Truberzi
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 75 mg film-coated tablets. 
 
Truberzi 100 mg film-coated tablets. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Truberzi 75 mg film-coated tablets 
Each film-coated tablet contains 75 mg of eluxadoline. 
 
Truberzi 100 mg film-coated tablets 
Each film-coated tablet contains 100 mg of eluxadoline. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Truberzi 75 mg film-coated tablets 
Modified capsule-shaped, pale yellow to light-tan film-coated tablet of approximately 7 mm x 17 mm, 
debossed with “FX75” on one side. 
 
Truberzi 100 mg film-coated tablets 
Modified capsule-shaped, pink-orange to peach film-coated tablet of approximately 8 mm x 19 mm, 
debossed with “FX100” on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D). 
 
4.2 Posology and method of administration 
 
Posology 
The treatment should be initiated and supervised by a physician experienced in diagnosis and 
management of gastrointestinal disorders. 
 
The recommended dose is 200 mg daily (one 100 mg tablet, twice daily). 
 
For patients who are unable to tolerate the 200 mg daily dose (one 100 mg tablet, twice daily), the 
dose can be lowered to 150 mg daily (one 75 mg tablet twice daily). 
 
Elderly 
In principle, general dose recommendations also apply to patients aged 65 years and above.  
However, given the potential for increased sensitivity to experience undesirable effects, it may be 
considered to initiate eluxadoline treatment in a dosage of 150 mg daily (one 75 mg tablet twice daily). 



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If this dosage is well tolerated, but not sufficiently effective, dosage may subsequently be increased to 
200 mg daily (one 100 mg tablet twice daily). See section 4.4. 
 
Patients with renal impairment 
No dose adjustment is necessary based on renal function (see sections 4.4 and 5.2). 
 
Paediatric population 
The safety and efficacy of eluxadoline in children aged 0 to18 years have not yet been established. 
No data are available. 
Benefits and risks of the treatment should be periodically assessed in the context of patient symptoms 
severity. 
 
Method of administration  
For oral use. 
The tablets should be taken with food in the morning and in the evening (see section 5.2). 
Patients should be instructed if they miss a dose (delay of 4 hours) to take the next dose at the regular 
time and not to take 2 doses at the same time to make up for a missed dose. 
 
4.3 Contraindications 
 
• Hypersensitivity to eluxadoline or to any of the excipients listed in section 6.1.  
• Alcoholism, alcohol abuse, alcohol addiction or chronic or acute excessive alcohol use. These 
patients are at increased risk for acute pancreatitis (see section 4.4). 
• Known or suspected biliary tree and/or pancreatic duct obstruction (e.g. gallstones, tumour, 
periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction. These patients are 
at increased risk for sphincter of Oddi spasm (see section 4.4). 
• Patients without a gallbladder (e.g. due to cholecystectomy or agenesis). These patients are at 
increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm 
(see section 4.4). 
• Patients on treatment with potent inhibitors of OATP1B1 (e.g. cyclosporine) 
• A history of pancreatitis; or known or suspected structural diseases of the pancreas, including 
pancreatic duct obstruction. These patients are at increased risk for acute pancreatitis (see section 4.4). 
• Hepatic impairment (Child-Pugh Class A-C). These patients are at risk for significantly increased 
plasma concentrations of eluxadoline (see sections 4.4 and 5.2). 
• A history of chronic or severe constipation or sequelae from constipation, or known or suspected 
mechanical gastrointestinal obstruction. These patients may be at risk for severe complications of 
bowel obstruction. 
 
4.4 Special warnings and precautions for use 
 
Pancreatitis 
There is an increased risk of pancreatitis with or without sphincter of Oddi spasm (see section 4.3) in 
patients taking eluxadoline. Serious cases resulting in hospitalization and death, primarily in patients 
without a gallbladder have been reported. Truberzi is contraindicated in patients without a gallbladder 
and other conditions that increase the risk of developing pancreatitis (see section 4.3). Most of the 
reported cases of serious pancreatitis occurred within a week of starting treatment with eluxadoline 
and some patients developed symptoms even after one to two doses but cases of pancreatitis after 
longer duration of treatment have also been reported.   
 
Patients should be informed of and monitored for signs and symptoms suggestive of pancreatitis e.g. 
abdominal pain, that may radiate to the back or shoulder, nausea and vomiting. Patients should be 
instructed to stop the medicinal product and seek medical attention if these symptoms develop while 
taking eluxadoline (see section 4.8). 
 
All patients should be instructed not to use alcohol while on treatment with eluxadoline. 



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Sphincter of Oddi Spasm 
Given the mu opioid receptor agonism of eluxadoline, there is a potential for increased risk of 
sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute 
abdominal pain (eg, biliary-type pain) in patients taking eluxadoline, especially in patients without a 
gallbladder (see sections 4.3 and 4.8).  
Postmarketing serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis 
resulting in hospitalization have been reported, primarily in patients without a gallbladder. Most of the 
reported cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with 
eluxadoline and some developed symptoms after one to two doses. Truberzi is contraindicated in 
patients without a gallbladder. Patients with known or suspected sphincter of Oddi disease or 
dysfunction and/or biliary tract or pancreatic disease, including a history of pancreatitis, must not 
receive Truberzi (see section 4.3).   
Patients should be instructed to stop the treatment immediately and seek medical attention if they 
experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal 
pain (e.g. acute epigastric or biliary [i.e., right upper quadrant] pain) that may radiate to the back or 
shoulder, with or without nausea and vomiting. Truberzi should not be restarted in patients who 
developed biliary duct obstruction or sphincter of Oddi spasm while taking Truberzi (see section 4.3). 
 
Constipation 
Eluxadoline may cause constipation.  Avoid use with other drugs that may cause constipation (see 
section 4.5).  If patients develop severe constipation, they should be instructed to stop Truberzi and 
seek medical attention. 
Risk of constipation with eluxadoline in patients with other IBS sub-types is unknown, but may be 
increased. Caution should be exercised when administering eluxadoline in IBS patients whose bowel 
habits vary over time. 
 
Somnolence and sedation 
There is a potential for increased risk of somnolence and sedation when taking eluxadoline (see 
section 4.8) in patients who may experience increased plasma levels, such as in patients with a genetic 
predisposition for poor function of OATP1B1 transporter. As patient’s genetic disposition may be 
unknown, it is recommended that patients be monitored for impaired mental or physical abilities 
needed to perform potentially hazardous activities such as driving a car or using machines (see 
sections 4.7. and  4.8). 
 
Drug dependence and potential for abuse 
Based on the physical-chemical and biopharmaceutical properties (very low oral bioavailability), 
eluxadoline is expected to have minimal abuse or dependence liability. 
 
Special populations 
Elderly  
Overall, there was an increased frequency of adverse events reported for patients aged 65 years or 
greater in the clinical studies. However, patients 65 years of age and older, treated with the 75 mg dose 
twice daily experienced a reduced rate of serious adverse events as well as adverse events leading to 
discontinuation compared to patients treated with 100 mg dose twice daily (see section 4.8). 
Therefore, the 75 mg dose twice daily can be considered for this population, but its benefit risk ratio 
should be periodically assessed in the context of their symptoms severity (see section 4.2). 
 
Paediatric population 
Eluxadoline should not be used in children and adolescents as it has not been studied in this population 
(see section 4.2). 
 



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Renal impairment 
In participants with end stage renal disease (ESRD) not yet on dialysis, exposure of eluxadoline was 
significantly increased compared with matched, healthy participants with normal renal function. 
However, such an increase is unlikely to be of clinical significance (see section 5.2). 
  
Hepatic impairment 
Eluxadoline must not be used in patients with a history of or known or suspected hepatic impairment 
(Child-Pugh Class A-C) (see section 4.3).  
 
Effect of OATP1B1 transporter function variability on plasma levels 
The plasma levels in patients with a genetic predisposition for poor function of OATP1B1 transporter 
are increased, and in these patients a higher rate of adverse events, especially with regard to 
gastrointestinal events, as well as CNS effects might be expected (see section 5.2). 
 
