Veltassa

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 
Veltassa 8.4 g powder for oral suspension 
Veltassa 16.8 g powder for oral suspension 
Veltassa 25.2 g powder for oral suspension 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium) 
Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium) 
Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium) 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for oral suspension. 
Off white to light brown powder, with occasional white particles. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Veltassa is indicated for the treatment of hyperkalaemia in adults. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended starting dose is 8.4 g patiromer once daily. 
 
The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level 
and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to 
reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below 
the desired range, the dose should be reduced or discontinued. 
 
If a dose is missed, the missed dose should be taken as soon as possible on the same day. The missed 
dose should not be taken with the next dose. 
 
Administration of Veltassa should be separated by 3 hours from other oral medicinal products (see 
section 4.5). 
 
The onset of action of Veltassa occurs 4 – 7 hours after administration. It should not replace 
emergency treatment for life threatening hyperkalaemia. 
 
Patients on dialysis 
 
There is limited data on the use of Veltassa in patients on dialysis. No special dose and administration 
guidelines were applied to these patients in clinical studies. 



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Elderly population (≥65 years of age) 
 
No special dose and administration guidelines are recommended for this population. 
 
Paediatric population 
 
The safety and efficacy of Veltassa in children aged under 18 years have not yet been established. No 
data are available. 
 
Method of administration 
 
Oral use. 
Veltassa should be mixed with water and stirred to a suspension of uniform consistency, according to 
the following steps: 
 
The complete dose should be poured into a glass containing approximately 40 mL of water, then 
stirred. Another approximately 40 mL of water should be added, and the suspension stirred again 
thoroughly. The powder will not dissolve. More water may be added to the mixture as needed for 
desired consistency. 
 
The mixture should be taken within 1 hour of initial suspension. If powder remains in the glass after 
drinking, more water should be added and the suspension stirred and taken immediately. This may be 
repeated as needed to ensure the entire dose is administered. 
 
Apple juice or cranberry juice can be used instead of water to prepare the mixture. Other liquids 
should be avoided as they may contain high amounts of potassium. 
In general, cranberry juice intake should be limited to moderate amounts (for example less than 
400 mL per day) due to its potential interaction with other medicinal products. 
 
Veltassa can be taken with or without food. It should not be heated (e.g. microwaved) or added to 
heated foods or liquids. It should not be taken in its dry form. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Low Magnesium 
 
In clinical studies, serum magnesium values <1.4 mg/dL (0.58 mmol/L) occurred in 9% of patients 
treated with patiromer. Mean decreases in serum magnesium were 0.17 mg/dL (0.070 mmol/L) or less. 
Serum magnesium should be monitored for at least 1 month after initiating treatment, and magnesium 
supplementation considered in patients who develop low serum magnesium levels. 
 
Gastrointestinal Disorders 
 
Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal 
disorders, or swallowing disorders were not included in the clinical studies. Gastrointestinal ischaemia, 
necrosis and/or intestinal perforation have been reported with other potassium binders. The benefits 
and risks of administering patiromer should be carefully evaluated in patients with current or history of 
severe gastrointestinal disorders, before and during treatment. 
 



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Discontinuing patiromer 
 
When discontinuing patiromer, serum potassium levels may rise, especially if RAAS inhibitor 
treatment is continued. Patients should be instructed not to discontinue therapy without consulting 
their physicians. Increases in serum potassium may occur as early as 2 days after the last patiromer 
dose. 
 
Serum potassium levels 
 
Serum potassium should be monitored when clinically indicated, including after changes are made to 
medicinal products that affect the serum potassium concentration (e.g. RAAS inhibitors or diuretics) 
and after the patiromer dose is titrated. 
 
Information about sorbitol 
 
Veltassa contains sorbitol as part of the counterion complex. The sorbitol content is approximately 4 g 
(10.4 kcal) per 8.4 g of patiromer. 
Patients with rare hereditary problems of fructose intolerance should not take this medicine. 
 
