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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 24/04/2013
SPC Revatio 20 mg film-coated tablets

When a pharmaceutical company changes an SPC or PIL, 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 24/04/2013 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Dec-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company


The revision date on the SPC has been updated from Jan2013 to December 2012, to reflect CHMP opinion date. Updated SPC and PILs are provided which replace those previously issued on 18th January.
Updated on 23/01/2013 and displayed until 24/04/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jan-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update section 4.8 to include the adverse events  haematuria, penile haemorrhage, haematospermia.
Updated on 10/07/2012 and displayed until 23/01/2013
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Jun-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Revatio tablets Sections, 4.2, 4.8, 5.1

Updated on 25/04/2012 and displayed until 10/07/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Apr-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Updates tp section 4.4 with a Vaso occlusive crisis in patients with sickle cell anaemia and section 4.8 updated.
Updated on 28/03/2012 and displayed until 25/04/2012
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Revatio tablets Sections 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.7,4.8, 5.1, 5.2, 6.1, 6.6 & 10
Updated on 19/01/2012 and displayed until 28/03/2012
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   10-Jan-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SmPC Update to section 6.6 to list the exicipients calcium sulphate and trisodium phosphate in compounding oral vehicle, and minor typographical updates
Updated on 07/11/2011 and displayed until 19/01/2012
Reasons for adding or 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
Date of revision of text on the SPC:   24-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SmPC Update to sections 4.2, 4.4, 5.1.

Updated on 15/07/2011 and displayed until 07/11/2011
Reasons for adding or updating:
  • SPC re-instated
Date of revision of text on the SPC:   02-May-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
n/a
Updated on 16/05/2011 and displayed until 15/07/2011
Reasons for adding or 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 4.4 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 11 - Dosimetry
  • SPC submitted in error
Date of revision of text on the SPC:   02-May-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update to sections 2, 4.1, 4.2, 4.4, 4.5, 4.6,4.7,4.8, 5.1,5.2,5.3,6.3*,6.4*,6.5*,6.6,9,10, 11
Updated on 04/04/2011 and displayed until 16/05/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   24-Mar-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Section 4.8 updated to include hypotension as additional side effect with frequency unknown.
The revision date has also been updated.
Updated on 28/01/2011 and displayed until 04/04/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   21-Jan-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Changes to Section 5.1
Updated on 14/10/2010 and displayed until 28/01/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   23-Sep-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
4.2, 4.3 and 4.5 Sections 6.2 and 6.6 have been amended to introduce information on diluent compatibility.
Updated on 19/01/2010 and displayed until 14/10/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
section 4.2 - information in patients with renal hepatic impairment and use in children has been revised

section 4.3 - the following statement was included "Co-administration with nitric oxide donors"
Updated on 21/07/2009 and displayed until 19/01/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company


Update to sections 4.1 and 5.1 of the SPC with functional class II and long-term survival data and typo’s amended in sections 4.5 and 4.8 for ‘cellulitis’, ‘paraesthesia’ and ‘rifampicine’.
Updated on 14/10/2008 and displayed until 21/07/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The following text has been removed from Section 5.1:

‘This medicinal product has been authorised under ‘Exceptional Circumstances’. This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary’.
Updated on 31/03/2008 and displayed until 14/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

Section 4.8: update to section 4.8 to include the following:

 

4.8       Undesirable effects

Ear and labyrinth disorders:

 

Not known- Sudden deafness
Updated on 13/04/2007 and displayed until 31/03/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
Section 4.8 addition of "priapism" and "prolonged erection"
Updated on 23/01/2007 and displayed until 13/04/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

Section 4.2 Posology

Addition of new sentence & deletion of epoprostenol under “use in patients using other medications”

 

Section 4.8 Undesirable effects

Update of existing text /addition of new summary.

Update of the ADR table:

  • Addition of 6 new ADRS with frequency common: blood shot eyes/red eyes, blurred vision, nasal congestion
  • Change of frequency grouping from common to uncommon for 4 ADRs: visual acuity reduced, diploplia, abnormal sensation in eye.
  • Deletion of 1 ADR: weight increased under Investigations MedDRA system organ class.

 

Section 5.1 Pharmacodynamics

 

Addition of clinical data:

  • First paragraph with summary of study design
  • Second paragraph with summary of results for primary efficacy endpoint = 6MWD
  • Third and last paragraph with summary of results for secondary efficacy endpoint = mPAP.
Updated on 25/09/2006 and displayed until 23/01/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   08/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.8 ' addition of 'skin rash' as an adverse event and rearranged the adverse events in a table as per MeDRA system organ.
Updated on 01/09/2006 and displayed until 25/09/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 14/07/2006 and displayed until 01/09/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

1 update with NAION new safety information:

-to add the NAION contraindication and warning/precaution wording  SPC section 4.3 & 4.4.

2 rewording of "nitrates contraindication" sentence:
The sentence "The use of Revatio and organic nitrates in any form, at any time is contraindicated" amended to "the use of Revatio in combination with nitrates in any form, at any time is contraindicated" .
Amended the sentence with "in combination", to reflect the approved SPC wording "in co-administration" and remove the term "organic".

Section 2, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.3, 6.6, 9 and 10 of the SmPC updated.
Updated on 11/07/2006 and displayed until 14/07/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 03/03/2006 and displayed until 11/07/2006
Reasons for adding or updating:
  • New SPC for new product

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