Moventig

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ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Moventig 12.5 mg film-coated tablets 
Moventig 25 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Moventig 12.5 mg film-coated tablets 
Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol. 
 
Moventig 25 mg film-coated tablets 
Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol. 
 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
 
Moventig 12.5 mg film-coated tablet (tablet). 
Oval, 10.5x5.5 mm, mauve tablet. 
 
Moventig 25 mg film-coated tablet (tablet). 
Oval, 13x7 mm, mauve tablet. 
 
Tablets are engraved with “nGL” on one side and the strength of the tablet on the other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who 
have had an inadequate response to laxative(s).  
 
For definition of inadequate response to laxative(s), see section 5.1. 
 
4.2 Posology and method of administration 
 
Posology 
The recommended dose of Moventig is 25 mg once daily. 
 
When naloxegol therapy is initiated, it is recommended that all currently used maintenance laxative 
therapy should be halted, until clinical effect of naloxegol is determined. 
 
Special populations 
Elderly  
No dose adjustment is recommended based on age (see section 5.2). 
 
Renal impairment  
The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg. If side effects 
impacting tolerability occur, naloxegol should be discontinued. The dose can be increased to 25 mg if 



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12.5 mg is well tolerated by the patient (see section 5.2). No dosage adjustment is required for patients 
with mild renal impairment. 
 
Hepatic impairment 
No dose adjustment is required for patients with mild to moderate hepatic impairment. Safety and 
efficacy have not been established in patients with severe hepatic impairment (see section 5.2). Use in 
patients with severe hepatic impairment is not recommended. 
 
CYP3A4 inhibitors 
The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 
12.5 mg once daily. The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see 
section 4.5). 
 
No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, 
atorvastatin (see section 4.5). 
 
Patients with cancer-related pain 
No dose adjustment is required for patients with cancer-related pain (see sections 4.3 and 4.4). 
 
Paediatric population 
The safety and efficacy of naloxegol in children <18 years of age has not yet been established.   
No data are available. 
 
Method of administration  
Oral use.  
 
It is recommended that Moventig is taken in the morning, for patient convenience to avoid bowel 
movements in the middle of the night. 
 
Moventig should be taken on an empty stomach at least 30 minutes prior to the first meal of the day or 
2 hours after the first meal of the day. 
 
For patients who are unable to swallow the tablet whole, the tablet can be crushed to a powder and 
mixed in half a glass of water (120 ml) and drunk immediately. The glass should be rinsed with a 
further half glass of water (120 ml) and the contents drunk. Refer to section 6.6 for further information 
on administration through a nasogastric tube. 
 
 
4.3 Contraindications 
 
Hypersensitivity 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other 
opioid antagonist. 
 
Gastrointestinal obstruction 
Patients with known or suspected gastrointestinal (GI) obstruction or in patients at increased risk of 
recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4). 
 
Conditions in patients with cancer pain 
• Patients with underlying cancer who are at heightened risk of GI perforation, such as those with:  

• underlying malignancies of gastrointestinal tract or peritoneum 
• recurrent or advanced ovarian cancer  
• vascular endothelial growth factor (VEGF) inhibitor treatment. 

 



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Strong CYP3A4 inhibitors 
Concomitant use with strong CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, itraconazole or 
telithromycin; protease inhibitors such as ritonavir, indinavir or saquinavir; grapefruit juice when 
consumed in large quantities), see section 4.5. 
 
4.4 Special warnings and precautions for use 
 
Conditions with increased potential for gastrointestinal perforation 
Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal 
cases when naloxegol was used in patients who were at an increased risk of gastrointestinal (GI) 
perforation. Naloxegol must not be used in patients with known or suspected gastrointestinal 
obstruction or in patients at increased risk of recurrent obstruction, or in patients with underlying 
cancer who are at heightened risk of GI perforation (see section 4.3). 
 
Caution with regards to the use of naloxegol should be exercised in patients with any condition which 
might result in impaired integrity of the gastrointestinal tract wall (e.g. severe peptic ulcer disease, 
Crohn’s Disease, active or recurrent diverticulitis, infiltrative gastrointestinal tract malignancies or 
peritoneal metastases). The overall benefit-risk profile for each patient should be taken into account. 
Patients should be advised to discontinue therapy with naloxegol and promptly notify their physician if 
they develop unusually severe or persistent abdominal pain. 
 
Clinically important disruptions of the blood-brain barrier 
Naloxegol is a peripherally acting mu-opioid receptor antagonist with restricted access to the central 
nervous system (CNS). The blood brain barrier integrity is important for minimizing naloxegol uptake 
into the CNS. Patients with clinically important disruptions to the blood-brain barrier (e.g. primary 
brain malignancies, CNS metastases or other inflammatory conditions, active multiple sclerosis, 
advanced Alzheimer’s disease etc.) were not included in clinical studies and may be at risk for 
naloxegol entry into the CNS. Naloxegol should be prescribed with caution in such patients taking into 
account their individual benefit-risk balance with observation for potential CNS effects, such as 
symptoms of opioid withdrawal and/or interference with opioid-mediated analgesia. If evidence for 
opioid-mediated interference with analgesia or opioid withdrawal syndrome occurs, patients should be 
instructed to discontinue Moventig and contact their physician. 
 
Concurrent methadone use 
Patients taking methadone as primary therapy for their pain condition were observed in clinical trials 
to have a higher frequency of gastrointestinal adverse reactions (such as abdominal pain and 
diarrhoea) than patients not receiving methadone. In a few cases, symptoms suggestive of opioid 
withdrawal when taking naloxegol 25 mg were observed in patients taking methadone for their pain 
condition. This was observed in a higher proportion of patients taking methadone than those not taking 
methadone. Patients taking methadone for treatment of opioid addiction were not included in the 
clinical development programme and use of naloxegol in these patients should be approached with 
caution.  
 
