Velphoro

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Velphoro 500 mg chewable tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of 
polynuclear iron(III)-oxyhydroxide, sucrose, and starches. 
 
The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches (potato 
starch and pregelatinised maize starch) per tablet. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Chewable tablet. 
Brown, circular tablets embossed with PA500 on one side. Tablets have a 20 mm diameter and a 
thickness of 6.5 mm. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) 
patients on haemodialysis (HD) or peritoneal dialysis (PD). 
 
Velphoro should be used within the context of a multiple therapeutic approach, which could include 
calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control 
the development of renal bone disease. 
 
4.2 Posology and method of administration 
 
Posology 
 
Starting dose 
 
The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the 
meals of the day. Velphoro is for oral administration only and must be taken with meals. 
Patients receiving Velphoro should adhere to their prescribed diets. 
 
Titration and maintenance 
 
Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in 
increments of 500 mg iron (1 tablet) per day every 2 – 4 weeks until an acceptable serum phosphorus 
level is reached, with regular monitoring afterwards. 
 
In clinical practice, treatment will be based on the need to control serum phosphorus levels, though 
patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 
1,500 – 2,000 mg iron per day (3 to 4 tablets). 
 
If one or more doses are missed, the normal dose of the medicinal product should be resumed with the 
next meal. 
 



3 

Maximum tolerated daily dose 
 
The maximum recommended dose is 3,000 mg iron (6 tablets) per day. 
 
Paediatric population 
 
The safety and efficacy of Velphoro in children and adolescents below the age of 18 years has not yet 
been established. No data are available. 
 
Elderly population (≥65 years of age) 
 
Velphoro has been administered to over 248 seniors (≥65 years of age) according to the approved 
dosing regimen. Of the total number of subjects in clinical studies of Velphoro, 29.7% were aged 65 
and over, while 8.7% were aged 75 and over. No special dose and administration guidelines were 
applied to seniors in these studies and the dosing schedules were not associated with any significant 
concerns. 
 
Renal impairment 
 
Velphoro is indicated for the control of serum phosphorus levels in adult CKD patients on HD or PD. 
There is no clinical data available with Velphoro in patients with earlier stages of renal impairment. 
 
Hepatic impairment 
 
Patients with severe hepatic impairment were excluded from participating in clinical studies with 
Velphoro. However, no evidence of hepatic impairment or significant alteration of hepatic enzymes 
were observed in the clinical studies with Velphoro. See further information in section 4.4. 
 
Method of administration 
 
Oral use. 
Velphoro is a chewable tablet that must be taken with meals. In order to maximise the adsorption of 
dietary phosphate, the total daily dose should be divided across the meals of the day. Patients are not 
required to drink more fluid than they normally would. Tablets must be chewed or crushed; tablets 
must not be swallowed whole. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• Haemochromatosis and any other iron accumulation disorders. 
 
4.4 Special warnings and precautions for use 
 
Peritonitis, gastric and hepatic disorders and gastrointestinal surgery 
 
Patients with a recent history of peritonitis (within the last 3 months), significant gastric or hepatic 
disorders and patients with major gastrointestinal surgery have not been included in clinical studies 
with Velphoro. Velphoro should only be used in these patients following careful assessment of 
benefit/risk. 
 
Information about sucrose and starches (carbohydrates) 
 
Velphoro contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-
galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 
It may be harmful to the teeth. 
 



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Velphoro contains potato starch and pregelatinised maize starch. Patients with diabetes should take 
notice that one tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates (equivalent to 
0.116 bread units). 
 
Discoloured stool 
 
Velphoro can cause discoloured (black) stool. Discoloured (black) stool may visually mask 
gastrointestinal bleeding (see section 4.5). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Velphoro is almost not absorbed from the gastrointestinal tract. Although the potential for interactions 
with medicinal products seems low, for concomitant treatment with medicinal products with a narrow 
therapeutic window, the clinical effect and adverse events should be monitored, on initiation or dose-
adjustment of either Velphoro or the concomitant medicinal product, or the physician should consider 
measuring blood levels. When administering any medicinal product that is already known to interact 
with iron (like alendronate and doxycycline) or has the potential to interact with Velphoro based only 
on in vitro studies like levothyroxine, the medicinal product should be administered at least one hour 
before or two hours after Velphoro. 
 
