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Viagra 25MG, 50MG, 100MG

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • 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 19 March 2024

File name

Viagra 25 mg, 50 mg and 100 mg Patient Information Leaflet - clean.pdf

Reasons for updating

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

Updated on 19 March 2024

File name

Viagra 25 mg, 50 mg and 100 mg Summary of Product Characteristics - clean.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 21 March 2023

File name

Patient Information Leaflet - Viagra tabs - Malta LR update - Clean.pdf

Reasons for updating

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

Updated on 25 November 2022

File name

Adv PIL VI 41_0 25_50_100mg 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 25 November 2022

File name

Adv SPC VI 39_0 25_50_100mg 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)

Updated on 26 August 2022

File name

Adv PIL VI 40_0 25_50_100mg IE UK (NI) - clean.pdf

Reasons for updating

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

Updated on 07 February 2022

File name

Adv PIL VI 39_0 25_50_100mg 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  • Individual PILs superseded by joint PIL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 20 November 2020

File name

DEC202050641-V_Adv SPC VI 38_1 25_50_100mg IE clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 20 November 2020

File name

DEC202050641-V_Adv PIL VI 38_0 25_50_100mg IE clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 05 August 2020

File name

Adv SPC VI 37_0 25_50_100mg IE -Clean.pdf

Reasons for updating

  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

An error has been corrected in the new MAH address of the Viagra SPC for UK and IE (Rivium Westlaan 1427 changed to Rivium Westlaan 142).

Updated on 09 June 2020

File name

DEC202037517_Adv SPC VI 36_1 25_50_100mg IE - Clean .pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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: The MAH has been updated for the Change of Ownership from Pfizer MA EEIG to Upjohn EESV

Section 4.8: REPORTING DETAILS have been updated according to the market (UK or IE) for the splitting of the pack.

Section 10: DATE OF REVISION OF THE TEXT has been updated to align with the EU annex approval date.

Updated on 09 June 2020

File name

DEC202037517_Adv PIL VI 37_1 25_50_100mg 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 03 April 2020

File name

DEC202021401_Adv SPC VI 35_0 25_50_100mg UK & IE_CLEAN .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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 10: DATE OF REVISION OF THE TEXT has been updated to align with the EU annex approval date.

Updated on 03 April 2020

File name

DEC202021401_Adv PIL VI 36_0 25_50_100mg UK & IE _CLEAN.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 November 2019

File name

DEC201964539_Adv PIL VI 35_0 25_50_100mg UK & IE.pdf

Reasons for updating

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

Updated on 28 May 2019

File name

DEC201927248_Adv PIL VI 34_0 25_50_100mg UK & IE.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 May 2019

File name

DEC201927248_Adv SPC VI 34_0 25_50_100mg UK & 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)

Free text change information supplied by the pharmaceutical company

Section 10: DATE OF REVISION OF THE TEXT has been updated

Updated on 26 March 2019

File name

DEC201915317_Adv PIL VI 33_0 25_50_100mg UK & IE.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 26 March 2019

File name

DEC201915317_Adv SPC VI 33_0 25_50_100mg UK & 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)

Free text change information supplied by the pharmaceutical company

Section 10: DATE OF REVISION OF THE TEXT has been updated

Updated on 18 January 2019

File name

Adv SPC VI 32_1 25_50_100mg UK & IE.pdf

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines

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 4.7, a driving warnings statement has been added in line with QRD

Updated on 03 August 2018

File name

Adv PIL VI 71_0 25_50_100mg UK & IE_clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 03 August 2018

File name

Adv SPC VI 71_0 25_50_100mg UK & IE_clean .pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 – Change to MAH

SECTION 4.8: To add ADR statement ‘or search for MHRA Yellow Card in the Google Play or Apple App Store’

SECTION 10 – Date of revision of text

Updated on 23 June 2016

Reasons for updating

  • New SPC for new product

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

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

The SPC has been updated as follows:

Section 10: The revision date has been updated to June 2016 in line with the date of the EMA approved annexes.

