natgillin/translations-raw huggingface dataset:
Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should be taken when these medicinal products are co-administered.
Kljub pogosti sočasni obolevnosti za bipolarno motnjo I in motnjo pomanjkanja pozornosti je na voljo zelo malo podatkov o sočasni uporabi aripiprazola in stimulansov.
Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Pričakovati je mogoče, da imajo drugi močni zaviralci CYP3A4, npr. itrakonazol in zaviralci proteaz HIV, podobne učinke, zato je treba odmerjanje podobno zmanjšati
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
Akatizija V s placebom nadzorovanih preskušanjih je bila pojavnost akatizije pri bolnikih z bipolarno motnjo pri uporabi aripiprazola 12,1 %, pri uporabi placeba pa 3,2 %.
In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.
V dolgoročnem 26-tedenskem s placebom nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19 % in pri bolnikih, ki so dobivali placebo, 13,1 %.
LIST OF EXCIPIENTS Contains lactose and sodium.
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo monohidrat in natrij.
Each orodispersible tablet contains 10 mg/15 mg/30 mg of aripiprazole.
Ena orodisperzibilna tableta vsebuje 10 mg/15 mg/30 mg aripiprazola.
Before treatment with Aripiprazole Zentiva, tell your doctor if you suffer from
Pred začetkom zdravljenja z zdravilom Aripiprazol Zentiva morate obvestiti zdravnika, če:
In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapine-treated patients.
V drugem dolgoročnem 26-tedenskem nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 14,8 % in pri bolnikih, zdravljenih z olanzapinom, 15,1 %.
Excipient with known effect: each orodispersible tablet contains 111 mg of lactose (as monohydrate) and 3.93 mg of sodium.
Pomožna snov z znanim učinkom: ena orodisperzibilna tableta vsebuje 111 mg laktoze (v obliki monohidrata) in 3,93 mg natrija.
Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia
Srčne bolezni tahikardija nenadna nepojasnjena smrt torsades de pointes podaljšanje intervala QT
Always take the tablet with water and swallow it whole.
Ni pomembno, ali ga vzamete s hrano ali brez nje, vedno pa jo vzemite z vodo in jo pogoltnite celo.
In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients.
26-tedenski vzdrževalni fazi s placebom nadzorovanega preskušanja je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 18,2 %, pri bolnikih, ki so prejemali placebo pa 15,7 %.
• Pain killers (such as tramadol and pethidine) used for pain relief
• zdravila proti bolečinam (kot sta tramadol in petidin) uporabljamo za ublažitev bolečine,
Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Zdravilo Aripiprazol Zentiva je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več.
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva, you should see your doctor.
Če opazite kakršen koli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Aripiprazol Zentiva, obiščite zdravnika.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate.
Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, krospovidon, hidroksipropilceluloza, brezvodni koloidni silicijev dioksid, premrežen natrijev karmelozat,
Renal impairment No dosage adjustment is required in patients with renal impairment.
Ledvična okvara Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
SN:
(MNS)
Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
zvišana aktivnost gama glutamiltransferaze (GGT)
What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 10 mg orodispersible tablets are white to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Izgled zdravila Aripiprazol Zentiva in vsebina pakiranja Aripiprazol Zentiva 10 mg orodisperzibilne tablete so bele do umazano bele, okrogle tablete z oznako ‘10' na eni strani in zarezo na drugi strani, s premerom približno 7 mm.
Excipient with known effect: each orodispersible tablet contains 37 mg of lactose (as monohydrate) and 1.31 mg of sodium.
Pomožna snov z znanim učinkom: ena orodisperzibilna tableta vsebuje 37 mg laktoze (v obliki monohidrata) in 1,31 mg natrija.
strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) a tendency to wander away.
− prenajedanje (uživanje velikih količin hrane v kratkem obdobju) ali kompulzivno uživanje hrane (uživanje večjih količin hrane od normalnih in več, kot je potrebno za potešitev lakote),
Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Trzaji, povezani s Tourettovim sindromom, pri pediatričnih bolnikih (glejte poglavje 4.2) Učinkovitost aripiprazola je bila raziskana pri pediatrični populaciji s Tourettovo motnjo (aripiprazol: n = 99, placebo: n = 44) v 8-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, zasnovani z zdravljenimi skupinami, ki so prejemale nespremenjen odmerek glede na telesno maso posameznika v razponu od 5 mg/dan do 20 mg/dan, z začetnim odmerkom 2 mg. Bolniki so bili stari od 7 do 17 let, povprečni izhodiščni rezultat njihovega števila trzajev po skupni oceni resnosti trzajev na lestvici TTS-YYGTSS (angl. Total Tic Severity Score - Yale Global Tic Severity Scale) pa je bil 30.
