Dalacin Cream 2%
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal 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 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
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.
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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
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
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
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
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
'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
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
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)