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Lopid 600 mg film-coated tablet

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Pharmacy Only: Prescription
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Updated on 31 October 2024

File name

Reg PIL LP 22_0 300mg caps & 600mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PIL has been updated. 

Section 6

Address of Manufacturer change.


Updated on 15 October 2024

File name

Reg SPC LP 17_0 600mg tabs IE-clean (1).pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 15 October 2024

File name

Reg PIL LP 20_0 300mg caps & 600mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 30 July 2024

File name

Reg SPC LP 16_1 600mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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 6.6

Update to disposal of unused medicinal product or waste material


Updated on 21 March 2023

File name

RegPILLP191300mgcaps600mgtabsIEclean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 14 February 2023

File name

DEC202084956_Reg SPC LP 15_1 600mg tabs IE-clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 18 December 2020

File name

DEC202084956_Reg SPC LP 15_1 600mg tabs IE-clean.pdf

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • Correction of spelling/typing errors
  • Change to section 6 - Pharmaceutical particulars

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

Updated on 18 December 2020

File name

DEC202084956_Reg PIL LP 18_2 300mg caps & 600mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 16 December 2019

File name

DEC201970511_Reg SPC LP 14_1 600mg tabs IE-clean.pdf

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

File name

DEC201970511_Reg PIL LP 17_1 300mg caps & 600mg tabs IE-clean.pdf

Reasons for updating

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

Updated on 25 February 2019

File name

Reg PIL LP 16_1 300mg caps 600mg tabs IE Clean.pdf

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

File name

PIL_8784_599.pdf

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

File name

Reg SPC LP 13_2 600mg tabs IE-Clean.pdf

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 06 June 2016

Reasons for updating

  • New SPC for new product

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

Updated on 06 June 2016

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 03 June 2016

File name

PIL_8784_599.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 June 2016

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

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 01 April 2015

Reasons for updating

  • Change to drug interactions

Updated on 09 September 2014

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 03 September 2014

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

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 02 November 2010

Reasons for updating

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

Updated on 06 April 2009

Reasons for updating

  • Change of inactive ingredient

Updated on 06 March 2007

Reasons for updating

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

Updated on 02 December 2005

Reasons for updating

  • Change of active ingredient
  • Change to side-effects

Updated on 10 December 2004

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

Reasons for updating

  • Improved electronic presentation

Updated on 14 September 2004

Reasons for updating

  • New PIL for medicines.ie

Pfizer Healthcare Ireland Unlimited Company

Pfizer Healthcare Ireland Unlimited Company