Zofran Syrup

  • Name:

    Zofran Syrup

  • 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: 10/09/19

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Summary of Product Characteristics last updated on medicines.ie: 6/6/2019

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Novartis Ireland Limited

Novartis Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Myfortic 180 mg gastro-resistant tablets Active Ingredients Mycophenolic acid
Medicine Name Myfortic 360 mg gastro-resistant tablets Active Ingredients Mycophenolic acid
Medicine Name Neoral 100mg Capsules Active Ingredients Ciclosporin
Medicine Name Neoral 100mg/ml concentrate for oral solution Active Ingredients Ciclosporin
Medicine Name Neoral 25mg Capsules Active Ingredients Ciclosporin
Medicine Name Neoral 50mg Capsules Active Ingredients Ciclosporin
Medicine Name Nevanac 1mg/ml eye drops, suspension Active Ingredients Nepafenac
Medicine Name Onbrez Breezhaler 150 microgram inhalation powder, hard capsules Active Ingredients Indacaterol maleate
Medicine Name Onbrez Breezhaler 300 microgram inhalation powder, hard capsules Active Ingredients Indacaterol maleate
Medicine Name Opatanol 1mg/ml eye drops solution Active Ingredients Olopatadine (as hydrochloride)
Medicine Name Revolade 12.5mg, 25 mg and 50mg film-coated tablets Active Ingredients Eltrombopag olamine
Medicine Name Ritalin LA Prolonged Release Capsules 20mg Active Ingredients Methylphenidate Hydrochloride
Medicine Name Ritalin LA Prolonged Release Capsules 30mg Active Ingredients Methylphenidate Hydrochloride
Medicine Name Ritalin LA Prolonged Release Capsules 40mg Active Ingredients Methylphenidate Hydrochloride
Medicine Name Ritalin Tablets Active Ingredients Methylphenidate Hydrochloride
Medicine Name Sandimmun 100mg Soft Capsules Active Ingredients Ciclosporin
Medicine Name Sandimmun 100mg/ml concentrate for oral solution Active Ingredients Ciclosporin
Medicine Name Sandimmun 25mg Soft Capsules Active Ingredients Ciclosporin
Medicine Name Sandimmun 50mg Soft Capsules Active Ingredients Ciclosporin
Medicine Name Sandimmun 50mg/ml concentrate for solution for infusion Active Ingredients Ciclosporin
Medicine Name Sandostatin Ampoules 100mcg/ml Active Ingredients octreotide acetate
Medicine Name Sandostatin Ampoules 500mcg/ml Active Ingredients octreotide acetate
Medicine Name Sandostatin Ampoules 50mcg/ml Active Ingredients octreotide acetate
Medicine Name Sandostatin LAR 10mg Active Ingredients octreotide acetate
Medicine Name Sandostatin LAR 20mg Active Ingredients octreotide acetate
51 - 75 of 116 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 10 September 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 6 June 2019 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 10 - Date of revision of the text

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

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

  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • 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 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 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
  • 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 30 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 May 2013 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 6.1 - List of excipients

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 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION,
Section 4.4 - Special warnings and precautions for use,
Section 6.1 - List of excipients

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 16 February 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

QRD template formatting changes & warning to section 4.4 regarding fructose intolerance & to include in section 6.3 to discard product after 28 days.

Updated on 27 November 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use

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 12 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 25 October 2005 PIL

Reasons for updating

  • Change to side-effects

Updated on 8 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

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 13 October 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 25 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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