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Rinatec Nasal Spray

  • Name:

    Rinatec Nasal Spray

  • Company:
    info
  • Active Ingredients:

    ipratropium bromide monohydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 15/8/2017
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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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 15 August 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 15 August 2017 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/27/2 has been replaced by PA 540/189/1.

Section 10 (Date of Revision of the Text) has been amended from November 2014 to August 2017.

Updated on 11 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 August 2017 PIL

Reasons for updating

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

Updated on 10 April 2015 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 14 November 2014 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 14 November 2014 SPC

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

The required adverse event reporting statements have been added to the end of section 4.8 (Undesirable effects) as follows:

 

4.8 Undesirable effects

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

10. Date of revision

Updated to November 2014

 

Updated on 16 October 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 6 October 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 4 October 2010 SPC

Reasons for updating

  • 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
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Paragraph relating to ‘Immediate hypersensitivity reactions…’ has been moved to the beginning of the section to improve prominence of this important information.

 

Additional statement added relating to ‘pre-existing urinary outflow tract obstruction’

 

Additional paragraph added to provide information on the preservative benzalkonium chloride.

 

Section 4.6

Statement added to advise about the availability of data relating to the effects on human fertility


Section 4.7

Addition of information taking into account the listed side effects which may impair ability to drive and use machines

 

Section 4.8

Summary of safety profile added. Data on side effects now tabulated with frequencies ascribed. List of adverse events mapped according to appropriate MedDRA preferred terms. Addition of side effect ‘stomatitis’ plus inclusion of side effects that were previously included in the special warnings and precautions section.

 

Section 4.9

Change of ‘accomodation disturbances’ to ‘accomodation disorder’

 

Section 5.2

Section revised based on existing references, reworded and restructured according to ADME. Additional information included to provide more comprehensive information.


Section 10

Revision date changed to August 2010

 

 

 

 

 

 

 

 

 

 

Updated on 9 March 2009 SPC

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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 1: Revision to Name of Product

Section 2: Addition of information on excipients

Section 3: Editorial Change

Section 6.1: Editorial Change

Section 6.3: Editorial Change

Section 6.5: More information on container

Updated on 11 December 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 October 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 28 July 2008 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

  Section 1 The product name has been changed include the word ‘Solution’ -   RINATEC Nasal Spray solution 0.03% w/v

Updated on 13 June 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 24 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 November 2004 SPC

Reasons for updating

  • 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 22 April 2004 SPC

Reasons for updating

  • 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)

Updated on 10 November 2003 SPC

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)

Updated on 2 July 2003 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 26 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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