LYRICA Capsules

  • Name:

    LYRICA Capsules

  • Company:
    info
  • Active Ingredients:

    pregabalin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/04/21

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Summary of Product Characteristics last updated on medicines.ie: 7/4/2021

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Pfizer Healthcare Ireland

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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 BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 233 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 15 April 2021 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 7 April 2021 SPC

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 SPC has been updated as follows:

Update to Section 5.1 of the SPC following completion of a paediatric study (A0081105)

Updated on 7 April 2021 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 27 November 2020 SPC

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)

Updated on 27 November 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 October 2020 SPC

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4: Special warnings and precautions for use has been updated to include the Sodium content warning

Section 4.8: Undesirable effects has been updated to include updates to Paediatric population data

Section 5.1 Pharmacodynamic properties has been updated to include updates to Paediatric population data

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

Updated on 16 October 2020 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 9 June 2020 PIL

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 9 June 2020 SPC

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

Due to the spilt of the joint SPC/PIL, Section 4.8: Undesirable effects has been updated to reflect market specific ADR reporting information

Section 7: MARKETING AUTHORISATION HOLDER has been updated FROM: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium TO: Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den Ijssel, Netherlands

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

Updated on 1 April 2020 SPC

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 1 April 2020 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 13 January 2020 SPC

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

The SPC has been updated as follows:

In section 4.4, Special warnings and precautions for use, a section is added to include information on concomitant use with opioids.

The following statement is added to section 4.4 of the SPC, under ‘concomitant use with opioids’

This increased risk was observed at low doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 – 2.22]) and there was a trend for a greater risk at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 – 5.06]).

 

In section 4.5, Interaction with other medicinal products and other forms of interaction, information on opioids is added.

 

Updated on 13 January 2020 PIL

Reasons for updating

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

Updated on 19 November 2019 PIL

Reasons for updating

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

Updated on 28 May 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 May 2019 SPC

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 17 May 2019 PIL

Reasons for updating

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

Updated on 16 May 2019 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 6.5 and 10 - updated to remove 2x56 bundle pack information and changed date of revision of text to 05/2019.

Updated on 27 March 2019 SPC

Reasons for updating

  • 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 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 SPC

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 12 May 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 12 January 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 12 January 2018 SPC

Reasons for updating

  • 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

The SPC has been updated as follows: update to section 4.8 & 5.1 with pediatric wording

Updated on 13 December 2017 SPC

Reasons for updating

  • Previous version of SPC reinstated

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

Free text change information supplied by the pharmaceutical company

Hi All

 

Following error below, note that eMC and medicines.ie should not have been updated.

 

Please revert and update eMC and medicines.ie with previous version, see attachments.

 

KR

 

Nathalie

Updated on 24 November 2017 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Type II – Art 46  - update Section 4.8 Undesirable effects and Section 5.1 Pharmacodynamic properties of the pregabalin SmPC to reflect the availability of information

Updated on 13 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 July 2017 SPC

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: addition of Hepatobiliary disorders in section 4.8. (uncommon, rare and very rare)

Updated on 13 July 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 March 2017 PIL

Reasons for updating

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

Updated on 21 March 2017 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Addition of pack size for 25mg capsules

Updated on 18 November 2016 SPC

Reasons for updating

  • Change to section 4.9 - Overdose

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:

-        Update of section 4.9 of the SmPC to add information about seizures. The Package leaflet is updated accordingly
-        Update of the Product Information to QRD version 9.1 and a combined SmPCs for all strengths of pregabalin capsules is introduced.

Updated on 23 June 2016 SPC

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: New revision date / Approval date only

Updated on 21 June 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 26 June 2015 PIL

Reasons for updating

  • Removal/change of distributor

Updated on 27 April 2015 SPC

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
  • 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:

Updated paediatric information in sections 4.2, 4.8, 5.1 and 5.2 as requested after assessment of studies A0081074 & A0081075 submitted as post authorisation measures under Article 46 and Article 45.

Updated on 26 January 2015 SPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

SPC sections 4.6 (Fertility, pregnancy, and lactation) and 5.2 (Pharmacokinetic properties) have been updated to reflect new data available for lactation, based on the results of a recently completed study.

Updated on 21 January 2015 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 3 September 2014 PIL

Reasons for updating

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

Updated on 6 August 2014 SPC

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 to sections 4.4 & 4.8

Updated on 31 July 2014 PIL

Reasons for updating

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

Updated on 29 May 2014 SPC

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

Update to:

Section 6.5 & 8  to add a new pack size of a 70 day pack for Lyrica 75mg capsules

Updated on 22 May 2014 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 4 March 2014 SPC

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

Updates to section 4.8 of the SPC to update the frequency categories for ADRs in the Lyrica SPC based on the all-causality adverse events clinical trial dataset

Updated on 27 February 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 4 December 2013 SPC

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

Update to sections 4.4 & 4.8

Updated on 29 November 2013 PIL

Reasons for updating

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

Updated on 30 April 2013 SPC

Reasons for updating

  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

To remove the sentence " In overdose up to 15 g no unexpected reactions were reported" and to add a reference to cases of coma.(SPC Section 4.9 Overdose).

