Isentress 400 mg tablets

Product Information *

  • Company:

    MSD Ireland (Human Health) Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 July 2021

File name

ISENTRESS-H-C-0860_PSUSA-00010373-202009-SPC-400-IE-en-CRT_1626788425.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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to include a risk of a DDI with iron salts and a recommendation to stagger administration.

Updated on 20 July 2021

File name

QRD-IE-MT-ISENTRESS-400-LFT-PSUSA-202009 -28062021_1626788264.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 08 April 2021

File name

ISENTRESS-H-C-0860-IB-095-G-SPC-400mg-IE-en-CRT_1617878759.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

ATC code update

Updated on 06 November 2020

File name

QRD-IE-MT-ISENTRESS-400mg-IB092-LFT-102020.pdf_1604671964.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 06 November 2020

File name

ISENTRESS-H-C-0860-IB-092-SPC-400mg-IE-en.pdf_1604671523.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to implement the 2017 excipient guideline

 

 

Updated on 24 July 2019

File name

QRD_400mg_PIL_ISENTRESS-H-C-0860-IB-087-en-CRT (002)_1563964668.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 23 July 2019

File name

IE-ELOCON_LOTION-EN-SPC-20170912-CRT(002)_1561626529_1563875174.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 16 July 2019

File name

QRD_400mg_PIL_ISENTRESS-H-C-0860-IB-087-en-CRT (002)_1563279286.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 01 March 2019

File name

ISENTRESS-H-C-0860-II-078-400mg-SPC-en-CRT_1551446081.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC

Change to section 10 - Date of revision of the text

Editorial updates

 

Updated on 21 November 2018

File name

400mg_PIL_ISENTRESS-H-C-0860-II-073-PI-en-CRT_1542786436.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 21 November 2018

File name

400mg_SPC_ISENTRESS-H-C-0860-II-073-PI-en-CRT_1542786551.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.6 & 5.3 (update regarding pregnancy and risk of malformative or foetal toxicity (LEG)

Updated on 22 October 2018

File name

ISENTRESS 400mg-H-C-0860-IG-0994-SPC-IE-en-CRT (2)_1540197322.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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.4  & Change to section 4.8: addition of "autoimmune hepatitis”

 

Updated on 26 June 2018

File name

SPC_400mg_ISENTRESS-H-C-0860-T-075-PI-en-CRT (2).docx

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 7 - Marketing authorisation holder

Present

Proposed

Merck Sharp & Dohme Ltd.
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Updated on 26 June 2018

File name

PIL_400mg_ISENTRESS-H-C-0860-T-075-PI-en-CRT (2).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 03 May 2018

File name

ISENTRESS400mgtabletsII064GSPCIEenCRTMar2018.docx

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.1 (update regarding Paediatric population) Change to section 4.2 (update regarding Paediatric population); Change to Section 4.8 (update the safety information); Change to section 5.2 (update regarding Paediatric population)

 

Updated on 24 April 2018

File name

QRD_PIL.IST.400mg.18.UK.6304.II-064G (2).pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 27 March 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 March 2018

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to Section 4.8 (update the safety information);  Change to section 5.1 (editorial corrections);

Updated on 06 November 2017

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 6.5: add the term “multipack”

Updated on 06 November 2017

File name

PIL_12801_414.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 November 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 11 August 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.2 - update of posology; Change to section 4.5 –update of information regarding interactions; Change to section 4.6 – update of information regarding breast-feeding; Change to Section 4.8 – update of the Summary of the safety profile of the product;  10 - Update of revision of the text; editorial corrections in the text

Updated on 10 August 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 December 2016

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 SPC change details: Minor formatting changes to tables

Updated on 21 January 2015

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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2, 4.4, 4.5, 10 - Updated pharmacokinetic interaction data

Updated on 04 September 2014

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updated indications (age groups) and posology

Updated on 26 June 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Addition of information on reporting a side effect.

Updated on 03 June 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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 6.6 - 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to Sections: 2, 4.2, 4.4, 4.5, 4.8, 6.6, 10
Updated interactions (Effect on pharmacokinetics of boceprevir)

Updated on 13 September 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 06 September 2013

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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updated warnings re: co-administration with aluminium and/or magnesium antacids

Updated on 03 July 2013

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 June 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
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC sections have changed: 4.4, 4.5, 4.8, 10 - Updated warnings re: autoimmune disorders; interactions with boceprevir

Updated on 08 April 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section

Updated on 06 March 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Following SPC sections have changed: 2, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 10.
Added paediatric indication; updated interactions (omeprazole and famotidine); updated fertility, pregnancy and lacation information; updated side effects

Updated on 11 January 2013

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC sections: 4.5, 10 - Updated pharmacokinetics for raltegravir and darunavir

Updated on 10 January 2013

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 03 December 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Detailed SPC change information: Added reference to hepatic failure (uncommon)


Updated on 12 September 2012

Reasons for updating

  • Change to further information section

Updated on 24 August 2012

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Section 5.2 - Added information on presence of raltegravir in cerebrospinal fluid

Updated on 10 April 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section

Updated on 04 April 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 (Special warnings and precautions for use


Added warning on depression

 


Updated on 29 February 2012

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.8 (

Undesirable effects), 5.1 (Pharmacodynamic properties)
Added side effects / modified side effect frequencies.

Updated on 16 January 2012

Reasons for updating

  • Change to side-effects

Updated on 07 December 2011

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 updated
Added warnings for Severe skin and hypersensitivity reactions and updated uncommon side effects

Updated on 24 November 2010

Reasons for updating

  • Change to side-effects

Updated on 22 September 2010

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 & 10

4.8 T
he update concerns the addition of the terms "rhabdomyolysis" and "thrombocytopenia" in section 4.8 of the SPC based upon post-marketing reports. The frequency category of the ADRs identified in the post-marketing period "Stevens-Johnson Syndrome" and "Suicidal ideation and suicidal behaviour" is changed from "not known" to "uncommon

10 - Amend date of revision

 

Updated on 17 May 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 21 April 2010

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To include additional clinical data (96 weeks data)

Section 4.1, 4.4, 4.8, 5.1 and 10 have changed  

Section 4.1, 4.4, 4.8, 5.1 and 10

Updated on 06 October 2009

Reasons for updating

  • Change to side-effects
  • Changes to therapeutic indications

Updated on 02 October 2009

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 5.3 - Preclinical safety data
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.1, 4.2 and 4.4 have been updated to include data related to treatment-naïve patients. 4.5 updated to add interactions with etravirine, maraviroc, methadone medications 4.8 updated to include details of clinical study in treatment-naïve patients 5.1 to include clinical experience in treatment-naïve patients 5.3 Change b.i.d. to twice daily 9. Update to date of last renewal 10. update to revision of text.

Updated on 12 August 2009

Reasons for updating

  • Change to side-effects

Updated on 10 June 2009

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Section 5.3 Preclinical safety data.

Updated on 20 May 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



To add the following to section 4.8:

 

suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness).

 

 

 

Updated on 15 May 2009

Reasons for updating

  • Change to side-effects

Updated on 28 January 2009

Reasons for updating

  • Improved electronic presentation

Updated on 20 January 2009

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes are to Sections 4.1, 4.5, 4.8, 5.1, 8 & 10.

Updated on 08 September 2008

Reasons for updating

  • Change to side-effects

Updated on 05 September 2008

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes are to Section 4.8 and 10.

Updated on 31 January 2008

Reasons for updating

  • New PIL for new product

Updated on 31 January 2008

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)