natgillin/translations-raw huggingface dataset:
INFORMATION FOR THE USER Karvezide 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
114 NAVODILO ZA UPORABO Karvezide 300 mg/ 25 mg filmsko obložene tablete irbesartan/ hidroklorotiazid
116 Your doctor will normally advise you to stop taking Karvezide as soon as you know you are pregnant.
116 drugo vrsto zdravljenja proti zvišanemu krvnemu tlaku.
117 Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Not known: frequency cannot be estimated from the available data.
Pogosti: pri 1 do 10 od 100 bolnikov Občasni: pri 1 do 10 od 1. 000 bolnikov Neznana: ni mogoče oceniti iz razpoložljivih podatkov.
Do not use Karvezide after the expiry date which is stated on the carton and on the blister after EXP.
118 Zdravila Karvezide ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake “ Uporabno do ”.
Each film-coated tablet of Karvezide 300 mg/ 25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Ena Karvezide 300 mg/ 25 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
What Karvezide looks like and contents of the pack Karvezide 300 mg/ 25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Na eni strani imajo vtisnjeno obliko srca, na drugi pa vrezano številko 2788.
Karvezide 300 mg/ 25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Karvezide 300 mg/ 25 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij o podlagi za priporočil CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Kentera is a transdermal patch (deliver the drug across the skin) that contains the active substance oxybutynin.
Zdravilo Kentera je transdermalni obliž (dovaja učinkovino skozi kožo), ki vsebuje zdravilno učinkovino oksibutinin.
Kentera is used in adult patients with an unstable bladder (an overactive bladder, when the bladder muscles contract suddenly) to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the condition.
Zdravilo Kentera je namenjeno odraslim bolnikom z nestabilnim mehurjem (prekomerno aktivnim mehurje, pri katerem se mišice mehurja nenadoma skrčijo), in sicer za zdravljenje urgentne inkontinence (nenadne izgube nadzora na uriniranjem), povišane pogostosti uriniranja (potrebe po pogostem uriniranju) ter urgentnosti (nenadne nuje po uriniranju).
The recommended dosage of Kentera is one patch twice a week (every 3 to 4 days).
Priporočen odmerek zdravila Kentera je en obliž dvakrat na teden (vsakih 3 do 4 dni).
The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet.
Obliž je potrebno namestiti na suho, nepoškodovano kožo na trebuhu, bokih ali zadnjici, in sicer takoj po odstranitvi zaščitne vrečke.
A new application site should be chosen with each new patch so the same place is not used within 7 days.
Za vsak nov obliž je potrebno izbrati novo mesto namestitve, tako da obliža 7 dni ne nameščamo na isto mesto.
The active substance in Kentera, oxybutynin, is an anticholinergic medicine.
Zdravilna učinkovina oksibutinin, ki jo vsebuje zdravilo Kentera, je antiholinergično zdravilo.
It blocks some receptors in the body, the muscarinic M1 and M3 receptors, and in the bladder, this causes the muscles that push urine out of the bladder to relax.
Le- to blokira nekatere receptorje v telesu, muskarinske receptorje M1 in M3, ter receptorje v mehurju, ter s tem povzroči, da se sprostijo mišice, ki potiskajo urin iz mehurja.
This leads to an increase in the capacity of the bladder, and to changes in the way the bladder muscles contract as the bladder fills up.
To vodi do povečanja kapacitete mehurja in do sprememb v načinu krčenja mišic mehurja, ko se ta napolni.
This helps Kentera to prevent unwanted urination.
Na tak način zdravilo Kentera preprečuje neželeno uriniranje.
Oxybutinin has been available as a tablet for the treatment of overactive bladder since the 1970’ s.
Oksibutinin je v obliki tablet za zdravljenje prekomerno aktivnega mehurja na trgu od sedemdesetih let naprej.
Kentera has been studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies.
Zdravilo Kentera so preučevali v dveh glavnih raziskavah, in sicer na skupno 881 bolnikih, predvsem starejših ženskah s prekomerno aktivnim mehurjem.
In one study (520 patients), Kentera was compared with placebo (dummy treatment), in the second (361 patients), Kentera was compared with tolterodine capsules (another medicine used to treat urge incontinence).
V eni od raziskav (s 520 bolniki) so zdravilo Kentera primerjali s placebom, v drugi (s 361 bolniki) pa s kapsulami tolterodina (zdravila, ki je prav tako namenjeno zdravljenju urgentne inkontinence).