Information about calcium 
 
Veltassa contains calcium as part of the counterion complex. Calcium is partially released some of 
which may be absorbed (see section 5.1). The benefits and risks of administering this medicinal 
product should be carefully evaluated in patients at risk of hypercalcaemia. 
 
Limitations of the clinical data 
 
Patients with end-stage renal disease (ESRD) 
 
Patiromer has been studied only in a limited number of patients with estimated glomerular filtration 
rate (eGFR) <15 mL/min/1.73 m² and patients receiving dialysis treatment. 
 
Severe hyperkalaemia 
 
There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L. 
 
Long term exposure 
 
Clinical trials with patiromer have not included exposure longer than one year. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Effect of patiromer on other medicinal products 
 
Patiromer has the potential to bind some oral co administered medicinal products, which could 
decrease their gastrointestinal absorption. As patiromer is not absorbed or metabolised by the body, 
there are limited effects on the function of other medicinal products. 
 
As precautionary measure, and based on the data summarised below, administration of patiromer 
should therefore be separated by at least 3 hours from other oral medicinal products. 
 
Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, 
levothyroxine and metformin. However, there was no interaction when patiromer and these medicinal 
products were taken 3 hours apart. 
 
In vitro studies have shown potential interaction of patiromer with quinidine. 
 



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Concomitant administration of patiromer did however not affect the bioavailability as measured by the 
area under the curve (AUC) of amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, 
trimethoprim, verapamil and warfarin. 
 
In vitro studies have shown no potential interaction of patiromer with the following active substances: 
allopurinol, amoxicillin, apixaban, acetylsalicylic acid, atorvastatin, cephalexin, digoxin, glipizide, 
lisinopril, phenytoin, riboflavin, rivaroxaban, spironolactone and valsartan. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no data from the use of patiromer 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 patiromer during pregnancy. 
 
Breast feeding 
 
No effects on the breast fed newborn/infant are anticipated since the systemic exposure of the breast-
feeding woman to patiromer is negligible. A decision must be made whether to discontinue breast 
feeding or to discontinue/abstain from patiromer therapy taking into account the benefit of breast 
feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
There are no data on the effect of patiromer on fertility in humans. Animal studies showed no effects 
on reproductive function or fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Patiromer has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The majority of the adverse reactions (ARs) reported from trials were gastrointestinal disorders, with 
the most frequently reported ARs being constipation (6.2%), diarrhoea (3%), abdominal pain (2.9%), 
flatulence (1.8%) and hypomagnesaemia (5.3%). Gastrointestinal disorder reactions were generally 
mild to moderate in nature, did not appear to be dose related, generally resolved spontaneously or with 
treatment, and none were reported as serious. Hypomagnesaemia was mild to moderate, with no 
patient developing a serum magnesium level <1 mg/dL (0.4 mmol/L). 
 
Tabulated list of adverse reactions 
 
Adverse reactions are listed below by system organ class and by frequency. Frequencies are defined as: 
very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100), rare 
(≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available 
data). Within each frequency grouping, undesirable effects are presented in order of decreasing 
seriousness. 
 



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System Organ Class 
 

Common Uncommon 

Metabolism and nutrition 
disorders 

Hypomagnesaemia  

Gastrointestinal disorders Constipation 
Diarrhoea 
Abdominal pain 
Flatulence 

Nausea 
Vomiting 

 
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 
 
Since excessive doses of Veltassa may result in hypokalaemia, serum potassium levels should be 
monitored. Patiromer is excreted after approximately 24 to 48 hours, based on average gastrointestinal 
transit time. If it is determined that medical intervention is required, appropriate measures to restore 
serum potassium may be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia. ATC 
code: V03AE09 
 
Mechanism of action 
 
Patiromer is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol complex as a 
counterion. 
 
Patiromer increases faecal potassium excretion through binding of potassium in the lumen of the 
gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the 
gastrointestinal lumen, resulting in a reduction of serum potassium levels. 
 
