Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets
- Name:
Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets
- Company:
Shire Pharmaceuticals Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/05/19
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Shire Pharmaceuticals Ireland Limited
Company Products
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 21 May 2019 PIL
Reasons for updating
- Change of manufacturer
Updated on 5 December 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Company name change or merger
Updated on 5 December 2018 SPC
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 PIL
Reasons for updating
- Change to other sources of information section
Updated on 23 October 2017 SPC
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 SPC
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
Update to the date of revision of the text.
Updated on 20 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 20 October 2017 PIL
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 7 July 2016 SPC
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 5 July 2016 PIL
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 PIL
Reasons for updating
- Deletion of a pack size
- Change to name of manufacturer
Updated on 16 March 2015 SPC
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 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 4 March 2015 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 23 April 2013 SPC
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 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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to improve clarity and readability
Updated on 18 January 2012 SPC
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
Section 5.1 - update to include information on paediatric population.
Updated on 16 January 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 6 January 2012 PIL
Reasons for updating
- Change of manufacturer
Updated on 17 June 2011 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 12 November 2010 SPC
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
- The text "To aid with chewing the tablets may be crushed". was added.
- The risk/benefit statement over 2 years was removed.
- 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).
-
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 8 November 2010 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
- Change to dosage and administration
Updated on 20 November 2009 SPC
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
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 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 12 August 2009 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 14 May 2009 PIL
Reasons for updating
- Improved electronic presentation
Updated on 16 October 2008 SPC
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 SPC
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
Updated on 12 September 2007 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 27 February 2007 SPC
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
Updated on 4 August 2006 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)