natgillin/translations-raw huggingface dataset:
The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown: 
Spodnja preglednica prikazuje neželene učinke, zbrane preko spontanega sistema poročanja po prihodu zdravila na trg, zato njihova pogostnost ni znana: Organski sistem
Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat (see section 4.4 and 4.5) 
Zmanjšana vrednost protrombina, povečan INR in neuravnovešeno antikoagulacijsko zdravljenje, ki povzroča spremembe hemostatskih parametrov pri bolnikih, ki se zdravijo z antikoagulanti in orlistatom (glejte poglavji 4.4 in 4.5).
No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GITS), nifedipine slow release, sibutramine or alcohol have been observed. 
Interakcij z amitriptilinom, atorvastatinom, bigvanidi, digoksinom, fibrati, fluoksetinom, losartanom, fenitoinom, fenterminom, pravastatinom, nifedipin gastrointestinalnim terapevtskim sistemom (GITS),
The mean difference in weight loss with the drug compared to placebo was 3.2 kg. 
Povprečna razlika v zmanjšanju telesne mase skupine z zdravilom v primerjavi s placebom je znašala 3,2 kg.
Therefore, these patients should be monitored for possible changes in the frequency and/or severity of convulsions. 
Vzročne povezave za medsebojno delovanje ni mogoče izključiti, zato je treba pri takih bolnikih nadzorovati morebitne spremembe v pogostosti in resnosti konvulzij.
If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase. 
Če vzame orlistat z obrokom, ki vsebuje zelo veliko maščob, se lahko poveča nevarnost gastrointestinalnih neželenih učinkov.
Bottles: Do not store above 30 °C. 
Stekleničke: shranjujte pri temperaturi do 30 °C.
There are some case reports of reduced efficacy of antiretroviral HIV medicines, antidepressants antipsychotics (including lithium) and benzodiazepines coincidental to the initiation of orlistat treatment in previously well-controlled patients. 
HIV, antidepresivov, antipsihotikov (vključno z litijem) in benzodiazepinov, ki je sovpadalo s pričetkom zdravljenja z orlistatom pri predhodno urejenih bolnikih.
Rectal bleeding Diverticulitis Pancreatitis 
Bolezni prebavil krvavitev iz rektuma divertikulitis pankreatitis
Cases of rectal bleeding have been reported with Xenical. 
Pri uporabi zdravila Xenical so poročali o primerih rektalne krvavitve.
Driving and using machines Xenical has no known effect on your ability to drive a car or operate machinery. 
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, da bi zdravilo Xenical vplivalo na sposobnost za vožnjo avtomobila ali upravljanje strojev.
Pharmaco-therapeutic group: Peripherally acting antiobesity agent, ATC code A08AB01. 
Oznaka ATC: A08AB01.
The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides. 
Neaktivni encim tako ne hidrolizira trigliceridov v proste maščobne kisline in monogliceride in tako prepreči njihovo absorpcijo.
What XENICAL looks like and contents of the pack 
Izgled zdravila Xenical in vsebina pakiranja
Store in original package and keep the blister in the outer carton in order to protect from light and moisture. 
Shranjujte v originalni ovojnini, pretisne omote pa v zunanji ovojnini za zagotovitev zaščite pred svetlobo in vlago.
Like all medicines, Xenical can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Xenical capsules are turquoise with the imprint “XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules. 
Kapsule zdravila Xenical so turkizne barve z napisom XENICAL 120, na voljo so v pretisnih omotih in stekleničkah, ki vsebujejo po 21, 42 in 84 kapsul.
However, if such concomitant use is unavoidable, more frequent monitoring of ciclosporin blood levels should be performed both after addition of orlistat and upon discontinuation of orlistat in ciclosporin treated patients. 
Vendar pa je v primeru, da se sočasnemu jemanju ne moremo izogniti, potrebno pri bolnikih, zdravljenih s ciklosporinom, pogosteje spremljati koncentracije ciklosporina v krvi, tako pri uvedbi kot tudi pri ukinitvi orlistata.
Rectal pain/discomfort, soft stools, incontinence (stools), bloating (experienced by some people with type 2 diabetes), tooth/gum disorder, irregularity of menstrual cycle, tiredness. 
Bolečina/neudobje v danki, mehko blato, inkontinenca (blato), napenjanje (pri nekaterih osebah s sladkorno boleznijo tipa 2), motnje zob/dlesni, neredna menstruacija, utrujenost.
