natgillin/translations-raw huggingface dataset:
• Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting) 
• Vnetje trebušne slinavke - znaki vključujejo hudo bolečino v zgornjem delu trebuha, pogosto z občutkom slabosti (navzeo) in bruhanjem
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 odmerek 3 mg zmanjša aktivnost acetilholinesteraze (AChE) v cerebrospinalni tekočini (CSF) za približno 40 % v poldrugi uri po zaužitju.
Some people who have accidentally taken too much Rivastigmine Actavis have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. 
Pri nekaterih ljudeh, ki so pomotoma vzeli preveč zdravila Rivastigmin Actavis, so se pojavili siljenje na bruhanje (navzea), bruhanje, driska, zvišan krvni tlak in halucinacije.
Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category. 
V Preglednici 1 in Preglednici 2 so neželeni učinki navedeni glede na organski sistem po MedDRA klasifikaciji in glede na kategorijo pogostnosti.
• if you have, or have ever had, asthma or severe respiratory disease. 
• če imate ali če ste kdaj imeli astmo ali hudo bolezen dihal.
PHARMACEUTICAL FORM AND CONTENTS 250 hard capsules 
FARMACEVTSKA OBLIKA IN VSEBINA 250 trdih kapsul
Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema, oedema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal. 
Na alergijski kontaktni dermatitis je treba pomisliti v primeru, da se reakcija na mestu apliciranja razširi preko površine, ki jo pokriva obliž, in je mogoče opaziti večjo izraženost lokalne reakcije (na primer vse bolj izražen eritem, edem, papularen ali vezikulozen izpuščaj), simptomi pa se v 48 urah po odstranitvi obliža bistveno ne izboljšajo.
These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.). 
Med njimi so ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, Lestvica za oceno kognitivnih sposobnosti bolnikov z Alzheimerjevo boleznijo, merilo kognitivne zmogljivosti, ki temelji na izvrševanju aktivnosti), CIBIC-Plus (Clinician's Interview Based Impression of ChangePlus, Zdravnikova ocena spremembe bolezni na podlagi pogovora, celostno globalno ocenjevanje bolnika, ki ga opravlja zdravnik in ki zajema tudi podatke, ki jih daje/-jo negovalec/-ci) in PDS (Progressive Deterioration Scale, Lestvica progresivnega slabšanja, negovalčeva ocena vsakodnevnih aktivnosti, na primer osebne higiene, hranjenja, oblačenja,gospodinjskih opravil, na primer nakupovanja, ohranjanje zmožnosti orientacije v okolju, pa tudi ukvarjanje z denarnimi zadevami itn.).
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine. 
Neželene učinke, navedene v spodnji Preglednici 1, so zbrali pri bolnikih z Alzheimerjevo demenco, zdravljenih z rivastigminom.
Pruritus, allergic dermatitis (disseminated) 
Srbenje, alergijski dermatitis (diseminirana oblika)
By blocking these enzymes, Rivastigmine Actavis allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease. 
Zdravilo Rivastigmin Actavis z zaviranjem navedenih encimov omogoča zvišanje koncentracije acetilholina v možganih in s tem pomaga pri zmanjševanju simptomov Alzheimerjeve bolezni in demence v povezavi s Parkinsonovo boleznijo.
Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with rivastigmine capsules. 
Preglednica 2 prikazuje neželene učinke, o katerih so poročali iz kliničnih študij, ki so jih izvajali pri bolnikih z demenco, povezano s Parkinsonovo boleznijo, zdravljenih s kapsulami rivastigmina.
• Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite) 
• Jetrne motnje (porumenelost kože, porumenelost očesnih beločnic, nenormalno temen urin ali nepojasnjena slabost v želodcu, bruhanje, utrujenost in izguba apetita)
Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6). 
Prav tako so boljši učinek opazili pri tistih bolnikih, ki so imeli vidne halucinacije (glejte Preglednico 6).
• Aggression, feeling restless 
• Agresivnost, občutek nemira
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC(IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Do not take Rivastigmine Actavis 
Ne jemljite zdravila Rivastigmin Actavis
NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis logo] 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Actavis logotip]
• if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch. 
