Urispas 200mg film-coated tablets *
Pharmacy Only: Prescription

Updated on 09 August 2019

File name

Urispas-200mg-SmPC-May-18 (1)_1565357474.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 27 November 2018

File name

urispas-200mg-film-coated-tablets-package-leaflet-april-18_1543317485.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 29 May 2018

File name

Urispas-200mg-SmPC-May-18.docx

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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 21 October 2014

File name

PIL_9318_252.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 October 2014

Reasons for updating

  • New SPC for new product

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

Updated on 21 October 2014

Reasons for updating

  • 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

SPC updated to include change in ADR reporting details from IMB to HPRA details
Revision date updated

Updated on 21 October 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 05 March 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 4.2 Posology & Method of Administration: Inserted "Paediatric Population: Urispas should not be used in children younger than 12 years of age."
Deleted: "Children: Urispas tablets are not recommended for children under 12 years of age."

Section 4.3 Contraindications
Deleted "of Urispas" and inserted "listed in section 6.1."

Section 4.5 Interactions with other medicinal products and other forms of interaction
Deleted "none known" and inserted "No interaction studies have been performed."

Section 4.7 Effects on the ability to drive and on use of machines
Inserted "Patients should be informed about the possible occurrence"...and "should be cautioned about driving or operating machines"

Section 4.8 Undesirable Effects
Changed layout to MedDRA system organ class and frequency.
Changed "not known" to "Not known (frequency cannot be estimated from available data)"

Section 10 Date of Revision of Text

Changed to January 2013

Updated on 05 February 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 21 February 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of 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

In Section 2 (Qualitative and Quantitative Composition), "Excipients - contains Lactose Monohydrate 64.0mg" has been added
In Section 4.6 (Pregnancy & Lactation), "Fertility" has been added to section title
In Section 6.1 (List of Excipients), "monohydrate" has been added after the word lactose - tablet core
In Section 6.5 (Nature & Contents of Container) pack sizes "250, 100, 90 or 6" has been added. "Not all pack sizes may be marketed" has also been added.
In Section 9 (Date of First Authorisation), "Date of last renewal 15OCT2010" has been added
In Section 10 (Date of Revision of Text), "21JAN2011" has been added

Updated on 15 February 2011

Reasons for updating

  • Change to packaging

Updated on 16 October 2007

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7  The MAH is now Recordati Ireland Limited

Updated on 16 October 2007

Reasons for updating

  • Improved electronic presentation

Updated on 11 September 2007

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 21 September 2006

Reasons for updating

  • 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

SPC section 4.9 -overdose statement  on gastric lavage has been updated

Updated on 20 July 2006

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

update to Immune System disorders and skin and subcutaneous tissue disorders for hypersensitivity reactions.

Updated on 20 July 2006

Reasons for updating

  • Change to side-effects

Updated on 24 May 2006

Reasons for updating

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

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

Updated on 24 May 2006

Reasons for updating

  • Change to information about driving or using machinery

Updated on 23 February 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 07 October 2004

Reasons for updating

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

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

Updated on 06 November 2003

Reasons for updating

  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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