Renagel

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 



2 

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 400 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 400 mg sevelamer hydrochloride. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
The off-white, oval tablets are imprinted with “Renagel 400” on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis 
or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, 
which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to 
control the development of renal bone disease. 
 
4.2 Posology and method of administration 
 
Posology 
 
Starting dose 
The recommended starting dose of sevelamer hydrochloride is 2.4 g, 3.6 g or 4.8 g per day based on 
clinical needs and serum phosphorus level.  Renagel must be taken three times per day with meals. 
 
Serum phosphate level in patients not on 

phosphate binders 
Starting dose of Renagel 400 mg 

tablets 
1.76 – 2.42 mmol/L (5.5-7.5 mg/dl) 2 tablets, 3 times per day 

2.42- 2.91 mmol/L (7.5-9 mg/dl) 3 tablets, 3 times per day 
> 2.91 mmol/L 4 tablets, 3 times per day 

 
For patients previously on phosphate binders, Renagel should be given on a gram for gram basis with 
monitoring of serum phosphorus levels to ensure optimal daily doses. 
 
Titration and maintenance 
Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated 
by 0.4 g or 0.8 g three times per day (1.2 g/day or 2.4 g/day) increments with the goal of lowering 
serum phosphate to 1.76 mmol/L (5.5mg/dl) or less. Serum phosphate should be tested every two to 
three weeks until a stable serum phosphate level is reached and on a regular basis thereafter. 
 
The dose range may vary between 1 and 10 tablets per meal.  The average actual daily dose used in 
the chronic phase of a one year clinical study was 7 grams of sevelamer. 
 



3 

Paediatric population 
The safety and efficacy of this product have not been established in patients below the age of 18 
years.  
 
Renal impairment 
The safety and efficacy of this product have not been established in predialysis patients.  
 
Method of administration 
For oral use. 
Patients should take Renagel with meals and adhere to their prescribed diets. The tablets must be 
swallowed whole. Do not crush, chew or break into pieces prior to administration. 
 
4.3 Contraindications 
 
• Hypersensitivity to sevelamer or to any of the excipients listed in section 6.1. 
• Hypophosphataemia 
• Bowel obstruction. 
 
4.4 Special warnings and precautions for use 
 
Efficacy and safety of Renagel has not been studied in patients with: 

• swallowing disorders 
• active inflammatory bowel disease 
• gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis 

retention of gastric contents and abnormal or irregular bowel motion 
• patients with a history of major gastrointestinal surgery  

Therefore caution should be exercised when Renagel is used in patients with these disorders. 
 
Intestinal obstruction and ileus/subileus 
In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during 
treatment with sevelamer hydrochloride. Constipation may be a preceding symptom. Patients who are 
constipated should be monitored carefully while being treated with sevelamer hydrochloride. Renagel 
treatment should be re-evaluated in patients who develop severe constipation or other severe 
gastrointestinal symptoms. 
 
Fat-soluble vitamins 
Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low 
vitamin A, D, E and K levels. It cannot be excluded that Renagel can bind fat-soluble vitamins 
contained in ingested food. Therefore, in patients not taking these vitamins, monitoring vitamin A, D 
and E levels and assessing vitamin K status through the measurement of thromboplastin time should 
be considered and the vitamins should be supplemented if necessary. Additional monitoring of 
vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical 
study, vitamin A, D, E and K levels were not measured in these patients. 
 
Folate deficiency 
There is at present insufficient data to exclude the possibility of folate deficiency during long term 
Renagel treatment. 
 
Hypocalcaemia/hypercalcaemia 
Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia. Renagel does not 
contain calcium. Serum calcium levels should be monitored as is done in normal follow-up of a 
dialysis patient. Elemental calcium should be given as a supplement in case of hypocalcaemia.  
 
Metabolic acidosis 
Patients with chronic renal failure are predisposed to developing metabolic acidosis. Worsening of 
acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of 



4 

studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated 
with calcium-based binders were observed. Closer monitoring of serum bicarbonate levels is therefore 
recommended. 
 
Peritonitis 
Patients receiving dialysis are subject to certain risks for infection specific to the dialysis modality. 
Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical 
study with Renagel, a number of peritonitis cases were reported. Therefore, patients on PD should be 
closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt 
recognition and management of any signs and symptoms associated with peritonitis. 
 
Swallowing and choking difficulties 
Uncommon reports of difficulty swallowing the Renagel tablet have been reported. Many of these 
cases involved patients with co-morbid conditions including swallowing disorders or oesophageal 
abnormalities. Caution should be exercised when Renagel is used in patients with difficulty 
swallowing. 
 
Hypothyroidism 
Closer monitoring of patients with hypothyroidism co-administered with sevelamer hydrochloride and 
levothyroxine is recommended (see section 4.5). 
 
Long term chronic treatment 
As data on the chronic use of sevelamer for over one year are not yet available, potential absorption 
and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see 
section 5.2). 
 
Hyperparathyroidism 
Renagel alone is not indicated for the control of hyperparathyroidism. In patients with secondary 
hyperparathyroidism Renagel should be used within the context of a multiple therapeutic approach, 
which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to 
lower the intact parathyroid hormone (iPTH) levels. 
 
Serum chloride 
Serum chloride may increase during Renagel treatment as chloride may be exchanged for phosphorus 
in the intestinal lumen. Although no clinically significant serum chloride increase has been observed 
in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a 
dialysis patient. One gram of Renagel contains approximately 180 mg (5.1 mEq) chloride. 
 
Inflammatory Gastrointestinal Disorders  
Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including 
serious complications such as haemorrhage, perforation, ulceration, necrosis, colitis and 
colonic/caecal mass) associated with the presence of sevelamer crystals have been reported (see 
section 4.8).  Inflammatory disorders may resolve upon sevelamer discontinuation. Sevelamer 
hydrochloride treatment should be re-evaluated in patients who develop severe gastrointestinal 
symptoms.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Dialysis 
Interaction studies have not been conducted in patients on dialysis. 
 
Ciprofloxacin 
In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of 
ciprofloxacin by approximately 50% when co-administered with Renagel in a single dose study. 
Consequently, Renagel should not be taken simultaneously with ciprofloxacin. 
 



5 

Anti-arrhythmics and anti-seizure medicinal products 
Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure 
medicinal products for the control of seizure disorders were excluded from clinical trials.  Caution 
should be exercised when prescribing sevelamer hydrochloride to patients also taking these medicinal 
products. 
 
Levothyroxine 
During post marketing experience, very rare cases of increased thyroid stimulating hormone (TSH) 
levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine. 
Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal 
products. 
 
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients 
Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant 
patients when coadministered with sevelamer hydrochloride without any clinical consequences (i.e 
graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood 
concentrations of mycophenolate mofetil,  ciclosporin and tacrolimus should be considered during the 
use of combination and after its withdrawal.  
 
Digoxin, warfarin, enalapril or metoprolol  
In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, 
warfarin, enalapril or metoprolol. 
 
Proton pump inhibitors 
During post-marketing experience, very rare cases of increased phosphate levels have been reported in 
patients taking proton pump inhibitors co-administered with sevelamer hydrochloride.  
 
Bioavailability 
Renagel is not absorbed and may affect the bioavailability of other medicinal products. When 
administering any medicinal product where a reduction in the bioavailability could have a clinically 
significant effect on safety or efficacy, the medicinal product should be administered at least one hour 
before or three hours after Renagel, or the physician should consider monitoring blood levels. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
The safety of sevelamer hydrochloride has not been established in pregnant women. In animal studies 
there was no evidence that sevelamer induced embryo-foetal toxicity. Renagel should only be given to 
pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both 
the mother and the foetus (see section 5.3). 
 
Breast-feeding 
The safety of sevelamer hydrochloride has not been established in breast-feeding women. Renagel 
should only be given to breast-feeding women if clearly needed and after a careful risk/benefit 
analysis has been conducted for both the mother and the infant (see section 5.3). 
 
Fertility 
There are no data from the effect of sevelamer on fertility in humans.  Studies in animals have shown 
that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 
2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative body surface 
area. 
 
4.7 Effects on ability to drive and use machines 
 
Sevelamer has no or negligible influence on the ability to drive and use machines. 
 



6 

4.8 Undesirable effects 
 
Summary of the safety profile 
The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal 
disorders system organ class.  
 
Tabulated list of adverse reactions 
Parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 
weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted. 
Adverse reactions from these studies (299 patients),  from uncontrolled clinical trials (384 patients), 
and that were spontaneously reported from post-marketing experience  are listed by frequency in the 
table below. The reporting rate is classified as 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), not known 
(cannot be estimated from the available data). 
 
MedDRA 
System Organ 
Class 

Very  
Common 

Common Uncommon Very Rare Not known 

Immune system 
disorders 

   Hypersensitivity*  

Metabolism and 
nutrition 
disorders 

  Acidosis, 
increased 
serum 
chloride 
levels 

  

Gastrointestinal 
disorders 

Nausea, 
vomiting 

Diarrhoea, 
dyspepsia, 
flatulence, 
upper 
abdominal 
pain, 
constipation 

  Abdominal pain, 
intestinal 
obstruction, 
ileus/subileus, 
diverticulitis, 
intestinal 
perforation1, 
gastrointestinal 
hemorrhage*1, 
intestinal 
ulceration*1, 
gastrointestinal 
necrosis*1,  
colitis*1, 
intestinal mass*1 

Skin and 
subcutaneous 
tissue disorders 

    Pruritus, rash 

Investigations     Crystal deposit 
intestine*1 

*post-marketing experience 
1 See inflammatory gastrointestinal disorders warning in section 4.4 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 

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


7 

4.9 Overdose 
 
Renagel has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of 
thirty five 400 mg tablets per day for eight days with no undesirable effects.  
 
 
5 PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Treatment of hyperphosphatemia. ATC code: V03AE02. 
 
Renagel contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) 
polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the 
polymer backbone. These amines become partially protonated in the intestine and interact with 
phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the 
gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum. 
 
In clinical trials, sevelamer has been shown to be effective in reducing serum phosphorus in patients 
receiving haemodialysis or peritoneal dialysis. 
 
Sevelamer decreases the incidence of hypercalcaemic episodes as compared to patients using calcium 
based phosphate binders alone, probably because the product itself does not contain calcium. The 
effects on phosphate and calcium were proven to be maintained throughout a study with one year 
follow-up. 
 
Sevelamer has been shown to bind bile acids in vitro and in vivo in experimental animal models. Bile 
acid binding by ion exchange resins is a well-established method of lowering blood cholesterol. In 
clinical trials mean total and LDL cholesterol declined by 15-31%. This effect is observed after 2 
weeks is maintained with long-term treatment. Triglycerides, HDL cholesterol and albumin did not 
change.  
 
In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and 
clinically significant effect on serum intact parathyroid hormone (iPTH). In the 12 week study 
involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with 
patients receiving calcium acetate. In patients with secondary hyperparathyroidism Renagel should be 
used within the context of a multiple therapeutic approach, which could include calcium supplements, 
1,25-dihydroxy Vitamin D3 or one of its analogues to lower the iPTH levels. 
 
In a clinical trial of one-year duration, Renagel had no adverse effect on bone turnover or 
mineralisation compared to calcium carbonate.  
 
5.2 Pharmacokinetic properties 
 
Renagel is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic 
study in healthy volunteers. Pharmacokinetic studies have not been carried out in renal failure patients 
(see section 4.4).  
 
5.3 Preclinical safety data 
 
In preclinical studies in rats and dogs, Renagel at a dose of 10 times the maximum human doses 
reduced absorption of fat soluble vitamins D, E and K, and folic acid. 
 
In a study in rats, administering sevelamer in 15-30 x the human dose, an increase in serum copper 
was detected. This was not confirmed in a dog study or in clinical trials. 



8 

Currently, no formal carcinogenicity data are available. However, in vitro and in vivo studies have 
indicated that Renagel does not have genotoxic potential. Also the medicinal product is not absorbed 
in the gastrointestinal tract. 
 
