Sevelamer carbonate Winthrop

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS  
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 800 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 800 mg sevelamer carbonate. 
 
For the full list of excipients, see section 6.1.  
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
The white to off-white tablets are imprinted with “SC800” on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving 
haemodialysis or peritoneal dialysis.  
 
Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with 
chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/L.  
 
Sevelamer carbonate Winthrop 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 to control the 
development of renal bone disease. 
 
4.2 Posology and method of administration 
 
Posology 
 
Starting dose 
The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and 
serum phosphorus level. Sevelamer carbonate Winthrop must be taken three times per day with meals. 
 

Serum phosphorus level in patients Total daily dose of sevelamer carbonate to be 
taken over 3 meals per day 

1.78 – 2.42 mmol/L (5.5 – 7.5 mg/dl) 2.4 g* 
> 2.42 mmol/L (> 7.5 mg/dl) 4.8 g* 

*Plus subsequent titrating, see section “Titration and maintenance” 
 
For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Sevelamer 
carbonate Winthrop should be given on a gram for gram basis with monitoring of serum phosphorus levels to 
ensure optimal daily doses. 
 
Titration and maintenance 
Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three 
times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, 
with regular monitoring thereafter. 
 
Patients taking Sevelamer carbonate Winthrop should adhere to their prescribed diets. 



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In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and 
the daily dose is expected to be an average of approximately 6 g per day. 
 
Special populations 
 
Elderly population 
No dosage adjustment is necessary in the elderly population. 
 
Hepatic impairment 
No studies have been performed in patients with hepatic impairment. 
 
Paediatric population 
The safety and efficacy of Sevelamer carbonate Winthrop in children below the age of 6 years or in children 
with a BSA (Body Surface Area) below 0.75 m2 have not been established. No data are available. 
 
The safety and efficacy of Sevelamer carbonate Winthrop in children over 6 year of age and a BSA 
>0.75 m2 have been established. Current available data are described in section 5.1. 
 
For paediatric patients the oral suspension should be administered, as tablet formulations are not 
appropriate for this population. 
 
Method of administration 
 
Oral use. 
Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to 
administration.  
Sevelamer carbonate Winthrop should be taken with food and not on an empty stomach. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
• Hypophosphataemia.  
• Bowel obstruction.  
 
4.4 Special warnings and precautions for use 
 
The safety and efficacy of sevelamer carbonate have not been established in adult patients with chronic 
kidney disease not on dialysis with serum phosphorus < 1.78 mmol/L. Therefore it is currently not 
recommended for use in these patients. 
 
The safety and efficacy of sevelamer carbonate have not been established in patients with the following 
disorders: 
• dysphagia 
• swallowing disorders 
• severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric 

contents and abnormal or irregular bowel motion 
• active inflammatory bowel disease 
• major gastrointestinal tract surgery 
Treatment of these patients with Sevelamer carbonate Winthrop should only be initiated after careful 
benefit/risk assessment. If the therapy is initiated, patients suffering from these disorders should be 
monitored. Sevelamer carbonate treatment should be reevaluated in patients who develop severe constipation 
or other severe gastrointestinal symptoms. 
 



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Intestinal obstruction and ileus/subileus 
 
In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment 
with sevelamer hydrochloride (capsules/tablets), which contains the same active moiety as sevelamer 
carbonate. Constipation may be a preceding symptom. Patients who are constipated should be monitored 
carefully while being treated with sevelamer carbonate. The treatment should be re-evaluated in patients who 
develop severe constipation or other severe gastrointestinal symptoms. 
 
Fat-soluble vitamins and folate deficiency 
 
Patients with CKD may develop low levels of fat-soluble vitamins A, D, E and K, depending on dietary 
intake and the severity of their disease. It cannot be excluded that sevelamer carbonate can bind fat-soluble 
vitamins contained in ingested food. In patients not taking supplemental vitamins but on sevelamer, serum 
vitamin A, D, E and K status should be assessed regularly. It is recommended that vitamin supplements be 
given if necessary. It is recommended that CKD patients not on dialysis are given vitamin D supplements 
(approximately 400 IU of native vitamin D daily) which can be part of a multivitamin preparation to be taken 
apart from their dose of sevelamer carbonate. In patients undergoing peritoneal dialysis additional 
monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were 
not measured in a clinical study in these patients. 
 
There is at present insufficient data to exclude the possibility of folate deficiency during long term sevelamer 
carbonate treatment. In patients not taking supplemental folic acid but on sevelamer, folate level should be 
assessed regularly. 
 
Hypocalcaemia/hypercalcaemia 
 
Patients with CKD may develop hypocalcaemia or hypercalcaemia. Serum calcium levels should therefore 
be monitored at regular intervals and elemental calcium should be given as a supplement if required.  
 
Metabolic acidosis 
 
Patients with CKD are predisposed to developing metabolic acidosis. As part of good clinical practice, 
monitoring of serum bicarbonate levels is therefore recommended. 
 
Peritonitis 
 
Patients receiving dialysis are subject to certain risks for infection specific to dialysis modality. Peritonitis is 
a known complication in patients receiving peritoneal dialysis and in a clinical trial with sevelamer 
hydrochloride, a greater number of peritonitis cases were reported in the sevelamer group than in the control 
group. Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate 
aseptic technique with the prompt recognition and management of any signs and symptoms associated with 
peritonitis. 
 
Swallowing and choking difficulties 
 
Difficulties swallowing the Sevelamer carbonate Winthrop tablet have been reported. Many of these cases 
involved patients with co-morbid conditions including swallowing disorders or oesophageal abnormalities. 
Proper swallowing ability should be carefully monitored in patients with co-morbid conditions. The use of 
sevelamer carbonate powder in patients with a history of difficulty swallowing should be considered. 
 
Hypothyroidism 
 
Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and 
levothyroxine is recommended (see section 4.5). 
 



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Hyperparathyroidism 
 
Sevelamer carbonate is not indicated for the control of hyperparathyroidism. In patients with secondary 
hyperparathyroidism sevelamer carbonate should be used within the context of a multiple therapeutic 
approach, which could include calcium as supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues 
to lower the intact parathyroid hormone (iPTH) levels. 
 
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 carbonate treatment should be re-
evaluated in patients who develop severe gastrointestinal symptoms. 
 
Sodium content 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially 
‘sodium-free’. 
 
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, which contains the same active moiety 
as sevelamer carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when co-
administered with sevelamer hydrochloride in a single dose study. Consequently, sevelamer carbonate 
should not be taken simultaneously with ciprofloxacin. 
 
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients 
 
Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant 
patients when co-administered with sevelamer hydrochloride without any clinical consequences (e.g., graft 
rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood 
concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of 
combination and after its withdrawal.  
 
Levothyroxine 
 
Very rare cases of hypothyroidism have been reported in patients co-administered with sevelamer 
hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine. Closer 
monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving 
sevelamer carbonate and levothyroxine. 
 
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. Therefore, possible reduction 
in absorption cannot be excluded. The anti-arrhythmic medical product should be taken at least one hour 
before or three hours after Sevelamer carbonate Winthrop, and blood monitoring can be considered. 
 
Proton pump inhibitors 



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During post-marketing experience, very rare cases of increased phosphate levels have been reported in 
patients taking proton pump inhibitors co-administered with sevelamer carbonate. Caution should be 
exercised when prescribing PPI to patients concomitantly treated with Sevelamer carbonate Winthrop. The 
phosphate serum level should be monitored and the sevelamer carbonate dosage adjusted consequently. 
 
Bioavailability 
 
Sevelamer carbonate 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 sevelamer carbonate, or the physician should consider monitoring blood levels. 
 
Digoxin, warfarin, enalapril or metoprolol 
  
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety 
as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of sevelamer in pregnant women. Animal studies have 
shown some reproductive toxicity when sevelamer was administered to rats at high doses (see section 5.3). 
Sevelamer has also been shown to reduce the absorption of several vitamins including folic acid (see 
sections 4.4 and 5.3). The potential risk to humans is unknown. Sevelamer carbonate 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. 
 
Breast-feeding 
 
It is unknown whether sevelamer/metabolites are excreted in human milk. The non-absorbed nature of 
sevelamer indicates that excretion of sevelamer in breast milk is unlikely. A decision on whether to 
continue/discontinue breast-feeding or to continue/discontinue therapy with sevelamer carbonate should be 
made taking into account the benefit of breast-feeding to the child and the benefit of sevelamer carbonate 
therapy to the woman. 
 
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 BSA. 
 
4.7 Effects on ability to drive and use machines 
 
Sevelamer has no or negligible influence on the ability to drive and use machines. 
 



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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: nausea (very common), vomiting (very common), upper abdominal pain (very common), 
constipation (very common), diarrhea (common), dyspepsia (common) and flatulence (common).  
 
Constipation can be an early symptom of serious gastrointestinal adverse reactions. The most serious adverse 
reactions are hypersensitivity (very rare frequency), intestinal obstruction (not known frequency), 
ileus/subileus (not known frequency), intestinal perforation (not known frequency), serious inflammatory 
gastrointestinal disorders associated with the presence of sevelamer crystals (not known frequency). 
 
 
Tabulated list of adverse reactions 
 
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous 
clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks 
(724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis 
patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with 
CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer 
hydrochloride and 49 with sevelamer carbonate). 
 
Adverse reactions that occurred during clinical trials or 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 
 

Very rare 
 

Not known 

Immune system 
disorders 

  Hypersensitivity  

Gastrointestinal 
disorders 

Nausea,  
Vomiting,  
Upper abdominal 
pain,  
Constipation 

Diarrhoea,  
Dyspepsia,  
Flatulence,  
Abdominal pain 

 Intestinal 
obstruction,  
Ileus/subileus,  
Intestinal 
perforation1 
Gastrointestinal 
hemorrhage1, 
Intestinal 
ulceration1, 
Gastrointestinal 
necrosis1,  
Colitis1, 
Intestinal mass1 

Skin and 
subcutaneous 
tissue disorders 

   Pruritus,  
Rash 

Investigations    Crystal deposit 
intestine1 

1 See inflammatory gastrointestinal disorders warning in section 4.4 
 
Paediatric population 
 
In general, the safety profile for children and adolescents (6 to 18 years of age) is similar to the safety profile 
for adults. 



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Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 
to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose 
 
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to 
normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reactions. In 
CKD patients, the maximum average daily dose studied was 14.4 grams of sevelamer carbonate in a single 
daily dose. 
 
The symptoms observed in case of overdose are similar to adverse reactions listed in section 4.8, including 
mainly constipation and other known gastrointestinal disorders. 
 
