Diflucan 200 mg hard Capsules

  • Name:

    Diflucan 200 mg hard Capsules

  • Company:
    info
  • Active Ingredients:

    Fluconazole

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/03/19

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Summary of Product Characteristics last updated on medicines.ie: 19/3/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 227 items.Total: Infinity pages

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 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 SmPC

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

 

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 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 SmPC

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 SmPC

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 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 SmPC

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 6 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 December 2017 SmPC

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:

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 4 December 2017 PIL

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 7 November 2017 PIL

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 PIL

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 SmPC

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 SmPC

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

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 21 March 2017 PIL

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 3 March 2017 PIL

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 6 November 2015 SmPC

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 5 November 2015 PIL

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 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 5 June 2015 SmPC

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 (CCDS

Updated on 28 January 2015 SmPC

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

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

Updated on 26 January 2015 SmPC

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

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 20 January 2015 PIL

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 6 October 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 24 January 2014 PIL

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 13 July 2012 SmPC

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

Correction of typo.

Updated on 8 May 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 9 January 2012 SmPC

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

None provided

Updated on 6 January 2012 PIL

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 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 16 March 2011 PIL

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 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 17 January 2008 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 18 May 2007 PIL

Reasons for updating

  • Change of special precautions for disposal
  • Change of inactive ingredient

Updated on 20 July 2006 PIL

Reasons for updating

  • Change of active ingredient
  • Change of inactive ingredient
  • Change of manufacturer
  • Change to dosage and administration

Updated on 16 August 2005 PIL

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 PIL

Reasons for updating

  • New PIL for medicines.ie