natgillin/translations-raw huggingface dataset:
Uncommon (may affect up to 1 in 100 people) side effects: low blood pressure, weakness, thirst, headache, dizziness, shaking, dry mouth, swallowing difficulties, change in taste sensation, heartburn, hardening of the stool, inflammation or pain of the stomach or bowel, change in bowel habit, sleeplessness, itching, dry skin, rash, hives, itching red spots, collection of blood (haematoma) e.g. under the skin, joint pain, back pain, pain in limbs, muscle pain or spasms, increased blood levels of parathyroid hormone (a protein), certain blood fats and liver enzymes and a low level of folate (a vitamin). 
Manje česte (mogu se javiti u manje od 1 na 100 osoba) nuspojave: niski krvni tlak, slabost, žeđ, glavobolja, omaglica, drhtanje, suha usta, poteškoće pri gutanju, promjene osjeta okusa, žgaravica, tvrda stolica, upala ili bol u želucu ili crijevima, promjena crijevnih navika, nesanica, svrbež, suha koža, osip, koprivnjača, crvene točke koje svrbe, nakupine krvi (hematomi) npr. ispod kože, bol u zglobovima, bol u leđima, bol u udovima, mišićni bol ili grčevi, povišene razine paratiroidnog hormona (jedne bjelančevine) u krvi, određenih masnoća u krvi i enzima jetre te niska razina folata (vitamina).
13.1 g. The rate of responders (either a reduction in serum phosphorus ≤ 1.78 mmol/L and/or a reduction from baseline ≥ 0.3 mmol/L) was 50.4 % and 43.8% in the two studies, respectively (placebo 30.8% and 
Brzina odgovora (smanjenje fosfora u serumu ≤ 1,78 mmol/l i/ili smanjenje u odnosu na početnu vrijednost ≥ 0,3 mmol/l) bila je 50,4 % odnosno 43,8% u ta dva ispitivanja (placebo 30,8% odnosno 26,3%).
BindRen did not induce a clinically relevant reduction in folate absorption during clinical studies of up to one year. 
BindRen nije izazvao klinički značajno smanjenje apsorpcije folata tijekom kliničkih ispitivanja u trajanju do godinu dana.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
After one year, the mean serum phosphorus level was 1.89 mmol/L with a significant reduction from baseline of 0.39 mmol/L and responder rate (phosphorus level <1.78 mmol/L) was 44%. 
Nakon jedne godine, srednja vrijednost fosfora u serumu bila je 1,89 mmol/l uz značajno sniženje u odnosu na početnu vrijednost za 0,39 mmol/l, a brzina odgovora (razina fosfora <1,78 mmol/l) bila je 44%.
Serum cholesterol 
Kolesterol u serumu
INFORMATION IN BRAILLE BindRen 1 g tablets 
16. PODACI NA BRAILLEOVOM PISMU BindRen 1 g tablete
• Serum albumin <30 g/L 
• nedavni peritonitis kod bolesnika na peritonejskoj dijalizi • serumski albumin <30 g/l
Serum calcium In clinical studies, colestilan had no effect on serum calcium levels over a period of up to one year. 
U kliničkim ispitivanjima, kolestilan nije imao učinka na razine kalcija u serumu u razdoblju do godinu dana.
BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis. 
BindRen je indiciran za liječenje hiperfosfatemije u odraslih bolesnika u 5. stadiju kroničnog bubrežnog zatajenja (KBZ) koji se liječe hemodijalizom ili peritonejskom dijalizom.
In subjects with baseline HbA1c ≥7.0%, colestilan showed a reduction of between 0.36 to 1.38% at week 12 in the fixed-dose study, and by 0.94 and 0.91% at week 12 in the two flexible-dose studies. 
U ispitanika s početnim HbA1c ≥7,0%, kolestilan je pokazao smanjenje za 0,36 do 1,38% u 12. tjednu u ispitivanju s fiksnom dozom te za 0,94 odosno 0,91% u 12. tjednu u dva ispitivanja s fleksibilnom dozom.
Acetic acid esters of mono- and diglycerides of fatty acids Polysorbate 80 
Film ovojnica hipromeloza esteri acetatne kiseline i mono- i diglicerida masnih kiselina polisorbat 80
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 3 G GRANULES IN SACHETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA - 3 G GRANULE U VREĆICAMA
Patients should be encouraged to adhere to their prescribed low phosphate diets. 
Bolesnike treba poticati da se pridržavaju propisane dijete s niskim sadržajem fosfata.
BindRen contains the active substance colestilan. 
BindRen sadrži djelatnu tvar kolestilan.
The Phase II and III clinical studies involving 1,410 patients with CKD Stage 5 on dialysis treated with BindRen for up to one year constituted the safety population. 
U kliničkim ispitivanjima faze II i III, sigurnost lijeka ispitana je na populaciji od 1410 bolesnika u 5. stadiju KBZ-a na dijalizi liječenih BindRenom u trajanju do godinu dana.
The colestilan-bound phosphorus is then excreted from your body in faeces. 
Fosfor vezan za kolestilan se potom izlučuje iz Vašeg tijela stolicom.
The other ingredients are purified water, hydroxypropylcellulose, colloidal, anhydrous silica, hydrogenated castor oil, hypromellose, acetic acid esters of mono- and diglycerides of fatty acids, polysorbate 80, shellac, indigo carmine aluminium lake (E132) and carnauba wax. 
Drugi sastojci su pročišćena voda, hidroksipropilceluloza, koloidni, bezvodni silicijev dioksid, hidrogenirano ricinusovo ulje, hipromeloza, esteri acetatne kiseline i mono- i diglicerida masnih kiselina, polisorbat 80, šelak, indigo carmine aluminium lake (E132) i karnauba vosak.
Muscle spasm, musculoskeletal pain, arthralgia, back pain, pain in extremities 
spazmi mišića, mišićno-koštani bol, artralgije, bol u leđima, bol u ekstremitetima
This includes medicines for irregular heart rhythm (such as digoxin), for treating high blood pressure (such as enalapril maleate), anti-seizure medicines (such as valproic acid, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, gabapentin, vigabatrin, zonisamide and levetiracetam), levothyroxine (used to treat thyroid hormone deficiency), oral birth control medicines (oestrogen, progestogen or combination pills), immune system suppressing medicines (such as cyclosporine, mycophenolate mofetil, tacrolimus). 
To uključuje lijekove za nepravilan srčani ritam (kao što je digoksin), za liječenje povišenog krvnog tlaka (kao što je enalapril maleat), antiepilepsijske lijekove (kao što su valproična kiselina, fenitoin, karbamazepin, lamotrigin, okskarbazepin, topiramat, gabapentin, vigabatrin, zonisamid i levetiracetam),
Patients that become pregnant and where a benefit/risk assessment confirms continued treatment with BindRen, supplementation of vitamins may be required, see section 4.4. 
Bolesnicama koje zatrudne i kod kojih procjena omjera koristi i rizika potvrđuje korist od nastavka liječenja BindRenom može biti potrebna nadoknada vitamina, vidjeti dio 4.4.
Bottles 
Boce
Changes in the bile acid pool in the gastrointestinal tract have also been observed to lower serum glucose. 
Također je opaženo da promjene u količini žučnih kiselina u probavnom traktu snižavaju glukozu u serumu.
Hypothyroidism 
Hipotireoidizam
BindRen granules are white cylindrical granules. 
Kako BindRen izgleda i sadržaj pakovanja BindRen granule bijele, cilindrične granule.
The safety and efficacy of BindRen has not been studied in patients with: 
4.4 Posebna upozorenja i mjere opreza pri uporabi Sigurnost i djelotvornost BindRena nije ispitana u bolesnika s:
Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, abdominal discomfort 
konstipacija, abdominalni bol, povraćanje, distenzija abdomena, mučnina, gastritis, dispepsija, proljev, flatulencija, abdominalna nelagoda
Granules. 
Granule.
Colestilan may also bind uric acid in the gastrointestinal tract. 
Kolestilan može vezati mokraćnu kiselinu u probavnom sustavu.
The other ingredients are: purified water, hydroxypropylcellulose, colloidal, anhydrous silica, hydrogenated castor oil, ethylcellulose, hypromellose, macrogol 8000, triethyl citrate, titanium dioxide, talc, cetanol and sodium laurilsulfate. 
Drugi sastojci su pročišćena voda, hidroksipropilceluloza, koloidni, bezvodni silicijev dioksid, hidrogenirano ricinusovo ulje, etilceluloza, hipromeloza, makrogol 8000, trietilcitrat, titanijev dioksid, talk, cetanol i natrijev laurilsulfat.
Talk to your doctor or pharmacist if during your treatment with BindRen, any of the following applies to you: - you experience constipation, since your doctor may wish to monitor your bowel function to detect potential side effects (see section 4). 
Obratite se svom liječniku ili ljekarniku ako tijekom liječenja BindRenom nešto od slijedećeg vrijedi za Vas: - imate zatvor, liječnik će možda htjeti pratiti funkciju Vaših crijeva kako bi prepoznao moguće nuspojave (vidjeti dio 4). - rečeno Vam je da imate poremećaj zbog kojeg je smanjena sposobnost crijeva da apsorbiraju hranjive sastojke (malapsorpcijski sindrom) ili ako se liječite takozvanim kumarinskim antikoagulansima (npr.
Calcium-phosphorus ion product was reduced by at least 0.48 mmol2/L2 at week 12 compared to placebo at doses ≥9 g/day in fixed-dose study and by 1.05 and 0.86 mmol2/L2 at week 12 in two flexible-dose studies. 
Umnožak kalcija i fosfora u serumu bio je smanjen za najmanje 0,48 mmol2/l2 u 12. tjednu u usporedbi s placebom u dozama od ≥9 g na dan u ispitivanju s fiksnom dozom i za 1,05 odnosno 0,86 mmol2/l2 u 12. tjednu u dva ispitivanja s fleksibilnom dozom.
Patients that breast-feed and where a benefit/risk assessment confirms continued treatment with BindRen, supplementation of vitamins may be required, see section 4.4. 
Bolesnicama koji doje i kod kojih procjena omjera koristi i rizika potvrđuje korist od nastavka liječenja BindRenom može biti potrebna nadoknada vitamina, vidjeti dio 4.4.
BindRen 1 g film-coated tablets colestilan 
BindRen 1 g filmom obložene tablete kolestilan
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 g colestilan. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 1 g kolestilana.
No data on the use of BindRen in pre-dialysis patients are available. 
Nema dostupnih podataka o primjeni BindRena u bolesnika koji još nisu na dijalizi.
In these patients, monitoring of vitamin A, D and E concentrations or assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary. 
Kod tih se bolesnika preporučuje pratiti koncentracije vitamina A, D i E ili procijeniti status vitamina
Serum parathyroid hormone (PTH) 
Paratiroidni hormon (PTH) u serumu
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - FILM-COATED TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI - FILMOM OBLOŽENE TABLETE
BindRen is indicated for use in patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis. 
BindRen je indiciran za primjenu u bolesnika u 5. stadiju kroničnog bubrežnog zatajenja (KBZ) na hemodijalizi ili peritonejskoj dijalizi.
Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, 
konstipacija, abdominalni bol, povraćanje, distenzija abdomena, mučnina, gastritis, dispepsija, proljev,
However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption syndromes and patients treated with coumarin anticoagulants (e.g. warfarin). 
K ili vitamina topljivih u mastima, kao što su bolesnici sa sindromima malapsorpcije i bolesnici koji se liječe kumarinskim antikoagulansima (npr. varfarinom).
What BindRen is and what it is used for What you need to know before you take BindRen How to take BindRen 
Što morate znati prije nego počnete uzimati BindRen
Each film-coated tablet contains 1 g of colestilan. 
Jedna filmom obložena tableta sadrži 1 g kolestilana.
Hyperparathyroidism 
hiperparatireoidizam
The frequency of adverse reactions increased with dose. 
Učestalost nuspojava povećavala se s dozom.
These were considered to result from a deficiency of vitamin K following a reduction in the absorption of fat-soluble vitamins (see section 4.4). 
K nakon smanjenja apsorpcije vitamina topljivih u mastima (vidjeti dio 4.4).
Colestilan binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood. 
Kolestilan veže fosfor iz hrane u probavnom traktu i tako sprječava apsorpciju fosfora u krv.
Do not use this medicine after the expiry date stated on the box or the sachet after the abbreviation “EXP”. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili vrećici iza „Rok valjanosti”.
Fixed-dose study: 
Ispitivanje fiksne doze:
Posology The recommended starting dose is 6-9 g per day (2-3 g three times daily). 
Doziranje Preporučena početna doza je 6-9 g na dan (2-3 g tri puta na dan).
BindRen is not absorbed from the gastrointestinal tract but may affect the bioavailability or absorption rate of other medicinal products. 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija BindRen se ne apsorbira iz probavnog trakta, ali može utjecati na bioraspoloživost ili brzinu apsorpcije drugih lijekova.
Rare (may affect up to 1 in 1000 people) side effects: blockage of intestines, a low level of vitamin K, obstruction of the blood vessels that supply the heart muscle and swelling of the ankles or extremities. 
Rijetke (mogu se javiti u manje od 1 na 1000 osoba) nuspojave: blokada crijeva, niska razina vitamina K,
No data are available to assess the safety and efficacy in breast-feeding women. 
Nema dostupnih podataka da bi se mogla procijeniti sigurnost i djelotvornost u dojilja.
In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with BindRen. 
Vrlo rijetko tijekom liječenja BindRenom opaženi su slučajevi intestinalne opstrukcije i ileus/subileus.
BindRen does not contain calcium and your doctor may prescribe additional calcium tablets. 
BindRen ne sadrži kalcij i liječnik Vam može dodatno propisati tablete kalcija. - imate nenormalno visoke razine kalcija u krvi zbog prejake aktivnosti paratiroidnih žlijezda.
- BindRen 2 g granules: each sachet contains 2 g of colestilan. 
BindRen 2 g granule: jedna vrećica sadrži 2 g kolestilana.
If you take more BindRen than you should If you take too much BindRen, tell your doctor or pharmacist. 
Ako uzmete previše BindRena, obavijestite svog liječnika ili ljekarnika.
About high blood phosphorus levels (hyperphosphataemia) If your kidneys no longer function properly you may undergo dialysis, which replaces many of the functions of your kidneys. 
Ako Vam bubrezi ne rade uredno, ići ćete na dijalizu koja zamjenjuje mnoge funkcije bubrega.
NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets 
NAZIV LIJEKA BindRen 1 g filmom obložene tablete
Infections and infestations Uncommon: 
Infekcije i infestacije
Sometimes, the dialysis and diet are not enough to stop the phosphorus in your blood rising to high levels, a condition referred to by your doctor as hyperphosphataemia. 
Ponekad, dijaliza i dijeta nisu dovoljne za sprječavanje porasta razine fosfora u krvi.
In these patients, monitoring serum folate status and supplementation with folic acid should be considered. 
U tih je bolesnika potrebno razmotriti praćenje koncentracije folata u serumu te nadoknadu folne kiseline.
