Tasermity

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 

 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Tasermity 800 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
The off-white, oval tablets are imprinted with “SH800” on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving 
haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a 
multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 
or one of its analogues to control the development of renal bone disease. 
 
4.2 Posology and method of administration 
 
Posology 
 
Starting dose 
The recommended starting dose of sevelamer hydrochloride is 2.4 g or 4.8 g per day based on clinical 
needs and serum phosphorus level. Sevelamer hydrochloride must be taken three times per day with 
meals. 
 
Serum phosphate level in patients not on 

phosphate binders 
Starting dose of Sevelamer 

hydrochloride 800 mg tablets 
1.76 – 2.42 mmol/L (5.5-7.5 mg/dl) 1 tablet, 3 times per day 

> 2.42 mmol/L (>7.5 mg/dl) 2 tablets, 3 times per day 
 
For patients previously on phosphate binders, Sevelamer hydrochloride should be given on a gram for 
gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses. 
 
Titration and maintenance 
Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated 
by 0.8 g three times per day (2.4 g/day) increments with the goal of lowering serum phosphate to 1.76 
mmol/L (5.5 mg/dl) or less. Serum phosphate should be tested every two to three weeks until a stable 
serum phosphate level is reached and on a regular basis thereafter. 
 
The dose range may vary between 1 and 5 tablets of 800 mg per meal. The average actual daily dose 
used in the chronic phase of a one year clinical study was 7 grams of sevelamer hydrochloride. 
 

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

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

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

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

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

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In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of 
ciprofloxacin by approximately 50% when co-administered with sevelamer hydrochloride in a single 
dose study. Consequently, sevelamer hydrochloride should not be taken simultaneously with 
ciprofloxacin. 
 
Anti-arrhythmics and anti-seizure medicinal products 
Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure 
medicinal products for the control of seizure disorders were excluded from clinical trials. Caution 
should be exercised when prescribing sevelamer hydrochloride to patients also taking these medicinal 
products. 
 
Levothyroxine 
During post marketing experience, very rare cases of increased thyroid stimulating hormone (TSH) 
levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine. 
Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal 
products. 
 
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients 
Reduced levels of ciclosporin,  mycophenolate mofetil and tacrolimus have been reported in 
transplant patients when coadministered with sevelamer hydrochloride without any clinical 
consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close 
monitoring of blood concentrations of mycophenolate mofetil, ciclosporin and tacrolimus should be 
considered during the use of combination and after its withdrawal.  
 
Digoxin, warfarin, enalapril or metoprolol  
In interaction studies in healthy volunteers, sevelamer hydrochloride had no effect on the 
bioavailability of digoxin, warfarin, enalapril or metoprolol. 
 
Proton pump inhibitors 
During post-marketing experience, very rare cases of increased phosphate levels have been reported in 
patients taking proton pump inhibitors co-administered with sevelamer hydrochloride.  
 
Bioavailability 
Sevelamer hydrochloride 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 hydrochloride, or the physician should consider 
monitoring blood levels. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
The safety of sevelamer hydrochloride has not been established in pregnant women. In animal studies 
there was no evidence that sevelamer induced embryo-foetal toxicity. Sevelamer hydrochloride should 
only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been 
conducted for both the mother and the foetus (see section 5.3). 
 
Breast-feeding 
The safety of sevelamer hydrochloride has not been established in breast-feeding women. Sevelamer 
hydrochloride should only be given to breast-feeding women if clearly needed and after a careful 
risk/benefit analysis has been conducted for both the mother and the infant (see section 5.3). 
 
Fertility 
There are no data from the effect of sevelamer on fertility in humans.  Studies in animals have shown 
that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 

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2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative body surface 
area. 
 
4.7 Effects on ability to drive and use machines 
 
Sevelamer hydrochloride 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.  
 
Tabulated list of adverse reactions 
In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 
weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted 
Adverse reactions from these studies (299 patients),  from uncontrolled clinical trials (384 patients) 
and that were spontaneously reported from post-marketing experience are listed by frequency in the 
table below. The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), 
uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known 
(cannot be estimated from the available data). 
 
MedDRA 
System Organ 
Class 

Very 
Common 

Common Uncommon Very Rare Not known 

Immune system 
disorders 

   Hypersensitivity*  

Metabolism and 
nutrition 
disorders 

  Acidosis, 
increased 
serum 
chloride 
levels 

  

Gastrointestinal 
disorders 

Nausea, 
vomiting 

Diarrhoea, 
dyspepsia, 
flatulence, 
upper 
abdominal 
pain, 
constipation 

  Abdominal 
pain, intestinal 
obstruction, 
ileus/subileus, 
diverticulitis, 
intestinal 
perforation 

Skin and 
subcutaneous 
tissue disorders 

    Pruritus, rash 

*post-marketing experience 
 
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 has been given to normal healthy volunteers in doses up to 14 grams, the 
equivalent of seventeen 800 mg tablets, per day for eight days with no undesirable effects.  
 