Appropriate symptomatic treatment should be provided. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: All other therapeutic products, drugs for treatment of hyperkalemia and 
hyperphosphataemia. ATC code: V03A E02. 
 
Mechanism of action 
 
Sevelamer carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding crosslinked polymer. 
Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become 
protonated in the stomach. These protonated amines bind negatively charged ions such as dietary phosphate 
in the intestine.  
 
Pharmacodynamic effects 
 
By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the 
phosphorus concentration in the serum. Regular monitoring of serum phosphorus levels is always necessary 
during phosphate binder administration. 
 
Clinical efficacy and safety 
 
In two randomised, cross over clinical trials, sevelamer carbonate in both tablet and powder formulations 
when administered three times per day has been shown to be therapeutically equivalent to sevelamer 
hydrochloride and therefore effective in controlling serum phosphorus in CKD patients on haemodialysis. 
 
The first study demonstrated that sevelamer carbonate tablets dosed three times per day was equivalent to 
sevelamer hydrochloride tablets dosed three times per day in 79 haemodialysis patients treated over two 
randomised 8 week treatment periods (mean serum phosphorus time-weighted averages were 
1.5 ± 0.3 mmol/L for both sevelamer carbonate and sevelamer hydrochloride). The second study 
demonstrated that sevelamer carbonate powder dosed three times per day was equivalent to sevelamer 
hydrochloride tablets dosed three times per day in 31 hyperphosphataemic (defined as serum phosphorus 
levels ≥ 1.78 mmol/L) haemodialysis patients over two randomised 4 week treatment periods (mean serum 
phosphorus time-weighted averages were 1.6 ± 0.5 mmol/L for sevelamer carbonate powder and 
1.7 ± 0.4 mmol/L for sevelamer hydrochloride tablets).  
 

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


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In the clinical trials in haemodialysis patients, sevelamer alone did not have a consistent and clinically 
significant effect on iPTH. In a 12 week study involving peritoneal dialysis patients however, similar iPTH 
reductions were seen compared with patients receiving calcium acetate. In patients with secondary 
hyperparathyroidism sevelamer carbonate should be used within the context of a multiple therapeutic 
approach, which could include calcium as supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues 
to lower the iPTH levels. 
 
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 
of sevelamer, both the mean total-cholesterol and LDL-cholesterol declined by 15-39%. The decrease in 
cholesterol has been observed after 2 weeks of treatment and is maintained with long-term treatment. 
Triglycerides, HDL-cholesterol and albumin levels did not change following sevelamer treatment. 
 
Because sevelamer binds bile acids, it may interfere with the absorption of fat soluble vitamins such as A, D, 
E and K. 
 
Sevelamer does not contain calcium and decreases the incidence of hypercalcaemic episodes as compared to 
patients using calcium based phosphate binders alone. The effects of sevelamer on phosphorus and calcium 
were proven to be maintained throughout a study with one year follow-up. This information was obtained 
from studies in which sevelamer hydrochloride was used. 
 
Paediatric population 
 
The safety and effectiveness of sevelamer carbonate in hyperphosphatemic paediatric patients with CKD was 
evaluated in a multicenter study with a 2-week, randomised, placebo-controlled, fixed dose period (FDP) 
followed by a 6-month, single-arm, open-label, dose titration period (DTP). A total of 101 patients (6 to 18 
years old with a BSA range of 0.8 m2 to 2.4 m2) were randomised in the study. Forty-nine (49) patients 
received sevelamer carbonate and 51 received placebo during the 2 week FDP. Thereafter all patients 
received sevelamer carbonate for the 26-week DTP. The study met its primary endpoint, meaning sevelamer 
carbonate reduced serum phosphorus by an LS mean difference of 0.90 mg/dL compared to placebo, and 
secondary efficacy endpoints. In paediatric patients with hyperphosphatemia secondary to CKD, sevelamer 
carbonate significantly reduced serum phosphorus levels compared to placebo during a 2-week FDP. The 
treatment response was maintained in the paediatric patients who received sevelamer carbonate during the 6-
month open-label DTP. 27% of paediatric patients reached their age appropriate serum phosphorus level at 
end of treatment. These figures were 23% and 15% in the subgroup of patients on hemodialysis and 
peritoneal dialysis, respectively. The treatment response during the 2-week FDP was not affected by BSA, in 
contrast however, no treatment response was observed in paediatric patients with qualifying phosphorus 
levels <7.0 mg/dL. Most of adverse reactions reported were gastrointestinal in nature. No new risks or safety 
signals were identified with the use of sevelamer carbonate during the study. 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic studies have not been carried out with sevelamer carbonate. Sevelamer hydrochloride, 
which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal 
tract, as confirmed by an absorption study in healthy volunteers. 
 
In a clinical trial of one year, no evidence of accumulation of sevelamer was seen. However the potential 
absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally 
excluded. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, 
repeated dose toxicity or genotoxicity.  
 



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Carcinogenicity studies with oral sevelamer hydrochloride were conducted in mice (doses of up to 
9 g/kg/day) and rats (0.3, 1, or 3 g/kg/day). There was an increased incidence of urinary bladder transitional 
cell papilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial 
dose of 14.4 g). There was no increased incidence of tumours observed in mice (human equivalent dose 
3 times the maximum clinical trial dose). 
 
In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a 
statistically significant increase in the number of structural chromosome aberrations. Sevelamer 
hydrochloride was not mutagenic in the Ames bacterial mutation assay. 
 
In rats and dogs, sevelamer reduced absorption of fat soluble vitamins D, E and K (coagulation factors), and 
folic acid. 
 
Deficits in skeletal ossification were observed in several locations in foetuses of female rats dosed with 
sevelamer at intermediate and high doses (human equivalent dose less than the maximum clinical trial dose 
of 14.4 g). The effects may be secondary to vitamin D depletion. 
 
In pregnant rabbits given oral doses of sevelamer hydrochloride by gavage during organogenesis, an increase 
of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical 
trial dose). 
 
Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study 
in which the females were treated from 14 days prior to mating through gestation and the males were treated 
for 28 days prior to mating. The highest dose in this study was 4.5 g/kg/day (human equivalent dose 2 times 
the maximum clinical trial dose of 13 g/day, based on a comparison of relative BSA). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core: 
 
Microcrystalline cellulose 
Sodium chloride 
Zinc stearate 
 
Film-coating: 
 
Hypromellose (E464) 
Diacetylated monoglycerides 
 
Printing ink: 
 
Iron oxide black (E172) 
Propylene glycol 
Isopropyl alcohol 
Hypromellose (E464) 
 
6.2 Incompatibilities 
 
Not applicable. 
 



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6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Keep the bottle tightly closed in order to protect from moisture. 
 
This medicinal product does not require any special temperature storage conditions. 
 
6.5 Nature and contents of container 
 
HDPE bottles with a child resistant polypropylene closure and a foil induction seal. 
Each bottle contains 30 tablets or 180 tablets. 
Packs of 1 bottle of 30 tablets or bottles of 180 tablets without outer carton. 
 
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 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/952/001   180 film-coated tablets 
EU/1/14/952/004   30 film-coated tablets 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15 January 2015 
Date of latest renewal: 11 November 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/


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1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 0.8 g powder for oral suspension 
 
 
2.    QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each sachet contains 0.8 g sevelamer carbonate. 
 
Excipient with known effect 
This medicine contains 8.42 mg propylene glycol alginate (E405) in each 0.8 g sachet 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for oral suspension. 
Pale yellow powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving 
haemodialysis or peritoneal dialysis. 
 
Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with 
chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/l. 
 
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in paediatric patients (>6 
years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease. 
 
Sevelamer carbonate Winthrop 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 to control the 
development of renal bone disease. 
 
4.2 Posology and method of administration 
 
Posology 
 
Starting dose 
 
Adults 
The recommended starting dose of sevelamer carbonate for adults is 2.4 g or 4.8 g per day based on clinical 
needs and serum phosphorus level. Sevelamer carbonate Winthrop must be taken three times per day with 
meals. 
 

Serum phosphorus level in patients Total daily dose of sevelamer carbonate to be 
taken over 3 meals per day 

1.78 – 2.42 mmol/l (5.5 – 7.5 mg/dl) 2.4 g* 
> 2.42 mmol/l (> 7.5 mg/dl) 4.8 g* 

*Plus subsequent titrating, see section “Titration and maintenance”  
 
Children/adolescents (>6 years of age and a BSA of >0.75m2) 



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The recommended starting dose of sevelamer carbonate for children is between 2.4 g and 4.8 g per day based 
on the patient’s BSA category. Sevelamer carbonate Winthrop must be taken three times per day with meals or 
snacks.    
 

BSA (m2) Total daily dose of sevelamer carbonate to be taken over 3 meals/snacks per day 
>0.75 to <1.2 2.4 g** 

≥1.2 4.8 g** 
       **Plus subsequent titrating, see section “Titration and maintenance” 
 
For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Sevelamer 
carbonate Winthrop should be given on a gram for gram basis with monitoring of serum phosphorus levels to 
ensure optimal daily doses. 
 
Titration and maintenance 
 
Adults 
For adult patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated 
by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus 
level is reached, with regular monitoring thereafter. 
 
In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and 
the daily adult dose is expected to be an average of approximately 6 g per day. 
 
Children and adolescents (>6 years of age and a BSA of >0.75m2): 
For paediatric patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate 
titrated in increments based on patient’s BSA, three times per day every 2-4 weeks until an acceptable serum 
phosphorus level is reached, with regular monitoring thereafter. 
 

Paediatric dose based on BSA (m2) 
 

BSA (m2) Starting dose Titration increases/decreases 
>0.75 to <1.2 0.8 g three times daily Titrate up/down by 0.4 g three times daily 

≥1.2 1.6 g three times daily Titrate up/down by 0.8 g three times daily 
 
Patients taking sevelamer carbonate should adhere to their prescribed diets. 
 
Special populations 
 
Elderly population 
No dosage adjustment is necessary in the elderly population. 
 
Hepatic impairment 
No studies have been performed in patients with hepatic impairment. 
 
Paediatric population 
The safety and efficacy of Sevelamer carbonate Winthrop in children below the age of 6 years or in children 
with a BSA below 0.75 m2 have not been established. No data are available.  
 
For paediatric patients with a <1.2 BSA (m2), the oral suspension should be administered, as tablet 
formulations were not tested in this population and therefore are not appropriate for this population.   
 
Method of administration: 
 
Oral use. 



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Each sachet of 0.8 g of powder is to be dispersed in 30 mL of water prior to administration (see section 6.6). 
The suspension should be ingested within 30 minutes after being prepared. Sevelamer carbonate Winthrop 
should be taken with food and not on an empty stomach. 
As an alternative to water, the powder may be pre-mixed with a small amount of beverage or food (e.g. 
100grams/120 ml) and consumed within 30 minutes. Sevelamer carbonate Winthrop powder should not be 
heated (e.g. microwave) or added to heated foods or liquids. 
 
(Instructions for presentation WITH dosing spoon) 
To achieve the correct dose, the dosing spoon provided in the carton must be used to measure 0.4 g of 
Sevelamer carbonate Winthrop. Further instructions are detailed in the patient leaflet.  
 
(Instructions for presentation WITHOUT dosing spoon) 
 
To achieve the correct dose when the sachet has to be divided, please use the dedicated presentation of 0.8 g 
powder with dosing spoon. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
• Hypophosphataemia.  
• Bowel obstruction.  
 
4.4 Special warnings and precautions for use 
 
The safety and efficacy of sevelamer carbonate have not been established in adult patients with chronic 
kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Therefore it is currently not 
recommended for use in these patients. 
 
The safety and efficacy of sevelamer carbonate have not been established in patients with the following 
disorders: 
• dysphagia 
• swallowing disorders 
• severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric 

contents and abnormal or irregular bowel motion 
• active inflammatory bowel disease 
• major gastrointestinal tract surgery 
 
Treatment of these patients with Sevelamer carbonate Winthrop should only be initiated after careful 
benefit/risk assessment. If the therapy is initiated, patients suffering from these disorders should be 
monitored. Sevelamer carbonate treatment should be reevaluated in patients who develop severe constipation 
or other severe gastrointestinal symptoms. 
 
Intestinal obstruction and ileus/subileus 
 
In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment 
with sevelamer hydrochloride (capsules/tablets), which contains the same active moiety as sevelamer 
carbonate. Constipation may be a preceding symptom. Patients who are constipated should be monitored 
carefully while being treated with sevelamer carbonate. The treatment should be re-evaluated in patients who 
develop severe constipation or other severe gastrointestinal symptoms. 
 
Fat-soluble vitamins and folate deficiency 
 
Patients with CKD may develop low levels of fat-soluble vitamins A, D, E and K, depending on dietary 
intake and the severity of their disease. It cannot be excluded that sevelamer carbonate can bind fat-soluble 
vitamins contained in ingested food. In patients not taking supplemental vitamins but on sevelamer, serum 
vitamin A, D, E and K status should be assessed regularly. It is recommended that vitamin supplements be 



15 

given if necessary. It is recommended that CKD patients not on dialysis are given vitamin D supplements 
(approximately 400 IU of native vitamin D daily) which can be part of a multivitamin preparation to be taken 
apart from their dose of sevelamer carbonate. In patients undergoing peritoneal dialysis additional 
monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were 
not measured in a clinical study in these patients. 
 
There is at present insufficient data to exclude the possibility of folate deficiency during long term sevelamer 
carbonate treatment. In patients not taking supplemental folic acid but on sevelamer, folate level should be 
assessed regularly. 
 
Hypocalcaemia/hypercalcaemia 
 
Patients with CKD may develop hypocalcaemia or hypercalcaemia. Serum calcium levels should therefore 
be monitored at regular intervals and elemental calcium should be given as a supplement if required.  
 
Metabolic acidosis 
 
Patients with CKD are predisposed to developing metabolic acidosis. As part of good clinical practice, 
monitoring of serum bicarbonate levels is therefore recommended. 
 
Peritonitis 
 
Patients receiving dialysis are subject to certain risks for infection specific to dialysis modality. Peritonitis is 
a known complication in patients receiving peritoneal dialysis and in a clinical trial with sevelamer 
hydrochloride, a greater number of peritonitis cases were reported in the sevelamer group than in the control 
group. Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate 
aseptic technique with the prompt recognition and management of any signs and symptoms associated with 
peritonitis. 
 
Hypothyroidism 
 
Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and 
levothyroxine is recommended (see section 4.5). 
 
Hyperparathyroidism 
 
Sevelamer carbonate is not indicated for the control of hyperparathyroidism. In patients with secondary 
hyperparathyroidism sevelamer carbonate  should be used within the context of a multiple therapeutic 
approach, which could include calcium as supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues 
to lower the intact parathyroid hormone (iPTH) levels. 
 
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 carbonate treatment should be re-
evaluated in patients who develop severe gastrointestinal symptoms. 
 
Sodium content 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 



16 

Dialysis 
 
Interaction studies have not been conducted in patients on dialysis. 
 
Ciprofloxacin 
 
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety 
as sevelamer carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when co-
administered with sevelamer hydrochloride in a single dose study. Consequently, sevelamer carbonate 
should not be taken simultaneously with ciprofloxacin. 
 
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients 
 
Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant 
patients when co-administered with sevelamer hydrochloride without any clinical consequences (e.g., graft 
rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood 
concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of 
combination and after its withdrawal.  
 
Levothyroxine 
 
Very rare cases of hypothyroidism have been reported in patients co-administered with sevelamer 
hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine. Closer 
monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving 
sevelamer carbonate and levothyroxine. 
 
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.  Therefore, possible reduction 
in absorption cannot be excluded. The anti-arrhythmic medicinal product should be taken at least one hour 
before or three hours after Sevelamer carbonate Winthrop and blood monitoring can be considered. 
 
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 carbonate. Caution should be 
exercised when prescribing PPI to patients concomitantly treated with Sevelamer carbonate Winthrop. The 
phosphate serum level should be monitored and the Sevelamer carbonate dosage adjusted consequently. 
 
Bioavailability 
 
Sevelamer carbonate 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 sevelamer carbonate, or the physician should consider monitoring blood levels. 
 
Digoxin, warfarin, enalapril or metoprolol 
  
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety 
as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 



17 

There are no or limited amount of data from the use of sevelamer in pregnant women. Animal studies have 
shown some reproductive toxicity when sevelamer was administered to rats at high doses (see section 5.3). 
Sevelamer has also been shown to reduce the absorption of several vitamins including folic acid (see 
sections 4.4 and 5.3). The potential risk to humans is unknown. Sevelamer carbonate 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. 
 
Breast-feeding 
 
It is unknown whether sevelamer/metabolites are excreted in human milk. The non-absorbed nature of 
sevelamer indicates that excretion of sevelamer in breast milk is unlikely.  A decision on whether to 
continue/discontinue breast-feeding or to continue/discontinue therapy with sevelamer carbonate  should be 
made taking into account the benefit of breast-feeding to the child and the benefit of sevelamer carbonate  
therapy to the woman.  
 
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 BSA. 
 
4.7 Effects on ability to drive and use machines 
 
Sevelamer has no or negligible influence on the ability to drive and use machines. 
 
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: nausea (very common), vomiting (very common), upper abdominal pain (very common), 
constipation (very common), diarrhea (common), dyspepsia (common) and flatulence (common).  
 
Constipation can be an early symptom of serious gastrointestinal adverse reactions. The most serious adverse 
reactions are hypersensitivity (very rare frequency), intestinal obstruction (not known frequency), 
ileus/subileus (not known frequency), intestinal perforation (not known frequency), serious inflammatory 
gastrointestinal disorders associated with the presence of sevelamer crystals (not known frequency). 
 
Tabulated list of adverse reactions 
 
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous 
clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks 
(724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis 
patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with 
CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer 
hydrochloride and 49 with sevelamer carbonate). 
 
Adverse reactions that occurred during clinical trials or 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 available data). 
  



18 

MedDRA System 
Organ Class 

Very common Common Very rare Not known 

Immune system 
disorders 

  Hypersensitivity  

Gastrointestinal 
disorders 

Nausea,  
Vomiting,  
Upper abdominal 
pain,  
Constipation 

Diarrhoea,  
Dyspepsia,  
Flatulence,  
Abdominal pain 

 Intestinal 
obstruction,  
Ileus/subileus,  
Intestinal 
perforation1,  
Gastrointestinal 
hemorrhage1 
Intestinal 
ulceration1, 
Gastrointestinal 
necrosis1,  
Colitis1, 
Intestinal mass1 

Skin and 
subcutaneous 
tissue disorders 

   Pruritus,  
Rash 

Investigations    Crystal deposit 
intestine1 

1 See inflammatory gastrointestinal disorders warning in section 4.4 
 
Paediatric population 
 
In general, the safety profile for children and adolescents (6 to 18 years of age) is similar to the safety profile 
for adults. 
 
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 
 
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to 
normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reactions. In 
CKD patients, the maximum average daily dose studied was 14.4 grams of sevelamer carbonate in a single 
daily dose. 

 
The symptoms observed in case of overdose are similar to adverse reactions listed in section 4.8, including 
mainly constipation and other known gastrointestinal disorders. 
 
Appropriate symptomatic treatment should be provided. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: All other therapeutic products, drugs for treatment of hyperkalemia and 
hyperphosphataemia. ATC code: V03A E02. 
 
Mechanism of action 

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


19 

 
Sevelamer carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding crosslinked polymer. 
Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become 
protonated in the stomach. These protonated amines bind negatively charged ions such as dietary phosphate 
in the intestine.  
 
Pharmacodynamic effects 
 
By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the 
phosphorus concentration in the serum. Regular monitoring of serum phosphorus levels is always necessary 
during phosphate binder administration. 
 
Clinical efficacy and safety 
 
In two randomised, cross over clinical trials, sevelamer carbonate has been shown to be therapeutically 
equivalent to sevelamer hydrochloride and therefore effective in controlling serum phosphorus in CKD 
patients on haemodialysis.  These also demonstrated that sevelamer carbonate in both tablet and powder 
formulations are therapeutically equivalent to sevelamer hydrochloride. 
 
The first study demonstrated that sevelamer carbonate tablets dosed three times per day was equivalent to 
sevelamer hydrochloride tablets dosed three times per day in 79 haemodialysis patients treated over two 
randomised 8 week treatment periods (mean serum phosphorus time-weighted averages were 
1.5 ± 0.3 mmol/l for both sevelamer carbonate and sevelamer hydrochloride). The second study 
demonstrated that sevelamer carbonate powder dosed three times per day was equivalent to sevelamer 
hydrochloride tablets dosed three times per day in 31 hyperphosphataemic (defined as serum phosphorus 
levels ≥ 1.78 mmol/l) haemodialysis patients over two randomised 4 week treatment periods (mean serum 
phosphorus time-weighted averages were 1.6 ± 0.5 mmol/l for sevelamer carbonate powder and 
1.7 ± 0.4 mmol/l for sevelamer hydrochloride tablets). 
 
In the clinical trials in haemodialysis patients, sevelamer alone did not have a consistent and clinically 
significant effect on 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 sevelamer carbonate should be used within the context of a multiple therapeutic 
approach, which could include calcium as supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues 
to lower the iPTH levels. 
 