Serum phosphorus 
Fosfor u serumu
• Severe gastrointestinal disorders such as chronic or severe constipation, intestinal stenosis, intestinal diverticulum, sigmoid colitis, gastrointestinal ulcers, or recent major gastrointestinal surgery 
divertikuloza crijeva, kolitis sigmoidnog kolona, gastrointestinalni ulkusi ili nedavni veliki kirurški zahvat na gastrointestinalnom traktu
Serum uric acid 
Mokraćna kiselina u serumu
BindRen did not induce any clinically relevant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year. 
Tijekom kliničkih ispitivanja u trajanju do godinu dana, BindRen nije izazvao nikakvo klinički značajno smanjenje apsorpcije vitamina A, D, E ili K.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g colestilan. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 2 g kolestilana.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 3 g colestilan. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 3 g kolestilana.
Gastrointestinal haemorrhage, oesophagitis, faecaloma, dysphagia, change in bowel habit, dry mouth 
gastrointestinalno krvarenje, ezofagitis, fekaliti (vrlo tvrda stolica), disfagija, promjene u pražnjenju crijeva, suha usta
Three Phase III studies and two long term follow-up studies have been performed in patients with CKD Stage 5 on dialysis, in order to investigate efficacy and safety in this population. 
Djelotvornost i sigurnost populacije bolesnika u 5. stadiju KBZ-a na dijalizi ispitana je u jednom ispitivanju faze III i dva ispitivanja s dugotrajnim praćenjem.
Elemental calcium should be given as a supplement in case of hypocalcaemia. 
U slučaju hipokalcemije potrebno je primijeniti nadomjesnu terapiju kalcijem.
In the first study, the mean serum phosphorus level was 2.33 mmol/L at baseline and 1.96 mmol/L (mean reduction by 0.36 mmol/L) at week 12 on a colestilan mean daily dose of 11.5 g. Similarly in the second study, the mean serum phosphorus level was 2.44 mmol/L at baseline and 1.94 mmol/L at week 12 (mean reduction by 0.50 mmol/L) on a colestilan mean daily dose of 
U prvom ispitivanju, srednja vrijednost fosfora u serumu bila je 2,33 mmol/l na početku i 1,96 mmol/l (smanjenje srednje vrijednosti za 0,36 mmol/l) u 12. tjednu, srednja vrijednost dnevne doze kolestilana iznosila je 11,5 g.
Foil laminate (polyethylene terephthalate/polyethylene/aluminium foil/polyethylene/polyvinylidene chloride) sachets. 
Vrećice od laminirane folije (polietilentereftalat/polietilen/aluminijska folija/polietilen/poliviniliden klorid) Jedna vrećica sadrži 3 g granula.
Caution should be exercised when treating patients with conditions which predispose to gastrointestinal haemorrhage, such as recent history of gastrointestinal haemorrhage, gastrointestinal ulcers, gastritis, diverticulosis, colitis and haemorrhoids. 
Ovo uključuje stanja kao što su nedavno gastrointestinalno krvarenje, gastrointestinalni ulkusi, gastritis, divertikuloza, kolitis i hemoroidi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - FILM-COATED TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU NALJEPNICA BOCE - FILMOM OBLOŽENE TABLETE
ATC code: not yet assigned. 
ATK oznaka: nije još dodijeljena BindRen sadrži kolestilan.
Purified water Hydroxypropylcellulose Silica, colloidal anhydrous Castor oil, hydrogenated 
Jezgra tablete voda, pročišćena hidroksipropilceluloza silicijev dioksid, koloidni, bezvodni ricinusovo ulje, hidrogenirano
NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules 
NAZIV LIJEKA BindRen 2 g granule
NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules 
NAZIV LIJEKA BindRen 3 g granule
The daily dose of BindRen granules should be taken in three equally divided doses with or immediately after meals with a sufficient amount of water to aid swallowing. 