Gastrointestinal adverse reactions 
Reports of severe abdominal pain and diarrhoea have been observed in clinical trials with the 25 mg 
dose, typically occurring shortly after initiation of treatment. There was a higher incidence of 
discontinuations in patients taking the 25 mg dose compared to placebo due to diarrhoea (0.7% for 
placebo versus 3.1% for naloxegol 25 mg) and abdominal pain (0.2% versus 2.9%, respectively). 
Patients should be advised to promptly report severe, persistent or worsening symptoms to their 
physician. Consideration may be given to lowering the dose to 12.5mg in patients experiencing severe 
gastrointestinal adverse events depending upon the response and tolerability of individual patients. 
 
Opioid withdrawal syndrome 
Cases of opioid withdrawal syndrome have been reported in the naloxegol clinical programme (DSM-
5). Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: 
dysphoric mood, nausea, vomiting, muscle aches, lacrimation, rhinorrhoea, pupillary dilation, 



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piloerection, sweating, diarrhoea, yawning, fever or insomnia. Opioid withdrawal syndrome typically 
develops within minutes to several days following administration of an opioid antagonist. If opioid 
withdrawal syndrome is suspected the patient should discontinue Moventig and contact their 
physician. 
 
Patients with CV conditions 
Naloxegol was not studied in the clinical trial programme in patients who had a recent history of 
myocardial infarction within 6 months, symptomatic congestive heart failure, overt cardiovascular 
(CV) disease or patients with a QT interval of ≥ 500 msec. Moventig should be used with caution in 
these patients. A QTc study performed with naloxegol in healthy volunteers did not indicate any 
prolongation of the QT interval. 
 
CYP3A4 inducers 
Naloxegol is not recommended in patients who are taking strong CYP3A4 inducers (e.g. 
carbamazepine, rifampin, St. John’s Wort) (see section 4.5). 
 
For information regarding concomitant use with CYP3A4 inhibitors, see sections 4.2, 4.3 and 4.5. 
 
Renal impairment  
The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg. If side effects 
impacting tolerability occur, naloxegol should be discontinued. The dose can be increased to 25 mg if 
12.5 mg is well tolerated by the patient (see section 5.2). 
 
Severe hepatic impairment 
Naloxegol has not been studied in patients with severe hepatic impairment. The use of naloxegol is not 
recommended in such patients. 
 
Cancer-related pain 
There is limited clinical experience with the use of naloxegol in OIC patients with cancer-related pain. 
Therefore, caution should be used when prescribing naloxegol to such patients (see section 4.3). 
 
Moventig contains sodium 
This medicinal product contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is 
to say essentially ‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Interaction with CYP3A4 inhibitors and inducers 
Interaction with strong CYP3A4 inhibitors 
In an open-label, non-randomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate 
the effect of multiple doses of ketoconazole on the single dose PK of naloxegol, co-administration of 
ketoconazole and naloxegol resulted in a 12.9 fold (90% CI: 11.3-14.6) increase in naloxegol AUC 
and a 9.6-fold increase in naloxegol Cmax (90% CI: 8.1-11.3), compared to when naloxegol was 
administered alone. Therefore, concomitant use with strong CYP3A4 inhibitors is contraindicated (see 
section 4.3). Grapefruit juice has been classified as a potent CYP3A4 inhibitor when consumed in 
large quantities. No data are available on the concomitant use of naloxegol with grapefruit juice. 
Concomitant consumption of grapefruit juice while taking naloxegol should generally be avoided and 
considered only in consultation with a healthcare provider (see section 4.3). 
 
Interaction with moderate CYP3A4 inhibitors 
In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate 
the effect of multiple doses of diltiazem on the single dose PK of naloxegol, co-administration of 
diltiazem and naloxegol resulted in a 3.4-fold (90% CI: 3.2-3.7) increase in naloxegol AUC and a 2.9-
fold increase in naloxegol Cmax (90% CI: 2.6-3.1), compared to when naloxegol was administered 
alone. Therefore, a dose adjustment of naloxegol is recommended when co-administered with 
diltiazem and other moderate CYP3A4 inhibitors (see section 4.2). The starting dose for patients 



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taking moderate CYP3A4 inhibitors is 12.5 mg once daily and the dose can be increased to 25 mg if 
12.5 mg is well tolerated by the patient (see section 4.2). 
 
No dosage adjustment is required for patients taking weak CYP3A4 inhibitors. 
 
Interaction with strong CYP3A4 inducers 
In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, single-dose, crossover study 
to evaluate the effect of multiple doses of rifampin on the single dose PK of naloxegol, co-
administration of rifampin and naloxegol resulted in a 89% (90% CI: 88%-90%) decrease in naloxegol 
AUC and a 76% decrease in naloxegol Cmax (90% CI: 69%-80%), compared to when naloxegol was 
administered alone. Therefore, Moventig is not recommended in patients who are taking strong 
CYP3A4 inducers (see section 4.4). 
 
Interaction with P-gp inhibitors 
A double-blind, randomized, 2-part, crossover, single centre study was conducted to evaluate the 
effect of quinidine on the pharmacokinetics of naloxegol and the effect of the co-administration of 
naloxegol and quinidine on morphine-induced miosis in healthy volunteers. Co-administration of the 
P-gp inhibitor quinidine resulted in a 1.4 fold increase in the AUC (90% CI: 1.3-1.5) and a 2.4 fold 
increase in the Cmax (90% CI: 2.2-2.8) of naloxegol. Co-administration of naloxegol and quinidine did 
not antagonize the morphine-induced miosis effect, suggesting that P-gp inhibition does not 
meaningfully change the capacity of naloxegol to cross the blood-brain barrier at therapeutic doses. 
 
As the effects of P-gp inhibitors on the PK of naloxegol were small relative to the effects CYP3A4 
inhibitors, the dosing recommendations for Moventig when co-administered with medicinal products 
causing both P-gp and CYP3A4 inhibition should be based on CYP3A4 inhibitor status - strong, 
moderate or weak (see sections 4.2, 4.3 and 4.5).  
 
