Urispas 200mg film-coated tablets
*Company:
Recordati Ireland LimitedStatus:
UpdatedLegal 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 16 April 2024
File name
ie_urispas_200_mg fct_SmPC_en_clean_march2024.pdf
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 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
Urispas contains lactose. Patients with rare hereditary problems of galactose
intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this
medicine.
Urispas contains less than 1 mmol sodium (23 mg) per tablet, that is to say
essentially ‘sodium-free’.
Urispas has minor influence on the ability to drive and use machines.
March 2024
Updated on 16 April 2024
File name
ie_urispas_200_mg fct_PIL_en_clean_march2024.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Urispas contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free.
- The other ingredients are:
Lactose monohydrate, sodium starch glycolate, povidone, talc, magnesium stearate, cellulose microcrystalline, hypromellose, macrogol 6000, macrogol stearate, magnesium stearate, titanium dioxide (E171)
This leaflet was last revised in March 2024
Updated on 17 February 2023
File name
ie-spc-urispas-march2018.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 August 2019
File name
Urispas-200mg-SmPC-May-18 (1).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.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
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
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 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
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
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)