Lijek se uzima uz obrok ili neposredno nakon obroka uz dovoljnu količinu vode da se lakše progutaju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLES - FILM-COATED TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA ZA BOCE - FILMOM OBLOŽENE TABLETE
3 years 
6.3 Rok valjanosti 3 godine
- BindRen 3 g granules: each sachet contains 3 g of colestilan. 
BindRen 3 g granule: jedna vrećica sadrži 3 g kolestirana.
METHOD OF ADMINISTRATION Read the package leaflet before use. 
NAČIN PRIMJENE LIJEKA Prije primjene pročitati Uputu o lijeku.
NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules colestilan 
NAZIV LIJEKA BindRen 2 g granule kolestilan
NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules colestilan 
NAZIV LIJEKA BindRen 3 g granule kolestilan
INFORMATION IN BRAILLE BindRen 3 g granules 
16. PODACI NA BRAILLEOVOM PISMU BindRen 3 g granule
The least squares mean reduction from baseline to week 12 as compared to placebo was 0.16, 0.21, 0.19 and 0.37 mmol/L at 6, 9, 12 and 15 g/day respectively. 
Sniženje srednjih vrijednosti izračunatih metodom najmanjih kvadrata od početne vrijednosti do 12. tjedna u usporedbi s placebom iznosilo je 0,16 mmol/l uz dozu od 6 g na dan, 0,21
Serum calcium-phosphorus ion product 
Umnožak fosfora i kalcija u serumu
INFORMATION IN BRAILLE BindRen 2 g granules 
16. PODACI NA BRAILLEOVOM PISMU BindRen 2 g granule
Shellac 
Blisteri
Cetyl alcohol Sodium laurilsulfate Castor oil, hydrogenated 
Film ovojnica etilceluloza hipromeloza makrogol 8000 trietilcitrat titanijev dioksid talk cetilni alkohol natrijev laurilsulfat ricinusovo ulje, hidrogenirano
- swallowing problems - severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines - recent major stomach or bowel surgery - gall bladder obstruction - severe liver problems - seizures - recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity 
- teške tegobe sa želucem ili pražnjenjem crijeva, kao što su zatvor, čirevi želuca ili crijeva ili hemoroidi, budući da ova stanja mogu dovesti do povećanog rizika od, npr., krvarenja u crijevima
4 years 
6.3 Rok valjanosti 4 godine
Severe hepatic impairment 
Srčani poremećaji
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION BindRen 3 g granules colestilan 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA BindRen 3 g granule kolestilan
- If you get any side effects, talk to your doctor or pharmacist or nurse. 
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTERS - FILM-COATED TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA ZA BLISTERE - FILMOM OBLOŽENE TABLETE
Common (may affect up to 1 in 10 people) side effects: feeling sick (nausea), vomiting, a burning sensation in your stomach, diarrhoea, bloating, stomach ache and bowel pain, gas, a decreased appetite and low blood calcium. 
Česte (mogu se javiti u manje od 1 na 10 osoba) nuspojave: mučnina, povraćanje, žarenje u želucu, proljev,
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION BindRen 2 g granules colestilan 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA BindRen 2 g granule kolestilan
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/001-005 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/804/001-005
Musculoskeletal and connective tissue disorders Uncommon: 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/011-013 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/804/011-013
(peritonitis) - low levels of albumin (a protein) in your blood 
- teške tegobe s jetrom - napadaji - nedavna upala sluznice koja obavija trbušnu šupljinu (peritonitis) - niske razine albumina (proteina) u krvi.
abdominal discomfort 
flatulencija, abdominalna nelagoda
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/014-016 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/804/014-016
NAME OF THE MARKETING AUTHORISATION HOLDER Mitsubishi Tanabe Pharma Europe Ltd. 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Mitsubishi Tanabe Pharma Europe
If you get any side effects, talk to you doctor or pharmacist. 
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/006-010 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/804/006-010
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/001-010 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/804/001-010
Fat-soluble vitamins 
Vitamini topljivi u mastima