The main measure of effectiveness was the effect of the treatment on the number of incontinence episodes over a 7- or a 3-day period.
Glavno merilo učinkovitosti je bil vpliv zdravljenja na število inkontinenčnih epizod v obdobju 7 ali 3 dni.
What benefit has Kentera shown during the studies?
Kakšne koristi je zdravilo Kentera izkazalo med raziskavami?
Kentera was more effective than placebo: after 12 weeks, the average number of incontinence episodes per week had decreased by 19 (or about 3 per day) with Kentera, against a decrease of 15 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Zdravilo Kentera je bilo učinkovitejše od placeba: po 12 tednih se je povprečno število inkontinenčnih epizod na teden ob uporabi zdravila Kentera zmanjšalo za 19 (ali za okoli 3 na dan), v primerjavi z 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged episodes in the placebo group.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged zmanjšanjem za 15 epizod na teden pri skupini, zdravljeni s placebom.
Kentera was as effective as tolterodine, both treatments decreasing the number of episodes by about 3 per day.
Zdravilo Kentera je bilo v primerjavi s tolterodinom enako učinkovito, saj se je število epizod pri obeh načinih zdravljenja zmanjšalo za približno 3 na dan.
The most common side effects (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application).
Najpogostejši neželeni stranski učinki (opaženi pri več kot 1 bolniku izmed 10) so reakcije na mestu aplikacije (vključno s srbenjem okoli mesta namestitve obliža).
Other side effects reported were redness at the site of application, dry mouth, constipation, diarrhoea, upset stomach, headache, or sleepiness dizziness, blurred vision, and urinary infection.
Drugi opaženi neželeni stranski učinki so bili rdečica na mestu aplikacije, suha usta, zaprtje, driska, razdražen želodec, glavobol, zaspanost, omotica in zamegljen vid ter okužba sečil.
For the full list of all side effects reported with Kentera, see the Package Leaflet.
Celovit opis vseh neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Kentera, najdete v Navodilih za uporabo.
Kentera should not be used in people who may be hypersensitive (allergic) to oxybutynin or any of the other ingredients, and in patients with urinary retention (difficulty in passing urine), severe gastro- intestinal conditions, uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves causing muscle weakness).
Zdravila Kentera se ne sme uporabljati pri ljudeh, ki so preobčutljivi (alergični) na oksibutinin ali katero drugo sestavino tega zdravila, kakor tudi ne pri bolnikih z zastojem urina (s težavami pri izločanju urina), hudim gastrointestinalnim obolenjem, nenadzorovanim ozkokotnim glavkomom (povečanim tlakom v očeh navkljub zdravljenju) ali hudo miastenijo (boleznijo živčnega sistema, ki privede do mišične slabosti).
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of Kentera had been shown to be at the level of the oral presentation, already on the market.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo Kentera enako učinkovito kot peroralna oblika, ki je že prisotna na trgu.
They decided that Kentera’ s benefits are greater than its risks for the symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Sklenili so, da so koristi uporabe zdravila Kentera pri simptomatskem zdravljenju urgentne inkontinence in/ ali povečane pogostosti uriniranja ter urgentnosti, kot se lahko pojavi pri bolnikih s sindromom prekomerno aktivnega mehurja, večje od tveganj, povezanih z njim.
They recommended that Kentera be given marketing authorisation.
Zato so priporočili, da se za zdravilo Kentera podeli dovoljenje za promet.
Other information about Kentera:
Druge informacije o zdravilu Kentera:
The European Commission granted a marketing authorisation valid throughout the European Union for Kentera to Nicobrand Limited on 15 June 2004.
Evropska komisija je dovoljenje za promet z zdravilom Kentera, veljavno po vsej Evropski uniji, odobrila družbi Nicobrand Limited dne 15. junija 2004.
The full EPAR for Kentera is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kentera je na voljo tukaj.
Sachet (LDPE/ paper laminate)
Vrečka (LDPE/ papirni laminat)
Kentera 3.9 mg / 24 hours, transdermal patch
Kentera 3, 9 mg / 24 h transdermalni obliž
Each transdermal patch contains 36 mg of oxybutynin.
Vsak transdermalni obliž vsebuje 36 mg oksibutinina.
The area of the patch is 39 cm2, releasing a nominal 3.9 mg of oxybutynin per 24 hours.
Površina obliža 39 cm2 sproš a nominalnih 3, 9 mg oksibutinina na 24 ur.
Symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with unstable bladder
Zdravljenje simptomov urgentne inkontinence in/ ali povišane pogostosti uriniranja ter urgentnosti, ki se lahko pojavi pri bolnikih z nestabilnim mehurjem.
The patch should be applied to dry, intact skin on the abdomen, hip, or buttock immediately after removal from the protective sachet.
Po odstranitvi zaš itne vre ke transdermalni obliž takoj namestimo na suho, nepoškodovano kožo na trebuhu, bokih ali zadnjici.
A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days.
Obliža 7 dni ne nameš ajte na isto mesto.
The recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days).
Priporo en odmerek je 3, 9 mg transdermalnega obliža dvakrat tedensko (vsake 3 do 4 dni).
No studies have been performed in children or adolescents, therefore Kentera is not recommended for use in children or adolescents.
Študije pri otrocih ali mladostnikih niso bile izvedene, zato obliža Kentera ne priporo amo za otroke ali mladostnike.
Hypersensitivity to the active substance or to any other excipients of the transdermal patch.
Preob utljivost na u inkovino ali druge pomožne snovi transdermalnega obliža.
Kentera is contraindicated in patients with urinary retention, severe gastro-intestinal condition, myasthenia gravis or narrow-angle glaucoma and in patients who are at risk for these conditions.
Kentera je kontraindiciran pri bolnikih z zastojem urina, hudim gastrointestinalnim obolenjem, hudo miastenijo ali ozkokotnim glavkomom ter pri bolnikih, pri katerih obstaja tveganje teh obolenj.
Kentera should be used with caution in patients with hepatic or renal impairment.
Priporo amo previdnost pri uporabi obliža Kentera pri bolnikih z ledvi nimi boleznimi ali okvaro jeter.
The use of Kentera in patients with hepatic impairment should be carefully monitored.
Uporabo obliža Kentera pri bolnikih z ledvi nimi boleznimi ali okvaro jeter skrbno nadzirajte.
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Kentera.
Druge vzroke pogostega uriniranja (nezadostno delovanje srca ali ledvi ne bolezni) je potrebno oceniti pred za etkom zdravljenja z obližem Kentera.
If urinary tract infection is present, an appropriate antibacterial therapy should be started.
V primeru okužbe se il je potrebno za eti z ustrezno antibioti no terapijo.
Urinary Retention:
Zastoj urina:
Antichloinergic products should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
Priporo amo previdnost pri uporabi antiholinergi nih zdravil pri bolnikih s klini no pomembno obstrukcijo vratu mehurja zaradi tveganja zastajanja urina.
Because anticholinergic agents such as oxybutynin may produce drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution.
Antiholinergi ne u inkovine kot je oksibutinin lahko povzro ijo omoti nost, zaspanost ali zamegljen vid, zato je treba bolnikom svetovati previdnost.
Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.
Bolnike je treba opozoriti, da lahko alkohol stopnjuje zaspanost, ki jo povzro ijo antiholergi ne u inkovine kot je oksibutinin.
2 Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics..
2 Pri uporabi obliža Kentera pri starejših bolnikih svetujemo previdnost, saj so lahko bolj ob utljivi na u inek centralno delujo ega antiholinergika in izkazujejo razlike v farmakokinetiki.
Oral administration of oxybutynin may warrant the following cautionary statements, but these events were not observed during clinical trials with Kentera:
Peroralno dajanje oksibutinina je lahko vzrok za varnostne napotke, opisane v nadaljevanju, eprav taka stanja niso bila opažena med klini nimi preskušanji z obližem Kentera:
Gastrointestinal Disorders:
Bolezni prebavil:
Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
Antiholinergi na zdravila lahko zmanjšajo gastrointestinalno gibljivost, zato jih je potrebno pri bolnikih z gastrointestinalnimi obstrukcijami dajati previdno zaradi tveganja želod nega zastajanja.
Also in conditions such as ulcerative colitis, and intestinal atony.
Enako velja za stanja kot je ulcerozni kolitis in revesno atonijo.
Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/ gastro-oesophageal reflux and/ or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.
