Renagel 800 mg film-coated tablets
*Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 August 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Renagel 800mg (3).pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 August 2023
File name
1.3.1.3 Package Leaflet (PIL Text)- Renagel 800mg Tablets (IE-MT-NI) (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 14 August 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Renagel 800mg (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 not be renewed (A)
Updated on 14 August 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Renagel 800mg (2).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 not be renewed (A)
Updated on 14 August 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Renagel 800mg Tablets (IEMTNI) (1).pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 01 August 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Renagel 800mg tablets (IENI) Waterford details only (1).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 01 August 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Renagel 800mg tablets (IENI) Waterford details only (1).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 13 June 2023
File name
1.3.1.3 Package Leaflet (PIL Text)- Renagel 800mg Tablets (IE-MT-NI).pdf
Reasons for updating
- New PIL for new product
Updated on 09 June 2023
File name
1.3.1.3 Package Leaflet (PIL Text) Renagel 800mg Tablets (IEMTNI).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
Updated on 01 June 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Renagel 800mg (1).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 January 2022
File name
1.3.1 IENI - Renagel - PIL text (1).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 02 December 2020
File name
PIL Text - Oct 2020.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 01 June 2020
File name
IE Renagel 800mg - PIL text.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 29 May 2020
File name
IE Renagel 800mg - PIL text.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 April 2020
File name
UK Renagel 800mg - 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
Renagel 800mg PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 14 October 2019
File name
Renagel 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 not be renewed (A)
Updated on 14 October 2019
File name
Renagel 800mg PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 12 September 2019
File name
Renegel 800mg SmPC.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 January 2019
File name
PIL Renagel 800mg Tablets leaflet text.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 09 January 2019
File name
SmPC Renagel 800mg fc tablets.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
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 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: New paragraph ‘Excipients’ added.
Minor changes throughout the 800mg Tablets 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 06 September 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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 not be renewed (A)
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 not be renewed (A)
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 03 February 2016
File name
PIL_14631_183.pdf
Reasons for updating
- New PIL for new product
Updated on 03 February 2016
Reasons for updating
- Change to side-effects
Updated on 28 January 2016
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of section 4.8 of the SmPC to add
hypersensitivity as a new ADR with frequency very rare based on
postmarketing reports.
Updated on 10 March 2015
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 05 March 2015
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 12 December 2014
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 4.6 - 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 6.1 - List of excipients
- 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 8 - MA number
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2:
- Titration and maintenance updated to include times daily.
- Paediatric Population text deleted 'Renagel is not recommended in children below the age of 18 years.'
- Renal impairment text deleted 'Renagel is not recommended in these patients.'
- Method of administration text included 'Do not crush, chew or break into pieces prior to administration.'
Section 4.4:
- Paragraph deleted: 'Anti arrhythmic and anti seizure medicinal products'.
Section 4.5:
- Paragraph headings included
Section 4.6:
- Lactating changed to breast-feeding.
- Under 'Fertility' text added: 'based on a comparison of relative body surface area.'
Section 4.8:
- Paragraph headings included and text moved from one paragraph to another.
- Not known details included.
- Reporting of suspected adverse reactions included.
Section 4.9:
- Text deleted: 'No case of overdose has been reported.'
Section 5.1:
- Text included 'Pharmacotherapeutic group'
Section 5.2:
- section 4.4 title removed.
Section 6.1: E464 included
Section 6.5: pack sizes updated.
Section 6.6: text deleted 'No special requirements for disposal.'
Section 8: pack details included.
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 not be renewed (A)
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 16 March 2011
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 01 July 2010
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Undesirable effects. Diverticulitis addes to "Post-marketing experienc" paragraph
Section 10 - Date of Revision of the Text. Updated revision date added.
Updated on 01 July 2010
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 01 April 2010
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 April 2010
Reasons for updating
- New PIL for medicines.ie