Exforge HCT film-coated tablets *
Pharmacy Only: Prescription

Updated on 05 April 2022

File name

Exforge HCT_REG PIL_PF22-0042_March 2022_Clean_1649146369.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Addition to section 2

  • if you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Exforge HCT, seek medical attention immediately.

 

Addition to section 4

Very rare (may affect up to 1 in 10,000 people):

  • acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion)

Updated on 05 April 2022

File name

Exforge HCT_REG SPC_PF22-0042_March 2022_IPHA_1649146081.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)

Free text change information supplied by the pharmaceutical company

Addition to Section 4.4

Acute respiratory toxicity

Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS), have been reported after taking hydrochlorothiazide. Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake. At the onset, symptoms include dyspnoea, fever, pulmonary deterioration and hypotension. If diagnosis of ARDS is suspected, Exforge HCT should be withdrawn, and appropriate treatment given. Hydrochlorothiazide should not be administered to patients who previously experienced ARDS following hydrochlorothiazide intake.

Addition to Section 4.8

Acute respiratory distress syndrome (ARDS) (see section 4.4) - Very rare

 

Updated on 09 September 2021

File name

Exforge HCT_REG PIL_PF21-0114_Sept 2021_Clean_1631188571.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 01 July 2020

File name

Exforge_HCT family_REG PIL_PF 20-0127_IPHA_1593615906.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 01 July 2020

File name

Exforge_HCT_REG SPC_PF 20-0127_June 2020_IPHA_1593615162.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 19 August 2019

File name

Exforge_HCT family_REG PIL_PF 19-0155_IPHA_1566204813.pdf

Reasons for updating

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

Updated on 28 January 2019

File name

Exforge HCT family_REG PIL_1136900_A19_IE_IPHA_1548669246.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 - date of revision

Updated on 28 January 2019

File name

Exforge_HCT_REG SPC_PF 18-0274_Clean_IPHA_1548669563.pdf

Reasons for updating

  • Other

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

Updated on 02 January 2019

File name

Exforge_HCT_REG SPC_PF 18-0274_Clean_1546432128.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 5.1 - Pharmacodynamic properties

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

Updated on 10 July 2018

File name

Exforge HCT family_REG PIL_1136900_A18_IE_p1_LFT_X-4_.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 03 July 2018

File name

REG_Exforge HCT SmPC_PF18-0139_MAH Transfer_clean.docx

Reasons for updating

  • New SPC for new product

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

Updated on 03 July 2018

File name

Exforge REG SmPC PF 18-0163_CLEAN.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 02 July 2018

File name

Exforge REG SmPC PF 18-0163_CLEAN.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 27 June 2018

File name

Exforge REG SmPC PF 18-0163_CLEAN.docx

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 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)

Updated on 08 June 2017

File name

PIL_17182_167.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 April 2017

Reasons for updating

  • New SPC for new product

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