natgillin/translations-raw huggingface dataset:
Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin).
Stoga je potreban oprez kada se rivastigmin kombinira s beta blokatorima i drugim tvarima za bradikardiju (npr. antiaritmicima skupine III, antagonistima kalcijevih kanala, digitalis glikozidom, pilokarpinom).
It has the same dosage and frequency of administration as rivastigmine capsules.
Primjenjuje se u istoj dozi i učestalosti kao i rivastigmin kapsule.
There have been rare post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Postojala su rijetka iskustva s alergijskim dermatitisom (diseminiranim) u bolesnika nakon stavljanja lijeka u promet kod primjene rivastigmina bez obzira na put primjene (peroralno, transdermalno).
Urinary infection
Infekcija urinarnog trakta
Furthermore, rivastigmine can induce dizziness and somnolence, mainly when initiating treatment or increasing the dose.
Nadalje, rivastigmin može dovesti do omaglice i somnolencije, posebice na početku liječenja ili pri povećavanju doze.
Pre-defined adverse events that may reflect worsening of parkinsonian symptoms in patients with dementia associated with Parkinson's disease
Unaprijed definirani štetni događaji koji mogu odražavati pogoršanje simptoma parkinsonizma u bolesnika s demencijom povezanom s Parkinsonovom bolešću
No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Nisu zapaženi neželjeni učinci na srčano provođenje nakon istodobne primjene digoksina i rivastigmina.
Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Inhibitore kolinesteraze treba pažljivo propisivati bolesnicima koji u anamnezi imaju astmu ili opstruktivnu bolest pluća.
Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia) Sick sinus syndrome
Aritmija srca (npr. bradikardija, atrioventrikularni blok fibrilacija atrija i tahikardija) Sindrom bolesnog sinusnog čvora
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.
Nije istražena primjena rivastigmina u bolesnika s teškom demencijom Alzheimerove bolesti ili onom povezanom s Parkinsonovom bolešću, drugim vrstama demencije ili drugim vrstama poremećaja pamćenja (npr. smanjenje kognitivne sposobnosti povezane s dobi) te se stoga ne preporučuje primjena u ovoj populaciji bolesnika.
The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Kapsule i raspadljive tablete za usta također se mogu primjenjivati u liječenju demencije u odraslih bolesnika s Parkinsonovom bolešću.
Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6).
Slično tome, zapažen je veći učinak liječenja u bolesnika s vidnim halucinacijama (vidjeti Tablicu 6).
Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Ukoliko je potrebno mogu se razmotriti moguće prilagodbe doze ili privremeni prekid liječenja.
Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Tablica 3 navodi broj i postotak bolesnika iz specifičnog kliničkog ispitivanja u trajanju od 24 tjedna, provedenog s rivastigminom u bolesnika s demencijom povezanom s Parkinsonovom bolešću, pri čemu su nuspojave, koje bi mogle odražavati pogoršanje simptoma parkinsonizma, bile unaprijed definirane.
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.
Klinička ispitivanja u demenciji povezanoj s Parkinsonovom bolešću Djelotvornost rivastigmina kod demencije povezane s Parkinsonovom bolešću pokazana je u 24tjednom multicentričnom, dvostruko slijepom, placebo kontroliranom, osnovnom ispitivanju te njegovoj 24-tjednoj otvorenoj produženoj fazi.
If you are pregnant, the benefits of using Nimvastid must be assessed against the possible effects on your unborn child. Nimvastid should not be used during pregnancy unless clearly necessary.
Ako ste trudni, potrebno je ocijeniti koristi od primjene Nimvastida u usporedbi s mogućim učincima na Vaše nerođeno dijete.
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.
U ispitivanjima na miševima i štakorima pri maksimalnoj dozi koju su životinje podnosile, nije utvrđen dokaz kancerogenosti, iako je izloženost rivastigminu i njegovim metabolitima bila niža od izloženosti u ljudi.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Simptomatsko liječenje blage do umjereno teške demencije u bolesnika s idiopatskom Parkinsonovom bolešću.
