Blopress Plus Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/07/19

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Summary of Product Characteristics last updated on medicines.ie: 16/11/2018

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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Medicine Name Alunbrig Active Ingredients Brigatinib
Medicine Name Blopress Plus Tablets Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Blopress tablets Active Ingredients Candesartan Cilexetil
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Medicine Name Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Competact 15 mg/850 mg film-coated Tablets Active Ingredients Metformin Hydrochloride, pioglitazone hydrochloride
Medicine Name Condyline Cutaneous Solution 5 mg/ml Active Ingredients Podophyllotoxin
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Medicine Name Mepact 4mg powder for suspension for infusion Active Ingredients Mifamurtide
Medicine Name Midon 2.5 mg Tablets Active Ingredients Midodrine Hydrochloride
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Medicine Name Prostap 6 DCS Active Ingredients Leuprorelin Acetate
Medicine Name Prostap SR DCS Active Ingredients Leuprorelin Acetate
Medicine Name Protium 20mg Active Ingredients Pantoprazole sodium sesquihydrate
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1 - 0 of 26 items.Total: Infinity pages

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 12 July 2019 PIL

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 PIL

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 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 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 SmPC

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 6 June 2018 SmPC

Reasons for updating

  • New SmPC 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 4 May 2018 PIL

Reasons for updating

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

Updated on 31 January 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 31 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 January 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to name of medicinal product

Updated on 2 November 2016 PIL

Reasons for updating

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

Updated on 27 October 2016 PIL

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 PIL

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 PIL

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)