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 
of sevelamer, both the mean total-cholesterol and LDL-cholesterol declined by 15-39%. The decrease in 
cholesterol has been observed after 2 weeks of treatment and is maintained with long-term treatment. 
Triglycerides, HDL-cholesterol and albumin levels did not change following sevelamer treatment. 
 
Because sevelamer binds bile acids, it may interfere with the absorption of fat soluble vitamins such as A, D, 
E and K. 
 
Sevelamer does not contain calcium and decreases the incidence of hypercalcaemic episodes as compared to 
patients using calcium based phosphate binders alone. The effects of sevelamer on phosphorus and calcium 
were proven to be maintained throughout a study with one year follow-up. This information was obtained 
from studies in which sevelamer hydrochloride was used. 
 
Paediatric population 
 
The safety and effectiveness of sevelamer carbonate in hyperphosphatemic paediatric patients with CKD was 
evaluated in a multicenter study with a 2-week, randomised, placebo-controlled, fixed dose period (FDP) 
followed by a 6-month, single-arm, open-label, dose titration period (DTP). A total of 101 patients (6 to 18 
years old with a BSA range of 0.8 m2 to 2.4 m2) were randomised in the study. Forty-nine (49) patients 



20 

received sevelamer carbonate and 51 received placebo during the 2 week FDP. Thereafter all patients 
received sevelamer carbonate for the 26-week DTP. The study met its primary endpoint, meaning sevelamer 
carbonate reduced serum phosphorus by an LS mean difference of 0.90 mg/dL compared to placebo, and 
secondary efficacy endpoints. In paediatric patients with hyperphosphatemia secondary to CKD, sevelamer 
carbonate significantly reduced serum phosphorus levels compared to placebo during a 2-week FDP. The 
treatment response was maintained in the paediatric patients who received sevelamer carbonate during the 6-
month open-label DTP. 27% of paediatric patients reached their age appropriate serum phosphorus level at 
end of treatment. These figures were 23% and 15% in the subgroup of patients on hemodialysis and 
peritoneal dialysis, respectively. The treatment response during the 2-week FDP was not affected by BSA, in 
contrast however, no treatment response was observed in pediatric patients with qualifying phosphorus levels 
<7.0 mg/dL. Most of adverse reactions reported were gastrointestinal in nature. No new risks or safety 
signals were identified with the use of sevelamer carbonate during the study. 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic studies have not been carried out with sevelamer carbonate. Sevelamer hydrochloride, 
which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal 
tract, as confirmed by an absorption study in healthy volunteers. 
 
In a clinical trial of one year, no evidence of accumulation of sevelamer was seen. However the potential 
absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally 
excluded. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, 
repeated dose toxicity or genotoxicity.  
 
Carcinogenicity studies with oral sevelamer hydrochloride were conducted in mice (doses of up to 
9 g/kg/day) and rats (0.3, 1, or 3 g/kg/day). There was an increased incidence of urinary bladder transitional 
cell papilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial 
dose of 14.4 g). There was no increased incidence of tumors observed in mice (human equivalent dose 
3 times the maximum clinical trial dose). 
 
In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a 
statistically significant increase in the number of structural chromosome aberrations. Sevelamer 
hydrochloride was not mutagenic in the Ames bacterial mutation assay. 
 
In rats and dogs, sevelamer reduced absorption of fat soluble vitamins D, E and K (coagulation factors), and 
folic acid. 
 
Deficits in skeletal ossification were observed in several locations in foetuses of female rats dosed with 
sevelamer at intermediate and high doses (human equivalent dose less than the maximum clinical trial dose 
of 14.4 g). The effects may be secondary to vitamin D depletion. 
 
In pregnant rabbits given oral doses of sevelamer hydrochloride by gavage during organogenesis, an increase 
of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical 
trial dose). 
 
Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study 
in which the females were treated from 14 days prior to mating through gestation and the males were treated 
for 28 days prior to mating. The highest dose in this study was 4.5 g/kg/day (human equivalent dose 2 times 
the maximum clinical trial dose of 13 g/day, based on a comparison of relative BSA).  
 
 



21 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Propylene glycol alginate (E405) 
Citrus cream flavour 
Sodium chloride 
Sucralose 
Iron oxide yellow (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
After reconstitution 
  
The oral suspension must be administered within 30 minutes. 
 
(Instructions for presentation with dosing spoon)  
The sachet has to be discarded after 24 hours of opening 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Sachet of ethylene methacrylic acid copolymer, polyester, LDPE and aluminium foil laminate, with a heat seal.  
 
Each sachet contains 0.8 g of sevelamer carbonate.  
 
(Instructions for presentation with dosing spoon) 
Each carton contains 90 sachets and a dosing spoon to measure the 0.4 g dose of powder.  
 
6.6 Special precautions for disposal and other handling 
 
The powder should be dispersed in 30 mL of water per sachet prior to administration. The suspension powder 
is pale yellow and has a citrus flavour. 
 
The powder may also be pre-mixed with cold beverage or unheated food (see section 4.2). The powder should 
not be heated (e.g. microwave). 
 
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 
 



22 

 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/952/005 90 sachets 
EU/1/14/952/006 90 sachets (with dosing spoon) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15 January 2015 
Date of latest renewal: 11 November 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/


23 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 2.4 g powder for oral suspension 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each sachet contains 2.4 g sevelamer carbonate. 
 
Excipient with known effect 
This medicine contains 25.27 mg propylene glycol alginate (E405) in each 2.4 g sachet. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for oral suspension. 
Pale yellow powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving 
haemodialysis or peritoneal dialysis. 
 
Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with 
chronic kidney disease (CKD) not on dialysis with serum phosphorus > 1.78 mmol/L. 
 
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in paediatric patients (>6 
years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease. 
 
Sevelamer carbonate Winthrop 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 to control the 
development of renal bone disease. 
 
4.2 Posology and method of administration 
 
Posology 
 
Starting dose 
 
Adults 
The recommended starting dose of sevelamer carbonate for adults is 2.4 g or 4.8 g per day based on clinical 
needs and serum phosphorus level. Sevelamer carbonate Winthrop must be taken three times per day with 
meals. 
 

Serum phosphorus level in patients Total daily dose of sevelamer carbonate to be 
taken over 3 meals per day 

1.78 – 2.42 mmol/L (5.5 – 7.5 mg/dl) 2.4 g* 
> 2.42 mmol/L (> 7.5 mg/dl) 4.8 g* 

*Plus subsequent titrating, see section “Titration and maintenance” 
 
Children/adolescents (>6 years of age and a BSA of >0.75m2) 



24 

The recommended starting dose of sevelamer carbonate for children is between 2.4 g and 4.8 g per day based 
on the patient’s BSA category.  Sevelamer carbonate Winthrop must be taken three times per day with meals 
or snacks.    

 

BSA (m2) Total daily dose of sevelamer carbonate to be taken over 3 meals/snacks per day 
>0.75 to <1.2 2.4 g** 

≥1.2 4.8 g** 
       **Plus subsequent titrating, see section “Titration and maintenance” 
 
For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Sevelamer 
carbonate Winthrop should be given on a gram for gram basis with monitoring of serum phosphorus levels to 
ensure optimal daily doses. 
 
Titration and maintenance 
 
Adults 
For adult patients, serum phosphorus must be monitored and the dose of sevelamer carbonate titrated by 0.8 
g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is 
reached, with regular monitoring thereafter. 
 
In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and 
the daily adult dose is expected to be an average of approximately 6 g per day. 
 
Children and adolescents (>6 years of age and a BSA of >0.75m2) 
For paediatric patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate 
titrated in increments based on patient’s BSA, three times per day every 2-4 weeks until an acceptable serum 
phosphorus level is reached, with regular monitoring thereafter. 
 

                          Paediatric dose based on BSA (m2) 
 

BSA (m2) Starting dose Titration increases/decreases 

>0.75 to <1.2 0.8 g three times daily Titrate up/down by 0.4 g three times daily 

≥1.2 1.6 g three times daily Titrate up/down by 0.8 g three times daily 
 
Patients taking sevelamer carbonate should adhere to their prescribed diets. 
 
Special populations 
 
Elderly population 
No dosage adjustment is necessary in the elderly population. 
 
Hepatic impairment 
No studies have been performed in patients with hepatic impairment. 
 
Paediatric population 
The safety and efficacy of Sevelamer carbonate Winthrop in children below the age of 6 years or in children 
with a BSA below 0.75 m2 have not been established. No data are available. 
 
For paediatric patients with a <1.2 BSA (m2), the oral suspension should be administered, as tablet 
formulations were not tested in this population and therefore are not appropriate for this population.   
 



25 

Method of administration 
 
Oral use. 
Each sachet of 2.4 g of powder is to be dispersed in 60 ml of water prior to administration (see section 6.6). 
The suspension should be ingested within 30 minutes after being prepared. Sevelamer carbonate Winthrop 
should be taken with food and not on an empty stomach.  
As an alternative to water, the powder may be pre-mixed with a small amount of beverage or food (e.g. 100 
grams/120 ml) and consumed within 30 minutes. Sevelamer carbonate Winthrop powder should not be 
heated (e.g. microwave) or added to heated foods or liquids. 
 
If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
• Hypophosphataemia.  
• Bowel obstruction.  
 
4.4 Special warnings and precautions for use 
 
The safety and efficacy of sevelamer carbonate have not been established in adult patients with chronic 
kidney disease not on dialysis with serum phosphorus < 1.78 mmol/L. Therefore it is currently not 
recommended for use in these patients. 
 
The safety and efficacy of sevelamer carbonate have not been established in patients with the following 
disorders: 
• dysphagia 
• swallowing disorders 
• severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric 

contents and abnormal or irregular bowel motion 
• active inflammatory bowel disease 
• major gastrointestinal tract surgery 
 
Treatment of these patients with Sevelamer carbonate Winthrop should only be initiated after careful 
benefit/risk assessment. If the therapy is initiated, patients suffering from these disorders should be 
monitored. Sevelamer carbonate treatment should be reevaluated in patients who develop severe constipation 
or other severe gastrointestinal symptoms. 
 
Intestinal obstruction and ileus/subileus 
 
In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment 
with sevelamer hydrochloride (capsules/tablets), which contains the same active moiety as sevelamer 
carbonate. Constipation may be a preceding symptom. Patients who are constipated should be monitored 
carefully while being treated with sevelamer carbonate. The treatment should be re-evaluated in patients who 
develop severe constipation or other severe gastrointestinal symptoms. 
 
Fat-soluble vitamins and folate deficiency 
 
Patients with CKD may develop low levels of fat-soluble vitamins A, D, E and K, depending on dietary 
intake and the severity of their disease. It cannot be excluded that sevelamer carbonate can bind fat-soluble 
vitamins contained in ingested food. In patients not taking supplemental vitamins but on sevelamer, serum 
vitamin A, D, E and K status should be assessed regularly. It is recommended that vitamin supplements be 
given if necessary. It is recommended that CKD patients not on dialysis are given vitamin D supplements 
(approximately 400 IU of native vitamin D daily) which can be part of a multivitamin preparation to be taken 
apart from their dose of sevelamer carbonate. In patients undergoing peritoneal dialysis additional 



26 

monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were 
not measured in a clinical study in these patients. 
 
There is at present insufficient data to exclude the possibility of folate deficiency during long term sevelamer 
carbonate treatment. In patients not taking supplemental folic acid but on sevelamer, folate level should be 
assessed regularly. 
 
Hypocalcaemia/hypercalcaemia 
 
Patients with CKD may develop hypocalcaemia or hypercalcaemia. Serum calcium levels should therefore 
be monitored at regular intervals and elemental calcium should be given as a supplement if required. 
 
Metabolic acidosis 
 
Patients with CKD are predisposed to developing metabolic acidosis. As part of good clinical practice, 
monitoring of serum bicarbonate levels is therefore recommended. 
 
Peritonitis 
 
Patients receiving dialysis are subject to certain risks for infection specific to dialysis modality. Peritonitis is 
a known complication in patients receiving peritoneal dialysis and in a clinicaltrial with sevelamer 
hydrochloride, a greater number of peritonitis cases were reported in the sevelamer group than in the control 
group. Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate 
aseptic technique with the prompt recognition and management of any signs and symptoms associated with 
peritonitis. 
 
Hypothyroidism 
 
Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and 
levothyroxine is recommended (see section 4.5). 
 
Hyperparathyroidism 
 
Sevelamer carbonate is not indicated for the control of hyperparathyroidism. In patients with secondary 
hyperparathyroidism sevelamer carbonate should be used within the context of a multiple therapeutic 
approach, which could include calcium as supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues 
to lower the intact parathyroid hormone (iPTH) levels. 
 
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 carbonate treatment should be re-
evaluated in patients who develop severe gastrointestinal symptoms. 
 
Sodium content 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Dialysis 
 
Interaction studies have not been conducted in patients on dialysis. 



27 

 
Ciprofloxacin 
 
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety 
as sevelamer carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when co-
administered with sevelamer hydrochloride in a single dose study. Consequently, sevelamer carbonate 
should not be taken simultaneously with ciprofloxacin. 
 
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients 
 
Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant 
patients when co-administered with sevelamer hydrochloride without any clinical consequences (e.g., graft 
rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood 
concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of 
combination and after its withdrawal.  
 
Levothyroxine  
 
Very rare cases of hypothyroidism have been reported in patients co-administered with sevelamer 
hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine. Closer 
monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving 
sevelamer carbonate and levothyroxine. 
 
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. Therefore, possible reduction 
in absorption cannot be excluded. The anti-arrhythmic medical product should be taken at least one hour 
before or three hours after Sevelamer carbonate Winthrop and blood monitoring can be considered. 
 
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 carbonate. Caution should be 
exercised when prescribing PPI to patients concomitantly treated with Sevelamer carbonate Winthrop. The 
phosphate serum level should be monitored and the sevelamer carbonate dosage adjusted consequently. 
 
Bioavailability 
 
Sevelamer carbonate 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 sevelamer carbonate, or the physician should consider monitoring blood levels. 
 
Digoxin, warfarin, enalapril or metoprolol  
 
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety 
as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of sevelamer in pregnant women. Animal studies have 
shown some reproductive toxicity when sevelamer was administered to rats at high doses (see section 5.3). 
Sevelamer has also been shown to reduce the absorption of several vitamins including folic acid (see 



28 

sections 4.4 and 5.3). The potential risk to humans is unknown. Sevelamer carbonate 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. 
 
Breast-feeding 
 
It is unknown whether sevelamer/metabolites are excreted in human milk. The non-absorbed nature of 
sevelamer indicates that excretion of sevelamer in breast milk is unlikely. A decision on whether to 
continue/discontinue breast-feeding or to continue/discontinue therapy with sevelamer carbonate should be 
made taking into account the benefit of breast-feeding to the child and the benefit of sevelamer carbonate 
therapy to the woman. 
 
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 BSA. 
 
4.7 Effects on ability to drive and use machines 
 
Sevelamer has no or negligible influence on the ability to drive and use machines. 
 
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: nausea (very common), vomiting (very common), upper abdominal pain (very common), 
constipation (very common), diarrhea (common), dyspepsia (common) and flatulence (common).  
 
Constipation can be an early symptom of serious gastrointestinal adverse reactions. The most serious adverse 
reactions are hypersensitivity (very rare frequency), intestinal obstruction (not known frequency), 
ileus/subileus (not known frequency), intestinal perforation (not known frequency), serious inflammatory 
gastrointestinal disorders associated with the presence of sevelamer crystals (not known frequency). 
 
Tabulated list of adverse reactions 
 
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous 
clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks 
(724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis 
patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with 
CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer 
hydrochloride and 49 with sevelamer carbonate). 
 
Adverse reactions that occurred during clinical trials or 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). 
  



29 

MedDRA System 
Organ Class 

Very common Common Very rare Not known 

Immune system 
disorders 

  Hypersensitivity  

Gastrointestinal 
disorders 

Nausea,  
Vomiting,  
Upper abdominal 
pain, 
Constipation 

Diarrhoea, 
Dyspepsia, 
Flatulence, 
Abdominal pain 

 Intestinal 
obstruction,  
Ileus/subileus,  
Intestinal 
perforation1, 
Gastrointestinal 
hemorrhage1, 
Intestinal 
ulceration1, 
Gastrointestinal 
necrosis1,  
Colitis1, 
Intestinal mass1 

Skin and 
subcutaneous 
tissue disorders 

   Pruritus,  
Rash 

Investigations    Crystal deposit 
intestine1 

1 See inflammatory gastrointestinal disorders warning in section 4.4 
 
Paediatric population 
 
In general, the safety profile for children and adolescents (6 to 18 years of age) is similar to the safety profile 
for adults. 
 
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 
 
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to 
normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reaction. In 
CKD patients, the maximum average daily dose studied was 14.4 grams of sevelamer carbonate in a single 
daily dose. 
 
The symptoms observed in case of overdose are similar to adverse reactions listed in section 4.8, including 
mainly constipation and other known gastrointestinal disorders. 
 
Appropriate symptomatic treatment should be provided. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: All other therapeutic products, drugs for treatment of hyperkalemia and 
hyperphosphataemia. ATC code: V03A E02. 
 
Mechanism of action 

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


30 

 
Sevelamer carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding crosslinked polymer. 
Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become 
protonated in the stomach. These protonated amines bind negatively charged ions such as dietary phosphate 
in the intestine.  
 
Pharmacodynamic effects 
 
By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the 
phosphorus concentration in the serum. Regular monitoring of serum phosphorus levels is always necessary 
during phosphate binder administration. 
 
Clinical efficacy and safety 
 
In two randomised, cross over clinical trials, sevelamer carbonate has been shown to be therapeutically 
equivalent to sevelamer hydrochloride and therefore effective in controlling serum phosphorus in CKD 
patients on haemodialysis. These also demonstrated that sevelamer carbonate in both tablet and powder 
formulations are therapeutically equivalent to sevelamer hydrochloride. 
 
The first study demonstrated that sevelamer carbonate tablets dosed three times per day was equivalent to 
sevelamer hydrochloride tablets dosed three times per day in 79 haemodialysis patients treated over two 
randomised 8 week treatment periods (mean serum phosphorus time-weighted averages were 
1.5 ± 0.3 mmol/L for both sevelamer carbonate and sevelamer hydrochloride). The second study 
demonstrated that sevelamer carbonate powder dosed three times per day was equivalent to sevelamer 
hydrochloride tablets dosed three times per day in 31 hyperphosphataemic (defined as serum phosphorus 
levels ≥ 1.78 mmol/L) haemodialysis patients over two randomised 4 week treatment periods (mean serum 
phosphorus time-weighted averages were 1.6 ± 0.5 mmol/L for sevelamer carbonate powder and 
1.7 ± 0.4 mmol/L for sevelamer hydrochloride tablets). 
 
In the clinical trials in haemodialysis patients, sevelamer alone did not have a consistent and clinically 
significant effect on iPTH. In a 12 week study involving peritoneal dialysis patients however, similar iPTH 
reductions were seen compared with patients receiving calcium acetate. In patients with secondary 
hyperparathyroidism sevelamer carbonate should be used within the context of a multiple therapeutic 
approach, which could include calcium as supplements, 1,25dihydroxy Vitamin D3 or one of its analogues to 
lower the iPTH levels. 
 
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 
of sevelamer, both the mean total-cholesterol and LDL-cholesterol declined by 15-39%. The decrease in 
cholesterol has been observed after 2 weeks of treatment and is maintained with long-term treatment. 
Triglycerides, HDL-cholesterol and albumin levels did not change following sevelamer treatment. 
 
Because sevelamer binds bile acids, it may interfere with the absorption of fat soluble vitamins such as A, D, 
E and K. 
 
Sevelamer does not contain calcium and decreases the incidence of hypercalcaemic episodes as compared to 
patients using calcium based phosphate binders alone. The effects of sevelamer on phosphorus and calcium 
were proven to be maintained throughout a study with one year follow-up. This information was obtained 
from studies in which sevelamer hydrochloride was used. 
 
Paediatric population 
 
The safety and effectiveness of sevelamer carbonate in hyperphosphatemic paediatric patients with CKD was 
evaluated in a multicenter study with a 2-week, randomised, placebo-controlled, fixed dose period (FDP) 
followed by a 6-month, single-arm, open-label, dose titration period (DTP). A total of 101 patients (6 to 18 
years old with a BSA range of 0.8 m2  to 2.4 m2) were randomised in the study. Forty-nine (49) patients 



31 

received sevelamer carbonate and 51 received placebo during the 2 week FDP. Thereafter all patients 
received sevelamer carbonate for the 26-week DTP. The study met its primary endpoint, meaning Sevelamer 
carbonate reduced serum phosphorus by an LS mean difference of 0.90 mg/dL compared to placebo and 
secondary efficacy endpoints. In paediatric patients with hyperphosphatemia secondary to CKD, sevelamer 
carbonate significantly reduced serum phosphorus levels compared to placebo during a 2-week FDP. The 
treatment response was maintained in the paediatric patients who received sevelamer carbonate during the 6-
month open-label DTP. 27% of paediatric patients reached their age appropriate serum phosphorus level at 
end of treatment. These figures were 23% and 15% in the subgroup of patients on hemodialysis and 
peritoneal dialysis, respectively. The treatment response during the 2-week FDP was not affected by BSA, in 
contrast however, no treatment response was observed in paediatric patients with qualifying phosphorus 
levels <7.0 mg/dL. Most of adverse reactions reported  were gastrointestinal in nature. No new risks or safety 
signals were identified with the use of sevelamer carbonate during the study. 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic studies have not been carried out with sevelamer carbonate. Sevelamer hydrochloride, 
which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal 
tract, as confirmed by an absorption study in healthy volunteers. 
 
In a clinical trial of one year, no evidence of accumulation of sevelamer was seen. However the potential 
absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally 
excluded. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, 
repeated dose toxicity or genotoxicity.  
 
Carcinogenicity studies with oral sevelamer hydrochloride were conducted in mice (doses of up to 
9 g/kg/day) and rats (0.3, 1, or 3 g/kg/day). There was an increased incidence of urinary bladder transitional 
cell papilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial 
dose of 14.4 g). There was no increased incidence of tumours observed in mice (human equivalent dose 
3 times the maximum clinical trial dose). 
 
In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a 
statistically significant increase in the number of structural chromosome aberrations. Sevelamer 
hydrochloride was not mutagenic in the Ames bacterial mutation assay. 
 
In rats and dogs, sevelamer reduced absorption of fat soluble vitamins D, E and K (coagulation factors), and 
folic acid. 
 
Deficits in skeletal ossification were observed in several locations in foetuses of female rats dosed with 
sevelamer at intermediate and high doses (human equivalent dose less than the maximum clinical trial dose 
of 14.4 g). The effects may be secondary to vitamin D depletion. 
 
In pregnant rabbits given oral doses of sevelamer hydrochloride by gavage during organogenesis, an increase 
of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical 
trial dose). 
 
Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study 
in which the females were treated from 14 days prior to mating through gestation and the males were treated 
for 28 days prior to mating. The highest dose in this study was 4.5 g/kg/day (human equivalent dose 2 times 
the maximum clinical trial dose of 13 g/day, based on a comparison of relative BSA). 
 
 



32 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Propylene glycol alginate (E405) 
Citrus Cream flavour 
Sodium chloride 
Sucralose 
Iron oxide yellow (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
After reconstitution  
 
The oral suspension must be administered within 30 minutes. 
The sachet has to be discarded after 24 hours of opening. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Sachet of ethylene methacrylic acid copolymer, polyester, LDPE and aluminium foil laminate, with a heat seal.  
Each sachet contains 2.4g of sevelamer carbonate. Each carton contains 60 or 90 sachets.  
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The powder should be dispersed in 60 ml of water per sachet prior to administration. The suspension powder 
is pale yellow with a citrus flavour. 
  
The powder may also be pre-mixed with cold beverage or unheated food (see 4.2). The powder should not be 
heated (e.g. microwave). 
 
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 
 
 



33 

8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/952/002  60 sachets 
EU/1/14/952/003  90 sachets 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15 January 2015 
Date of latest renewal: 11 November 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/


34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
  
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 

USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

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

 
 



35 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Genzyme Ireland Limited 
IDA Industrial Park 
Old Kilmeaden Road 
Waterford 
IRELAND 
 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer 
responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION  
 
• Periodic safety update reports (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. 

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

OF THE MEDICINAL PRODUCT 
 

• Risk management plan (RMP) 
 

The marketing authorization 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.  

 
 

  



36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

  



37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 

  



38 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL - BOTTLE OF 180 TABLETS WITHOUT OUTER CARTON 
 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 800 mg film-coated tablets 
sevelamer carbonate 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each tablet contains 800 mg sevelamer carbonate. 
 
 

3. LIST OF EXCIPIENTS 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
180 film-coated tablets 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
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, IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP  
 
 

9. SPECIAL STORAGE CONDITIONS 
 
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 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 



39 

 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/14/952/001 180 film-coated tablets 
 
 

13. BATCH NUMBER 
 
Batch  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Sevelamer carbonate 800 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



40 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – BOTTLE OF 30 TABLETS  
 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 800 mg film-coated tablets 
sevelamer carbonate 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each tablet contains 800 mg sevelamer carbonate. 
 
 

3. LIST OF EXCIPIENTS 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
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, IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP  
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Keep 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 

 
 



41 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/14/952/004   30 film-coated tablets 
 
 

13. BATCH NUMBER 
 
Batch  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Sevelamer 
carbonate 
800 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



42 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL - BOTTLE OF 30 TABLETS  
 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 800 mg film-coated tablets 
sevelamer carbonate 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each tablet contains 800 mg sevelamer carbonate. 
 
 

3. LIST OF EXCIPIENTS 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
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, IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP  
 
 

9. SPECIAL STORAGE CONDITIONS 
 
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 

 
 



43 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/14/952/004 30 film-coated tablets 
 
 

13. BATCH NUMBER 
 
Batch  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



44 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 0.8 g powder for oral suspension 
sevelamer carbonate 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each sachet contains 0.8 g sevelamer carbonate. 
 
 

3. LIST OF EXCIPIENTS 
 
Contains propylene glycol (See leaflet for further information). 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral suspension 
 
90 sachets 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use.  
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 

7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP  
 
After reconstitution  
The oral suspension must be administered within 30 minutes. 
 
 

9. SPECIAL STORAGE CONDITIONS 
 



45 

 
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 NUMBERS 
 
EU/1/14/952/005 90 sachets 
EU/1/14/952/006  90 sachets (with a dosing spoon) 
 
 

13. BATCH NUMBER 
 
Batch  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Sevelamer carbonate Winthrop  
0.8 g  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



46 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL - SACHETS 
 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 0.8 g powder for oral suspension 
sevelamer carbonate 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each sachet contains 0.8 g sevelamer carbonate. 
 
 

3. LIST OF EXCIPIENTS 
 
Contains propylene glycol (See leaflet for further information). 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral suspension 
 
0.8 g powder 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 

7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP  
 
After reconstitution  
The oral suspension must be administered within 30 minutes. 
 
 

9. SPECIAL STORAGE CONDITIONS 
 



47 

 
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 NUMBERS 
 
EU/1/14/952/005 90 sachets 
EU/1/14/952/006  90 sachets (with dosing spoon) 
 
  

13. BATCH NUMBER 
 
Batch  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
 
 
 
 
 
 
 
 



48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – CARTON OF 60 or 90 SACHETS 
 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 2.4 g powder for oral suspension 
sevelamer carbonate 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each sachet contains 2.4 g sevelamer carbonate. 
 
 

3. LIST OF EXCIPIENTS 
 
Contains propylene glycol (See leaflet for further information). 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral suspension 
60 sachets 
90 sachets 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use.  
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 

7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP  
 
After reconstitution  
The oral suspension must be administered within 30 minutes. 
 
 

9. SPECIAL STORAGE CONDITIONS 
 



49 

 
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 NUMBERS 
 
EU/1/14/952/002   60 sachets 
EU/1/14/952/003   90 sachets 
 
 

13. BATCH NUMBER 
 
Batch  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Sevelamer carbonate Winthrop  
2.4 g  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



50 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL - SACHETS 
 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sevelamer carbonate Winthrop 2.4 g powder for oral suspension 
sevelamer carbonate 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each sachet contains 2.4 g sevelamer carbonate. 
 
 

3. LIST OF EXCIPIENTS 
 
Contains propylene glycol (See leaflet for further information). 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral suspension 
2.4 g powder 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use.  
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 

7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP  
 
After reconstitution  
The oral suspension must be administered within 30 minutes. 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
 



51 

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 NUMBERS 
 
EU/1/14/952/002   60 sachets 
EU/1/14/952/003   90 sachets 
 
 

13. BATCH NUMBER 
 
Batch  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



52 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



53 

Package leaflet: Information for the user 
 

Sevelamer carbonate Winthrop 800 mg film-coated tablets 
sevelamer carbonate 

 
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. This includes any possible side effects not listed in this 

leaflet. See section 4. 
 
What is in this leaflet 
1. What Sevelamer carbonate Winthrop is and what it is used for 
2. What you need to know before you take Sevelamer carbonate Winthrop 
3. How to take Sevelamer carbonate Winthrop 
4. Possible side effects 
5. How to store Sevelamer carbonate Winthrop 
6. Contents of the pack and other information 
 
 
1. What Sevelamer carbonate Winthrop is and what it is used for 
 
Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate. It binds phosphate from 
food in the digestive tract and so reduces serum phosphorus levels in the blood. 
 
This medicine is used to control hyperphosphataemia (high blood phosphate levels) in: 
• adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing 

haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the 
abdomen and an internal body membrane filters the blood); 

• patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) 
phosphorus level equal to or above 1.78 mmol/L.  

 
This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent 
the development of bone disease. 
 
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. 
 
 
2. What you need to know before you take Sevelamer carbonate Winthrop 
 
Do not take Sevelamer carbonate Winthrop: 
• if you are allergic to sevelamer carbonate or any of the other ingredients of this medicine (listed in 

section 6). 
• if you have low levels of phosphate in your blood (your doctor will check this for you). 
• if you have bowel obstruction.  
 
Warnings and precautions  
Talk to your doctor before taking Sevelamer carbonate Winthrop: 
• if you have swallowing problems. Your doctor can rather prescribe sevelamer carbonate powder for 

oral suspension. 
• if you have problems with motility (movement) in your stomach and bowel 
• if you have active inflammation of the bowel 



54 

• if you have undergone major surgery on your stomach or bowel. 
 
Talk to your doctor while taking Sevelamer carbonate Winthrop: 
• 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 crystal 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 low or high levels of calcium in your blood. Since this medicine 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. 

• have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body 
tissue. Your doctor should monitor the level of bicarbonate in your blood. 

 
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.  
 
Children 
Do not give this medicine to children below the age of 6 years because the safety and efficacy in children 
(below the age of 6 years) have not been studied. 
 
Other medicines and Sevelamer carbonate Winthrop 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
 
• Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop. 
 

• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used 
to suppress the immune system) may be reduced by Sevelamer carbonate Winthrop. Your doctor will 
advise you if you are taking these medicines. 

 
• Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine 

(used to treat low thyroid hormone levels) and Sevelamer carbonate Winthrop. Therefore your doctor 
may monitor the levels of thyroid stimulating hormone in your blood more closely.  

 
• Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, 

pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of 
Sevelamer carbonate Winthrop.  Your doctor may monitor the phosphate level in your blood. 

 
Your doctor will check for interactions between Sevelamer carbonate Winthrop and other medicines on a 
regular basis. 
 
In some cases where Sevelamer carbonate Winthrop 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 Sevelamer carbonate 
Winthrop intake. Your doctor may also consider monitoring the levels of that medicine in your blood. 



55 

 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 
doctor for advice before taking this medicine.  
The potential risk of Sevelamer carbonate Winthrop during human pregnancy is unknown. Talk to your 
doctor who will decide if you can continue the treatment with Sevelamer carbonate Winthrop. 
 
It is unknown whether Sevelamer carbonate Winthrop is excreted in breast milk and may affect your baby. 
Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop 
Sevelamer carbonate Winthrop treatment. 
 
Driving and using machines 
Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or to use machines. 
 
Excipients 
This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’. 
 
 
3. How to take Sevelamer carbonate Winthrop 
 
Always take this medicine exactly as your doctor has told you. He will base the dose on your serum 
phosphorus level.  
 
The recommended starting dose of this medicine for adults and elderly is one to two tablets of 800 mg with 
each meal, 3 times a day. Check with your doctor, pharmacist or nurse if you are not sure. 
 
Take Sevelamer carbonate Winthrop after your meal or with food. 
 
The tablets must be swallowed whole. Do not crush, chew or break into pieces. 
 
Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the 
dose of Sevelamer carbonate Winthrop when necessary to reach an adequate phosphate level.  
 
Follow the diet prescribed by your doctor. 
 
If you take more Sevelamer carbonate Winthrop than you should 
In the event of a possible overdose you should contact your doctor immediately. 
 
If you forget to take Sevelamer carbonate Winthrop 
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. 
 
If you stop taking Sevelamer carbonate Winthrop 
Taking your Sevelamer carbonate Winthrop treatment is important to maintain an appropriate phosphate level 
in your blood. Stopping Sevelamer carbonate Winthrop would lead to important consequences such as 
calcification in the blood vessels. If you consider stopping your Sevelamer carbonate Winthrop treatment, 
contact your doctor or pharmacist first. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Constipation is a very common side effect. It can be an early symptom of a blockage in your intestine. In 
case of constipation, please inform your doctor or pharmacist if you experience it. 
 



56 

Some side effects could be serious. If you get any of the following side effects, seek immediate medical 
attention: 
- Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side effect (may 
affect up to 1 in 10,000 people). 
- Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe 
constipation) has been reported. Frequency is not known. 
- Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a 
tender abdomen) has been reported. Frequency is not known. 
- 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. Frequency is not known. 
 
Other side effects have been reported in patients taking Sevelamer carbonate Winthrop:  
 
Very common (may affect more than 1 in 10 people): 
• vomiting,  
• upper abdominal pain, 
• nausea. 
 
Common (may affect up to 1 in 10 people): 
• diarrhoea,  
• stomach ache, 
• indigestion,  
• flatulence. 
 
Not known (frequency cannot be estimated from the available data): 
• cases of itching, 
• rash,  
• slow intestine motility (movement). 
 
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 Sevelamer carbonate Winthrop 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date stated on the bottle and/or carton after “EXP”. The expiry date 
refers to the last day of that month. 
 
Keep the bottle container tightly closed in order to protect from moisture.  
This medicine does not require any special temperature storage conditions.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Sevelamer carbonate Winthrop contains 
 
- The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer 

carbonate. 

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


57 

- The other ingredients are microcrystalline cellulose, sodium chloride, zinc stearate, hypromellose (E464), 
diacetylated monoglycerides, iron oxide black (E172), isopropyl alcohol and propylene glycol. 

 
What Sevelamer carbonate Winthrop looks like and contents of the pack 
 
Sevelamer carbonate Winthrop film-coated tablets are white to off-white tablets with SC800 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:  
Each bottle contains 30 tablets or 180 tablets. 
Packs of 1 bottle of 30 tablets or 180 tablets with no outer carton 
Not all pack sizes may be marketed. 
 
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.r.l. 
Tel: +39 02 39394275 
 

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

Nederland 
Genzyme Europe 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 

  



58 

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  

 
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 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.r.l. 
Tel: 800 536 389  
 

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

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 
Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

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

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/


59 

Package leaflet: Information for the user 
 

Sevelamer carbonate Winthrop 0.8 g powder for oral suspension 
sevelamer carbonate 

 
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 of the side effects, talk to your doctor. This includes any possible side effects not listed in 

this leaflet. See section 4. 
 
What is in this leaflet 
1. What Sevelamer carbonate Winthrop is and what it is used for 
2. What you need to know before you take Sevelamer carbonate Winthrop 
3. How to take Sevelamer carbonate Winthrop 
4. Possible side effects 
5. How to store Sevelamer carbonate Winthrop 
6. Contents of the pack and other information 
 
 
1. What Sevelamer carbonate Winthrop is and what it is used for 
 
Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate. It binds phosphate from 
food in the digestive tract and so reduces serum phosphorus levels in the blood. 
 
This medicine is used to control hyperphosphataemia (high blood phosphate levels) in: 
• adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing 

haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the 
abdomen and an internal body membrane filters the blood); 

• adult patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) 
phosphorus level equal to or above 1.78 mmol/l. 

• paediatric patients with chronic (long-term) kidney disease above the age of 6 and above a certain height 
and weight (used to calculate body surface area by your physician). 
 

This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent the 
development of bone disease. 
 
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. 
 
 
2. What you need to know before you take Sevelamer carbonate Winthrop 
 
Do not take Sevelamer carbonate Winthrop : 
• if you are allergic to sevelamer carbonate  or  any of the other ingredients of this medicine (listed in 

section 6). 
• if you have low levels of phosphate in your blood (your doctor will check this for you) 
• if you have bowel obstruction  
 
Warnings and precautions 
Talk to you doctor before taking Sevelamer carbonate Winthrop: 
• if you have problems with motility (movement) in your stomach and bowel 
• if you have active inflammation of the bowel 



60 

• if you have undergone major surgery on your stomach or bowel. 
 
Talk to your doctor while taking Sevelamer carbonate Winthrop: 
• 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 crystal 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 low or high levels of calcium in your blood. Since this medicine 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. 

• have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body 
tissue. Your doctor should monitor the level of bicarbonate in your blood. 

 
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.  
 
Children 
Do not give this medicine to children below the age of 6 years because the safety and efficacy in children 
(below the age of   6 years) have not been studied.  
 
Other medicines and Sevelamer carbonate Winthrop 
Tell your doctor if you are taking or have recently taken or might take any other medicines.  
 
• Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop. 
 

• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to 
suppress the immune system) may be reduced by Sevelamer carbonate Winthrop. Your doctor will 
advise you if you are taking these medicines. 
 

• Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used 
to treat low thyroid hormone levels) and Sevelamer carbonate Winthrop. Therefore your doctor may 
monitor the levels of thyroid stimulating hormone in your blood more closely.  
 

• Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, 
pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of 
Sevelamer carbonate Winthrop. Your doctor may monitor the phosphate level in your blood. 

 
Your doctor will check for interactions between Sevelamer carbonate Winthrop and other medicines on a 
regular basis. 
 
In some cases where Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop 
intake. Your doctor may also consider monitoring the levels of that medicine in your blood. 
 



61 

Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 
doctor for advice before taking this medicine. The potential risk of Sevelamer carbonate Winthrop during 
human pregnancy is unknown. Talk to your doctor who will decide if you can continue the treatment with 
Sevelamer carbonate Winthrop. 
 
It is unknown whether Sevelamer carbonate Winthrop is excreted in breast milk and may affect your baby. 
Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop 
Sevelamer carbonate Winthrop treatment. 
 
Driving and using machines 
Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or to use machines. 
 
Excipients 
This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free’. 
 
This medicine contains 8.42 mg propylene glycol in each 0.8 g sachet. 
 
 
3. How to take Sevelamer carbonate Winthrop 
 
You must take Sevelamer carbonate Winthrop as prescribed by your doctor. They will base the dose on your 
serum phosphorus level.  
 
For a 0.8 g dose, the powder for oral suspension should be dispersed in 30 mL of water per sachet. Drink within 
30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass 
with water and drink this as well to ensure that all of the powder is swallowed. 
Instead of water, the powder may be pre-mixed with a small amount of cold beverage (about 120 ml or half a 
glass) or food (about 100 grams) and consumed within 30 minutes. Do not heat Sevelamer carbonate Winthrop 
powder (e.g. microwave) or add to hot foods or liquids. 
 
The recommended starting dose of this medicine for adults and elderly is 2.4-4.8g per day equally divided over 
three meals. Check with your doctor, pharmacist or nurse if you are not sure. The exact starting dose and 
regimen will be determined by your doctor. 
 
Take Sevelamer carbonate Winthrop after your meal or with food. 
 
(Instructions for presentation with dosing spoon) 
For 0.4 g doses, the powder in the sachet may be divided. In this case the 0.4 g dose of Sevelamer Carbonate 
Winthrop powder must be measured using the dosing spoon provided in the carton. 
 
Always use the dosing spoon provided in the carton. 
 
(Instructions for presentation WITHOUT dosing spoon) 
If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon. 
 
Use in children and adolescents 
The recommended starting dose of Sevelamer carbonate Winthrop for children is based on their height and 
weight (used to calculate body surface area by your physician). For children, the powder is preferred, as 
tablets are not appropriate in this population.  This medicine should not be given on an empty stomach and 
should be taken with meals or snacks. The exact starting dose and regimen will be determined by your 
doctor. 
 
For doses of less than 0.8 g, the powder in the sachet may be divided. The 0.4 g dose of Sevelamer carbonate 
Winthrop powder must be measured using the dosing spoon provided in the carton.  
 



62 

Preparation using a dosing spoon: 
 
Use the provided dosing spoon for each 0.4 g dose of Sevelamer Carbonate Winthrop powder. 
 

For a 0.4 g dose: 
o Shake the sachet holding the top corner before opening, to move the powder to the bottom of 

the sachet 
o Open the sachet by tearing along the marked line. 
o Ensure the dosing spoon is dry. 
o Hold the dosing spoon horizontally and pour the powder out of the sachet into the dosing 

spoon. 
o Fill the powder to the spoon level.  
o Do not tap the dosing spoon to compact the powder. 
o Mix the powder from the dosing spoon in 30 mL of water. Stir the suspension and drink it 

within 30 minutes of being prepared. It is important to drink all of the liquid to ensure that 
all of the powder is swallowed. 

o Close the sachet by folding over twice. 
o The remaining powder may be used within 24 hours for the next dose.  
o Discard sachets of powder that have been opened for more than 24 hours. 
 

Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the 
dose of Sevelamer carbonate Winthrop when necessary to reach an adequate phosphate level. 
 