Pharmacodynamic effects 
 
In healthy adult subjects, patiromer caused a dose dependent increase in faecal potassium excretion, 
and a corresponding decrease in urinary potassium excretion with no change in serum potassium. 
25.2 g of patiromer, administered once daily for 6 days, resulted in a mean increase in faecal 
potassium excretion of 1283 mg/day, and a mean decrease in urinary potassium excretion of 
1438 mg/day. Daily urinary calcium excretion increased from baseline by 53 mg/day. 
 
In an open label study to assess the time to onset of action, a statistically significant reduction in serum 
potassium in hyperkalaemic patients was observed at 7 hours after the first dose. Following 
discontinuation of patiromer, potassium levels remained stable for 24 hours after the last dose, then 
rose again during a 4-day observation period. 
 
Clinical efficacy and safety 
 
The safety and efficacy of patiromer were demonstrated in a two-part, single blind randomised 
withdrawal study that evaluated this treatment in hyperkalaemic patients with chronic kidney disease 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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(CKD) on stable doses of at least one RAAS inhibitor (i.e. angiotensin converting enzyme inhibitor 
[ACEI], angiotensin II receptor blocker [ARB] or aldosterone antagonist [AA]). 
 
In Part A, 243 patients were treated with patiromer for 4 weeks. Patients with a baseline serum 
potassium of 5.1 mEq/L to <5.5 mEq/L (mmol/L) received a starting dose of 8.4 g patiromer per day 
(as a divided dose) and patients with a baseline serum potassium of 5.5 mEq/L to <6.5 mEq/L received 
a starting dose of 16.8 g patiromer per day (as a divided dose). The dose was titrated, as needed, based 
on the serum potassium level, assessed starting on Day 3 and then at weekly visits to the end of the 
4 week treatment period, with the aim of maintaining serum potassium in the target range (3.8 mEq/L 
to <5.1 mEq/L). The mean daily doses of patiromer were 13 g and 21 g in patients with serum 
potassium of 5.1 to <5.5 mEq/L and 5.5 to <6.5 mEq/L, respectively. 
 
The mean age of patients was 64 years (54% aged 65 and over, 17% aged 75 and over), 58% of 
patients were men, and 98% were Caucasian. Approximately 97% of patients had hypertension, 57% 
had type 2 diabetes, and 42% had heart failure. 
 
Mean serum potassium levels and change in serum potassium from Part A Baseline to Part A Week 4 
is shown in Table 1. For the Part A secondary outcome, 76% (95% CI: 70%, 81%) of patients had a 
serum potassium in the target range of 3.8 mEq/L to <5.1 mEq/L at Part A Week 4. 
 
Table 1: Patiromer treatment phase (Part A): Primary endpoint 
 Baseline Potassium Overall Population 

(n=237) 5.1 to <5.5 mEq/L 
(n=90) 

5.5 to <6.5 mEq/L 
(n=147) 

Serum Potassium (mEq/L) 
Baseline, mean (SD) 5.31 (0.57) 5.74 (0.40) 5.58 (0.51) 
Week 4 Change from 
Baseline, Mean ± SE 
(95% CI) 

−0.65 ± 0.05 
 

(−0.74, −0.55) 

−1.23 ± 0.04 
 

(−1.31, −1.16) 

−1.01 ± 0.03 
 

(−1.07, −0.95) 
p value   <0.001 
 
In Part B, 107 patients with a Part A baseline serum potassium of 5.5 mEq/L to <6.5 mEq/L and whose 
serum potassium was in the target range (3.8 mEq/L to <5.1 mEq/L) at Part A Week 4 and still 
receiving RAAS inhibitor treatment were randomised to continue patiromer or to receive placebo for 
8 weeks to evaluate the effect of withdrawing patiromer on serum potassium. In patients randomised to 
patiromer, the mean daily dose was 21 g at the start of Part B and during Part B. 
 
The Part B primary endpoint was the change in serum potassium from Part B baseline to the earliest 
visit at which the patient’s serum potassium was first outside of the range of 3.8 to <5.5 mEq/L or to 
Part B Week 4 if the patient’s serum potassium remained in the range. In Part B, serum potassium in 
patients on placebo increased significantly relative to patients who remained on patiromer (p<0.001). 
 
