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Dalacin Cream 2%

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Pharmacy Only: Prescription

Updated on 16 October 2024

File name

Reg PIL DA 23_0 cream IE clean.pdf

Reasons for updating

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

Updated on 16 October 2024

File name

Reg SPC DA 17_0 cream 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 03 October 2023

File name

RegPILDA220creamIEclean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PILs have been updated in Manufacturer section: The Legal Entity Update from Pfizer Service Company BVBA to Pfizer Service Company BV. 


Updated on 13 February 2023

File name

DEC202135304_Reg SPC DA 16_3 cream IE (clean).pdf

Reasons for updating

  • Document format updated

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

Updated on 26 May 2021

File name

DEC202135304_Reg SPC DA 16_3 cream 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients

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

Updated on 26 May 2021

File name

DEC202135304_Reg PIL DA 21_4 cream IE (clean).pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 03 February 2021

File name

DEC202107057_PIL cream IE - Clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 10 December 2019

File name

DEC201969231_Reg SPC DA 15_2 cream IE cl.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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)

Updated on 10 December 2019

File name

DEC201969231_Reg PIL DA 18_1 cream IE cl.pdf

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 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 10 May 2019

File name

DEC201924590_Reg PIL DA 17_2 cream IE clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 July 2018

File name

Reg SPC DA 14_1 cream IE cl.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

The SPC has been updated as follows:

Updates to “Section 5.1, Pharmacodynamic Properties”

Updated on 08 February 2018

File name

PIL_13490_643.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 08 February 2018

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:
S4.5 – removal of subsection headed Vitamin K antagonists containing warnings of increased coagulation tests and bleeding following PRAC clarification that text only applies to systemic forms of clindamycin. Change in line with CDS.

Updated on 08 February 2018

Reasons for updating

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

Updated on 26 August 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

s4.8  CDS update to add adverse drug reaction frequencies.

Updated on 24 August 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 18 November 2014

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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

 

Section 4.3: Contra-indications – Update in line update in line with QRD version 9 on excipients.

 

Section 4.4:Special warnings and precautions for use- Update to the SPC in line with the Core safety profile  

 

Section 4.5: Interaction with other medicinal products and other forms of interaction – Addition of text “Systemic” at the beginning of the first paragraph

 

Section 4.6:Fertility, pregnancy and lactation - Update to the SPC in line with the Core safety profile.

 

Section 4.7:Effects on ability to drive and use machines – Update in line with CSP. The  following text has been included “Clindamycin has no or negligible influence on the ability to drive and use machines”

 

Section 4.8:Undesirable effects – Revision of the ADRs and frequencies to be in line with the CSP.

 

Updated on 12 November 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 08 July 2014

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 - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Update to section 4.5 and 4.8 of SPC

Updated on 07 July 2014

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 15 November 2013

Reasons for updating

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

update to sections 4.6, 4.8 and 5.3

Updated on 11 November 2013

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Improved electronic presentation

Updated on 26 June 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Section 1 & 3

Updated on 14 May 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Update to sections 2, 4.2, 4.3, 4.4, 4.5,4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3

Updated on 13 May 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 17 December 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7. MARKETING AUTHORISATION HOLDER

 

Updated on 05 December 2012

Reasons for updating

  • Change to marketing authorisation holder

Updated on 25 October 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

SmPC changes to section 7 -  MA Holder’s name change and Section 10 – revision date.

Updated on 20 October 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 07 October 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 May 2009

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

Section 4.3: Text added:
'Dalacin Cream 2% is also contraindicated individuals with a history of inflammatory bowl disease or a history of antibiotic-associated colitis.'

Section 4.5: Text added:
'Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents23,24. Therefore, it should be used with caution in patients receiving such agents.'

Updated on 13 May 2009

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 19 August 2008

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 10 - Update - date of revision of the text

Updated on 11 August 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 September 2007

Reasons for updating

  • Improved electronic presentation

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

Updated on 29 August 2007

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 3 - Changes to SPC to bring it in line with the core data sheet
Section 4.2 - Changes to SPC to bring it in line with the core data sheet
Section 4.3 - Changes to SPC to bring it in line with the core data sheet
Section 4.5 - Changes to SPC to bring it in line with the core data sheet
Section 4.6 - Changes to SPC to bring it in line with the core data sheet
Section 4.8 - Changes to SPC to bring it in line with the core data sheet
Section 4.9 - Changes to SPC to bring it in line with the core data sheet
Section 5.2 - Changes to SPC to bring it in line with the core data sheet
Section 6.4 - Changes to SPC to bring it in line with the core data sheet
Section 6.6 - Changes to SPC to bring it in line with the core data sheet
Section 7 - MAH Address change
Section 10 - Changes to SPC to bring it in line with the core data sheet
 

Updated on 04 July 2003

Reasons for updating

  • New SPC for medicines.ie

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