Zofran Tablets 4mg

  • Name:

    Zofran Tablets 4mg

  • Company:
    info
  • Active Ingredients:

    Ondansetron hydrochloride dihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/09/19

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Summary of Product Characteristics last updated on medicines.ie: 12/4/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 116 items.Total: Infinity 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 9 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 15 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 November 2016 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses

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 4.9 - 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 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 4.1 - Therapeutic indications
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 4.1 . Clarification to SmPC 4.1 Indications on paediatric treatment to separate adult and paediatric indications and to give age ranges for paediatric indications.
Section 4.2. Addition of ‘IV’ to Table 2 for consistency with Table 1.
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 27 July 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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 3 - PHARMACEUTICAL FORM

4mg Film-coated tablet.

Yellow, oval, biconvex tablets “GXET3” on one face and plain on the other face.

 

Updated on 26 July 2012 PIL

Reasons for updating

  • Change to appearance of the medicine

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 18 April 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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.         NAME OF THE MEDICINAL PRODUCT

 

Zofran 4mg Film-coated Tablets

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains ondansetron 4mg as ondansetron hydrochloride dihydrate.

Excipients contain Lactose Anhydrous 81.875mg

For a full list of excipients see Section 6.1.

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4.4       Special Warnings and Special Precautions for Use

 

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT3 receptor antagonists.

 

Very rarely and predominantly with intravenous Zofran, transient ECG changes including QT interval prolongation have been reported. Caution is advised if patients have recieved cardiotoxic agents and in patients with a history or family history of prolonged QT syndrome.

 

As Zofran is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.

 

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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4.5       Interaction with other medicinal productsMedicaments and other Forms of Interaction

 

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4.6       Fertility, Pregnancy and Lactation

 

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6.1       List of Excipients

Core

Lactose Anhydrous

Microcrystalline cellulose

Pregelatinised maize starch

Magnesium stearate

 

Film-coating

Hypromellose

Titanium dioxide (E171)

Iron oxide (E172)

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6.5       Nature and Contents of Container

 

Zofran film-coated tablets are available in double foil blister packs of double aluminium foil or PVC comprising of a PVC/aluminium blister film with aluminium lidding foil or PVC/aluminium blister film with aluminium lidding foil, containing 10 or 30 tablets.

 

Not all pack sizes may be marketed.

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6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the productInstructions for Use and Handling

 

Swallow whole with a glass of water.

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7.         MARKETING AUTHORISATION HOLDER

 

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

Ireland

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8.                  MARKETING AUTHORISATION NUMBERS

 

Zofran Tablets 4mg: PA 1077/16/5

 

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9.         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

Date of first authorisation: 27th June 1990

Date of last renewal: / 27th June 20052010

 

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10.       DATE OF REVISION OF THE TEXT

 

January 2007

March 2011

Updated on 26 August 2008 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 11 May 2007 PIL

Reasons for updating

  • Change to side-effects

Updated on 9 March 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 3 November 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 22 July 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 13 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie