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Zofran Suppositories

  • Name:

    Zofran Suppositories

  • Company:
    info
  • Active Ingredients:

    Ondansetron

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/01/20

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Summary of Product Characteristics last updated on medicines.ie: 22/1/2020

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Novartis Ireland Limited

Novartis Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Voltarol Retard 75mg film-coated prolonged-release tablets. Active Ingredients Diclofenac Sodium
Medicine Name Votrient 200 mg film-coated tablets and 400mg film-coated tablets Active Ingredients Pazopanib Hydrochloride
Medicine Name Xolair 150mg solution for injection Active Ingredients Omalizumab
Medicine Name Xolair 75mg solution for injection Active Ingredients Omalizumab
Medicine Name Zofran Injection 2ml Active Ingredients Ondansetron hydrochloride dihydrate
Medicine Name Zofran Injection 4ml Active Ingredients Ondansetron hydrochloride dihydrate
Medicine Name Zofran Suppositories Active Ingredients Ondansetron
Medicine Name Zofran Syrup Active Ingredients Ondansetron hydrochloride dihydrate
Medicine Name Zofran Tablets 4mg Active Ingredients Ondansetron hydrochloride dihydrate
Medicine Name Zofran Tablets 8mg Active Ingredients Ondansetron hydrochloride dihydrate
Medicine Name Zofran Zydis 4mg Active Ingredients Ondansetron
Medicine Name Zofran Zydis 8mg Active Ingredients Ondansetron
Medicine Name Zometa 4mg/100ml solution for infusion Active Ingredients Zoledronic acid
Medicine Name Zykadia 150 mg hard capsules Active Ingredients Ceritinib
101 - 114 of 114 items.Total: 5 pages

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 22 January 2020 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 22 January 2020 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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)

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

Section 4.9 updated to include information on paediatric population.

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

Change of Marketing Authorisation Holder.

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 include toxic skin eruption, including toxic epidermal necrolyis as an Undesirable Effect.

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

Section 4.9 – Information added to the 'Symptoms and Signs and Treatment' sections of the Overdose section

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

Update to MA holder contact details - Address change

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

Changes to:

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.

 

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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)