• če opazite kožno reakcijo, ki se širi preko površine, ki jo pokriva transdermalni obliž, če je reakcija na tem mestu močneje izražena (če se pojavijo mehurčki, če je vnetje oziroma oteklina vse bolj izrazita) in če se ti znaki v 48 urah po odstranitvi transdermalnega obliža ne izboljšajo.
Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4). 
Anamneza reakcije na mestu apliciranja, ki bi bile lahko znak alergijskega kontaktnega dermatitisa pri uporabi transdermalnih obližev z rivastigminom (glejte poglavje 4.4).
Restlessness Hallucination, visual Depression 
Vidne halucinacije Depresija Agresivnost
Therefore, women on rivastigmine should not breast-feed. 
Zato matere, ki jemljejo rivastigmin, ne smejo dojiti.
• The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles, 
• Poslabšanje znakov Parkinsonove bolezni ali pojav podobnih znakov - na primer togih mišic ali težav pri izvajanju gibov
Capsule content: Magnesium stearate, colloidal anhydrous silica, hypromellose and microcrystalline cellulose. 
Vsebina kapsule: magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza in mikrokristalna celuloza.
Placebo of parkinsonian symptoms in patients with dementia n (%) 
Placebo odražajo poslabšanje simptomov Parkinsonove bolezni pri bolnikih z demenco, povezano s Parkinsonovo boleznijo n (%)
Rivastigmine Actavis may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. 
Zdravilo Rivastigmin Actavis lahko povzroči vrtoglavost in zaspanost, predvsem na začetku zdravljenja ali ob povečanju odmerka.
The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects. 
Cmax rivastigmina je bila za približno 60 % večja in AUC rivastigmina več kot dvakrat večja pri osebah z blago do zmerno jetrno okvaro kot pri zdravih osebah.
Patients with severe hepatic impairment have not been studied, however, Rivastigmine Actavis capsules may be used in this patient population provided close monitoring is exercised (see section 4.4 and 5.2). 
Uporabe zdravila pri bolnikih s težko jetrno okvaro niso proučili, bolniki iz te populacije lahko kljub temu uporabljajo zdravilo Rivastigmin Actavis v obliki kapsul, vendar jih je treba skrbno spremljati (glejte poglavji 4.4 in
• Problems with your heartbeat such as fast or slow heartbeat 
• Motnje srčnega ritma, kot sta prepočasen ali prehiter srčni utrip
The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with rivastigmine transdermal patches: agitation (common). 
Naslednji neželeni učinek so, poleg že navedenih, opažali v študiji pri bolnikih, ki so imeli demenco v povezavi s Parkinsonovo boleznijo in so bili zdravljeni s transdermalnimi obliži z rivastigminom: agitiranost (pogosti).
There is no relevant use of Rivastigmine Actavis in the paediatric population in the treatment of Alzheimer's disease. 
Zdravila Rivastigmin Actavis ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
Allergic dermatitis (disseminated) 
Hiperhidroza Alergijski dermatitis (diseminirana oblika)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [Actavis logo] 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Actavis logotip]
Uncommon (may affect up to 1 in 100 people) • Uneven heartbeat and poor control of movements 
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) • Nepravilen srčni utrip in motnje koordinacije gibov
Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g oxybutynin, tolterodine). 
Rivastigmin lahko moti delovanje antiholinergičnih zdravil (na primer oksibutinina in tolterodina).
• if you have, or have ever had, irregular or slow heartbeat. 
• če imate ali ste kdaj imeli nepravilen ali počasen srčni utrip.
Motor dysfunction 
Rigor Motorične motnje
Infections and infestations Very rare 
Infekcijske in parazitske bolezni Zelo redki
• Decreased appetite 
• Zmanjšan apetit
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer's disease. 
Pediatrična populacija Rivastigmina ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 10 
V standardni bateriji testov in vitro in in vivo rivastigmin ni bil mutagen, razen v testu kromosomskih
Rivastigmine Actavis should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). 
Zdravila Rivastigmin Actavis ne smete jemati sočasno z metoklopramidom (zdravilom, ki ga uporabljamo za ublažitev ali preprečevanje navzee (slabosti s siljenjem na bruhanje) in bruhanja).