Bile acid malabsorption 
A relevant proportion of patients diagnosed with IBS-D may be affected by bile-acid malabsorption as 
a potential reason for IBS-D symptoms. The safety and efficacy of eluxadoline in this subgroup of 
IBS-D patients has not been established. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Medicinal products that cause constipation 
Although no direct drug-drug interactions have been demonstrated, chronic use of loperamide with 
eluxadoline should be avoided as this may increase the risk of constipation. The use of eluxadoline 
with other medicinal products that may cause constipation (for example anticholinergics, opioids etc) 
should also be avoided. 
 
OATP1B1 inhibitors 
Co-administration of OATP1B1 inhibitors (cyclosporine, gemfibrozil, antiretrovirals [atazanavir, 
lopinavir, ritonavir, saquinavir, tipranavir], rifampin) with eluxadoline may increase exposure to 
eluxadoline (see section 5.2). Eluxadoline should not be administered concomitantly with such 
medicinal products (see section 4.3). 
 
OATP1B1 substrates  
Eluxadoline increases the exposure of the co-administered OATP1B1 substrate; rosuvastatin (see 
section 5.2) by up to 40% of the total exposure which is usually not considered to be clinically 
relevant. The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin 
and atorvastatin), however, may be more pronounced. Caution should therefore be exercised in 
patients receiving such medicinal products especially with high doses. 
Other substrates potentially affected include e.g. sartans (valsartan, olmesaran). 
 
CYP3A substrates  
Systemic exposure to medicinal products metabolised by CYP3A4 may be decreased when co-
administered with Eluxadoline. Loss of efficacy can occur, especially when medicinal products with 
low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, 
pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There is limited amount of data from the use of eluxadoline in pregnant women. Animal studies do not 
indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a 
precautionary measure, it is preferable to avoid the use of Truberzi during pregnancy. 



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Breast-feeding 
It is unknown whether eluxadoline is excreted in human milk. Available 
pharmacodynamic/toxicological data in animals have shown excretion of eluxadoline in milk (for 
details see section 5.3). A risk to the newborns/infants cannot be excluded. A decision must be made 
whether to discontinue breast-feeding or to discontinue/abstain from Truberzi therapy taking into 
account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
No human data on the effect of eluxadoline on fertility are available. In rats, there was no effect on 
mating, fertility and fecundity indices (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Eluxadoline has a minor influence on the ability to drive and use machines. 
Due to events of somnolence and sedation observed in clinical studies, caution should be exercised 
(see sections 4.4 and 4.5). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most common adverse reactions (incidence of >5%) reported were constipation (7% and 8% of 
patients receiving 75 mg and 100 mg respectively), nausea (8% and 7% of patients receiving 75 mg 
and 100 mg respectively) and abdominal pain (6% and 7% of patients receiving 75 mg and 100 mg 
respectively). Serious adverse reactions of pancreatitis (0.2% and 0.3% of patients receiving 75 mg 
and 100 mg respectively) and sphincter of Oddi spasm (0.2% of patients receiving 75 mg and 0.8% of 
patients receiving 100 mg) may also occur. 
 
Tabulated list of adverse reactions 
The following adverse reactions considered related to eluxadoline treatment from clinical trials and 
spontaneous reporting are presented according to the MedDRA System Organ Classification and 
frequency convention: 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). 
 
System organ class Common 

 
Uncommon 
 

Not known 

Immune system disorders   Hypersensitivity6 
Nervous system disorders Dizziness 

Somnolence1 
 
 

 

Gastrointestinal disorders 
 

Constipation 
Nausea 
Abdominal pain2 
Vomiting 
Flatulence  
Abdominal distention 
Gastroesophageal 
reflux disease4 

Sphincter of Oddi 
spasm3  
Pancreatitis 
 
 
 
 
 

 

Skin and subcutaneous tissue 
disorders 

Rash5   

Investigations Increased ALT  
Increased AST 

  

1“Somnolence” term includes: somnolence and sedation. 
2“Abdominal pain" term includes: abdominal pain, abdominal pain lower, and abdominal pain upper. 



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3 “Sphincter of Oddi spasm” term includes: manifestation as pancreatitis (terms include alcoholic 
pancreatitis, pancreatitis, and pancreatitis acute) and hepatic enzyme elevations with abdominal pain 
(terms include abdominal pain, abdominal pain upper, dyspepsia, and sphincter of Oddi dysfunction). 
4 “Gastrooesophageal reflux disease” term includes gastrooesophageal reflux disease, dyspepsia and 
gastritis. 
5 “Rash" term includes: dermatitis, dermatitis allergic, rash, rash generalized, rash macula-papular, 
rash papular, rash pruritic, urticaria, and idiopathic urticarial. 
6”Hypersensitivity” term includes: anaphylaxis, angioedema, (e.g. swollen face and/or throat), 
dyspnea, throat tightness and chest pain/tightness - spontaneously reported in the post-marketing 
period. 
 
Description of selected adverse reactions 
Constipation 
Approximately 50% of constipation events occurred within the first 2 weeks of treatment.  
Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline 
and there were no serious complications of constipation related to eluxadoline use in pivotal studies. 
1% of patients receiving 75 mg and 2% of patients receiving 100 mg discontinued treatment or 
temporarily suspended dosing secondary to constipation, respectively, compared to <1% of patients 
treated with placebo. Patients should be instructed to stop the medicinal product and seek medical 
attention if they develop severe constipation (see section 4.4). 
 
Sphincter of Oddi spasm 
In clinical studies, events of sphincter of Oddi spasm manifested as elevated hepatic enzymes 
associated with abdominal pain in 8 patients, pancreatitis in 1 patient and abdominal pain with lipase 
elevation less than 3 times the upper limit of normal in 1 patient. 80% (8/10) of sphincter of Oddi 
spasm events presented within the first week of treatment. All events resolved upon discontinuation of 
Truberzi, with symptoms typically improved by the following day. All events of sphincter of Oddi 
spasm occurred in patients without a gallbladder. Therefore, eluxadoline is contraindicated in this 
population as well as in those with previous biliary tract problems (see sections 4.2, 4.3 and 4.4). The 
occurrence of such events in patients with an intact biliary tract cannot be excluded. 
 
Pancreatitis 
Additional cases of pancreatitis not associated with sphincter of Oddi spasm were reported in clinical 
studies. Of the 5 cases reported, 3 were associated with excessive alcohol intake, 1 was associated 
with biliary sludge, and in one case the patient discontinued eluxadoline 2 weeks prior to the onset of 
symptoms.  
All pancreatic events, whether or not associated with sphincter of Oddi spasm, were retrospectively 
evaluated as mild, indicating an absence of organ failure and local or systemic complications. All 
pancreatic events resolved with lipase normalization upon discontinuation of eluxadoline, with 80% 
(4/5) resolving within 1 week of treatment discontinuation (see section 4.4). 
 
Elderly  
Of 1,795 IBS-D patients who were enrolled in clinical studies of eluxadoline and assigned to 75 mg or 
100 mg twice daily, 139 (7.7%) were at least 65 years of age, while 15 (0.8%) were at least 75 years 
old. 
There was an overall increased frequency of adverse events in the older population compared to 
patients <65 years which was comparable across all treatment groups, including placebo. 
The frequency of serious adverse events, gastrointestinal events, and events leading to discontinuation 
tended to be lower for the 75 mg dose compared to the 100 mg dose. Therefore, in this population, the 
75 mg dose twice daily can be used. (see sections 4.2 and 4.4).  
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 



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professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
Single supratherapeutic oral doses of eluxadoline up to 1,000 mg and single intranasal doses up to 
200 mg were associated with a higher incidence of adverse events than a 100 mg single dose, 
especially gastrointestinal and central nervous system events. An overdose of eluxadoline may result 
in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal 
product. 
 
Management 
In the event of acute overdose, the patient should be carefully observed and given standard supportive 
treatment as required. Gastric lavage or charcoal administration should be considered. Given 
eluxadoline’s action at opioid receptors, administration of a narcotic mu opioid antagonist, such as 
naloxone, should be considered. Considering the short half-life of naloxone, repeated administration 
may be necessary. In the event of naloxone administration, subjects should be monitored closely for 
the return of overdose symptoms, which may indicate need for repeated naloxone injection. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antipropulsives, ATC code: A07DA06  
 
Mechanism of action 
Eluxadoline is a locally acting, mixed mu opioid receptor (μOR) agonist and delta opioid receptor 
(δOR) antagonist. Eluxadoline is also an agonist at the kappa opioid receptor (κOR). The binding 
affinities (Ki) of eluxadoline for human μOR and δOR are 1.8 nM and 430 nM, respectively. The 
binding affinity (Ki) of eluxadoline for human κOR has not been determined; however, the Ki for 
guinea pig cerebellum κOR is 55 nM. In animals, eluxadoline interacts with opioid receptors in the 
gut. Eluxadoline has demonstrated efficacy in normalizing GI transit and defecation in several models 
of stress induced or post GI inflammation-altered GI function in animals. Eluxadoline has very low 
oral bioavailability and exerts no detectable central nervous system (CNS)-mediated effects when 
administered orally to animals at effective doses. Eluxadoline also reverses hyperalgesic responses in 
an animal model of acute colitis-induced visceral pain. 
 
