Summary of Product Characteristics
last updated on the eMC:
31/01/2012
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 31/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 22-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 updated to include precaution information regarding difficulties in swallowing Renagel tablets.
Also a general update to align with the QRD update.
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Updated on 29/06/2010 and displayed until 31/01/2012
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 02-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Updates made to:
Section 4.8 - Undesirable effects. Diverticulitis has been added to the "Post-marketing experience" paragraph
Section 10 - Date of Revidion of the Text. New revision date.
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Updated on 04/01/2010 and displayed until 29/06/2010
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 08-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes made to:
Section 2 - Qualitative and Quantitative Composition - addition of hydrochloride
Section 4.2 - Psology and method of administration - updated to include a statement on Paediatric population and Renal impairment.
Section 4.4 - Special warnings and precautions for use - added information on:
- Fat-soluble vitamins
- Folate deficiency
- Hyocalcaemia/hypercalcaemia
- Metabolic acidosis
- Peritonitis
- Anti-arrhythmic and anti-seizure medicinal products
- Long term chronic treatment
Section 4.5 - Interaction with other medicinal products and other forms of interaction - addition of information on bioavailability.
Section 4.5 - Pregnancy and lactation - statement added on use in pregnancy.
Section 9 - Date of first authorisation/renewal of the authorisation - Date of renewal added
Section 10 - Date of revision of the text - date added.
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Updated on 26/08/2009 and displayed until 04/01/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 27-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Updates to Sections 4.4 Special warnings and percautions for use
- addition of term diverticulosis to paragraph 2
- moved paragraph 10 relating to hypothyroidism to section 4.5 (interaction with other medicinal products and other forms of interaction).
Section 4.8 Undesirable effects
- Addition of rash, puritus and abdominal pain
Section 6.3 Shelf life
- Shelf life changed from 2 years to 3 years
These changes have been made following PSUR assessment.
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Updated on 08/09/2008 and displayed until 26/08/2009
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Reasons for adding or updating:
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Introduction of new pack/pack size
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 15-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 6.5 Nature and contents of container - Addition of new packsize
6 x 30 tablets
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Updated on 05/08/2008 and displayed until 08/09/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Correction of spelling/typing errors
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.8 (Undesirable Effects) involving 244 haemodialysis patients with treatment duration of up to 54 amended from 202 and 52 respectively. The side effect profile and frequencies has changed.
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In Section 5.1(Pharmacodynamic properties) The sentence 'Renagel had no adverse effect on bone turnover or mineralisation compared to calcium carbonate' has been included.
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Updated on 18/06/2007 and displayed until 05/08/2008
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 Extended indication to include patients on peritoneal dialysis
Section 4.2 Better presentation of dosage
Section 4.4 Added information about the new patient population
Section 4.8 Included 1) a statement on efficacy and 2) information on iPTH in new patient population
Section 6.6 Additional statement on disposal
Sections 9 & 10: change of dates
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Updated on 07/06/2006 and displayed until 18/06/2007
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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