Rinatec Nasal Spray
- Name:
Rinatec Nasal Spray
- Company:
SANOFI
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/08/17
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
SANOFI
Company Products
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 15 August 2017 SmPC
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 SmPC
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 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 PA 7/27/2 has been replaced by PA 540/189/1.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 SmPC
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 14 November 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
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 SmPC
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 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 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 SmPC
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
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 SmPC
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 SmPC
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 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)
Updated on 2 July 2003 SmPC
Reasons for updating
- Improved electronic presentation
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)