Pharmacodynamic effects 
Since bioavailability is limited, the pharmacodynamic activity of eluxadoline is based predominantly 
on local action within the GI tract. Supporting the lack of systemic pharmacodynamic effects are 
results from an oral abuse liability study in recreational opioid users that showed oral doses up to 
1,000 mg did not produce significant pupillary constriction or significant drug liking. An abuse 
liability study with 100 mg and 200 mg intranasal doses of eluxadoline resulted in higher systemic 
concentrations of eluxadoline that produced changes in pupil diameter but were associated with drug 
disliking. In patients with IBS-D, no signal for central nervous system-mediated adverse events was 
identified. Taken together these results suggest that when using the medicinal product as directed at 
therapeutic doses patients will not experience significant central nervous system effects or adverse 
events consistent with a drug of abuse.  
 
Clinical efficacy and safety 
The efficacy and safety of eluxadoline in IBS-D patients was established in two randomized, multi-
center, multi-national, double-blind, placebo-controlled studies (Studies 1 & 2). A total of 
1,282 patients in Study 1 (IBS-3001) and 1,146 patients in Study 2 (IBS-3002) were enrolled and 



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received treatment with Truberzi 75 mg, Truberzi 100 mg or placebo twice daily. Overall, patients had 
a mean age of 45 years (range 18-80 years with 10% at least 65 years of age or older), 66% female, 
86% white, 12% black, and 27% Hispanic. 
All patients met Rome III criteria for IBS and were required to meet the following criteria: 
•  an average of worst abdominal pain (WAP) scores in the past 24 hours of >3.0 on a 0 to 10 scale 
over the week prior to randomization. 
•  an average daily stool consistency score (BSS) of ≥5.5 and at least 5 days with a BSS score ≥5 
on a 1 to 7 scale over the week prior to randomization. 
•  an average global symptom score >2.0 on a 0-4 scale (0 corresponds to no symptoms, 1 
corresponds to mild symptoms, 2 corresponds to moderate symptoms, 3 corresponds to severe 
symptoms and 4 corresponds to very severe symptoms) over the week prior to randomization 
 
The study designs were identical through the first 26 weeks. Study1 (IBS-3001) continued 
double-blinded for an additional 26 weeks for long-term safety (total of 52 weeks of treatment), 
followed by a 2-week follow-up. Study 2 (IBS-3002) included a 4-week single-blinded, 
placebo-withdrawal period upon completion of the 26-week treatment period.  
 
Efficacy of eluxadoline was assessed using an overall responder analyses as defined by the 
simultaneous improvement in the daily WAP score by ≥30% as compared to the baseline weekly 
average AND a reduction in the BSS to <5 on at least 50% of the days within a time interval. 
Improvements in global symptoms of IBS were assessed based on an adequate relief response 
endpoint defined as achieving adequate relief of IBS symptoms on at least 50% of weeks and on a 
global symptom response endpoint defined by a daily rating of global symptoms of none or mild on at 
least 50% of days. Results for endpoints were based on electronic daily diary entries by patients. 
The efficacy results for ≥50% of responder days (primary composite endpoint) over 6 months are 
shown in Table 2. In both studies, the proportion of patients who were composite responders to 
Truberzi 100 mg twice daily was statistically significantly higher than placebo. The proportion of 
patients who were adequate relief responders was statistically significantly higher than placebo for 
Truberzi 100 mg twice daily over 6 month interval in both studies. The proportion of patients who 
were global symptom responders was statistically significantly higher than placebo for Truberzi 
100 mg twice daily over 6 month interval in Study 2 and numerically higher than placebo in Study 1. 
There were no efficacy differences according to gender. 
 



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Table 2: Efficacy Results in Randomized Clinical Studies 
 Study 1 (IBS 3001) Study 2 (IBS 3002) 

  
Truberzi 
100 mg 
n=426 

Truberzi 
75 mg 
n=427 

Placebo 
n=427 

Truberzi 
100 mg 
n=382 

Truberzi 
75 mg  
n=381 

Placebo 
n=382 

Composite Response   
   

 

Responder rates 29% 23% 19% 33% 30% 20% 
P values <0.001 0.112  <0.001 0.001  
Abdominal Pain Response       
Responder rates 47% 45% 43% 50% 48% 45% 
P values 0.355 0.852  0.148 0.448  
BSS <5 Response      

 

Responder rates 34% 28% 24% 40% 34% 24% 
P values 0.001 0.186  <0.001 <0.001  
Adequate Relief Response       
Responder rates 49.5% 45.7% 40.0% 53.7% 52.8% 43.7% 
P values 0.005 0.097  0.006 0.013  
Global Symptom Response       

Responder rates 34.7% 35.1% 28.8% 43.2% 45.1% 34.3% 
P values 0.063 0.048  0.012 0.002  
 
For the daily composite response, eluxadoline began to separate from placebo shortly after initiating 
treatment with a maximal effect seen at 4-6 weeks that was maintained throughout the course of 
treatment. Additionally, the proportion of patients who were composite responders to eluxadoline at 
each 4-week interval for months 1 through 6 was higher than placebo for both doses in both Phase 3 
studies demonstrating that efficacy is maintained with continuous eluxadoline treatment. 
Treatment with eluxadoline also resulted in significant improvements in patients whose IBS-D 
symptoms were not adequately controlled with use of loperamide prior to enrolment. 
When the threshold for abdominal pain response was increased to ≥40% or ≥50% improvement from 
baseline in daily worst abdominal pain, the proportion of abdominal pain responders was 6%-7% 
higher for eluxadoline 100 mg twice daily compared to placebo which was statistically significant (P ≤ 
0.009) for the pooled (Study 1 and Study 2) data. Patients receiving eluxadoline also reported 
significant reductions in bowel movement frequency and abdominal bloating compared to placebo as 
demonstrated by changes from baseline in daily bowel movements and bloating score at Weeks 12 and 
26. Patients receiving eluxadoline reported significant increases in urgency-free days both for ≥50% 
urgency-free days as well as ≥75% urgency free days. Also, eluxadoline significantly improves 
patients quality of life as demonstrated by change from baseline score in the IBS-QOL questionnaire 
at weeks 12 and 26.  
 
During the 4 week single-blind withdrawal period in Study 2 (IBS-3002), no evidence of rebound 
diarrhoea or abdominal pain was demonstrated. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of clinical studies 
with Truberzi in one or more subsets of the paediatric population in IBS-D (see section 4.2 for 
information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Eluxadoline’s systemic exposure following oral administration is low and is consistent with its local 
action in the GI tract. The active substance has linear pharmacokinetics with no accumulation upon 



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repeated twice daily dosing. Mean plasma elimination half-life is 5 hours with high inter-subject 
variability. Eluxadoline is primarily cleared as such via the biliary system with the kidney playing a 
minimal role in elimination. Eluxadoline is not an inducer/inhibitor of major CYP enzymes, however, 
eluxadoline has some potential for the metabolism based inactivation of CYP3A4. It is a substrate and 
an inhibitor of the hepatic uptake transporter OATP1B1; and a substrate for the hepatic efflux 
transporter MRP2. Hepatic impairment or coadministration with cysclosporine results in significant 
increases in plasma concentrations of eluxadoline. 
 
Absorption 
The absolute bioavailability of eluxadoline has not been determined but is estimated to be low due to 
limited absorption and first pass effects. The absorption of eluxadoline was rapid under fasting 
conditions, with a median Tmax value of 2 hours. The administration of eluxadoline with a high fat 
meal significantly decreased both Cmax (50%) and AUC (60%) without any effect on Tmax. Upon 
administration of multiple oral doses twice daily, there was no accumulation of active substance. 
 