In reproduction studies there was no evidence that sevelamer induced embryolethality, foetotoxicity 
or teratogenicity at the doses tested (up to 1 g/kg/day in rabbits and up to 4.5 g/kg/day in rats). 
Deficits in skeletal ossification were observed in several locations in fetuses of female rats dosed with 
sevelamer at 8-20 times the maximum human dose of 200 mg/kg. The effects may be secondary to 
vitamin D and/or vitamin K depletion at these high doses. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core:  
Silica, colloidal anhydrous 
Stearic acid 
 
Film-coating:  
Hypromellose (E464)  
Diacetylated monoglycerides 
 
Printing ink: 
Iron oxide black (E172) 
Propylene glycol  
Hypromellose (E464) 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf-life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not store above 25ºC. 
Keep the bottle tightly closed in order to protect from moisture. 
 
6.5 Nature and contents of container 
 
HDPE bottles, with a child resistant polypropylene closure and a foil induction seal. 
 
Package sizes are: 
1 bottle of 360 film-coated tablets 
multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) 
multipacks containing 1080 film-coated tablets (3 bottles of 360 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. 



9 

 
 
7. MARKETING AUTHORISATION HOLDER 
 
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/005  1 bottle of 360 film-coated tablets 
EU/1/99/123/006  multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) 
EU/1/99/123/007  multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 28 January 2000 
Date of latest renewal: 28 January 2015 
 
 
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/
http://www.ema.europa.eu/


10 

1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 800 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
The off-white, oval tablets are imprinted with “Renagel 800” on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis 
or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, 
which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to 
control the development of renal bone disease. 
 
4.2 Posology and method of administration 
 
Posology 
 
Starting dose 
The recommended starting dose of sevelamer hydrochloride is 2.4 g or 4.8 g per day based on clinical 
needs and serum phosphorus level.  Renagel must be taken three times per day with meals. 
 
Serum phosphate level in patients not on 

phosphate binders 
Starting dose of Renagel 800 

mg tablets 
1.76 – 2.42 mmol/L (5.5-7.5 mg/dl) 1 tablet, 3 times per day 

> 2.42 mmol/L (>7.5 mg/dl) 2 tablets, 3 times per day 
 
For patients previously on phosphate binders, Renagel should be given on a gram for gram basis with 
monitoring of serum phosphorus levels to ensure optimal daily doses. 
 
Titration and maintenance 
Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated 
by 0.8 g three times per day (2.4 g/day) increments with the goal of lowering serum phosphate to 1.76 
mmol/L (5.5 mg/dl) or less. Serum phosphate should be tested every two to three weeks until a stable 
serum phosphate level is reached and on a regular basis thereafter. 
 
The dose range may vary between 1 and 5 tablets of 800 mg per meal.  The average actual daily dose 
used in the chronic phase of a one year clinical study was 7 grams of sevelamer. 
 
Paediatric population 
The safety and efficacy of this product have not been established in patients below the age of 
18 years. 
 



11 

Renal impairment 
The safety and efficacy of this product have not been established in predialysis patients.  
 
Method of administration 
For oral use 
Patients should take Renagel with meals and adhere to their prescribed diets. The tablets must be 
swallowed whole. Do not crush, chew or break into pieces prior to administration. 
 
4.3 Contraindications 
 
• Hypersensitivity to sevelamer or to any of the excipients listed in section 6.1. 
• Hypophosphataemia 
• Bowel obstruction. 
 
4.4 Special warnings and precautions for use 
 
Efficacy and safety of Renagel has not been studied in patients with: 

• swallowing disorders 
• active inflammatory bowel disease 
• gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis 

retention of gastric contents and abnormal or irregular bowel motion 
• patients with a history of major gastrointestinal surgery 

Therefore caution should be exercised when Renagel is used in patients with these disorders. 
 
Intestinal obstruction and ileus/subileus 
In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during 
treatment with sevelamer hydrochloride. Constipation may be a preceding symptom. Patients who are 
constipated should be monitored carefully while being treated with sevelamer hydrochloride. Renagel 
treatment should be re-evaluated in patients who develop severe constipation or other severe 
gastrointestinal symptoms. 
 
Fat-soluble vitamins 
Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low 
vitamin A, D, E and K levels. It cannot be excluded that Renagel can bind fat-soluble vitamins 
contained in ingested food. Therefore, in patients not taking these vitamins, monitoring vitamin A, D 
and E levels and assessing vitamin K status through the measurement of thromboplastin time should 
be considered and the vitamins should be supplemented if necessary. Additional monitoring of 
vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical 
study, vitamin A, D, E and K levels were not measured in these patients. 
 
Folate deficiency 
There is at present insufficient data to exclude the possibility of folate deficiency during long term 
Renagel treatment. 
 
Hypocalcaemia/hypercalcaemia 
Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia. Renagel does not 
contain calcium. Serum calcium levels should be monitored as is done in normal follow-up of a 
dialysis patient. Elemental calcium should be given as a supplement in case of hypocalcaemia.  
 
Metabolic acidosis 
Patients with chronic renal failure are predisposed to developing metabolic acidosis. Worsening of 
acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of 
studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated 
with calcium-based binders were observed. Closer monitoring of serum bicarbonate levels is therefore 
recommended. 
 



12 

Peritonitis 
Patients receiving dialysis are subject to certain risks for infection specific to the dialysis modality. 
Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical 
study with Renagel, a number of peritonitis cases were reported. Therefore, patients on PD should be 
closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt 
recognition and management of any signs and symptoms associated with peritonitis. 
 
Swallowing and choking difficulties 
Uncommon reports of difficulty swallowing the Renagel tablet have been reported.  Many of these 
cases involved patients with co-morbid conditions including swallowing disorders or oesophageal 
abnormalities.  Caution should be exercised when Renagel is used in patients with difficulty 
swallowing. 
 
Hypothyroidism 
Closer monitoring of patients with hypothyroidism co-administered with sevelamer hydrochloride and 
levothyroxine is recommended (see section 4.5). 
 
Long term chronic treatment 
As data on the chronic use of sevelamer for over one year are not yet available, potential absorption 
and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see 
section 5.2). 
 
Hyperparathyroidism 
Renagel alone is not indicated for the control of hyperparathyroidism. In patients with secondary 
hyperparathyroidism Renagel should be used within the context of a multiple therapeutic approach, 
which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to 
lower the intact parathyroid hormone (iPTH) levels. 
 
