Viagra 25MG, 50MG, 100MG

  • Name:

    Viagra 25MG, 50MG, 100MG

  • Company:
    info
  • Active Ingredients:

    sildenafil citrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/05/19

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Summary of Product Characteristics last updated on medicines.ie: 28/5/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name Atorvastatin Pfizer 10 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 20 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 40 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 80 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
1 - 0 of 231 items.Total: Infinity pages

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 28 May 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 May 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 26 March 2019 SmPC

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 SmPC

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 3 August 2018 PIL

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 3 August 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 June 2016 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 June 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 12 October 2015 PIL

Reasons for updating

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

Updated on 12 October 2015 SmPC

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 25 June 2015 SmPC

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 7 May 2015 SmPC

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 PIL

Reasons for updating

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

Updated on 1 October 2014 PIL

Reasons for updating

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

Updated on 2 September 2014 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 7 March 2014 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 23 April 2013 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 20 July 2010 SmPC

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 PIL

Reasons for updating

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

Updated on 20 February 2009 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 19 February 2009 SmPC

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 PIL

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 SmPC

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 2 April 2008 SmPC

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 PIL

Reasons for updating

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

Updated on 27 November 2007 SmPC

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 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 21 November 2007 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 24 October 2007 SmPC

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 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 10 May 2007 PIL

Reasons for updating

  • Change to further information section

Updated on 5 September 2006 PIL

Reasons for updating

  • Change of contraindications

Updated on 4 September 2006 SmPC

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 PIL

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 30 November 2005 SmPC

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 10 May 2005 PIL

Reasons for updating

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

Updated on 10 May 2005 SmPC

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 7 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 July 2004 SmPC

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 2 February 2004 SmPC

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 8 October 2003 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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