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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 21/04/2017
SPC ZITHROMAX CAPSULES 250MG

When a pharmaceutical company changes an SPC or PIL, 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 21/04/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Mar-2017
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 4.4 of the SmPC has been updated to include the addition of text regarding the increased incidence of infantile hypertrophic pyloric stenosis (IHPS) in neonates in connection with the use of Azithromycin.

Updated on 08/03/2016 and displayed until 21/04/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Mar-2016
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 4.4 of the SmPC has been updated to include the addition of text regarding the increased incidence of infantile hypertrophic pyloric stenosis (IHPS) in neonates in connection with the use of Azithromycin.

Updated on 14/01/2016 and displayed until 08/03/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jan-2016
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 4.8 of the SmPC has been updated to add the Adverse Drug Reaction ‘DRESS’ and consequentially the Section 4.4 of the SmPC has been updated to revise the text on hypersensitivity reactions.

Updated on 16/12/2014 and displayed until 14/01/2016
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Oct-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



·         Section 4.2 of the SmPC has been updated to add text relating to use in the elderly.

·         Section 4.4 of the SmPC has been updated to revise the text on hypersensitivity, hepatotoxicity. In  addition an enhanced precautionary text on prolongation of the QT interval has been added.

·         Section 4.5 of the SmPC has been updated to add precautionary text for Digoxin and to add text for  Atorvastin.

·         Section 4.6 ofthe SmPC has been updated to add text pertaining to breast milk and fertility.

·         Section 4.8 of the SmPC has been updated to add the Adverse Drug Reactions 'deafness', 'tinnitus   and 'hearing impaired' to the Post-marketing subsection.

·         Section 5.1 of the SmPC now includes updated text on microbiology information.

·         Section 4.4 of the SmPC has been updated to draw attention to the possible fatal issue of QT prolongation

·         Section 5.1 of the SmPC now includes updated text on cardiac electrophysiology with regards to co-administration of azithromycin and chloroquine.

To align with CSP

Updated on 25/06/2014 and displayed until 16/12/2014
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   02-Jun-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.1 and 4.2 of the SPC has been updated to include the indication gonococcal infection treatment and relevant dosing included in section 4.2.

Updated on 18/02/2013 and displayed until 25/06/2014
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01-Feb-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 6.1 – list of excipients - Addition of propylene glycol to the list of excipients for the capsule shell.
Updated on 06/08/2012 and displayed until 18/02/2013
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Jul-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section: 6.5. - Nature and contents of container

Section 6.6. - Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product



Updated on 26/07/2011 and displayed until 06/08/2012
Reasons for adding or updating:
  • 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 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Changes to Sections: 4.2, 4.3, 4.4, 4.5 and 4.8
Updated on 31/10/2008 and displayed until 26/07/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.4 Special Warnings and Precautions for Use and 4.8 Undesirable effects of the SPC to align with the company core data sheet: Clostridium difficile associated diarrhoea, caution warning for diabetic patients, addition of Hypoesthesia to side effects.

Updated on 03/10/2007 and displayed until 31/10/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.5
Spelling of Cyclosporim has changed to Ciclosporim
Updated on 27/07/2007 and displayed until 03/10/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   04/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Zithromax Capsules 250mg:

Section 1 Reformatting of medicinal product name

Section 2 Inclusion of lactose content

Section 3 More detailed description of pharmaceutical form as ‘Capsule, hard’

Section 4.5 Amend ‘Cyclosporine’ to ‘Cyclosporin’

Section 6.1 Reformatting of text for excipients

Section 6.2 Replacement of text from ‘none known’ to ‘not applicable’

Section 6.3 Reformatting of text for shelf-life from duration in months to years.

Section 6.6 Update section heading in line with QRD template = Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product; also amended special precautions for disposal and handling amended to ‘no special requirements’

Section 9 Updated renewal date

Zithromax Powder for Oral Suspension 200mg/5ml

Section 1 Reformatting of medicinal product name

Section 2 Inclusion of sucrose content

Section 4.4 Typographical error amended (‘ketokide’ to ‘ketolide’)

Section 4.5 Amend ‘Cyclosporine’ to ‘Cyclosporin’

Section 6.1 Reformatting of text for excipients

Section 6.2 Replacement of text from ‘none known’ to ‘not applicable’

Section 6.5 Deletion of text detailing age and weight recommendations in nature and contents of container

Section 6.6 Update heading according in line with QRD template = Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Section 9 Updated renewal date

Updated on 25/10/2006 and displayed until 27/07/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects
  • 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 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

Sections 4.1 and 4.4 - revised in line with Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections

 

Sections 4.2, 4.3, 4.5, 4.6, 4.8, 5.1, 5.2 & 5.3 - safety changes in line with CDS

 

Sections 6.2, 6.5, 6.6 and 10 - formatting changes

Updated on 28/09/2004 and displayed until 25/10/2006
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 29/07/2004 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Updated on 27/06/2003 and displayed until 29/07/2004
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 26/06/2003 and displayed until 27/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Azithromycin dihydrate