Distribution 
In a population pharmacokinetic analysis, the estimated apparent volume of distribution of eluxadoline 
was 27,100 L. In healthy subjects, eluxadoline was moderately (81%) bound to plasma proteins. 
 
Biotransformation 
Eluxadoline is primarily excreted in the feces, either as unabsorbed active substance or via the biliary 
system with the kidney playing a minimal role in elimination. 
In vitro studies demonstrated that eluxadoline was stable in human hepatocytes, liver and intestinal 
microsomes, and that the only minor and inactive metabolite of eluxadoline detected was the acyl 
glucuronide metabolite (M11) formed through glucuronidation of the methoxybenzoic acid moiety. 
Following a 1,000 mg oral dose in healthy male volunteers, M11 was detected in urine but not in 
systemic circulation.  
Eluxadoline exists predominantly as the (S,S)-diastereomer (>99%) and undergoes little or no chiral 
conversion in vivo. 
Eluxadoline has a low potential for drug-drug interactions based on limited in vitro CYP 
inhibition/induction and given that eluxadoline is not a substrate for CYPs at clinically meaningful 
concentrations. 
 
OATP1B1 inhibitors 
Eluxadoline is a substrate of the hepatic uptake transporter OATP1B1. Co-administration of 
eluxadoline with cyclosporine (an OATP1B1 inhibitor) increased eluxadoline exposure by 
approximately 5-fold (see sections 4.3 and 4.5).  
 
MRP2 inhibitors 
Eluxadoline is a substrate of the hepatic efflux transporter MRP2. Co-administration of eluxadoline 
with probenecid (MRP2 inhibitor) resulted in approximately 1.4-fold increase in exposure to 
eluxadoline. No dose adjustment is necessary. 
 
OATP1B1 substrates 
Eluxadoline is an inhibitor of the hepatic uptake transporter OATP1B1. Co-administration of 
eluxadoline with rosuvastatin (an OATP1B1 substrate) resulted in an up to 1.4-fold increase in 
exposure of rosuvastatin and the major active metabolite, n-desmethyl rosuvastatin compared to 
administration of rosuvastatin alone. No dose adjustment is necessary for co-administered OATP1B1 
substrates. However, caution should be exercised in patients receiving high doses of OATP1B1 
substrates (see section 4.5). 
 
Assessment of drug interactions 
In vitro studies indicate that eluxadoline is neither an inducer of CYP1A2, CYP2B6, CYP2C9, 
CYP2C19, and CYP3A4, nor an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, 
CYP2C8 and CYP2D6 at clinically relevant concentrations. CYP2E1 was slightly inhibited (50% 



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inhibitory concentration [IC50] of approximately 20 µM [11 µg/mL]), although this is not expected to 
result in any clinically meaningful interactions.  
In vitro studies in human liver microsomes showed that eluxadoline is not a direct inhibitor of 
CYP3A4 at clinically relevant concentrations [IC50 =450 µM] but in human intestinal microsomes, 
eluxadoline was a metabolism dependent inhibitor of CYP3A4 with kinact of 0.1 min-1 and K-I of 
450 µM (256 µg/mL). However, in a clinical study in healthy subjects, administration of eluxadoline 
100 mg twice daily for one week, with a single oral dose of 4 mg of midazolam resulted in no change 
to the midazolam Cmax and a slight decrease in AUC (~10%). Cmax and AUC for the metabolite 1-
hydroxy-midazolam increased by ~14% and 7% respectively, suggesting that eluxadoline may be a 
mild inducer of CYP3A4 and may decrease the exposure of concomitantly administered CYP3A4 
substrates. (see section 4.5). 
In vitro studies indicated that eluxadoline is a substrate and an inhibitor of the hepatic uptake 
transporter OATP1B1; a substrate for the hepatic efflux transporter MRP2 and is not a substrate or 
inhibitor of the P-gp and BCRP transporters. 
 
Elimination 
Following a single oral dose of 300 mg [14C] eluxadoline in healthy male subjects, 82.2% of the total 
[14C] eluxadoline was recovered in faeces in 336 hours and less than 1% was recovered in urine in 
192 hours. 
 
Specific populations 
Gender, age, ethnicity 
Given eluxadoline’s local action in the GI tract, low Foral and lack of metabolism, prospective clinical 
studies regarding differences in age, body mass index (BMI), ethnicity, and gender were deemed 
unnecessary. Pharmacokinetic data for healthy volunteers pooled across Phase 1 studies (using the 
100 mg single oral dose) and analyzed for potential differences based on sex, age, race, and BMI 
demonstrated no significant differences. 
 
Renal Impairment 
In ESRD participants not yet on dialysis relative to matched, healthy participants with normal renal 
function, eluxadoline plasma Cmax was 2.2-fold higher and AUC0-t was 4.2-fold higher.  Unchanged 
eluxadoline recovered in urine was 0.01% and 0.05% of dose in ESRD and healthy participants, 
respectively. Although exposure of eluxadoline was significantly increased in ESRD participants not 
yet on dialysis compared with matched, healthy participants with normal renal function, such an 
increase is unlikely to be of clinical significance because the geometric mean Cmax and AUC0-t in the 
participants with ESRD was in the same range as observed in several larger studies in healthy 
volunteers. 
 
Hepatic impairment 
The apparent clearance of eluxadoline is markedly reduced and half-life increases in hepatic-impaired 
patients (see sections 4.3 and 4.4). Following single oral 100 mg dose in subjects with varying degrees 
of liver impairment and healthy subjects, eluxadoline plasma levels were on average 6-fold, 4-fold, 
and 16-fold elevated in mild, moderate, and severe hepaticimpaired subjects (Child Pugh Class A, B, 
C), respectively, while half-life increased 3-5 fold (see sections 4.3 and 4.4). 
 
OATP1B1 poor function haplotypes 
The plasma levels in patients with a genetic predisposition for poor function of OATP1B1 transporter 
are increased and in these patients a higher rate of adverse events, especially with regard to 
gastrointestinal events, as well as CNS effects might be expected (see section 4.4). 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to 



13 
 

reproduction and development. In rat, eluxadoline was excreted into milk in an approximately dose 
proportional manner with maximal concentrations less than plasma concentrations.  
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Silicified microcrystalline cellulose (E460); 
Colloidal anhydrous silica (E551); 
Crospovidone, type B (E1202); 
Mannitol (E421); 
Magnesium stearate (E572); 
Polyvinyl alcohol (E1203); 
Titanium dioxide (E171); 
Macrogol 3350 (E1521); 
Talc (E553b); 
Iron oxide yellow (E172); 
Iron oxide red (E172). 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
PCTFE/PVC/Al-blister containing 14 film-coated tablets. Pack sizes of 28, 56 and a multipack 
containing 168 (3 packs of 56) film-coated tablets.   
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1126/001-006 
 



14 
 

 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 September 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



15 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 

 



16 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturer responsible for batch release 

Warner Chilcott Deutschland GmbH 
Dr.-Otto-Roehm-Strasse 2-4,  
64331 Weiterstadt,  
Germany  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product 
Characteristics, section 4.2). 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING  
AUTHORISATION  

• Periodic safety update reports  
 

The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

• Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• 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.  

