Triumeq 50 mg/600 mg/300 mg film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/07/19

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Summary of Product Characteristics last updated on medicines.ie: 8/7/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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ViiV Healthcare UK Ltd

ViiV Healthcare UK Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Celsentri film-coated tablets Active Ingredients Maraviroc
Medicine Name Combivir Film-Coated Tablets Active Ingredients Lamivudine, Zidovudine
Medicine Name Dovato 50 mg/300 mg film-coated tablets Active Ingredients Dolutegravir sodium
Medicine Name Epivir Film-Coated Tablets 150mg Active Ingredients Lamivudine
Medicine Name Epivir Film-Coated Tablets 300mg Active Ingredients Lamivudine
Medicine Name Epivir Oral Solution 10mg/ml Active Ingredients Lamivudine
Medicine Name Juluca 50 mg/25 mg film-coated tablets Active Ingredients Dolutegravir sodium, Rilpivirine Hydrochloride
Medicine Name Kivexa film-coated tablets Active Ingredients Abacavir Sulfate, Lamivudine
Medicine Name Retrovir Capsules 100mg Active Ingredients Zidovudine
Medicine Name Retrovir IV Active Ingredients Zidovudine
Medicine Name Retrovir Oral Solution Active Ingredients Zidovudine
Medicine Name Telzir 50mg/ml Oral Suspension Active Ingredients Fosamprenavir calcium
Medicine Name Telzir 700mg Film-Coated Tablets Active Ingredients Fosamprenavir calcium
Medicine Name Tivicay film-coated tablets Active Ingredients Dolutegravir sodium
Medicine Name Triumeq 50 mg/600 mg/300 mg film-coated tablets Active Ingredients Abacavir Sulfate, Dolutegravir sodium, Lamivudine
Medicine Name Trizivir Film-Coated Tablets Active Ingredients Abacavir Sulfate, Lamivudine, Zidovudine
Medicine Name Ziagen Film-Coated Tablets 300mg Active Ingredients Abacavir Sulfate
Medicine Name Ziagen Oral Solution 20mg/ml Active Ingredients Abacavir Sulfate
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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 8 July 2019 PIL

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 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Removal of Black Inverted Triangle
  • Change to date of revision

Updated on 8 July 2019 SmPC

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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

- Removal of the equilateral triangle
- section 4.3, contraindications – removal of the contraindication with dofetilide
- section 4.4, warnings and precautions – minor text updates to bring it in line with the current QRD template, SmPC guideline and other relevant guideline(s), including recent update to excipient guideline.
- section 4.5, interactions - removal of the interactions of telaprevir and dofetilide
- section 4.6, undesirable effects – minor additions and removals of text
- section 5.1, pharmacodynamic properties – minor formatting and grammatical updates
- section 5.2, pharmacokinetic properties – minor formatting and grammatical updates
- section 6.1, list of excipients, update to information updates to bring it in line with the SmPC guideline

 

Updated on 13 February 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 13 February 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 4.6 - Pregnancy with information on neural tube defect (NTD) risk a

Updated on 13 February 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

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

Updated on 20 December 2018 PIL

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

Updated on 20 December 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Brexit - MAH transfer to ViiV Healthcare BV - the MAH Name and Address has been updated in SmPC, labelling and PIL

Pursuant to Article 3 of Commission Regulation (EC) No 2141/96 of 7 November 1996, ViiV Healthcare UK Limited submitted to the Agency on 17/08/2018 an application for the Transfer of Marketing Authorisation from ViiV Healthcare UK Limited to ViiV Healthcare BV for the above mentioned medicinal product. 
 

Updated on 21 September 2018 SmPC

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

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

Free text change information supplied by the pharmaceutical company

To add Autoimmune Hepatitis (AIH) to SmPC sections 4.4 and 4.8.

Updated on 24 July 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 July 2018 SmPC

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

Update of section 4.8 of the SPC to add the new ADR ‘acute hepatic failure’ with a frequency 'rare' based on post-marketing and clinical trial data.
 

Updated on 3 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 3 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 3 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 March 2018 SmPC

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of sections 4.5 and 5.2 of the SmPC based on new in vitro studies conducted for abacavir (ABC) and lamivudine (3TC).

In addition, the MAH took the opportunity to implement minor corrections in section 5.1 of the SmPC and minor editorial changes in the SmPC (Section 4.6 and Section 5.1).

Updated on 21 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 8 March 2018 SmPC

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

Update of section 4.8 of the SPC to add the new ADR ‘anxiety’ with a frequency of ‘common’ based on post-marketing and clinical trial data.

Updated on 8 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 March 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 2 February 2018 SmPC

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 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 4.4: a minor amendment has been implemented throughout the SmPC in order to update the clinical terminology of Pneumocystis carinii pneumonia to Pneumocystis jiroveci pneumonia.

Section 4.5: add information regarding the interaction between lamivudine and sorbitol

Section 4.8: UK reporting details updated in line with EMA Appendix V

Updated on 31 January 2018 PIL

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 January 2017 SmPC

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

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: to add the ADR myalgia with a frequency of common, and to update the source of observed ADRs with the combination of dolutegravir + abacavir/lamivudine plus minor typographical update.

Section 5.1: To include data from ARIA and STRIIVING clinical studies.

Updated on 13 January 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 December 2016 SmPC

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 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 of section 4.4 of the SmPC with revised wording related to mitochondrial dysfunction, and section 4.2 of the SmPC with an amended recommendation related to dose reduction in patients with hepatic impairment, in line with the SmPCs of other abacavir containing products.

Updated on 16 December 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 4 October 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3 of the SmPC has been updated to increase the shelf life from 2 to 3 years.

Updated on 28 July 2016 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of sections 4.4 and 4.5 of the SmPC to remove the current information regarding a potential interaction between abacavir and ribavirin.

Updated on 27 July 2016 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 9 February 2016 SmPC

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

EU Labelling revisions on Lipodystrophy & Lactic Acidosis–PRAC recommendations

Updated on 8 February 2016 PIL

Reasons for updating

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

Updated on 1 October 2015 SmPC

Reasons for updating

  • 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

Update of section 5.1 of the SmPC in order to include additional, long-term efficacy and safety data from week 144 of the Phase III study ING114467 (SINGLE) and week 96 of the Phase IIIb study ING114915 (FLAMINGO).

Updated on 30 September 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 30 June 2015 SmPC

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

To update section 4.8 of the SmPC to include ideation or suicide attempt (particularly in patients with pre-existing history of depression or psychiatric illness) as an uncommon side effect.

Update to section 4.4 and 4.5 with drug interaction data. 

Updated on 29 June 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 8 May 2015 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 Section 4.6 of SmPC  to include WHO Breast-feeding guidance

Updated on 6 May 2015 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 13 April 2015 SmPC

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
  • 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

Description of change to SPC:

Section 4.4 – correction of typographical errors;

Section 4.5 – update to data on interaction with midazolam; update to data on interaction with boceprevir; correction of typographical errors

Section 5.2 – update to data on interaction with midazolam; update to information on effect of DTG on substrates of hepatic uptake transporters

 

Updated on 9 April 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 7 January 2015 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 5 January 2015 PIL

Reasons for updating

  • New PIL for new product