Renvela 800 mg film coated tablets
*Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company

Updated on 05 February 2025
File name
1.3.1 Package Leaflet (PIL Text) Renvela 800mg Tablets (IE & MT) (2).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 05 February 2025
File name
1.3.1.Summary of Product Characteristics (SmPC) Renvela 800mg Tablets (IE) (2).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 January 2025
File name
1.3.1 Package Leaflet (PIL Text) Renvela 800mg Tablets (IE & MT).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 02 January 2025
File name
1.3.1.Summary of Product Characteristics (SmPC) Renvela 800mg Tablets (IE).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 January 2025
File name
1.3.2.5 Mock-up - Fix-a-form Renvela 800mg Tablets IENI AMBARES.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 05 October 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Renvela 800mg Tablets (UK(NI), IE) (2).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 October 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Renvela 800mg Tablets (UK(NI), IE, MT) (2).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 October 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Renvela 800mg Tablets (UK(NI), IE, MT).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 13 October 2022
File name
1.3.1.3 Package Leaflet (PIL Text) Renvela 800mg Tablets.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 October 2022
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Renvela 800mg Tablets.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 January 2022
File name
IE PIL Text 800mg.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 November 2021
File name
IE PIL Text 800mg .pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 June 2020
File name
IE Renvela 800mg Tablets - PIL text.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 29 May 2020
File name
IE Renvela 800mg Tablets - PIL text.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 April 2020
File name
Renvela 800mg Tablets - PIL text.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 22 October 2019
File name
Renvela 800mg PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 14 October 2019
File name
Renvela 800mg SmPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 October 2019
File name
Renvela 800mg PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 12 September 2019
File name
Renvela 800mg SmPC (Tablets).pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 April 2019
File name
PIL text 800mg Tablets SA939-41.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 11 March 2019
File name
SmPC 800mg Tablets SA939-41.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Renvela should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Titration and mMaintenance
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 Renvela have not been established in children below the age of 6 years or in children with a BSA below 0.75 m2 have not been established. Not data are available.
The safety and efficacy of Renvela 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.
- major gastrointestinal tract surgery
Therefore caution should be exercised when it is used in these patients.Treatment of these patients with Renvela should only be initiated after careful benefit/risk assessment. If the therapy is initiated, patients suffering from these disorders should be monitored. Renvela treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Intestinal obstruction and ileus/subileus
Fat‑soluble vitamins and folate deficiency
Folate deficiency
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.
Swallowing and choking difficulties
Uncommon reports of difficulty swallowing the Renvela 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. Caution should be exercised when it is used in patients with difficulty swallowing. 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).
Long‑term chronic treatment
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 (see section 5.2).
Hyperparathyroidism
Inflammatory Ggastrointestinal Ddisorders
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per 800 mg tablet, that is to say essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of interaction
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 Renvela, and blood monitoring can be considered.Caution should be exercised when prescribing sevelamer carbonate to patients also taking these medicinal products.
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.
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 Renvela. The phosphate serum level should be monitored and the Renvela 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
MedDRA System Organ Class |
Very |
Common |
Very |
Not known |
-
- 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 undesirable effectsadverse 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
- 5.2 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
- 6.5 Nature and contents of container
HDPE bottles with a polypropylene cap and a foil induction seal.
Each bottle contains 30 tablets or 180 tablets.
Packs of 1 bottle of 30 or 180 tablets (without outer carton) and a multipack containing 180 (6 bottles of 30) tablets.
Not all pack sizes may be marketed.
Updated on 15 January 2019
File name
PIL Renvela 800mg Tablets leaflet text.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 09 January 2019
File name
SPC Renvela 800mg fc Tablets.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
7. MARKETING AUTHORISATION HOLDER
Genzyme Europe B.V.
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
Updated on 06 December 2018
File name
PIL Renvela 800mg fc tablets text.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Improved presentation of PIL
Updated on 04 October 2018
File name
1.3.1.1 IE SPC800mg tablets.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Change to section 11 - Dosimetry
- Change to section 12 - Instructions for preparation of radiopharmaceuticals
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4: New paragraph ‘Excipients’ added.
Minor changes throughout the 800mg Tablets and 2.4g Powder SmPC in line with the QRD template:
- Changing ‘Renvela’ to ‘sevelamer carbonate’.
- ‘Chronic Kidney Disease’ changed to ‘CKD’.
- Section 5.1 headings added.
- ‘Body surface area’ change to ‘BSA’.
- ‘Clinical studies’ changed to ‘clinial trials’.
Updated on 09 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 October 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.1 added
Renvela 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.
4.2 added:-
Wording amended.
Children/adolescents (>6 years of age and a body surface area (BSA) of >0.75m2)
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 body surface area (BSA) category. Renvela must be taken three times per day with meals or snacks.
children below the age of 6 years or in children with a BSA below 0.75 m2.
For paedi atri c pati ent s the oral suspension should be administered, as tablet formulations are not appropriate for this population.
4.2 deleted:-
Patients taking Renvela should adhere to their prescribed diets.
Renvela should be taken with food and not on an empty stomach.
4.8 added:-
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.
5.1 added:-
The safety and effectiveness of sevelamer carbonate in hyperphosphatemic paediatric patients with Chronic Kidney Disease (CKD) was evaluated in a multicenter study with a 2-week, randomized, 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 randomized 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 body surface area (BSA), in contrast however, no treatment response was observed in pediatric patients with qualifying phosphorus levels <7.0 mg/dL. Most of AEs reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. No new risks or safety signals were identified with the use of sevelamer carbonate during the study
Updated on 05 October 2017
File name
PIL_14633_668.pdf
Reasons for updating
- New PIL for new product
Updated on 05 October 2017
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 18 July 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 06 September 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 February 2016
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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.
Updated on 11 February 2016
Reasons for updating
- Change to side-effects
Updated on 25 January 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
section 4.8 of the SmPC to add
hypersensitivity as a new ADR with frequency very rare based on postmarketing reports.
Updated on 14 April 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 November 2012
Reasons for updating
- Change to further information section
Updated on 07 September 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Also a general update to align with the QRD template.
Updated on 04 September 2012
Reasons for updating
- Change to warnings or special precautions for use
Updated on 01 October 2010
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 30 September 2010
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to sections:
4.6 Fertility, pregnancy and lactation
Addition of “Fertility” in the header.
Addition to the last paragraph “Fertility - There are no data from the effect of sevelamer on fertility in humans. Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative body surface area.”
4.8 Undesirable effects
Post-marketing experience – Paragraph changed from – “In very rare cases (estimated post-marketing frequency of < 1/10,000), intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate” to “During post-approval use, cases of pruritus, rash, intestinal obstruction, ileus/subileus, and intestinal perforation have been reported in patients during treatment with sevelamer.”
5.3 Preclinical safety data
In the last paragraph changed the human equivalent dose from 3 to 2 and the maximum clinical trial dose from 14.4 to 13 g/day with addition to “based on a comparison of relative body surface”area.
10 Date of Revision of the Text
Change of date.
Updated on 27 April 2010
Reasons for updating
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 April 2010
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 April 2010
Reasons for updating
- New PIL for medicines.ie
SANOFI
Address:
Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
iemedinfo@sanofi.comTelephone:
+353 1 4035600