CARDURA XL 4MG Prolonged-release tablets

  • Name:

    CARDURA XL 4MG Prolonged-release tablets

  • Company:
    info
  • Active Ingredients:

    Doxazosin mesilate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/04/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 13/2/2020

Click on this link to Download PDF directly

Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 232 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 3 April 2020 PIL

Reasons for updating

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

Updated on 13 February 2020 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follow: Section 4.1 -indication of benign prostatic hyperplasia added’, ‘Section 4.4- Screening for Prostate Cancer added’ and ‘Section 5.1 – text added regarding benign prostatic hyperplasia

Updated on 13 February 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 19 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 19 February 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

The SPC has been updated in sections 2, 3, 4.3, 4.4, 9 and 10 of the SPC in line with CDS and QRD to reflect work sharing procedure DE/H/xxxx/WS 535

Updated on 7 November 2018 PIL

Reasons for updating

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

Updated on 4 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 September 2017 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Lactation information in section 4.6 was updated in line with the CDS.  Section 5.3 was also updated in line with the WRS SPC.

Updated on 19 June 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.4 has been updated with the priapism warning.  Formatting corrections have been made throughout the SPCs.  For Cardura Section 5.1 has also been corrected to remove the ATC code G04CA05 for benign prostatic hyperplasia.

Updated on 15 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 June 2017 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 25 May 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Sections 4.5 and 5.2 have been updated in-line with the CDS

Updated on 19 February 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Updated wording with respect to the paediatric population

Updated on 18 February 2016 PIL

Reasons for updating

  • Change of contraindications

Updated on 26 October 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

GI Obstruction:

Section 4.8

QRD/Editorial:

Sections 1 / 2 / 3 / 4.1 / 4.2 / 4.3 / 4.4 / 4.5 / 4.6 / 4.8 / 5.1 / 5.2 / 5.3 / 6.5 / 6.6.

Updated on 22 October 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 9 June 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

SPC section 4.4 – Addition of a warning relating to priapism.

Updated on 5 June 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Correction of spelling/typing errors

Updated on 2 October 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 3 June 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 16 April 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf-life changed to 3 years

Updated on 9 April 2013 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

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

Free text change information supplied by the pharmaceutical company

Update to section 4.3, 4.4, 4.5,4.6 & 4.8

Updated on 5 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 August 2012 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

section 6.3; shelf life extended to 3 years

Updated on 27 April 2010 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Section 3 -Updated to change the wording “For excipients, see 6.1”    to “For a full list of excipients see section, 6.1.”

Section 6.4 Updated to change the wording   “Store in the original package” to “Store in the original package in order to protect from moisture

Updated on 10 December 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 November 2009 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company



Section 4.3 – Updated to include a history of orthostatic hypotension and BPH patients with urinary tract problems or bladder stones as additional contra-indications

Section 4.4 – Updated to amend the wording of the warnings for patients with acute cardiac conditions, impaired renal function, hepatic impairment and use with PDE-5 inhibitors

Section 4.5 – Updated to include a statement that data from formal drug/drug interaction studies are not present. This section has alos been re-ordered.

Section 4.6 – Updated to included additional information on the use of Cardura in pregnancy and lactation

Section 4.7 – Amended the wording around on the ability to drive and operate machinery

Section 4.8 – Updated to include additional side effects and amended frequencies to be in line with the CSP.

Section 4.9 – Updated to provide further details on treatment of overdose

Updated on 9 November 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 2 July 2008 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 25 March 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 19 March 2008 SmPC

Reasons for updating

  • 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

 

4.8 – addition of retrograde ejaculation 

Updated on 4 September 2007 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Updated on 4 September 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 3 May 2007 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 12 March 2007 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Section 6.1 has been updated to include a new ink component – propylene glycol.

Updated on 28 November 2005 PIL

Reasons for updating

  • Change of manufacturer

Updated on 16 August 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 3 - Pharmaceutical form
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation

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

Updated on 16 August 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 4 October 2004 PIL

Reasons for updating

  • Change of manufacturer

Updated on 16 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 2 August 2004 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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)

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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