natgillin/translations-raw huggingface dataset:
If a patient misses a dose, the patient should take ulipristal acetate as soon as possible. 
Če bolnica pozabi vzeti odmerek, mora vzeti ulipristalacetat čim prej.
Treatment must not be initiated if transaminases (alanine transaminase (ALT) or aspartate aminotransferase (AST)) exceed 2 x ULN (isolated or in combination with bilirubin >2 x ULN). 
Zdravljenje se ne sme uvesti, če vrednost transaminaz (alanin transaminaze (ALT) ali aspartat aminotransferaze (AST) preseže 2 x ZMN (same ali v kombinaciji z bilirubinom > 2 x ZMN).
• the contraindications of pregnancy and breastfeeding, genital bleeding of unknown aetiology or for reasons other than uterine fibroids, and uterine, cervical, ovarian or breast cancer as well as underlying hepatic disorder. 
• kontraindikacije: nosečnost in dojenje, krvavitve iz spolovil z neznano etiologijo ali zaradi drugih razlogov razen materničnih leiomiomov, rak maternice, materničnega vratu, jajčnikov ali dojke, kot tudi osnovna bolezen jeter,
It is used either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count. 
Uporablja se pred kirurškim posegom zaradi leiomiomov ali dolgoročno za zmanjševanje velikosti leiomiomov, za ustavitev ali zmanjševanje krvavitev in za povečevanje števila eritrocitov.
Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, high density lipoprotein and low density lipoprotein. 
Ulipristalacetat se v veliki meri veže (> 98 %) na beljakovine v plazmi, vključno z albuminom, glikoproteinom kisline alfa-l, lipoproteinom velike gostote in lipoproteinom majhne gostote.
NA N=199 N=191 
N=199 N=191
• Educational material for patients which contains o Patient card 
• Izobraževalno gradivo za bolnice, ki vsebuje: o opozorilno kartico za bolnico.
Co-administration of moderate or potent CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.4). 
Sočasna uporaba zmernih ali močnih zaviralcev CYP3A4 in ulipristalacetata ni priporočljiva (glejte poglavje 4.4).
The direct action on the endometrium results in class-specific changes in histology termed PAEC. 
Neposredno delovanje na endometrij povzroči za razred značilne spremembe histologije, ki se imenujejo spremembe PAEC.
If the dose was missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. 
Če je odmerek zamudila za več kot 12 ur, ne sme vzeti izpuščenega odmerka, ampak mora preprosto nadaljevati običajni razpored odmerjanja.
After treatment course 2 (two times 3 months of treatment) 
Po 2. ciklu zdravljenja (dvakratno 3-mesečno zdravljenje)
Mechanism of action Ulipristal acetate exerts a direct effect on the endometrium. 
Mehanizem delovanja Ulipristalacetat ima neposreden učinek na endometrij.
Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids. 
Zdravljenje z zdravilom Esmya morajo uvesti in nadzorovati zdravniki, z izkušnjami pri diagnosticiranju in zdravljenju materničnih leiomiomov.
If you have been prescribed several courses of Esmya 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion. 
Če so vam predpisali več ciklov trimesečnega zdravljenja z zdravilom Esmya, lahko začnete vsak cikel šele med drugo menstruacijo po koncu prejšnjega zdravljenja.
In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Esmya less effective. 
Poleg tega lahko hormonska kontracepcijska sredstva in progestageni (npr. noretindron ali levonorgestrel) zmanjšajo učinek zdravila Esmya.
c N and % include withdrawn patients d Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding (not including days of spotting) during the last 2 months of a treatment course. 
d Nadzorovana krvavitev je bila opredeljena kot odsotnost epizod močnih krvavitev in največ 8 dni krvavitve (ne vključuje dni pojavljanja madežev) v zadnjih 2 mesecih cikla zdravljenja.
In the first 3-month treament course of the two long term Phase III trials, the frequency was 5.3% and 5.8% for ulipristal acetate, respectively. 
V prvem 3-mesečnem ciklu zdravljenja v dveh dolgotrajnih kliničnih preskušanjih III. faze je bila pogostnost oblivov pri uporabi ulipristalacetata 5,3 % oz. 5,8 %.
White to off-white, round biconvex tablet of 7 mm engraved with “ES5” on one face. 
Bela do umazano bela okrogla bikonveksna tableta s premerom 7 mm, z vtisnjenim napisom »ES5« na eni strani.
It is used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb). 
Uporablja se za zdravljenje zmernih do hudih simptomov leiomiomov maternice (znanih kot miomi), ki so nerakasti tumorji v maternici.
Therefore concomitant administration of medicinal products containing progestagen is not recommended (see sections 4.4 and 4.6). 
Zato sočasna uporaba zdravil, ki vsebujejo progestagen, ni priporočljiva (glejte poglavji 4.4 in 4.6).
Ulipristal acetate is readily converted to its mono-N-demethylated and subsequently to its di-N-demethylated metabolites. 
Ulipristalacetat se hitro pretvori v mono-N-demetilirane, potem pa še v di-N-demetilirane presnovke.
A daily dose of ulipristal acetate 5 mg partially suppresses FSH levels but serum oestradiol levels are maintained in the mid-follicular range in the majority of patients and are similar to levels in patients who received placebo. 
Odmerek ulipristalacetata 5 mg dnevno delno zmanjša ravni FSH, ravni estradiola v serumu pa se pri večini bolnic vzdržujejo v srednjefolikularnem razponu in so podobne ravnem pri bolnicah, ki so prejemale placebo.
Myoma size reduction was generally maintained during this follow-up period in patients originally treated with ulipristal acetate but some re-growth occurred in patients treated with leuprorelin. 
Zmanjšanje velikosti miomov se je med sledenjem navadno ohranilo pri bolnicah, ki so izvirno prejemale ulipristalacetat, pri bolnicah, ki so prejemale levprorelin, pa je prišlo do nekaj ponovnih rašč.
In some women, uterine fibroids may cause heavy menstrual bleeding (your ‘period'), pelvic pain (discomfort in the belly) and create pressure on other organs. 
Pri nekaterih ženskah lahko maternični leiomiomi povzročijo močne menstrualne krvavitve (»mesečno perilo«) in bolečine v medenici (neprijeten občutek v trebuhu) ter pritiskajo na druge organe.
Medicinal products affecting gastric pH 
Zdravila, ki vplivajo na pH v želodcu
There is no relevant use of ulipristal acetate in the paediatric population. 
Ulipristalacetat ni primeren za uporabo pri pediatrični populaciji.
Your period should generally return within 4 weeks after treatment with Esmya is stopped. 
Mesečno perilo se ponavadi povrne v 4 tednih po prekinitvi zdravljenja z zdravilom Esmya.
Esmya is to be taken daily during treatment courses of up to 3 months continuously. 
Zdravilo Esmya je treba jemati neprekinjeno vsak dan v času cikla zdravljenja, ki traja po največ 3 mesece.
A majority of women taking a therapeutic dose of ulipristal acetate have anovulation, however, the level of fertility while taking multiple doses of ulipristal acetate has not been studied. 
Pri večini žensk, ki jemljejo terapevtske odmerke ulipristalacetata, se pojavi anovulacija, vendar stopnje plodnosti pri jemanju večkratnih odmerkov ulipristalacetata niso raziskovali.
In addition, reversible increase of the endometrium thickness may occur under treatment. 
Poleg tega se lahko med zdravljenjem pojavi reverzibilna odebelitev endometrija.
One tablet contains 5 mg of ulipristal acetate. 
Ena tableta vsebuje 5 mg ulipristalacetata.
The treating physician should explain to the patient the requirement for treatment free intervals. 
Lečeči zdravnik mora bolnici pojasniti, zakaj potrebuje obdobja brez zdravljenja.
Ulipristal acetate is excreted in human milk. 
