natgillin/translations-raw huggingface dataset:
Date of first authorisation: 10 March 2004 Date of latest renewal: 12 March 2009 
Datum posljednje obnove odobrenja: 12. ožujka 2009.
Common: Headache 
Često: glavobolja
The safety and efficacy of Cholestagel in children aged 0 to 17 years have not yet been established. 
Sigurnost i djelotvornost lijeka Cholestagel u djece u dobi od 0 do 17 godina nisu još ustanovljene.
Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested. 
Doze veće od maksimalno preporučene (4,5 g na dan (7 tableta)) nisu ispitivane.
Therefore advice is given to closely monitor ciclosporin blood concentrations (see also section 4.4). 
Stoga se savjetuje pažljivo praćenje koncentracija ciklosporina u krvi (vidjeti dio 4.4).
A total of 85% of the patients were on either atorvastatin (50% of whom received 80 mg dose) or rosuvastatin (72% of whom received 40 mg dose). 
Ukupno je 85% bolesnika dobivalo ili atorvastatin (od kojih je njih 50% dobivalo dozu od 80 mg) ili rosuvastatin (72% njih dobivalo je dozu od 40 mg).
Therefore, Cholestagel is not recommended for use in this population. 
Stoga se Cholestagel ne preporučuje primjenjivati u ovoj populaciji.
The tablets should be swallowed whole and not broken, crushed or chewed. 
Tablete je potrebno progutati cijele i ne smiju se lomiti, drobiti ili žvakati.
When administering medicinal products for which alterations in blood levels could have a clinically significant effect on safety or efficacy, physicians should consider monitoring serum levels or effects. 
Kada se primjenjuju lijekovi kod kojih promjene koncentracije u krvi mogu klinički značajno utjecati na sigurnost i djelotvornost, liječnici trebaju razmisliti o praćenju njihovih serumskih razina ili učinaka.
The medicines may be taken at the same time or at separate times according to what your doctor has prescribed. 
Ti se lijekovi mogu uzimati istodobno ili odvojeno, sukladno onome što Vam je propisao liječnik.
The tablets should be swallowed whole. 
Tablete je potrebno progutati cijele.
Since there is a high degree of variability in the bioavailability of verapamil, the clinical significance of this finding is unclear. 
S obzirom na visok stupanj varijabilnosti u bioraspoloživosti verapamila, klinički značaj ovog nalaza nije jasan.
Without the recycling process, your liver has to make additional bile acids. 
Ako ne dolazi do recikliranja, jetra mora stvarati dodatne količine žučne kiseline.
The tablets are packed in plastic bottles with child resistant closures. 
Tablete su pakirane u plastične bočice sa sigurnosnim zatvaračem za djecu.
This leaflet was last revised in 
Ova je uputa zadnji puta revidirana u Drugi izvori informacija
Other medicines and Cholestagel 
Drugi lijekovi i Cholestagel
Your doctor may increase your dose to 7 tablets per day. 
Liječnik Vam može povećati dozu na 7 tableta na dan.
The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 
(≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
If you need to take other medicines more than once a day, remember that your Cholestagel tablets can be taken once a day. 
Ako ostale lijekove morate uzimati češće nego jedanput na dan, upamtite da Cholestagel tablete možete uzimati jedanput na dan.
What you need to know before you take Cholestagel 
Što morate znati prije nego počnete uzimati Cholestagel
Secondary causes of hypercholesterolaemia 
Sekundarni uzroci hiperkolesterolemije
What Cholestagel looks like and contents of the pack 
Kako Cholestagel izgleda i sadržaj pakiranja
A study conducted in rats did not result in any differences in reproductive parameters between the groups that might imply reproductive effects attributable to colesevelam. 
Rezultati istraživanja na štakorima nisu pokazali razlike u parametrima reprodukcije između skupina koje bi mogle implicirati učinke na reprodukciju pripisive kolesevelamu.
• Verapamil or olmesartan (medicines used to treat high blood pressure). 
• verapamila ili olmesartana (lijekovi za liječenje visokog krvnog tlaka).
Do not use this medicine after the expiry date which is stated on the carton and bottle label after “EXP'' 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza "Rok valjanosti" ili „EXP“.
Monitoring of the clinical effects of treatment with ursodeoxycholic acid should be considered. 
Treba razmotriti praćenje kliničkih učinaka liječenja ursodeoksikolnom kiselinom.
Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract. 
Ipak, u slučaju predoziranja bi glavni mogući štetni učinak mogla biti opstrukcija gastrointestinalnog trakta.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ 
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
Since Cholestagel is not absorbed, the risk of systemic toxicity is low. 
Budući da se Cholestagel ne apsorbira, rizik od sustavne toksičnosti je malen.
Do not break, crush or chew the tablets. 
Nemojte ih lomiti, drobiti ili žvakati.
Cholestagel may affect the way in which the following medicines work: 
Cholestagel može utjecati na djelovanje sljedećih lijekova:
However, in one study triglycerides tended to increase more when Cholestagel was given as a single dose with breakfast. 
Međutim, u jednom su ispitivanju trigliceridi rasli više kada se Cholestagel davao u jednoj dozi uz doručak.
Interaction with ciclosporin 
Interakcija s ciklosporinom
A concomitant increase in very low density lipoprotein synthesis can occur. 
Može doći do istodobnog povećanja sinteze lipoproteina vrlo male gustoće.
There is no need for dose adjustment when Cholestagel is administered to elderly patients. 
Nije potrebno prilagođavati dozu kada se Cholestagel primjenjuje starijim bolesnicima.
Cholesterol is the sole precursor of bile acids. 
Kolesterol je jedini prethodnik žučnih kiselina.
The following side effects have been reported in patients taking Cholestagel: 
Sljedeće su nuspojave prijavljene u bolesnika koji su uzimali Cholestagel:
If you take a medicine called either Neoral® or ciclosporin, please ensure to take it with Cholestagel in a consistent pattern over the day; either always together or always separate for a set number of hours. 
Uzimate li lijek pod nazivom Neoral® ili ciklosporin, pazite da ga s lijekom Cholestagel uzimate uvijek na isti način tijekom dana, odnosno ili uvijek zajedno ili uvijek odvojeno uz isti vremenski razmak.
If you are taking medicines for diabetes, you should consult with your physician so that you can be closely monitored. 
Ako uzimate lijekove protiv šećerne bolesti morate se posavjetovati s Vašim liječnikom kao bi Vas mogao pažljivo kontrolirati.
This is especially important for patients with coronary heart disease and angina pectoris. 
Ovo je osobito važno u bolesnika s bolešću krvnih žila srca i anginom pektoris.
This prevents your body from recycling the bile acids from your intestines in the usual way. 
Na taj način tijelo ne može reciklirati žučne kiseline iz crijeva na uobičajen način.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
• Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
In addition, Total-C decreased 7 to 10%, HDL-C increased 3% and triglycerides increased 9 to 10%. 
Osim toga, ukupni je kolesterol bio snižen za 7 do 10%, HDL kolesterol povišen za 3%, a vrijednosti triglicerida povišene za 9 do 10%.
The maximum recommended dose is 7 tablets per day. 
Maksimalna preporučena doza je 7 tableta na dan.
Gastrointestinal symptoms could occur. 
Mogu se javiti gastrointestinalni simptomi.
If you think any of these apply to you, you should inform your doctor or pharmacist before taking Cholestagel. 
Ako mislite da se nešto od navedenoga odnosi na Vas, morate o tome obavijestiti svog liječnika ili ljekarnika prije nego počnete uzimati Cholestagel.
Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1). 
Cholestagel se može koristiti i u kombinaciji s ezetimibom, sa ili bez statina, u odraslih bolesnika s primarnom hiperkolesterolemijom, uključujući bolesnike s obiteljskom hiperkolesterolemijom (vidjeti dio 5.1).
Description of selected adverse events 
Opis odabranih nuspojava
Safety and efficacy are not established for patients with triglyceride levels greater than 3.4 mmol/L, since such patients were excluded from the clinical studies. 
Sigurnost i djelotvornost primjene u bolesnika čije su vrijednosti triglicerida više od 3,4 mmol/l nisu ustanovljene, budući da takvi bolesnici nisu bili uključeni u klinička ispitivanja.
In controlled clinical studies involving approximately 1400 patients and during post-approval use, the following adverse reactions were reported in patients given Cholestagel. 
U kontroliranim kliničkim ispitivanjima s približno 1400 uključenih bolesnika i tijekom primjene nakon stavljanja lijeka u promet, u bolesnika koji su dobivali Cholestagel prijavljene su sljedeće nuspojave.
Off-white, capsule-shaped film-coated tablets imprinted with “C625” on one side. 
Bjelkaste, filmom obložene tablete u obliku kapsule, s utisnutom oznakom “C625” na jednoj strani.
The dosing of the statin and the ezetimibe should follow the instructions for that particular medicine. 
Doziranje statina i ezetimiba treba biti u skladu s uputama za pojedini navedeni lijek.
• Antidiabetic medications (medicines used to treat diabetes, such as metformin extended-release (ER) tablets, glimepiride, glipizide, pioglitazone, repaglinide or glyburide). 
• antidijabetika (lijekova protiv šećerne bolesti, npr. tableta metformina s produženim oslobađanjem, glimepirida, glipizida, pioglitazona, repaglinida ili gliburida).
Caution should be exercised when prescribing to pregnant women. 
Potreban je oprez kada se ovaj lijek propisuje trudnicama.
Not known (frequency cannot be estimated from the available data): blockage of the intestines (which can increase among patients with a history of blockage of the intestines or intestinal removal). 
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): blokada crijeva (može se povećati kod bolesnika koji u povijesti bolesti imaju blokadu crijeva ili uklanjanje crijeva).
Cholestagel can induce or worsen present constipation. 
Cholestagel može izazvati ili pogoršati postojeću konstipaciju.
These studies have demonstrated that colesevelam binds bile acids, including glycocholic acid, the major bile acid in humans. 
Ta su ispitivanja pokazala da kolesevelam veže žučne kiseline, uključujući i glikokolnu kiselinu, glavnu žučnu kiselinu u čovjeka.
Furthermore, Cholestagel should always be administered at the same times consistently since the timing of intake of Cholestagel and ciclosporin could theoretically influence the degree of reduced bioavailability of ciclosporin. 
Nadalje, Cholestagel uvijek treba uzimati u isto vrijeme jer bi vremenski raspored unosa lijeka Cholestagel i ciklosporina teoretski mogao utjecati na stupanj smanjene bioraspoloživosti ciklosporina.
Pack sizes are 24 (1 x 24), 100 (2 x 50) and 180 (1 x 180) tablets. 
Veličine pakiranja: 24 (1 x 24), 100 (2 x 50) i 180 (1 x 180) tableta.
If you are going to take Cholestagel and one of these medicines, your doctor may want to do tests to make sure that Cholestagel does not interfere with these medicines. 
Ako ćete uzimati Cholestagel i jedan od tih lijekova, liječnik će možda zahtijevati provođenje pretraga kako bi bio siguran da Cholestagel ne utječe na djelovanje tih lijekova.
Cholestagel is not absorbed from the gastrointestinal tract. 
Cholestagel se ne apsorbira iz gastrointestinalnog trakta.
Specific clinical interaction studies with colesevelam and vitamin K have not been performed. 
Nisu provedena posebna klinička ispitivanja interakcije kolesevelama i vitamina K.
Your doctor may stop your medicine. 
Liječnik će možda odlučiti prekinuti liječenje ovim lijekom.
Cholestagel can affect the bioavailability of the oral contraceptive pill when administered simultaneously. 
Cholestagel može utjecati na bioraspoloživost oralne kontracepcijske tablete ako je uzet istodobno.
These could include poorly controlled diabetes, untreated hypothyroidism (low levels of thyroid hormone for which no treatment is being given currently), proteins in urine (nephrotic syndrome), altered protein levels in the blood (dysproteinaemias), and blockage of the bile transport to your gall bladder (obstructive liver disease). 
Ona bi mogla uključivati loše kontroliranu šećernu bolest, neliječenu hipotireozu (niska razina hormona štitnjače za koju trenutno ne uzimate lijekove), bjelančevine u mokraći (nefrotski sindrom), promjenu razine bjelančevina u plazmi (disproteinemija) i blokadu prijenosa žuči u žučnu vrećicu (opstruktivna bolest jetre).
Clinical trials have shown that Cholestagel and statins can be co-administered or dosed apart, and that Cholestagel and ezetimibe can be coadministered or dosed apart. 
Klinička ispitivanja su pokazala da se Cholestagel i statini mogu uzimati istodobno ili odvojeno kao i da se Cholestagel i ezetimib mogu uzimati istodobno ili odvojeno.
The risk of constipation should especially be considered in patients with coronary heart disease and angina pectoris. 
Rizik od konstipacije mora se posebice uzeti u obzir u bolesnika s koronarnom bolešću srca i anginom pektoris.
• Ciclosporin (a medicine used to suppress the immune system). 
• ciklosporina (lijeka za potiskivanje imunološkog sustava).
It is important to ensure that Cholestagel is administered at least 4 hours after the oral contraceptive pill to minimise the risk of any interaction (see also section 4.5). 
Važno je osigurati da se Cholestagel uzima najmanje 4 sata nakon uzimanja oralne kontracepcijske tablete, kako bi se rizik od bilo kakve interakcije sveo na najmanju moguću mjeru (vidjeti također dio 4.5).
Studies examining administration of Cholestagel as a single dose with breakfast, a single dose with dinner, or as divided doses with breakfast and dinner did not show significant differences in LDL-C reduction for different dosing schedules. 
Ispitivanja u kojima se ispitivala primjena lijeka Cholestagel u jednoj dozi uz doručak, u jednoj dozi uz večeru ili u dvije odvojene doze uz doručak i večeru nisu ukazala na značajne razlike u sniženju LDL kolesterola kod različitih rasporeda uzimanja.
Cholestagel may affect the bioavailability of other medicinal products. 
Cholestagel može utjecati na bioraspoloživost ostalih lijekova.
Co-administration of Cholestagel and repaglinide had no effect on the AUC and caused a 19% reduction in the Cmax of repaglinide, the clinical significance of which is unknown. 
Istodobna primjena lijeka Cholestagel i repaglinida nije utjecala na AUC, no izazvala je 19%-tno smanjenje Cmax repaglinida, za koje klinički značaj nije poznat.
Triglycerides in the Cholestagel group increased by 19% and 13% at 6 and 12 weeks vs an increase of 6% and 13% in the placebo group, but the increases were not significantly different. 
Vrijednosti triglicerida su u skupini koja je dobivala Cholestagel porasle za 19% u 6. tjednu te za 13% u 12. tjednu, u usporedbi s povišenjem od 6% odnosno 13% u placebo skupini, ali se ta povišenja nisu značajno razlikovala.
However, formal interaction studies with ursodeoxycholic acid have not been performed. 
Međutim, nisu provedena formalna ispitivanja interakcija s ursodeoksikolnom kiselinom.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.. 
• prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
No clinical data are available on the use of Cholestagel in pregnant women. 
Nema kliničkih podataka o primjeni lijeka Cholestagel u trudnica.
180 tablets (1 X 180) 
180 tableta (1 x 180)
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP. 
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjenje u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
If you forget to take Cholestagel 
Ako ste zaboravili uzeti Cholestagel
During normal digestion, bile acids are secreted into the intestine. 
Tijekom normalne probave žučne se kiseline izlučuju u crijevo.
HDL-C and hsCRP levels were also not significantly different compared to placebo at 12 weeks. 
Vrijednosti HDL kolesterola i (visoko osjetljivog) hsCRP-a također se u 12. tjednu nisu značajno razlikovale od onih u placebo skupini.
Cholestagel has no or negligible influence on the ability to drive and use machines. 
Cholestagel ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
There were no significant effects on growth, sexual maturation, fat-soluble vitamin levels or clotting factors, and the adverse reaction profile for Cholestagel was comparable to that seen with placebo. 
Nisu zabilježeni značajni učinci na rast, spolno sazrijevanje, razinu vitamina topivih u masti ni faktore zgrušavanja, a profil nuspojava kod primjene lijeka Cholestagel bio je usporediv s onim zabilježenim pri primjeni placeba.
There have been very rare reports of reduced phenytoin levels in patients who have received Cholestagel administered with phenytoin. 
Vrlo su rijetko prijavljene smanjene razine fenitoina u bolesnika koji su dobivali Cholestagel zajedno s fenitoinom.
Prior to initiating therapy with Cholestagel, if secondary causes of hypercholesterolaemia (i.e., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease) are considered, these should be diagnosed and properly treated. 
Ako se prije početka terapije lijekom Cholestagel razmatraju sekundarni uzroci hiperkolesterolemije (npr. loše kontrolirana šećerna bolest, hipotireoza, nefrotski sindrom, disproteinemije, opstruktivna bolest jetre), potrebno ih je dijagnosticirati i pravilno liječiti.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, 
Istraživanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na trudnoću, razvoj embrija/fetusa, okot i postnatalni razvoj (vidjeti dio 5.3).
For concomitant medications which require administration via divided doses, it should be noted that the required dose of Cholestagel can be taken once a day. 
Ako se istodobno uzimaju lijekovi koji se moraju primjenjivati u odvojenim dozama, treba napomenuti da se potrebna doza lijeka Cholestagel može uzeti jedanput na dan.
The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known. 
Učinci kombinacije fenofibrata i lijeka Cholestagel na rizik od miopatije odnosno hepatotoksičnosti nisu poznati.
Taking Cholestagel helps to lower the level of cholesterol in your blood. 
Cholestagel pomaže u snižavanju razine kolesterola u krvi.
However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption. 
Međutim, potreban je oprez u liječenju bolesnika s mogućim nedostatkom vitamina K ili vitamina topivih u masti, kao što su npr. bolesnici s malapsorpcijom.
If you are prescribed Cholestagel and a statin together it is important that you tell your doctor if you are pregnant or if you are planning to become pregnant because statins must not be used during pregnancy; the patient information leaflet that comes with that particular statin should be consulted. 
Ako Vam je propisan Cholestagel u kombinaciji sa statinom, važno je da obavijestite liječnika da ste trudni ili da planirate trudnoću jer se statini ne smiju koristiti tijekom trudnoće; svakako pročitajte
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Bowel or biliary obstruction 
• Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Opstrukcija crijeva ili žučnih vodova.
Cholestagel in combination with statins and in combination with ezetimibe was well tolerated and the adverse reactions observed were consistent with the known safety profile of statins or ezetimibe alone. 
Cholestagel se u kombinaciji sa statinima i u kombinaciji s ezetimibom dobro podnosio, a opažene nuspojave bile su u skladu s poznatim profilom sigurnosti statina odnosno ezetimiba primijenjenih samostalno.
Cholestagel is prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated) in adults. 
Cholestagel se propisuje za liječenje bolesti koja se zove primarna hiperkolesterolemija (povišene vrijednosti kolesterola u krvi) u odraslih.
SPECIAL STORAGE CONDITIONS Keep the bottle tightly closed in order to protect from moisture. 
POSEBNE MJERE ČUVANJA Bočicu čuvati čvrsto zatvorenu radi zaštite od vlage.
Co-administration of Cholestagel and glyburide (also known as glibenclamide) caused a decrease in the AUC0-inf and Cmax of glyburide by 32% and 47%, respectively. 
Istodobna primjena lijeka Cholestagel i gliburida (poznatog i kao glibenklamid) izazvala je smanjenje AUC0-inf gliburida za 32% i Cmax za 47%.
Oral contraceptive pill 
Oralne kontracepcijske tablete
Your doctor may tell you to take the Cholestagel dose either once a day or twice a day; in either case Cholestagel should be taken with a meal. 
Liječnik Vam može reći da dozu lijeka Cholestagel uzimate jedanput na dan ili dvaput na dan, a u svakom slučaju lijek treba uzimati uz obrok.
So far, no studies have been conducted that directly demonstrate whether treatment with Cholestagel as monotherapy or combination therapy has any effect on cardiovascular morbidity or mortality. 
Do sada nisu provedena ispitivanja koja bi izravno pokazala utječe li liječenje lijekom Cholestagel u monoterapiji ili u kombiniranoj terapiji na pobol i smrtnost od bolesti srca i krvožilja.
In interaction studies in healthy volunteers, Cholestagel had no effect on the bioavailability of digoxin, metoprolol, quinidine, valproic acid, and warfarin. 
U ispitivanjima interakcija u zdravih dobrovoljaca Cholestagel nije utjecao na biorasploživost digoksina, metoprolola, kinidina, valproatne kiseline i varfarina.
Tablets should be taken with liquid and with a meal. 
Tablete se moraju uzimati s tekućinom, uz obrok.
In a 6 week study 129 patients with mixed hyperlipidaemia were randomised to fenofibrate 160 mg plus 3.8 g Cholestagel or fenofibrate alone. 
U jednom 6-tjednom ispitivanju je 129 bolesnika s miješanom hiperlipidemijom bilo randomizirano u skupinu koja je dobivala fenofibrat od 160 mg i Cholestagel od 3,8 g ili samo fenofibrat.
- Cholestagel may also be used together with ezetimibe (a cholesterol-lowering medicine that works by reducing cholesterol absorption from the gut), with or without a statin. 
- Cholestagel se također može koristiti zajedno s ezetimibom (lijek za snižavanje kolesterola koji djeluje tako da smanjuje apsorpciju kolesterola iz crijeva), sa ili bez statina.