More placebo patients (91% [95% CI: 83%, 99%]) developed a serum potassium ≥5.1 mEq/L at any 
time during Part B than patiromer patients (43% [95% CI: 30%, 56%]), p<0.001. More placebo 
patients (60% [95% CI: 47%, 74%]) developed a serum potassium ≥5.5 mEq/L at any time during 
Part B than patiromer patients (15% [95% CI: 6%, 24%]), p<0.001. 
 
The potential of patiromer to enable concomitant RAAS inhibitor treatment was also assessed in part B. 
Fifty two percent (52%) of subjects receiving placebo discontinued RAAS inhibitor treatment because 
of recurrent hyperkalaemia compared with 5% of subjects treated with patiromer. 
 
The effect of treatment with patiromer for up to 52 weeks was evaluated in an open label study of 304 
hyperkalaemic patients with CKD and type 2 diabetes mellitus on stable doses of a RAAS inhibitor. 
The mean age of patients was 66 years (59.9% aged 65 and over, 19.7% aged 75 and over), 63% of 
patients were men, and all were Caucasian. Decreases in serum potassium with patiromer treatment 
were maintained over 1 year of chronic treatment as shown in Figure 1, with a low incidence of 



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hypokalaemia (2.3%) and the majority of subjects reaching (97.7%) and maintaining target serum 
potassium levels (overall during maintenance period, serum potassium was within the target range for 
approximately 80% of the time). In patients with a baseline serum potassium of >5.0 to 5.5 mEq/L 
who received an initial dose of 8.4 g patiromer per day, the mean daily dose was 14 g; in those with a 
baseline serum potassium of >5.5 to <6.0 mEq/L who received an initial dose of 16.8 g patiromer per 
day, the mean daily dose was 20 g during the entire study. 
 
 
Figure 1: Mean (95% CI) serum potassium over time 
   Baseline Serum K+ > 5.0 to 5.5 mEq/L 

M
ea

n 
(9

5%
 C

l) 
S

er
um

 P
ot

as
si

um
 (m

E
q/

L)
 

  Baseline Serum K+ > 5.5 to < 6.0 mEq/L 

 
  Study Visit (week) Follow-Up (day) 

Number of Subjects: 
Lower K+ Stratum: 218 199 192 175 168 161 161 163 158 156 151 148 149 145 131 126 
Higher K+ Stratum: 83 73 70 65 62 62 62 61 53 53 53 52 49 49 48 47 

 
The ability of patiromer to enable concomitant spironolactone treatment was investigated in a 
randomised, double-blind, placebo-controlled study in heart failure patients who were clinically 
indicated to receive AA. Patients initiated spironolactone at 25 mg/day at the same time as their 
randomised treatment (patiromer 12.6 g BID or placebo), and were up-titrated to 50 mg/day after 
Day 14 if serum potassium was >3.5 and ≤5.1 mEq/L. Of the 105 patients who were randomised and 
received study treatment (patiromer 56; placebo 49), mean age was 68.3 years, 60.6% were men, 
97.1% were Caucasian, and mean eGFR was 81.3 mL/min. Mean baseline serum potassium values 
were 4.71 mEq/L for patiromer and 4.68 mEq/L for placebo. 
The primary efficacy endpoint, change from baseline in serum potassium to the end of the 28-day 
treatment period, was significantly lower (p<0.001) in the patiromer group (LS mean [SEM]: −0. 21 
[0.07] mEq/L) as compared to the placebo group (LS mean [SEM]: +0.23 [0.07] mEq/L). There were 
also fewer patients in the patiromer group with serum potassium values >5.5 mEq/L (7.3% vs. 24.5%; 
p=0.027) and more patients on spironolactone 50 mg/day (90.9% versus 73.5%, p=0.022). 
 
Overall, in the phase 2 and 3 clinical studies, 99.4% of patients were receiving RAAS inhibitor therapy 
at baseline, 81.2% had CKD with eGFR <60 mL/min/1.73 m2, 72.8% had diabetes mellitus and 48.7% 
had heart failure. 
 



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Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
patiromer in one or more subsets of the paediatric population in the treatment of hyperkalaemia (see 
section 4.2 for information on paediatric use). 
 
Effect of Food 
 
In an open-label study, 114 patients with hyperkalaemia were randomized to patiromer once daily 
with food or without food. Serum potassium at the end of treatment, the change from baseline in serum 
potassium, and the mean dose of patiromer were similar between groups. 
 
5.2 Pharmacokinetic properties 
 
Patiromer works by binding potassium in the gastrointestinal tract and thus the serum concentration is 
not relevant for its efficacy. Due to the insolubility and nonabsorptive characteristics of this medicinal 
product, many classical pharmacokinetic studies cannot be carried out. 
 
Patiromer is excreted approximately 24 to 48 hours after intake, based on average gastrointestinal 
transit time. 
 
5.3 Preclinical safety data 
 
In radiolabeled studies in rats and dogs, patiromer was not systemically absorbed and was excreted in 
the faeces. Quantitative whole-body autoradiography analysis in rats demonstrated that radioactivity 
was limited to the gastrointestinal tract, with no detectable level of radioactivity in any other tissues or 
organs. 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction and development. 
 
Patiromer was not genotoxic in the reverse mutation test (Ames assay), chromosome aberration or rat 
micronucleus assays. 
 
Carcinogenicity studies have not been performed. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Xanthan gum 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Store and transport refrigerated (2°C – 8°C). 
Patients may store Veltassa below 25°C for up to 6 months. 
For either storage condition, Veltassa should not be used after the expiry date printed on the sachet. 
The mixture should be taken within 1 hour of initial suspension. 
 



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6.5 Nature and contents of container 
 
8.4 g, 16.8 g or 25.2 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, 
polyethylene, polyester and paper. 
 
Pack sizes: boxes of 30, 60 or 90 sachets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Vifor Fresenius Medical Care Renal Pharma France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1179/001 
EU/1/17/1179/002 
EU/1/17/1179/003 
EU/1/17/1179/004 
EU/1/17/1179/005 
EU/1/17/1179/006 
EU/1/17/1179/007 
EU/1/17/1179/008 
EU/1/17/1179/009 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 July 2017 
 
 
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. 
 

http://www.ema.europa.eu/


11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 
 



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A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Vifor France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
OM Pharma S.A. 
R. da Indústria, 2 
Quinta Grande 
Amadora, 2610-088 
Portugal 
 
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. The 
marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation 
 
 
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. 

 



13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 



14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 



15 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – Veltassa 8.4 g 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veltassa 8.4 g powder for oral suspension 
patiromer 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder for oral suspension 
30 sachets 
60 sachets 
90 sachets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
 
Take within 1 hour after preparation of suspension. 
Read the package leaflet before 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 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Can be stored below 25°C for up to 6 months. 
Date when taken out of the refrigerator:______ 
 
 
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 
 
Vifor Fresenius Medical Care Renal Pharma France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1179/001 30 sachets 
EU/1/17/1179/002 60 sachets 
EU/1/17/1179/003 90 sachets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
VELTASSA 8.4 G 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



17 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



18 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
SACHET of Veltassa 8.4 g 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veltassa 8.4 g powder for oral suspension 
patiromer 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder for oral suspension 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Take within 1 hour after preparation of suspension. 
Read the package leaflet before 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 
 
Store in a refrigerator. Can be stored below 25°C for up to 6 months. 
 
