Dalacin C 150 mg Hard Capsules
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal 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 16 October 2024
File name
Reg PIL DA 31_0 Caps 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 25_0 Caps 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 02 October 2024
File name
Reg SPC DA 24_1 Caps IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 October 2024
File name
Reg PIL DA 30_1 Caps IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 February 2023
File name
RegSPCDA232CapsIEclean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 March 2022
File name
RegSPCDA232CapsIEclean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
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 4.2 to add information re dosing in obese children. Section 5.1 update to correct ATC code. Section 5.2 to add new information regarding PK and PD data for clindamycin in obese children. Also, minor typographical updates, including update to HPRA ADR reporting details.
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Updated on 29 March 2022
File name
RegPILDA291CapsIEclean.pdf
Reasons for updating
- Change to section 3 - use in children/adolescents
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 04 October 2021
File name
DEC202163920_Reg SPC DA 22_0 Caps IE cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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:
Updates to SmPC Sections 4.4 and 4.8 for safety signal of acute renal failure.
Updated on 04 October 2021
File name
DEC202163920_Reg PIL DA 28_0 Caps IE cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 October 2021
File name
DEC202163920_Reg SPC DA 22_0 Caps IE cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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:
Updates to SmPC Sections 4.4 and 4.8 for safety signal of acute renal failure.
Updated on 04 October 2021
File name
DEC202163920_Reg PIL DA 28_0 Caps IE cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 September 2020
File name
Reg PIL DA 27_0 Caps IE cl.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 09 March 2020
File name
Reg SPC DA 21_2 Caps IE clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 January 2020
File name
DEC202006172_Reg SPC DA 21_1 Caps IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic 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:
Section 4.2 updated to remove the minimum recommended dosage in paediatric dosing
Section 4.5 and 5.2 updated for the addition of text related to the drug interaction between clindamycin and cytochrome P450 (CYP) 3A4 inducers including rifampicin
Updated on 31 January 2020
File name
DEC202006172_Reg PIL DA 26_1 Caps IE clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 10 December 2019
File name
DEC201969210_Reg SPC DA 19_3 Caps 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- 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
DEC201969210_Reg PIL DA 24_3 Caps IE cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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 - use in children/adolescents
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 08 January 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 January 2018
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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:
Section 4.3 – removal of contraindication regarding concomitant use of erythromycin.
Section 4.4 – addition of warning regarding possibility of cross resistance to macrolides and lincosamides for some individual bacterial strains.
Section 5.1 – update to add new data, as per CDS update.Updated on 04 January 2018
File name
PIL_11701_78.pdf
Reasons for updating
- New PIL for new product
Updated on 04 January 2018
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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 6 - date of revision
Updated on 15 August 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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:
S4.2 QRD update
s4.4, CDS update - addition of hypersensitivity and severe skin reaction information (DRESS, SJS, TEN & AGEP).
s4.8 CDS update- addition of the adverse drug reactions, clostridium difficile colitis, anaphylactic shock, anaphylactic reaction, hypersensitivity and angioedema
Updated on 12 August 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 16 July 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
s2 QRD update
s4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 & 4.9 CDS / CSP / QRD update
s5.1 and 5.3 CDS / QRD update
s6.5 and 6.6 CDS / QRD update
Updated on 10 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to how the medicine works
- Change to further information section
- Change to date of revision
- Change to dosage and administration
- Change of special precautions for disposal
Updated on 05 January 2015
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 3 Pharmaceutical form – Product appearance (capsule appearance and contents) amended.
Section 4.8:Undesirable effects – Change in IE regulatory agency name (IMB to HPRA), e-mail address and website details for reporting point suspected adverse reactions.
Updated on 23 December 2014
Reasons for updating
- Change to date of revision
- Change to appearance of the medicine
Updated on 02 October 2014
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 02 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
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 4.5 and 4.8 of SPC
Updated on 27 June 2014
Reasons for updating
- Change to side-effects
- Change to drug interactions
Updated on 04 October 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 10 July 2013
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 05 July 2013
Reasons for updating
- Change of licence holder
Updated on 05 July 2012
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
Updated on 02 July 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 20 March 2012
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 19 March 2012
Reasons for updating
- Introduction of new pack/pack size
Updated on 20 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 19 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 August 2011
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
Updated on 17 July 2009
Reasons for updating
- Change of manufacturer
- Change to date of revision
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
Section 4.4 - updated to include a warning for Clostridium difficile associated diarrhoea (CDAD)
Updated on 13 May 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 11 January 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- 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
- 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
2 – Change of quantity of Lactose monohydrate to 237mg
3 – Colour of capsule changed to White/White and printed with CLIN 150 and Pfizer on body
4.2 – dosage modification is not necessary in patients with renal insufficiency
4.3 - Not to be used with erythromycin, in patients with diarrhoea or intestinal inflammatory disease, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
4.6 – update of safety during pregnancy and lactation
4.8 - additions and moving text from section 4.4. - of Gastro-intestinal tract, Haemopoietic, skin & mucous membranes, hypersensitivity reactions, hepatic, nervous system and cardiovascular.
4.9 – warnings on allergic reaction
5.1 – addition of organisms
5.2 – detailed updates on drug absorption
5.3 – no long term studies performed that would evaluate carcinogenic potential. Mutagenesis tests were negative. No effects on fertility or mating ability.
Updated on 11 January 2008
Reasons for updating
- Change to date of revision
- Change to warnings or special precautions for use
- Change of manufacturer
- Improved electronic presentation
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 December 2006
Reasons for updating
- New PIL for medicines.ie
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)