Serum chloride 
Serum chloride may increase during Renagel treatment as chloride may be exchanged for phosphorus 
in the intestinal lumen. Although no clinically significant serum chloride increase has been observed 
in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a 
dialysis patient. One gram of Renagel contains approximately 180 mg (5.1 mEq) chloride. 
 
Inflammatory Gastrointestinal Disorders  
Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including 
serious complications such as haemorrhage, perforation, ulceration, necrosis, colitis and 
colonic/caecal mass) associated with the presence of sevelamer crystals have been reported (see 
section 4.8). Inflammatory disorders may resolve upon sevelamer discontinuation. Sevelamer 
hydrochloride treatment should be re-evaluated in patients who develop severe gastrointestinal 
symptoms.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Dialysis 
Interaction studies have not been conducted in patients on dialysis. 
 
Ciprofloxacin 
In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of 
ciprofloxacin by approximately 50% when co-administered with Renagel in a single dose study. 
Consequently, Renagel should not be taken simultaneously with ciprofloxacin. 
 
Anti-arrhythmics and anti-seizure medicinal products 
Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure 
medicinal products for the control of seizure disorders were excluded from clinical trials.  Caution 



13 

should be exercised when prescribing sevelamer hydrochloride to patients also taking these medicinal 
products. 
 
Levothyroxine 
During post marketing experience, very rare cases of increased thyroid stimulating hormone (TSH) 
levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine. 
Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal 
products. 
 
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients 
Reduced levels of ciclosporin,  mycophenolate mofetil and tacrolimus have been reported in 
transplant patients when coadministered with sevelamer hydrochloride without any clinical 
consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close 
monitoring of blood concentrations of mycophenolate mofetil, ciclosporin and tacrolimus should be 
considered during the use of combination and after its withdrawal.  
 
Digoxin, warfarin, enalapril or metoprolol  
In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, 
warfarin, enalapril or metoprolol. 
 
Proton pump inhibitors 
During post-marketing experience, very rare cases of increased phosphate levels have been reported in 
patients taking proton pump inhibitors co-administered with sevelamer hydrochloride.  
 
Bioavailability 
Renagel is not absorbed and may affect the bioavailability of other medicinal products. When 
administering any medicinal product where a reduction in the bioavailability could have a clinically 
significant effect on safety or efficacy, the medicinal product should be administered at least one hour 
before or three hours after Renagel, or the physician should consider monitoring blood levels. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
The safety of sevelamer hydrochloride has not been established in pregnant women. In animal studies 
there was no evidence that sevelamer induced embryo-foetal toxicity. Renagel should only be given to 
pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both 
the mother and the foetus (see section 5.3). 
 
Breast-feeding 
The safety of sevelamer hydrochloride has not been established in breast-feeding women. Renagel 
should only be given to breast-feeding women if clearly needed and after a careful risk/benefit 
analysis has been conducted for both the mother and the infant (see section 5.3). 
 
Fertility 
There are no data from the effect of sevelamer on fertility in humans.  Studies in animals have shown 
that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 
2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative body surface 
area. 
 
4.7 Effects on ability to drive and use machines 
 
Sevelamer has no or negligible influence on the ability to drive and use machines. 
 



14 

4.8 Undesirable effects 
 
Summary of the safety profile 
The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal 
disorders system organ class.  
 
Tabulated list of adverse reactions 
In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 
weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted. 
Adverse reactions from these studies (299 patients),  from uncontrolled clinical trials (384 patients), 
and that were spontaneously reported from post-marketing experience are listed by frequency in the 
table below. The reporting rate is classified as 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), not known 
(cannot be estimated form the available data). 
 
MedDRA 
System Organ 
Class 

Very  
Common 

Common Uncommon Very Rare Not known 

Immune system 
disorders 

   Hypersensitivity*  

Metabolism and 
nutrition 
disorders 

  Acidosis, 
increased 
serum 
chloride 
levels 

  

Gastrointestinal 
disorders 

Nausea, 
vomiting 

Diarrhoea, 
dyspepsia, 
flatulence, 
upper 
abdominal 
pain, 
constipation 

  Abdominal pain, 
intestinal 
obstruction, 
ileus/subileus, 
diverticulitis, 
intestinal 
perforation1, 
gastrointestinal 
hemorrhage*1, 
intestinal 
ulceration*1, 
gastrointestinal 
necrosis*1,  
colitis*1, 
intestinal mass*1 

Skin and 
subcutaneous 
tissue disorders 

    Pruritus, rash 

Investigations     Crystal deposit 
intestine*1 

*post-marketing experience 
1 See inflammatory gastrointestinal disorders warning in section 4.4 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 

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


15 

4.9 Overdose 
 
Renagel has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of 
seventeen 800 mg tablets per day for eight days with no undesirable effects.  
 
 
5 PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Treatment of hyperphosphatemia. ATC code: V03AE02. 
 
Renagel contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) 
polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the 
polymer backbone. These amines become partially protonated in the intestine and interact with 
phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the 
gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum. 
 
In clinical trials, sevelamer has been shown to be effective in reducing serum phosphorus in patients 
receiving haemodialysis or peritoneal dialysis. 
 
Sevelamer decreases the incidence of hypercalcaemic episodes as compared to patients using calcium 
based phosphate binders alone, probably because the product itself does not contain calcium. The 
effects on phosphate and calcium were proven to be maintained throughout a study with one year 
follow-up. 
 
Sevelamer has been shown to bind bile acids in vitro and in vivo in experimental animal models. Bile 
acid binding by ion exchange resins is a well-established method of lowering blood cholesterol. In 
clinical trials mean total and LDL cholesterol declined by 15-31%. This effect is observed after 2 
weeks is maintained with long-term treatment. Triglycerides, HDL cholesterol and albumin did not 
change.  
 
In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and 
clinically significant effect on serum intact parathyroid hormone (iPTH). In the 12 week study 
involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with 
patients receiving calcium acetate. In patients with secondary hyperparathyroidism Renagel should be 
used within the context of a multiple therapeutic approach, which could include calcium supplements, 
1,25-dihydroxy Vitamin D3 or one of its analogues to lower the iPTH levels. 
 
In a clinical trial of one-year duration, Renagel had no adverse effect on bone turnover or 
mineralisation compared to calcium carbonate.  
 
5.2 Pharmacokinetic properties 
 
Renagel is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic 
study in healthy volunteers. Pharmacokinetic studies have not been carried out in renal failure patients 
(see section 4.4).  
 
5.3 Preclinical safety data 
 
In preclinical studies in rats and dogs, Renagel at a dose of 10 times the maximum human doses 
reduced absorption of fat soluble vitamins D, E and K, and folic acid. 
 
In a study in rats, administering sevelamer in 15-30 x the human dose, an increase in serum copper 
was detected. This was not confirmed in a dog study or in clinical trials. 



16 

Currently, no formal carcinogenicity data are available. However, in vitro and in vivo studies have 
indicated that Renagel does not have genotoxic potential. Also the medicinal product is not absorbed 
in the gastrointestinal tract. 
 
In reproduction studies there was no evidence that sevelamer induced embryolethality, foetotoxicity 
or teratogenicity at the doses tested (up to 1 g/kg/day in rabbits and up to 4.5 g/kg/day in rats). 
Deficits in skeletal ossification were observed in several locations in fetuses of female rats dosed with 
sevelamer at 8-20 times the maximum human dose of 200 mg/kg. The effects may be secondary to 
vitamin D and/or vitamin K depletion at these high doses. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients   
 
Tablet core:  
Silica, colloidal anhydrous 
Stearic acid 
 
Film-coating: 
Hypromellose (E464) 
Diacetylated monoglycerides 
 
Printing ink: 
Iron oxide black (E172) 
Propylene glycol 
Hypromellose (E464) 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf-life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 25ºC. 
Keep the bottle tightly closed in order to protect from moisture. 
 
6.5 Nature and contents of container 
 
HDPE bottles, with a child resistant polypropylene closure and a foil induction seal. 
 
Package sizes are: 
1 bottle of 100 film-coated tablets 
1 bottle of 180 film-coated tablets 
multipacks containing 180 film-coated tablets (6 bottles of 30 tablets) 
multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) 
multipacks containing 540 film-coated tablets (3 bottles of 180 tablets) 
 
Not all pack sizes may be marketed. 
 



17 

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 
 
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/008  1 bottle of 180 film-coated tablets 
EU/1/99/123/009  multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) 
EU/1/99/123/010  multipacks containing 540 film-coated tablets (3 bottles of 180 tablets) 
EU/1/99/123/011  1 bottle of 100 film-coated tablets 
EU/1/99/123/012  1 bottle of 180 film-coated tablets without outer carton 
EU/1/99/123/013  multipacks containing 180 film-coated tablets (6 bottles of 30 tablets) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 28 January 2000 
Date of latest renewal: 28 January 2015 
 
 
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/
http://www.ema.europa.eu/


18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 

 
 



19 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release 

Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland 

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 marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and 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.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time. 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



22 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – 1 BOTTLE OF 360 TABLETS 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 400 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 400 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
360 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 
 
 



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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/005 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel 
400 mg  
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON with the Blue Box – MULTIPACK OF 720 (2 BOTTLES OF 360) 
TABLETS 400 mg 
OUTER CARTON with the Blue Box – MULTIPACK OF 1080 (3 BOTTLES OF 360) 
TABLETS 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 400 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 400 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 720 (2 bottles of 360) film-coated tablets.  
Multipack: 1080 (3 bottles of 360) film-coated tablets. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 
 



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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/006 multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) 
EU/1/99/123/007 multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
400 mg  
 
 
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 
 
LABEL - BOTTLE OF 360 TABLETS 400 mg  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 400 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 400 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
360 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 



27 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/005 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
400 mg 
 
 



28 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL without Blue Box - BOTTLE OF 360 TABLETS 400 mg (MULTIPACK 
PRESENTATION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 400 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 400 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
360 film-coated tablets. Component of a multipack, can’t be sold separately.  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 
 



29 

 
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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/006  multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) 
EU/1/99/123/007  multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
400 mg 



30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON with Blue Box – MULTIPACK OF 180 (6 BOTTLES OF 30) TABLETS 
800 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 800 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 180 (6 bottles of 30) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 



31 

 
 
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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/013 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
800 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



32 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – 1 BOTTLE OF 100 TABLETS 800 mg 
OUTER CARTON – 1 BOTTLE OF 180 TABLETS 800 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 800 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 film-coated tablets 
180 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 
 



33 

 
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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/011 1 bottle of 100 film-coated tablets 
EU/1/99/123/008 1 bottle of 180 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
800 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



34 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON with Blue Box - MULTIPACK OF 360 (2 BOTTLES OF 180) TABLETS 
800 mg 
OUTER CARTON with Blue Box - MULTIPACK OF 540 (3 BOTTLES OF 180) TABLETS 
800 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 800 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 360 (2 bottles of 180) film-coated tablets 
Multipack: 540 (3 bottles of 180) film-coated tablets. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 
 



35 

 
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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/009  multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) 
EU/1/99/123/010  multipacks containing 540 film-coated tablets (3 bottles of 180 tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
800 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



36 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING  
 
LABEL without Blue Box - BOTTLE OF 30 TABLETS 800 mg (MULTIPACK 
PRESENTATION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 800 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 



37 

 
 
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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/013 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
800 mg  



38 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING  
 
LABEL – BOTTLE OF 100 TABLETS 800 mg  
LABEL - BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON 
LABEL with Blue Box – 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 800 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 film-coated tablets 
180 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 



39 

 
 
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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/011 1 bottle of 100 film-coated tablets 
EU/1/99/123/008 1 bottle of 180 film-coated tablets with outer carton 
EU/1/99/123/012 1 bottle of 180 film-coated tablets without outer carton 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
800 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



40 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL without Blue Box – BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON 
(MULTIPACK PRESENTATION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Renagel 800 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
180 film-coated tablets. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For 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 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 



41 

 
 
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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/123/009  multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) 
EU/1/99/123/010  multipacks containing 540 film-coated tablets (3 bottles of 180 tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Renagel  
800 mg  
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



42 

 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



43 

Package leaflet: Information for the user 
 

Renagel 400 mg film-coated tablets 
sevelamer hydrochloride 

 
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 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 Renagel is and what it is used for 
2. What you need to know before you take Renagel 
3. How to take Renagel 
4. Possible side effects 
5. How to store Renagel 
6. Contents of the pack and other information 
 
 
1. What Renagel is and what it is used for 
 
Renagel contains sevelamer as the active ingredient. It binds phosphate from food in the digestive 
tract and so reduces serum phosphate levels in the blood. 
 
Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on 
haemodialysis or peritoneal dialysis treatment.  
 
Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis 
are not able to control the level of serum phosphate in their blood. The amount of phosphate then rises 
(your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to 
hard deposits in your body called calcification. These deposits can stiffen your blood vessels and 
make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to 
itchy skin, red eyes, bone pain and fractures. 
 
Renagel may be used with other medicines which include calcium or vitamin D supplements to 
control the development of renal bone disease. 
 
 
2. What you need to know before you take Renagel  
 
Do not take Renagel: 
• if you have low levels of phosphate in your blood (your doctor will check this for you). 
• if you have bowel obstruction.  
• if you are allergic to sevelamer or to any of the other ingredients of this medicine (listed in 

section 6). 
 

Warnings and precautions 
Talk to your doctor before taking Renagel if any of the following applies to you: 

• if you are not on dialysis 
• if you have swallowing problems 
• if you have problems with motility (movement) in your stomach and bowel 
• if you have symptoms of delayed emptying of stomach contents such as feeling of fullness, 



44 

nausea and/or vomiting  
• if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory 

bowel disease) 
• if you have undergone major surgery on your stomach or bowel 

 
Talk to your doctor while taking Renagel: 

• if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool 
(gastrointestinal bleeding). These symptoms can be due to serious inflammatory bowel 
disease caused by sevelamer crystals deposit in your bowel. Contact your doctor who will 
decide on continuing the treatment or not. 

 
Additional treatments: 
Due to either your kidney condition or your dialysis treatment you may: 

• develop a low or high level of calcium in your blood. Since Renagel does not contain calcium 
your doctor might prescribe additional calcium tablets. 

• have a low amount of vitamin D in your blood. Therefore, your doctor may monitor the levels 
of vitamin D in your blood and prescribe additional vitamin D as necessary. If you do not take 
multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid 
in your blood and therefore your doctor may monitor these levels and prescribe supplemental 
vitamins as necessary. 

 
Changing treatment: 
When you switch from another phosphate binder to Renagel, your doctor might consider monitoring 
the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of 
bicarbonate. 
 
Special note for patients on peritoneal dialysis 
You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal 
dialysis. This risk can be reduced by careful adherence to sterile techniques during bag changes. You 
should tell your doctor immediately if you experience any new signs or symptoms of abdominal 
distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, 
constipation, fever, chills, nausea or vomiting. 
You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, 
K and folic acid. 
 
Children and adolescents 
The safety and efficacy in children (below the age of 18 years) has not been studied. Therefore 
Renagel is not recommended for use in this population. 
 
Other medicines and Renagel 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
 

• Renagel should not be taken at the same time as ciprofloxacin (an antibiotic). 
 

• If you are taking medicines for heart rhythm problems or for epilepsy, you should consult 
your doctor when taking Renagel. 

 
• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus 

(medicines used in transplant patients) may be reduced by Renagel. Your doctor will advise 
you if you are taking these medicines. 

 
• In certain people taking levothyroxine (a thyroid hormone) and Renagel, increased levels of 

thyroid stimulating hormone (TSH, a substance in your blood which helps control your 
body’s chemical functions) may very rarely be observed. Therefore your doctor may monitor 
the levels of TSH in your blood more closely. 



45 

 
• If you are taking medicine such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, 

gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor when 
taking Renagel. 

 
Your doctor will check for interactions between Renagel and other medicines on a regular basis. 
 
In some cases where Renagel should be taken at the same time as another medicine, your doctor may 
advise you to take this medicine 1 hour before or 3 hours after Renagel intake, or he/she may consider 
monitoring the blood levels of that medicine. 
 
Pregnancy and  breast-feeding 
The safety of Renagel has not been established in pregnant or breast-feeding women. Renagel should 
only be given to pregnant or breast-feeding women if clearly needed. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine.  
 
Driving and using machines 
Renagel is unlikely to affect your ability to drive or to use machines. 
 
 
3. How to take Renagel  
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. He will base the dose on your serum phosphate level. The recommended starting dose of 
Renagel for adults and the elderly (>65 years) is two to four tablets with each meal 3 times a day. 
 
Initially your doctor will check the levels of phosphate in your blood every 2-3 weeks and  may adjust 
the dose of Renagel when necessary (between 1 and 10 tablets of 400 mg per meal) to reach an 
adequate phosphate level. 
 
The tablets must be swallowed whole. Do not crush, chew or break into pieces prior to swallowing. 
 
Patients taking Renagel should adhere to their prescribed diet and liquid intake.  
 
If you take more Renagel than you should 
In the event of a possible overdose you should contact your doctor immediately. 
 
If you forget to take Renagel 
If you have missed one dose, this dose should be omitted and the next dose should be taken at the 
usual time with a meal. Do not take a double dose to make up for a forgotten dose. 
 
 
4. Possible side effects   
 
Like all medicines, this medicine  can cause side effects, although not everybody gets them. 
 
Since constipation may be a preceding symptom in very rare cases of blockages in your intestine, it is 
important to inform your doctor or pharmacist of this symptom before or during the use of Renagel. 
 
The following side effects have been reported in patients taking Renagel:  
Very common (may affect more than 1 in 10 people): 
nausea, vomiting. 
Common (may affect up to 1 in 10 people):  
diarrhoea, indigestion, abdominal pain, constipation, flatulence. 



46 

Uncommon (may affect up to 1 in 100 people):  
increased acidity of the blood.  
Very rare (may affect up to 1 in 10000 people): 
hypersensitivity. 
Not known (frequency cannot be estimated from the available data): 
cases of itching, rash, abdominal pain, slow intestine motility (movement), inflammation of abnormal 
small pouches (called diverticula) in the large intestine, blockages in the intestine (signs include: 
severe bloating; abdominal pain, swelling or cramps; severe constipation),  rupture in the intestine 
wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen), 
serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or 
intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine 
have been reported. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. 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 Renagel  
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date stated on the carton and bottle after “EXP”. The expiry 
date refers to the last day of that month. 
 
Do not store this medicine above 25 °C. Keep the bottle tightly closed 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 to protect the environment. 
 
 
6. Contents of the pack and other information   
 
What Renagel contains 
 
- The active substance is sevelamer hydrochloride. Each tablet contains 400 mg sevelamer 
hydrochloride. 
- The other ingredients are silica colloidal anhydrous and stearic acid, hypromellose (E464), 
diacetylated monoglycerides, iron oxide black (E172) and propylene glycol. 
 
What Renagel looks like and contents of the pack 
 
Renagel tablets are film coated, off white, oval tablets with Renagel 400 imprinted on one side. 
The tablets are packed in high density polyethylene bottles with a child resistant polypropylene 
closure and an induction seal. 
 
Pack sizes are: 
1 bottle of 360 tablets 
multipacks containing 720 tablets  (2 bottles of 360 tablets) 
multipacks containing 1080 tablets  (3 bottles of 360 tablets) 
 
Not all pack sizes may be marketed. 
 

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


47 

Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder: 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
Manufacturer:  
Genzyme Ireland Limited 
IDA Industrial Park 
Old Kilmeaden Road 
Waterford 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg 
Sanofi Belgium 
Tél/Tel: + 32 2 710 54 00 
 

Lietuva 
UAB „SANOFI-AVENTIS LIETUVA“ 
Tel. +370 5 275 5224 
 

България 
SANOFI BULGARIA EOOD 
Tел: +359 2 9705300 

Magyarország 
SANOFI-AVENTIS Zrt 
Tel: +36 1 505 0050 
 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Malta 
Sanofi S.p.A. 
Tel: +39 02 39394275 

Danmark 
Sanofi A/S  
Tlf: +45 45 16 70 00 
 

Nederland 
sanofi-aventis Netherlands B.V.  
Tel: +31 20 245 4000 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel: +49 (0)180 2 222010 
 

Norge 
sanofi-aventis Norge AS 
Tlf: + 47 67 10 71 00 
 

Eesti 
sanofi-aventis Estonia OÜ 
Tel. +372 6 273 488 
 

Österreich 
sanofi-aventis GmbH 
Tel: + 43 1 80 185 - 0 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 1600 

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 

España 
sanofi-aventis, S.A. 
Tel: +34 93 485 94 00 
  

Portugal 
Sanofi – Produtos Farmacêuticos, Lda. 
Tel: +351 21 35 89 400 
 

 
France 
sanofi-aventis France 
Tél : 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 

România 
Sanofi Romania SRL 
Tel: +40 (0) 21 317 31 36  
 



48 

 
Hrvatska 
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 4800 

 
Ireland 
sanofi-aventis Ireland Ltd T/A SANOFI 
Tel:  +353 (0) 1 4035 600  
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel.:  +421 2 33 100 100 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Suomi/Finland 
Sanofi Oy 
Puh/Tel: + 358 201 200 300 
 

Italia 
Sanofi S.p.A. 
Tel: 800.536 389 

Sverige 
Sanofi AB 
Tel: +46 (0)8 634 50 00 
 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

 

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

http://www.emea.europa.eu/
http://www.emea.europa.eu/


49 

Package leaflet: Information for the user 
 

Renagel 800 mg film-coated tablets 
sevelamer hydrochloride 

 
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 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 Renagel is and what it is used for 
2. What you need to know before you take Renagel 
3. How to take Renagel 
4. Possible side effects 
5. How to store Renagel 
6. Contents of the pack and other information.  
 
 
1. What Renagel is and what it is used for  
 
Renagel contains sevelamer as the active ingredient. It binds phosphate from food in the digestive 
tract and so reduces serum phosphate levels in the blood. 
 
Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on 
haemodialysis or peritoneal dialysis treatment.  
 
Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis 
are not able to control the level of serum phosphate in their blood. The amount of phosphate then rises 
(your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to 
hard deposits in your body called calcification. These deposits can stiffen your blood vessels and 
make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to 
itchy skin, red eyes, bone pain and fractures. 
 
Renagel may be used with other medicines which include calcium or vitamin D supplements to 
control the development of renal bone disease. 
 
 
2. What you need to know before you take Renagel 
 
Do not take Renagel: 
• if you have low levels of phosphate in your blood (your doctor will check this for you). 
• if you have bowel obstruction.  
• if you are allergic to sevelamer or to any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions 
Talk to your doctor before taking Renagel if any of the following applies to you: 

• if you are not on dialysis 
• if you have swallowing problems 
• if you have problems with motility (movement) in your stomach and bowel 
• if you have symptoms of delayed emptying of stomach contents such as feeling of fullness, 



50 

nausea and/or vomiting 
• if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory 

bowel disease) 
• if you have undergone major surgery on your stomach or bowel. 

 
Talk to your doctor while taking Renagel: 

• if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool 
(gastrointestinal bleeding). These symptoms can be due to serious inflammatory bowel 
disease caused by sevelamer crystals deposit in your bowel. Contact your doctor who will 
decide on continuing the treatment or not. 

 
Additional treatments: 
Due to either your kidney condition or your dialysis treatment you may: 
• develop a low or high level of calcium in your blood. Since Renagel does not contain calcium 

your doctor might prescribe additional calcium tablets. 
• have a low amount of vitamin D in your blood. Therefore, your doctor may monitor the levels 

of vitamin D in your blood and prescribe additional vitamin D as necessary. If you do not take 
multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid 
in your blood and therefore your doctor may monitor these levels and prescribe supplemental 
vitamins as necessary. 

 
Changing treatment: 
When you switch from another phosphate binder to Renagel, your doctor might consider monitoring 
the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of 
bicarbonate. 
 
Special note for patients on peritoneal dialysis: 
You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal 
dialysis. This risk can be reduced by careful adherence to sterile techniques during bag changes. You 
should tell your doctor immediately if you experience any new signs or symptoms of abdominal 
distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, 
constipation, fever, chills, nausea or vomiting.  
You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, 
K and folic acid. 
 
Children and adolescents 
The safety and efficacy in children (below the age of 18 years) has not been studied. Therefore 
Renagel is not recommended for use in this population. 
 
Other medicines and Renagel 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
 

• Renagel should not be taken at the same time as ciprofloxacin (an antibiotic). 
 

