Dalacin C 150 mg Hard Capsules *

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 04 October 2021

File name

DEC202163920_Reg SPC DA 22_0 Caps IE cl_1633346734.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_1633346685.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_1633345053.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_1633344931.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_1600273488.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_1583754174.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_1580459820.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_1580459735.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_1575973617.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_1575973475.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

Change of Ownership.) Update to section 7.

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

SPC update to section 4.8 Undesirable effects



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

Changes to Section 6.5 in the SPC

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

SmPC changes to Sections 7 and 10

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

Change to Section 4.5

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.

 

6.1 – deletion of Indigo carmine and Erythrosine  and addition of Black iron oxide & propylene glycol from printing ink used for the capsule

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

  • New PIL for medicines.ie

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

Section 7:  Updated to reflect updated MAH address
 
Section 10:  Updated revision date

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)