Rythmodan Retard Tablets
- Name:
Rythmodan Retard Tablets
- 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: 12/12/16
(Click to Download)XPIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. What Rythmodan Retard is and what it is used for
1. What Rythmodan Retard is and what it is used for
2. What you need to know before you take Rythmodan Retard
2. What you need to know before you take Rythmodan Retard
3. How to take Rythmodan Retard
3. How to take Rythmodan Retard
4. Possible side effects
4. Possible side effects
5. How to store Rythmodan Retard
5. How to store Rythmodan Retard
6. Contents of the pack and other Information
6. Contents of the pack and other Information
Print ViewKeyword Search SmPC
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 3 May 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 3 May 2017 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 4.8 – Undesirable effects - how to report a side effect
- 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 4.4 is updated with regard to glaucoma and paralytic ileus
- Section 4.5 is updated to include the appropriate cross reference to section 4.4 & 4.8
- Section 4.8 is updated to include adverse event Agranulocytosis
- Section 4.9 updated to include reference to paralytic ileus
Updated on 12 December 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 12 December 2016 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 14 February 2013 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 14 November 2012 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 7 July 2011 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 6 July 2011 PIL
Reasons for updating
- Improved electronic presentation
Updated on 2 February 2011 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 19 January 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 16 August 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 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Type II to update SPC with regard to:
-
Sections 4.4 & 4.8 were updated with regard to cognitive disorders in the elderly
-
Section 4.6 was updated to be more consistent with the guideline on risk assessment of medicinal products on human reproduction and lactation.
Updated on 22 October 2009 SmPC
Reasons for updating
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Additional warnings on heart disease, renal impairment, arrhythmias
Updated on 16 October 2009 PIL
Reasons for updating
- Improved electronic presentation
Updated on 5 October 2009 SmPC
Reasons for updating
- 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
pack size, contents of container (60 tablets)
shelf-life (18 months)
Updated on 31 August 2009 SmPC
Reasons for updating
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 15 September 2008 PIL
Reasons for updating
- Improved electronic presentation
Updated on 12 September 2008 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 1 August 2008 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 August 2007 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 12 December 2006 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
Updated on 14 August 2006 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 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 March 2006 SmPC
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 28 July 2004 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)
Updated on 17 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)