Dementia associated with ADAS-Cog ADAS-Cog ADCS- CGIC ADCS-CGIC Parkinson's Disease 
ADAS-Cog ADAS-Cog ADCS- CGIC ADCS-CGIC Parkinsonovo boleznijo Rivastigmin Placebo Rivastigmin Placebo
Magnesium stearate Silica colloidal, anhydrous Hypromellose Microcrystalline cellulose 
magnezijev stearat brezvoden koloidni silicijev dioksid hipromeloza mikrokristalna celuloza
The following additional adverse reactions have been observed with rivastigmine transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known). 
Pri uporabi transdermalnih obližev rivastigmina so dodatno opažali še naslednje neželene učinke: delirij, zvišano telesno temperaturo, zmanjšan apetit, urinska inkontinenca (pogosto), psihomotorična hiperaktivnost (občasno), eritem, urtikarija, mehurčki, alergijski dermatitis (pogostnost neznana).
The active substance of Rivastigmine Actavis is rivastigmine. 
Zdravilna učinkovina v zdravilu Rivastigmin Actavis je rivastigmin.
• The highest dose that should be taken is 6 mg twice a day. 
• Najvišji dovoljeni odmerek je 6 mg dvakrat na dan.
How to take Rivastigmine Actavis 
Kako jemati zdravilo Rivastigmin Actavis
• Fainting or accidentally falling 
• Omedlevica ali nezgodni padci
You should not breast-feed during treatment with Rivastigmine Actavis. 
Med zdravljenjem z zdravilom Rivastigmin Actavis ne smete dojiti.
• Accidentally falling 
• Nezgodni padec
1.5 mg twice a day. 
Začetni odmerek 1,5 mg dvakrat na dan.
If you are pregnant, the benefits of using Rivastigmine Actavis must be assessed against the possible effects on your unborn child. Rivastigmine Actavis should not be used during pregnancy, unless clearly necessary. 
V primeru, da ste noseči, je treba pretehtati koristi uporabe zdravila Rivastigmin Actavis in možne učinke na nerojenega otroka.
• Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus) 
• Močno bruhanje, ki lahko povzroči raztrganje požiralnika (cevi med usti in želodcem)
Dementia associated with ADAS-Cog ADAS-Cog ADAS-Cog ADAS-Cog Parkinson's Disease 
ADAS-Cog ADAS-Cog ADAS-Cog ADAS-Cog Parkinsonovo boleznijo Rivastigmin Placebo Rivastigmin Placebo
Caution when Rivastigmine Actavis is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). 
Previdnost je potrebna pri sočasni uporabi zdravila Rivastigmin Actavis in katerega od antagonistov adrenergičnih receptorjev beta (učinkovin, kot je atenolol, ki ga uporabljamo za zdravljenje visokega krvnega tlaka, angine pektoris in drugih bolezni srca).
The ink may or may not contain potassium hydroxide. 
Črnilo lahko vsebuje kalijev hidroksid.
Not known 
Pogostnost neznana
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 June 2011 
Datum prve odobritve: 16.
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. 
Titriranje odmerka: V kratkem času po povečanju odmerka so opazili neželene učinke (npr. hipertenzijo in halucinacije pri bolnikih z Alzheimerjevo demenco in poslabšanje ekstrapiramidnih simptomov, zlasti tremorja, pri bolnikih z demenco v povezavi s Parkinsonovo boleznijo).
• Fits (seizures) 
• Napadi krčev (epileptični napadi)
Mean change at 24 weeks 2.5 ± 8.4 ± SD 
Povprečna sprememba po 2,5 ± 8,4 24 tednih ± SD
Shellac, propylene glycol, red iron oxide (E172). 
Tiskarsko črnilo: šelak, propilenglikol, rdeči železov oksid (E172).
• if you have, or have ever had, difficulties in passing urine. 
• če imate ali če ste kdaj imeli težave z uriniranjem.
• if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. 
• če imate prebavne težave, kot so slabost s siljenjem na bruhanje (navzea), bruhanje in driska.
Cardiac disorders Rare 
Srčne bolezni Redki
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali z medicinsko sestro.
