Dalacin Cream 2%
- Name:
Dalacin Cream 2%
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/12/19
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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 10 December 2019 SmPC
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 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 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 PIL
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 SmPC
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 8 February 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 8 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 8 February 2018 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
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 8 February 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 26 August 2016 SmPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 18 November 2014 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 4.7 - 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
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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 PIL
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 8 July 2014 SmPC
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 7 July 2014 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 15 November 2013 SmPC
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 PIL
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 SmPC
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 SmPC
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 PIL
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 SmPC
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 5 December 2012 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 25 October 2011 SmPC
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 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 7 October 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 19 May 2009 SmPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 19 August 2008 SmPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 26 September 2007 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 29 August 2007 SmPC
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 4 July 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)