Diflucan 10 mg/ml powder for oral suspension

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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 01 February 2021

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 5.1

Addition under subsection Susceptibility in vitro:

C. krusei is intrinsically resistant to fluconazole. The wild-type population of C. glabrata is of intermediate susceptibility (I) to fluconazole. The MICs and epidemiological cut-off value (ECOFF) of fluconazole for C. guilliermondiishows a wide range of are higher than for C. albicans susceptibility while C. krusei is resistant to fluconazole. The recently emerging species C. auris tends to be relatively resistant to fluconazole.

Addition under subsection Mechanisms of resistance:

In usually susceptible species of Candida, the most commonly encountered mechanism of resistance development involves the target enzymes of the azoles, which are responsible for the biosynthesis of ergosterol. Resistance may be caused by mutation, increased production of an enzyme, drug efflux mechanisms, or the development of compensatory pathways.

and

The resistance mechanisms have not been completely elucidated in some intrinsically resistant (C. krusei) or emerging (C. auris) species of Candida.

Addition under EUCAST Breakpoints

European Committee on Antimicrobial Susceptibility Testing, Antifungal Agents, Breakpoint tables for interpretation of MICs, Version 10.0, valid from 2020-02-04).

and

Candida dubliniensis to the table under ‘Species-related breakpoints’ column and update to the footer of the table

Updated on 10 December 2020

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 December 2020

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 14 May 2020

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 14 May 2020

Reasons for updating

  • 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 be renewed (B)

Updated on 29 April 2019

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 29 April 2019

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC: Updated as follows:

Section 2 : sodium benzoate added as an excipient with known effects

Section 4.4: the information on excipients with known effects has been updated to include statements on sugar and sodium benzoate

Updated on 19 March 2019

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 19 March 2019

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

 

SmPC: Updated as follows:

Section 2 updated for Diflucan 10mg/ml Powder for Oral Suspension to declare sodium as an excipient in line with the EU guideline on “Excipients in labelling and package leaflet of medicinal products for human use”.

 Section 4.4 updated to include sodium warning for Diflucan Capsules and Oral suspensions.

 Section 6.1 updated for Diflucan Powder for Oral Suspension and Capsules to add E numbers for gelatin, black iron oxide, propylene glycol, potassium hydroxide (Diflucan capsules), Xanthan gum, Sodium benzoate (Diflucan Powder for Oral Suspension)

 

Updated on 11 October 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 October 2018

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland.

Section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 10 September 2018

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC updated to extend the shelf-life for Diflucan POS (licenses from 24 to 36 months.

Updated on 28 August 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC: updated

Addition of Drug-Drug Interaction information between fluconazole and tofacitinib in section 4.5 of the Summary of Product Characteristics (SmPC) in line with the company's Core Data Sheet (CDS) following approval of the Marketing Authorisation Application for Xeljanz (tofacitinib) in Europe on 22nd March 2017. Also section 2 of SmPC has been updated to include a statement regarding prescription of most appropriate pharmaceutical form and strength according to age.

Updated on 18 May 2018

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 18 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 18 May 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC: updated

Addition of Drug-Drug Interaction information between fluconazole and tofacitinib in section 4.5 of the Summary of Product Characteristics (SmPC) in line with the company's Core Data Sheet (CDS) following approval of the Marketing Authorisation Application for Xeljanz (tofacitinib) in Europe on 22nd March 2017. Also section 2 of SmPC has been updated to include a statement regarding prescription of most appropriate pharmaceutical form and strength according to age.

Updated on 06 December 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC:

Update section 4.2 of the SmPC to update text from “regular dialysis” to “hemodialysis''

Update sections 4.4. and 4.5 of the SmPC with text regarding fluconazole and cytochrome P450 (CYP) isozymes

Update sections 4.6 and 5.2 of the SmPC and section 2 of the PL with text related to use of fluconazole during lactation and pharmacokinetics during lactation

Update section 4.8 of the SmPC and section 4 of the PL to add the adverse drug reaction (ADR) “Drug reaction with eosinophilia and systemic symptoms (DRESS)”

Updated on 06 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 December 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

SmPC:

Update section 4.2 of the SmPC to update text from “regular dialysis” to “hemodialysis''

Update sections 4.4. and 4.5 of the SmPC with text regarding fluconazole and cytochrome P450 (CYP) isozymes

Update sections 4.6 and 5.2 of the SmPC and section 2 of the PL with text related to use of fluconazole during lactation and pharmacokinetics during lactation

Update section 4.8 of the SmPC and section 4 of the PL to add the adverse drug reaction (ADR) “Drug reaction with eosinophilia and systemic symptoms (DRESS)”

Updated on 04 December 2017

Reasons for updating

  • New PIL for new product

Updated on 27 April 2017

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Update to section 4.6 of SmPC to include data from an observational study in line with PRAC recommendations.

