Exforge HCT 5/160/12.5mg, 10/160/12.5mg, 5/160/25 mg film-coated tablets
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 06 February 2024
File name
Exforge HCT_REG PIL_PF24-0024-Jan2024_clean_IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 06 February 2024
File name
Exforge HCT_REG SPC_PF24-0024_Jan_clean_IPHA.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 November 2022
File name
Exforge HCT_REG PIL_PF22-0221_Nov2022_IPHA.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 22 November 2022
File name
Exforge HCT_REG SPC_PF22-0221_Nov 2022_clean_IPHA.pdf
Reasons for updating
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 April 2022
File name
Exforge HCT_REG PIL_PF22-0042_March 2022_Clean.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.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.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.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.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.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.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.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.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)