Ulipristalacetat se izloča v mleko pri človeku.
• reminder of the effect of ulipristal acetate on the endometrium. 
• opomnik o učinku ulipristalacetata na endometrij,
Study 3 was on open-label study assessing ulipristal acetate 10 mg, where each of the 3-month treatment was followed by 10 days of double-blind treatment with progestin or placebo. 
Študija 3 je bila odprta študija, v kateri so ocenili 10 mg odmerek ulipristalacetata; vsakemu 3-mesečnemu ciklu zdravljenja je sledilo 10 dni dvojno slepega zdravljenja s progestinom ali placebom.
Thus hormonal contraceptives and progestagens are likely to reduce ulipristal acetate efficacy by competitive action on the progesterone receptor. 
Verjetno je, da bodo ta hormonska kontracepcijska sredstva in progestageni prek kompetitivnega delovanja na receptor za progesteron zmanjšali učinkovitost ulipristalacetata.
In study 2, the reduction in menstrual blood loss was comparable for the patients treated with ulipristal acetate and the gonadotrophin releasing hormone-agonist (leuprorelin). 
V drugi študiji je bilo zmanjšanje izgube menstrualne krvi pri bolnicah, ki so prejemale ulipristalacetat in agonist gonadoliberina (levprorelinom), primerljivo.
During treatment with Esmya, your doctor will carry out regular blood tests to check your liver function. 
Med zdravljenjem z zdravilom Esmya boste po navodilu zdravnika opravljali redne krvne preiskave za preverjanje delovanja jeter.
Leuprorelin 3.75 mg/ month N=93 
Levprorelin 3,75 mg/mesec N=93
Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended. 
Za ženske s hudo obliko astme, ki je neustrezno nadzorovana s peroralnimi glukokortikoidi, uporaba zdravila ni priporočljiva.
Median PBAC at baseline 
Mediana PBAC ob izhodišču
• inform the patients on the need to warn their physicians on any liver problems they may have. 
• bolnice obvestite, da morajo svojim zdravnikom povedati o morebitnih težavah z jetri.
In about 10-15% of patients treated with ulipristal acetate the endometrium may thicken (> 16 mm) during the first 3-month treatment course. 
Pri približno 10-15 % bolnic, ki se zdravijo z ulipristalacetatom, se lahko v prvem 3-mesečnem ciklu zdravljenja endometrij odebeli (> 16 mm).
Esmya can cause side effects although not everybody gets them. 
Zdravilo Esmya lahko povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
If during the treatment you experience any liver related signs such as feeling of being sick (nausea or vomiting), fatigue, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache, you should stop treatment and immediately contact a doctor, who will check the functioning of your liver and decide if you can continue the treatment. 
Če se vam med zdravljenjem pojavijo znaki, povezani z delovanjem jeter, kot so slabost (siljenje na bruhanje) ali bruhanje, utrujenost, huda utrujenost, zlatenica (porumenelost oči ali kože), temen urin, srbenje ali bolečina v zgornjem delu trebuha, morate o tem takoj obvestiti zdravnika, ki bo preveril delovanje vaših jeter in se odločil, ali boste z zdravljenjem nadaljevali.
Ulipristal acetate is rapidly transformed into a pharmacologically active metabolite with a Cmax of 9.0 ± 4.4 ng/ml and 20.6 ± 10.9 ng/ml also occurring approximately 1 h after ingestion, and with an AUC0-∞ of 26.0 ± 12.0 ng.h/ml and 63.6 ± 30.1 ng.h/ml respectively. 
Ulipristalacetat se hitro pretvori v farmakološko aktivni presnovek z vrednostjo Cmax 9,0 ± 4,4 ng/ml in 20,6 ± 10,9 ng/ml približno eno uro po zaužitju ter AUC0-∞ 26,0 ± 12,0 ng.h/ml oziroma 63,6 ± 30,1 ng.h/ml.
Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment (see sections 4.4 and 4.5). 