Updated on 27 April 2017

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Update to section 4.6 of SmPC to include data from an observational study in line with PRAC recommendations.

Updated on 23 March 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

 

The SPC has been updated as follows: Dose conversion information  in section 4.2 and section 6.6, Update to section 6.5 with deletion of measuring spoon and inclusion of syringe.

The PIL has been updated.

Updated on 23 March 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

The SPC has been updated as follows: Dose conversion information  in section 4.2 and section 6.6, Update to section 6.5 with deletion of measuring spoon and inclusion of syringe.

The PIL has been updated.

Updated on 08 March 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Minor typos in section 4.1, section 4.2-update to posology table with other minor edits, section 4.3 with deletion of Amiodarone, section 4.4-info abut QT prolongation added, update to section 4.5 with update to information regarding Amiodarone.

Updated on 08 March 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Minor typos in section 4.1, section 4.2-update to posology table with other minor edits, section 4.3 with deletion of Amiodarone, section 4.4-info abut QT prolongation added, update to section 4.5 with update to information regarding Amiodarone.

Updated on 06 November 2015

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.3: Added contraindication to include co-administration with amiodarone.

Section 4.4:  Added warning to include risk of adrenal insufficiency.

Section 4.5: Added interactions with amiodarone, hydrochlorothiazide and indanedione.

Section 4.6: Pregnancy - the order of labeling text has been modified.

Section 4.8: Drug eruption (added footnote: * including fixed drug eruption).

Updated on 06 November 2015

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.3: Added contraindication to include co-administration with amiodarone.

Section 4.4:  Added warning to include risk of adrenal insufficiency.

Section 4.5: Added interactions with amiodarone, hydrochlorothiazide and indanedione.

Section 4.6: Pregnancy - the order of labeling text has been modified.

Section 4.8: Drug eruption (added footnote: * including fixed drug eruption).

Updated on 05 June 2015

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows.

To update section 4.5 of the SPC by adding information regarding the action of fluconazole on CYP219 enzyme in line with the Marketing Authorisation Holder’s (MAH’s) Company Core Data Sheet (CCDS

Updated on 05 June 2015

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows.

To update section 4.5 of the SPC by adding information regarding the action of fluconazole on CYP219 enzyme in line with the Marketing Authorisation Holder’s (MAH’s) Company Core Data Sheet (CCDS

Updated on 28 January 2015

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 5.3 Preclinical safety data has been updated with mutagenesis safety information..

Updated on 28 January 2015

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Section 5.3 Preclinical safety data has been updated with mutagenesis safety information..

Updated on 26 January 2015

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Free text change information supplied by the pharmaceutical company

SPC section 4.5 has been updated with new interaction (ivacaftor and fluconazole) in line with the French Medical Interaction Thesaurus for Diflucan (all formulations).

Updated on 26 January 2015

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC section 4.5 has been updated with new interaction (ivacaftor and fluconazole) in line with the French Medical Interaction Thesaurus for Diflucan (all formulations).

Updated on 15 October 2014

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

6.6        Instruction for use and handling; An arrow (è) has been added to the reconstitution instructions.

Updated on 15 October 2014

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

6.6        Instruction for use and handling; An arrow (è) has been added to the reconstitution instructions.

Updated on 01 August 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Updates to Section 2, 4.8, 6.4, 6.5, 6.6, 10

Updated on 01 August 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Section 2, 4.8, 6.4, 6.5, 6.6, 10

Updated on 28 March 2012

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 6 - Pharmaceutical particulars
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Introduction of new strength

Free text change information supplied by the pharmaceutical company

Introduction of 40mg/ml

Updated on 28 March 2012

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 6 - Pharmaceutical particulars
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Introduction of new strength

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Introduction of 40mg/ml

Updated on 19 December 2011

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 19 December 2011

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided