carton.
Zdravila Rivastigmine Teva ne smete uporabljati po izteku roka uporabnosti, ki je naveden na zunanji ovojnini.
No evidence of carcinogenicity was found in studies in mice and rats at the maximum tolerated dose, although the exposure to rivastigmine and its metabolites was lower than the human exposure.
V študijah pri miših in podganah z največjim odmerkom, ki so ga živali prenašale, niso ugotovili nikakršnih dokazov za kancerogenost, vendar je bila izpostavljenost rivastigminu in njegovim presnovkom manjša kot pri človeku.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Simptomatsko zdravljenje blage do zmerne demence pri bolnikih z idiopatsko Parkinsonovo boleznijo.
Yellow iron oxide (E 172)
rdeči železov oksid (E 172)
Very rare Not known
Zelo redki Neznana
• High blood pressure
Zelo redki • visok krvni tlak
If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tolerated dose or the treatment may be discontinued.
Če se neželeni učinki ne prenehajo, je treba dnevni odmerek začasno zmanjšati na prejšnjega, ki ga je bolnik še dobro prenašal, ali prekiniti zdravljenje.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva Pharma B.V.
In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40 % within the first 1.5 hours after administration.
Pri zdravih mladih moških peroralni 3-miligramski odmerek zmanjša aktivnost acetilholinesteraze (AChE) v cerebrospinalni tekočini za približno 40 % v prvi 1,5 uri po uporabi.
Re-initiation of therapy:
Ponoven začetek zdravljenja:
Total patients studied Total patients with pre-defined AE(s) Tremor
Skupno število bolnikov v študiji Skupno število bolnikov z vnaprej opredeljenimi neželenimi dogodki
Slow heart beat and fainting may also occur.
Lahko pride tudi do počasnega utripa srca in omedlevice.
Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
V kliničnih študijah so ugotovili, da so bolnice bolj dovzetne za gastrointestinalne neželene učinke in izgubo telesne mase kot moški bolniki.
Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Kot drugi holinomimetiki, lahko tudi rivastigmin poslabša ali sproži ekstrapiramidalne simptome.
2 Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
ITT: Intent-To-Treat (namera zdravljenja); RDO: Retrieved Drop Outs (nadomeščeni izpadli); LOCF: Last Observation Carried Forward (zadnje opažanje preneseno naprej).
In patients with Alzheimer's disease, inhibition of AChE in CSF by rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
Pri bolnikih z Alzheimerjevo boleznijo je bilo zaviranje AChE v cerebrospinalni tekočini odvisno od odmerka do 6 mg rivastigmina dvakrat na dan, kar je bil največji preskušeni odmerek.
Rivastigmine Teva might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
(zdravil, ki se uporabljajo za lajšanje želodčnih krčev ali spazmov, za zdravljenje Parkinsonove bolezni ali za preprečevanje potovalne bolezni).
Subjects with hepatic impairment:
Bolniki z ledvično okvaro:
Very common (affects more than 1 patient in 10) Common (affects 1 to 10 patients in 100) Uncommon (affects 1 to 10 patients in 1,000) Rare (affects 1 to 10 patients in 10, 000) Very rare (affects less than 1 patient in 10,000) Not known (frequency cannot be estimated from the available data)
Pogostnosti so opredeljene, kot sledi: zelo pogosti (pojavijo se pri več kot 1 bolniku od 10 bolnikov) pogosti (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov) občasni (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov) redki (pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov) zelo redki (pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov) neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
Care should be exercised in treating patients with active gastric or duodenal ulcers or patients predisposed to these conditions.
Pri zdravljenju bolnikov z aktivnimi razjedami želodca ali dvanajstnika, ali bolnikov, ki so tem boleznim nagnjeni, je potrebna previdnost.
Rivastigmine Teva 1.5 mg hard capsules Rivastigmine Teva 3 mg hard capsules Rivastigmine Teva 4.5 mg hard capsules Rivastigmine Teva 6 mg hard capsules Rivastigmine
Rivastigmine Teva 1,5 mg trde kapsule Rivastigmine Teva 3 mg trde kapsule Rivastigmine Teva 4,5 mg trde kapsule Rivastigmine Teva 6 mg trde kapsule rivastigmin
This medicinal product does not require any special storage conditions Medicines should not be disposed of via wastewater or household waste.
Zdravil ne smete odstraniti v odpadne vode ali gospodinjske odpadke.
The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26-week multicentre studies in patients with mild-to-moderately severe Alzheimer's Dementia, are provided in Table 4 below.
V tabeli 4 spodaj so navedeni rezultati za bolnike, ki so se klinično pomembno odzivali na zdravljenje, zbrane iz dveh študij s prožnimi odmerki med tremi ključnimi 26-tedenskimi multicentričnimi študijami pri bolnikih z blago do zmerno Alzheimerjevo demenco.
Cmax and AUC of rivastigmine were more than twice as high in subjects with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in subjects with severe renal impairment.
Pri bolnikih z zmerno ledvično okvaro sta bili vrednosti Cmax in AUC rivastigmina več kot dvakrat večji, kot pri zdravih osebah; vendar pri osebah s hudo ledvično okvaro sprememb vrednosti Cmax in AUC rivastigmina niso opazili.
The efficacy of rivastigmine has been established through the use of three independent, domain specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods.
Učinkovitost rivastigmina so ugotovili s tremi neodvisnimi orodji za ocenjevanje, specifičnimi za to področje.
- 50 x 1 capsules in PVC/Alu push through perforated unit dose blisters Not all pack sizes may be marketed.
- 50 x 1 kapsula v pretisnem omotu iz PVC/Alu, perforiranem za enkratne odmerke.
Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90 %) within 24 hours.
V 24 urah po uporabi 14C-rivastigmina je bilo izločanje skozi ledvice hitro in skoraj popolno
Protein binding of rivastigmine is approximately 40 %.
Približno 40 % rivastigmina se veže na beljakovine plazme.
The active substance is rivastigmine
Zdravilna učinkovina je rivastigmin.
Dose titration: 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.
Titracija odmerkov: Kmalu po povečanju odmerka so opazili neželene učinke (npr. hipertenzijo in halucinacije pri bolnikih z Alzheimerjevo demenco ter poslabšanje ekstrapiramidnih simptomov, zlasti tremorja, pri bolnikih z demenco, povezano s Parkinsonovo boleznijo).
Adjusted treatment difference p-value versus placebo
Prilagojena razlika v zdravljenju vrednost p v primerjavi s placebom
You may have side effects more often when you start your medicine or when your dose is increased.
Neželeni učinki bodo morda pogostejši ob začetku zdravljenja in ob zviševanju odmerka.
Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Pogostnost je definirana s pomočjo naslednjega dogovora: zelo pogosti (> 1/10); pogosti (> 1/100 do < 1/10); občasni (> 1/1000 do < 1/100); redki (> 1/10.000 do < 1/1000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
- 28, 56 or 112 capsules in transparent PVC/Alu push through blisters
- 28, 50, 56 ali 112 kapsul v prosojnem pretisnem omotu iz PVC/Alu.
Taking this medicine
Kako jemati to zdravilo
Capsule contents - microcrystalline cellulose, hypromellose, colloidal silicon dioxide, magnesium stearate.
Pomožne snovi so: vsebina kapsule - mikrokristalna celuloza, hipromeloza, koloidni silicijev dioksid, magnezijev stearat.
The PSUR submission schedule for Rivastigmine TEVA hard capsules should follow PSURs submission schedule for the reference medicinal product.
Načrt oddajanja PSUR-ov mora biti usklajen z načrtom oddajanja PSUR-ov za referenčno zdravilo.
Bottles 250 hard capsules
Steklenice 250 trdih kapsul
Cholinomimetics may induce or exacerbate urinary obstruction and seizures.
Holinomimetiki lahko sprožijo ali poslabšajo obstrukcijo sečil in epileptične napade.
As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours.
9 ur, zato je pri asimptomatičnem prevelikem odmerjanju priporočljivo naslednjih 24 ur prekiniti dajanje dodatnih odmerkov rivastigmina.
Metabolism and nutrition disorders Very common
Presnovne in prehranske motnje Zelo pogosti
If you have to undergo surgery whilst taking Rivastigmine Teva, tell your doctor before you are given any anaesthetics, because Rivastigmine Teva may exaggerate the effects of some muscle relaxants during anaesthesia.
preden vam dajo kakršenkoli anestetik, ker lahko zdravilo Rivastigmine Teva okrepi učinke nekaterih mišičnih relaksantov med anestezijo.
Pallagi út 13
Swensweg 5
Mean change at 24 weeks ± SD
Povprečna sprememba po 24
Sick sinus syndrome
Bolezen sinusnega vozla
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine.
V tabeli 1 spodaj so prikazani neželeni učinki, ki so jih zbrali pri bolnikih z Alzheimerjevo demenco, ki so jemali rivastigmin.
Initial dose: 1.5 mg twice a day.
Začetni odmerek: 1,5 mg dvakrat na dan.
NAME OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva Pharma B.V.
Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients.
Z izgubo telesne mase pri teh bolnikih so povezani zaviralci holinesteraze, vključno z rivastigminom.
No dose adjustment is necessary for patientS with mild to moderate renal or hepatic impairment.
Pri bolnikih z blago do zmerno okvaro ledvic ali jeter ni potrebno prilagajati odmerjanja.
Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Alzheimerjeva bolezen lahko postopno zmanjša sposobnost vožnje ali poslabša zmožnost upravljanja s stroji.
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Nekateri primeri hudega bruhanja so bili povezani z rupturo ezofagusa (glejte poglavje 4.8).
- if you have, or have ever had, asthma or severe respiratory disease.
- če imate ali ste kadarkoli imeli težave z uriniranjem, - če imate ali ste kadarkoli imeli epileptične napade, - če imate ali ste kadarkoli imeli astmo ali hudo bolezen dihal,
Iron oxide black
črni železov oksid amonijev hidroksid
You may become dehydrated (losing too much fluid) if vomiting or diarhoea are prolonged.
Če bruhanje ali driska trajata dolgo, lahko postanete dehidrirani (izgubite preveč tekočine).
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, povezano s Parkinsonovo boleznijo, so opazili poslabšanje (vključno z bradikinezijo, diskinezijo in motnjami hoje) in povečano pogostnost ali stopnjo tremorja (glejte poglavje 4.8).
Ink used for imprinting - Black S-1-17822/S-1-17823 Shellac glaze-45%
Ovoj kapsule: titanov dioksid (E 171) želatina črnilo za tisk - črno S-1-17822/S-1-17823: glazura iz šelaka - 45 %
- if you have, or have ever had, an active stomach ulcer.
- če imate ali ste kadarkoli imeli aktivno razjedo na želodcu,
Capsule contents Microcrystalline cellulose Hypromellose Colloidal silicon dioxide Magnesium stearate
mikrokristalna celuloza hipromeloza koloidni silicijev dioksid magnezijev stearat
As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Kot zaviralec holinesteraze lahko rivastigmin poslabša učinke sukcinilholinskih mišičnih relaksantov med anestezijo.
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
Nekateri primeri hudega bruhanja so bili povezani z rupturo ezofagusa (glejte poglavje 4,4).
Swallow the capsules whole with a drink.
• Kapsule pogoltnite cele z nekaj tekočine.
Dose titration:
Titracija odmerkov:
Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Bolnikom z astmo ali obstrukcijsko pljučno boleznijo v anamnezi je treba zaviralce holinesteraze predpisovati previdno.
Movement disorder Bradykinesia
Diskinezija Parkinsonizem Hipokinezija Motnje gibanja Bradikinezija Distonija Motnje pri hoji
Rivastigmine Teva 1.5 mg hard capsules contains 1.5 mg rivastigmine as rivastigmine hydrogen tartrate
Zdravilo Rivastigmine Teva 1.5 mg trde kapsule vsebuje 1,5 mg rivastigmina v obliki rivastigminhidrogentartrata.
They also have some additional side effects:
Pri teh bolnikih so nekateri neželeni učinki bolj pogosti, poleg tega pa se pri njih pojavljajo nekateri dodatni neželeni učinki:
- If you have gastrointestinal reactions such as feeling sick (nausea) and being sick (vomiting) and diarrhoea.
- če imate prebavne težave, kot so slabost s siljenjem na bruhanje (navzea), bruhanje in driska.
Fatigue and asthenia
Utrujenost in astenija
Abdominal pain and dyspesia
Bolečine v trebuhu in dispepsija
- HDPE tablet container with a polypropylene cap and induction seal: 250 capsules
- Plastenka iz HDPE s polipropilenskim pokrovčkom in indukcijsko zatesnjenim vsebnikom:
• Feeling agitated
• občutek nemira
- Rivastigmine Teva 1.5 mg hard capsules: White cap imprinted with “R” & white body
- Rivastigmine Teva 1,5 mg trde kapsule: bela kapa z natisnjenim napisom »R« in belo telo z natisnjenim napisom »1.5«.
Hard capsule Orange colour cap imprinted with “R” & orange color body imprinted with “4.5”
Trda kapsula Kapa oranžne barve z natisnjenim napisom »R« in telo oranžne barve z natisnjenim napisom »4,5«.
Not applicable.
ni na voljo ni na voljo
Rivastigmine Teva 6 mg hard capsules contains 6 mg rivastigmine as rivastigmine hydrogen tartrate
Zdravilo Rivastigmine Teva 6 mg trde kapsule vsebuje 6 mg rivastigmina v obliki rivastigminhidrogentartrata.
The highest dose that should be taken is 6.0 mg twice a day.
• Najvišji dovoljeni odmerek je 6,0 mg dvakrat na dan.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA