Lopid 600 mg film-coated tablet

  • Name:

    Lopid 600 mg film-coated tablet

  • Company:
    info
  • Active Ingredients:

    Gemfibrozil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/12/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 16/12/2019

Click on this link to Download PDF directly

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 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 229 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 16 December 2019 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 10 - Date of revision of the text

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:

Section 4.4 – addition of sodium warning

Section 4.5 – addition of selexipag information, and CYP2C8 reference

Section 10 – update date and tracking number

Updated on 16 December 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 25 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 16 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 16 August 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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:

1, 4.8, 5.2, 6.1, 6.6 – administrative updates

3 – administrative update (300 mg capsules only)

4.2 – ‘Method of administration’ sub-heading and text moved to the end of the section

4.3 - updated with text about concomitant use of selexipag

4.5 - with text about interactions with selexipag and enzalutamide

10 – date of National Authority approval

Updated on 6 June 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 June 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 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

SmPC:

Section 4.3:     addition of a new contraindication of concomitant use with dasabuvir

Section 4.4      addition of information regarding gemfibrozil's inhibition of CYP enzymes 2C8, organic anion-transporting polypeptide (OATP) 1B1 and UDP-glucuronosyltransferase

Section 4.5:     subsequent drug-drug interactions involving gemfibrozil and updates to the repaglinide and dasabuvir  information

s2, s3, s4.2 & s5.2  Editorial changes for updates in line with QRD v.9.1 are also being made, including adjustment of subsection headers in line with QRD v.9.1 and correction of typographical errors, both in the SmPC and PIL.

Updated on 3 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 June 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to how the medicine works
  • Change to date of revision

Updated on 13 April 2015 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC:

Section 4.4:     To update section on concomitant anticoagulants

Section 4.5      To update section on anticoagulants

Updated on 1 April 2015 PIL

Reasons for updating

  • Change to drug interactions

Updated on 9 September 2014 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Section 2:        Updated in line with QRD

Section 3:        Typographical changes

Section 4.2      Typographical changes, sub-headings added

Section 4.3:     To include the contra-indication; concomitant use of simvastatin.

Section 4.4:     To include the special warning that the concomitant administration of gemfibrozil with simvastatin is contraindicated. Typographical changes

Section 4.5:     To include drug interaction statements between gemfibrozil and 1) simvastatin and 2) colchicines.  

Section 4.6:     Updated in line with QRD. Fertility subsection added to include the statement that reversible decreases in male fertility have been observed in reproductive toxicity studies in rats.

Section 4.8:     Updated in line with QRD; minor typographical changes and statement regarding additional reporting of suspected adverse reactions.

Section 6.6:     Updated in line with QRD

Updated on 3 September 2014 PIL

Reasons for updating

  • Change of licence holder
  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to information about drinking alcohol
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision

Updated on 12 July 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 2 November 2010 PIL

Reasons for updating

  • Change to packaging
  • Change to storage instructions
  • Change to date of revision
  • Change to appearance of the medicine

Updated on 6 April 2009 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 6 March 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder address
  • Change to date of revision

Updated on 2 December 2005 PIL

Reasons for updating

  • Change of active ingredient
  • Change to side-effects

Updated on 10 December 2004 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to drug interactions
  • Change to information about driving or using machinery

Updated on 17 September 2004 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie