Dalacin T Topical Solution
- Name:
Dalacin T Topical Solution
- 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: 19/11/19
(Click to Download)Click on this link to Download PDF directly
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 19 November 2019 SmPC
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 PIL
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 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”
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 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 16 September 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
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 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 27 May 2014 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 7 January 2014 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 3 January 2014 PIL
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 20 May 2013 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
Updated on 16 May 2013 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 8 December 2011 SmPC
Reasons for updating
- 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 4 November 2011 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 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
- New individual PIL (was previously included in a combined PIL)
Updated on 18 May 2009 SmPC
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 4 July 2008 SmPC
Reasons for updating
- 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 7 December 2006 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 30 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)