• Changes in how well your liver is working 
• Spremembe v delovanju jeter
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR CAPSULE CONTAINER 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA VSEBNIK ZA KAPSULE
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea 
• Prebavne težave, kot so navzea (slabost s siljenjem na bruhanje) ali bruhanje, driska
Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules rivastigmine 
Rivastigmin Actavis 1,5 mg trde kapsule Rivastigmin Actavis 3 mg trde kapsule Rivastigmin Actavis 4,5 mg trde kapsule Rivastigmin Actavis 6 mg trde kapsule
• if you have, or have ever had, an active stomach ulcer. 
• če imate ali ste kdaj imeli aktivno želodčno razjedo.
Muscle rigidity 
Mišična rigidnost
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4). 
V nekaterih primerih je bilo hudo bruhanje povezano z rupturo požiralnika (glejte poglavje 4.4)
• Feeling restless 
• Občutek nemira
Vascular disorders Very rare 
Žilne bolezni Zelo redki
Rivastigmine Placebo Rivastigmine Placebo Patients with visual 
Rivastigmin Placebo Rivastigmin Placebo 6-12 mg
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf. 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis Group PTC ehf.
Mean change at 24 weeks 2.1 ± 8.2 ± SD 
Povprečna sprememba po 2,1 ± 8,2 24 tednih ± SD
• Ulcers in your stomach or intestine 
• Razjede želodca ali črevesja
Pre-defined adverse events that may reflect worsening Rivastigmine 
Vnaprej opredeljeni neželeni dogodki, ki lahko
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR CAPSULE CONTAINER 
PODATKI NA STIČNI OVOJNINI NALEPKA ZA VSEBNIK ZA KAPSULE
INFORMATION IN BRAILLE Rivastigmine Actavis 1.5 mg 
PODATKI V BRAILLOVI PISAVI Rivastigmin Actavis 1,5 mg
INFORMATION IN BRAILLE Rivastigmine Actavis 4.5 mg 
PODATKI V BRAILLOVI PISAVI Rivastigmin Actavis 4,5 mg
• Headache 
• Glavobol
INFORMATION IN BRAILLE Rivastigmine Actavis 6 mg 
PODATKI V BRAILLOVI PISAVI Rivastigmin Actavis 6 mg
Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatine. 
Rivastigmin Actavis 3 mg, 4,5 mg in 6 mg trde kapsule: rdeči železov oksid (E172), titanov dioksid (E171), rumeni železov oksid (E172) in želatina.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristic, section 4.2). 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Nightmares Agitation 
Nočne more
Initial dose 
Povprečje ob izhodišču ±
Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland 
Reykjavíkurvegur 76-78 220 Hafnarfjörður Islandija
Each Rivastigmine Actavis 6 mg capsule contains 6 mg of rivastigmine. 
Ena kapsula zdravila Rivastigmin Actavis 6 mg vsebuje 6 mg rivastigmina.
INFORMATION IN BRAILLE Rivastigmine Actavis 3 mg 
PODATKI V BRAILLOVI PISAVI Rivastigmin Actavis 3 mg
General disorders and administrationsite conditions 
Splošne težave in spremembe na mestu aplikacije
Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine. 
Ena kapsula zdravila Rivastigmin Actavis 4,5 mg vsebuje 4,5 mg rivastigmina.
Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine. 
Ena kapsula zdravila Rivastigmin Actavis 1,5 mg vsebuje 1,5 mg rivastigmina.
Rivastigmine Actavis 1.5 mg hard capsules Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine 
Rivastigmin Actavis 1,5 mg trde kapsule titanov dioksid (E171) rumeni železov oksid (E172) želatina
• Nightmares 
• Nočne more
Metabolism and nutrition disorders Common 
Presnovne in prehranske motnje
What Rivastigmine Actavis looks like and contents of the pack - Rivastigmine Actavis 1.5 mg hard capsules, which contain off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “RIV 1.5mg” on body. 
Izgled zdravila Rivastigmin Actavis in vsebina pakiranja Rivastigmin Actavis 1,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rumen pokrovček in rumeno telo z rdečim napisom “RIV 1,5mg” na telesu.
Rivastigmine Actavis 4.5 mg hard capsules 
Rivastigmin Actavis 4,5 mg trde kapsule
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja Pogosti
Rivastigmine Actavis 1.5 mg hard capsules 
Rivastigmin Actavis 1,5 mg trde kapsule
• Heartburn 
• Tesnoba
Talk to your doctor before taking Rivastigmine Actavis: 
Pred začetkom jemanja zdravila Rivastigmin Actavis se posvetujte s svojim zdravnikom:
Capsule shell: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatine. 