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


7 

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

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In reproduction studies there was no evidence that sevelamer induced embryolethality, foetotoxicity 
or teratogenicity at the doses tested (up to 1 g/kg/day in rabbits and up to 4.5 g/kg/day in rats). 
Deficits in skeletal ossification were observed in several locations in fetuses of female rats dosed with 
sevelamer at 8-20 times the maximum human dose of 200 mg/kg. The effects may be secondary to 
vitamin D and/or vitamin K depletion at these high doses. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients   
 
Tablet core:  
Silica, colloidal anhydrous 
Stearic acid 
 
Film-coating: 
Hypromellose (E464) 
Diacetylated monoglycerides 
 
Printing ink: 
Iron oxide black (E172) 
Propylene glycol 
Hypromellose (E464) 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf-life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 25ºC. 
Keep the bottle tightly closed in order to protect from moisture. 
 
6.5 Nature and contents of container 
 
HDPE bottles, with a child resistant polypropylene closure and a foil induction seal. 
Each bottle contains 180 film-coated tablets. 
 
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., Gooimeer 10, 1411 DD Naarden, the Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/14/953/001 

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 February 2015 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 
 

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


10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE 

AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

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A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
Genzyme Ireland Limited 
IDA Industrial Park 
Old Kilmeaden Road 
Waterford 
IRELAND 
 
Genzyme Limited 
37 Hollands Road 
Suffolk 
Haverhill  
CB9 8PU 
UNITED KINGDOM 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  

 
The marketing authorisation holder shall submit the first periodic safety update report for this 
product with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-
portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the  
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 

An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

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

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12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

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A. LABELLING 
 

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PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL with Blue Box – 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tasermity 800 mg film-coated tablets 
sevelamer hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 800 mg sevelamer hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
180 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Tablets must be swallowed whole. Do not chew. 
Read the package leaflet before use. 
For oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
Keep the bottle tightly closed in order to protect from moisture. 

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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. 
Gooimeer 10  
1411 DD Naarden 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/14/953/001 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Tasermity 
800 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  

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B. PACKAGE LEAFLET 
 

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Package leaflet: Information for the user 
 

Tasermity 800 mg film-coated tablets 
sevelamer hydrochloride 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side 

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

section  6). 
 

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

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

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

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

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

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

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

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

• Tasermity 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 before taking Tasermity. 

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

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

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

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

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

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

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

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Uncommon (may affect up to 1 in 100 people):  
increased acidity of the blood.  
Very rare (may affect up to 1 in 10000 people): 
hypersensitivity. 
 
Not known (frequency cannot be estimated from the available data): 
cases of itching, rash, abdominal pain, slow intestine motility (movement), blockages in the intestine, 
inflammation of abnormal small pouches (called diverticula) in the large intestine and perforation in 
the intestine wall have been reported. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 
leaflet. You can also report side effects directly via the national reporting system listed in Appendix 
V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store Tasermity  
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date stated on the bottle after “EXP”. The expiry date refers 
to the last day of that month. 
 
Do not store this medicine above 25 °C. Keep the bottle tightly closed in order to protect from 
moisture.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Tasermity contains 
 
- The active substance is sevelamer hydrochloride. Each tablet contains 800 mg sevelamer 
hydrochloride. 
- The other ingredients are silica colloidal anhydrous and stearic acid, hypromellose (E464),  
diacetylated monoglycerides, iron oxide black (E172) and propylene glycol. 
 
What Tasermity looks like and contents of the pack 
 
Tasermity tablets are film-coated, off-white, oval tablets with “SH800” imprinted on one side. The 
tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure 
and an induction seal. 
 
Pack size: 
1 bottle of 180 tablets 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder:  
Genzyme Europe B.V. 
Gooimeer 10 
1411 DD Naarden 
The Netherlands 

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


21 

 
Manufacturer:  
Genzyme Ireland Ltd. 
IDA Industrial Park 
Old Kilmeaden Road 
Waterford 
Ireland 
 
Genzyme Ltd. 
37 Hollands Road 
Haverhill, Suffolk  
CB9 8PU 
United Kingdom 
 
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 Malta Ltd 
Tel: +356 21493022 
 

Danmark 
sanofi-aventis Denmark A/S  
Tlf: +45 45 16 70 00 
 

Nederland 
sanofi-aventis Netherlands B.V.  
Tel: +31 182 557 755 

Deutschland 
Zentiva Pharma GmbH 
Tel: +49 (0) 180 20 200 10 
 

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  
 

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22 

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

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

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

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

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

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

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

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

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

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

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

 

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

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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