 



17 
 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



18 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



19 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON – 75 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 75 mg film-coated tablets.  
eluxadoline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 75 mg of eluxadoline. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
28 tablets 
56 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



20 
 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1126/001 56 film-coated tablets 
EU/1/16/1126/002 28 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRUBERZI 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number} 
NN: {number}  
 
 



21 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER LABEL (WITH BLUE BOX – MULTIPACK ONLY) – 75 mg 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 75 mg film-coated tablets.  
eluxadoline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 75 mg of eluxadoline. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
Multipack: 168 (3 packs of 56) tablets. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



22 
 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1126/005 168 film-coated tablets (3packs of 56) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRUBERZI 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number} 
NN: {number}  
 
 



23 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON (WITHOUT BLUE BOX – MULTIPACK ONLY) – 75 mg 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 75 mg film-coated tablets.  
eluxadoline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 75 mg of eluxadoline. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
56 tablets. Component of a multipack, can’t be sold separately  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



24 
 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1126/005 168 film-coated tablets (3 packs of 56)  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRUBERZI 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number} 
NN: {number} 
 



25 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON – 100 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 100 mg film-coated tablets.  
eluxadoline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 100 mg of eluxadoline. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
28 tablets 
56 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



26 
 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1126/003 56 film-coated tablets 
EU/1/16/1126/004 28 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRUBERZI 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number} 
NN: {number}  
 
 



27 
 

 
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER LABEL (WITH BLUE BOX – MULTIPACK ONLY) – 100 mg 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 100 mg film-coated tablets.  
eluxadoline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 100 mg of eluxadoline. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
Multipack: 168 (3 packs of 56) tablets. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



28 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1126/006 168 film-coated tablets (3 packs of 56)  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRUBERZI 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number} 
NN: {number}  
 
 



29 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON (WITHOUT BLUE BOX – MULTIPACK ONLY) – 100 mg 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 100 mg film-coated tablets.  
eluxadoline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 100 mg of eluxadoline. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
56 tablets. Component of a multipack, can’t be sold separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
 



30 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1126/006 168 film-coated tablets (3 packs of 56)  
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRUBERZI 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number} 
NN: {number} 
 



31 
 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER – 75 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 75 mg film-coated tablets.  
eluxadoline  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



32 
 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER – 100 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Truberzi 100 mg film-coated tablets.  
eluxadoline  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals International Limited 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



33 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



34 
 

Package leaflet: Information for the patient 
 

Truberzi 75 mg film-coated tablets 
Eluxadoline 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your  doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Truberzi is and what it is used for  
2. What you need to know before you take Truberzi  
3. How to take Truberzi  
4. Possible side effects  
5. How to store Truberzi  
6. Contents of the pack and other information 
 
 
1. What Truberzi is and what it is used for 
 
Truberzi is a medicine that contains the active substance eluxadoline. It is used to treat irritable bowel 
syndrome (‘IBS’) with diarrhoea (IBS-D) in adults. 
 
IBS is a common gut disorder. The main symptoms of IBS-D include: 
- stomach ache; 
- stomach discomfort;  
- diarrhoea; 
- urgent bowel movements. 
 
Truberzi acts on the surface of your gut to restore the normal function of your bowels and block the 
sensation of pain and discomfort in IBS-D patients. 
 
 
2. What you need to know before you take Truberzi   
 
Do not take Truberzi: 
- if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in 

section 6); 
- if you have, or have had, pancreatitis (inflammation of the pancreas); 
- if you don’t have a gallbladder by birth or your gallbladder has been surgically removed; 
- if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink 

alcohol; 
- if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as 

gallstones, tumour, duodenal diverticulum); 
- if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle 

in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine); 



35 
 

- if you have liver disease with decreased liver function;  
- if you have had constipation for a while or if constipation is the main symptom of your IBS 

(called ‘IBS with constipation’ [IBS-C]);  
- if you have, or may have, a blockage in your intestine/bowels; 
- If you take medicines that may increase the level of the concentration of eluxadoline in the 

blood (so-called OATP1B1 inhibitor, e.g. ciclosporin). 
 
Talk to your doctor or pharmacist if you are unsure if any of the above apply to you.  
 
Warnings and precautions  
Stop taking Truberzi and seek medical attention immediately if you develop any of the following 
while taking this medicine: 
- new or worsening pain in the belly, with or without nausea and vomiting; 

• pain may begin soon after you start Truberzi. You may feel pain on the right side of your 
belly or the upper area of the belly, right below the ribs. The pain may feel like it is moving 
through to your back or shoulder; 

• these symptoms are uncommon and may indicate pancreas or bile duct system problems 
(i.e. inflammation of the pancreas or spasm of the sphincter of Oddi); 
o your risk of developing pancreas or bile duct system problems may be higher if you 

drink alcohol in excess,   
o the spasm of the sphincter of Oddi usually goes away when you stop Truberzi. 

- severe constipation. 
 
Please report to your doctor: 
- how much alcohol you drink (e.g. daily number of drinks); 
- if you experience any effects, such as dizziness and sleepiness. 
 
Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain 
side effects (see section 4).  
 
Children and adolescents 
Truberzi should not be given to children and adolescents less than 18 years old as there is no 
information about its use in this age group. 
 
Other medicines and Truberzi 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this 
may increase the risk of constipation. Avoid taking Truberzi with any other medicines that may cause 
constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used 
to treat cardiac disorders among other indications]).  
 
Some medicines may increase the level of Truberzi in the blood. These medicines can include: 
- ciclosporin (immunosuppressant used to reduce inflammation);  
- gemfibrozil (used to lower lipid levels); 
- atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV); 
- rifampicin (antibiotic used to treat infections).  
Do not take Truberzi with any of the above medicines.  
 
Truberzi may increase the level of some medicines in the blood. These medicines can include: 
- rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease); 
- valsartan and olmesartan (used to treat high blood pressure); 
 
Truberzi may decrease the level of some medicines in the blood. These medicines can include: 
- erythromycin (used to treat infections); 



36 
 

- midazolam (a medicine to sedate you when you e.g.undergo endoscopic procedures); 
- nifedipine (used to treat high blood pressure); 
- alfentanil, fentanyl (opioid analgesic used to treat pain); 
- dihydroergotamine, ergotamine (used to treat migraine); 
- pimozide (used to treat mental disorders); 
- quinidine (used to treat heart diseases);  
- sirolimus, tacrolimus (immunosuppressant used for the control of body’s immune response). 
If any of the above applies to you, tell your doctor or pharmacist before taking Truberzi. Check with 
your doctor or pharmacist if you are not sure. 
 
Pregnancy and breast-feeding 
Truberzi should not be taken whilst pregnant or breast-feeding. If you are pregnant or breast-feeding 
or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before 
taking this medicine. 
 
Driving and using machines 
It is unlikely that Truberzi will affect your ability to drive or use tools or machines. However, you may 
experience side effects such as sleepiness or dizziness while taking Truberzi which might affect your 
ability to drive or use machines. Do not drive or use machines while taking this medicine until you 
know how it affects you. 
 
 
3. How to take Truberzi 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. 
 
The usual recommended dose is one 100 mg tablet twice a day. 
Your doctor may prescribe you a lower dose of one 75 mg tablet twice a day if you:  
- are 65 years of age or older; 
- are unable to tolerate the 100 mg dose; 
The tablets should be taken orally with food in the morning and in the evening. 
 
If you take more Truberzi than you should 
If you have taken more Truberzi than you should, tell your doctor or seek urgent medical assistance. 
 
If you forget to take Truberzi 
Do not take a double dose to make up for a forgotten dose. Take the next dose at the next scheduled 
time and continue as normal. 
 
If you stop taking Truberzi 
Do not stop taking Truberzi without first talking to your doctor as your symptoms may worsen. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Some side effects can be serious 
Stop taking Truberzi, and seek medical attention immediately if you have new or worsening stomach 
pain, with or without nausea and vomiting, while taking Truberzi. These symptoms occur 
uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system 
problems (e.g. inflammation of the pancreas or spasm of the sphincter of Oddi).  
 



37 
 

Serious allergic reactions have happened in some people after taking 1 or 2 doses of Truberzi. Stop 
taking Truberzi right away and get emergency medical care if you have signs or symptoms of an 
allergic reaction, including: 
- swelling of your face, lips, mouth, tongue, and/or throat 
- shortness of breath or other breathing problems 
- chest pain or tightness 
- itching 
- rash 
- hives 
 
Severe constipation that can lead to hospitalization has happened after taking Truberzi. Stop taking 
Truberzi and call your doctor right away if you develop severe constipation while taking Truberzi. 
Avoid taking Truberzi with any other medicines that may cause constipation (see Section 2: Other 
medicines and Truberzi). 
 
Other side effects can include 
Common: may affect up to 1 in 10 people 
- dizziness; 
- sleepiness; 
- constipation; 
- feeling sick (nausea); 
- stomach ache;  
- being sick (vomiting); 
- gas (flatulence); 
- feeling bloated;  
- heartburn or acid reflux;  
- rash; 
- abnormal blood test results (increased levels of certain liver enzymes). 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. 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. 
 
 
5. How to store Truberzi 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on blister and the carton after EXP. The 
expiry date refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 



38 
 

6. Contents of the pack and other information 
 
What Truberzi contains  
- The active substance is eluxadoline. Each tablet contains 75 mg of eluxadoline. 
- The other ingredients are: 

Core tablet: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); 
crospovidone, type B (E1202); mannitol (E421) and magnesium stearate (E572). 
Film-coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc 
(E553b); iron oxide yellow (E172) and iron oxide red (E172). 

 
What Truberzi looks like and contents of the pack 
The film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with 
‘FX75’ on one side.  
The tablets are packed in PCTFE/PVC/Al-blisters. Truberzi is available in packs containing 28 or 
56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each 
containing 56 film-coated tablets. 
 
Not all pack sizes may be marketed.  
 
Marketing Authorisation Holder 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
Manufacturer 
Warner Chilcott Deutschland GmbH 
Dr.-Otto-Roehm-Strasse 2-4,  
64331 Weiterstadt,  
Germany 
 



39 
 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg/Nederland 
Allergan n.v 
Tél /Tel : +32 (0)2 351 24 24 
 

Italia 
Allergan S.p.A 
Tel: + 39 06 509 562 90 
 

Česká republika 
Allergan CZ s.r.o. 
Tel: +420 800 188 818 

Ireland/Malta 
Allergan Pharmaceuticals International  
Limited 
Tel: + 1800 931 787 (IE);  
+ 356 27780331 (MT) 
 

Deutschland 
Allergan GmbH  
Tel: + 49 69 92038-1050 
 

Latvija/Lietuva/Eesti 
Allergan Baltics UAB  
Tel: + 371 676 60 831 (LV);  
+ 37 052 072 777 (LT);  
+ 37 2634 6109 (ET) 
 

Danmark/Norge/Suomi/Finland/Sverige 
Allergan Norden AB 
Tlf/Puh/Tel: + 4580884560 (DK);  
+ 47 80 01 04 97 (NO);  
+ 358 800 115 003 (FI);  
+ 46 8 594 100 00 (SE) 
 
Ελλάδα/ Κύπρος 
Allergan Hellas Pharmaceuticals S.A.  
Τηλ: +30 210 74 73 300 
 

Magyarország 
Allergan Hungary Kft.  
Tel.: +36 80 100 101 
 
 
 
 
Österreich 
Pharm-Allergan GmbH  
Tel: +43 1 99460 6355 

España 
Allergan S.A. 
Tel: + 34 91 807 6130 
 

Polska 
Allergan Sp. z o.o.  
Tel: +48 22 256 3700 
 

France 
Allergan France SAS  
Tél: +33 (0)1 49 07 83 00 
 

Portugal 
Profarin Lda 
Tel: + 351 21 425 3242 
 

Hrvatska 
Ewopharma d.o.o.  
Tel: +385 1 6646 563 
 

România 
Allergan S.R.L. 
Tel: +40 21 301 53 02 
 

България 
Алерган България ЕООД  
Тел.: +359 (0) 800 20 280 
 

Slovenija 
Ewopharma d.o.o. 
Tel: + 386 (0) 590 848 40 
 

 Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
Allergan SK s.r.o. 
Tel: +421 800 221 223 
 

United Kingdom 
Allergan Ltd 
Tel: + 44 (0) 1628 494026 
 
 



40 
 

This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 



41 
 

 
Package leaflet: Information for the patient 

 
 Truberzi 100 mg film-coated tablets 

Eluxadoline 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Truberzi is and what it is used for  
2. What you need to know before you take Truberzi  
3. How to take Truberzi  
4. Possible side effects  
5. How to store Truberzi  
6. Contents of the pack and other information 
 
 
1. What Truberzi is and what it is used for 
 
Truberzi is a medicine that contains the active substance eluxadoline. It is used to treat irritable bowel 
syndrome (‘IBS’) with diarrhoea (IBS-D) in adults. 
 
IBS is a common gut disorder. The main symptoms of IBS-D include: 
- stomach ache; 
- stomach discomfort;  
- diarrhoea; 
- urgent bowel movements. 
 
Truberzi acts on the surface of your gut to restore the normal function of your bowels and block the 
sensation of pain and discomfort in IBS-D patients. 
 
 
2. What you need to know before you take Truberzi   
 
Do not take Truberzi: 
- if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in 

section 6); 
- if you have, or have had, pancreatitis (inflammation of the pancreas); 
- if you don’t have a gallbladder by birth or your gallbladder has been surgically removed; 
- if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink 

alcohol; 
- if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as 

gallstones, tumour, duodenal diverticulum); 



42 
 

- if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle 
in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine); 

- if you have liver disease with decreased liver function;  
- if you have had constipation for a while or if constipation is the main symptom of your IBS 

(called ‘IBS with constipation’ [IBS-C]);  
- if you have, or may have, a blockage in your intestine/bowels; 
- If you take medicines that may increase the level of the concentration of eluxadoline in the 

blood (so-called OATP1B1 inhibitor, e.g. ciclosporin). 
 
Talk to your doctor or pharmacist if you are unsure if any of the above apply to you.  
 
Warnings and precautions  
Stop taking Truberzi and seek medical attention immediately if you develop any of the following 
while taking this medicine: 
- new or worsening pain in the belly, with or without nausea and vomiting; 

• pain may begin soon after you start Truberzi. You may feel pain on the right side of your 
belly or the upper area of the belly, right below the ribs. The pain may feel like it is moving 
through to your back or shoulder; 

• these symptoms are uncommon and may indicate pancreas or bile duct system problems 
(i.e. inflammation of the pancreas or spasm of the sphincter of Oddi); 
o your risk of developing pancreas or bile duct system problems may be higher if you 

drink alcohol in excess,   
o the spasm of the sphincter of Oddi usually goes away when you stop Truberzi. 

- severe constipation. 
 
Please report to your doctor: 
- how much alcohol you drink (e.g. daily number of drinks); 
- if you experience any effects, such as dizziness and sleepiness. 
 
Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain 
side effects (see section 4).  
 
Children and adolescents 
Truberzi should not be given to children and adolescents less than 18 years old as there is no 
information about its use in this age group. 
 
Other medicines and Truberzi 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this 
may increase the risk of constipation. Avoid taking Truberzi with any other medicines that may cause 
constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used 
to treat cardiac disorders among other indications]).  
 
Some medicines may increase the level of Truberzi in the blood. These medicines can include: 
- ciclosporin (immunosuppressant used to reduce inflammation);  
- gemfibrozil (used to lower lipid levels); 
- atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV); 
- rifampicin (antibiotic used to treat infections).  
Do not take Truberzi with any of the above medicines.  
 
Truberzi may increase the level of some medicines in the blood. These medicines can include: 
- rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease); 
- valsartan and olmesartan (used to treat high blood pressure); 
 



43 
 

Truberzi may decrease the level of some medicines in the blood. These medicines can include: 
- erythromycin (used to treat infections); 
- midazolam (a medicine to sedate you when you e.g. undergo endoscopic procedures); 
- nifedipine (used to treat high blood pressure); 
- alfentanil, fentanyl (opioid analgesic used to treat pain); 
- dihydroergotamine, ergotamine (used to treat migraine); 
- pimozide (used to treat mental disorders); 
- quinidine (used to treat heart diseases);  
- sirolimus, tacrolimus (immunosuppressant used for the control of body’s immune response). 
If any of the above applies to you, tell your doctor or pharmacist before taking Truberzi. Check with 
your doctor or pharmacist if you are not sure. 
 
Pregnancy and breast-feeding 
Truberzi should not be taken whilst pregnant or breast-feeding. If you are pregnant or breast-feeding 
or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before 
taking this medicine. 
 
Driving and using machines 
It is unlikely that Truberzi will affect your ability to drive or use tools or machines. However, you may 
experience side effects such as sleepiness or dizziness while taking Truberzi which might affect your 
ability to drive or use machines. Do not drive or use machines while taking this medicine until you 
know how it affects you. 
 
 
3. How to take Truberzi 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. 
 
The recommended dose is one 100 mg tablet twice a day. 
The tablets should be taken orally with food in the morning and in the evening. 
 
If you take more Truberzi than you should 
If you have taken more Truberzi than you should, tell your doctor or seek urgent medical assistance. 
 
If you forget to take Truberzi 
Do not take a double dose to make up for a forgotten dose. Take the next dose at the next scheduled 
time and continue as normal. 
 
