Blopress Plus Tablets *
Company:
Takeda Products Ireland LtdStatus:
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
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 09 March 2021
File name
m1-3-1-leaflet-blopress-plus-combined-ie-19.11.2020_1615299530.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 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 09 March 2021
File name
m1-3-1-spc-blopress-plus-combined-ie-19.11.2020_1615299166.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 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4. Updated with the addition of a section on chloroidal effusion, acute myopia and secondary angle-closure glaucoma
Section 4.8 Addition of choroidal effusion in the adverse reactions with hydrochlorothiazide monotherapy usually with doses of 25 mg or higher table. Reporting of suspected adverse reactions section has also been updated
Updated on 09 March 2021
File name
m1-3-1-leaflet-blopress-plus-combined-ie-2020.02_1598536847.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 4 - how to report a side effect
Updated on 27 August 2020
File name
m1-3-1-leaflet-blopress-plus-combined-ie-2020.02_1598536847.pdf
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
The MAH (Takeda Products Ireland Limited) address has been changed to: 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland. This is the legally registered office.
The local representative address has been updated to: 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
Updated on 27 August 2020
File name
m1-3-1-spc-blopress-plus-combined-ie-25.05.2020_1598536667.pdf
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 7, the MAH (Takeda Products Ireland Limited) address has been changed to:
6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland.
This is the legally registered office.
Updated on 12 July 2019
File name
m1-3-1-leaflet-clean-2018.11_1562927090.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 16 November 2018
File name
plus_m1-3-1-leaflet-16.02.2018_clean_1542381577.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 16 November 2018
File name
m1-3-1-SPC-combined-08.11.2018_1542381520.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Section |
Change |
|
4.4 - Special warnings and precautions for use |
Additional text: Non-melanoma skin cancer An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. Photosensitizing actions of hydrochlorothiazide could act as a possible mechanism for NMSC. Patients taking Blopress Plus should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. The use of Blopress Plus may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8). |
|
4.8 - Undesirable effects
|
The following Undesirable Effect has been added to the table: System Organ Class: Neoplasms benign, malignant and unspecified (incl cysts and polyps): Frequency: Not known Undesirable Effect: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma) Additional text: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed (see also sections 4.4 and 5.1). |
|
10 - Date of revision of the text |
8th November 2018 |
Updated on 12 July 2018
File name
m1-3-1-SPC-combined-07.05.2018.docx
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Reformatting in Section 3.
Updated on 06 June 2018
File name
m1-3-1-SPC-combined-07.05.2018.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 (Undesirable effects) has been update to include diarrhoea.
Updated on 04 May 2018
File name
plus_m1-3-1-leaflet-16.02.2018_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 31 January 2017
File name
PIL_16130_746.pdf
Reasons for updating
- New PIL for new product
Updated on 31 January 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 20 January 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to name of medicinal product
Updated on 02 November 2016
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 27 October 2016
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to name of medicinal product
Updated on 23 April 2015
Reasons for updating
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to appearance of the medicine
- Change to improve clarity and readability
Updated on 10 October 2014
Reasons for updating
- New individual PIL (was previously included in a combined PIL)