Zofran Suppositories
- Name:
Zofran Suppositories
- Company:
Novartis Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/09/19
(Click to Download)Click on this link to Download PDF directly
Novartis Ireland Limited
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 10 September 2019 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 12 April 2019 SmPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- 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 not be renewed (A)
Updated on 23 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 July 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 19 September 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 19 September 2016 PIL
Reasons for updating
- Change to instructions about overdose
- Change to date of revision
Updated on 25 August 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 August 2016 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 February 2016 SmPC
Reasons for updating
- Change to marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 1 February 2016 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 Update to provide clarification on the setting of dizziness, and existing Undesirable Effect.
Updated on 28 January 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
Updated on 10 December 2015 SmPC
Reasons for updating
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 July 2015 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 July 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 13 April 2015 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 addition of dosing regime (spoonful)
4.8 addition of how to report an adverse event
Updated on 10 April 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 24 February 2014 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 - Posology and method of administration,
Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.9 - Overdose,
Section 5.1 - Pharmacodynamic properties,
Section 5.2 - Pharmacokinetic properties,
Section 5.3 - Preclinical safety data
Updated on 19 February 2014 PIL
Reasons for updating
- Change to drug interactions
- Change to dosage and administration
Updated on 25 July 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
Updated on 1 June 2012 SmPC
Reasons for updating
- 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to:
Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.8 - Undesirable effects
Updated on 23 August 2011 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes to the following:
· Section 2
· Section 4.2
· Section 4.4
· Section 4.7
· Section 4.8
· Section 5.1
· Section 5.2
· Section 5.3
· Section 6.6
Updated on 7 February 2011 PIL
Reasons for updating
- Change to storage instructions
Updated on 22 September 2010 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
1. TRADE NAME OF THE MEDICINAL PRODUCT
Zofran 16 mg Suppositories 16mg
*************************************************
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 16.00 mg of ondansetron.
For a full list of excipients, see section 6.1.
************************************************
6.4 Special Precautions for Storage
Do not store above 30°C Store in the original package in order to protect from light and moisture.
************************************************
6.5 Nature and Contents of Container
Zofran Suppositories are packaged in individually sealed cavities formed from a foil laminate, enclosed in a perforated cardboard mount and packed into a carton.
Zofran Suppositories are available in pack sizes of one suppository.
************************************************
6.6 Instructions for Use/HandlingSpecial precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
No special requirements. Any unused product should be disposed of in accordance with local requirements.
************************************************
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1st May 1998/ 1st May 20083
************************************************
10 DATE OF (PARTIAL) REVISION OF THE TEXT
February 2007August 2010
Updated on 27 August 2007 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 April 2007 PIL
Reasons for updating
- Change to side-effects
Updated on 4 August 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 22 July 2005 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 12 November 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 9 August 2004 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 August 2003 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)