In vitro studies with the following active substances did not show any relevant interaction: 
acetylsalicylic acid, cephalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, 
metformin, metoprolol, nifedipine, pioglitazone and quinidine. 
 
Drug-drug interaction studies have only been performed in healthy volunteers. They have been 
conducted in healthy human male and female subjects with losartan, furosemide, digoxin, warfarin, 
and omeprazole. Concomitant administration of Velphoro did not affect the bioavailability of these 
medicinal products as measured by the area under the curve (AUC). 
 
Data from clinical studies have shown that Velphoro does not affect the lipid lowering effects of 
HMG-CoA reductase inhibitors (e.g., atorvastatin and simvastatin). In addition, post-hoc analyses 
from clinical studies demonstrated no impact of Velphoro on iPTH lowering effect of oral Vitamin D 
analogues. Vitamin D and 1,25-dihydroxy Vitamin D levels remained unchanged. 
 
Velphoro does not affect guaiac based (Haemoccult) or immunological based (iColo Rectal and 
Hexagon Obti) faecal occult blood tests. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human 
pregnancies. 
 
Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, 
embryonic/foetal development, parturition or postnatal development (see section 5.3). Velphoro should 
only be used by pregnant women if clearly needed following careful assessment of benefit/risk. 
 
Breast-feeding 
 
There are no available clinical data from the use of Velphoro in breast-feeding women. Since 
absorption of iron from Velphoro is minimal (see section 5.2), excretion of iron from Velphoro in 
breast milk is unlikely. A decision on whether to continue breast-feeding or to continue therapy with 
Velphoro should be made taking into account the benefit of breast-feeding to the child and the benefit 
of Velphoro therapy to the mother. 
 



5 

Fertility 
 
There are no data on the effect of Velphoro on fertility in humans. In animal studies, there were no 
adverse effects on mating performance, fertility, and litter parameters following treatment with 
Velphoro (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Velphoro has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The current safety profile of Velphoro is based on a total of 778 patients on haemodialysis and 57 
patients on peritoneal dialysis, who received Velphoro treatment of up to 55 weeks. 
 
In these clinical trials, approximately 43% of patients experienced at least one adverse reaction during 
Velphoro treatment, which were reported as serious adverse reactions in 0.36%. The majority of the 
adverse reactions reported from trials were gastrointestinal disorders, with the most frequently reported 
adverse reactions being diarrhoea and discoloured faeces (very common). The vast majority of these 
gastrointestinal disorders occurred early during treatment and abated with time with continued dosing. 
No dose-dependent trends were observed in the adverse reaction profile of Velphoro. 
 
Tabulated list of adverse reactions 
 
Adverse reactions reported from the use of Velphoro at doses from 250 mg iron/day to 3,000 mg 
iron/day in these patients (n=835) are listed in Table 1. 
The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon 
(≥1/1,000 to <1/100). 
 
Table 1 Adverse reactions detected in clinical trials 
 
System Organ Class Very common Common Uncommon 

Metabolism and 
nutrition disorders 

  Hypercalcaemia 
Hypocalcaemia 

Nervous system 
disorders 

  Headache 

Respiratory, thoracic 
and mediastinal 
disorders 

  Dyspnoea 

Gastrointestinal 
disorders 

Diarrhoea* 
Faeces discoloured 

Nausea 
Constipation 

Vomiting 
Dyspepsia 

Abdominal pain 
Flatulence 

Tooth discolouration 

Abdominal distension 
Gastritis 

Abdominal discomfort 
Dysphagia 

Gastro-oesophageal 
reflux disease (GORD) 
Tongue discolouration 

Skin and subcutaneous 
tissue disorders 

  Pruritus Rash 

General disorders and 
administration site 
conditions 

 Product taste abnormal Fatigue 



6 

 
Description of selected adverse reactions 
*Diarrhoea 

Diarrhoea occurred in 11.6% of patients in clinical trials. In the 55 weeks long term studies, the 
majority of these diarrhoea adverse reactions were transient, occurred early during treatment 
initiation and led to treatment discontinuation in 3.1% of the patients. 

 
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 
 
Any instances of overdose of Velphoro (e.g. hypophosphataemia) should be treated by standard 
clinical practice. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia; ATC 
code: V03AE05 
 
Mechanism of action 
 
Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide (pn-FeOOH), sucrose and starches. 
Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the 
phosphate ions throughout the physiological pH range of the gastrointestinal tract. 
 
Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption. 
 
Clinical efficacy 
 
One phase 3 clinical study has been performed in patients with CKD on dialysis to investigate the 
efficacy and safety of Velphoro in this population. This study was an open-label, randomised, active-
controlled (sevelamer carbonate), parallel group study for up to 55 weeks. Adult patients with 
hyperphosphataemia (serum phosphorus levels ≥1.94 mmol/L) were treated with Velphoro at a starting 
dose of 1,000 mg iron/day followed by an 8-week dose titration period. Non-inferiority to sevelamer 
carbonate was determined at week 12. Subjects were continued on their study medication from 
week 12 to week 55. From week 12 to 24, dose titrations were allowed for both tolerability and 
efficacy reasons. Treatment of patient sub-populations from week 24 to week 27 with maintenance 
dose of Velphoro (1,000 to 3,000 mg iron/day) or low dose (250 mg iron/day) of Velphoro 
demonstrated superiority of the maintenance dose. 
 
In Study-05A, 1,055 patients on hemodialysis (N=968) or peritoneal dialysis (N=87) with serum 
phosphorus ≥1.94 mmol/L following a 2 – 4-week phosphate binder washout period, were randomized 
and treated with either Velphoro, at a starting dose of 1,000 mg iron/day (N=707), or active-control 
(sevelamer carbonate, N=348) for 24 weeks. At the end of week 24, 93 patients on hemodialysis 
whose serum phosphorus levels were controlled (<1.78 mmol/L) with Velphoro in the first part of the 
study, were re-randomized to continue treatment with either their week 24 maintenance dose (N=44 or 
a non-effective low dose control 250 mg iron/day, N=49) of Velphoro for a further 3 weeks. 
 

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


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Following completion of Study-05A, 658 patients (597 on hemodialysis and 61 on peritoneal dialysis) 
were treated in the 28-week extension study (Study-05B) with either Velphoro (N=391) or sevelamer 
carbonate (N=267) according to their original randomization. 
 
Mean serum phosphorus levels were 2.5 mmol/L at baseline and 1.8 mmol/L at week 12 for Velphoro 
(reduction by 0.7 mmol/L). Corresponding levels for sevelamer carbonate at baseline were 2.4 mmol/L 
and 1.7 mmol/L at week 12 (reduction by 0.7 mmol/L), respectively. 
 
The serum phosphorus reduction was maintained over 55 weeks. Serum phosphorus levels and 
calcium-phosphorus product levels were reduced as a consequence of the reduced dietary phosphate 
absorption. 
 
The response rates, defined as the proportion of subjects achieving serum phosphorus levels within the 
KDOQI (Kidney Disease Outcomes Quality Initiative) recommended range were 45.3% and 59.1% at 
week 12 and 51.9% and 55.2% at week 52, for Velphoro and sevelamer carbonate, respectively. 
 
The mean daily dose of Velphoro over 55 weeks of treatment was 1,650 mg iron and the mean daily 
dose of sevelamer carbonate was 6,960 mg. 
 
Post-authorization data 
 
A prospective, non-interventional, post-authorisation safety study (VERIFIE) has been conducted, 
evaluating the short- and long-term (up to 36 months) safety and effectiveness of Velphoro in adult 
patients on haemodialysis (n=1,198) or peritoneal dialysis (n=160), who were followed in routine 
clinical practice for 12 to 36 months (safety analysis set, N=1,365). During the study, 45% (n=618) of 
these patients were concomitantly treated with phosphate binder(s) other than Velphoro. 
 
In the safety analysis set, the most common ADRs were diarrhoea and discoloured faeces, reported by 
14% (n=194) and 9% (n=128) of patients, respectively. The incidence of diarrhoea was highest in the 
first week and decreased with duration of use. Diarrhoea was of mild to moderate intensity in most 
patients and resolved in the majority of patients within 2 weeks. Discoloured (black) faeces is expected 
for an oral iron-based compound, and may visually mask gastrointestinal bleeding. For 4 of the 40 
documented concomitant gastrointestinal bleeding events, Velphoro-related stool discolouration was 
reported as causing an insignificant delay in diagnosis of gastrointestinal bleeding, without affecting 
patient health. In the remaining cases, no delay in diagnosis of gastrointestinal bleeding has been 
reported. 
 
The results from this study showed that the effectiveness of Velphoro in a real-life setting (including 
concomitant use of other phosphate binders in 45% of patients), was in line with that observed in the 
phase 3 clinical study. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Velphoro in one or more subsets of the paediatric population in the treatment of hyperphosphataemia 
(see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Velphoro works by binding phosphate in the gastrointestinal tract and thus the serum concentration is 
not relevant for its efficacy. Due to the insolubility and degradation characteristics of Velphoro, no 
classical pharmacokinetic studies can be carried out, e.g., determination of the distribution volume, 
area under the curve, mean residence time, etc. 
 
In 2 Phase 1 studies, it was concluded that the potential for iron overload is minimal and no dose 
dependent effects were observed in healthy volunteers. 
 



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Absorption 
 
The active moiety of Velphoro, pn-FeOOH, is practically insoluble and therefore not absorbed. Its 
degradation product, mononuclear iron species, can however be released from the surface of pn-
FeOOH and be absorbed. 
 
The absolute absorption studies in humans were not performed. Non-clinical studies in several species 
(rats and dogs) showed that systemic absorption was very low (≤1% of the administered dose). 
 
The iron uptake from radiolabelled Velphoro drug substance, 2,000 mg iron in 1 day was investigated 
in 16 CKD patients (8 pre-dialysis and 8 haemodialysis patients) and 8 healthy volunteers with low 
iron stores (serum ferritin <100 mcg/L). In healthy subjects, the median uptake of radiolabelled iron in 
the blood was estimated to be 0.43% (range 0.16 – 1.25%) on Day 21, in pre-dialysis patients 0.06% 
(range 0.008 – 0.44%) and in haemodialysis patients 0.02% (range 0 – 0.04%). Blood levels of 
radiolabelled iron were very low and confined to the erythrocytes. 
 
Distribution 
 
The distribution studies in humans were not performed. Non-clinical studies in several species (rats 
and dogs) showed that pn-FeOOH is distributed from the plasma to the liver, spleen and bone marrow, 
and utilized by incorporation into red blood cells. 
 
In patients, absorbed iron is expected to be also distributed to the target organs, i.e. liver, spleen and 
bone marrow, and utilized by incorporation into red blood cells. 
 
Biotransformation 
 
The active moiety of Velphoro, pn-FeOOH, is not metabolised. However, the degradation product of 
Velphoro, mononuclear iron species, can be released from the surface of polynuclear iron(III)-
oxyhydroxide and be absorbed. Clinical studies have demonstrated that the systemic absorption of iron 
from Velphoro is low. 
 
In vitro data suggest that the sucrose and starch components of the drug substance can be digested to 
glucose and fructose, and maltose and glucose, respectively. These compounds can be absorbed in the 
blood. 
 
Elimination 
 
In animal studies with rats and dogs administered 59Fe-Velphoro drug substance orally, radiolabelled 
iron was recovered in the faeces but not the urine. 
 
5.3 Preclinical safety data 
 
Nonclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity and genotoxicity. 
 
Effects seen in the rabbit embryo-foetal development toxicity study (skeletal variations and incomplete 
ossificaton) are related to exaggerated pharmacology, and likely not relevant for patients. Other 
reproduction toxicity studies showed no adverse effects. 
 
Carcinogenicity studies were performed in mice and rats. There was no clear evidence of a 
carcinogenic effect in mice. Mucosal hyperplasia, with diverticulum/cyst formation was observed in 
the colon and caecum of mice after 2-years treatment, but this was considered a species-specific effect 
with no diverticula/cysts seen in long term studies in rats or dogs. In rats, there was a slightly increased 
incidence of benign C-cell adenoma in the thyroid of male rats given the highest dose of sucroferric 
oxyhydroxide. This is thought to be most likely an adaptive response to the pharmacological effect of 
the drug, and not clinically relevant. 



9 

 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Woodberry flavour 
Neohesperidin-dihydrochalcone 
Magnesium stearate 
Colloidal anhydrous silica 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
Shelf life after first opening of the bottle: 90 days 
 
6.4 Special precautions for storage 
 
Store in the original package in order to protect from moisture. 
 
6.5 Nature and contents of container 
 
High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction 
seal, containing a molecular sieve desiccant and cotton. Pack sizes of 30 or 90 chewable tablets. 
 
Child-resistant aluminium/aluminium perforated unit-dose blister, each blister containing 6 chewable 
tablets. Pack sizes of 30 × 1 or multipack of 90 (3 packs of 30 × 1) chewable tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
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/1/14/943/001 
EU/1/14/943/002 
EU/1/14/943/003 
EU/1/14/943/004 
 
 



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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 August 2014 
Date of latest renewal: 25 March 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. 
 

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


11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 



12 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Vifor France 
100–101 Terrasse Boieldieu 
Tour Franklin La Défense 8 
92042 Paris la Défense Cedex 
FRANCE 
 
 
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 (PSURs) 
 
The requirements for submission of PSURs 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 (MAH) shall submit the first PSUR 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 marketing authorisation holder (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 – BOTTLE OF 30 AND 90 CHEWABLE TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Velphoro 500 mg chewable tablets 
iron as sucroferric oxyhydroxide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sucrose, potato starch and pregelatinised maize starch. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 chewable tablets 
90 chewable tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be chewed or crushed and taken with meals. 
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: 
Shelf-life after first opening the bottle: 90 days 
Opening date: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from moisture. 



16 

 
 
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/1/14/943/001 30 chewable tablets 
EU/1/14/943/002 90 chewable tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
velphoro 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



17 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL – BOTTLE OF 30 AND 90 CHEWABLE TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Velphoro 500 mg chewable tablets 
iron as sucroferric oxyhydroxide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sucrose, potato starch and pregelatinised maize starch. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 chewable tablets 
90 chewable tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be chewed or crushed and taken with meals. 
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: 
Shelf-life after first opening the bottle: 90 days 
Opening date: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from moisture. 



18 

 
 
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/1/14/943/001 30 chewable tablets 
EU/1/14/943/002 90 chewable tablets 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 



19 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON –30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Velphoro 500 mg chewable tablets 
iron as sucroferric oxyhydroxide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sucrose, potato starch and pregelatinised maize starch. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 × 1 chewable tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be chewed or crushed and taken with meals. 
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 
 
Store in the original package in order to protect from moisture. 
 
 



20 

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/1/14/943/003 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
velphoro 
 
 
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 
 
OUTER CARTON – 30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE 
TABLETS), PART OF MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Velphoro 500 mg chewable tablets 
iron as sucroferric oxyhydroxide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sucrose, potato starch and pregelatinised maize starch. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 × 1 chewable tablets. 
Component of a multipack. Can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be chewed or crushed and taken with meals. 
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 
 
Store in the original package in order to protect from moisture. 
 



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 
 
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/1/14/943/003 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
velphoro 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (MULTIPACK) – 90 (3 PACKS OF 30) CHEWABLE TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Velphoro 500 mg chewable tablets 
iron as sucroferric oxyhydroxide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sucrose, potato starch and pregelatinised maize starch. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 90 (3 packs of 30) chewable tablets. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be chewed or crushed and taken with meals. 
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 
 
Store in the original package in order to protect from moisture. 
 