If you stop taking Truberzi 
Do not stop taking Truberzi without first talking to your doctor as your symptoms may worsen. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Some side effects can be serious 
Stop taking Truberzi, and seek medical attention immediately if you have new or worsening stomach 
pain, with or without nausea and vomiting, while taking Truberzi. These symptoms occur 
uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system 
problems (e.g. inflammation of the pancreas or spasm of the sphincter of Oddi).  
 



44 
 

Serious allergic reactions have happened in some people after taking 1 or 2 doses of Truberzi. Stop 
taking Truberzi right away and get emergency medical care if you have signs or symptoms of an 
allergic reaction, including: 
- swelling of your face, lips, mouth, tongue, and/or throat 
- shortness of breath or other breathing problems 
- chest pain or tightness 
- itching 
- rash 
- hives 
 
Severe constipation that can lead to hospitalization has happened after taking Truberzi. Stop taking 
Truberzi and call your doctor right away if you develop severe constipation while taking Truberzi. 
Avoid taking Truberzi with any other medicines that may cause constipation (see Section 2: Other 
medicines and Truberzi). 
 
Other side effects can include 
Common: may affect up to 1 in 10 people 
- dizziness; 
- sleepiness; 
- constipation; 
- feeling sick (nausea); 
- stomach ache;  
- being sick (vomiting); 
- gas (flatulence); 
- feeling bloated;  
- heartburn or acid reflux;  
- rash; 
- abnormal blood test results (increased levels of certain liver enzymes). 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. 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. 
 
 
5. How to store Truberzi 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on blister and the carton after EXP. The 
expiry date refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 



45 
 

6. Contents of the pack and other information 
 
What Truberzi contains  
- The active substance is eluxadoline. Each tablet contains 100 mg of eluxadoline. 
- The other ingredients are: 

Core tablet: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); 
crospovidone, type B (E1202); mannitol (E421) and magnesium stearate (E572). 
Film-coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc 
(E553b); iron oxide yellow (E172) and iron oxide red (E172). 

 
What Truberzi looks like and contents of the pack 
The film-coated tablets are modified capsule-shaped, pink-orange to peach and debossed with 
‘FX100’ on one side.  
The tablets are packed in PCTFE/PVC/Al-blisters. Truberzi is available in packs containing 28 or 
56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each 
containing 56  film-coated tablets. 
 
Not all pack sizes may be marketed.  
 
Marketing Authorisation Holder 
Allergan Pharmaceuticals International Limited 
Clonshaugh Business & Technology Park, 
Dublin 17, D17 E400, 
Ireland 
 
Manufacturer 
Warner Chilcott Deutschland GmbH 
Dr.-Otto-Roehm-Strasse 2-4,  
64331 Weiterstadt,  
Germany 



46 
 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg/Nederland 
Allergan n.v 
Tél /Tel : +32 (0)2 351 24 24 
 

Ireland/Malta 
Allergan Pharmaceuticals International  
Limited 
Tel: +1800 931 787 (IE) 
+ 356 27780331 (MT) 
 

Česká republika 
Allergan CZ s.r.o. 
Tel: +420 800 188 818 

Latvija/Lietuva/Eesti 
Allergan Baltics UAB  
Tel: + 371 676 60 831 (LV);  
+ 37 052 072 777 (LT);  
+ 37 2634 6109 (ET) 
 

Deutschland 
Allergan GmbH  
Tel: + 49 69 92038-1050 
 

Magyarország 
Allergan Hungary Kft.  
Tel.: +36 80 100 101 
 

Danmark/Norge/Suomi/Finland/Sverige 
Allergan Norden AB 
Tlf/Puh/Tel: + 4580884560 (DK);  
+ 47 80 01 04 97 (NO);  
+ 358 800 115 003 (FI);  
+ 46 8 594 100 00 (SE) 
 
Ελλάδα/ Κύπρος 
Allergan Hellas Pharmaceuticals S.A.  
Τηλ: +30 210 74 73 300 
 

Österreich 
Pharm-Allergan GmbH  
Tel: +43 1 99460 6355 
 
 
 
Polska 
Allergan Sp. z o.o.  
Tel: +48 22 256 3700 
 

España 
Allergan S.A. 
Tel: + 34 91 807 6130 
 

Portugal 
Profarin Lda 
Tel: + 351214253242 
 

France 
Allergan France SAS  
Tél: +33 (0)1 49 07 83 00 
 

România 
Allergan S.R.L. 
Tel: +40 21 301 53 02 
 

Hrvatska 
Ewopharma d.o.o.  
Tel: +385 1 6646 563 
 

Slovenija 
Ewopharma d.o.o. 
Tel: + 386 (0) 590 848 40 
 

България 
Алерган България ЕООД  
Тел.: +359 (0) 800 20 280 
 

Slovenská republika 
Allergan SK s.r.o. 
Tel: +421 800 221 223 
 

 Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 
 

United Kingdom 
Allergan Ltd 
Tel: + 44 (0) 1628 494026 

Italia 
Allergan S.p.A 
Tel: + 39 06 509 562 90 
 

 
 

 
 

 

  



