Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets *
Pharmacy Only: Prescription

Updated on 15 February 2022

File name

ie-spc-foznolchewtabs-common-TIA-049-Jan-22-clean_1644947873.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4 has been updated as follows:

 

In section 4.8

 

Tissue deposition of lanthanum has been shown with Foznol in animal studies. In 105 bone biopsies from patients treated with Foznol, some for up to 4.5 years, rising levels of lanthanum were noted over time (see section 5.1). Cases of lanthanum deposition in gastrointestinal mucosa, mainly after long term use, have been reported. Lanthanum deposition in gastroduodenal mucosa is demonstrated endoscopically as whitish lesions of different sizes and shapes. Also, various pathological features were identified in gastroduodenal mucosa with lanthanum deposition, such as chronic or active inflammation, glandular atrophy, regenerative changes, foveolar hyperplasia, intestinal metaplasia and neoplasia.

In section 4.8, Product residue present1 has been added 'Not known'

1See Lanthanum deposition in gastrointestinal mucosa warning in section 4.4 Special warnings and precautions for use

 

Updated on 15 February 2022

File name

ie-pl-foznolcombinedchewables-TIA-049-Jan-22-clean_1644947599.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 24 December 2021

File name

Ireland SmPC Foznol chewable tablets combined 250mg 500mg 750 mg and 1000 mg 02 DEC 2021_1640356285.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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Main changes are as follows:
Section 4: Wording added to state that where Foznol oral powder is available, it can replace chewable tablets in patients who have difficulty chewing tablets
Section 4.9 Paediatric wotding removed and moved to Section 4.8
Section 5.1 Paediatric population data updated
Section 5.2 Paediatric population data updated
Section 7: MA Holder amended to Takeda Pharmaceutical International AG Ireland Branch from Shire Pharmaceuticals Ireland Ltd
Section 8: MA numbers updated

Updated on 10 December 2021

File name

ie-pl-foznolcombinedchewables-Oct-21_1639153241.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Summary of changes:

  • Transfer of the Marketing Authorization Holder (from Shire Pharmaceuticals Ireland Limited to Takeda Pharmaceuticals International AG Ireland Branch).

Updated on 13 August 2021

File name

Ireland PIL Foznol combined 500 mg, 750 mg and 1000 mg chewable tablets - JUL 2021_1628859295.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 May 2019

File name

Foznol tabs-PIL-deletion of manu-May19-clean_1558425603.pdf

Reasons for updating

  • Change of manufacturer

Updated on 05 December 2018

File name

ie-mockup-pl-Oct2018_1544012394.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Company name change or merger

Updated on 05 December 2018

File name

ie-spc-combined-fosrenol-Oct2018_1544012600.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Company name change or merger

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 (Marketing authroisation holder), changed from from Shire Pharmaceutical Contracts Limited, One Kingdom Street, W2 6BD, London, United Kingdom to Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland

Section 8 (Marketing authroisationnumbers), new marketing authorisation numbers generated due to the MAH transfer

Updated on 21 September 2018

File name

ie-pl-foznolcombinedctenclean_1537544642.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 23 October 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 October 2017

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)

Free text change information supplied by the pharmaceutical company

Change of the address of the MAH from Chineham in Hampshire to Kingdom Street in London.
Update to the date of revision of the text.

Updated on 20 October 2017

File name

PIL_12326_508.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 October 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 07 July 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 has been updated for Fosrenol chewable tablets to include the terms intestinal obstruction, ileus and subileus with a frequency of “uncommon” based on findings in clinical studies. The term intestinal perforation has been added with a frequency of “rare” based on findings in clinical studies.

Updated on 05 July 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 22 July 2015

Reasons for updating

  • Deletion of a pack size
  • Change to name of manufacturer

Updated on 16 March 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • 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

In Section 2  Excipient(s) with known effect has been added

In Section 3 

250 mg: White, round, 13mm,  beveled-edge flat tablets debossed with ‘S405/250’ on one side.

500 mg: White, round, 18mm,  beveled-edge flat tablets debossed with ‘S405/500’ on one side.

750 mg: White, round, 20mm,  beveled-edge flat tablets debossed with ‘S405/750’ on one side.

1000 mg: White, round, 22mm,  beveled-edge flat tablets debossed with ‘S405/1000’ on one side.

In Section 4.2

Paediatric population

The safety and efficacy of Foznol in children and adolescents below the age of 18 years has not been established (see section 4.4 and 5.1) has been added

In Section 4.4 Pediatiric population has been added

In Section 4.6

Fertility

There are no fertility data available on lanthanum carbonate in humans.  In rat toxicology studies, lanthanum carbonate had no adverse effects on fertility.

  In section 4.8

Reporting of suspected adverse reactions is added

In Section 9 Renewal date has been update
In section 10 Revision date has been updated

Updated on 04 March 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 23 April 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 6.5 - Nature and contents of container
  • 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

Change to 4.2 Posology and method of administration to state that the tablets must be chewed completely and not swallowed whole.

Change to 2 Qualitative and Quantitative composition to reflect that the chewable tablets contain glucose.  Appropriate warning updated in section 4.4.

QRD amendments made for the other sections.

Updated on 22 April 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability

Updated on 18 January 2012

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Secftion 4.8 - update to reformat table and include sentence on post-marketing experience.
Section 5.1 - update to include information on paediatric population.

Updated on 16 January 2012

Reasons for updating

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

Updated on 06 January 2012

Reasons for updating

  • Change of manufacturer

Updated on 17 June 2011

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

In section 4.4 (Special warnings and precautions for use) the following text has been added:

Foznol is known to cause constipation (see section 4.8) and therefore caution should be exercised in patients predisposed to bowel obstruction (e.g. previous abdominal surgery, peritonitis).

Updated on 15 June 2011

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 12 November 2010

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • In section 4.2 (Posology and method of administration) the following text was changed:
    • The text "To aid with chewing the tablets may be crushed". was added.
    • The risk/benefit statement over 2 years was removed.
  • In section 4.4 (Special warnings and precautions for use) the following text was changed:
    • The risk/benefit statement was replaced with "The use of Fosrenol in clinical studies beyond 2 years is currently limited. However, treatment of subjects with Fosrenol for up to 6 years has not demonstrated a change in the benefit/risk profile.
    • Safety and efficacy of Fosrenol have not been established in children and adolescents; use in children and adolescents is not recommended (see section 4.2).
  • In section 4.5 (Interaction with other medicinal products and other forms of interaction the following text was changed:
    • However, interactions with drugs such as tetracycline and doxycycline are theoretically possible and if these compounds are to be co-administered, it is recommended that they are not to be taken within 2 hours of dosing with Fosrenol.

    • The following text was added:

      The bioavailability of oral ciprofloxacin was decreased by approximately 50% when taken with Fosrenol in a single dose study in healthy volunteers. It is recommended that oral floxacin formulations are taken at least 2 hours before or 4 hours after Fosrenol.

       

      Phosphate binders (including Fosrenol) have been shown to reduce the absorption of levothyroxine. Consequently, thyroid hormone replacement therapy should not be taken within 2 hours of dosing with Fosrenol and closer monitoring of TSH levels is recommended in patients receiving both medicinal products.

  • In section 4.8 (Undesirable effects) the reporting of reactions was amended in line with QRD.

  • Updated on 08 November 2010

    Reasons for updating

    • Change to drug interactions
    • Change to date of revision
    • Change to dosage and administration

    Updated on 20 November 2009

    Reasons for updating

    • Change to section 4.1 - Therapeutic indications
    • 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

    In section 4.1 (Therapeutic Indications) the following text was added:

    Foznol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels ³1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.



    In section 4.4 (Special warnings and precautions for use) the following text was revised:

    Lanthanum is not metabolised by liver enzymes but it is most likely excreted in the bile. Conditions resulting in a marked reduction of bile flow may be associated with incrementally slower elimination of lanthanum, which may result in higher plasma levels and increased tissue deposition of lanthanum (see sections 5.2 and 5.3).   As the liver is the principle organ of elimination of absorbed lanthanum monitoring of liver function tests is recommended.

    Updated on 17 November 2009

    Reasons for updating

    • Change to, or new use for medicine
    • Change to date of revision

    Updated on 12 August 2009

    Reasons for updating

    • Correction of spelling/typing errors

    Updated on 14 May 2009

    Reasons for updating

    • Improved electronic presentation

    Updated on 16 October 2008

    Reasons for updating

    • Change to section 6.3 - Shelf life
    • 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 6.3 Shelf-life changed from 2 years to 3 years.

    Updated on 24 September 2007

    Reasons for updating

    • Change to section 4.4 - Special warnings and precautions for use
    • 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 4.4 - Addition of a statement regarding the possible effect of the product on abdominal x-rays.
    Section 4.8 - Gastrointestinal ADRs added to the table.

    Updated on 12 September 2007

    Reasons for updating

    • New PIL for medicines.ie

    Updated on 27 February 2007

    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 4.6 - Pregnancy and lactation
    • Change to section 5.1 - Pharmacodynamic properties

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Update to the wording in sections 4.2, 4.4, 4.6, 4.7 and 5.1

    Updated on 04 August 2006

    Reasons for updating

    • Correction of spelling/typing errors

    Legal category:Product subject to medical prescription which may be renewed (B)

    Updated on 23 March 2006

    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 5.1 - Pharmacodynamic properties

    Legal category:Product subject to medical prescription which may be renewed (B)

    Updated on 12 December 2005

    Reasons for updating

    • New SPC for new product

    Legal category:Product subject to medical prescription which may be renewed (B)