Other side effects seen with rivastigmine transdermal patches and which may occur with the hard capsules:
Ostale nuspojave zabilježene s rivastigmin transdermalnim flasterima a koje se mogu pojaviti s tvrdim kapsulama:
Marketing Authorisation Holder and Manufacturer KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
Hallucinations Aggression, restlessness
Halucinacije Agresivnost, nemir
Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it,
Primite blister za rubove i razdvojite jedno polje blistera od ostalog dijela, pažljivo trgajući duž perforacija koje ga okružuju.
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 bio je oko 60% veći, a AUC rivastigmina bila je više nego dvostruko veća u ispitanika s blagim do umjerenim oštećenjem jetre, nego u zdravih ispitanika.
Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with rivastigmine capsules.
Tablica 2 pokazuje nuspojave zabilježene tijekom kliničkih ispitivanja provedenih u bolesnika s demencijom povezanom s Parkinsonovom bolešću liječenih rivastigmin kapsulama.
Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g oxybutynin, tolterodine).
Rivastigmin može utjecati na djelovanje antikolinergika (npr. oksibutinina, tolterodina).
Rivastigmine should be administered twice a day, with morning and evening meals.
Rivastigmin treba primjenjivati dva puta dnevno, uz jutarnji i večernji obrok.
Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease and Parkinson's disease.
Stoga rivastigmin može imati ublažavajuće djelovanje na kolinergički posredovane deficite kognitivne funkcije kod demencije povezane s Alzheimerovom i Parkinsonovom bolešću.
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 doze: nuspojave (npr. hipertenzija i halucinacije u bolesnika s Alzheimerovom demencijom te pogoršanje ekstrapiramidalnih simptoma, osobito tremora, u bolesnika s demencijom povezanom s Parkinsonovom bolešću) zapažene su ubrzo nakon povećanja doze.
Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Slično tome, zapažen je veći učinak u bolesnika s Parkinsonovom bolešću i s vidnim halucinacijama (vidjeti dio 5.1).
Other side effects seen with rivastigmine transdermal patches and which may occur with the orodispersible tablets:
Ostale nuspojave zabilježene s rivastigmin transdermalnim flasterima a koje se mogu pojaviti s raspadljivim tabletama za usta:
Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Obzirom da bradikardija predstavlja rizik za pojavu torsades de pointes, kombinacija rivastigmina s lijekovima koji mogu inducirati torsades de pointes kao što su što su antipsihotici npr. neki fenotiazini (klorpromazin, levomepromazin), benzamidi (sulpirid, sultoprid, amisulprid, tiaprid, veralipride), pimozid, haloperidol, droperidol, cisaprid, citalopram, difemanil, eritromicin IV, halofantrin, mizolastin, metadon, pentamidin i moksifloksacin mora se pažljivo pratiti te također može biti potrebno kliničko praćenje (EKG).
Cholinergic toxicity has been reported with muscarinic symptoms that are observed with moderate poisonings such as miosis, flushing, digestive disorders including abdominal pain, nausea, vomiting and diarrhoea, bradycardia, bronchospasm and increased bronchial secretions, hyperhidrosis, involuntary urination and/or defecation, lacrimation, hypotension and salivary hypersecretion.
Zabilježena je kolinergička toksičnost s muskarinskim simptomima koji su uočeni uz umjereno trovanje kao što su mioza, crvenilo uz osjećaj vrućine, probavni poremećaji uključujući bol u abdomenu, mučninu, povraćanje i proljev, bradikardija, bronhospazam i pojačano izlučivanje bronhijalne sluzi, hiperhidroza, nevoljno mokrenje i/ili defekacija, suzenje očiju, hipotenzija i hipersekrecija sline.
• Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
- Upala gušterače - znakovi uključuju jaku bol u gornjem dijelu trbuha, često s osjećajem mučnine ili povraćanjem
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.
U usporedbi sa zdravim ispitanicima, Cmax i AUC rivastigmina bili su više nego dvostruko veći u ispitanika s umjerenim oštećenjem bubrega; no, u ispitanika s teškim oštećenjem bubrega nije bilo promjena u Cmax i AUC vrijednostima rivastigmina.
Nimvastid may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Nimvastid može uzrokovati omaglicu i pospanost, pogotovo na početku liječenja ili prilikom povećanja doze.
Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochromes isoemzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1,
Na temelju in vitro ispitivanja, ne očekuje se nikakva farmakokinetička interakcija s lijekovima koji se metaboliziraju sljedećim izoenzimima citokroma: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1,
Your mouth should be empty before taking the tablet.
Ne smijete imati ništa u ustima prije uzimanja tablete.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristic, Section 4.2.)
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
The starting dose is 1.5 mg twice a day.
Početna doza je 1,5 mg dva puta na dan.
Parkinson's disease (worsening) Bradykinesia
Parkinsonova bolest (pogoršanje) Bradikinezija
Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 mg hard capsules Rivastigmine
Nimvastid 1,5 mg tvrde kapsule Nimvastid 3 mg tvrde kapsule Nimvastid 4,5 mg tvrde kapsule Nimvastid 6 mg tvrde kapsule rivastigmin
Date of first authorisation: 11/5/2009 Date of latest renewal: DD month YYYY
Datum prvog odobrenja: 11. svibnja 2009.
Patients with severe hepatic impairment have not been studied, however, Nimvastid orodispersible tablets may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).
Nisu proučavani bolesnici s teškim oštećenjem jetre, međutim, Nimvastid tablete mogu se primjenjivati u ovoj bolesničkoj populaciji pod uvjetom da se provodi pažljivo praćenje (vidjeti dijelove 4.4 i 5.2).
difficulty in carrying out movements and muscle weakness
otežanog izvođenja pokreta te slabost mišića
Patients with Alzheimer's disease may lose weight.
Moguć je gubitak tjelesne težine u bolesnika s Alzheimerovom bolešću.
How to store Nimvastid
Kako čuvati Nimvastid
Patients with severe hepatic impairment have not been studied, however, Nimvastid capsules may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).
Nisu proučavani bolesnici s teškim oštećenjem jetre, međutim, Nimvastid kapsule mogu se primjenjivati u ovoj bolesničkoj populaciji pod uvjetom da se provodi pažljivo praćenje (vidjeti dijelove 4.4 i 5.2).
Patients with clinically significant renal or hepatic impairment might experience more adverse reactions (see sections 4.2 and 5.2).
U bolesnika s klinički značajnim oštećenjem bubrega ili jetre može se razviti više nuspojava (vidjeti dijelove 4.2 i 5.2).
Last Observation Carried Forward
Last Observation Carried Forward; zadnje zapažanje prenešeno dalje).
Nervous system disorders Very common
Poremećaji živčanog sustava Vrlo često
Spearmint flavour (peppermint oil, maize maltodextrin) Peppermint flavour (maltodextrine, gum arabic, sorbitol E420, corn mint oil, L-menthol) Crospovidone
Aroma spearminta (ulje paprene metvice, maltodekstrin kukuruza) Aroma paprene metvice (maltodekstrin, arapska guma, sorbitol E420, ulje divlje metvice, L-mentol) Krospovidon
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva Često
Removal of the intact orodispersible tablet from the mouth is difficult.
Raspadljiva tableta za usta teško se vadi iz usta.
Initial dose 1.5 mg twice a day.
Početna doza 1,5 mg dva puta na dan.
Metabolism and nutritional disorders Very common
Poremećaji metabolizma i prehrane Vrlo često
Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets Rivastigmine
Nimvastid 1,5 mg raspadljive tablete za usta Nimvastid 3 mg raspadljive tablete za usta Nimvastid 4,5 mg raspadljive tablete za usta Nimvastid 6 mg raspadljive tablete za usta rivastigmin
Hyperhydrosis
Hiperhidroza
No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
U ispitivanjima na zdravim dobrovoljcima nije zapažena farmakokinetička interakcija između rivastigmina i digoksina, varfarina, diazepama ili fluoksetina.
Blister pack (PVC/PVDC/Alu-foil): boxes of 14 (only for 1.5 mg), 28, 30, 56, 60 or 112 hard capsules are available.
Blister pakiranje (PVC/PVDC/Al folija): Dostupne su kutije od 14 (samo za 1,5 mg), 28, 30, 56, 60 ili 112 tvrdih kapsula.
