Diflucan 200 mg hard Capsules
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 October 2024
File name
Reg SPC DF 38_0 200mg Capsules IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 October 2024
File name
Reg PIL DF 23_0 50mg & 200mg Capsules IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 22 February 2024
File name
Reg SPC DF 37_0 200mg Capsules IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2024
File name
Reg SPC DF 37_0 200mg Capsules IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2024
File name
Reg PIL DF 22_0 50mg 200mg Capsules IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 22 February 2024
File name
Reg PIL DF 22_0 50mg 200mg Capsules IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 17 November 2022
File name
RegSPCDF361200mgCapsulesIEclean.pdf
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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.5: all formulation
Addition of Abrocitinib and instruction to adjust dose if co-administered with fluconazole.
Updated on 17 November 2022
File name
RegPILDF21150mg200mgCapsulesIEclean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 11 April 2022
File name
RegSPCDF350200mgCapsulesIEclean.pdf
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
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2022
File name
RegSPCDF350200mgCapsulesIEclean.pdf
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
- Change to section 4.6 - Pregnancy and lactation
- 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
The SPC has been updated as follows:
Section 4.4: Capsules only-
Updated Excipients- replace Lapp with total
Section 4.5: all formulation
Update HMG- CoA reductase inhibitors
Updated-ivacaftor
Spelling correction- Immunosuppressors
Addition of Lurasidone
Section 4.6: all formulation
Under Pregnancy
Added-Before becoming pregnant a washout period of approximately 1 week (corresponding to 5-6 half-lives) is recommended after a single-dose or discontinuation of a course of treatment (see section 5.2).
Section 6.6: POS only
Update to Reconstitution instructions
Updated on 06 April 2022
File name
RegPILDF20050mg200mgCapsulesIEclean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 02 August 2021
File name
DEC202151340_Reg SPC DF 33_1 200mg Capsules IE-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: Section 4.4: Drug reaction with eosinophilia and systemic symptoms (DRESS). Infections with Candida species other than C. albicans. Section 4.6-under pregnancy addition of data when pregnant women treated with a cumulative dose of ≤ 150 mg of fluconazole, administered in the first trimester. Section 4.8- Drug reaction with eosinophilia and systemic symptoms (DRESS). Section 5.1: Susceptibility in vitro updated. Superinfection with Candida species updated under subcategory Mechanisms of resistance. |
Updated on 02 August 2021
File name
DEC202151340_Reg PIL DF 18_2 50mg & 200mg Capsules IE-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 01 February 2021
File name
DEC202106264_Reg SPC DF 32_1 200mg Capsules IE-clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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
File name
DEC202082514_Reg SPC DF 31_2 200mg Capsules IE-clean.pdf
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 not be renewed (A)
Updated on 10 December 2020
File name
DEC202082514_Reg PIL DF 17_1 50mg & 200mg Capsules IE-clean.pdf
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
File name
DEC202031354_Reg PIL DF 15_4 - 50mg_200mg Caps-clean.pdf
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
File name
DEC202031354_Reg SPC DF 30_2 200mg Capsules IE-clean.pdf
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 not be renewed (A)
Updated on 19 March 2019
File name
DEC201913854_Reg PIL DF 14_1 - 50mg_200mg Caps IE - Clean.pdf
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
File name
DEC201913854_Reg SPC DF 29_1 200mg Capsules IE - Clean.pdf
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
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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
File name
Reg PIL DF 13_0 50mg_200mg Caps Clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 11 October 2018
File name
Reg SPC DF 28_0 200mg Capsules IE 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)
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
File name
Reg_SPC_DF_26_1_200mg_capsules_IE_clean.pdf
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 not be renewed (A)
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
File name
Reg PIL DF 11_1 50mg_200mg Caps-Clean.pdf
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
File name
Reg_SPC_DF_26_1_200mg_capsules_IE_clean.docx
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 not be renewed (A)
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
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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 not be renewed (A)
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 04 December 2017
File name
PIL_8760_866.pdf
Reasons for updating
- New PIL for new product
Updated on 04 December 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 November 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 18 May 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Submitted in error
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 not be renewed (A)
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 4.1 - 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 March 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 03 March 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
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 not be renewed (A)
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 November 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 27 October 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
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 not be renewed (A)
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
Reasons for updating
- 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
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 January 2015
Reasons for updating
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
Updated on 06 October 2014
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 24 January 2014
Reasons for updating
- Change to information about pregnancy or lactation
Updated on 13 July 2012
Reasons for updating
- 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
Updated on 08 May 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 09 January 2012
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 January 2012
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
- Change to product name
- Change of trade or active ingredient name
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to further information section
Updated on 24 May 2011
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 16 March 2011
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about driving or using machinery
- Change to date of revision
Updated on 14 February 2011
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 17 January 2008
Reasons for updating
- Change of inactive ingredient
- Change to date of revision
Updated on 18 May 2007
Reasons for updating
- Change of special precautions for disposal
- Change of inactive ingredient
Updated on 20 July 2006
Reasons for updating
- Change of active ingredient
- Change of inactive ingredient
- Change of manufacturer
- Change to dosage and administration
Updated on 16 August 2005
Reasons for updating
- Change of active ingredient
- Change to storage instructions
- Change to further information section
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 16 September 2004
Reasons for updating
- New PIL for medicines.ie