ZOCOR Tablets
*Company:
Organon Pharma (Ireland) LimitedStatus:
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 12 July 2023
File name
ZOCOR-FI-H-995-002-004-WS-1385-SPC-IE-en-CRT.pdf
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)
Updated on 12 July 2023
File name
QRD-IE-ZOCOR-10mg,20mg,40mg-PIL-WS-1385-en-CRT.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 - manufacturer
Updated on 28 March 2023
File name
QRD-IE-ZOCOR-10mg,20mg,40mg-PIL-IA757G Heist SNC-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 January 2023
File name
ZOCOR-FI-H-995-002-004-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 August 2021
File name
ZOCOR-FI-H-995-002-004-MAT-SPC-IE-en-CRT.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)
Updated on 30 August 2021
File name
QRD-IE-ZOCOR-10mg,20mg,40mg-PIL-MAT-CRT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change of licence holder
Updated on 03 February 2021
File name
ZOCOR-FI-H-995-002-004-WS-072-SPC-IE-en-CRT (002).pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
Update to PI to implement image harmonisation.
Updated on 03 February 2021
File name
QRD-IE-ZOCOR-10mg20mg40mg-LFT-WS072-012021_CRT (002).pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 07 January 2021
File name
ZOCOR-FI-H-995-002-004-WS-079-SPC-IE-en-CRT (002).pdf
Reasons for updating
- 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
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to PI with information about interaction with Ticagrelor
Updated on 07 January 2021
File name
QRD-IE-ZOCOR-10mg20mg40mg-LFT-WS079-122020_CRT (002).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 08 December 2020
File name
QRD-IE-ZOCOR-10mg20mg40mg-LFT-IA645G-102020 (002).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 29 July 2020
File name
ZOCOR-FI-H-995-002-004-WS-071-SPC-IE-en-CRT (002).pdf.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Earlier upload not displaying pdf once published, had to upload again due to system error.
Updated on 29 July 2020
File name
ZOCOR-FI-H-995-002-004-WS-071-SPC-IE-en-CRT (002).
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to implement CMDh’s recommendation
Updated on 29 July 2020
File name
QRD-ZOCOR-10mg 20mg 40mg-WS-071-PIL-IE-en-CRT (002).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 22 July 2020
File name
QRD-ZOCOR-10mg 20mg 40mg-Art 61(3)-PIL-IE-en-CRT (002).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 November 2019
File name
ZOCOR-FI-H-995-002-004-WS-591-PIL-IE-en-CRT.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 2 and section 6
Updated on 13 November 2019
File name
ZOCOR-FI-H-995-002-004-WS-591-SPC-IE-en-CRT (002).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
Safety Label Update to include text regarding an increased risk of myopathy and/or rhabdomyolysis by co-administration of HMGCoA reductase inhibitors and daptomycin for the sections 4.4 and 4.5
Updated on 17 June 2019
File name
ZOCOR-FI-H-0995-002-005-IA-063-SPC-IE-en-CRT.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
Converted the SPC from word format to pdf file format
Updated on 15 October 2018
File name
QRD Zocor Tablets PIL new SKU (2).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 11 June 2018
File name
ZOCOR_FI_H_0995_002_005_IA_063_SPC_IE_en_CRT.docx
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
Addition of information regarding anaphylaxis added to section 4.8 of the SPC
Updated on 11 June 2018
File name
ZOCOR_FI_H_0995_002_005_IA_063_PIL_IE_en_CRT.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 06 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 April 2018
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 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
- Update to section 4.4 and section 4.5 to include text regarding an increased risk of myopathy with interacting drugs that interfere with statin metabolism and/or transporter pathways.
- Update to section 4.5 to include reference to consult the prescribing information of all concomitantly used drugs to obtain further information about their potential interactions with simvastatin and/or the potential for enzyme or transporter alterations and possible adjustments to dose and regimens
- Insertion of the following text (highlighted in red) in section 4.5 / subsection Fusidic acid:
‘If treatment with systemic fusidic acid is necessary, simvastatin treatment should be discontinued throughout the duration of the fusidic acid treatment. Also see section 4.4.’
- Updates to SPC in line with the QRD template and editorial changes also undertaken.
Updated on 05 April 2018
File name
PIL_10384_230.pdf
Reasons for updating
- New PIL for new product
Updated on 05 April 2018
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
- Correction of spelling/typing errors
Updated on 01 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 August 2017
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 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)
Free text change information supplied by the pharmaceutical company
Insertion of the following text in section 4.2 (inserted text highlighted in red):
‘Posology
The dosage range is 5‑80 mg/day of simvastatin given orally as a single dose in the evening.’
Editorial updates undertaken to sections 4.4 & 6.5.
Updated on 31 July 2017
File name
PIL_10384_105.pdf
Reasons for updating
- New PIL for new product
Updated on 31 July 2017
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 10 May 2017
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
- Change to section 5.2 - Pharmacokinetic properties
- 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
SPC change details:
Update to sections 4.2, 4.4, 4.5 & 5.2 to include information on drug-drug interaction of BCRP inhibitors with HMG-CoA reductase inhibitors (statins) and on concomitant use of HMG-CoA reductase inhibitors (statins) with fusidic acid
Updated on 09 May 2017
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 6 - date of revision
Updated on 05 August 2015
Reasons for updating
- Change to date of revision
Updated on 29 July 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
Updated on 24 July 2015
Reasons for updating
- Change to warnings or special precautions for use
Updated on 12 March 2015
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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 warnings/interactions; Change of contraindications
Added warnings regarding taking Zocor with lomitapide and patients with HoFH; Cobicistat added as interacting agent
Updated on 12 March 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 25 February 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Discontinuation of one or more strengths
Updated on 22 January 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
- 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
Sections 4.4, 4.5 & 5.2 -
Reasons for submission: Approval of Type II Work-Sharing Variation- Notification regarding increased risk of myopathy with the SLCO1B1 gene
Updated on 27 August 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 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
Sections 4.4, 4.5, 10
Updated on 20 January 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 16 May 2013
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 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 15 March 2013
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 19 December 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 05 November 2012
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
- 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
Sections 4.3, 4.4, 4.5, 4.8, 10
Updated contraindications
Updated on 04 October 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 08 August 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 01 June 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 06 March 2012
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 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
Update to Sections: 4.2, 4.3, 4.4, 4.5, 4.8, 10.
Updated adverse events / contraindications.
Updated on 13 April 2011
Reasons for updating
- Change to side-effects
Updated on 10 March 2011
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 adverse events - Sections 4.4, 4.5, 4.8.
Updated on 10 March 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
Updated on 17 February 2011
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
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Additional warnings - Contraindications / updated storage conditions
Updated on 07 July 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 07 May 2010
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
- Change to section 4.8 - Undesirable effects
- 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
Change to sections 4.2, 4.4, 4.5, 4.8, 5.1
II25 (safety - Cholesterol, Homocysteine), II28 (safety - based on HPS2 THRIVE)
Updated on 06 April 2010
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 4.8 - 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
Change to sections 4.2, 4.4, 4.8, 5.1, 5.2
II23 (insomnia, memory impairment), II27 (paediatric worksharing)
Updated on 10 March 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
Change to sections 2 and 6.1 (renewal completion).
More detailed information on excipients.
Updated on 15 July 2008
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
- 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
4.4 Special warnings and precautions for use – removal of niacin dose cap and interaction with fusidic acid
4.8 Undesirable effects – addition of very rarely hepatic failure
Updated on 15 July 2008
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 07 February 2008
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
The changes are to Sections 4.2; 4.4 and 4.5.
Updated on 20 September 2007
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
SPC for Zocor - the change is to section 4.8 (to include hepatic failure).
Updated on 16 March 2007
Reasons for updating
- Change to marketing authorisation holder
Updated on 19 February 2007
Reasons for updating
- Change to marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 May 2006
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)
Updated on 12 May 2006
Reasons for updating
- Change to drug interactions
- Change to warnings or special precautions for use
Updated on 16 August 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 17 May 2004
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
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 December 2003
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 November 2003
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 September 2003
Reasons for updating
- Correction of spelling/typing errors
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 August 2003
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)