Tivicay film-coated tablets

  • Name:

    Tivicay film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Dolutegravir sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/04/19

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Summary of Product Characteristics last updated on medicines.ie: 1/4/2019
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

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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 1 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 1 April 2019 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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 black triangle

Updated on 7 December 2018 PIL

Reasons for updating

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

Updated on 7 December 2018 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 21 November 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 21 November 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 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 4.4:
Addition of GEMINI data including Warning & Precaution regarding resistance to lamivudine and dolutegravir

Section 4.8:
update to improve clarity of message concerning frequency of suicide ideation and suicide attempt

Sections 5.1:
Addition of GEMINI data including Warning & Precaution regarding resistance to lamivudine and dolutegravir

Updated on 26 October 2018 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 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 Warnings:
- Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

Section 4.8 Undesirable events:
- Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. (see section 4.4).

- Removal of the UK reporting information.

Updated on 1 October 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 1 October 2018 SmPC

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 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • 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

- Minor amendments to the SPC sections section 4.2, 4.4, 4.8 and 5.1.
- Section 2 - Changes were made to the PI to bring it in line with the current QRD template, SmPC guideline and other relevant guideline(s), including recent update to excipient guideline which resulted in very minor changes proposed relating to sodium content.
- Section 4.5 - to delete the information in the SmPC related to telaprevir (i.e. section 4.5) due to its withdrawal from EU market
- Section 6.4 - addition of a statement 'do not swallow the desiccant.'

Updated on 20 July 2018 PIL

Reasons for updating

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

Updated on 20 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 5 June 2018 PIL

Reasons for updating

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

Updated on 1 June 2018 SmPC

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

Section 7 of SPC updated: MAH transfer.

Updated on 9 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 7 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 7 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 6 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 March 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 July 2017 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

Update to Section 6.3 (Shelf Life) of combined SmPC:

To extend the shelf-life of the Tivicay 10 mg tablets as packaged for sale from 3 to 5 years.
To extend the shelf-life of the Tivicay 25 mg tablets as packaged for sale from 3 to 4 years.
To extend the shelf-life of the Tivicay 50 mg tablets as packaged for sale from 2 to 5 years.

Updated on 8 March 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - 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 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

Extension of Indication to include paediatric patients from 6 years of age infected with HIV for Tivicay 50mg film-coated tablets; as a consequence, sections 4.1, 4.2, 4.5, 4.7, 4.8, 5.1, 5.2, and 5.3 of the SmPC are updated based on the analysis of the pivotal study ING112578 and the non-clinical investigations performed for the paediatric development program.

Updated on 7 March 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • 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 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 31 January 2017 SmPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Added the ADRs arthralgia and myalgia with a frequency of uncommon.
Section 5.1 - Minor typographical correction.

Updated on 27 January 2017 PIL

Reasons for updating

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

Updated on 13 September 2016 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 1 December 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

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

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 17 August 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 5.1 - 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 with week-48 results (end of study) from Phase III Study.

Update of sections 4.4 and 4.5 of the SmPC to reflect:

- Data from a drug:drug interaction study 200901 with dolutegravir (DTG) and carbamazepine (REC 2);

- Metformin drug:drug interaction data from study 201167;

- Daclatasvir drug:drug interaction data from study 201102;

- PK modelling of DTG when co-administered with etravirine (ETV) without a ritonavir (RTV)-boosted protease inhibitor (PI);

- PK modelling of DTG when co-administered with the metabolic inducers phenytoin, phenobarbital, oxcarbazepine, and St. John’s Wort (hyperforin).

Updated on 14 August 2015 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 6 May 2015 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 SmPC to add the term depression with a frequency “common” and the term suicidal ideation or suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness) with a frequency “uncommon”.

Updated on 1 May 2015 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 3 October 2014 SmPC

Reasons for updating

  • 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:

·         to update section 4.5 of the SmPC in order to revise information concerning the interaction between dolutegravir and boceprevir based on a drug-drug interaction study

·         to update section 5.2 of the SmPC to include in vitro information on which enzymes dolutegravir is not a substrate of.

Updated on 31 July 2014 SmPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5 – Update to “Effect of dolutegravir on the pharmacokinetics of other agents”

Section 5.2 – Inclusion of wording around effect of dolutegravir on medicinal products that are substrates of major enzymes or transporters

Updated on 7 July 2014 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

·         4.4 - Admin update

·         4.5 – reference to organic anion transporters added, concentration at end of dosing interval added, Tivicay reference throughout changed to active “dolutegravir”, deletion of protease inhibitor statements

·         4.6 – update to the statements about the data available for use of product in pregnant women

·         4.8 – update to include longer term treatment data, reference to active rather than brand name, update to IE reporting details

·         5.1- admin updates, update to data on VIKING-3 study, inclusion of 48 week data from FLAMINGO study

·         9 – Update to include licence authorisation date

Updated on 4 July 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 9 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 3 February 2014 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 29 January 2014 PIL

Reasons for updating

  • New PIL for new product