DIFLUCAN CAPSULES 150MG
- Name:
DIFLUCAN CAPSULES 150MG
- 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 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 15 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 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
- 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
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
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 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 14 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 14 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 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 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 8 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 8 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 PIL
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
Updated 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 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 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 12 January 2012 PIL
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Updated on 12 January 2012 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 March 2011 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- 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
Section 4.3 – Contraindications
Section 4.5 – Interaction with other medicinal products and other sforms of interaction
Chnage to section 4.6 – Pregnancy and lactation
Change to 4.7 – Effects on ability to drive and use machines
Changes to section 4.8 – Undesirable efffects
Updated on 18 March 2011 PIL
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Section 4.3 – Contraindications
Section 4.5 – Interaction with other medicinal products and other sforms of interaction
Chnage to section 4.6 – Pregnancy and lactation
Change to 4.7 – Effects on ability to drive and use machines
Changes to section 4.8 – Undesirable efffects
Updated on 24 February 2011 SPC
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 February 2011 PIL
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 25 March 2008 PIL
Reasons for updating
- 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
4.4 – addition of sucrose warning
4.5 – addition of interaction with fluvastatin
Updated on 25 March 2008 SPC
Reasons for updating
- 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
4.4 – addition of sucrose warning
4.5 – addition of interaction with fluvastatin
Updated on 17 January 2008 PIL
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
6.1 – updated list of excipients to include composition of replacement and alternative inks used for marking/imprinting capsules.
Updated on 17 January 2008 SPC
Reasons for updating
- 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
6.1 – updated list of excipients to include composition of replacement and alternative inks used for marking/imprinting capsules.
Updated on 18 May 2007 PIL
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
4.5 – Change from BAN to
5.1 – Change from BAN to
Updated on 18 May 2007 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
4.5 – Change from BAN to
5.1 – Change from BAN to
Updated on 5 September 2006 PIL
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 5 September 2006 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 April 2004 PIL
Reasons for updating
- Improved electronic presentation
Updated on 29 April 2004 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 June 2003 PIL
Reasons for updating
- New SPC for medicines.ie