Dalacin C 150 mg Hard Capsules
- Name:
Dalacin C 150 mg Hard Capsules
- 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: 16/09/20
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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 16 September 2020 PIL
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 9 March 2020
Reasons for updating
- Change to section 3 - Pharmaceutical form
Updated on 31 January 2020
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
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 PIL
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
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
Updated on 10 December 2019 PIL
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 8 January 2018
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 8 January 2018 SPC
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 4 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 4 January 2018 PIL
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 SPC
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 PIL
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 SPC
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 PIL
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 5 January 2015 SPC
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 PIL
Reasons for updating
- Change to date of revision
- Change to appearance of the medicine
Updated on 2 October 2014 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 2 July 2014 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
Updated on 4 October 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 10 July 2013 SPC
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 5 July 2013 PIL
Reasons for updating
- Change of licence holder
Updated on 5 July 2012 SPC
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 2 July 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 20 March 2012 SPC
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 PIL
Reasons for updating
- Introduction of new pack/pack size
Updated on 20 October 2011 SPC
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 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 August 2011 SPC
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 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 18 May 2009 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 11 January 2008 PIL
Reasons for updating
- Change to date of revision
- Change to warnings or special precautions for use
- Change of manufacturer
- Improved electronic presentation
Updated on 11 January 2008 SPC
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 7 December 2006 SPC
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 7 December 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 4 July 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)