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0%), extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100,
Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več Pri mladostnikih z bipolarno motnjo I so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih: somnolence (23,0 %), ekstrapiramidnih motenj (18,4 %), akatizije (16,0 %) in utrujenosti (11,8 %), ki so bili zelo pogosti (≥ 1/10), ter bolečine v zgornjem predelu trebuha, hitrejšega srčnega utripa, povečanja telesne mase, povečanega apetita, trzanja mišic in diskinezije, ki so bili pogosti (≥ 1/100, < 1/10).
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
• serotoninski sindrom (reakcija, ki lahko povzroči močan občutek sreče, omotico, okornost, nemir, občutek pijanosti, zvišano telesno temperaturo, znojenje in togost mišic),
In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I Disorder who achieved sustained remission (Y-MRS and MADRS total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46% decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65% decreased risk (hazard ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate superiority over placebo in preventing recurrence into depression.
V 52-tedenskem, s placebom nadzorovanem preskušanju pri bolnikih s trenutno manično ali mešano epizodo bipolarne motnje I, pri katerih je bilo pri dodatnem zdravljenju z aripiprazolom (v odmerku od 10 mg/dan do 30 mg/dan) poleg litija ali valproata doseženo začasno izboljšanje zdravstvenega stanja, ki je trajalo 12 zaporednih tednov (skupna ocena 12 ali manj po lestvicah Y-MRS in MADRS), se je dodatno zdravljenje z aripiprazolom izkazalo za učinkovitejše od dodatka placeba, s 46 %
In the adolescent (13 - 17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 25.6% and 45.0%, respectively.
Pri populaciji mladostnikov (starosti od 13 do 17 let) s shizofrenijo, ki so največ 72 mesecev izpostavljeni apriprazolu 5 do 30 mg, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah (< 3 ng/ml) 25,6 % in pri moških (< 2 ng/ml) 45,0 %.
Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm.
Aripiprazol Zentiva 30 mg tablete so bele do umazano bele, okrogle tablete z oznako ‘30' na eni strani in razdelilno zarezo na drugi strani, s premerom približno 10,2 mm.
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or “mini” stroke, abnormal blood pressure
• imate srčnožilne bolezni (bolezni srca in ožilja), srčnožilne bolezni v družini, možgansko kap ali
• agitation,
• hujšanje,
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/027
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/027
Blood glucose fluctuation Increased creatine phosphokinase
Preiskave zvišana vrednost glukoze v krvi zvišana vrednost glikoziliranega hemoglobina nihanje vrednosti glukoze v krvi zvišana aktivnost kreatinfosfokinaze
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/021
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/021
Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Pri vrednotenju po podlestvici razdražljivosti na osnovi kontrolnega seznama odklonskega vedenja (“Aberrant Behaviour Checklist Irritability subscale”) se je izkazalo, da je aripiprazol statistično učinkovitejši od placeba, vendar pa pomen te ugotovitve za klinično uporabo ostaja neznan.
In two long term trials with adolescent (13 - 17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 37.0 % and 59.4 %, respectively.
Pri dveh dolgotrajnih preskušanjih pri mladostnikih s shizofrenijo in bipolarno motnjo (starosti od 13 do 17 let), ki so se zdravili z aripiprazolom, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah 37,0 % (< 3 ng/ml) in pri moških (< 2 ng/ml) 59,4 %.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/024
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/024
What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Izgled zdravila Aripiprazol Zentiva in vsebina pakiranja Aripiprazol Zentiva 5 mg so bele do umazano bele, okrogle, ploske, neobložene tablete s poševnim robom, z oznako ‘5' na eni strani in brez oznake na drugi strani, s premerom približno 6 mm.
In the pooled adolescent schizophrenia population (13 - 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 29.5% and 48.3%, respectively.