Balance disorder Musculoskeletal stiffness Rigors
Mišićna rigidnost Poremećaj ravnoteže Muskuloskeletna ukočenost Tresavica
Container: 200 hard capsules 250 hard capsules
200 tvrdih kapsula 250 tvrdih kapsula
Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochromes isoemzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Na temelju in vitro ispitivanja, ne očekuje se nikakva farmakokinetička interakcija s lijekovima koji se metaboliziraju sljedećim izoenzimima citokroma: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19 ili CYP2B6.
The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine.
Primjena rivastigmina ne utječe na povećanje protrombinskog vremena koje inducira varfarin.
Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity.
Reakcije na mjestu primjene obično su blagog ili umjerenog intenziteta i mogu se pojaviti kod primjene rivastigminskog flastera.
In other cases, rivastigmine has been discontinued (see section 4.8).
U ostalim je slučajevima prekinuta primjena rivastigmina (vidjeti dio 4.8).
- The other ingredients for Nimvastid 1.5 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content, and titanium dioxide (E171), yellow iron oxide (E172) and gelatine in the capsule shell.
- Drugi sastojci za Nimvastid 1,5 mg kapsule su mikrokristalična celuloza, hipromeloza, koloidni bezvodni silicijev dioksid i magnezijev stearat u sadržaju kapsule i titanijev dioksid (E171), žuti željezov oksid (E172) i želatina u ovojnici kapsule.
In peri/postnatal studies in rats, an increased gestation time was observed.
U ispitivanjima u štakora tijekom i nakon trudnoće uočeno je produljenje vremena gestacije.
Insomnia Anxiety Restlessness
Konfuzija Anksioznost Nesanica
- The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, spearmint flavour (peppermint oil, maize maltodextrin), peppermint flavour (maltodextrine, gum arabic, sorbitol E420, corn mint oil, L-menthol), crospovidone, calcium silicate, magnesium stearate.
- Drugi sastojci su manitol, mikrokristalična celuloza, hidroksipropilceluloza, aroma spearminta (ulje paprene metvice, maltodekstrin kukuruza), aroma paprene metvice (maltodekstrin, arapska guma, sorbitol E420, ulje divlje metvice, L-mentol), krospovidon, kalcijev silikat i magnezijev stearat.
• Take Nimvastid twice a day, in the morning and evening, with food.
- Nimvastid morate uzimati dva puta na dan, ujutro i uvečer uz obrok.
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.
U Tablici 4 ispod prikazani su rezultati bolesnika s klinički relevantnim odgovorom, iz udruženih rezultata dva ispitivanja s fleksibilnom dozom, od tri osnovna 26-tjedna multicentrična ispitivanja u bolesnika s blagom do umjereno teškom Alzheimerovom demencijom.
Capsule content Microcrystalline cellulose Hypromellose Silica, colloidal anhydrous Magnesium stearate
Silicijev dioksid, koloidni, bezvodni Magnezijev stearat
• The highest dose that should be taken is 6.0 mg twice a day.
- Najviša doza koju smijete uzimati je 6.0 mg dva puta na dan.
Uncommon (may affect up to 1 in 100 people)
Manje često (mogu se javiti u do 1 na 100 ljudi)
In pregnant animals, rivastigmine and/or metabolites crossed the placenta.
Rivastigmin i/ili metaboliti prelaze posteljicu u gravidnih životinja.
There is no accumulation of rivastigmine or the decarbamylated metabolite in patients with Alzheimer's disease.
U bolesnika s Alzheimerovom bolešću nema nakupljanja rivastigmina ili dekarbamiliranog metabolita.
• Take Nimvastid twice a day, once with your breakfast and once with your evening meal.
- Nimvastid morate uzimati dva puta na dan, uz doručak i uz večeru.
However, a greater treatment effect was seen in Parkinson's disease patients with moderate dementia.
No, veći terapijski učinak uočen je u bolesnika s Parkinsonovom bolešću i s umjerenom demencijom.
• Feeling tired or weak
- Osjećaj nemira - Osjećaj umora ili slabosti
White to almost white powder in a capsule with yellow cap and yellow body.
Bijeli do gotovo bijeli prašak u kapsuli sa žutom kapicom i žutim tijelom.