Interaction with other opioid antagonists 
Use of naloxegol with another opioid antagonist (e.g. naltrexone, naloxone) should be avoided due to 
the potential for an additive effect of opioid receptor antagonism and an increased risk of opioid 
withdrawal. 
 
Paediatric population 
Interaction studies have only been performed in adults. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are limited data from the use of naloxegol in pregnant women. 
 
Studies in animals have shown reproductive toxicity where systemic exposures were several times 
above the therapeutic exposure level (see section 5.3).  
 
There is a theoretical potential for provoking opioid withdrawal in the foetus with use of an opioid 
receptor antagonist in the mother, who is being treated with a concurrent opioid. Naloxegol use is 
therefore not recommended during pregnancy. 
 
Breast-feeding 
It is unknown whether naloxegol is excreted in human milk. Available toxicological data in rats have 
shown naloxegol excreted in milk (see section 5.3). 
 
At therapeutic doses, most opioids (e.g. morphine, meperidine, methadone) are excreted into breast 
milk in minimal amounts. There is a theoretical possibility that naloxegol could provoke opioid 
withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist. Therefore, use 
in breast-feeding mothers is not recommended. 
 



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Fertility 
The effect of naloxegol on fertility in humans has not been studied. Naloxegol was found to have no 
effect on fertility of male and female rats at oral doses up to 1,000 mg/kg per day (greater than 
1,000 times the human therapeutic exposure (AUC) at the recommended human dose of 25 mg/day). 
 
4.7 Effects on ability to drive and use machines 
 
Moventig has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
In the pooled data from clinical trials the most commonly reported adverse reactions with naloxegol 
(≥ 5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence. The majority of 
gastrointestinal adverse reactions were graded as mild to moderate, occurred early in treatment and 
resolved with continued treatment. They were often reported as having a component of cramping 
discomfort.  
 
Tabulated list of adverse reactions 
Adverse reactions are classified according to frequency and System Organ Class. Frequency 
categories are defined according to the following conventions: 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). 
 
Table 1 Adverse reactions by System Organ Class (SOC) and frequency 
 

System Organ 
Classification 

 
Very 

Common 
 

 
Common 

 

 
Uncommon 

 

 
Rare 

 

 
Not known 
 

Infections and 
Infestations 
 

 Nasopharyngitis    

Immune system 
disorders 
 

     
Hypersensitivity 

Nervous system 
disorders 

 Headache Opioid 
withdrawal 
syndrome 

  

      
Gastrointestinal 
disorders 

Abdominal 
paina, 
diarrhoea 

Flatulence, 
nausea, 
vomiting 

  Gastrointestinal 
perforation (see 
section 4.4) 

      
Skin and subcutaneous 
tissue disorders 

 Hyperhidrosis    

Note: Selection of ADRs and their frequencies based on the 25 mg dose 
a Reflects MedDRA Preferred Terms of: “abdominal pain”, “abdominal pain upper”, “abdominal pain lower” and 
“gastrointestinal pain”.  
 
Description of selected adverse reactions 
Opioid withdrawal syndrome 
Naloxegol at therapeutic doses has minimal uptake across the blood brain barrier. In some patients, 
however, a constellation of symptoms has been reported, which resembles the syndrome of central 
opioid withdrawal. Most such reports were observed shortly after initial administration with the 
medicinal product and were mild or moderate in intensity. 



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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 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
  
4.9 Overdose 
 
Doses of naloxegol up to 1,000 mg were administered in healthy volunteers in clinical studies.  A 
potential CNS effect (reversal of opioid-induced miosis, as measured by pupillometry) was observed 
in 1 volunteer in the 250 mg group and 1 volunteer in the 1,000 mg group. In a clinical study of 
patients with OIC, a daily dose of 50 mg was associated with an increased incidence of intolerable 
gastrointestinal effects (primarily abdominal pain). 
No antidote is known for naloxegol and dialysis was noted to be ineffective as a means of elimination 
in a clinical study in patients with renal failure. 
 
If a patient on opioid therapy receives an overdose of naloxegol, the patient should be monitored 
closely for potential evidence of opioid withdrawal symptoms or reversal of central analgesic effect. In 
cases of known or suspected overdose of naloxegol, symptomatic treatment as well as monitoring of 
vital functions should be performed. 
 
Paediatric population 
The use of naloxegol in the paediatric population has not been studied. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists 
ATC code: A06AH03 
 
Mechanism of action and pharmacodynamic effects 
Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone. PEGylation 
reduces naloxegol’s passive permeability and also renders the compound a substrate for the 
P-glycoprotein transporter. Due to poorer permeability and increased efflux of naloxegol across the 
blood-brain barrier, related to P-gp substrate properties, the CNS penetration of naloxegol is minimal. 
 
In vitro studies demonstrate that naloxegol is a full neutral antagonist at the mu-opioid receptor. 
Naloxegol acts by binding to mu-opioid receptors in the GI tract targeting the underlying causes of 
OIC (i.e. reduced GI motility, hypertonicity and increased fluid absorption resulting from long-term 
opioid treatment). 
 
Naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in the gastrointestinal tract, 
thereby decreasing the constipating effects of opioids without impacting opioid-mediated analgesic 
effects on the central nervous system. 
 