47 
 

This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what truberzi is and what it is used for', 'Section_Content': "truberzi is a medicine that contains the active substance eluxadoline. it is used to treat irritable bowel syndrome ('ibs') with diarrhoea (ibs-d) in adults. ibs is a common gut disorder. the main symptoms of ibs-d include: - stomach ache; - stomach discomfort; - diarrhoea; - urgent bowel movements. truberzi acts on the surface of your gut to restore the normal function of your bowels and block the sensation of pain and discomfort in ibs-d patients.", 'Entity_Recognition': [{'Text': 'truberzi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 7, 'BeginOffset': 0, 'EndOffset': 8, 'Score': 0.29396960139274597, 'Text': 'truberzi', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 22}, {'Text': 'the active substance eluxadoline', 'Type': 'TREATMENT', 'BeginOffset': 37, 'EndOffset': 69}, {'Id': 9, 'BeginOffset': 91, 'EndOffset': 115, 'Score': 0.9109175801277161, 'Text': 'irritable bowel syndrome', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9600419998168945}]}, {'Id': 0, 'BeginOffset': 101, 'EndOffset': 106, 'Score': 0.781830370426178, 'Text': 'bowel', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 10, 'BeginOffset': 118, 'EndOffset': 121, 'Score': 0.6278569102287292, 'Text': 'ibs', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.6660109758377075}]}, {'Id': 11, 'BeginOffset': 129, 'EndOffset': 138, 'Score': 0.9607728719711304, 'Text': 'diarrhoea', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.7321072220802307}]}, {'Id': 12, 'BeginOffset': 158, 'EndOffset': 161, 'Score': 0.6310601234436035, 'Text': 'ibs', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.5658052563667297}]}, {'Text': 'a common gut disorder', 'Type': 'PROBLEM', 'BeginOffset': 165, 'EndOffset': 186}, {'Text': 'the main symptoms', 'Type': 'PROBLEM', 'BeginOffset': 188, 'EndOffset': 205}, {'Text': 'ibs', 'Type': 'PROBLEM', 'BeginOffset': 209, 'EndOffset': 212}, {'Id': 14, 'BeginOffset': 226, 'EndOffset': 238, 'Score': 0.8933172225952148, 'Text': 'stomach ache', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8579935431480408}]}, {'Id': 15, 'BeginOffset': 242, 'EndOffset': 260, 'Score': 0.9141087532043457, 'Text': 'stomach discomfort', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8908727765083313}]}, {'Id': 16, 'BeginOffset': 264, 'EndOffset': 273, 'Score': 0.9834837317466736, 'Text': 'diarrhoea', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7392014861106873}]}, {'Text': 'urgent bowel movements', 'Type': 'PROBLEM', 'BeginOffset': 277, 'EndOffset': 299}, {'Id': 18, 'BeginOffset': 301, 'EndOffset': 314, 'Score': 0.4051114618778229, 'Text': 'truberzi acts', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7222996354103088}], 'Attributes': [{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.9667508006095886, 'RelationshipScore': 0.9923464059829712, 'RelationshipType': 'SYSTEM_ORGAN_SITE', 'Id': 5, 'BeginOffset': 338, 'EndOffset': 341, 'Text': 'gut', 'Category': 'ANATOMY', 'Traits': []}, {'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.992067813873291, 'RelationshipScore': 0.7804220914840698, 'RelationshipType': 'SYSTEM_ORGAN_SITE', 'Id': 6, 'BeginOffset': 381, 'EndOffset': 387, 'Text': 'bowels', 'Category': 'ANATOMY', 'Traits': []}]}, {'Id': 5, 'BeginOffset': 338, 'EndOffset': 341, 'Score': 0.9667508006095886, 'Text': 'gut', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 6, 'BeginOffset': 381, 'EndOffset': 387, 'Score': 0.992067813873291, 'Text': 'bowels', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 19, 'BeginOffset': 415, 'EndOffset': 419, 'Score': 0.9685579538345337, 'Text': 'pain', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8699255585670471}]}, {'Text': 'discomfort in ibs', 'Type': 'PROBLEM', 'BeginOffset': 424, 'EndOffset': 441}]}
{'Title': '2. what you need to know before you take truberzi', 'Section_Content': "do not take truberzi: - if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6); - if you have, or have had, pancreatitis (inflammation of the pancreas); - if you don't have a gallbladder by birth or your gallbladder has been surgically removed; - if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink alcohol; - if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum); - if you have, or have had, disease or dysfunction of the sphincter of oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine); 35 - if you have liver disease with decreased liver function; - if you have had constipation for a while or if constipation is the main symptom of your ibs (called 'ibs with constipation' [ibs-c]); - if you have, or may have, a blockage in your intestine/bowels; - if you take medicines that may increase the level of the concentration of eluxadoline in the blood (so-called oatp1b1 inhibitor, e.g. ciclosporin). talk to your doctor or pharmacist if you are unsure if any of the above apply to you. warnings and precautions stop taking truberzi and seek medical attention immediately if you develop any of the following while taking this medicine: - new or worsening pain in the belly, with or without nausea and vomiting; pain may begin soon after you start truberzi. you may feel pain on the right side of your belly or the upper area of the belly, right below the ribs. the pain may feel like it is moving through to your back or shoulder; these symptoms are uncommon and may indicate pancreas or bile duct system problems (i.e. inflammation of the pancreas or spasm of the sphincter of oddi); o your risk of developing pancreas or bile duct system problems may be higher if you drink alcohol in excess, o the spasm of the sphincter of oddi usually goes away when you stop truberzi. - severe constipation. please report to your doctor: - how much alcohol you drink (e.g. daily number of drinks); - if you experience any effects, such as dizziness and sleepiness. take special care if you are 65 years of age or older, as there is a higher risk that you may have certain side effects (see section 4). children and adolescents truberzi should not be given to children and adolescents less than 18 years old as there is no information about its use in this age group. other medicines and truberzi tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking truberzi as this may increase the risk of constipation. avoid taking truberzi with any other medicines that may cause constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used to treat cardiac disorders among other indications]). some medicines may increase the level of truberzi in the blood. these medicines can include: - ciclosporin (immunosuppressant used to reduce inflammation); - gemfibrozil (used to lower lipid levels); - atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat hiv); - rifampicin (antibiotic used to treat infections). do not take truberzi with any of the above medicines. truberzi may increase the level of some medicines in the blood. these medicines can include: - rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease); - valsartan and olmesartan (used to treat high blood pressure); truberzi may decrease the level of some medicines in the blood. these medicines can include: - erythromycin (used to treat infections); 36 - midazolam (a medicine to sedate you when you e.g.undergo endoscopic procedures); - nifedipine (used to treat high blood pressure); - alfentanil, fentanyl (opioid analgesic used to treat pain); - dihydroergotamine, ergotamine (used to treat migraine); - pimozide (used to treat mental disorders); - quinidine (used to treat heart diseases); - sirolimus, tacrolimus (immunosuppressant used for the control of body's immune response). if any of the above applies to you, tell your doctor or pharmacist before taking truberzi. check with your doctor or pharmacist if you are not sure. pregnancy and breast-feeding truberzi should not be taken whilst pregnant or breast-feeding. if you are pregnant or breast-feeding or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. driving and using machines it is unlikely that truberzi will affect your ability to drive or use tools or machines. however, you may experience side effects such as sleepiness or dizziness while taking truberzi which might affect your ability to drive or use machines. do not 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{'Title': '3. how to take truberzi', 'Section_Content': 'always take this medicine exactly as your doctor has told you. check with your doctor if you are not sure. the usual recommended dose is one 100 mg tablet twice a day. your doctor may prescribe you a lower dose of one 75 mg tablet twice a day if you: - are 65 years of age or older; - are unable to tolerate the 100 mg dose; the tablets should be taken orally with food in the morning and in the evening. if you take more truberzi than you should if you have taken more truberzi than you should, tell your doctor or seek urgent medical assistance. if you forget to take truberzi do not take a double dose to make up for a forgotten dose. take the next dose at the next scheduled time and continue as normal. if you stop taking truberzi do not stop taking truberzi without first talking to your doctor as your symptoms may worsen. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'truberzi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Text': '100', 'Type': 'NUMBER', 'BeginOffset': 141, 'EndOffset': 144}, {'Text': '75', 'Type': 'NUMBER', 'BeginOffset': 218, 'EndOffset': 220}, {'Text': '65', 'Type': 'NUMBER', 'BeginOffset': 257, 'EndOffset': 259}, {'Text': '100', 'Type': 'NUMBER', 'BeginOffset': 312, 'EndOffset': 315}, {'Text': 'the tablets', 'Type': 'TREATMENT', 'BeginOffset': 325, 'EndOffset': 336}, {'Id': 9, 'BeginOffset': 422, 'EndOffset': 430, 'Score': 0.2634334862232208, 'Text': 'truberzi', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.8439754843711853, 'RelationshipScore': 0.74012291431427, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 8, 'BeginOffset': 353, 'EndOffset': 359, 'Text': 'orally', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 10, 'BeginOffset': 570, 'EndOffset': 578, 'Score': 0.39677828550338745, 'Text': 'truberzi', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 591, 'EndOffset': 604}, {'Id': 11, 'BeginOffset': 727, 'EndOffset': 735, 'Score': 0.4994504451751709, 'Text': 'truberzi', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.7973395586013794}]}, {'Id': 12, 'BeginOffset': 755, 'EndOffset': 763, 'Score': 0.5038654804229736, 'Text': 'truberzi', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.8906707763671875}]}, {'Text': 'your symptoms', 'Type': 'PROBLEM', 'BeginOffset': 804, 'EndOffset': 817}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 878, 'EndOffset': 891}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. some side effects can be serious stop taking truberzi, and seek medical attention immediately if you have new or worsening stomach pain, with or without nausea and vomiting, while taking truberzi. these symptoms occur uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system problems (e.g. inflammation of the pancreas or spasm of the sphincter of oddi). serious allergic reactions have happened in some people after taking 1 or 2 doses of truberzi. stop taking truberzi right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including: - swelling of your face, lips, mouth, tongue, and/or throat - shortness of breath or other breathing problems - chest pain or tightness - itching - rash - hives severe constipation that can lead to hospitalization has happened after taking truberzi. stop taking truberzi and call your doctor right away if you develop severe constipation while taking truberzi. avoid taking truberzi with any other medicines that may cause constipation (see section 2: other medicines and truberzi). other side effects can include common: may affect up to 1 in 10 people - dizziness; - sleepiness; - constipation; - feeling sick (nausea); - stomach ache; - being sick (vomiting); - gas (flatulence); - feeling bloated; - heartburn or acid reflux; - rash; - abnormal blood test results (increased levels of certain liver enzymes). reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. 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.', 'Entity_Recognition': [{'Text': 'truberzi', 'Type': 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{'Title': '5. how to store truberzi', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on blister and the carton after exp. the expiry date refers to the last day of that month. this medicinal product does not require any special storage conditions. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what truberzi contains - the active substance is eluxadoline. each tablet contains 75 mg of eluxadoline. - the other ingredients are: core tablet: silicified microcrystalline cellulose (e460); colloidal anhydrous silica (e551); crospovidone, type b (e1202); mannitol (e421) and magnesium stearate (e572). film-coating: polyvinyl alcohol (e1203); titanium dioxide (e171); macrogol 3350 (e1521); talc (e553b); iron oxide yellow (e172) and iron oxide red (e172). what truberzi looks like and contents of the pack the film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with 'fx75' on one side. the tablets are packed in pctfe/pvc/al-blisters. truberzi is available in packs containing 28 or 56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each containing 56 film-coated tablets. not all pack sizes may be marketed.", 'Entity_Recognition': 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