• if you are allergic (hypersensitive) to orlistat or to any of the other ingredients of Xenical, 
• če ste alergični na orlistat ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
The daily intake of fat, carbohydrate and protein should be distributed over three main meals. 
Dnevni vnos maščob, ogljikovih hidratov in beljakovin mora biti porazdeljen med tri glavne obroke.
Do not use Xenical after the expiry date stated on the bottle. 
Zdravila Xenical ne smete uporabljati po izteku roka uporabnosti, ki je naveden na steklenički.
Weight loss may also affect the dose of medicines taken for other conditions (e.g. high cholesterol or diabetes). 
Opozorila in previdnostni ukrepi Zaradi hujšanja je včasih treba prilagoditi odmerek zdravila, ki ga jemljete za zdravljenje drugih bolezenskih stanj (na primer zvišanega holesterola ali sladkorne bolezni).
Stop Xenical if such symptoms occur and tell your doctor. 
Če se pojavijo taki simptomi, prenehajte z jemanjem zdravila Xenical in se pogovorite s svojim zdravnikom.
Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings. 
4.9 Preveliko odmerjanje Enkratni odmerki orlistata po 800 mg in večkratni odmerki do 400 mg 3-krat na dan 15 dni niti pri osebah z normalno telesno maso niti pri debelih bolnikih niso imeli pomembnejših neželenih učinkov.
Pancreatitis (inflammation of the pancreas). 
Pankreatitis (vnetje trebušne slinavke).
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja bulozni izpuščaj
Do not use Xenical after the expiry date stated on the carton. 
Zdravila Xenical ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici.
The daily intake of fat should be distributed over three main meals. 
Dnevno količino zaužitih maščob je treba porazdeliti med tri glavne obroke hrane.
In order to ensure adequate nutrition, patients on a weight control diet should be advised to have a diet rich in fruit and vegetables and use of a multivitamin supplement could be considered. 
Da bi zagotovili ustrezno prehranjenost, bolnikom na dieti svetujemo, naj uživajo veliko sadja in zelenjave.
Antiepileptics patient: Orlistat may unbalance anticonvulsivant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions (see section 4.5). 
Bolniki, ki jemljejo antiepileptike: orlistat lahko deluje na antikonvulzivno zdravljenje tako, da zmanjša absorpcijo antiepileptikov, kar lahko vodi do konvulzij (glejte poglavje 4.5).
Very common: Headache Respiratory, thoracic and mediastinal disorders Very common: 
Zelo pogosti: glavobol Bolezni dihal, prsnega koša in mediastinalnega prostora
Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall. 
Študije na živalih kažejo, da se orlistat presnavlja pretežno v steni prebavil.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za peroralno uporabo
The great majority of diabetes cases came from the subgroup of patients with impaired glucose tolerance at baseline, which represented 21 % of the randomised patients. 
Velika večina primerov sladkorne bolezni se je pojavila pri podskupini bolnikov, ki je imela pred začetkom zdravljenja moteno toleranco za glukozo.
In the absence of a teratogenic effect in animals, no malformative effect is expected in man. To date, active substances responsible for malformations in man have been found teratogenic in animals when well-conducted studies were performed in two species. 
Do zdaj so namreč vsa zdravila z malformacijskim učinkom pri človeku pokazala teratogeno delovanje tudi pri živalih, če so bile opravljene ustrezne študije pri dveh vrstah.
The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.4). 
Mehanizem, ki pa ni potrjen, vključuje zmanjšano absorpcijo jodovih soli in/ali levotiroksina (glejte poglavje 4.4).
If a multivitamin supplement is recommended, it should be taken at least two hours after the administration of orlistat or at bedtime. 
Multivitaminski pripravek naj bolnik vzame vsaj dve uri po odmerku orlistata ali pred spanjem.
ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
PRILOGA II A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
• If you have any further questions, please ask your doctor or your pharmacist. 
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period. 
V kliničnem preskušanju, ki je potekalo 4 leta, je bil splošen vzorec porazdelitve neželenih učinkov podoben tistemu, ki so ga opazili pri 1 in 2 leti trajajočih študijah.
The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.5). 
Mehanizem, ki pa ni potrjen, vključuje zmanjšano absorpcijo jodovih soli in/ali levotiroksina (glejte poglavje 4.5).