Antiholinergi na zdravila je treba pazljivo uporabljati pri bolnikih, ki imajo hiatusno kilo/ gastro- ezofagealni refluks in/ ali trenutno jemljejo zdravila (kot so bisfosfonati), ki lahko povzro ijo ali poslabšajo ezofagitis.
Anticholinergic medicinal products should be used with caution in patients who have autonomic neuropathy, cognitive impairment or Parkinson's disease
Previdnost pri jemanju antiholinergi nih zdravil je potrebna pri bolnikih, ki imajo avtonomno nevropatijo, zmanjšane kognitivne sposobnosti ali Parkinsonovo bolezen.
Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment.
Bolnike je treba informirati, da lahko pride do vro inske kapi (zvišana telesna temperatura in vro inska kap zaradi zmanjšanega znojenja) pri uporabi antiholinergikov kot je oksibutinin v zelo vro em okolju.
Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy
Oksibutinin lahko poslabša simptome hipertiroidizma, koronarnih sr nih bolezni, kongestivne zmanjšane zmogljivosti srca, sr ne aritmije, tahikardije, hipertenzije in hipertrofije prostate.
Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis.
Oksibutinin lahko vpliva na izlo anje žleze slinavke, kar lahko povzro i zobno gnilobo, paradentozo ali ustno kandidiazo.
The concomitant use of oxybutynin with other anticholinergic medicinal products or with other agents that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of dry mouth, constipation, and drowsiness.
So asno jemanje oksibutinina z drugimi antiholinergi nimi zdravili ali z drugimi u inkovinami, ki tekmujejo za encim presnove CYP3A4 lahko povišajo pogostost ali resnost suhih ust, zaprtja in zaspanosti.
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Antikolinergi ne u inkovine lahko spremenijo absorpcijo dolo enih zdravil, ki se jemljejo so asno, zaradi antikolinergi nega u inka na gastrointestinalno gibljivost.
As oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4, interactions with drugs that inhibit this isoenzyme cannot be ruled out.
Ker oksibutinin presnavlja citokromski P 450 izoencim CYP 3A4, medsebojnega delovanja z zdravili, ki inhibirajo ta izoencim, ni mogo e izklju iti.
This should be borne in mind when using azole antifungals (e. g. ketoconasole) or macrolide antibiotics (e. g. erythromycin) concurrently with oxybutynin.
To je treba upoštevati pri so asni uporabi azolnih antimikotikov (npr. ketokonazola) ali makrolidnih antibiotikov (npr. eritromicina) z oksibutininom.
The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e. g. biperiden, levodopa), antihistamines, antipsychotics (e. g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinc antispasmodics, dipyridamole.
Antikolinergi no delovanje oksibutinina je pove ano ob so asnem jemanju drugih antikolinergikov ali zdravil z antikolinergi nim delovanjem, kot so na primer amantadin ali druga antikolinergi na antiparkinsonska zdravila (npr. biperiden, levodopa), antihistaminiki, antipsihotiki (npr. fenotiazini, butirofenoni, klozapin), kvinidin, tricikli ni antidepresivi, atropin in sorodne u inkovine, kot so atropinski spazmolitiki, dipiridamol.
Pregnancy There are no adequate data on the use of oxybutynin transdermal patch in pregnant women.
Nose nost Ustreznih podatkov glede uporabe oksibutininskega transdermalnega obliža pri nose ih ženskah ni.
Studies in animals have shown minor reproductive toxicity (see section 5.3).
Preizkusi na živalih so pokazali manj pomembno toksi nost za plodnost (glejte poglavje 5. 3).
Kentera should not to be used during pregnancy unless clearly necessary
Obliža Kentera ne uporabljajte med nose nostjo, razen e je to nujno potrebno.
3 Lactation When oxybutynin is used during lactation, a small amount is excreted in the mother’ s milk.
Dojenje Pri uporabi oksibutinina med dojenjem se manjša koli ina izlo a v materino mleko.
Breast feeding while using oxybutynin is therefore not recommended.
Dojenje med uporabo oksibutinina zato odsvetujemo.
Oxybutynin may cause drowsiness, blurred vision, dizziness and fatigue, therefore caution is recommended when driving or operating machines.
Oksibutinin lahko povzro a omoti nost, zamegljen vid, vrtoglavico in utrujenost, zato priporo amo pazljivost med vožnjo in upravljanjem s stroji.
The most commonly reported adverse drug reactions were application site reaction (Kentera 23.1%, placebo 7.6%).