Updated on 21 June 2016

File name

PIL_8583_232.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 June 2016

Reasons for updating

  • Change to date of revision

Updated on 12 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:

On 3rd July 2015 Pfizer received a communication from the EMA informing us in advance of the publication of the minutes of June 2015 PRAC Plenary, of a 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. 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 25 June 2015

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 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 5.2: correction of values:

"In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200% and 79% respectively."

Section 4.8: removal of the following sentence:

"In addition, the frequency of medically important adverse reactions reported from post marketing experience is included as not known."

In addition the opportunity is being taken to remove an * incorrectly included in Section 4.8 of the 100 mg tablets SPC for "Transient ischaemic attack"

Updated on 07 May 2015

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • 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

Addition of 24 pack size for the 50mg & 100mg strengths only.

SPC sections impacted are 6.5, 8 & 10.

Updated on 30 April 2015

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 01 October 2014

Reasons for updating

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

Updated on 02 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

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

Updated on 28 August 2014

Reasons for updating

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

Updated on 28 April 2014

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 of the SPC has been updated following a review of the clinical trial data to re-assess the estimated frequencies of adverse drug reactions.

Updated on 24 April 2014

Reasons for updating

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

Updated on 07 March 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

Section 4.4  additional information regarding priapism 
Section 4.5 update to effects of other medicines on sildenafil

Updated on 27 February 2014

Reasons for updating

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

Updated on 29 August 2013

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Update to section 4.4  revise the information on acute NAION based on new data coming from the clinical study

Updated on 23 August 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

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 4.4 - 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 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • 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

Sections 2, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.5, 9 & 10 have been revised. The changes are concerned with updates to headings, formatting and additional information for sections 4.6 and 5.1.

Updated on 22 April 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change due to harmonisation of PIL
  • Improved electronic presentation

Updated on 28 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 to include the ADRs haematuria, haematospermia and penile haemorrhage in the section 4.8 of the SmPC of Viagra.

Updated on 24 January 2013

Reasons for updating

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

Updated on 20 July 2010

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



Addition of

Severe Cutaneous Adverse Reactions (SCAR) to Section 4.8

 

 

Updated on 13 July 2010

Reasons for updating

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

Updated on 20 February 2009

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 19 February 2009

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 date of revision updated

Updated on 18 September 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to date of revision

Updated on 16 September 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 2: Administrative change

Section 3: Administrative change

Section 4.2: Update to use in children to include adolescents

Section 4.8: Reformatted. Somnolence, hypoaesthesia, atrial fibrillation, vertigo, tinnitus, nausea, dry mouth, lacrimation disorders added.

Updated on 02 April 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

4.8 inclusion of updated post-marketing surveillance information regarding hearing loss/sudden deafness.

Updated on 25 March 2008

Reasons for updating

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

Updated on 27 November 2007

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

6.5 – details of 1 pack size removed

8.0 – details of 1 pack size removed

Updated on 27 November 2007

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 21 November 2007

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 24 October 2007

Reasons for updating

  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Updated on 24 October 2007

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 10 May 2007

Reasons for updating

  • Change to further information section

Updated on 05 September 2006

Reasons for updating

  • Change of contraindications

Updated on 04 September 2006

Reasons for updating

  • 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

Change to section 4.3 - Contra-indications

Updated on 30 November 2005

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 30 November 2005

Reasons for updating

  • Change of active ingredient
  • Change to warnings or special precautions for use
  • Change to information about driving or using machinery
  • Change to side-effects
  • Change to further information section

Updated on 10 May 2005

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 10 May 2005

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change of contraindications

Updated on 07 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 July 2004

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 4.8 - Undesirable effects
  • 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 02 February 2004

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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 10 - Date of revision of the text

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

Updated on 08 October 2003

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
  • Change to section 6.5 - Nature and contents of container
  • Correction of spelling/typing errors
  • 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 24 June 2003

Reasons for updating

  • New SPC for medicines.ie

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