ZITHROMAX CAPSULES 250MG
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal 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 26 June 2023
File name
Reg SPC ZX 35_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 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2023
File name
Reg PIL ZX 32_1 Caps IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
DEC202102575_Reg SPC ZX 33_2 Caps IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 January 2021
File name
DEC202102575_Reg SPC ZX 33_2 Caps IE clean.pdf
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)
Updated on 15 January 2021
File name
DEC202102575_Reg PIL ZX 30_2 Caps IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- 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 29 May 2019
File name
DEC201928045_Reg SPC ZX 32_1 Caps IE_clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 April 2019
File name
DEC201917487_Reg PIL ZX 29_1 Caps IE clean.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 05 April 2019
File name
DEC201917487_Reg SPC ZX 31_1 Caps IE clean.pdf
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
The SPC has been updated as follows: Section 4.8 DRESS frequency has been corrected from Very Rare to Rare
Updated on 25 October 2018
File name
Reg PIL ZX 28_1 Caps IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 25 October 2018
File name
Reg SPC ZX 30_1 Caps IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
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 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.
Updated on 23 July 2018
File name
Reg SPC ZX 29_0 Caps IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
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:
4.6. Fertility, pregnancy and lactation
Subsection on breast-feeding updated in line with CDS.
Updated on 14 May 2018
File name
Reg_SPC_ZX_28_0_Caps_IE_clean.docx
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
The SPC has been updated as follows:
4.5. Interactions with other medicinal products and other forms of interaction
Inclusion of colchicine
Updated on 08 May 2018
File name
Reg PIL ZX 27_0 Caps IE clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 18 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 July 2017
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 14 July 2017
File name
PIL_9058_375.pdf
Reasons for updating
- New PIL for new product
Updated on 14 July 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 April 2017
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
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 20 April 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 08 March 2016
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
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 07 March 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 14 January 2016
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:
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 12 January 2016
Reasons for updating
- Change of trade or active ingredient name
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 16 December 2014
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 4.5 - 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
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 09 December 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 12 August 2014
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
- Change to name of manufacturer
Updated on 25 June 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
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 20 June 2014
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
- Change to dosage and administration
Updated on 18 February 2013
Reasons for updating
- 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
Updated on 14 February 2013
Reasons for updating
- Change of inactive ingredient
- Change to date of revision
Updated on 06 August 2012
Reasons for updating
- 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
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 July 2011
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 July 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 05 February 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 03 November 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 31 October 2008
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
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 October 2007
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 27 September 2007
Reasons for updating
- Change of special precautions for disposal
Updated on 30 July 2007
Reasons for updating
- Change of trade or active ingredient name
- Change to storage instructions
- Change to date of revision
- Change from the BAN of the active substance to the rINN
Updated on 27 July 2007
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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 26 October 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
- Change to side-effects
- Change to further information section
Updated on 25 October 2006
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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 30 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 28 September 2004
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)
Updated on 29 July 2004
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)