Diflucan 10 mg/ml powder for oral suspension
- Name:
Diflucan 10 mg/ml powder for oral suspension
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/12/20
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Pfizer Healthcare Ireland
Company Products
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 1 February 2021 SPC
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
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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 SPC
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 PIL
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 29 April 2019 SPC
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 PIL
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 SPC
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
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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)
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Updated on 11 October 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 11 October 2018 SPC
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 SPC
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 SPC
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 PIL
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 SPC
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 SPC
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 6 December 2017 SPC
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:
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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 6 December 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 December 2017 PIL
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:
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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 4 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 27 April 2017 SPC
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 PIL
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 PIL
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
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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. |
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The PIL has been updated. |
Updated on 23 March 2017 SPC
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
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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. |
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The PIL has been updated. |
Updated on 8 March 2017 PIL
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
Updated on 8 March 2017 SPC
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
Updated on 6 November 2015 PIL
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 6 November 2015 SPC
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 5 June 2015 SPC
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 (CCDSUpdated on 5 June 2015 PIL
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 (CCDSUpdated on 28 January 2015 SPC
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
Updated on 28 January 2015 PIL
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
Updated on 26 January 2015 PIL
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
Updated on 26 January 2015 SPC
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
Updated on 15 October 2014 PIL
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
Updated on 15 October 2014 SPC
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
Updated on 1 August 2014 PIL
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 1 August 2014 SPC
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 PIL
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
Updated on 28 March 2012 SPC
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
Updated on 19 December 2011 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Updated on 19 December 2011 SPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may be renewed (B)