LOPID 300MG CAPSULES

  • Name:

    LOPID 300MG CAPSULES

  • 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

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Summary of Product Characteristics last updated on medicines.ie: 16/12/2019

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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
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
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Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
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 228 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 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 - how to report a side effect
  • 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 3 - Pharmaceutical form
  • 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 6 June 2016 PIL

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 4.3 - 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

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 8 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 8 April 2015 PIL

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

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 9 September 2014 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 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6 - Pharmaceutical particulars

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 9 September 2014 PIL

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 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6 - Pharmaceutical particulars

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 13 July 2011 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

SmPC: changes to sections: 1, 2, 4.1, 4.8, 5.1, 6.4 and 6.5

Updated on 13 July 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • 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

SmPC: changes to sections: 1, 2, 4.1, 4.8, 5.1, 6.4 and 6.5

Updated on 6 April 2009 PIL

Reasons for updating

  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 6.1 List of excipients;

Removal of 2-ethoxyethanol, soya lecithin and dimethicone.

Addition of Propylene glycol.

Updated on 6 April 2009 SmPC

Reasons for updating

  • 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 6.1 List of excipients;

Removal of 2-ethoxyethanol, soya lecithin and dimethicone.

Addition of Propylene glycol.

Updated on 6 March 2007 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

 
Section 7 address change
 
Section 10 change of date of revision

Updated on 6 March 2007 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 
Section 7 address change
 
Section 10 change of date of revision

Updated on 2 December 2005 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Updated on 2 December 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 8 December 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 4.2 - 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 be renewed (B)

Updated on 8 December 2004 PIL

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 4.2 - 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Updated on 13 October 2003 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • 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 be renewed (B)

Updated on 13 October 2003 PIL

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 27 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie