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ZOCOR Tablets

*
Pharmacy Only: Prescription

  • Company:

    Organon Pharma (Ireland) Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Simvastatin

    *Additional information is available within the SPC or upon request to the company

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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

Additional warning regarding "very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins" has been added

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

SPC sections have changed: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 10
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

Updates to Sections 4.3, 4.4, 4.5, 10.

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

Sections 7 and 10 - Updated MA Holder address

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

4.4 - addition of information regarding diabetes and statins
4.8 - addition of new side effect

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

4.2 Posology and method of administration – removal of niacin dose cap
4.4 Special warnings and precautions for use – removal of niacin dose cap and interaction with fusidic acid
4.5 Interaction with other medicinal products and other forms of interaction – 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

Cahnge of PA licence holder from Merck, Sharp and Dohme to Merck Sharp and Dohme Ireland Human Health Ltd

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)

Organon Pharma (Ireland) Limited

Organon Pharma (Ireland) Limited