Relpax 40mg Film-Coated Tablets

  • Name:

    Relpax 40mg Film-Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Eletriptan hydrobromide

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/03/18

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Summary of Product Characteristics last updated on medicines.ie: 1/3/2018
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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 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 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 1 March 2018 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
A five tablet pack size has been added to section 6.5

Updated on 1 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 March 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
A five tablet pack size has been added to section 6.5

Updated on 1 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 9 September 2014 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 4.3 Contraindications: 

inclusion of reference to:  Patients with coronary artery vasospasm (Prinzmetal’s angina),

Section 4.8 Undesirable effects:

amendment of bilirubinaemia to hyperbilirubinaemia under hepatobillary disorders and inclusion of reporting of adverse events to HPRA.

Section 5.1:  Pharmacodynamic properties: 

Removal of statement  “The efficacy of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials that included about 5000 patients who received RELPAX”  and replaced with “The efficacy and safety of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials involving more than 6000 patients (all treatment groups)….”

Section 6.1 List of Excipients:

amended text is highlighted in yellow:  Film Coat: titanium dioxide (E171), hypromellose, lactose monohydrate, glycerol triacetate  and Sunset Yellow FCF Aluminium Lake (E110)

Updated on 9 September 2014 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3 Contraindications: 

inclusion of reference to:  Patients with coronary artery vasospasm (Prinzmetal’s angina),

Section 4.8 Undesirable effects:

amendment of bilirubinaemia to hyperbilirubinaemia under hepatobillary disorders and inclusion of reporting of adverse events to HPRA.

Section 5.1:  Pharmacodynamic properties: 

Removal of statement  “The efficacy of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials that included about 5000 patients who received RELPAX”  and replaced with “The efficacy and safety of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials involving more than 6000 patients (all treatment groups)….”

Section 6.1 List of Excipients:

amended text is highlighted in yellow:  Film Coat: titanium dioxide (E171), hypromellose, lactose monohydrate, glycerol triacetate  and Sunset Yellow FCF Aluminium Lake (E110)

Updated on 18 September 2013 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 1 in line with version 8 QRD

Update to section 2 in line with version 8 QRD

Sections 4.2 - 4.8 updated in line with Core Safety Profile

Sections 5.1 – 5.2 updated in line with version 8 QRD

Updated on 18 September 2013 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Update to section 1 in line with version 8 QRD

Update to section 2 in line with version 8 QRD

Sections 4.2 - 4.8 updated in line with Core Safety Profile

Sections 5.1 – 5.2 updated in line with version 8 QRD

Updated on 6 September 2012 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Addition of Medication overuse headache (MOH) to section 4.4 Special Warnings and Precautions for Use

Including angioedema in section 4.8 undesirable effects

Updated on 6 September 2012 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of Medication overuse headache (MOH) to section 4.4 Special Warnings and Precautions for Use

Including angioedema in section 4.8 undesirable effects

Updated on 8 July 2011 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4: Additional text has been added regarding the overuse of triptans.
Section 4.8: Minor changes to the way two current adverse events are described.

Updated on 8 July 2011 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: Additional text has been added regarding the overuse of triptans.
Section 4.8: Minor changes to the way two current adverse events are described.

Updated on 26 February 2009 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 26 February 2009 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)