Be sure to discuss these and other medicines you may be taking with your doctor. 
O sočasnem jemanju teh in drugih zdravil se morate posvetovati z zdravnikom.
Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors. 
Zdravilo Xenical je indicirano za zdravljenje debelosti ob hkratni zmerno nizkokalorični dieti pri bolnikih z indeksom telesne mase (ITM) 30 kg/m ali več ter pri bolnikih s preveliko telesno maso
PVC/ PVDC blisters containing 21, 42 and 84 hard capsules. 
6.5 Vrsta ovojnine in vsebina PVC/PVDC pretisni omoti, ki vsebujejo 21, 42 in 84 trdih kapsul.
The capsule has a turquoise cap and turquoise body bearing the imprint of “XENICAL 120”. 
Ovoj kapsule in pokrovček sta turkizne barve z napisom XENICAL 120.
In addition, doses of 240 mg tid have been administered to obese patients for 6 months. 
Za zdravljenje debelosti so bolniki 6 mesecev prejemali odmerke po 240 mg 3-krat na dan.
Capsule shell: gelatine indigo carmine (E132) titanium dioxide (E171) edible printing ink (black iron oxide, ammonia solution concentrated, potassium hydroxide, shellac, propylene glycol) 
Ovojnica kapsule: želatina, indigotin (E132), titanov dioksid (E171), barvila za potiskanje (črni železov oksid, koncentrirana raztopina amonijaka, kalijev hidroksid, šelak, propilen glikol).
Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed drug was the major route of elimination. 
Študije, v katerih so sodelovale osebe z normalno in preveliko telesno maso, so pokazale, da se neabsorbirano zdravilo izloča pretežno z blatom.
In the 2-year studies and the 4-year study, a hypocaloric diet was used in association with treatment in both the orlistat and the placebo treated groups. 
V 2-letnih študijah in 4-letni študiji so bolniki skupaj z zdravljenjem s placebom ali orlistatom prejemali tudi nizkokalorično dieto.
MARKETING AUTHORISATION NUMBERS EU/1/98/071/001-006 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/98/071/001-006
Each capsule contains 120 mg of orlistat. 
Vsaka kapsula vsebuje 120 mg orlistata.
The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink. 
Ovoj kapsule vsebuje želatino, barvili indigotin (E132), titanov dioksid (E171) in barvila za potiskanje.
However, there was an unexplained increase in the incidence of bone fractures (6 % versus 2.8 % in the orlistat and placebo groups, respectively). 
Neželeni učinki so bili v splošnem podobni kot pri odraslih, prišlo pa je do nepojasnjenega povečanja v incidenci zlomov kosti (6 % v skupini, ki je prejemala orlistat, in 2,8 % v skupini, ki je prejemala placebo).
Headache, abdominal pain/discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes). 
Zelo pogosti neželeni učinki (prizadenejo več kot 1 od 10 uporabnikov) Glavobol, bolečina/neudobje v trebuhu, nujna ali povečana potreba po odvajanju blata, vetrovi z izcedkom, oljnat izcedek, oljnato ali mastno blato, tekoče blato, nizka raven sladkorja v krvi (pri nekaterih osebah s sladkorno boleznijo tipa 2).
Oxalate nephropathy that may lead to renal failure 
Oksalatna nefropatija, ki lahko vodi do odpovedi ledvic.
Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily. 
Če zdravila niste jemali natančno tako, kot vam je predpisal zdravnik, ga o tem obvestite, sicer bo menil, da zdravilo ni učinkovito ali da ga slabo prenašate in vam po nepotrebnem spremenil zdravljenje.
More patients on orlistat or placebo lost baseline body weight of at least 5 % at 12 weeks or 10 % at one year in the XENDOS study than in the five 2-year studies. 
V študiji XENDOS je več bolnikov, ki je jemalo orlistat ali placebo izgubilo najmanj 5 % izhodiščne telesne mase po 12 tednih zdravljenja ali 10 % po enem letu kot pa v petih 2-letnih študijah.
Medicinal product subject to medical prescription. 
Izdaja zdravila je le na recept
Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ml) eight hours following oral administration of orlistat. 
Osem ur po peroralnem vnosu je bila koncentracija nespremenjenega orlistata v plazmi nemerljiva (< 5 ng/ml).
Data from the 4-year XENDOS clinical trial showed that 60 % of orlistat patients and 35 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment. 
