Lopid 600 mg film-coated tablet
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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