 



19 

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 
 
Vifor Fresenius Medical Care Renal Pharma France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 



20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – Veltassa 16.8 g 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veltassa 16.8 g powder for oral suspension 
patiromer 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder for oral suspension 
30 sachets 
60 sachets 
90 sachets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Take within 1 hour after preparation of suspension. 
Read the package leaflet before 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 
 
Store in a refrigerator. Can be stored below 25°C for up to 6 months. 
Date when taken out of the refrigerator:______ 



21 

 
 
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 
 
Vifor Fresenius Medical Care Renal Pharma France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1179/004 30 sachets 
EU/1/17/1179/005 60 sachets 
EU/1/17/1179/006 90 sachets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
VELTASSA 16.8 G 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



22 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
SACHET of Veltassa 16.8 g 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veltassa 16.8 g powder for oral suspension 
patiromer 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder for oral suspension 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Take within 1 hour after preparation of suspension. 
Read the package leaflet before 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 
 
Store in a refrigerator. Can be stored below 25°C for up to 6 months. 
 
 



23 

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 
 
Vifor Fresenius Medical Care Renal Pharma France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – Veltassa 25.2 g 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veltassa 25.2 g powder for oral suspension 
patiromer 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder for oral suspension 
30 sachets 
60 sachets 
90 sachets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Take within 1 hour after preparation of suspension. 
Read the package leaflet before 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 
 
Store in a refrigerator. Can be stored below 25°C for up to 6 months. 
Date when taken out of the refrigerator:______ 



25 

 
 
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 
 
Vifor Fresenius Medical Care Renal Pharma France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1179/007 30 sachets 
EU/1/17/1179/008 60 sachets 
EU/1/17/1179/009 90 sachets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
VELTASSA 25.2 G 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



26 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
SACHET of Veltassa 25.2 g 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veltassa 25.2 g powder for oral suspension 
patiromer 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium) 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder for oral suspension 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For oral use. 
Take within 1 hour after preparation of suspension. 
Read the package leaflet before 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 
 
Store in a refrigerator. Can be stored below 25°C for up to 6 months. 
 
 



27 

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 
 
Vifor Fresenius Medical Care Renal Pharma France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 



28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



29 

Package leaflet: Information for the patient 
 

Veltassa 8.4 g powder for oral suspension 
Veltassa 16.8 g powder for oral suspension 
Veltassa 25.2 g powder for oral suspension 

patiromer (as patiromer sorbitex calcium) 
 
 

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 Veltassa is and what it is used for 
2. What you need to know before you take Veltassa 
3. How to take Veltassa 
4. Possible side effects 
5. How to store Veltassa 
6. Contents of the pack and other information 
 
 
1. What Veltassa is and what it is used for 
 
Veltassa is a medicine that contains the active substance patiromer. 
 
Veltassa is used to treat adults with high levels of potassium in their blood. 
 
Too much potassium in the blood can affect how your nerves control your muscles. This can lead to 
weakness or even paralysis. High potassium levels can also result in an abnormal heartbeat, which can 
cause serious effects on your heart rhythm. 
 
Veltassa works by attaching to potassium in your gut. This prevents potassium from entering your 
bloodstream and lowers potassium levels in your blood back to normal. 
 
 
2. What you need to know before you take Veltassa 
 
Do not take Veltassa 
 
• if you are allergic to patiromer or any of the other ingredients of this medicine (listed in 

section 6). 
 



30 

Warnings and precautions 
 
Talk to your doctor or pharmacist before taking Veltassa if you have: 
• problems swallowing 
• severe stomach or bowel problems 
• had major surgery on your stomach or bowel. 
 
Low blood magnesium can occur when taking Veltassa. Your doctor will check the magnesium level 
during treatment with Veltassa for at least 1 month and may prescribe a magnesium supplement if 
required. 
 
Veltassa contains sorbitol. If you have been told by your doctor that you have an intolerance to some 
sugars, contact your doctor before taking this medicinal product. The sorbitol content is approximately 
4 g (10.4 kcal) per 8.4 g of patiromer. 
 
Children and adolescents 
 
Do not give Veltassa to children under 18 years, as it has not been studied in this age group. 
 
Other medicines and Veltassa 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
 
Veltassa may affect certain medicines if they are taken by mouth and at the same time, such as: 
• ciprofloxacin: a medicine to treat bacterial infections 
• levothyroxine: a medicine to treat thyroid hormone deficiency 
• metformin: a medicine to treat diabetes 
• quinidine: a medicine to treat irregular heart rhythm. 
 
Take all medicines taken by mouth at least 3 hours before or after you take Veltassa, unless your 
doctor or pharmacist gives you different advice. Ask your doctor or pharmacist if you are not sure. 
 
Pregnancy and breast feeding 
 
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Use Veltassa during pregnancy and breast feeding only if your doctor considers it necessary. 
 
Driving and using machines 
 
Veltassa has no or negligible influence on your ability to drive and use machines. 
 
 
3. How to take Veltassa 
 
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: 
• starting dose: 8.4 g patiromer (the content of one 8.4 g sachet) once daily 
• maximum dose: 25.2 g patiromer (the content of one 25.2 g sachet) once daily 
 
Your doctor may adjust the dose depending on the potassium level in your blood. 
Take Veltassa at least 3 hours before or after other medicines taken by mouth unless your doctor or 
pharmacist gives you different advice. 
 



31 

Method of administration 
 
Mix Veltassa with water and stir until it is thoroughly mixed, as follows: 
• Prepare about 40 mL (3 tablespoons) of water in a glass. 
• Add the required number of Veltassa sachets and stir. 
• Add about 40 mL (3 tablespoons) of additional water and stir thoroughly. The powder does not 

dissolve but forms a suspension, which might feel grainy. 
• You may add more water to the mixture to help you swallow the medicine. 
• Drink the mixture within 1 hour after preparation. If powder remains in the glass after drinking, 

add more water, stir and drink immediately. You may need to do this again to make sure that 
you have taken all the powder. 

 
You can use apple juice or cranberry juice instead of water. Other liquids cannot be used as they may 
contain high amounts of potassium. You should drink only moderate amounts (less than 400 mL per 
day) of cranberry juice as it can affect other medicines. 
 
Take the prepared Veltassa suspension with or without food, preferably at the same time each day. 
Never heat Veltassa or add it to heated foods or liquids. 
Do not take Veltassa as a dry powder. 
 
If you take more Veltassa than you should 
 
Stop taking Veltassa and talk to your doctor or pharmacist immediately. 
 
If you forget to take Veltassa 
 
If you have missed a dose, take it as soon as possible on the same day. Do not take a double dose to 
make up for a forgotten dose. If you miss more than one dose, contact your doctor. 
 
If you stop taking Veltassa 
 
Do not stop taking the medicine without your doctor’s approval, as your potassium blood level may 
increase. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The following side effects have been reported: 
Common, may affect up to 1 in 10 people: 
• constipation 
• diarrhoea 
• abdominal pain 
• wind 
• low blood magnesium seen in tests 
 
Uncommon, may affect up to 1 in 100 people: 
• nausea 
• vomiting 
 
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. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


32 

 
 
5. How to store Veltassa 
 
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 or sachet after “EXP”. The 
expiry date refers to the last day of that month. 
 
Store and transport refrigerated (2°C – 8°C). 
Once you have received Veltassa, it can be stored below 25°C for up to 6 months. 
 
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 Veltassa contains 
 
The active substance is patiromer (as patiromer sorbitex calcium). 
• Veltassa 8.4 g powder for oral suspension: each sachet contains 8.4 g of patiromer 
• Veltassa 16.8 g powder for oral suspension: each sachet contains 16.8 g of patiromer. 
• Veltassa 25.2 g powder for oral suspension: each sachet contains 25.2 g of patiromer. 
 
The other ingredient is xanthan gum. 
 
What Veltassa looks like and contents of the pack 
 
The powder for oral suspension is off white to light brown, with occasional white particles. 
 
Veltassa is available in packs containing 30, 60 or 90 sachets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
Vifor Fresenius Medical Care Renal Pharma France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
Manufacturer 
 
Vifor France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris La Défense Cedex 
France 
 
OM Pharma S.A. 
R. da Indústria, 2 
Quinta Grande 
Amadora, 2610-088 
Portugal 
 



33 

For any information about this medicine, please contact the Marketing Authorisation Holder. 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/

	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

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