V populaciji mladostnikov s shizofrenijo (13-17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
• nenadzorovani gibi ust, jezika in udov, (tardivna diskinezija),
Aspiration pneumonia Laryngospasm Oropharyngeal spasm
prsnega koša in mediastinalnega prostora kolcanje aspiracijska pljučnica laringospazem orofaringealni spazem
• fast heart beat,
• pospešen srčni utrip,
Photosensitivity reaction Alopecia
Bolezni kože in podkožja izpuščaj fotosenzibilnostna reakcija alopecija hiperhidroza
Name and address of the manufacturer responsible for batch release Zentiva SA
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zentiva, k.s.
White to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm.
Bele do umazano bele, okrogle tablete z oznako ‘30' na eni strani in zarezo na drugi strani, s premerom približno 10,2 mm.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Zdravilo Aripiprazol Zentiva vsebuje laktozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Aripiprazole Zentiva 30 mg tablets
Aripiprazol Zentiva 30 mg tablete
NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva logo
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
• fits (seizures) since your doctor may want to monitor you more closely
• imate epileptične krče (konvulzije), saj bo zdravnik v tem primeru morda želel natančneje spremljati vaše stanje, • imate nehotne, neredne gibe mišic, zlasti na obrazu,
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
on aripiprazole (N = 18, or 13% of evaluable patients), compared to olanzapine (N = 45, or 33% of evaluable patients).
V tej študiji je bilo zvečanje telesne mase za vsaj 7 % nad izhodiščno (tj. za vsaj 5,6 kg pri povprečni izhodiščni masi ~ 80,5 kg) značilno redkejše pri bolnikih, ki so dobivali aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Acesulfame potassium Mango flavour Magnesium stearate
6.1 Seznam pomožnih snovi laktoza monohidrat mikrokristalna celuloza krospovidon hidroksipropilceluloza brezvodni koloidni silicijev dioksid premreženi natrijev karmelozat kalijev acesulfamat aroma manga magnezijev stearat
Aripiprazole Zentiva 30 mg tablets are white to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Aripiprazol Zentiva 30 mg so bele do umazano bele, okrogle, neobložene tablete z oznako ‘30' na eni strani in zarezo na drugi strani, s premerom približno 15,5 x 8 mm.
Aripiprazole Zentiva 10 mg tablets
Aripiprazol Zentiva 10 mg tablete
Aripiprazole Zentiva 15 mg tablets
Aripiprazol Zentiva 15 mg tablete
White to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Bele do umazano bele, okrogle, ploske, neobložene tablete s poševnim robom, z oznako ‘5' na eni strani in brez oznake na drugi strani, s premerom približno 6 mm.
Sodium
Natrija
• Triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
generalizirano anksiozno motnjo, obsesivno-kompulzivno motnjo (OCD) in socialno fobijo, kot tudi za migrene in bolečine,
White to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Bele do umazano bele, okrogle, neobložene tablete z oznako ‘30' na eni strani in zarezo na drugi strani, s premerom približno 15,5 x 8 mm.
In the paediatric bipolar population (10 - 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, respectively.
V pediatrični populaciji z bipolarno motnjo (10-17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa
Tardive dyskinesia
Ledvična okvara
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Med antipsihotičnim zdravljenjem lahko do izboljšanja bolnikovega kliničnega stanja mine od nekaj dni do več tednov.
Aripiprazole Zentiva 15 mg tablets are white to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Aripiprazol Zentiva 15 mg so bele do umazano bele, okrogle, ploske, neobložene tablete s poševnim robom, z oznako ‘15' na eni strani in brez oznake na drugi strani, s premerom približno 8,8 mm.
Aripiprazole Zentiva 5 mg tablets
Aripiprazol Zentiva 5 mg tablete
Aripiprazole Zentiva 10 mg tablets are white to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Aripiprazol Zentiva 10 mg so bele do umazano bele, okrogle, neobložene tablete z oznako ‘10' na eni strani in razdelilno zarezo na drugi strani, s premerom približno 8 mm.
• seizure,
• zaspanost,
Other medicines and Aripiprazole Zentiva
Shranjevanje zdravila Aripiprazol Zentiva
Aripiprazole Zentiva contains sodium
Zdravilo Aripiprazol Zentiva vsebuje natrij
Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Magnesium stearate
6.1 Seznam pomožnih snovi laktoza monohidrat mikrokristalna celuloza krospovidon hidroksipropilceluloza brezvodni koloidni silicijev dioksid premreženi natrijev karmelozat magnezijev stearat
Hyponatremia Anorexia Weight decreased Weight gain
Presnovne in prehranske motnje sladkorna bolezen hiperglikemija hiponatriemija anoreksija zmanjšanje telesne mase povečanje telesne mase
• abdominal discomfort,
• prekomerno potenje,
In a 26week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg)
Izvedena je bila 26-tedenska z olanzapinom kontrolirana, dvojno slepa multinacionalna študija shizofrenije, ki je zajela 314 odraslih bolnikov; primarna končna točka je bilo zvečanje telesne mase.
Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets aripiprazole
Aripiprazol Zentiva 5 mg tablete Aripiprazol Zentiva 10 mg tablete Aripiprazol Zentiva 15 mg tablete Aripiprazol Zentiva 30 mg tablete aripiprazol
Nervousness
Plodnost
Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets
Aripiprazol Zentiva 5 mg tablete Aripiprazol Zentiva 10 mg tablete Aripiprazol Zentiva 15 mg tablete Aripiprazol Zentiva 30 mg tablete
Patients were 7 - 17 years of age and presented an average score of 30 on Total Tic Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline.
Bolniki so bili stari od 6 do 18 let, njihov povprečni izhodiščni rezultat na lestvici TTS- YGTSS pa je bil 29.
Schizophrenia
Odrasli Shizofrenija
What Aripiprazole Zentiva contains
Kaj vsebuje zdravilo Aripiprazol Zentiva
White to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Bele do umazano bele, okrogle, neobložene tablete z oznako ‘10' na eni strani in zarezo na drugi strani, s premerom približno 8 mm.
Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets aripiprazole
Aripiprazol Zentiva 10 mg orodisperzibilne tablete Aripiprazol Zentiva 15 mg orodisperzibilne tablete Aripiprazol Zentiva 30 mg orodisperzibilne tablete aripiprazol
Excipient with known effect: each tablet contains 66 mg of lactose (as monohydrate) and 1.87 mg of sodium.
Pomožna snov z znanim učinkom: ena tableta vsebuje 66 mg laktoze (v obliki monohidrata) in
District 3, 032266
50 Theodor Pallady Blvd. District 3, 032266
Consider dose reduction or stopping the medication if a patient develops such urges while taking aripiprazole (see section 4.8).
Če se med zdravljenjem z aripiprazolom pri bolniku pojavijo taki impulzi, razmislite o zmanjšanju odmerka ali ukinitvi zdravila (glejte poglavje 4.8).Bolniki s sočasno motnjo pomanjkanja pozornosti (ADHD - Attention deficit hyperactivity disorder)
Constipation Dyspepsia Nausea
Očesne bolezni zamegljen vid diplopija okulogirna kriza
Increased Alanine Aminotransferase (ALT) Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
žolčnika in žolčevodov odpoved jeter hepatitis zlatenica zvišana aktivnost alanin aminotransferaze (ALT)
Tel: +385 155 17 772 PV-Croatia@zentiva.com
Tel.: +36 165 55 722 PV-Hungary@zentiva.com
Do not stop your treatment just because you feel better.
Odločite se samo za zdravljenje ali samo za dojenje.
Slovenská republika Zentiva, a.s.
Slovenija Zentiva, k.s.
The orodispersible tablets may be used as an alternative to Aripiprazole Zentiva tablets for patients who have difficulty swallowing Aripiprazole Zentiva tablets (see section 5.2).
Orodisperzibilne tablete se lahko uporabijo kot alternativa tabletam Aripiprazol Zentiva pri bolnikih,
It may harm them,
Bolezni dihal,
Nervous system disorders
Attention deficit hyperactivity disorder).
• life-threatening irregular heart beat,
• nepravilno bitje srca, ki lahko ogrozi življenje,
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva rabdomioliza mialgija togost
Talk to your doctor before taking Aripiprazole Zentiva.
Pred začetkom jemanja zdravila Aripiprazol Zentiva se posvetujte z zdravnikom.
Aripiprazole Zentiva 15 mg orodispersible tablets
Aripiprazol Zentiva 15 mg orodisperzibilne tablete aripiprazol
Excipient with known effect: each tablet contains 198 mg of lactose (as monohydrate) and 5.62 mg of sodium.
Pomožna snov z znanim učinkom: ena tableta vsebuje 198 mg laktoze (v obliki monohidrata) in
Rhabdomyolysis Myalgia Stiffness
ventrikularna aritmija zastoj srca bradikardija
These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Zentiva; if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva, you should see your doctor.
Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila Aripiprazol Zentiva.