Dalacin T Topical Lotion
*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
RegPILDA160lotionIEclean.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
DEC201964836_Reg SPC DA 19_2 Lotion IE cl.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 November 2019
File name
DEC201964836_Reg SPC DA 19_2 Lotion IE cl.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 November 2019
File name
DEC201964836_Reg PIL DA 15_2 lotion IE cl.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 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 18 July 2018
File name
Reg SPC DA 18_1 Lotion 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”
Also, administrative change to section 5.1 of the CDS to correct error: the date of a study from “1012” to “2012” in the content of text.
Updated on 08 February 2018
File name
PIL_15161_231.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 02 February 2015
Reasons for updating
- 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
Section 4.8
Addition of dry skin as an adverse event (frequency – very common).
Updated on 22 January 2015
Reasons for updating
- Change to side-effects
Updated on 16 September 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 - 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
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. Addition of the adverse event “pseudomembraneous colitis”, dry skin, seborrhoea, eye pain to section 4.8.
Updated on 10 September 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 23 April 2014
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 14 April 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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 April 2014
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to marketing authorisation holder
Updated on 07 January 2014
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 03 January 2014
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
Updated on 04 November 2011
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 October 2011
Reasons for updating
- Change to section 10 - Date of revision of the text
- 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
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
- New individual PIL (was previously included in a combined PIL)
Updated on 26 August 2011
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 19 August 2011
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 29 April 2010
Reasons for updating
- 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
Section 6.1 List of Excipients (Change of excipient name from
Tegin (self-emulsifying glyceryl monostearate) to Glyceryl Stearate SE)
Updated on 18 May 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
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 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 07 December 2006
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 07 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)