Najpogostejši neželeni u inki na zdravilo so bile reakcije na mestu uporabe (Kentera 23, 1%, placebo 7, 6%).
Other adverse drug reactions reported were dry mouth (Kentera 8.6%, placebo 5.2%), constipation (Kentera 3.9%, placebo 2%), diarrhea (Kentera 3.2%, placebo 2%), headache (Kentera 3.0%, placebo 2.4%), dizziness (Kentera 2.3%, placebo 1.2%), and blurred vision (Kentera 2.3%, placebo 0.89%).
Drugi neželeni u inki so bili suha usta (Kentera 8, 6%, placebo 5, 2%), zaprtje (Kentera 3, 9%, placebo 2%), driska (Kentera 3. 2%, placebo 2%), glavobol (Kentera 3. 0%, placebo 2. 4%), omoti nost (Kentera 2. 3%, placebo 1. 2%) in zamegljen vid (Kentera 2. 3%, placebo 0. 89%).
Undesirable effects known to be associated with anticholinergic therapy, but not observed with Kentera during clinical studies are anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, disorientation, poor ability to concentrate, fatigue, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, confusion, anxiety, paranoia, hallucinations, photosensitivity, erectile dysfunction.
Neželeni u inki, ki jih povezujejo z antikolinergi no terapijo, vendar niso bili opaženi pri Kentera v asu klini nih študij so: anoreksija, bruhanje, refluks ezofagitis, zmanjšano znojenje, vro inska kap, zmanjšano izlo anje solz, midriaza, tahikardija, aritmija, motnje orientacije, zmanjšana sposobnost koncentracije, utrujenost, no ne more, nemirnost, sunkoviti kr i, intraokularna hipertenzija in indukcija glavkoma, zmedenost, anksioznost, paranoja, halucinacije, preob utljivost na svetlobo, disfunkcija erekcije.
Reported Adverse Drug Reactions and rate of occurrence:
Znani neželeni u inki in stopnja pojavnosti:
Application site reactions
Reakcije na mestu nanosa
All application site reactions -Application site pruritis -Application site erythema -Application site reaction -Application site rash
Vse reakcije na mestu nanosa - Srbenje mesta nanosa - Zardelost mesta nanosa - Reakcija na mestu nanosa - Izpuš aj na mestu nanosa Infekcijske in parazitske bolezni:
23.1% 14.3% 5.7% 3.5% 3.0%
23, 1% 14. 3% 5. 7% 3. 5% 3. 0%
Very common very common common common common
Zelo pogosto zelo pogosto pogosto pogosto pogosto
Urinary Tract Upper Respiratory Tract Fungal Eye disorders
Se ila Zgornji del dihal Glivice O esne motnje
1.2% 0.2% 0.2%
1. 2% 0. 2% 0. 2%
common uncommon uncommon
pogosto ob asno redko
Vision abnormalities Ear and labyrinth disorders
Nenormalnosti vida
2.3%
2. 3%
Dizziness Cardiac Disorders
Omoti nost Sr ne motnje
Palpitations Vascular disorders
Palpitacije Motnje ožilja
0.3%
0. 3%
uncommon
redko
Hot flushes Urticaria Gastrointestinal disorders
Vro inski vali Koprivnica Prebavne motnje
0.3% 0.4%
0. 3% 0. 4%
uncommon uncommon
redko redko
Dry Mouth Constipation Diarrhea Nausea Abdominal Pain Dyspepsia Abdominal Discomfort Musculoskeletal disorders
Suha usta Zaprtje Driska Slabost Bole ine v trebuhu Dispepsija Nelagodnost v trebuhu Motnje mišic in kosti
8.6% 3.9% 3.2% 2.1% 1.2% 0.4% 0.5%
8. 6% 3. 9% 3. 2% 2. 1% 1. 2% 0. 4% 0. 5%
common common common common common uncommon uncommon
pogosto pogosto pogosto pogosto pogosto redko redko
Back Pain
redko
0.8%
0. 3% 0. 9%
uncommon
redko redko
Urinary retention Dysuria General disorders
Glavobol Dremavica Vnetje nosne sluznice Poškodbe
0.3% 0.9%
3. 0% 1. 2% 0. 5%
uncommon uncommon
pogosto pogosto redko
common common uncommon
Prizadetost zaradi poškodb