Follow the diet prescribed by your doctor. 
 
If you take more Sevelamer carbonate Winthrop than you should 
In the event of a possible overdose you should contact your doctor immediately. 
 
If you forget to take Sevelamer carbonate Winthrop 
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. 
 
If you stop taking Sevelamer carbonate Winthrop 
Taking your Sevelamer carbonate Winthrop treatment is important to maintain an appropriate phosphate level 
in your blood. Stopping Sevelamer carbonate Winthrop would lead to important consequences such as 
calcification in the blood vessels. If you consider stopping your Sevelamer carbonate Winthrop treatment, 
contact your doctor or pharmacist first. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Constipation is a very common side effect. It can be an early symptom of a blockage in your intestine.In case 
of constipation, please inform your doctor or pharmacist if you experience it. 
 
Some side effects could be serious. If you get any of the following side effects, seek immediate medical 
attention: 
- Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side effect (may 
affect up to 1 in 10,000 people). 
- Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe 
constipation) has been reported. Frequency is not known. 
- Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender 
abdomen) has been reported. Frequency is not known. 



63 

- 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. Frequency is not known. 
 
Other side effects have been reported in patients taking Sevelamer carbonate Winthrop:  
 
Very common (may affect more than 1 in 10 people): 
• vomiting,  
• upper abdominal pain, 
•  nausea. 
 
Common (may affect up to 1 in 10 people): 
• diarrhoea,  
• stomach ache,  
• indigestion,  
• flatulence. 
 
Not known (frequency cannot be estimated from the available data): 
• cases of itching,  
• rash,  
• slow intestine motility (movement). 
 
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 Sevelamer carbonate Winthrop 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date stated on the sachet and carton after the letters “EXP”. The 
expiry date refers to the last day of that month. 
 
The reconstituted suspension must be administered within 30 minutes of reconstitution. 
This medicine does not require any special storage conditions. 
 
(Instructions for presentation with dosing spoon) 
Discard the sachet after 24 hours of opening. 
 
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 Sevelamer carbonate Winthrop contains 
 
-  The active substance is sevelamer carbonate. Each sachet contains 0.8 g of sevelamer carbonate. 
-  The other ingredients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, 

sucralose and iron oxide yellow (E172). 
 

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


64 

What Sevelamer carbonate Winthrop looks like and contents of the pack 
 
Sevelamer carbonate Winthrop powder for oral suspension is a pale yellow powder supplied in a foil sachet 
with a heat seal. The sachets are packaged in an outer carton. 
 
(Instructions for presentation with dosing spoon) 
A 0,4 g dosing spoon is provided in the carton. 
 
Pack size:  
90 sachets per carton 
 
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.r.l. 
Tel: +39 02 39394275 

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

Nederland 
Genzyme Europe 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 



65 

 
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  

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 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.r.l. 
Tel: 800 536 389  
 

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

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

 

 

  
 

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

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

 
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/


66 

Package leaflet: Information for the user 
 

Sevelamer carbonate Winthrop 2.4 g powder for oral suspension 
sevelamer carbonate 

 
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. This includes any possible side effects not listed in this 

leaflet. See section 4. 
 
What is in this leaflet 
1. What Sevelamer carbonate Winthrop is and what it is used for 
2. What you need to know before you take Sevelamer carbonate Winthrop 
3. How to take Sevelamer carbonate Winthrop 
4. Possible side effects 
5. How to store Sevelamer carbonate Winthrop 
6. Contents of the pack and other information 
 
 
1. What Sevelamer carbonate Winthrop is and what it is used for 
 
Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate. It binds phosphate from 
food in the digestive tract and so reduces serum phosphorus levels in the blood. 
 
This medicine is used to control hyperphosphataemia (high blood phosphate levels) in: 
• adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing 

haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the 
abdomen and an internal body membrane filters the blood); 

• adult patients with chronic (long-term) kidney disease who are not on dialysis and have a serum 
(blood) phosphorus level equal to or above 1.78 mmol/L. 

• paediatric patients with chronic (long-term) kidney disease above the age of 6 and above a certain 
height and weight (used to calculate body surface area by your physician). 

 
This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent 
the development of bone disease. 
 
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. 
 
 
2. What you need to know before you take Sevelamer carbonate Winthrop 
 
Do not take Sevelamer carbonate Winthrop: 
• if you are allergic to sevelamer carbonate or  any of the other ingredients of this medicine (listed in 

section 6). 
• if you have low levels of phosphate in your blood (your doctor will check this for you) 
• if you have bowel obstruction  
 
Warnings and Precautions 
 
Talk to your doctor before taking Sevelamer carbonate Winthrop : 
• if you have problems with motility (movement) in your stomach and bowel 



67 

• if you have active inflammation of the bowel 
• if you have undergone major surgery on your stomach or bowel. 
 
Talk to your doctor while taking Sevelamer carbonate Winthrop: 
• 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 crystal 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 low or high levels of calcium in your blood. Since this medicine 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. 

• have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body 
tissue. Your doctor should monitor the level of bicarbonate in your blood. 

 
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.  
 
Children 
Do not give this medicine to children below the age of 6 years because because the safety and efficacy in 
children (below the age of 6 years) have not been studied. 
 
Other medicines and Sevelamer carbonate Winthrop 
Tell your doctor if you are taking or have recently taken or might take any other medicines.  
 
• Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop. 
 

• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used 
to suppress the immune system) may be reduced by Sevelamer carbonate Winthrop. Your doctor will 
advise you if you are taking these medicines. 

 
• Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine 

(used to treat low thyroid hormone levels) and Sevelamer carbonate Winthrop. Therefore your doctor 
may monitor the levels of thyroid stimulating hormone in your blood more closely.  

 
• Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, 

pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of 
Sevelamer carbonate Winthrop.  Your doctor may monitor the phosphate level in your blood. 

 
Your doctor will check for interactions between Sevelamer carbonate Winthrop and other medicines on a 
regular basis. 
 



68 

In some cases where Sevelamer carbonate Winthrop 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 Sevelamer carbonate 
Winthrop intake. Your doctor may also consider monitoring the levels of that medicine in your blood. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 
doctor for advice before taking this medicine.  The potential risk of Sevelamer carbonate Winthrop during 
human pregnancy is unknown. Talk to your doctor who will decide if you can continue the treatment with 
Sevelamer carbonate Winthrop. 
 
It is unknown whether Sevelamer carbonate Winthrop is excreted in breast milk and may affect your baby. 
Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop 
Sevelamer carbonate Winthrop treatment. 
 
Driving and using machines 
Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or to use machines. 
 
Excipients 
This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free’. 
 
This medicine contains 25.27 mg propylene glycol in each 2.4 g sachet. 
 
 
3. How to take Sevelamer carbonate Winthrop 
 
Always take this medicine exactly as your doctor has told you. He will base the dose on your serum 
phosphorus level.  
 
For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 ml of water per sachet. Drink 
within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse 
the glass with water and drink this as well to ensure that all of the powder is swallowed. 
Instead of water, the powder may be pre-mixed with a small amount of cold beverage (about 120 ml or half a 
glass) or food (about 100 grams) and consumed within 30 minutes. Do not heat Sevelamer carbonate 
Winthrop powder (e.g. microwave) or add to hot foods or liquids. 
 
The recommended starting dose of this medicine for adults and elderly is 2.4-4.8g per day equally divided over 
three meals. The exact starting dose and regimen will be determined by your doctor. Check with your doctor, 
pharmacist or nurse if you are not sure. 
 
Take Sevelamer carbonate Winthrop after your meal or with food. 
 
If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing 
spoon. 
 
Use in children and adolescents 
The recommended starting dose of Sevelamer carbonate Winthrop for children is based on their height and 
weight (used to calculate body surface area by your physician). For children, the powder is preferred, as 
tablets are not appropriate for this population. This medicine should not be given on an empty stomach and 
should be taken with meals or snacks. The exact starting dose and regimen will be determined by your 
doctor. 
 
Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and they may adjust 
the dose of Sevelamer carbonate Winthrop when necessary to reach an adequate phosphate level. 
 
Follow the diet prescribed by your doctor. 



69 

 
If you take more Sevelamer carbonate Winthrop than you should 
In the event of a possible overdose you should contact your doctor immediately. 
 
If you forget to take Sevelamer carbonate Winthrop 
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. 
 
If you stop taking Sevelamer carbonate Winthrop 
Taking your Sevelamer carbonate Winthrop treatment is important to maintain an appropriate phosphate level 
in your blood. Stopping Sevelamer carbonate Winthrop would lead to important consequences such as 
calcification in the blood vessels.  If you consider stopping your Sevelamer carbonate Winthrop treatment, 
contact your doctor or pharmacist first. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Constipation is a very common side effect. It can be an early symptom of a blockage in your intestine.In case 
of constipation, please inform your doctor or pharmacist if you experience it. 
 
Some side effects could be serious. If you get any of the following side effects, seek immediate medical 
attention: 
- Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side effect (may 
affect up to 1 in 10,000 people). 
- Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe 
constipation) has been reported. Frequency is not known. 
- Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a 
tender abdomen) has been reported. Frequency is not known. 
- 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. Frequency is not known. 
 
Other side effects have been reported in patients taking Sevelamer carbonate Winthrop:  
 
Very common (may affect more than 1 in 10 people): 
• vomiting, 
• upper abdominal pain, 
• nausea. 
 
Common (may affect up to 1 in 10 people): 
• diarrhoea, 
• stomach ache, 
• indigestion, 
• flatulence. 
 
Not known (frequency cannot be estimated from the available data): 
• cases of itching, 
• rash, 
• slow intestine motility (movement). 
 



70 

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 Sevelamer carbonate Winthrop 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date stated on the sachet and carton after “EXP”. The expiry date 
refers to the last day of that month. 
 
The reconstituted suspension must be administered within 30 minutes of reconstitution. 
This medicine does not require any special storage conditions.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Sevelamer carbonate Winthrop contains 
 
- The active substance is sevelamer carbonate. Each sachet contains 2.4 g of sevelamer carbonate. 
- The other ingredients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, 

sucralose and iron oxide yellow (E172). 
 
What Sevelamer carbonate Winthrop looks like and contents of the pack 
 
Sevelamer carbonate Winthrop powder for oral suspension is a pale yellow powder supplied in a foil sachet 
with a heat seal. The sachets are packaged in an outer carton. 
 
Pack size:  
60 sachets per carton 
90 sachets per carton 
 
Not all pack sizes may be marketed. 
 
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 
 
 

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


71 

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.r.l. 
Tel: +39 02 39394275 

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

Nederland 
Genzyme Europe 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  

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 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.r.l. 
Tel: 800 536 389  

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



72 

 
Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 
Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

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

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/

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