• If you are taking medicines for heart rhythm problems or for epilepsy, you should consult 
your doctor when taking Renagel. 

 
• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus 

(medicines used in transplant patients) may be reduced by Renagel. Your doctor will advise 
you if you are taking these medicines. 

 
• In certain people taking levothyroxine (a thyroid hormone) and Renagel, increased levels of 

thyroid stimulating hormone (TSH, a substance in your blood which helps control your 
body’s chemical functions) may very rarely be observed. Therefore your doctor may monitor 
the levels of TSH in your blood more closely. 



51 

 
• If you are taking medicine such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, 
 gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor  

 when taking Renagel. 
 
Your doctor will check for interactions between Renagel and other medicines on a regular basis. 
 
In some cases where Renagel should be taken at the same time as another medicine, your doctor may 
advise you to take this medicine 1 hour before or 3 hours after Renagel intake, or he/she may consider 
monitoring the blood levels of that medicine. 
 
Pregnancy and breast-feeding  
The safety of Renagel has not been established in pregnant or breast-feeding women. Renagel should 
only be given to pregnant or breast-feeding women if clearly needed. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 
Driving and using machines 
Renagel is unlikely to affect your ability to drive or to use machines. 
 
 
3. How to take Renagel 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. He will base the dose on your serum phosphate level. The recommended starting dose of 
Renagel for adults and the elderly (>65 years) is one or two tablets with each meal 3 times a day.  
 
Initially your doctor will check the levels of phosphate in your blood every 2-3 weeks and may adjust 
the dose of Renagel when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an 
adequate phosphate level. 
 
The tablets must be swallowed whole. Do not crush, chew or break into pieces prior to swallowing. 
 
Patients taking Renagel should adhere to their prescribed diet and liquid intake.  
 
If you take more Renagel than you should 
In the event of a possible overdose you should contact your doctor immediately. 
 
If you forget to take Renagel 
If you have missed one dose, this dose should be omitted and the next dose should be taken at the 
usual time with a meal. Do not take a double dose to make up for a forgotten dose. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Since constipation may be a preceding symptom in very rare cases of blockages in your intestine, it is 
important to inform your doctor or pharmacist of this symptom before or during the use of Renagel. 
 
The following side effects have been reported in patients taking Renagel:  
Very common (may affect more than 1 in 10 people): 
nausea, vomiting. 
Common (may affect up to 1 in 10 people):  
diarrhoea, indigestion, abdominal pain, constipation, flatulence. 



52 

Uncommon (may affect up to 1 in 100 people):  
increased acidity of the blood. 
Very rare (may affect up to 1 in 10000 people): 
hypersensitivity. 
Not known (frequency cannot be estimated from the available data): 
cases of itching, rash, abdominal pain, slow intestine motility (movement), inflammation of abnormal 
small pouches (called diverticula) in the large intestine, blockages in the intestine (signs include: 
severe bloating; abdominal pain, swelling or cramps; severe constipation), rupture in the intestine wall 
(signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen),serious 
inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine 
disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have 
been reported. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. 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 Renagel  
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date stated on the carton and bottle after “EXP”. The expiry 
date refers to the last day of that month. 
 
Do not store this medicine above 25 °C. Keep the bottle tightly closed 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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Renagel contains 
 
- The active substance is sevelamer hydrochloride. Each tablet contains 800 mg sevelamer 
hydrochloride. 
- The other ingredients are silica colloidal anhydrous and stearic acid, hypromellose (E464), 
diacetylated monoglycerides, iron oxide black (E172) and propylene glycol. 
 
What Renagel looks like and contents of the pack 
 
Renagel tablets are film coated, off white, oval tablets with Renagel 800 imprinted on one side. The 
tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure 
and an induction seal. 
 
Pack sizes are: 
1 bottle of 100 tablets 
1 bottle of 180 tablets 
multipacks containing 180 tablets (6 bottles of 30 tablets) 
multipacks containing 360 tablets (2 bottles of 180 tablets) 
multipacks containing 540 tablets (3 bottles of 180 tablets) 
 

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


53 

Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder:  
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
Manufacturer:  
Genzyme Ireland Limited 
IDA Industrial Park 
Old Kilmeaden Road 
Waterford 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg 
Sanofi Belgium 
Tél/Tel: + 32 2 710 54 00 
 

Lietuva 
UAB „SANOFI-AVENTIS LIETUVA“ 
Tel. +370 5 275 5224 
 

България 
SANOFI BULGARIA EOOD 
Tел: +359 2 9705300 

Magyarország 
SANOFI-AVENTIS Zrt 
Tel: +36 1 505 0050 
 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Malta 
Sanofi S.p.A. 
Tel: +39 02 39394275 

Danmark 
Sanofi A/S  
Tlf: +45 45 16 70 00 
 

Nederland 
sanofi-aventis Netherlands B.V.  
Tel: +31 20 245 4000 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel: +49 (0)180 2 222010 
 

Norge 
sanofi-aventis Norge AS 
Tlf: + 47 67 10 71 00 
 

Eesti 
sanofi-aventis Estonia OÜ 
Tel. +372 6 273 488 
 

Österreich 
sanofi-aventis GmbH 
Tel: + 43 1 80 185 - 0 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 1600 

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 

España 
sanofi-aventis, S.A. 
Tel: +34 93 485 94 00 
  

Portugal 
Sanofi – Produtos Farmacêuticos, Lda. 
Tel: +351 21 35 89 400 
 

France 
sanofi-aventis France 
Tél : 0 800 222 555 

România 
Sanofi Romania SRL 
Tel: +40 (0) 21 317 31 36  



54 

Appel depuis l’étranger : +33 1 57 63 23 23  
 
Hrvatska 
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 
 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 4800 
 

Ireland 
sanofi-aventis Ireland Ltd T/A SANOFI 
Tel:  +353 (0) 1 4035 600  

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel.:  +421 2 33 100 100 

 
Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Suomi/Finland 
Sanofi Oy 
Puh/Tel: + 358 201 200 300 
 

Italia 
Sanofi S.p.A. 
Tel: 800.536 389 

Sverige 
Sanofi AB 
Tel: +46 (0)8 634 50 00 
 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

 

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

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