Renagel 800 mg film-coated tablets

  • Name:

    Renagel 800 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Sevelamer hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/10/19

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Summary of Product Characteristics last updated on medicines.ie: 14/10/2019

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22 October 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 October 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 12 September 2019 SmPC

Reasons for updating

  • New SmPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 15 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 9 January 2019 SmPC

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 4 October 2018 SmPC

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 6 September 2016 SmPC

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

Update of section 4.4 of the SmPC add a warning regarding gastrointestinal disorders associated with sevelamer crystals

Updated on 6 September 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 February 2016 SmPC

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 3 February 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 February 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 28 January 2016 SmPC

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 SmPC

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 updated to include 'acidosis, increased chloride serum levels'.

Updated on 5 March 2015 PIL

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 SmPC

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

Renagel changed to sevelamer hydrochloride throughout.

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 PIL

Reasons for updating

  • Change to further information section

Updated on 7 September 2012 SmPC

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

Section 4.4: update to include precaution information regarding difficulties in swallowing Renvela tablets.
Also a general update to align with the QRD template.

Updated on 4 September 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 16 March 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 1 July 2010 SmPC

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

Updates made to:

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 1 July 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 1 April 2010 SmPC

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

None provided

Updated on 1 April 2010 PIL

Reasons for updating

  • New PIL for medicines.ie