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Revatio 20 mg film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Sildenafil Citrate

    *Additional information is available within the SPC or upon request to the company

Updated on 22 March 2024

File name

Summary of Product Characteristics - IE -20 mg FCT - TII098 - clean .pdf

Reasons for updating

  • 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 11 - Dosimetry

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

Updated on 23 March 2023

File name

Revatio 20 mg Film-coated Tablets - Patient Information Leaflet.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Updated on 05 August 2022

File name

DEC202209217-V_Adv PIL RV FCT 44_0 IE UK (NI) - Clean.pdf

Reasons for updating

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

Updated on 26 May 2022

File name

Adv SPC RV 40_1 20mg tabs IE - clean.pdf

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

The SPC has been updated as follows:

Section 4.5 Interaction with other medicinal products and other forms of interaction – addition of wording relating to sacubitril/valsartan

Updated on 04 May 2022

File name

DEC202204975-V_Adv SPC RV 41_1 20mg tabs IE - clean.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.8 & 5.1 to include long term safety data in adults for the approved dose, and evidence of safe and effective use in adults in higher than recommended doese.

Updated on 08 April 2022

File name

Adv SPC RV 40_1 20mg tabs IE - clean.pdf

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

The SPC has been updated as follows:

Section 4.5 Interaction with other medicinal products and other forms of interaction – addition of wording relating to sacubitril/valsartan 

Updated on 08 April 2022

File name

Adv PIL RV FCT 43_1 IE UK (NI) - clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 03 March 2022

File name

Adv PIL RV 42_0 IE UK (NI) - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Individual PILs superseded by joint PIL

Updated on 18 November 2020

File name

DEC202050566-V_Adv SPC RV 39_1 20mg tabs IE - Clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 18 November 2020

File name

DEC202050566-V_Adv PIL RV 41_1 IE - Clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 09 June 2020

File name

DEC202037533_Adv SPC RV 38_1 20mg tabs IE.Clean.pdf

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

The SPC has been updated to change the MAH in section 7 from Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium to Upjohn EESV, Rivium Westlaan 1422909 LD Capelle aan den Ijssel,Netherlands.  

Updated on 09 June 2020

File name

DEC202037533_Adv PIL RV 40_1 IE.Clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Joint PIL superseded by individual PILs

Updated on 09 April 2020

File name

DEC202023178_Adv SPC RV 37_0 20mg tabs IE Clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 19 November 2019

File name

DEC201964508_Adv PIL RV 39_0 UK IE.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 29 May 2019

File name

Adv PIL RV 38_0 UK IE.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 May 2019

File name

Adv SPC RV 36_0 20mg tabs IE.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 03 August 2018

File name

Adv PIL RV 37_1 UK IE_clean.pdf

Reasons for updating

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

Updated on 03 August 2018

File name

Adv SPC RV 35_1 20mg tabs IE_clean.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 7: Marketing Authorisation Holder updated to new MAH, Pfizer EEIG, Belgium.

Section 10: Date of Revision of Text updated to 07/2018

Updated on 04 May 2018

File name

Adv_SPC_RV_34_0_20mg_tabs_IE.docx

Reasons for updating

  • 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

UK brand marketing

Not affected

Note – as this is a CP licensed product, the SPC revision date has been updated to reflect the EMA approval date (04/2018)

Updated on 26 April 2018

File name

Adv PIL RV 36_0 UK IE_clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 11 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 11 December 2017

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

The SPC (UK and IE) has been updated as follows: Section 4.6 Breast Feeding updated.

Updated on 07 December 2017

File name

PIL_11087_185.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 December 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 15 November 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 6.5 updated to include additional packing configuration (90 x 1 tablets in PVC/Aluminium perforated unit dose blisters.)

Updated on 11 November 2016

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 05 August 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Sections 4.2, 6.3, 6.4 and 6.6 have been updated to delete information related to the extemporaneously prepared oral suspension.

Updated on 03 August 2016

Reasons for updating

  • Change to storage instructions
  • Change to dosage and administration

Updated on 23 June 2016

Reasons for updating

  • 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 10 The revision date has been updated to 06/2016 in line with the date of the EMA annexes.

Updated on 22 June 2016

Reasons for updating

  • Change to date of revision

Updated on 16 October 2015

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

The SPC has been updated as follows:

PRAC recommendation applicable to tadalafil and all other authorised phosphodiesterase type 5 (PDE5) inhibitors with regards to the need to include a contraindication in the Product information of all authorised PDE5 inhibitors in view of the identified safety issue of the concomitant administration of Adempas (riociguat) and PDE5 inhibitors.

Updates have been made to the  SmPC sections 4.3 and 4.5, and section 2 of the PIL in line with the PRAC recommendation. In addition the SmPC & PIL have been aligned to the EU QRD 9.1 template, and spelling of calcium sulphate updated to calcium sulfate in Revatio tablets spc section 6.6 and PIL. Other minor editorial/formatting revisions have also been made

Updated on 12 October 2015

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision

Updated on 15 April 2015

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 6.5 has been updated to include 300 tablet pack size and statement not all pack sizes may be marketed.

Updated on 14 April 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details
  • Introduction of new pack/pack size

Updated on 28 October 2014

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

The SPC has been updated as follows. Section 4.5 has been revised to update the numerical results for bosentan exposure change based on the final population pharmacokinetic analysis for study A1481243

Updated on 27 October 2014

Reasons for updating

  • 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

SPC revision date (only) should be updated to October 2014

Updated on 27 October 2014

Reasons for updating

  • Change to side-effects

Updated on 02 October 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 10 September 2014

Reasons for updating

  • 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

The SPC Section 4.8 has been updated to change the ADR reporting details from the IMB to HPRA.

Updated on 04 September 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 02 July 2014

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 & 4.5

Updated on 30 June 2014

Reasons for updating

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

Updated on 30 January 2014

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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Update to sections 4.2, 4.4, 4.5 and 5.1

Updated on 24 January 2014

Reasons for updating

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

Updated on 06 January 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

tes to Sections 2, 4.8, 5.1, 6.5

Updated on 24 December 2013

Reasons for updating

  • Change to side-effects

Updated on 24 October 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to SPC section 4.8

Updated on 22 October 2013

Reasons for updating

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

Updated on 02 September 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - 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

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

Free text change information supplied by the pharmaceutical company

Update to Sections 2, 4.1-4.6, 4.8, 5.1, 5.2, 6.4, 6.5, 6.6, 9 & 10

Updated on 28 August 2013

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Improved electronic presentation

Updated on 24 April 2013

Reasons for updating

  • 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

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 April 2013

Reasons for updating

  • Change to date of revision

Updated on 23 January 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update section 4.8 to include the adverse events  haematuria, penile haemorrhage, haematospermia.

Updated on 21 January 2013

Reasons for updating

  • Change to side-effects

Updated on 07 August 2012

Reasons for updating

  • Improved electronic presentation

Updated on 10 July 2012

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

Revatio tablets Sections, 4.2, 4.8, 5.1

Updated on 03 July 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to improve clarity and readability

Updated on 25 April 2012

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)

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 March 2012

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 4.5 - 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

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

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 27 March 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 19 January 2012

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

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 17 January 2012

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 07 November 2011

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC Update to sections 4.2, 4.4, 5.1.

Updated on 04 November 2011

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Change to MA holder contact details

Updated on 15 July 2011

Reasons for updating

  • SPC re-instated

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

Free text change information supplied by the pharmaceutical company

n/a

Updated on 13 July 2011

Reasons for updating

  • PIL re-instated

Updated on 16 May 2011

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 4.4 - 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

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

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 13 May 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to date of revision
  • PIL Submitted in error

Updated on 04 April 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 hypotension as additional side effect with frequency unknown.
The revision date has also been updated.

Updated on 04 April 2011

Reasons for updating

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

Updated on 28 January 2011

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Changes to Section 5.1

Updated on 27 January 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to MA holder contact details

Updated on 14 October 2010

Reasons for 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

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

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 13 October 2010

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 19 January 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

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

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 12 January 2010

Reasons for updating

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

Updated on 21 July 2009

Reasons for 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

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

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 23 February 2009

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 15 October 2008

Reasons for updating

  • Change to further information section

Updated on 14 October 2008

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

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 01 April 2008

Reasons for updating

  • Change to side-effects

Updated on 31 March 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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: update to section 4.8 to include the following:

 

4.8       Undesirable effects

Ear and labyrinth disorders:

 

Not known- Sudden deafness

Updated on 10 September 2007

Reasons for updating

  • Change to date of revision
  • Change to further information section
  • Correction of spelling/typing errors

Updated on 24 August 2007

Reasons for updating

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

Updated on 13 April 2007

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 addition of "priapism" and "prolonged erection"

Updated on 13 April 2007

Reasons for updating

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

Updated on 24 January 2007

Reasons for updating

  • Change to side-effects

Updated on 23 January 2007

Reasons for 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

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

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 14 November 2006

Reasons for updating

  • Change to further information section

Updated on 25 September 2006

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 ' addition of 'skin rash' as an adverse event and rearranged the adverse events in a table as per MeDRA system organ.

Updated on 25 September 2006

Reasons for updating

  • Change to side-effects

Updated on 05 September 2006

Reasons for updating

  • Improved electronic presentation

Updated on 01 September 2006

Reasons for updating

  • Improved electronic presentation

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

Updated on 01 August 2006

Reasons for updating

  • New PIL for new product

Updated on 14 July 2006

Reasons for 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

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

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 July 2006

Reasons for 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

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

Updated on 03 March 2006

Reasons for updating

  • New SPC for new product

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