Lipitor 10 mg Chewable Tablets
*Company:
Upjohn EESVStatus:
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 26 April 2023
File name
Patient Information Leaflet - 003067906.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 April 2023
File name
SMPC-I~2.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 September 2021
File name
DEC202112636-V_Reg SPC LR 16_0 10mg Chew IE - clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
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 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address
Section 8 - updated with new PA number for Upjohn EESV
Updated on 29 September 2021
File name
DEC202112636-V_Reg PIL LR 23_1 Chew IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 20 September 2021
File name
DEC202112235-V_Reg SPC LR 15_1 10mg Chew 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
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 September 2021
File name
DEC202112235-V_Reg PIL LR 22_1 Chew IE - clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 31 March 2021
File name
DEC202104589-V_Reg SPC LR 14_1 10mg Chew 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 March 2021
File name
DEC202104589-V_Reg PIL LR 21_0 Chew IE-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
Updated on 27 January 2021
File name
DEC202101386-V_Reg PIL LR 19_1 Chew IE-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 03 September 2020
File name
DEC202046959-V_Reg SPC LR 13_1 10mg Chew IE clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 June 2020
File name
Reg PIL LR 18_0 Chew UK IE Clean (002).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 May 2020
File name
DEC201964482_Reg SPC LR 12_1 10mg Chew IE - Clean.pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC: Following section are updated to include drug interaction information of atorvastatin with letermovir.
Section 4.2 Posology and method of administration.
Section 4.4 Special warnings and precautions for use.
Section 4.5 Interaction with other medicinal products .
Updated on 19 November 2019
File name
DEC201964482_Reg PIL LR 18_0 Chew UK IE - Clean.pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 November 2019
File name
DEC201964482_Reg PIL LR 18_0 Chew UK IE - Clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 31 July 2019
File name
DEC201939369_Reg PIL LR 17_2 Chew UK IE .pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 31 July 2019
File name
DEC201939369_Reg SPC LR 11_2 10mg Chew IE.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC: Updated as follows:
Section 4.8- updated to include “Muscle rapture” under rare side effects on PRAC recommendation (All strengths).
Updated on 13 May 2019
File name
DEC201924154_Adv PIL LR 12_2 Chew UK IE - Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 May 2019
File name
DEC201924154_Reg SPC LR 10_1 10mg Chew IE - Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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: Sections 4.8, 10 has been updated as per the CMDh endorsed PRAC recommendation to include lupus related events.
Updated on 11 January 2019
File name
Adv PIL LR 11_1 Chew UK 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 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 11 January 2019
File name
Reg SPC LR 9_1 10mg Chew IE- Clean.pdf
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
|
The following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details.
|
Updated on 28 November 2018
File name
Reg SPC LR 8_1 10mg Chew IE.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 30 August 2018
File name
Reg_SPC_LR_8_1_10mg_Chew_IE_clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
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 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.
Section 5.1: an editorial update to the footnote for Table 3
Updated on 05 June 2018
File name
Reg_SPC_LR_8_1_10mg_Chew_IE_clean.docx
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
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 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.
Section 5.1: an editorial update to the footnote for Table 3
Updated on 17 February 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 February 2017
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- 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:
Sections 1, 2, 3, 4.6, 5.2, 5.3, 6.4, 6.6 – administrative update
Section 4.2, 4.8, 5.1 - paediatric data update
Section 4.4 – paediatric data update, CMDh wording for fusidic acid interaction
Updated on 16 February 2017
File name
PIL_15194_725.pdf
Reasons for updating
- New PIL for new product
Updated on 16 February 2017
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 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 01 March 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 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- 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:
Minor updates to the following sections of the SPC to bring in line with the QRD template:
Section: 2, 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 6.1, 6.3, 6.6, 9 and 10Updated on 29 February 2016
Reasons for updating
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to drug interactions
- Change to further information section
- Change to date of revision
Updated on 08 April 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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: Special warnings and precautions for use
Sub-heading: Concomitant treatment with other medicinal products
Update to wording on ‘immune-mediated necrotizing myopathy (IMNM)’ to bring it in line with the PRAC wording.
Section 4.8. Undesirable effects
Sub-heading: Musculoskeletal and connective tissue disorders
Addition of reference to section 4.4.
Updated on 30 March 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 29 May 2014
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 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 May 2014
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 07 November 2013
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 4.8 - Undesirable effects
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
changes to section 4.4, 4.5, 4.8
Updated on 01 November 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to improve clarity and readability
Updated on 05 July 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 July 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 23 November 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 November 2011
Reasons for updating
- New PIL for new product