Clinical efficacy and safety 
The efficacy and safety of naloxegol was established in two replicate double-blind, placebo-controlled 
studies in patients with OIC and non-cancer related pain (Kodiac 4 and Kodiac 5). Patients taking a 
minimum of 30 morphine equivalent units (meu) of opioids per day for at least 4 weeks before 
enrolment and self-reported OIC were eligible. OIC was confirmed through a two week run in period 
and defined as < 3 spontaneous bowel movements (SBMs) per week on average with constipation 
symptoms associated with at least 25% of bowel movements. Patients were prohibited from using 



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laxatives other than bisacodyl rescue laxative if they had not had a bowel movement for 72 hours. 
SBM was defined as a bowel movement without rescue laxative taken within the past 24 hours.  
Patients with mean Numeric Rating Scale (NRS) pain scores equal to or higher than 7 were not studied 
due to the risk of confounding the efficacy result as a result of uncontrolled pain. Patients who had a 
QTcF >500 msec at screening, had a recent history of myocardial infarction within 6 months before 
randomization, had symptomatic congestive heart failure, or had any other overt CV disease were 
excluded from the clinical studies. In a thorough QT/QTc study, as defined by the ICH E14 Guideline, 
there were no clinically important changes in HR, RR, QT, PR or QRS intervals or T wave 
morphology observed. In addition, no safety and tolerability concerns were identified in this study up 
to the highest dose given (150 mg). According to the ICH E14 Guideline, this is considered a 
definitively negative thorough QT/QTc study. Patients with moderate or severe hepatic insufficiency 
(Child’s-Pugh Class B or C) were excluded from the Phase III studies (Kodiac 4 and 5). Therefore, 
naloxegol has not been studied in OIC patients with moderate or severe hepatic impairment. Both 
studies were powered and stratified so that at least 50% of patients randomized to each treatment arm 
met baseline criteria to be categorized as a laxative inadequate responder (LIR).   
 
Definition of laxative inadequate responder 
To qualify as LIR, in the two weeks prior to first study visit patients had to have reported concurrent 
OIC symptoms of at least moderate severity while taking at least one laxative class for a minimum of 
four days during the pre study period.   
 
Efficacy in the patient population targeted in this SmPC 
Response over 12 weeks in the LIR group 
Efficacy and durability of effect were measured in the primary end-point as response over the 12-week 
treatment period to naloxegol as defined by > 3 SBMs per week and a change from baseline of > 1 
SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks. The first of three 
multiplicity protected secondary endpoints was the 12-week responder rate in the LIR subgroup. 
 
There was a statistically significant difference for the 25 mg dose versus placebo for the LIR subgroup 
responder rate in Kodiac 4 (p=0.002) and Kodiac 5 (p=0.014). Under multiplicity testing procedure, 
statistical significance for the 12.5 mg treatment group versus placebo in the LIR subgroup was 
observed in Kodiac 4 (p=0.028) but not in Kodiac 5 (p=0.074). In Kodiac 4, response rates in the 
placebo, 12.5 mg and 25 mg groups in the LIR subgroup were 28.8%, 42.6% and 48.7%, while in 
Kodiac 5, the corresponding response rates were 31.4, 42.4% and 46.8%. In the pooled data from 
Kodiac 4 and Kodiac 5, responder rates in the LIR subgroup were 30.1% for placebo, 42.5% for the 
12.5 mg dose, and 47.7% for the 25 mg dose, with the relative risk (95% CI) for treatment effect 
versus placebo of 1.410(1.106, 1.797) and 1.584(1.253, 2.001) for the 12.5 mg and 25 mg groups, 
respectively. 
 
Response over 12 weeks in patients with an inadequate response to at least two classes of laxative 
Response to naloxegol over 12 weeks was tested in the sub-group of patients with inadequate response 
to at least two laxative classes, approximately 20% of the patients randomized. In a pooled analysis of 
Kodiac 4 and Kodiac 5 (90, 88 and 99 patients in the placebo, 12.5 mg and 25 mg groups 
respectively), higher response rates in this population was observed for the 25 mg dose group 
compared with placebo (p=0.040). The responder rates in this population were placebo 30.0%, 
12.5 mg 44.3% and 25 mg 44.4%. 
 
Time to first spontaneous bowel movement 
The time to first SBM in the LIR subgroup after taking the first dose was shorter for the 25 mg dose as 
compared to placebo in Kodiac 4 (p<0.001) and Kodiac 5 (p=0.002). The 12.5 mg dose in the LIR 
subgroup also demonstrated shorter time to first post-dose SBM as compared to placebo in Kodiac 4 
(p=0.002) and Kodiac 5 (p<0.001).  In Kodiac 4, placebo, 12.5 mg and 25 mg dose had median time to 
first post dose SBM of 43.4, 20.6, and 5.4 hours, respectively. In Kodiac 5 the corresponding times to 
first post dose SBM were 38.2, 12.8, and 18.1 hours, respectively. 
 



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Mean number of days per week with at least one SBM 
There was an increase in the mean number of days per week with at least one SBM in the LIR 
subgroup for the 25 mg dose in Kodiak 4 and Kodiac 5 (p<0.001 in both studies) and also for the 
12.5 mg dose (p=0.006 in both studies).  
 
OIC symptom improvement 
The 25 mg dose in the LIR subgroup improved rectal straining (Kodiac 4 p=0.043, Kodiac 5 p<0.001). 
Stool consistency in the LIR subgroup as measured by the Bristol stool scale improved in Kodiac 5 
versus placebo (p<0.001) but not in Kodiac 4 (p=0.156). The 25 mg dose in the LIR subgroup 
increased mean days per week compared with placebo with at least 1 complete spontaneous bowel 
movement (CSBM) in both studies (Kodiac 4 p=0.002, Kodiac 5 p<0.001). 
 
Symptom responder end-point 
A “symptom responder” was defined as meeting both the 12-week responder criteria and 
demonstrating improvement in pre-specified OIC symptoms and no deterioration in symptoms. In the 
LIR subgroup, the 25 mg dose increased the symptom responder rates in both studies as compared to 
placebo (Kodiac 4 p=0.001, Kodiac 5 p=0.005). The LIR subgroup symptom responder rates in 
Kodiac 4 for placebo, 12.5 mg and 25 mg arms were 24.6%, 36.5% and 45.3% and the symptom 
responder rates in Kodiac 5 were 25.6%, 33.6% and 42.7%. 
 
Patient assessment of constipation symptoms (PAC-SYM) questionnaire 
Naloxegol 25 mg dose in the LIR subgroup resulted in a greater improvement (change from baseline) 
of patient assessment of constipation symptoms (PAC-SYM) total scores compared with placebo in 
both studies at 12 weeks (Kodiac 4 p=0.023, Kodiac 5 p=0.002). The 12.5 mg dose in the LIR 
subgroup also resulted in greater improvement in total PAC SYM at week 12 compared with placebo 
in both studies (p= 0.020 and p=0.001 respectively). Naloxegol 25 mg dose, compared with placebo, 
also resulted in greater improvement (change from baseline) of week 12 PAC-SYM rectal domain 
scores in both studies (p=0.004 and p<0.001, Kodiac 4 and 5, respectively) and for the stool domain 
scores in Kodiac 4 (p=0.031) and Kodiac 5 (p<0.001). There was no relevant impact on abdominal 
symptoms in either study (p=0.256 and p=0.916, Kodiac 4 and 5, respectively). 
 
Potential for interference with opioid-mediated analgesia    
There were no clinically relevant differences between naloxegol 12.5 mg, 25 mg, and placebo in 
average pain intensity, daily opioid dose or in opioid withdrawal scores over the 12-week study. 
 
In the 12-week studies (Kodiac 4 and 5), the frequency of back pain AEs was 4.3% for naloxegol 
25 mg versus 2.0% for placebo, and the frequency of extremity pain AEs was 2.2% for naloxegol 
25 mg, versus 0.7% for placebo. In a long-term safety study (Kodiac 8), the frequency of AE reports 
of back pain was 8.9% for naloxegol 25 mg versus 8.8% for usual care.  For extremity pain, the rate 
for naloxegol 25 mg was 3.5% versus 3.3% for usual care. 
 
Safety and tolerability over an extended 12-week period 
Kodiac 7 was a 12-week safety extension that allowed for patients from Kodiac 4 to continue the same 
blinded treatment from Kodiac 4 for an additional 12 weeks (placebo, naloxegol 12.5 mg or 
25 mg daily). The primary objective was to compare safety and tolerability among the three treatment 
groups for an additional 12 weeks (beyond that observed in Kodiac 4) using descriptive statistics. In 
this study, naloxegol at doses of 12.5 mg and 25 mg was generally safe and well tolerated as compared 
with placebo in the treatment of OIC patients with non-cancer-related pain. 
 
In all treatment groups, including placebo, improvements in PAC-SYM domains observed in Kodiac 4 
were maintained for patients continuing in Kodiac 7. 
 
Long-term safety and tolerability 
Kodiac 8 was a Phase III, 52-week, multi-center, open-label, randomized, parallel group, safety and 
tolerability study of naloxegol versus usual care in the treatment of OIC in patients with 
non-cancer-related pain. The primary objective was to assess long-term safety and tolerability for 
naloxegol 25 mg and to compare with usual care treatment using descriptive statistics. 



11 

 
Eligible patients were randomized in a 2:1 ratio to receive either naloxegol 25 mg daily (qd) or usual 
care treatment for OIC for 52 weeks. Patients assigned to usual care followed a laxative treatment 
regimen for OIC determined by the investigator according to best clinical judgment, excluding 
peripheral mu-opioid receptor antagonists.  
 
Of the 844 patients who were randomized, 61.1% completed the study (defined as completing the 
2-week follow-up visit after the 52-week treatment period). Overall 393 and 317 patients had at least 6 
and 12 months exposure to naloxegol 25 mg, respectively, in this study, which met the specified 
exposure requirements.  
 
Long-term exposure to naloxegol 25 mg, up to 52 weeks, was generally safe and well tolerated in the 
treatment of OIC patients with non-cancer-related pain.  During the 52-week treatment period there 
were no important unexpected differences in the safety and tolerability findings between the naloxegol 
25 mg treatment group and the usual care treatment group. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Moventig in one or more subsets of the paediatric population in opioid induced constipation  (see 
section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Following oral administration, naloxegol is absorbed rapidly, with peak concentrations (Cmax) 
achieved at less than 2 hours. In a majority of subjects, a secondary plasma concentration peak of 
naloxegol was observed approximately 0.4 to 3 hours after the first peak. Enterohepatic recirculation 
may be an explanation as extensive biliary excretion was seen in the rat. 
 
Food effects: A high-fat meal increased the extent and rate of naloxegol absorption. The Cmax and area 
under the plasma concentration-time curve (AUC) were increased by approximately 30% and 45%, 
respectively. 
 
Naloxegol as a crushed tablet mixed in water, given orally or administered through a nasogastric tube 
into the stomach, is bioequivalent to the whole tablet, with a median tmax of 0.75 and 1.50 hours (range 
0.23 to 5.02 hours) for the crushed tablet given orally and the crushed tablet given via NG tube, 
respectively. 
 
Distribution 
The mean apparent volume of distribution during the terminal phase (Vz/F) in healthy volunteers 
ranged from 968 to 2,140 L across dosing groups and studies. Results from a QWBA (Quantitative 
Whole Body Autoradiography) study in the rat and the lack of antagonism of CNS opiate effects in 
humans at naloxegol doses less than 250 mg, indicate minimal distribution of naloxegol into the CNS. 
Plasma protein binding of naloxegol in humans was low and the fraction unbound ranged from 80% to 
100%. 
 
Biotransformation 
In a mass balance study in humans, a total of 6 metabolites were identified in plasma, urine and faeces. 
These metabolites represented more than 32% of the administered dose and were formed via 
N-dealkylation, O-demethylation, oxidation and partial loss of the PEG chain. None of the metabolites 
were present in > 10% of the plasma concentrations of parent or total parent and metabolite related 
material. 
 
Elimination 
Following oral administration of radiolabelled naloxegol, 68% and 16% of total administered dose 
were recovered in the faeces and urine, respectively. Parent naloxegol excreted in the urine accounted 
for less than 6% of the total administered dose. Thus renal excretion is a minor clearance pathway for 



12 

naloxegol. In clinical pharmacology studies, the half-life of naloxegol at therapeutic dose ranged from 
6–11 hours. 
 
Linearity/non-linearity 
Across the range of doses evaluated peak plasma concentration and AUC increased in a dose-
proportional, or approximately dose proportional, manner. 
 
Special populations 
Age and gender 
There is a small effect of age on the pharmacokinetics of naloxegol (approximately 0.7% increase in 
AUC for every year increase in age). No dose adjustment is recommended for elderly patients. 
Patients over 65 years of age have been represented in the phase III studies. Clinical studies of 
naloxegol did not include sufficient numbers of patients aged 75 years or over to determine whether 
they respond differently than younger patients, however, based on the mode of action of the active 
substance there are no theoretical reasons for any requirement for dose adjustments in this age group. 
For dose recommendations for patients with moderate or severe renal insufficiency, see section 4.2. 
There is no gender effect on the PK of naloxegol. 
 
Race 
The effect of race on the pharmacokinetics of naloxegol is small (approximately 20% decrease in the 
AUC of naloxegol when other groups are compared to Caucasian) and, therefore, no dose adjustment 
is necessary. 
 
Body weight 
Naloxegol exposure was found to increase with increased weight, however, the differences in 
exposure were not considered clinically relevant. 
 
Renal impairment 
As renal clearance is a minor route of elimination for naloxegol, regardless of severity (i.e. moderate, 
severe and end stage renal failure), the impact of renal impairment on the pharmacokinetics of 
naloxegol was minimal in most subjects. However, in 2 out of 8 patients (in both the moderate and 
severe renal impairment groups but not in the end stage renal failure group) up to 10-fold increases in 
the exposure of naloxegol were observed. In these patients renal impairment may adversely affect 
other clearance pathways (hepatic/gut drug metabolism, etc.) resulting in higher exposure. The starting 
dose for patients with moderate or severe renal insufficiency is 12.5 mg. If side effects impacting 
tolerability occur, naloxegol should be discontinued. The dose can be increased to 25 mg if 12.5 mg is 
well tolerated by the patient (see section 4.2). Exposure of naloxegol in end-stage renal disease 
(ESRD) patients on haemodialysis was similar to healthy volunteers with normal renal function. 
 
Hepatic impairment 
Less than 20% decrease in AUC and 10% decrease in Cmax were observed in patients with mild and 
moderate hepatic impairment (Child-Pugh Class A and B). Effect of severe hepatic impairment 
(Child-Pugh Class C) on the pharmacokinetics of naloxegol was not evaluated. Use in patients with 
severe hepatic impairment is not recommended.  
 
Paediatric population 
The pharmacokinetics of naloxegol in the paediatric population has not been studied. 
 
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 and fertility. 
 
Embryo-foetal development studies were conducted in rats and rabbits.  A potentially treatment-
related increased incidence of the skeletal variant bipartite vertebral centrum and a single foetus with 
anorchism was seen at the highest dose tested in the rat embryo-foetal development study.  A possible 



13 

treatment-related foetal skeletal malformation of fused arches was noted at highest dose tested in the 
rabbit embryo-foetal development study, in the absence of maternal toxicity. In a separate pre- and 
post-natal development study in rats, body weights were lower for male pups following maternal 
administration at the high dose. All these effects were observed only at exposures considered 
sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.  
 
Carcinogenicity studies of naloxegol were conducted in rats and mice.  In male rats, a dose-related 
increase in Leydig cell adenomas and interstitial cell hyperplasia was observed at exposures 
considered sufficiently in excess of the maximum human exposure.  The observed neoplastic changes 
are well known hormonal and centrally mediated effects in the rat which are not relevant for humans. 
 
Studies in suckling rats have shown that naloxegol is excreted in the milk. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
mannitol (E421) 
cellulose microcrystalline (E460) 
croscarmellose sodium (E468) 
magnesium stearate (E470b) 
propyl gallate (E310) 
 
Tablet coat 
hypromellose (E464) 
titanium dioxide (E171) 
macrogol (E1521) 
iron oxide red (E172) 
iron oxide black (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
4 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
Alu/alu blister. 
 
12.5 mg film-coated tablets 
Pack sizes of 30 and 90 film-coated tablets in non-perforated blisters. 
Pack sizes of 30 x 1 and 90 x 1 film-coated tablets in perforated unit dose blisters. 
 
25 mg film-coated tablets 
Pack sizes of 10, 30 and 90 film-coated tablets in non-perforated blisters. 
Pack sizes of 10 x 1, 30 x 1, 90 x 1 and 100 x 1 film-coated tablets in perforated unit dose blisters. 
 
Not all pack sizes may be marketed. 



14 

 
6.6 Special precautions for disposal and other handling 
 
No special requirements for disposal. Any unused medicinal product or waste material should be 
disposed of in accordance with local requirements. 
 
The mixture can also be administered via a nasogastric tube (CH8 or greater), in this case the tablet 
can be crushed to a powder and mixed with water (120 ml). It is important to flush the nasogastric tube 
through with water after administration of the mixture. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Kyowa Kirin Holdings B.V. 
Bloemlaan 2 
2132NP Hoofddorp 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/962/001 
EU/1/14/962/002 
EU/1/14/962/003 
EU/1/14/962/004 
EU/1/14/962/005 
EU/1/14/962/006 
EU/1/14/962/007 
EU/1/14/962/008 
EU/1/14/962/009 
EU/1/14/962/010 
EU/1/14/962/011 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 8 December 2014 
Date of latest renewal: 23 September 2019 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
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. MANUFACTURERS 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. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Piramal Healthcare UK Limited 
Whalton Road 
Morpeth 
Northumberland, NE61 3YA 
United Kingdom 
 
Piramal Pharma Solutions (Dutch) B.V. 
Bargelaan 200 u 715 
Leiden 
2333CW 
Netherlands 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription  
 
 
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 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Moventig 12.5 mg film-coated tablets 
naloxegol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 12.5 mg naloxegol (as naloxegol oxalate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
90 film-coated tablets 
30 x 1 film-coated tablets 
90 x 1 film-coated 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 
 
Kyowa Kirin Holdings B.V. 
Bloemlaan 2 
2132NP Hoofddorp 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/962/001 30 film-coated tablets 
EU/1/14/962/002 90 film-coated tablets 
EU/1/14/962/008 30 x 1 film-coated tablets (unit dose)  
EU/1/14/962/003 90 x 1 film-coated tablets (unit dose) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
moventig 12.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



21 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Moventig 25 mg film-coated tablets 
naloxegol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 25 mg naloxegol (as naloxegol oxalate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 film-coated tablets 
30 film-coated tablets 
90 film-coated tablets 
10 x 1 film-coated tablets 
30 x 1 film-coated tablets 
90 x 1 film-coated tablets 
100 x 1 film-coated 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 
 
 



22 
 

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 
 
Kyowa Kirin Holdings B.V. 
Bloemlaan 2 
2132NP Hoofddorp 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/962/004   10 film-coated tablets 
EU/1/14/962/005   30 film-coated tablets 
EU/1/14/962/006   90 film-coated tablets 
EU/1/14/962/009   10 x 1 film coated tablets (unit dose) 
EU/1/14/962/010   30 x 1 film-coated tablets (unit dose) 
EU/1/14/962/007   90 x 1 film-coated tablets (unit dose) 
EU/1/14/962/011 100 x 1 film-coated tablets (unit dose) 
 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
moventig 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



23 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS 
 
Blister perforated unit dose 
Blister non-perforated  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Moventig 12.5 mg tablets 
naloxegol 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Kyowa Kirin  
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



24 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS 
 
Blister perforated unit dose 
Blister non-perforated 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Moventig 25 mg tablets 
naloxegol 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Kyowa Kirin 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



25 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



26 
 

Package leaflet: Information for the patient 
 

Moventig 12.5 mg film-coated tablets 
Moventig 25 mg film-coated tablets 

 
naloxegol 

 
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, pharmacist or nurse. 
- 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, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Moventig is and what it is used for  
2. What you need to know before you take Moventig  
3. How to take Moventig  
4. Possible side effects  
5. How to store Moventig  
6. Contents of the pack and other information 
 
 
1. What Moventig is and what it is used for 
 
Moventig contains the active substance naloxegol. It is a medicine used in adults to treat constipation 
specifically caused by pain medicines, called opioids, (e.g. morphine, oxycodone, fentanyl, tramadol, 
codeine) taken on a regular basis. It is used when laxatives have not provided acceptable relief of 
constipation. 
 
Constipation related to opioids can result in symptoms such as: 
• stomach pain  
• rectal straining (having to push very hard to move the stool out of the rectum, which can also 

cause pain in the anus during pushing) 
• hard stools (stools which are hard “like a rock”) 
• incomplete emptying of the rectum (after having a bowel movement, the feeling as if a stool is 

still in the rectum which needs to come out) 
 
In patients taking opioids with constipation, who have tried at least one laxative and had incomplete 
relief of constipation, Moventig has been shown in clinical trials to increase the number of bowel 
movements and improve symptoms of constipation caused by opioids. 
 
 
2. What you need to know before you take Moventig  
 
Do not take Moventig: 
• if you are allergic to naloxegol or similar medicines or any of the other ingredients of this 

medicine (listed in section 6). 
• if your bowels are, or may be, blocked (obstructed) or you have been warned that your bowels 

are at risk of becoming blocked. 
• if you have cancer in your gut or ‘peritoneum’ (the lining of your stomach area), advanced  or 

recurrent ovarian cancer or if you are taking medicines used to treat cancer such as “VEGF 
inhibitors” (e.g. bevacizumab). 



27 
 

• if you are taking certain other medicines such as ketoconazole or itraconazole (to treat fungal 
infections), clarithromycin or telithromycin (antibiotics) or ritonavir, indinavir or saquinavir (to 
treat HIV).  

 
Do not use Moventig if any of the above applies to you. If you are not sure, talk to your doctor, 
pharmacist or nurse before taking Moventig. 
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before taking Moventig: 
• if you have stomach ulcers, Crohn’s Disease (an illness where your gut is inflamed), 

diverticulitis (another illness where your gut is inflamed), cancer in your gut or ‘peritoneum’ 
(the lining of your stomach area), or any conditon that might damage the wall of your bowel  

• if you currently have unusually severe, persistent or worsening stomach pain  
• if the natural protective barrier between the blood vessels in the head and in the brain is 

damaged, for example if you have cancer in the brain or the central nervous system, or if you 
have a disease of the central nervous system like multiple sclerosis or Alzheimer’s disease – 
contact your doctor immediately if you experience lack of pain relief from your opioid medicine 
or symptoms of opioid withdrawal syndrome (see section 4).  

• if you are taking methadone (see section below “Other medicines and Moventig”) 
• if you have had a heart attack within the last 6 months, have heart failure with daily shortness of 

breath or other severe problems with your heart which cause daily symptoms 
• if you have kidney problems – your doctor may tell you to take a different dose (see section 

below “How to take Moventig”)  
• if you have severe liver illness  
• if you have cancer-related pain 
 
If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before 
taking Moventig. 
 
Talk to your doctor, pharmacist or nurse whilst taking Moventig: 
• if you develop severe, persistent or worsening stomach pain. This could be a symptom of 

damage to the wall of the gut and can be life-threatening. Tell your doctor immediately, you 
may need a lower dose or to stop taking Moventig.  

• if your opioid medicine is to be stopped for more than 24 hours 
• if you experience symptoms of opioid withdrawal syndrome  (see section 4 below). Tell your 

doctor, you may need to stop taking Moventig. 
 
Children and adolescents 
Moventig is not recommended for use in children and adolescents below 18 years of age because it has 
not been studied in these age-groups.  
 
Other medicines and Moventig 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Tell your doctor what opioid pain medicines you are taking and the dose of them.   
 
