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Zofran Zydis 8mg oral lyophilisate

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Ondansetron

    *Additional information is available within the SPC or upon request to the company

Updated on 21 June 2022

File name

Zofran Zydis REG PIL PF21-0312_June2022 clean_IPHA.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 21 June 2022

File name

Zofran Zydis 8mg REG SPC PF21-0312_June 2022 clean_IPHA.pdf

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 not be renewed (A)

Updated on 10 January 2022

File name

ZofranZydis_REGPIL_PF21-0045_IPHA_approvedDec2021.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 December 2021

File name

Zofran zydis 8mg_REG SPC_PF 21-0045_IPHA_Dec2021.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 26 January 2021

File name

Zofran zydis 8mg_REG SPC_PF 20-0191_IPHA.pdf

Reasons for updating

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

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

Updated on 26 January 2021

File name

Zofran Zydis 4mg_8mg_REG PIL PF20-0191_IPHA Jan 2021.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 22 January 2020

File name

Zofran Zydis REG PIL_PF19-0183_IPHA.pdf

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

File name

Zofran zydis 8mg_REG SPC_PF 19-0183_IPHA.pdf

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

File name

Zofran Zydis REG PIL2550_IE_IPHA.pdf

Reasons for updating

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

Updated on 12 April 2019

File name

Zofran zydis 8mg_REG SPC_PF 18-0261_IPHA.pdf

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

File name

Zofran Zydis REG PIL1402_IE_IPHA.pdf

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

File name

Zofran zydis 8mg_REG SPC_PF 18-0207_clean.pdf

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

File name

PIL_9105_734.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 November 2016

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 25 August 2016

Reasons for updating

  • New SPC for new product

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

Updated on 25 August 2016

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

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 01 February 2016

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

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 10 December 2015

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

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

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 13 April 2015

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

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 24 February 2014

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

Reasons for updating

  • Change to drug interactions
  • Change to dosage and administration

Updated on 25 July 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions

Updated on 01 June 2012

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

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 04 January 2011

Reasons for updating

  • Change to storage instructions

Updated on 22 September 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 Zydis 4 mg Oral Lyophilisate 4mg

 

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Zofran Zydis oral lyophilisate contains ondansetron 4 mg.

 

Each 4 mg Oral Lyophilisate contains 625 micrograms of aspartame (E951), 56 micrograms sodium methyl parahydroxybenzoate (E219) and 6.9 micrograms of sodium propyl parahydroxybenzoate (E217).

 

For a full list of excipients, see Ssection 6.1.

 

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4.5 Interaction with Other Medicaments Medicinal products and Other Forms of Interaction

There is no evidence that ondansetron either induces or inhibits the metabolism of other drugs commonly co-administered with it.  Specific studies have shown that there are no pharmacokinetic interactions when ondansetron is administered with alcohol, temazepam, frusemide, tramadol and propofol.

 

Ondansetron is metabolised by multiple hepatic cytochrome P450 enzymes: CYP3A4, CYP2D6 and CYP1A2.  Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement. 

 

Phenytoin, Carbamazepine and Rifampicin

In patients treated with potent inducers of CYP3A4 (i.e. phenytoin, carbamazepine and rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased. 

 

Tramadol

Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol. 

 

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6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Gelatin

Mannitol (E421)

Aspartame (E951)

Sodium methyl parahydroxybenzoate (E219)

Sodium propyl parahydroxybenzoate (E217)

Strawberry flavour

 

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6.2 Incompatibilities

None reported.Not applicable.

 

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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.

 

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6.5 Nature and Contents of Container

Double foil blister packs, consisting of a PVC/Polyamide/Aluminium/Polyamide an aluminium foil laminate base with a peelable, aluminium foil laminate lidding, inside a paperboard carton.

 

Each pack contains 10 Zofran Zydis oral lyophilisate dosage units.

 

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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

DO NOT attempt to push Zofran Zydis through the lidding foil.

PEEL BACK the lidding foil of one blister and GENTLY remove the Zofran Zydis.

Place the Zofran Zydis on top of the tongue, where it will disperse within seconds, then swallow.

Any unused product should be disposed of in accordance with local requirements.

 

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

13th July 1998 / 13th July 20083

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10. DATE OF (PARTIAL) REVISION OF THE TEXT

February 2007August 2010

 

 

 

 

Updated on 29 August 2007

Reasons for updating

  • Improved electronic presentation

Updated on 27 August 2007

Reasons for updating

  • Improved electronic presentation

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

Updated on 16 April 2007

Reasons for updating

  • Change to side-effects

Updated on 17 October 2005

Reasons for updating

  • Improved electronic presentation

Updated on 22 July 2005

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

Reasons for updating

  • New PIL for medicines.ie

Updated on 06 October 2004

Reasons for updating

  • New SPC for new product

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