V kliničnem preskušanju XENDOS, ki je potekalo 4 leta, je 60 % bolnikov, ki so jemali orlistat in 35 % bolnikov, ki so jemali placebo, izgubilo najmanj 5 % izhodiščne telesne mase po 12 tednih zdravljenja.
Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal. 
Študije, v katerih so sodelovale osebe z normalno in preveliko telesno maso, so pokazale, da se absorbira le minimalna količina orlistata.
A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly. 
Pri majhnem številu zdravih prostovoljcev so po enkratnem odmerku amiodarona in sočasnem jemanju orlistata opazili rahlo zmanjšanje koncentracij amiodarona v plazmi.
Xenical has no influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Xenical nima vpliva na sposobnost za vožnjo in upravljanje s stroji.
How to take XENICAL 
Kako jemati zdravilo Xenical
What you need to know before you take XENICAL 
Kaj morate vedeti, preden boste vzeli zdravilo Xenical Ne jemljite zdravila Xenical
• The other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium laurilsulfate and talc. 
• Pomožne snovi so mikrokristalna celuloza (E460), natrijev karboksimetilškrob (tip A), povidon (E1201), natrijev lavrilsulfat in smukec.
Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded. 
Pri bolnikih, ki so se sočasno zdravili z orlistatom in antiepileptiki, npr.valproatom ali lamotriginom, so poročali o konvulzijah.
* only unique treatment adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in obese type 2 diabetic patients. 
Pogosti: anksioznost * le enkratni neželeni učinki, ki so se pojavili s pogostnostjo > 2 % in incidenco ≥ 1 % v primerjavi s placebom pri bolnikih s preveliko telesno maso, ki imajo sladkorno bolezen tipa II.
It can be taken immediately before, during a meal or up to one hour after a meal. 
Kapsulo lahko vzamete tik pred obrokom, med njim ali do eno uro po njem.
The cumulative renal excretion of total orlistat-related materials was < 2 % of the given dose. 
Skupna količina presnovkov orlistata, ki se izloči skozi ledvice, znaša manj kot 2 % vnesenega odmerka.
Cases of hypothyroidism and/or reduced control of hypothyroidism may occur. 
Pojavi se lahko hipotiroidizem in/ali poslabša nadzor nad njim;
In a multi-centre (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat (n=357) or placebo (n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks. 
mladostnikov z debelostjo randomiziranih v skupino, ki je 52 tednov trikrat na dan kot dodatek nizkokalorični dieti in telesni aktivnosti prejemala ali 120 mg orlistata (n = 357) ali placebo (n = 182).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER PACKS 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ZA PRETISNE OMOTE
Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5 % of your body weight as measured at the start of treatment with Xenical. 
Če se vaša telesna masa po 12 tednih zdravljenja z zdravilom Xenical ne bo zmanjšala vsaj za pet odstotkov, vam bo zdravnik zdravljenje z zdravilom Xenical ukinil.
Bleeding from the back passage (rectum). 
Krvavitev iz danke (rektuma).
Orlistat may unbalance an anticonvulsivant treatment, by decreasing the absorption of antiepileptic drugs, thus leading to convulsions. 
Orlistat lahko deluje na zdravljenje epilepsije tako, da zmanjša absorpcijo antiepileptikov, kar lahko vodi do konvulzij (epileptičnih napadov).
Antiretrovirals for HIV: Orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV (see section 4.5). 
Protiretrovirusne učinkovine za zdravljenje okužbe s HIV: orlistat lahko morda zmanjša absorpcijo protiretrovirusnih učinkovin za zdravljenje okužbe s HIV in negativno vpliva na njihovo učinkovitost
After 1 year of treatment, 41 % of the orlistat treated patients versus 21 % of placebo treated patients lost ≥ 10 % of body weight with a mean difference of 4.4 kg between the two groups. 
Po enem letu zdravljenja je 41 % bolnikov, ki je jemalo orlistat in 21 % bolnikov, ki je jemalo placebo, izgubilo ≥ 10 % telesne mase s povprečno razliko med skupinama 4,4 kg.
Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42 % of the total plasma concentration. 
Izsledki študije, v kateri so sodelovali bolniki s preveliko telesno maso, so pokazali, da v majhnem deležu sistemsko absorbirane količine zdravila dva poglavitna presnovka M1 (hidrolizirani 4-členski laktonski obroč) in M3 (M1 z
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea. 
Za preprečitev morebitne neuspešnosti peroralnih kontracepcijskih sredstev, ki se lahko pojavi ob hudi driski, je priporočljivo uporabljati dodatne kontracepcijske metode.
The disposition of orlistat appeared to be similar between normal weight and obese volunteers. 
Kaže, da je izločanje orlistata pri prostovoljcih z normalno telesno maso in pri tistih s preveliko, podobno.
In orlistat-treated patients, the mean difference from placebo in weight loss was 1.83 kg to 3.06 kg and the mean difference from placebo in HbA1c reduction was 0.18 % to 0.55 %. 
Povprečna razlika v zmanjšanju HbA1c v primerjavi s placebom pa je znašala 0,18 do 0,55 %.
Gallstones. 
Žolčni kamni.
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
Abdominal pain/discomfort Oily spotting from the rectum Flatus with discharge Faecal urgency Fatty/oily stool Flatulence 
bolečina/neudobje v trebuhu oljni madeži iz rektuma flatus z izcedkom nujno odvajanje mastno/oljnato blato flatulenca tekoče blato oljnato odvajanje povečana pogostnost odvajanja bolečina/neudobje v rektumu mehko blato inkontinenca pri odvajanju abdominalna distenzija* bolezni zob bolezni dlesni
Of these, 62 % of orlistat treated patients and 52 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year. 
Od teh je 62 % bolnikov, ki so jemali orlistat in 52 % bolnikov, ki so jemali placebo, po enem letu zdravljenja izgubilo 10 % ali več izhodiščne telesne mase.
MARKETING AUTHORISATION NUMBER(S) EU/1/98/071/004 21 capsules 
ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/98/071/004 21 kapsul
EU/1/98/071/006 84 capsules 
EU/1/98/071/006 84 kapsul
Keep the container tightly closed in order to protect from moisture 
Vsebnik shranjujte tesno zaprt za zagotovitev zaščite pred vlago
There is no relevant indication for use of Xenical in children. 
Ustreznih indikacij za uporabo zdravila Xenical pri otrocih ni. 4.3 Kontraindikacije
Losing weight may mean you need adjustments to the dose of these medicines. 
Zaradi hujšanja je treba včasih prilagoditi njihov odmerek.
EU/1/98/071/005 42 capsules 
EU/1/98/071/005 42 kapsul
Hypersensitivity (e.g. pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis) 
Bolezni imunskega sistema preobčutljivost (npr. pruritus, izpuščaj, urtikarija,
9.5 % of the orlistat treated patients versus 3.3 % of the placebo treated patients lost ≥ 10 % of body weight after 1 year with a mean difference of 2.6 kg between the two groups. 
Po 1 letu je 9,5 % bolnikov, zdravljenih z orlistatom, in 3,3 % bolnikov, ki so prejemali placebo, izgubilo ≥ 10 % telesne mase s povprečno razliko 2,6 kg med skupinama.
NAME OF THE MEDICINAL PRODUCT Xenical 120 mg hard capsules 
IME ZDRAVILA Xenical 120 mg trde kapsule
Reproductive system and breast disorders Common: Menstrual irregularity 
Pogosti: neredna menstruacija
NAME OF THE MARKETING AUTHORISATION HOLDER CHEPLAPHARM Arzneimittel GmbH 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM CHEPLAPHARM Arzneimittel GmbH
Overall, after one year of treatment, the percentage of patients taking 120 mg orlistat who lost 10 % or more of their body weight was 20 % with orlistat 120 mg compared to 8 % of patients taking placebo. 
Skupno je po enoletnem zdravljenju v skupini, ki je jemala 120 mg orlistata, 20 % bolnikov shujšalo za 10 % ali več, medtem ko je bilo v kontrolni skupini takih bolnikov 8 %.
Antidiabetic medicinal product treatment may have to be closely monitored when taking orlistat. 
Ob jemanju orlistata mora biti zdravljenje z antidiabetiki skrbno nadzorovano.
Capsule filling: microcrystalline cellulose (E460) sodium starch glycolate (type A) povidone (E1201) sodium laurilsulfate talc 
Vsebina kapsule: mikrokristalna celuloza (E460), natrijev karboksimetilškrob (tip A), povidon (E1201), natrijev lavrilsulfat, smukec.
Orlistat, M1 and M3 are all subject to biliary excretion. 
Orlistat, M1 in