28 hard capsules 30 hard capsules 56 hard capsules 60 hard capsules 112 hard capsules
28 tvrdih kapsula 30 tvrdih kapsula 56 tvrdih kapsula 60 tvrdih kapsula 112 tvrdih kapsula
14 hard capsules 28 hard capsules 30 hard capsules 56 hard capsules 60 hard capsules 112 hard capsules
14 tvrdih kapsula 28 tvrdih kapsula 30 tvrdih kapsula 56 tvrdih kapsula 60 tvrdih kapsula 112 tvrdih kapsula
The patients studied had an MMSE (Mini-Mental State Examination) score of 10-24.
Mini-Mental State Examination) vrijednost od 10 do 24.
Cardiac disorders Rare
Srčani poremećaji Rijetko
Blister pack (PVC/PVDC/Alu-foil): 28, 30, 56, 60 or 112 hard capsules in a box.
Blister pakiranje (PVC/PVDC/Al folija): 28, 30, 56, 60 ili 112 tvrdih kapsula u kutiji.
Hydroxypropylcellulose
Hidroksipropilceluloza
Musculoskeletal stiffness Rigors
Mišićna rigidnost
Taking this medicine
UPUTA O LIJEKU
Blister pack (PVC/PVDC/Alu-foil): 14, 28, 30, 56, 60 or 112 hard capsules in a box.
Blister pakiranje (PVC/PVDC/Al folija): 14, 28, 30, 56, 60 ili 112 tvrdih kapsula u kutiji.
Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.
Svaka tvrda kapsula sadrži rivastigmin hidrogentartarat koji odgovara 1,5 mg, 3 mg, 4,5 mg ili 6 mg rivastigimina.
Pull up the edge of the foil and peel the foil off completely, 3.
Podignite rub folije te u potpunosti skinite foliju.
Bradycardia Atrial Fibrillation Atrioventricular block Sick sinus syndrome
Atrioventrikularni blok Sindrom bolesnog sinusnog čvora
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.
Svaka raspadljiva tableta za usta sadrži rivastigmin hidrogentartarat koji odgovara 1,5 mg, 3 mg, 4,5 mg ili 6 mg rivastigmina.
14 x 1 orodispersible tablet 28 x 1 orodispersible tablet 30 x 1 orodispersible tablet 56 x 1 orodispersible tablet 60 x 1 orodispersible tablet 112 x 1 orodispersible tablet
14 x 1 raspadljiva tableta za usta 28 x 1 raspadljiva tableta za usta 30 x 1 raspadljiva tableta za usta 56 x 1 raspadljiva tableta za usta 60 x 1 raspadljiva tableta za usta 112 x 1 raspadljiva tableta za usta
Not known (frequency cannot be estimated from the available data) • Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)
Nije poznato (učestalost se ne može procijeniti iz dostupnih podataka) - Alergijska reakcija na mjestu primjene flastera, kao što su mjehurići ili upala kože
Hypokinesia
Hipokinezija
28 x 1 orodispersible tablet 30 x 1 orodispersible tablet 56 x 1 orodispersible tablet 60 x 1 orodispersible tablet 112 x 1 orodispersible tablet
28 x 1 raspadljiva tableta za usta 30 x 1 raspadljiva tableta za usta 56 x 1 raspadljiva tableta za usta 60 x 1 raspadljiva tableta za usta 112 x 1 raspadljiva tableta za usta
Clinical monitoring is recommended for these adverse reactions.
Za te se nuspojave preporučuje kliničko praćenje.
Orodispersible tablet.
Raspadljiva tableta za usta.
14 x 1 (only for 1.5 mg), 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs are available.
Dostupne su 14 x 1 (samo za 1,5 mg), 28 x 1, 30 x 1, 56 x 1, 60 x 1 ili 112 x 1 tableta u perforiranim blisterima djeljivim na jedinične doze s OPA/Al/PVC filmom i PET/Al odvojivom folijom.
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Neki su slučajevi teškog povraćanja bili povezani s rupturom jednjaka (vidjeti dio 4.8).
Uncommon Uncommon Very rare
Manje često Manje često
Titanium dioxide (E171), Yellow iron oxide (E172), Gelatine
Ovojnica kapsule Titanijev dioksid (E171) Željezov oksid, žuti (E172) Želatina