Updated on 26 February 2013 SPC

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

Update of the sub heading in Section 4.5 of the SPC from Ethanol, lorazepam, oxycodone to CNS influencing medical products

Updated on 26 February 2013 PIL

Reasons for updating

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

Updated on 2 February 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 November 2011 SPC

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 of section 4.8 of the Summary of Product Characteristics (SmPC) and relevant section of the PL to add “gynaecomastia” and to replace “hypertrophy breast” with the term “breast enlargement”, as per MedDRA dictionary.

Updated on 21 November 2011 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

.

Updated on 8 November 2011 SPC

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

Update section 5.1

Updated on 30 June 2011 SPC

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

SmPC (update of section 4.8 in term of frequency of headache)

Updated on 24 June 2011 PIL

Reasons for updating

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

Updated on 15 September 2010 SPC

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 4.6 - 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

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

Free text change information supplied by the pharmaceutical company

SmPC
Administrative changes to sections 4.2, 4.4, 4.5, 4.6, 4.7, 4.8 & 5.1 of the SPC
Addition of text on fertility to sections 4.6 and 5.1 of the SPC


Updated on 13 September 2010 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to drug interactions

Updated on 1 July 2010 SPC

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

In section 4.4 : Side effects and Section 4.8 undesirbale effects.

Updated on 29 June 2010 PIL

Reasons for updating

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

Updated on 13 May 2010 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.4:

- Addition of anxiety as a discontinuation symptom

- Addition of possible paralytic ileus when pregabalin is co-administered with drugs known to reduce lower gastrointestinal tract function to section 4.4 (CDS has it under drug interactions rather than warning/precautions).

Section 4.8:

- Addition of anxiety as a discontinuation symptom

Updated on 12 May 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 8 March 2010 SPC

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 addition of malaise and aggressions as ADRs with unknown frequency to section 4.8 of the SPC.

Updated on 1 March 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 15 September 2009 SPC

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 undesirable effect

Removal of side effects emanating from clinical trial data from trials for indications for which Lyrica is not indicated.

Updated on 4 September 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 3 September 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 January 2009 SPC

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

Section 4.4 - Addition of vision loss and suicidal ideation information

Section 4.8 - Addition of vision loss information

Updated on 7 January 2009 PIL

Reasons for updating

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

Updated on 24 April 2008 PIL

Reasons for updating

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

Updated on 22 April 2008 SPC

Reasons for updating

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

 

4.4  Addition of information on hypersensitivity reactions, including cases of angioedema and visual changes

 

4.8 Addition of angioedema & Keratitis as new adverse events and visual field defect

      described under eye disorders

 

5.1 Addition of clinical trial data for visual changes

Updated on 25 March 2008 PIL

Reasons for updating

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

Updated on 19 March 2008 SPC

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

 

1) Strengthening of Congestive Heart Failure wording in section 4.4 of the SmPC and addition of urinary retention to section 4.8 of the SmPC

 

2) Addition of Stevens Johnson Syndrome (SJS) to section 4.8 of the SmPC

Updated on 27 July 2007 SPC

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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


Section 4.4 Addition of post marketing reports of consciousness, confusion and mental impairment

Section 4.5 Addition of interaction with CNS depressant medication and effects of ethanol & lorazepam

Section 4.8 Addition of loss of consciousness, mental impairment and headache

Section 4.9 Update of this section with post-marketing information

Section 6.5 Addition of 100 hard capsule PVC/Aluminium blister pack (non-perforated)

Section 8 – Addition of further license numbers

 

 

Updated on 27 July 2007 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change due to harmonisation of patient information leaflet

Updated on 14 June 2007 PIL

Reasons for updating

  • Change to further information section

Updated on 16 February 2007 SPC

Reasons for updating

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

 
Section 4.4 - special warning to use pregabalin with caution in patients with congestive heart failure
 
Section 4.8 - reformatting and addition of adverse events with unknown frequency.  In addition congestive heart failure is included to the list of adverse reactions
 
Section 6.6 - updated wording to 'Special precautions for disposal and other handling'

Updated on 7 February 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to MA holder contact details

Updated on 25 September 2006 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Change to section 2 - qualitative and quantitative composition, Change to section 4.1 - Therapeutic Indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.8 - Undesirable Effects, Change to section 5.1 - Pharmacodynamic

Updated on 22 September 2006 PIL

Reasons for updating

  • Change to how the medicine works

Updated on 21 August 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 17 August 2006 SPC

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

Change to section 4.8 - Undesirable Effects

Updated on 14 August 2006 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 8 - MA number
  • 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 12 June 2006 PIL

Reasons for updating

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

Updated on 21 April 2006 PIL

Reasons for updating

  • Change to how the medicine works
  • Change to drug interactions
  • Change to warnings or special precautions for use
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to side-effects
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 21 April 2006 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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 6.5 - Nature and contents of container

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

Updated on 5 January 2006 PIL

Reasons for updating

  • Change to side-effects

Updated on 21 December 2005 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 16 August 2005 PIL

Reasons for updating

  • Change to packaging

Updated on 20 July 2005 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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)

Updated on 20 July 2005 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 16 May 2005 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 17 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 November 2004 SPC

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)

Updated on 21 October 2004 SPC

Reasons for updating

  • New SPC for new product

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