Juluca 50 mg/25 mg film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/07/20

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Summary of Product Characteristics last updated on medicines.ie: 21/9/2020
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

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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 21 September 2020

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Free text change information supplied by the pharmaceutical company

update sections 4.8 and 5.1 of the SmPC with information on resistance in vivo and clinical efficacy, based on final results from Phase III studies 201636 (SWORD-1) and 201637 (SWORD-2). In addition, information regarding “Changes in laboratory biochemistries” with the Week 148 data are also updated.

Updated on 30 July 2020 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

section 2: update to the pregnancy information in relation to the occurrence of neural tube defects (NTD) with the DTG regimens

Section 6: update to the approval date

Updated on 30 July 2020

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

section 4.6: update to the pregnancy information in relation to the occurrence of neural tube defects (NTD) with the DTG regimens

Section 10: update to the approval date

Updated on 2 June 2020

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change of the address of the marketing authorisation holder. ViiV Healthcare BV Limited will be moving from their current location in Huis ter Heideweg 62, 3705 LZ Zeist, The Netherlands to the company's new address Van Asch van Wijckstraat 55H, 3811 LP Amersfoort.

Updated on 2 June 2020 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Change of the address of the marketing authorisation holder. ViiV Healthcare BV Limited will be moving from their current location in Huis ter Heideweg 62, 3705 LZ Zeist, The Netherlands to the company's new address Van Asch van Wijckstraat 55H, 3811 LP Amersfoort.

Updated on 21 April 2020 PIL

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

Free text change information supplied by the pharmaceutical company

Section 2 - addition of a contraindication in relation to co-administration with medicinal products with narrow therapeutic windows, that are substrates of OCT-2, including fampridine.

Section 2 - other edits to the interaction section including the removal of drug-drug interactions for products no longer authorised in the EU (boceprevir, dofetilide, nelfinavir).

Section 4 - Irish reporting details for the HPRA have been updated in section 4 of the PIL to reflect the update to Appendix V of the QRD template.

Section 6 - date of text

Updated on 21 April 2020

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

Free text change information supplied by the pharmaceutical company

SmPC section 4.3 - addition of a contraindication in relation to co-administration with medicinal products with narrow therapeutic windows, that are substrates of OCT-2, including fampridine.

SmPC section 4.5 - other edits to the interaction section including the removal of drug-drug interactions for products no longer authorised in the EU (boceprevir, dofetilide, nelfinavir).

SmPC section 10 - date of text

Updated on 24 February 2020

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

- SPC section 6.3: Shelf Life Extension from 24 moths to 36 months

- SPC section 4.8: Update to the HPRA reporting details as per update QRD Annex V.

Updated on 19 February 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 6 February 2019 PIL

Reasons for updating

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

Updated on 6 February 2019

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 7 updated: MAH transfer

Updated on 18 January 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 18 January 2019

Reasons for updating

  • 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

Free text change information supplied by the pharmaceutical company

Section 4.6 - Pregnancy with information on neural tube defect (NTD) risk in pregnancy.
Section 4.8 - removal of the UK reporting information.

Updated on 14 December 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

SmPC 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.

 

Updated on 5 June 2018

Reasons for updating

  • New SmPC for new product

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

Updated on 22 May 2018 PIL

Reasons for updating

  • New PIL for new product