Pri večini žensk, ki jemljejo terapevtske odmerke ulipristalacetata, ovulacija izostaja, kljub temu pa je med zdravljenjem priporočljivo uporabljati nehormonsko kontracepcijsko metodo (glejte poglavji 4.4 in 4.5).
Median change in myoma volume from baseline a Treatment course 2 assessment corresponds to Treatment course 2 plus one menstrual bleeding. 
Mediana sprememba prostornine leiomiomov glede na izhodišče a Ocena 2. cikla zdravljenja ustreza 2. ciklu zdravljenja in eni menstruacijski krvavitvi.
This effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets. 
Ni pričakovati, da bi bil učinek zdravil, ki povečajo pH v želodcu, klinično pomemben za dnevno uporabo tablet ulipristalacetata.
You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards. 
Vedeti morate, da med zdravljenjem in nekaj tednov po njem večina žensk nima menstrualnih krvavitev (perila).
• Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Esmya 
• Izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo (ginekologi), ki vsebuje: o spremno pismo, o povzetek glavnih značilnosti zdravila, o vodnik za predpisovanje zdravila Esmya za zdravnike.
The safety of ulipristal acetate has been evaluated in 1,053 women with uterine fibroids treated with 5 mg or 10 mg ulipristal acetate during Phase III studies. 
Varnost ulipristalacetata so ocenili pri 1053 ženskah z materničnimi leiomiomi, ki so jih v študijah III. faze zdravili s 5 mg ali 10 mg ulipristalacetata.
Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator characterised by a tissue-specific partial progesterone antagonist effect. 
Ulipristalacetat je peroralno delujoči, sintetični selektivni modulator progesteronskih receptorjev, za katerega je značilen za tkivo značilni, delni progesteronski antagonistični učinek.
Concomitant use of progestagen-only pills, a progestagen-releasing intrauterine device or combined oral contraceptive pills is not recommended (see section 4.5). 
Sočasna uporaba tablet, ki vsebujejo samo progestagen, materničnega vložka, ki sprošča progestagen ali kombiniranih peroralnih kontracepcijskih tablet ni priporočljiva (glejte poglavje 4.5).
Potential for ulipristal acetate to affect other medicinal products: 
Možnost vpliva ulipristalacetata na druga zdravila:
If you forget to take Esmya 
Če ste pozabili vzeti zdravilo Esmya
Do not take Esmya if you have liver problems.Tell your doctor if you know that you have problems with your liver or if you have any doubts about the condition of your liver. 
Povejte svojemu zdravniku, če veste, da imate težave z jetri ali če imate kakšne pomisleke glede stanja jeter.
In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations in the gastrointestinal wall during absorption. 
Podatki in vitro kažejo, da ulipristalacetat pri klinično pomembnih koncentracijah lahko zavira P-gp v steni prebavil med absorpcijo.
Treatments should only be initiated when menstruation has occurred: - The first treatment course should start during the first week of menstruation. 
Cikli se smejo začeti samo ob nastopu menstruacije: - prvi cikel zdravljenja se mora začeti v prvem tednu menstruacije.
When daily administration of a 5 mg dose is commenced during a menstrual cycle most subjects (including patients with myoma) will complete their first menstruation but will not menstruate again until after treatment is stopped. 
Če se jemanje odmerka 5 mg dnevno začne med menstruacijskim ciklom, se bo pri večini bolnic (vključno z bolnicami z miomom) prva menstruacija normalno končala, vendar do konca zdravljenja ne bodo imele več mesečne krvavitve.
Alopecia** Dry skin Hyperhidrosis 
Bolezni kože in podkožja akne alopecija** suha koža hiperhidroza angioedem
• nausea (feeling sick) 
• slabost (siljenje na bruhanje)
You need blood tests before starting each treatment course to find out how your liver is working. 
Pred vsakim začetkom cikla zdravljenja boste opravili krvne preiskave, da se ugotovi, kako delujejo vaša jetra.
If endometrial thickness persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, it may need to be investigated as per usual clinical practice to exclude other underlying conditions. 
Če odebelitev endometrija vztraja tudi po ponovnem pojavu menstruacije v obdobjih brez zdravljenja ali več kot 3 mesece po koncu ciklov zdravljenja, bo to morda potrebno raziskati skladno z običajno klinično prakso, da se izključijo druge obstoječe bolezni.
A daily dose of ulipristal acetate 5 mg inhibits ovulation in the majority of patients as indicated by progesterone levels maintained at around 0.3 ng/ml. 
Odmerek ulipristalacetata 5 mg dnevno zavira ovulacijo pri večini bolnic, kar se kaže z vzdrževanjem ravni progesterona pri približno 0,3 ng/ml.
Among these 1,053 women, the safety of repeated intermittent treatment courses (each limited to 3 months) has been evaluated in 551 women with uterine fibroids treated with 5 or 10 mg ulipristal acetate in two phase III studies (including 446 women exposed to four intermittent treatment courses of whom 53 were exposed to eight intermittent treatment courses) and demonstrated a similar safety profile to that observed for one treatment course. 
Pri 551 ženskah od 1053 z materničnimi leiomiomi, ki so se zdravile s 5 ali 10 mg ulipristalacetata, so ocenili varnost ponavljajočih se intermitentnih ciklov zdravljenja (vsakega omejenega na 3 mesece) v dveh študijah III. faze (vključenih je bilo 446 žensk, ki so prejele 4 intermitentne cikle zdravljenja; 53 od njih je prejelo osem intermitentnih ciklov zdravljenja) in ugotovili podoben varnostni profil kot pri enem ciklu zdravljenja.
It is therefore recommended that co-administration of ulipristal acetate and P-gp substrates (e.g. dabigatran etexilate, digoxin, fexofenadine) should be separated in time by at least 1.5 hours. 
Zaradi tega se pri sočasni uporabi ulipristalacetata in substratov P-gp (dabigatran eteksilat, digoksin, feksofenadin) priporoča vsaj 1,5 urni razmik.
There are no or limited amount of data from the use of ulipristal acetate in pregnant women. 
Podatkov o uporabi ulipristalacetata pri nosečnicah ni, ali pa so omejeni.
Ulipristal acetate may interfere with the action of hormonal contraceptive medicinal products (progestagen only, progestagen releasing devices or combined oral contraceptive pills) and progestagen administered for other reasons. 
Ulipristalacetat lahko vpliva na delovanje hormonskih kontracepcijskih sredstev (ki vsebujejo samo progestagen, vložkov, ki sproščajo progestagen ali kombiniranih peroralnih kontracepcijskih tablet) in progestagena, ki se uporablja zaradi drugih razlogov.
Liver function tests must be performed before starting treatment. 
Pred začetkom zdravljenja je treba opraviti preiskave delovanja jeter.
After treatment course 4 (four times 3 months of treatment) 
Po 4. ciklu zdravljenja (štirikratno 3-mesečno zdravljenje)
During the post-marketing experience, cases of liver injury and hepatic failure were reported (see section 4.3). 
Po začetku trženja so poročali o primerih okvare in odpovedi jeter (glejte poglavje 4.3).
Ulipristal acetate has a steroid structure and acts as a selective progesterone receptor modulator with predominantly inhibitory effects on the progesterone receptor. 
Ulipristalacetat ima steroidno zgradbo in deluje kot selektivni modulator progesteronskih receptorjev z večinoma zaviralnim učinkom nanje.
SIGNS AND SYMPTOMS OF POSSIBLE LIVER PROBLEMS Stop treatment and contact a doctor right away if you observe any of the following signs or symptoms: 
ZNAKI IN SIMPTOMI MOREBITNIH TEŽAV Z JETRI Če opazite katerega od naslednjih znakov ali simptomov, takoj prekinite zdravljenje in o tem obvestite svojega zdravnika:
• the need to investigate as per usual clinical practice persistence of endometrial thickening following treatment discontinuation and return of menstruation to exclude other underlying conditions. 
