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Sildenafil Pfizer 25mg, 50mg, 100mg film–coated tablets

  • Name:

    Sildenafil Pfizer 25mg, 50mg, 100mg film–coated tablets

  • 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: 07/01/16

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Summary of Product Characteristics last updated on medicines.ie: 18/1/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
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Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
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Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
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Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
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Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
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Medicine Name BeneFIX Active Ingredients nonacog alfa
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Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
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1 - 0 of 227 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 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 8 January 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 8 January 2016 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
  • 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

The SPC has been updated as follows: The SmPC and PIL has been updated in line with the PRAC recommendation adopted in June plenary on contraindication for concomitant administration of PDE5 inhibitors with riociguat. Minor corrections have also been made to sections 4.8 and 5.2 of the SmPC to align this with Viagra. In addition the MAH has also updated the SmPC to align with the EU QRD 9.1 template

Updated on 7 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 January 2016 PIL

Reasons for updating

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

Updated on 5 January 2015 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

The SPC has been updated as follows

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, this aligns Sildenafil SPC  to the Viagra SPC

Updated on 22 December 2014 PIL

Reasons for updating

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

Updated on 1 October 2014 PIL

Reasons for updating

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

Updated on 18 June 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

Update to sections 4.4 & 4.5

Updated on 11 June 2014 PIL

Reasons for updating

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

Updated on 9 April 2014 SmPC

Reasons for updating

  • Change to improve clarity and readability
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Update to section 4.4  revise the information on acute NAION based on new data coming from a clinical study.
Update to all SPC sections with regard to QRD V 9.

Updated on 28 March 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability

Updated on 13 November 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 section 4.8

Updated on 4 November 2013 PIL

Reasons for updating

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

Updated on 21 June 2013 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 21 June 2013 PIL

Reasons for updating

  • New PIL for medicines.ie