Ovojnica kapsule: Rivastigmin Actavis 1.5 mg trde kapsule: titanov dioksid (E171), rumeni železov oksid (E172) in želatina.
How to store Rivastigmine Actavis 
Shranjevanje zdravila Rivastigmin Actavis
Each Rivastigmine Actavis 3 mg capsule contains 3 mg of rivastigmine. 
Ena kapsula zdravila Rivastigmin Actavis 3 mg vsebuje 3 mg rivastigmina.
Rivastigmine Actavis 6 mg hard capsules 
Rivastigmin Actavis 6 mg trde kapsule
Rivastigmine Placebo Rivastigmine Placebo ITT + RDO population (n=329) 
Skupina ITT + RDO (n=329)
- Rivastigmine Actavis 4.5 mg hard capsules, which contain off-white to slightly yellow powder, have a red cap and red body, with white imprint “RIV 4.5mg” on body. 
Rivastigmin Actavis 4,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in rdeče telo z belim napisom “RIV 4,5mg” na telesu.
• Unusually slow movements or movements you cannot control 
• Neobičajno počasni gibi ali nehoteni gibi
Rivastigmine Actavis 3 mg hard capsules 
Rivastigmin Actavis 3 mg trde kapsule
Contents of the pack and other information What Rivastigmine Actavis contains - The active substance is rivastigmine hydrogen tartrate. 
Kaj vsebuje zdravilo Rivastigmin Actavis - Zdravilna učinkovina je rivastigminijev hidrogentartrat.
Balance disorder Musculoskeletal stiffness Rigors 
Otrdelost mišic in skeleta
Always take this medicine exactly as your doctor has told you. 
Pri jemanju tega zdravila natančno upoštevajte napotke zdravnika.
Rivastigmine Actavis 6 mg hard capsules EU/1/11/693/013 
Rivastigmin Actavis 6 mg trde kapsule EU/1/11/693/013
Somnolence 
Nespečnost
• Stomach pain 
• Bolečine v trebuhu
EU/1/11/693/007 [112 blister] 
EU/1/11/693/007 [112 pretisni omot]
• if you have, or have ever had impaired kidney function. 
• če imate ali če ste kdaj imeli okvarjeno delovanje ledvic.
- Rivastigmine Actavis 3 mg hard capsules, which contain off-white to slightly yellow powder, have an orange cap and orange body, with red imprint “RIV 3mg” on body. 
Rivastigmin Actavis 3 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo oranžen pokrovček in oranžno telo z rdečim napisom “RIV 3mg” na telesu.
- Rivastigmine Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, have an red cap and orange body, with red imprint “RIV 6mg” on body. 
Rivastigmin Actavis 6 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in oranžno telo z rdečim napisom “RIV 6mg” na telesu.
EU/1/11/693/015 [112 blister] 
EU/1/11/693/015 [112 pretisni omot]
Abdominal pain and dyspepsia 
Bolečine v trebuhu in dispepsija
• Anxiety 
• Nespečnost
Off-white to slightly yellow powder in a hard capsule with red cap and red body, with white imprint “RIV 4.5mg” on body. 
Belkast do rahlo rumen prašek v trdi kapsuli z rdečim pokrovčkom in rdečim telesom, z belim napisom “RIV 4,5mg” na telesu.
Hepatic impairment 
Splošno slabo počutje
Paediatric population 
Epileptični napadi
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/012 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/012
STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 4,5 mg rivastigmina (v obliki hidrogentartrata).
Cardiac disorders Common 
Srčne bolezni Pogosti
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/004 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/004
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/008 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/008
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/016 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/016
associated with Parkinson's disease Total patients studied Total patients with pre-defined AE(s) Tremor 
Vsi bolniki z neželenimi dogodki (AE - “adverse event”) Tremor
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/013[ 28 blister] 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/013[ 28 pretisni omot]
• Urinary tract infection 
• Okužbe sečil
STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 6 mg rivastigmine (as hydrogen tartrate). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 6 mg rivastigmina (v obliki hidrogentartrata).