• informacija, da je treba skladno z običajno klinično prakso raziskati odebelitev endometrija, ki ne izgine po prekinitvi zdravljenja in ponovnem pojavu menstruacije, da se izločijo druge obstoječe bolezni,
• liver function must be monitored monthly during the first 2 treatment courses, and thereafter when clinically indicated. 
• med zdravljenjem je treba v obdobju prvih dveh ciklov enkrat mesečno opraviti preiskave delovanja jeter, kasneje pa kot je klinično indicirano.
Very common (may affect more than 1 in 10 people) side effects: - reduction or absence of menstrual bleeding (amenorrhea) - thickening of the lining of the womb (endometrial thickening). 
Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 osebi od 10): - zmanjšanje ali odsotnost menstrualne krvavitve (amenoreja), - odebelitev maternične sluznice (odebelitev endometrija).
If you stop taking Esmya 
Če ste prenehali jemati zdravilo Esmya
Following oral administration of a single dose of 5 or 10 mg, ulipristal acetate is rapidly absorbed, with a Cmax of 23.5 ± 14.2 ng/ml and 50.0 ± 34.4 ng/ml occurring approximately 1 h after ingestion, and with an AUC0-∞ of 61.3 ± 31.7 ng.h/ml and 134.0 ± 83.8 ng.h/ml, respectively. 
Po peroralni uporabi enkratnega 5- ali 10-miligramskega odmerka se ulipristalacetat hitro absorbira, pri čemer je vrednost Cmax 23,5 ± 14,2 ng/ml, približno 1 uro po zaužitju pa 50,0 ± 34,4 ng/ml, in AUC0-∞ 61,3 ± 31,7 ng.h/ml oziroma 134,0 ± 83,8 ng.h/ml.
The terminal half-life of ulipristal acetate in plasma following a single dose of 5 or 10 mg is estimated to be about 38 hours, with a mean oral clearance (CL/F) of about 100 l/h. 
Ocenili so, da je končna razpolovna doba ulipristalacetata v plazmi po enkratnem odmerku 5 mg ali 10 mg približno 38 ur, povprečni peroralni očistek (CL/F) pa približno 100 l/h.
- Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion. 
- ponovna zdravljenja se lahko začnejo šele v prvem tednu druge menstruacije po zaključenem prejšnjem ciklu zdravljenja.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in na pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
What Esmya contains - The active substance is ulipristal acetate. 
Kaj vsebuje zdravilo Esmya - Učinkovina je ulipristalacetat.
• if a patient during treatment shows signs or symptoms compatible with liver injury, treatment should be stopped, and the patient should be investigated immediately, and liver function tests performed. 
• če bolnica med zdravljenjem kaže znake ali simptome, ki nakazujejo okvaro jeter, je treba zdravljenje prekiniti, bolnico pa nemudoma pregledati in opraviti preiskave delovanja jeter.
The MAH shall ensure that, at launch and thereafter, all prescribers of Esmya and pathologists who review samples from Esmya-treated patients, as well as patients treated with Esmya, are provided with educational material. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je ob prihodu zdravila na trg in ves čas trženja zdravila vsem zdravnikom, ki predpisujejo zdravilo Esmya, patologom, ki pregledujejo vzorce bolnic, ki se zdravijo z zdravilom Esmya, in bolnicam, ki se zdravijo z zdravilom Esmya, na voljo izobraževalno gradivo.
Esmya is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4). 
Zdravilo Esmya je kontraindicirano pri bolnicah z jetrno boleznijo (glejte poglavji 4.3 in 4.4).
Urinary incontinence 
Bolezni sečil urinarna inkontinenca
nausea or vomiting, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache. 
- slabost ali bruhanje, huda utrujenost, zlatenica (porumenelost oči ali kože), temen urin, srbenje ali bolečina v zgornjem delu trebuha.