Do not take Moventig if you are taking any of the following medicines (see section “Do not take 
Moventig”): 
• ketoconazole or itraconazole - to treat fungal infections 
• clarithromycin or telithromycin - antibiotics 
• ritonavir, indinavir or saquinavir – to treat HIV  
 
Do not take Moventig if any of the above apply to you.  
 
Tell your doctor, pharmacist or nurse if you are taking any of the following medicines: 
• other medicines for constipation (any laxatives) 
• methadone  



28 
 

• diltiazem or verapamil (for high blood pressure or angina). You may need to take a lower dose 
of Moventig 

• rifampin (an antibiotic), carbmazepine (for epilepsy) or the herbal medicine St. John’s wort (for 
depression). You may need to stop taking Moventig 

• medicines called ‘opioid antagonists’ (such as naltrexone and naloxone) which are used to 
counteract the effects of opioids  

 
If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before 
taking Moventig.  
 
Moventig with drink 
You should not drink large amounts of grapefruit juice whilst taking Moventig. This is because large 
amounts can affect how much of the naloxegol medicine gets into the body.  
 
Pregnancy and breast-feeding 
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, 
pharmacist or nurse for advice before taking this medicine. As there are additional data from the use of 
this medicine in pregnant women, the use of Moventig during pregnancy is not recommended. 
 
As it is not known whether this medicone is excreted in human milk, do not use Moventig during 
breast-feeding. 
 
Driving and using machines 
Moventig is not expected to affect you being able to drive a car or use any tools or machines.  
 
Moventig contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is to say 
essentially ‘sodium-free’. 
 
3. How to take Moventig 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose is 1 tablet of 25 mg each day.  
 
Take Moventig in the morning, to avoid bowel movements in the middle of the night. Moventig 
should be taken on an empty stomach at least 30 minutes before the first meal of the day or 2 hours 
after the first meal.  
 
When treatment with Moventig is started, all currently used laxatives should be stopped, until 
instructed by your doctor to restart. 
 
Your doctor may tell you to take a lower dose of 12.5 mg 
• if you have kidney problems 
• if you take diltiazem or verapamil (for high blood pressure or angina) 

 
Your doctor may tell you to increase the dose to 25 mg depending on how you respond to the 
medicine. 

 
If you have trouble swallowing the tablet 
If you have trouble swallowing the tablet you can crush it and mix with water as follows: 
• Crush the tablet to a powder 
• Pour the powder into half a glass of water (120 ml) 
• Stir and drink immediately 



29 
 

• To make sure there is no medicine left, rinse the empty glass with another half a glass of water 
(120 ml), and drink it 
 

If you take more Moventig than you should 
If you take more Moventig than you should, talk to a doctor or go to hospital.  
 
If you forget to take Moventig 
• If you miss a dose of Moventig, take it as soon as you remember. However, if it is less than 

12 hours until your next dose, skip the missed dose. 
• Do not take a double dose to make up for a missed dose. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Stop taking the medicine and tell your doctor straight away if you develop opioid withdrawal 
symptoms (if you have a combination of three or more of these symptoms: feeling depressed, nausea, 
vomiting, muscle aches, increased tearing, runny nose, dilation of the pupils, goosebumps, excess 
sweating, diarrhoea, yawning, fever or insomnia) which would usually occur within the first few days 
after starting naloxegol. Opioid withdrawal symptoms may affect up to 1 in 100 people. 
 
Other possible side effects: 
Very common (may affect more than 1 in 10 people): 
• stomach pain 
• diarrhoea (passing of frequent, watery stools) 
 
Common (may affect up to 1 in 10 people): 
• passing wind 
• nausea (feeling sick to the stomach) 
• vomiting 
• nasopharyngitis (runny or stuffy nose) 
• headache 
• excessive sweating 
 
Not known (frequency cannot be estimated from the available data):  
• allergic reaction 
• gastrointestinal perforation (a hole developing in the bowel wall) 

 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Moventig 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry 
date refers to the last day of that month. 
 



30 
 

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. 
 
 
6. Contents of the pack and other information 
 
What Moventig contains  
• The active substance is naloxegol. 

− Each Moventig 12.5 mg film-coated tablet (tablet) contains 12.5 mg naloxegol as 
naloxegol oxalate. 

− Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg naloxegol as naloxegol 
oxalate. 

• The other ingredients are: 
− tablet core: mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium 

(E468) – see section 2 under ‘Moventig contains sodium’, magnesium stearate (E470b), 
propyl gallate (E310) 

− film-coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), iron 
oxide red (E172) and iron oxide black (E172). 

 
What Moventig looks like and contents of the pack 
Moventig 12.5 mg: a mauve coloured, oval, dimensions 10.5 x 5.5 mm film-coated tablet, marked 
“nGL” on one side and “12.5” on the other side. 
 
Moventig 25 mg: a mauve coloured, oval, dimensions 13 x 7 mm, film-coated tablet, marked “nGL” 
on one side and “25” on the other side. 
 
Moventig 12.5 mg tablets are available in aluminium blisters in pack sizes of 30 or 90 film-coated 
tablets in non-perforated blisters and 30x 1 or 90x1 film-coated tablets in perforated unit dose blisters. 
 
Moventig 25 mg tablets are available in aluminium blisters in pack sizes of 10, 30 or 90 film--coated 
tablets in non-perforated blisters and 10x1, 30x1, 90x1 or 100x1 film-coated tablets in perforated unit 
dose blisters. 
 
Not all pack sizes may be marketed in your country. 
 
Marketing Authorisation Holder 
 
Kyowa Kirin Holdings B.V. 
Bloemlaan 2 
2132NP Hoofddorp 
The Netherlands 
 
 
Manufacturer 
 
Piramal Healthcare UK Limited 
Whalton Road 
Morpeth 
Northumberland, NE61 3YA 
United Kingdom 
 
Piramal Pharma Solutions (Dutch) B.V. 
Bargelaan 200 u 715 
Leiden 
2333CW 
Netherlands 



31 
 

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


	ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS 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