LOPID 300MG CAPSULES
*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 300mg caps 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 300mg caps 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 300mg caps 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 16 August 2018
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
Reg SPC LP 13_2 300mg caps 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 - 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 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 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 06 June 2016
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 03 June 2016
File name
PIL_8784_599.pdf
Reasons for updating
- New PIL for new product
Updated on 08 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 08 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
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 09 September 2014
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 09 September 2014
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
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
Updated on 13 July 2011
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
Updated on 06 April 2009
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 06 April 2009
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 06 March 2007
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
Updated on 06 March 2007
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
Updated on 02 December 2005
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 02 December 2005
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 08 December 2004
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 08 December 2004
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
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
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
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
Reasons for updating
- New SPC for medicines.ie