 



24 

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/1/14/943/004 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
velphoro 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



25 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER OF 6 CHEWABLE TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Velphoro 500 mg chewable tablets 
iron as sucroferric oxyhydroxide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Vifor Fresenius Medical Care Renal Pharma France 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 



26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



27 

Package leaflet: Information for the patient 
 

Velphoro 500 mg chewable tablets 
iron as sucroferric oxyhydroxide 

 
 
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 Velphoro is and what it is used for 
2. What you need to know before you take Velphoro 
3. How to take Velphoro 
4. Possible side effects 
5. How to store Velphoro 
6. Contents of the pack and other information 
 
 
1. What Velphoro is and what it is used for 
 
Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which is made up 
from iron, sugar (sucrose) and starches. 
 
Velphoro is for use by adult patients who undergo haemodialysis or peritoneal dialysis (procedures to 
eliminate toxic substances from the blood) because of chronic kidney disease; it is used in order to 
help control the phosphorus level in their blood when it is too high (hyperphosphataemia). 
 
Too much phosphorus in the blood can lead to calcium being deposited in tissues (calcification). This 
can result in stiffening of the blood vessels, making it harder for the blood to be pumped around the 
body. It may also lead to calcium deposits in soft tissues and bone causing effects such as red eyes, 
itchy skin and bone pain. 
 
Velphoro works by binding phosphorus from food in your digestive tract (stomach and intestines). 
This reduces the amount of phosphorus that can be absorbed into the bloodstream and thus lowers 
phosphorus levels in your blood. 
 
 
2. What you need to know before you take Velphoro 
 
Do not take Velphoro: 
 
– if you are allergic to sucroferric oxyhydroxide or any of the other ingredients of this medicine 

(listed in section 6) 
– if you have a history of abnormal iron build-up in your organs (haemochromatosis) 
– if you have any other disorder associated with too much iron. 
 
If you are not sure, talk to your doctor before taking this medicine. 
 



28 

Warnings and precautions 
 
Talk to your doctor or pharmacist before taking Velphoro: 
– if you have had peritonitis, an inflammation of the peritoneum (the thin tissue that lines the inner 

wall of the abdomen) within the last 3 months, 
– if you have significant stomach and/or liver problems, 
– if you have had major surgery on your stomach and/or intestines. 
 
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking 
this medicine. 
 
Velphoro can cause black stools. Any potential bleeding from your digestive tract (stomach and gut) 
may be hidden by these black stools. If you have black stools and also have symptoms like 
increasing tiredness and breathlessness contact your doctor immediately (see section 4). 
 
Children and adolescents 
 
The safety and efficacy of Velphoro in children and adolescents below the age of 18 years has not yet 
been established. Therefore Velphoro is not recommended for use in children and adolescents. 
 
Other medicines and Velphoro 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
 
If you are taking any other medicine that is known to be affected by iron (for example medicines 
containing the active substance alendronate (used to treat certain bone disorders) or doxycycline (an 
antibiotic)) or has the potential to be affected by iron (for example medicines containing the active 
substance levothyroxine (used to treat thyroid function disorder)), make sure that you take this 
medicine at least one hour before taking Velphoro or at least two hours after taking Velphoro. Ask 
your doctor if you are not sure. 
 
Pregnancy and breastfeeding 
 
There is no information on the effects of this medicine if taken during pregnancy or breastfeeding. If 
you are pregnant or breastfeeding, or you think you may be pregnant or are planning to have a baby, 
ask your doctor or pharmacist for advice before taking this medicine. 
 
Your doctor will advise you whether Velphoro should be used during pregnancy, based on benefit and 
risk assessment for use during pregnancy. 
 
If you are breastfeeding, your doctor will discuss with you whether to continue breastfeeding or to 
continue therapy with Velphoro, taking into account the benefit of Velphoro therapy to you and the 
benefit of breastfeeding to your child. 
 
It is unlikely that this medicine would pass into the mother’s milk. 
 
Driving and using machines 
 
This medicine has no significant effect on your ability to drive or to use tools or machines. 
 
Velphoro contains sucrose and starches (carbohydrates) 
 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicine. 
 
Velphoro may be harmful to the teeth. 
 



29 

Velphoro contains starches. If you have diabetes you should take notice that one tablet of Velphoro is 
equivalent to approximately 1.4 g of carbohydrates (equivalent to 0.116 bread units). 
 
 
3. How to take Velphoro 
 
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 usual recommended starting dose is the equivalent of 1,500 mg iron per day (3 tablets). 
The maximum recommended dose is 3,000 mg iron (6 tablets) per day. 
 
Your doctor may adjust the dose during the treatment course depending on the phosphorus level in 
your blood. 
 
Method of administration 
 
– Velphoro should only be taken by mouth. 
– Take the tablet during a meal and chew it (if necessary, the tablet may be crushed to make this 

easier for you). DO NOT swallow it whole. 
– The amount of tablets taken per day should be divided across the meals of the day. 
– When taking Velphoro you should adhere to your recommended diet and treatments prescribed 

by your doctor such as calcium supplements, vitamin D3 or calcimimetics. 
 
Only for the blister packs: 
– Separate the blister pack at perforations. 
– Peel back the paper foil at the corner. 
– Push the tablet through the aluminium foil. 
 
If you take more Velphoro than you should 
 
If you have accidentally taken too many tablets, do not take any more and talk to your doctor or 
pharmacist immediately. 
 
If you forget to take Velphoro 
 
If you have missed a dose, just take the next dose at the usual time with a meal. Do not take a double 
dose to make up for a forgotten dose. 
 
If you stop taking Velphoro 
 
Do not stop taking the medicine before talking to your doctor or pharmacist as the phosphorus level in 
your blood may increase (see section 1). 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Black stools may occur very commonly in patients taking Velphoro. If you also have symptoms like 
increasing tiredness and breathlessness contact your doctor immediately (see section 2 “Warnings”). 
 
The following side effects have also been reported in patients taking this medicine: 
 
Very common (may affect more than 1 in 10 people): diarrhoea (generally occurring early on in the 
treatment, and improving over time). 
 



30 

Common (may affect up to 1 in 10 people): feeling sick (nausea), constipation, vomiting, indigestion, 
pain in stomach and gut, gas, tooth discolouration, change in taste. 
 
Uncommon (may affect up to 1 in 100 people): bloating (abdominal distension), inflammation of the 
stomach, abdominal discomfort, difficulty swallowing, acid coming back up from the stomach (gastro-
oesophageal reflux disease), tongue discolouration, low or high calcium levels in the blood seen in 
tests, tiredness, itch, rash, headache, shortness of breath. 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Velphoro 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date stated on the carton, bottle or blister after “EXP”. The 
expiry date refers to the last day of that month. 
 
After first opening of the bottle the chewable tablets can be used for 90 days. 
 
Store in the original package in order to protect from moisture. 
 
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 Velphoro contains 
 
– The active substance is iron as sucroferric oxyhydroxide also known as a mixture of polynuclear 

iron(III)-oxyhydroxide, sucrose, and starches. Each chewable tablet contains 500 mg iron as 
sucroferric oxyhydroxide. Each tablet also contains 750 mg sucrose and 700 mg starches. See 
section 2 for further information on sucrose and starches. 

– The other ingredients are woodberry flavour, neohesperidin-dihydrochalcone, magnesium 
stearate, colloidal anhydrous silica. 

 
What Velphoro looks like and contents of the pack 
 
The chewable tablets are brown, circular, and embossed with PA500 on one side. The tablets have a 
20 mm diameter and a thickness of 6.5 mm. 
 
The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure 
and a foil induction seal, or in child resistant aluminium blister. 
 
Velphoro is available in packs containing 30 or 90 chewable tablets. Multipacks are available for the 
blister packs with 90 chewable tablets (containing 3 individual packs of 30 × 1 chewable tablets each). 
 
Not all pack sizes may be marketed. 
 

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


31 

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 
 
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. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET